j.2042-7166.2011.01138 2.x

SUMMARIES AND COMMENTARIES
Focus on Alternative and Complementary Therapies Volume 17(1) March 2012 4377 2012 The Authors FACT 2012 Royal Pharmaceutical Society ISSN 1465-3753
N o t e : All efforts are made to invite authors of original papers to comment on the reviewers commentary. If the authors cannot be contacted, or do not respond within the given deadline, the summary/commentary is published without their response.
ACUPUNCTURE
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Does acupuncture relieve tinnitus?

DOI 10.1111/j.2042-7166.2011.01138_1.x
Wang K, Bugge J, Bugge S. A randomised, placebo-controlled trial of manual and electrical acupuncture for the treatment of tinnitus. Complement Ther Med 2010; 18: 24955.
Aim To examine the effectiveness of manual/electrical acupuncture in adults with tinnitus. Design Single-blind, randomised, placebo-controlled trial with three parallel arms. Setting Acupuncture clinic, Denmark. Participants Fifty patients (46 men and four women), aged 3070 years, who had suffered from tinnitus for more than 3 months, were recruited. Patients with severe heart diseases were excluded. Intervention Participants were randomly allocated to one of three groups: (1) manual acupuncture, (2) electro-acupuncture (EA), and (3) placebo. All three groups received a 25-min treatment once a week, for 6 weeks, with 14 needles placed on the same points: GB 8, TE 17, GB 2, GB 20, GV 20, TE 3 and ST 36. De qi was evoked once in the manual group. For the EA group, needles at GB 8 and TE 17 were connected to an electrical stimulator and stimulated by alternating frequency (2/100 Hz). Acupuncture needles in the placebo group had blunt tips and were inserted into elastic foam, which caused a pricking sensation when they touched the skin. Main outcome measures The main outcomes were tinnitus occurrence (assessed on a five-point scale, ranging from 0 to +4), tinnitus intensity
(measured on a four-point scale, ranging from 0 to +3), and quality of life (assessed on a four-point scale, ranging from 0 to +3). All outcomes were measured at baseline, after treatment (week six) and 1 month after treatment. Main results The daily occurrence of tinnitus decreased from baseline to week six in the EA group, though there were no significant differences between the three groups. The intensity of tinnitus reduced at both 6 weeks and 1 month follow-up in the EA group when compared to baseline, with a borderline significant decrease detected in the manual acupuncture group. However, there were no significant differences between groups. Quality of life also improved in the EA and manual acupuncture groups, though no significant intergroup differences were detected. Authors conclusion In conclusion, the specific effects of reducing the tinnitus occurrence and tinnitus loudness were not detected. The treatment effects of the manual and electrical acupuncture were difficult to differentiate from the placebo control in the present study. However, electrical acupuncture showed some promising short-term general effects on tinnitus. Further carefully controlled research with bigger sample sizes and longer treatment periods are required. Address K Wang, Center for Sensory-motor Interaction, Orofacial Pain Laboratory, Aalborg University, Fredrik Bajers Vej 7 D-3, DK9220, Aalborg, Denmark. E-mail: kelun@smi.auc.dk
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March 2012 17(1)
Commentary Tinnitus is the perception of noise without external acoustic stimulation. Whilst the underlying mechanism causing tinnitus is largely unknown, it is suggested that tinnitus may be linked to brain regions responsible for emotions and cognition.1 Thus, interventions involving extra attention and meeting patient expectations may ameliorate these symptoms. Although there is no single treatment for tinnitus that has strong evidence of an effect, cognitive behavioural therapy has been suggested to improve tinnitus.2 There are a number of uncontrolled acupuncture trials indicating that acupuncture also may be effective in relieving tinnitus.3 The present RCT concluded that, although there were no differences between the study groups for any outcomes, the EA group did induce stronger relief of tinnitus symptoms as compared with manual and placebo acupuncture.3 However, an alternative conclusion can be drawn; namely that all groups improved as there were no differences between the interventions. Ideally, a no-treatment group should have been included to address the effect of attention and patient expectation.4 An alternative explanation may be that the placebo needle was not an inert control, and that all groups were active treatments.5,6 Therefore, it is recommended for future studies that acupuncture be compared with cognitive behavioural therapy as the latter has been shown to provide substantial relief of tinnitus symptoms.
E Stener-Victorin, Institute of Neuroscience and Physiology, Department of Physiology, Sahlgrenska Academy, University of Gothenburg, Sweden E-mail: elisabet.stener-victorin@neuro.gu.se
Conflict of interest None declared. References

1 Georgiewa P, Klapp BF, Fischer F et al. An integrative model of developing tinnitus based on recent neurobiological findings. Med Hypotheses 2006; 66: 592600. 2 Hesser H, Weise C, Westin VZ, Andersson G. A systematic review and meta-analysis of randomized controlled trials of cognitive-behavioral therapy for tinnitus distress. Clin Psychol Rev 2011; 31: 54553. 3 Wang K, Bugge J, Bugge S. A randomised, placebocontrolled trial of manual and electrical acupuncture for the treatment of tinnitus. Complement Ther Med 2010; 18: 24955. 4 Enblom A, Lekander M, Hammar M et al. Getting the grip on nonspecific treatment effects: emesis in patients randomized to acupuncture or sham compared to patients receiving standard care. PLoS One 2011; 6: e14766. 5 Lund I, Lundeberg T. Are minimal, superficial or sham acupuncture procedures acceptable as inert placebo controls? Acupunct Med 2006; 24: 1315. 6 Lund I, Naslund J, Lundeberg T. Minimal acupuncture is not a valid placebo control in randomised controlled trials of acupuncture: a physiologists perspective. Chin Med 2009; 4: 1.
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Authors reply The authors did not wish to add any comments.
Summaries/Commentaries
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Single acupuncture session does not decrease stress in women with phonotraumatic injuries
DOI 10.1111/j.2042-7166.2011.01138_2.x
Kwong EY, Yiu EM. A preliminary study of the effect of acupuncture on emotional stress in female dysphonic speakers. J Voice 2010; 24: 71923.
Aim To examine the efficacy of a single acupuncture session on emotional stress (as measured by salivary gland cortisol) in patients with dysphonia due to phonotraumatic injuries. Design Prospective, randomised placebo-controlled trial with two parallel arms. Setting Voice Research Laboratory, University of Hong Kong, Hong Kong, China. Participants Eighteen women with vocal cord nodules, vocal polyps, vocal fold oedema or chronic laryngitis (as diagnosed by an otolaryngologist) were recruited. All participants were aged between 20 and 55 years, had not received acupuncture for any condition within the preceding 10 years, had no history of neurological condition and showed no signs of upper respiratory infection at study entry. Intervention Participants were randomly assigned to either a single acupuncture session or a single sham acupuncture session, using the same five acupuncture points: Hegu (LI4), Lieque (Lu7), Lianquan (Ren 23), Renying (St9) and Zhaohai (Ki6). Foam stands and plastic guide tubes were used for both treatment groups. True acupuncture was delivered using 30 mm length guide tubes and 40 mm needles for Hegu (LI4), Lianquan (Ren 23) and Zhaohai (Ki6), while 25 mm length needles were used for Lieque (Lu7) and Renying (St9). Sham acupuncture guide tubes and needles for all acupuncture points were 47 mm and 25 mm in length, respectively. For the sham acupuncture treatments, a plastic tag was inserted at the top of the needle to maintain pressure against the skin surface to stimulate the feeling of needling. All acupuncture sessions were 30 min in length, and needles were stimulated every 5 min throughout the acupuncture session in both treatment groups. Main outcome measures The main outcome was salivary cortisol concentration. Salivary cortisol measurements were taken at five timepoints: 10 min before needling (PRE-10), immediately before needling (PRE-0), 15 min after needle insertion
(MID), immediately after needle removal (POST-0), and 10 min after needle removal (POST-10). Salivary cortisol values at PRE-10 and PRE-0 were then averaged (PRE mean). Main results All 18 patients completed the study. Both the experimental group and the placebo group showed a significant reduction in mean salivary cortisol concentration from the PRE mean time-point to the MID time-point. However, cortisol levels returned to baseline at the POST-0 and POST-10 time-points in both groups. Due to the small sample size, nonparametric Wilcoxon signed-rank tests were used to detect statistical significance. The acupuncture group decreased from 2.19 nmol/l at the PRE mean time-point to 1.28 nmol/l at the MID time-point (Z=-1.96l P=0.05). The placebo group decreased from 2.87 nmol/l at PRE mean time-point to 1.72 nmol/l at MID time-point (Z=-2.19, P=0.03). Both groups demonstrated an increase in cortisol levels after the MID time-point, with the true acupuncture group increasing to 2.41 nmol/l at POST-0 and 2.30 nmol/l at POST-10. Both values were higher than the PRE mean timepoint, but not statistically significantly. The sham acupuncture group showed greater stability in cortisol levels, with a POST-0 cortisol level of 1.77 nmol/l and POST-10 level of 1.80 nmol/l. The authors state that the lower cortisol level did not reach statistical significance at the POST-0 (Z=-1.6, P=0.11) or POST-10 (Z=-1.72, P=0.09) time-points when compared with the PRE mean time-point. However, the values reported showed a minimal increase from 1.72 nmol/l at MID time to 1.80 nmol/l at POST-10, which is still less than the PRE mean time-point of 2.87 nmol/l. Authors conclusion The findings from the present study did not lend support to the hypothesis that acupuncture brought about reduction in emotional stress level in female dysphonic speakers. Address E Kwong, Division of Speech & Hearing Sciences, Voice Research laboratory, University of Hong Kong, 5/F, Prince Philip Dental Hospital, 34 Hospital Road, Sai Ying Pun, Hong Kong, China. E-mail: jasperek@graduate.hku.uk
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March 2012 17(1)
Commentary Although acupuncture has been shown to be beneficial for many symptoms, this clinical trial suffers from numerous design flaws that prevent accurate hypothesis testing. First, expecting sustained results from an intervention consisting of only a single acupuncture treatment was not realistic. Rather, a series of multiple acupuncture sessions over the course of several weeks would have been a more realistic dose to test whether acupuncture sessions decrease stress or have a measurable treatment effect. A recently published RCT using acupuncture treatment for stress compared a 5-week series of acupuncture treatments to attention control and wait-list control.1 This is an example of an approach that is more appropriate methodologically. Second, using only the salivary gland cortisol measurement as an indicator of stress was not a reliable endpoint. Salivary cortisol is often used in clinical trials as a measure of stress; however, cortisol levels are notoriously erratic with large inter-individual variability as well as intra-individual variability in levels.2,3 Typically, questionnaires such as the STAI are used in conjunction with laboratory endpoints for measuring stress levels. Acupuncture has been shown to have an effect on heart rate variability; another marker for stress measurement and autonomic nervous system activity.4 Third, assigning the sham acupuncture group to receive needling at real acupuncture points, as well as periodic needle stimulation, may explain the large initial decrease in cortisol levels in the sham acupuncture group, as it is well known that sham acupuncture has a greater therapeutic effect than conventional placebos. When numerous sham needles are inserted, a cumulative, beneficial effect may result from multiple stimulations of superficial sensory nerve endings or connective tissue; two commonly discussed targets of acupuncture needling.5 This
would help explain why the sham acupuncture group had a similar decrease in the MID cortisol level from baseline as the real acupuncture group. Fourth, we recognise that stress may play a contributing role in the presentation of dysphonia symptoms; however, if there is clinical benefit from using acupuncture for dysphonia, the mechanisms of action are likely multifactorial and not solely related to a single stress reduction component.
K Wesa, Assistant Attending Physician, Memorial Sloan-Kettering Cancer Center, New York, USA B Cassileth, Chief, Integrative Medicine Service, Memorial Sloan-Kettering Cancer Center, New York, USA E-mail: Cassileth@mskcc.org

1 Huang W, Howie J, Taylor A, Robinson N. An investigation into the effectiveness of traditional Chinese acupuncture (TCA) for chronic stress in adults: a randomised controlled pilot study. Complement Ther Clin Prac 2011; 17: 1621. 2 Kudielka B, Hellhammer DH, Wst S. Why do we respond so differently? Reviewing determinants of human salivary cortisol responses to challenge. Psychoneuroendocrinology 2009; 34: 218. 3 Kirschbaum C, Hellhammer DH. Salivary cortisol in psychoneuroendocrine research: recent developments and applications. Psychoneuroendocrinology 1994; 19: 31333. 4 Lee S, Lee MS, Choi JY et al. Acupuncture and heart rate variability: a systematic review. Auton Neurosci 2010; 155: 513. 5 Helene M, Langevin PMW, MacPherson H et al. Paradoxes in acupuncture research: strategies for moving forward. Evid Based Complement Alternat Med 2011; 180805.
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Authors reply We would like to thank Dr Wesa and Dr Cassileth for their insightful comments. We also appreciate the editor giving us an opportunity to respond to this commentary. Wesa and Cassileth contended that expecting sustained results from an intervention consisting of only a single acupuncture treatment was not realistic. We agree with their observation, and agree that this is not a normal dose that one would receive. However, in this report we aimed to look at the immediate effect of acupuncture on stress reduction. To assess relaxation over a few sessions of acupuncture might include other confounding variables, other than the acupuncture itself, that might have brought along changes. Wesa and Cassileth also pointed out that salivary gland cortisol measurement as an indicator of stress was not a reliable endpoint. Although there are a number of
measurements that can be used, salivary cortisol is a more objective (as compared to the STAI) and a simpler procedure. This was not ideal and this was one of the reasons why we titled this paper to be a preliminary study. We take note of the variability in cortisol levels, and appreciate that the choice of a more conservative non-parametric statistical test would have minimised the effect of the variability. Wesa and Cassileth have pointed out that sham acupuncture has a greater therapeutic effect than conventional placebos. We agree with this interpretation. Lastly, the authors concluded that if there is clinical benefit from using acupuncture for dysphonia, the mechanisms of action are likely multi-factorial and not solely related to a single stress reduction component. Indeed, we concur with this conclusion. Based on previous studies,1,2 and preliminary findings of a large-scale RCT
funded by the US National Institutes of Health National Center for Complementary and Alternative Medicine, we have found acupuncture to be effective in treating specific types of benign vocal pathologies; our findings from the current cortisol paper lend us support that this was not merely due to a reduction in stress levels.
EML Yiu, EYL Kwong, Division of Speech and Hearing Sciences, Voice Research Laboratory, University of Hong Kong, Hong Kong, China
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References
1 Kwong E, Yiu E, Xie F et al. The effectiveness of acupuncture for vocal nodules: a randomized-controlled clinical trial (Abstract). J Altern Complement Med 2007; 13: 874. 2 Yiu EML, Xu JJ, Murry T et al. A randomized treatmentplacebo study of the effectiveness of acupuncture for benign vocal pathologies. J Voice 2006; 20: 14456.
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March 2012 17(1)
Acupressure wristbands for the prevention of nausea and vomiting during labour and delivery
DOI 10.1111/j.2042-7166.2011.01138_3.x
Sinha A, Paech MJ, Thew ME, Rhodes M, Luscombe K, Nathan E. A randomised, double-blinded, placebo-controlled study of acupressure wristbands for the prevention of nausea and vomiting during labour and delivery. Int J Obstet Anesth 2011; 20: 11017.
Aim The study had two aims: (1) to determine whether the use of acupressure, delivered at the P6 acupoint using a wristband, was an effective means of preventing nausea and/or vomiting during labour and delivery, and (2) to identify risk factors for nausea and vomiting for future development of validated risk scores or to guide clinical prophylaxis. Design Prospective, randomised, double-blind, controlled trial with two parallel arms. placebo-
white paper backing square replaced the button. No pressure was applied to the backing square. The study was terminated either at 2 h after vaginal delivery or at the time of the decision to proceed to caesarean delivery. Main outcome measures Primary outcomes included the incidence of nausea and/or vomiting. Secondary outcomes included the need for antiemetic treatment, severity of nausea or vomiting, number of vomiting episodes, maternal satisfaction with the control of nausea and maternal ratings of inconvenience or discomfort from the bands. Main results The incidence of nausea and vomiting, and need for antiemetic treatment, did not differ significantly between groups during labour and delivery. There also were no statistically significant differences between groups in the severity of nausea or vomiting. Maternal satisfaction scores for the control of nausea and/or vomiting and maternal ratings of inconvenience or discomfort from the bands did not differ significantly between groups. Risk factors associated with nausea and/or vomiting during labour and delivery included smoking, opioid analgesia, motion induced or post-operative nausea and vomiting and higher body mass index. Authors conclusion In conclusion, although P6 acupoint stimulation reduces nausea and vomiting in some clinical situations, it had no significant effect on nausea and vomiting during labour and delivery in this study. Address M Paech, Department of Anaesthesia and Pain Medicine, King Edward Memorial Hospital for Women, Western Australia, Australia. E-mail: michael.paech@health.wa.gov.au
Setting Hospital delivery unit, King Edward Memorial Hospital for Women, Western Australia. Participants Altogether 340 women of American Society of Anesthesiologists (ASA) physical status classification I or II at 37 weeks gestation, and admitted to the hospital delivery unit for induction of labour or in the early first stage of labour, were randomised. Women were excluded if they had a body mass index >40 kg/m2, had previously used acupressure, used drugs with antiemetic activity, had nausea or vomiting within the previous 6 h, reported skin sensitivity to adhesive tapes, or had a history of intrauterine death, foetal abnormality or intravenous drug use. Intervention Participants were randomised (using a computergenerated random number sequence, with allocation by means of consecutive, sealed opaque envelopes) to receive either bilateral acupressure bands (group A) or bilateral sham placebo bands (group P). The acupressure bands were adhesive wristbands incorporating a raised, smooth white plastic button to apply skin pressure at the P6 acupoint. The button was pressed firmly for 30 s to activate the P6 acupoint. The sham bands appeared identical to the adhesive wristband, except that a small
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Commentary The authors mention at the beginning of the article that approximately 50% of women experience nausea and/or vomiting during labour, and that fetal and neonatal exposure to antiemetic medication may raise concerns due to the sedative effects of some of these agents; therefore, sourcing alternative, non-invasive methods to prevent nausea and vomiting is important. The authors were good to explore whether P6 acupressure stimulation reduces or prevents nausea and vomiting during labour and delivery. Researchers used a robust study design, which was prospective, randomised, double-blind and placebo-controlled. The authors compared the effect of each treatment on the incidence of nausea, vomiting and need for antiemetic medication, the severity of nausea or vomiting, maternal satisfaction scores for the control of nausea and/or vomiting, and maternal ratings of inconvenience or discomfort from the bands. Although no statistically significant difference between groups was found for any of these outcomes, the authors did discuss possible reasons for the findings, as well as the limitations of the study, and suggestions for further study. For instance, the researchers used placebo sham bands but did not include a third reference group with no intervention; so it is possible that both the treatment and placebo group experienced a placebo effect.
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Further, the researchers applied a band that did not apply skin pressure to any specific acupoint. It is possible that different techniques of P6 acupoint stimulation show different efficacy,1 with stronger forms of stimulation (such as electro-acupuncture) likely to be more efficacious than acupressure.2 However, considering the scientific rigour of the trial, the study is useful for informing further research on P6 (or other acupoint) acupressure for the prevention of nausea or vomiting during labour and delivery.
D Li, Atlantic Institute of Oriental Medicine, Fort Lauderdale, Florida, USA E-mail: dcljdl@yahoo.com

1 Lee A, Done ML. The use of nonpharmacologic techniques to prevent postoperative nausea and vomiting: a meta-analysis. Anesth Analg 1999; 88: 13629. 2 Ezzo J, Streitberger K, Schneider A. Cochrane systematic reviews examine P6 acupuncture-point stimulation for nausea and vomiting. J Altern Complement Med 2006; 12: 48995.
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Authors reply FACT did not receive a reply from the authors.
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March 2012 17(1)
Does auricular acupuncture reduce postoperative pain after gynaecological surgery?

DOI 10.1111/j.2042-7166.2011.01138_4.x
Holzer A, Leitger U, Spacer A, Wenzl R, Herkner H, Kettner S. Auricular acupuncture for postoperative pain after gynaecological surgery: a randomized controlled trail [sic]. Minerva Anestesiol 2011; 77: 298304.
Aim To investigate the effects of electrical auricular acupuncture on postoperative pain in patients undergoing laparoscopy. Design Patient and assessor-blinded, randomised controlled trial with two parallel arms. Setting Medical University of Vienna, Austria. Participants Forty women aged between 18 and 60 years who underwent elective gynaecological laparoscopy for infertility, ovarian cyst removal, myomas, adnexal surgery, endometriosis or hysterectomy, were randomised. Patients with a history of drug abuse, regular use of sedatives, chronic analgesic medication use, neurological or psychiatric disease, adverse reactions to sevoflurane or paracetamol, American Society of Anesthesiologists physical status > III, pacemakers, or a history of acupuncture treatment were excluded. Intervention Patients in the acupuncture group had titan disposable needles inserted at acupoints shen men, thalamus and one segmental organ-specific point. The needles were connected to the P-Stim device and received continuous low-frequency electrical stimulation (1 Hz biphasic, 2 mA) for 72 h postoperatively. Patients in the control
group received electrodes without needles and the P-Stim devices were applied without electrical stimulation. Patients in both groups received identical ear dressings, covering the whole ear, so that neither the patient nor the independent observer could see the needle area. Main outcome measures The main outcomes were pain (measured by VAS at 0, 2, 24, 48 and 72 h postoperatively), number of patients requiring rescue analgesia, and doses of piritramide. Main results There was no difference in VAS scores or the consumption of piritramide during the first 72 h postoperatively between groups (acupuncture versus placebo: 2.32 [1.403.25] versus 2.62 [1.893.36] average pain on VAS 010; 15.3 [12.018.6] mg versus 13.9 [10.5 17.3] mg piritramide). Values are expressed as mean [CI]. Authors conclusion Our study shows no reduction in postoperative pain or an opioid sparing effect of auricular acupuncture in women undergoing laparoscopic procedures. Address A Holzer, Department of Anaesthesia, General Intensive Care and Pain control, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria. E-mail: andrea.holzer@meduniwien.ac.at
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Commentary This trial had a low risk of bias according to the CONSORT statement and STRICTA criteria for the conduct and reporting of clinical trials. The trial essentially examined the effectiveness of low frequency electrical auricular acupuncture for postoperative pain in 40 women who underwent laparoscopic surgery. The results of the study showed no significant difference between auricular acupuncture and placebo treatment in pain scores or consumption of piritramide at 72 h post operation. However, the safety of electrical auricular acupuncture was not reported.
There are several issues that are important to consider in the interpretation of these negative findings. Firstly, the sample size was small. Whilst authors estimated the sample size based on their own data, this was calculated using the estimated change in the secondary outcome (i.e. use of the analgesic drug piritramide) rather than the primary outcome (i.e. reduction in pain score). There was a lack of information about the computer program used to produce the sequence of random numbers and how this allocation was concealed during the assignment of patients.
In this trial, patients and outcome observers were blinded to the treatment. However, there was insufficient information about the success of the blinding. Regarding the participants, they were quite heterogeneous in terms of primary diseases and age. Since all patients received analgesia (i.e. 1000 mg paracetamol every 6 h) after surgery and additional piritramide was given on demand, this might have reduced the differential effect between the two groups. Besides, we do not know if the electrodes put on the acupuncture points (in the control group) might have stimulated the points and, to some degree, produced an analgesic effect. Lastly, the choice of acupoints was not justified, though an early reference was provided. In summary, this study found auricular acupuncture had no analgesic effect above that of placebo; however, this
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should not be seen as conclusive as a Cochrane review of 13 trials1 suggests acupuncture/acupressure may be effective for labour pain. We agree with the authors that this area of research needs to be studied further.
J Liu, Beijing University of Chinese Medicine, Beijing, China E-mail: jianping_l@hotmail.com
Conflict of interest None declared. Reference

1 Smith CA, Collins CT, Crowther CA, Levett KM. Acupuncture or acupressure for pain management in labour. Cochrane Database Syst Rev 2011; 7: CD009232.
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Authors reply We thank Dr Jianping Liu for his commentary on our article. Regarding blinding, the acupuncturist was the only one who knew of the randomisation. He was neither involved in the anaesthesia nor in the analysis of data postoperatively. The sample size was estimated based on a clinically meaningful reduction in consumption of piritramide. We estimated that a sample size of 18 per group would have provided 80% power to detect a difference of 25% (mean piritramide consumption 15 mg 4 mg). We tested the piritramide consumption in this group of patients prior to the present study. Therefore, despite the small sample size, we can clearly state that auricular acupuncture as performed in our study had either no or just minor effects on pain in women undergoing laparoscopic surgery. The participants were homogeneous in terms of primary disease and age (Tables 1 and 2). From our point of view, the choice of acupuncture points was justified, as we followed the recommendation of Nogier.1 The safety of auricular acupuncture is well known and proved. The electrodes without connection to the needles were not stimulated, so an analgesic effect seems unlikely. Moreover, we recorded the piritramide consumption in a pre-study sample, to receive data for our power analysis. The actual piritramide consumption in the study groups was similar to the pre-study sample.
We agree with Dr Liu that basic analgesia with paracetamol was a limiting factor. However, our institutional ethics committee requested the administration of paracetamol as basic analgesia in all participants as a requirement for conducting the study. The reviews cited in the Cochrane database for acupuncture and dysmenorrhoea, polycystic ovarian syndrome and labour pain are very cautious in their conclusions. These reviews highlight the necessity for developing future studies that are well-designed, doubleblind, randomised and adequately controlled. The present study meets these criteria. The negative results thus surprised us. However, it is a well-known fact that positive results are more easily (publication bias) and promptly (time lag bias) published than negative results. There is also a chance that the use of acupuncture for pain following gynaecological surgery and other gynaecological indications may prove ineffective.
A Holzer, A Spacek, R Wenzl, S Kettner, Department of Anaesthesia, Medical University of Vienna, Austria
Reference
1 Nogier P. Points Reflexes Auriculares. Maisonneuve: Moulines-les-Metz, 1987.
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March 2012 17(1)
Acupuncture for osteoarthritis of the knee

DOI 10.1111/j.2042-7166.2011.01138_5.x
Miller E, Maimon Y, Rosenblatt Y et al. Delayed effect of acupuncture treatment in OA of the knee: a blinded, randomized, controlled trial. Evid Based Complement Altern Med 2011; Article ID 792975. doi:10.1093/ecam/nen080
Aim To evaluate the efficacy of acupuncture as an adjunctive treatment for osteoarthritis (OA) of the knee in elderly patients. Design Single-blind, randomised, sham-controlled trial with two parallel arms. Setting Department of Orthopaedics, Tel Aviv Sourasky Medical Center, Israel. Participants Forty-one persons aged 45 years or older, who had OA of the knee for at least 6 months, with moderate to severe pain during the last month, completed the study. Persons who had received intra-articular corticosteroid injection during the 4 weeks preceding the study, or with severe, unstable chronic illness, were excluded. Intervention Participants received either TCM acupuncture or sham acupuncture (using the same acupoints but without insertion of a needle), twice weekly for 8 weeks, in addition to standard therapy.
Main outcome measures The primary outcome measures were the Knee Society Score (KSS) knee score, function and pain ratings at therapy onset, 8 weeks (end of study) and 12 weeks (4 weeks after last treatment). Secondary outcomes were patient satisfaction and validity of sham acupuncture. Main results After 8 weeks of therapy, there was a statistically significant improvement in the three primary outcomes in both acupuncture groups when compared to baseline, but there was no difference between the traditional and sham acupuncture treatments. At 12 weeks (4 weeks followup), the knee and function scores in the acupuncture group were statistically significantly different than the sham group. Patient satisfaction was higher in the acupuncture group. Authors conclusion Adjunctive acupuncture treatment seems to provide added improvement to standard care in elderly patients with OA of the knee. Address S Lev-Ari, Unit of Complementary Medicine, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. E-mail: compmed@tasmc.health.gov.il
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Commentary Older clinical trials have reported that acupuncture provides additional relief for chronic pain when added to usual care. However, these trials lacked a control for the acupuncture procedure. During the last decade, most trials have used a three-arm design, which includes traditional and sham acupuncture procedures and usual care alone. I have several concerns about the authors methods and interpretations of the findings: 1. The authors used two primary outcomes (i.e. changes in outcomes at 8 and 12 weeks), rather than the conventional single primary outcome. Although both groups exhibited significant improvements from baseline at 8 weeks, the authors arbitrarily emphasise differences between the traditional and sham treatments at the later time-point. They attribute that dif-
ference to a specific delayed benefit of traditional acupuncture, but they do not consider the possibility that differences between 8 and 12 weeks represent random fluctuation. 2. The lack of a group receiving usual care only makes it impossible to assess the magnitude of the clinical benefit (effect size) provided by the acupuncture treatments. Also, no information was provided about the size of the difference between the acupuncture treatments at 12 weeks. 3. It is unclear if the two groups were entirely comparable at baseline. The groups were small and statistically significant differences between them may have been obscured because of the very large standard deviations. 4. The observation that patient satisfaction was greater in the traditional acupuncture group raises questions
about the effectiveness of the blinding, and the possible effect of the attitude of the acupuncturists on the perceived benefit of the procedure.13 Data concerning the effectiveness of the blinding were not provided. In summary, the authors conclusion that this study demonstrated a specific delayed benefit of acupuncture for knee osteoarthritis is not warranted Although the paper was submitted for publication in 2007, it was published in 2011 and contains no references to studies published since then. As summarised in two recent reviews, most trials of acupuncture for treatment of back pain and knee osteoarthritis have found no clinically meaningful difference between the benefit provided by conventional and sham acupuncture.4,5 These findings, and the effects of patients expectations of benefit and the attitudes of acupuncturists on the outcome, suggest that acupuncture analgesia is largely a placebo effect.
DM Marcus, Department of Medicine, Bayor College of Medicine, Houston, Texas, USA E-mail: dmarcus@bcm.edu
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1 McManus CA, Kaptchuk TJ, Schnyer RN et al. Experiences of acupuncturists in a placebo-controlled randomized clinical trial. J Altern Complement Med 2007; 5: 53337. 2 Suarez-Almazor ME, Looney C, Liu Y et al. A Randomized controlled trial of acupuncture for osteoarthritis of the knee: effects of sham acupuncture and provider communication style. Arthritis Care Res 2010; 62: 122936. 3 Price DD, Finniss DG, Benedetti F. A comprehensive review of the placebo effect: recent advances and current thought. Annu Rev Psychol 2008; 59: 56590. 4 Madsen MV, Gotzsche PC, Hrobjartsson A. Acupuncture treatment for pain: systematic review of randomised clinical trials with acupuncture, placebo acupuncture, and no acupuncture groups. BMJ 2009; 338: a3115. 5 Marcus DM. Is acupuncture for pain a placebo treatment? Rheumatologist 2010; 4(1): 2836.
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March 2012 17(1)
Ear acupuncture for migraine

DOI 10.1111/j.2042-7166.2011.01138_6.x
Allais G, Romoli M, Rolando S, Airola G, Castagnoli Gabellari I, Allais R, Benedetto C. Ear acupuncture in the treatment of migraine attacks: a randomized trial on the efcacy of appropriate versus inappropriate acupoints. Neurol Sci 2011; 32: S173S5.
Aim To test the effectiveness of ear acupuncture for the treatment of migraine attacks by comparing selected ear acupoints (group A) to ear acupoints representing the sciatic nerve (group B). Design Single-blind, randomised controlled trial with two parallel groups. Setting Womens Headache Centre, Department of Gynaecology and Obstetrics, University of Turin, Italy. Participants Ninety-four women suffering from migraine without aura (according to International Classification of Headache Disorders criteria) of 4 h duration, were enrolled. The average age of participants in group A was 35.9 years (range 1560 years), and in group B, 33.2 years (range 1658 years). Intervention In group A, a semi-permanent needle (ASP SEDATELEC, France) was inserted ipsilaterally to the tender ear point on the side of prevalent cephalic pain after algometer testing for sensitivity. In group B, two needles were
inserted in each ear in the lower branch of the anthelix at the area corresponding to the sciatic nerve after algometer testing for insensitivity. Main outcome measures The main outcome was pain intensity measured by VAS after 10 min (T1), 30 min (T2), 60 min (T3), 120 min (T4), and 24 h (T5). Main results The VAS scores were significantly lower in group A than in group B at all time-points through and including 120 min. No difference between groups was found at baseline and after 24 h. At T4, 28/43 patients in group A and 6/46 in group B achieved at least a 50% reduction in pain score (X2 = 25.53; P < 0.001); 10/43 in group A and 2/46 in group B were totally pain free (X2 = 6.81; P = 0.009). Authors conclusion This study suggests that the therapeutic specificity of auricular points exists and is linked to the somatotopic representation of our body on the ear. Address G Allais, Department of Gynaecology and Obstetrics, Womens Headache Centre, University of Turin, Via Ventimiglia 3, 10126 Turin, Italy. E-mail: gb.allais@tiscali.it
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Commentary The ear has always been viewed as a more convenient place than other parts of the body to administer acupuncture. Several studies show that ear acupuncture is effective in relieving pain.1 Many practitioners select acupoints based on point function and correlated location. However, the notion that the outer ear resembles the shape of a human and represents the whole body has been challenged. That acupoints have specific activity is also seriously in doubt as many clinical studies suggest otherwise.2 This study could have made a valuable contribution to this knowledge gap as it sought to determine efficacy and point specificity of ear acupuncture in the treatment of migraine. However, it failed to accomplish both due to faulty methodology. To verify the therapeutic value of
auricular acupuncture, the control group should have received standard care with no acupuncture. And to examine point specificity, the same type and number of needles should have been used for both the control and the treatment group, but in different areas of the ear. The study assumed that an area in the anthelix, representing the sciatic nerve, is inappropriate for migraine and therefore could be used as a control. However, the effect, or lack of effect, in this area has never been confirmed. Although the study was described as a blinded randomised trial, the two groups received very different treatments. It was also unclear as to who was blinded. Patients could not have been blinded because only sensitive points were used in the active group. The acupuncturists by definition could not have been blinded either.
A good clinical study is designed to answer a specific research question. The fallacies of this trial were its poor design and overstated goal. Therefore, no credible conclusions can be drawn.
K Simon Yeung, BR Cassileth, Memorial Sloan-Kettering Cancer Center, New York, USA E-mail: cassileth@mskcc.org
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References
1 Asher GN, Jonas DE, Coeytaux RR et al. Auriculotherapy for pain management: a systematic review and meta-analysis of randomized controlled trials. J Altern Complement Med 2010; 16: 1097108. 2 Langevin HM, Wayne PM, Macpherson H. Paradoxes in acupuncture research: strategies for moving forward. Evid Based Complement Alternat Med 2011; Article ID: 180805. doi: 10.1155/2011/180805.
Conflict of interest None declared.
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Authors reply We thank Dr Yeung and Dr Cassileth for their interest in our paper. In previous studies,1,2 we tested the possibility of reducing migraine pain with ear acupuncture (EA) by stimulating a specific area of the antitragus. In this study (a continuation of the earlier ones), we chose another area (i.e. belonging to the sciatic nerve and considered inappropriate for the treatment of migraine) for a comparison of therapeutic effect. Regarding methodological biases, the following issues must be emphasised: 1. Our purpose was not to test the effectiveness of EA in comparison with anti-migraine drugs but rather the specificity of auricular areas, which remains an unanswered question. Even though we cannot exclude the possibility that there might be a therapeutic effect on migraine by stimulating the sciatic nerve region, no acupuncturist with specific experience would include this area in migraine treatment. 2. The work challenging the specificity of auricular points was dedicated to somatic acupuncture alone. Therefore, it seems rather inappropriate to try to draw specific conclusions about EA from that work. 3. Needles of the same type were used in both groups, though the number might have varied depending on
the appropriate area, as can happen in EA when one or more needles may be inserted for pain control. However, the average number of needles (3.2 0.23) for each patient was not statistically significantly different from the four needles consistently used for the inappropriate area. 4. As for the blinding, the patients were EA-naive and could not differentiate which area was more appropriate, as the needle insertion produced a similar amount of pain regardless of the area. The treatment was really very similar in both groups. Naturally, the acupuncturists were not blinded but an impartial operator, who evaluated the data, was.
G Allais, M Romoli, S Rolando, C Benedetto, Womens Headache Center, University of Turin, Italy
References
1 Romoli M, Allais G, Airola G, Benedetto C. Ear acupuncture in the control of migraine pain: selecting the right acupoints by the needle-contact test. Neurol Sci 2005; 26: S158 61. 2 Allais G, Romoli M, Rolando S et al. Ear acupuncture in unilateral migraine pain. Neurol Sci 2010; 31: S1857.
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Acupuncture for herpes zoster pain

DOI 10.1111/j.2042-7166.2011.01138_7.x
Ursini T, Tontodonati M, Manzoli L, Polilli E, Rebuzzi C, Congedo G, Di Profio S, Marani Toro P, Consorte A, Placido G, Lagan S, DAmario C, Granchelli C, Parruti G, Pippa L, VZV Pain Study Group. Acupuncture for the treatment of severe acute pain in herpes zoster: results of a nested, open-label, randomized trial in the VZV pain study. BMC Complement Altern Med 2011; 11: 46.
Aim To compare the effectiveness of acupuncture with standard pharmacological treatment for acute herpes zoster pain. Design Nested, open-label, randomised controlled trial with two parallel arms. Setting Pescara General Hospital, Pescara, Italy. Participants Sixty-six patients with a VAS pain score 7 were analysed, with 34 assigned to acupuncture and 32 to standard pharmacological treatment. (The study started with 52 and 50 patients, respectively, but 28 were excluded due to rapid disappearance of pain and eight were excluded for other reasons.) Intervention Acupuncture was administered twice weekly over a period of 4 weeks (eight sessions in total). Two physicians administered the acupuncture to eight acupoints. The standard pharmacological treatment consisted of pregabalin and levobupivacaine (trade name Chirocaine) and, for patients with very intense or refractory pain, either buprenorphine or oxycodone. Patients in both study arms were administered paracetamol orally or intrave-
nously up to three times daily if requested. Both study arms received antiviral treatment (including 82% of patients in the acupuncture arm and 84% in the standard treatment arm). Main outcome measures The primary outcome was a reduction in pain intensity after 4 weeks of treatment as assessed by VAS. The secondary outcome was a reduction in the McGill Pain Questionnaire (MPQ) score. Main results There was no statistically significant difference in pain reduction (in either the VAS or MPQ score) between the acupuncture treatment group and the standard pharmacological treatment group at 4 weeks. Authors conclusion This controlled and randomized trial provides the first evidence of a potential role of AC [acupuncture] for the treatment of acute herpetic pain. Address G Parruti, Infectious Diseases Unit, Pescara General Hospital, Pescara, Italy. E-mail: parruti@tin.it
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Commentary Both treatment arms received antiviral treatment; yet, information about the antiviral treatment was incomplete. Both treatment arms received paracetamol if desired. However, the authors did not report how frequently paracetamol was administered, nor if there was a difference between the acupuncture group and the standard pharmacological treatment group. Pain was not assessed during the study, only at the start and end. No sham acupuncture group was included. Also, it was not reported if all eight acupoints were used every time in all patients, or the duration of each treatment session. The latter is of importance because greater interaction between acupuncturist and patient may result in a larger placebo response.
I realise that it may be unethical to run a clinical study of a painful condition such as herpes zoster without offering antiviral treatment and acute pain relief (e.g. paracetamol). But if pain reduction is what is investigated, this makes it even more important to assess pain reduction during the course of the study, not only at the end, and to monitor paracetamol administration. In the absence of such information, I am afraid this report says nothing about pain reduction by acupuncture and cannot do so. The pain reduction at 4 weeks may of course be entirely due to the antiviral treatment. Given the abovementioned circumstances, it is truly surprising that this study received ethical approval and funding. I am also surprised that the study could be
published in BMC Complementary and Alternative Medicine, not only because of its lack of scientific value, but also because of important missing information, namely details about acupuncture treatment, antiviral treatment and paracetamol treatment. Furthermore, the Abstract had mixed up the results of the two treatment arms. Fortunately, this did not matter because the differences between the groups were not statistically significant, but this mix-up was confusing for the reader. The authors had used a 110 VAS to measure pain intensity, but one of the references they cited used a 1100 scale. The follow-up assessment of post-herpetic neuralgia at 3, 6 and 12 months found no significant difference between acupuncture and standard pharmacological treatment in the primary or secondary outcome. This suggests that acupuncture (eight sessions over 4 weeks) has no antiviral or anti-inflammatory effect.
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The authors note that there was no difference in the incidence of adverse events between acupuncture and standard pharmacological treatment. They remark that this could favour acupuncture because drugs may have cumulative toxicity. One might equally well draw the conclusion that these potent pain relievers fare no worse than acupuncture with regard to side-effects for this small number of patients. In summary, this is a totally non-informative study.
D Larhammar, Department of Neuroscience, Uppsala University, Uppsala, Sweden E-mail: dan.larhammar@neuro.uu.se
Conflict of interest D Larhammar is a member of the Swedish Skeptics.
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Authors reply 1. Antiviral therapy: Patients were prescribed acyclovir, valacyclovir, famcyclovir or brivudin at standard dosages for 721 days by each enrolling physician (see Table 1 and reference 14 in original article). There were no significant differences between the two arms, or to those of untreated patients, in the percentages of patients receiving each antiviral agent (as illustrated in Table 1). What we can add from a revision of the data is that all patients in the trial were prescribed antivirals within 4 days of herpes zoster (HZ) onset. Therefore, we feel that no bias was introduced in this respect. 2. Evaluation of pain: We understand that a more frequent assessment of pain could have clarified whether early pain quenching was different between the two arms; we already acknowledged this as a limitation in the paper. It was possible, however, to obtain the area under the curve (AUC) for each patient during the whole follow-up stage, taking into account the total burden of pain experienced; this was a strength as it allowed us to point out differences in long-term pain control between study regimens. With regard to the reference to a centesimal VAS to evaluate pain, we honestly find this irrelevant. 3. Paracetamol: Paracetamol (2501000 mg up to three times daily) was allowed for immediate pain relief in both arms. Review of available data on registered prescriptions indicates indifferent use between study arms. We did not report these data exactly because no bias was introduced into the study. 4. Acupoints and session duration: All indicated acupoints were used in 97% of patients according to treatment records, with sessions lasting 32.5 7.5 min. Interventions in both arms were discontinued invariably at the end of the fourth week. 5. Sham acupuncture: The lack of a control arm with sham acupuncture was already acknowledged as a limitation; our purpose, however, was to compare the effectiveness of two different methods of pain control already in use at our centre. 6. Adverse events: In the conclusion, we stated that acupuncture might be appropriately considered among the available therapeutic options for the control of severe acute HZ related pain, commenting on the lack of any difference in adverse events between study groups: what we meant was that neither treatment was superior in this respect. The risk of cumulative drug toxicity in patients receiving standard treatment was simply mentioned as a possibility, and not verified. Frankly, we do not see how differently we could have stated this. 7. Abstract: We acknowledge that a thorough understanding of the results in the abstract is achievable only in reference to Table 2; we agree, however, that this is not relevant although possibly confusing in view of the lack of any difference between study arms. In view of the above considerations, we totally reject the allegation that our study is irrelevant. Criticisms should never nullify the attempts to conduct clinical research.
G Parruti, Infectious Diseases Unit, Pescara General Hospital, Pescara, Italy
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C O M P L E M E N TA R Y T H E R A P I E S O T H E R Aromatherapy for procedural anxiety?

DOI 10.1111/j.2042-7166.2011.01138_8.x
Hu PH. Peng YC. Lin YT. Chang CS. Ou MC. Aromatherapy for reducing colonoscopy related procedural anxiety and physiological parameters: a randomized controlled study. Hepatogastroenterology 2010; 57: 10826.
Aim To investigate the effects of aromatherapy on procedural anxiety. Design RCT with two parallel groups. Setting Colonoscopy clinic, Taiwan. Participants Twenty-seven patients undergoing colonoscopy were randomised. Intervention Patients inhaled either Neroli oil (experimental group, n=14) or sunflower oil (control group, n=13) via an oxygen mask during the procedure. The dosage each patient received was not described in detail.
Main outcome measures Anxiety (STAI-state) and pain (VAS) were the primary endpoints. Blood pressure, heart rate and respiratory rate were also measured. Measurements were taken before and after the procedure. Main results There were no statistically significant treatment effects for any of the primary endpoints. Authors conclusion Aromatic care for colonoscopy, although with no significant effect on procedural anxiety, is an inexpensive, effective and safe pre-procedural technique that could decrease systolic blood pressure. Address M-C Ou, Department of Applied Cosmetology, Hungkuang University, no. 34, Chung-Chie Road Sha-Lu, Taichung, 43302 Taiwan. E-mail: mcou@sunrise.hk.edu.tw
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Commentary The concept of testing the effectiveness of CAM for procedural anxiety is appealing, not least because it generates results quickly and cheaply. Unfortunately, this study has numerous methodological weaknesses including, for instance, a small sample size, the lack of a power calculation and the lack of details on randomisation. Another irritation is the fact that this study is poorly reported, so it is difficult to make sense of it. Aromatherapists might argue that Neroli oil is not optimal for anxiety, that inhalation is less effective than topical application, or that the treatment was not long enough. My biggest concern with this article, however,
relates to a different issue: I fail to understand why authors draw positive conclusions from negative data. This is, I find, a wide-spread and most unfortunate phenomenon in CAM. If we want others to take CAMresearch seriously, we should find ways of addressing this issue.
E Ernst, Peninsula Medical School, University of Exeter, Exeter, UK E-mail: eernst@pms.ac.uk
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HERBAL MEDICINE Efficacy and safety of Antarth for osteoarthritis

DOI 10.1111/j.2042-7166.2011.01138_9.x
Gupta AK, Acharya K, Sancheti PS, Joshi RS. A double-blind, randomized, multicentric, placebo-controlled clinical trial of Antarth, a phytomedicine, in the treatment of osteoarthritis. Indian J Pharmacol 2011; 43: 6972.
Aim To test the safety and efficacy of Antarth, a polyherbal phytomedicine, in the treatment of osteoarthritis. Design Multicentre, double-blind, randomised, controlled trial with two parallel arms. Setting Not specified. Participants Ninety patients above the age of 18 years, with clinicallyand radiologically-confirmed osteoarthritis (OA), who had suffered from OA for more than 2 years, were recruited. Predefined clinical features were pain in the knees, swelling, stiffness, joint tenderness, and difficulty walking for more than 2 years in persons aged over 45 years. Radiological features included any one or more of the following: anterior spiking of the patella, subchondral sclerosis, lipping or spurring of the joint margin, osteophytes and reduction of medial joint space. Patients suffering from hyperacidity, peptic ulceration, gastritis, renal or liver disorders or other types of arthritis, or were on long-term steroid treatment, had surgical intervention or were pregnant or lactating, were excluded. Intervention Participants were randomly assigned to Antarth (formulation not described) or placebo at a dose of two capsules twice a day, for 3 months. placebo-
Main outcome measures Outcome measures were severity of pain (assessed using a 010 VAS), and pain while carrying out exercise (including walking, squatting, crossing legs and knees, and climbing steps; using scores ranging from 04). Other outcome measures included consumption of NSAIDs and Patient and Physician Global Assessment. Main results The difference in pain severity and level of pain while carrying out all exercises, before and after Antarth treatment, was statistically significant (P<0.05); changes in primary outcomes (excluding pain while climbing steps) in the placebo group were not significant. The statistically significant (P<0.05) reduction in NSAID use was only observed in the Antarth group. Authors conclusion In Patients Global Assessment, patients treated with Antarth were more satisfied than the ones treated with placebo. Observations were similar in Physicians Global Assessment too. There were no adverse events in both the groups. Address AK Gupta, Department of Orthopaedics, K.G. Medical College and Hospital, Manipal, 576 104, Karnataka, India. E-mail: guptadrakg@rediffmail.com
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Commentary Many herbal interventions used for the treatment of osteoarthritis, such as Harpagophytum procumbens (devils claw), capsaicin cream and Phytodolor, have been tested in RCTs and have demonstrated promising efficacy. This is the first RCT of the Ayurvedic herbal formula, Antarth. In clinical trials testing the efficacy/effectiveness of herbal medicine, it is essential that authors provide
detailed information on the herbal intervention tested. Recommendations for the reporting of these trials can be found in the herbal extension of the CONSORT statement.1 The authors of the Antarth trial provided little information on the dosage and characteristics of the herbal product, such as content of quantified herbal product constituents. In addition, there was no information on the total number of patients screened, method of
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randomisation, allocation concealment, double-blinding and power calculation. The poor quality of reporting thus dramatically increases the risk of bias. Two outcome measures the Patient and Physician Global Assessment were not compared statistically. Interestingly, the authors chose the results of these parameters as the basis of their conclusion. While the rest of the outcomes were compared statistically, authors seemed to report and discuss the results selectively. There is the possibility that results less favourable of Antarth (i.e. rescue medication consumption) were not mentioned intentionally. The trial results are encouraging regarding the safety of Antarth. Nevertheless, larger trials are still required to
provide robust research evidence on the efficacy and safety of this treatment.
SK Hung, Complementary Medicine, Peninsula Medical School, University of Exeter, Exeter, UK E-mail: Shao.hung@pms.ac.uk
Conflict of interest None declared. Reference

1 Gagnier JJ, Boon H, Rochon P et al. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Ann Intern Med 2006; 144: 3647.
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H O M E O PAT H Y Homeopaths attempt to salvage a positive result from treatment failure in an underpowered trial
DOI 10.1111/j.2042-7166.2011.01138_10.x
Brien S, Lachance L, Prescott P, McDermott C, Lewith G. Homeopathy has clinical benets in rheumatoid arthritis patients that are attributable to the consultation process but not the homeopathic remedy: a randomized controlled clinical trial. Rheumatology 2011; 50: 107082.
Aim To assess whether benefits from adjunctive homeopathic intervention in patients with rheumatoid arthritis (RA) are due to the homeopathic consultation, homeopathic remedies or both. Design Double-blind, randomised placebo-controlled trial with five arms. Setting Outpatient rheumatology clinics in three centres, across the UK and USA. Participants Fifty-six patients living with stable, well-controlled rheumatoid arthritis for at least 2 years completed the trial. Subjects with significant co-morbidities, severe RA, pregnant or breastfeeding, or taking biological disease modifying anti-rheumatic drugs (DMARDs) were excluded. Intervention Subjects were randomly assigned to one of five groups: (1) homeopathic consultation and commercial homeopathic preparation, (2) homeopathic consultation and individualised homeopathic treatment, (3) homeopathic consultation and placebo, (4) commercial homeopathic preparation only and (5) placebo only. All interventions were administered twice daily for 24 weeks; this was in addition to usual care provided by the rheumatology clinic involved.
Main outcome measures The two primary outcomes were a 20% improvement in American College of Rheumatologists (ACR) criteria (i.e. ACR20 response) and improvement in the subjective Global Assessment scale (using a 100 mm VAS) of at least 35%. Secondary outcome measures included the disease activity score (DAS-28), tender and swollen joint count, disease severity, pain, weekly patient and physician Global Assessment, and inflammatory markers. Main results Homeopathic remedies, whether they be standardised commercial preparations or preparations individualised by experienced homeopaths, failed to show superiority to placebo remedies. No significant differences between any of the groups were noted for any of the primary outcomes. Authors conclusion Homeopathic consultations but not homeopathic remedies are associated with clinically relevant benefits for patients with active but relatively stable RA. Address S Brien, Complementary and Integrated Medicine Research Unit, Primary Medical Care, Aldermoor Health Centre, Aldermoor Close, Southampton SO16 5ST, UK. E-mail: s.brien@southampton.ac.uk
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Commentary This trial sought to test whether any benefit accrued to patients with RA from the homeopathic consultation process, homeopathic remedies or both. In fact, by its own nominated primary outcome measures it failed to show this on both counts. For secondary outcome measures (14 in total), a handful of statistically significant differences were noted; these were reported by the authors as evidence of benefit of the
homeopathic consultation process. Clearly a study with two primary outcomes and 14 secondary outcomes, for a study population where an average of 10 subjects completed each of five arms must be highly likely to produce at least some positive statistical results. The authors invited 1135 subjects, of whom 121 were screened and 83 recruited. Of the 83 recruited, only 52 completed the whole protocol; which is a 38% dropout rate. The a priori
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power calculation reported by the authors to show a clinically meaningful effect in either primary outcome measure demanded 110 subjects. Hence, since the authors only completed the protocol with 47% of the required subjects, the study is virtually incapable of interpretation, despite being conducted with some degree of statistical and methodological rigour. The authors appear to base their claims of efficacy for the homeopathic consultation mainly on changes in one of the secondary outcome measures (i.e. DAS-28), for which they have only calculated the effect size and sample power retrospectively. The authors can therefore make no claim that they reached either primary outcome, nor indeed can they claim that any outcome, whether positive or negative, is worthy of interpretation, since they used post hoc analysis to identify these results. Such analysis is suitable for hypothesis generation but cannot legitimately constitute a prospectively predicted positive result. The above critique does not mention the frankly risible premise that the authors imply as a conclusion (i.e. they are claiming that simply being assessed by a homeo-
path is a direct cause of improvement in biological disease markers of RA to a degree comparable to rigorously tested DMARDs). The authors do not provide any rationale by which this may be achieved. A major result of this study not specifically referred to by the authors is that the individualised prescription of any remedy from the whole homeopathic materia medica was indistinguishable from either placebo or an off-theshelf homeopathic preparation. This failure was obtained over a 40-week follow-up period, which most reasonable commentators would agree is more than sufficient time for a constitutional homeopathic remedy to have the profound results of which such treatment is supposedly capable.
M Vagg, Consultant in Rehabilitation and Pain Medicine, Barwon Health, Geelong, Australia E-mail: mikeva@barwonhealth.org.au
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Homeopathic Plumbum metallicum is ineffective for lead toxicity in a fair trial

DOI 10.1111/j.2042-7166.2011.01138_11.x
Padilha RQ, Riera R, Atallah AN. Homeopathic Plumbum metallicum for lead poisoning: a randomized clinical trial. Homeopathy 2011; 100: 11621.
Aim To assess whether a homeopathic preparation of lead can reduce serum lead concentration in humans. Design Double-blind, RCT with two parallel arms. Setting Workers clinic, Ajax battery plant, Bauru, Sao Paulo State, Brazil. Participants Altogether 131 plant workers with work-related lead exposure, but with serum levels below the maximal safe level, were recruited. Workers who had recent chelation therapy for lead toxicity were excluded. Intervention Participants were randomised to receive either orally administered homeopathic lead (Plumbum metallicum)
15CH or placebo (a visually identical formulation with the same alcohol content), at a dose of 10 drops twice daily for 30 days. Main outcome measures The primary outcome was defined as a 25% or greater reduction in serum lead concentration over time. Main results The same percentage of workers in both groups showed a reduction in serum lead levels of 25% or greater. Therefore the homeopathic intervention was not superior to placebo. Authors conclusion The homeopathic preparation Plumbum metallicum had no effect, in this study, in terms of reducing serum lead in workers exposed to lead. Address R Riera, Rua Pedro de Toledo, 598, Vila Clementino, Sao Paulo, Brazil. E-mail: rachelriera@hotmail.com
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Commentary This paper begins with a description of the problem of industrial lead toxicity, which is generally accurate, though many of the references were quite dated. Available treatments for lead toxicity were reviewed in some detail, but the animal data and homeopathic rationale for justifying the hypothesis of the study were dispensed with inside two paragraphs. The study design was fair and well-described, using a typical RCT design and between-groups, ITT analysis. The discussion section was predictably disappointing, with the authors claiming that there was a paucity of evidence to support chelation approaches, as if this justified performing such an implausible RCT and obtaining a predictably negative result. The authors clearly missed the first three references cited below13 which, although quite dated, invalidate their argument that there is supposedly only one RCT of dimercaptosuccinic acid (DMSA) in children with low to moderate lead levels. This does not include the many more studies in children with higher serum levels, all of which demonstrate rapid and relatively well-tolerated reductions in lead load. In any case, the authors avoided the fact that there are abundant trials that clearly demon-
strate dramatic reductions in serum lead levels with all chelating agents, and that there are numerous review articles, including those listed below.48 The assertions by the authors that there is a practical absence of research on the effect of chelation therapy and that distancing a worker from the source is the only method that is supported by the scientific literature for workers with high lead concentrations are as demonstrably flimsy as the preclinical data supporting the idea that homeopathic lead would be expected to have any effect on lead exposure. A more realistic paper is that written by Gottesfeld and Pokhrel,9 who discuss the issues associated with lead exposure in the battery industry in the developing world, and conclude that enforcement of proper manufacturing standards is likely to be the most effective strategy for improving industrial lead exposure. In a fair test of both general and specific homeopathic theory, no support was given to the experimental hypothesis, nor to the tortuous reasoning that underlies it.
M Vagg, Consultant in rehabilitation and pain medicine, Barwon Health, Victoria, Australia E-mail: mikeva@barwonhealth.org.au
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1 Besunder JB, Anderson RL, Super DM. Short-term efficacy of oral dimercaptosuccinic acid in children with low to moderate lead intoxication. Pediatrics 1995; 96: 6837. 2 Liebelt EL, Shannon M, Graef JW. Efficacy of oral meso-2,3dimercaptosuccinic acid therapy for low-level childhood plumbism. J Pediatr 1994; 124: 31317. 3 Treatment of Lead-exposed Children Trial Group. Safety and efficacy of succimer in toddlers with blood lead levels of 2044 [mu]g/dL. Pediatr Res 2000; 48: 5939. 4 Bradberry S, Vale A. Dimercaptosuccinic acid (succimer; DMSA) in inorganic lead poisoning. Clin Toxicol (Phila) 2009; 47: 61731.
5 Bradberry S, Vale A. A comparison of sodium calcium edetate (edetate calcium disodium) and succimer (DMSA) in the treatment of inorganic lead poisoning. Clin Toxicol (Phila) 2009; 47: 84158. 6 Warniment C, Tsang K, Galazka SS. Lead poisoning in children. Am Fam Physician 2010; 81: 7517. 7 Kosnett MJ, Wedeen RP, Rothenberg SJ et al. Recommendations for medical management of adult lead exposure. Environ Health Perspect 2007; 115: 46371. 8 Woolf AD, Goldman R, Bellinger DC. Update on the clinical management of childhood lead poisoning. Pediatr Clin North Am 2007; 54: 27194, viii. 9 Gottesfeld P, Pokhrel AK. Review: lead exposure in battery manufacturing and recycling in developing countries and among children in nearby communities. J Occup Environ Hyg 2011; 8: 52032.
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M A N I P U L AT I V E T H E R A P I E S Low-level laser therapy may be more effective and less risky than chiropractic manipulative therapy in the management of cervical facet dysfunction
DOI 10.1111/j.2042-7166.2011.01138_12.x
Saayman L, Hay C, Abrahamse, H. Chiropractic manipulative therapy and low-level laser therapy in the management of cervical facet dysfunction: a randomized controlled study. J Manipulative Physiol Ther 2011; 34: 15363.
Aim To investigate the short-term effect of chiropractic joint manipulation therapy (CMT) and low-level laser therapy (LLLT) on pain and range of motion in the treatment of cervical facet dysfunction (CFD). Design Randomised, open-label, active-controlled trial with three parallel arms. Setting University of Johannesburg Chiropractic Day Clinic, Doornfontein, South Africa. Participants Sixty women, aged 1840 years, with cervical facet joint pain of more than 30 days duration and normal neurologic examination, were randomised. Participants were excluded if they had recent trauma to the neck; previous neck surgery; signs of ligamentous rupture or instability; abnormal neurologic signs in the upper limbs, relating to nerve entrapment or impingement, nerve root irritation or disk herniation from the cervical spine; systemic rheumatological disease; vertebrobasilar artery insufficiency syndrome; open wounds, haemorrhage or infection in the cervical spine region; cancer; osteoporosis; any form of drug abuse or dependency; photophobia or abnormally high sensitivity to light; or were unable to temporarily discontinue any activity that exacerbated the pain. Intervention Participants were randomly assigned to one of three treatments: (1) CMT of the cervical spine (comprising specific short-lever, high-velocity, low-amplitude diversified techniques of cervical manipulation); (2) LLLT to the cervical facet joints (comprising 50 s of laser treatment per point, at three points per joint, and a minimum of
three joints per treatment session); or (3) CMT and LLLT. All treatments were administered for 30 min (excluding the initial consultation, which lasted 90 min), twice a week for 3 weeks. Main outcome measures The primary outcome measures were the numerical pain rating scale (NPRS) and neck disability index (NDI). Secondary outcome measures included the cervical range of motion (CROM) instrument and the baseline digital inclinometer (BDI). All outcomes were measured at baseline and weeks two, three and four. Main results All three groups demonstrated significant improvements from baseline for all outcome measures. The combination treatment performed significantly better than LLLT, but not CMT, for the NDI. Pairwise comparisons found no significant difference between LLLT and CMT for any of the primary outcomes or six of the seven secondary outcomes; LLLT performed significantly better than CMT for one secondary outcome (CROM: flexion). Authors conclusion All 3 groups showed improvement in the primary and secondary outcomes. A combination of CMT and LLLT was more effective than either of the 2 on their own. Both therapies are indicated as potentially beneficial treatments for cervical facet dysfunction. Further studies are needed to explore optimal treatment procedures for CMT and LLLT and the possible mechanism of interaction between therapies. Address H Abrahamse, Laser Research Centre, Faculty of Health Sciences, University of Johannesburg, PO Box 17011, Doornfontein, Johannesburg 2028, South Africa. E-mail: habrahamse@uj.ac.za
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Commentary This was an interesting study to review, as I am aware that the use of CMT on the cervical spine is a somewhat contentious issue.1,2 On the other hand, there appears to be some evidence to support the effectiveness and safety of LLLT for joint disorders.3,4 The most intriguing aspect of this study was not that all three treatment arms showed significant improvements from baseline (as this could well be explained by placebo effects or the natural history of the disorder), but the pattern of improvements between the three treatment arms. Specifically, I was intrigued that there were no differences between CMT and LLLT for the two primary outcomes or six of the seven secondary outcomes, whereas LLLT was significantly better than CMT on the remaining secondary outcome (CROM: flexion). Although the authors ignore this point, one might conclude that given the inherent risks associated with CMT of the cervical spine,1,2 LLLT may be a safer and more effective alternative to CMT for the treatment of cervical facet dysfunction. Differences between all three treatments were more difficult to interpret, as the combined treatment (CMT and LLLT) was better than both individual treatments for one secondary outcome (CROM: rotation), better than LLLT for one primary and two secondary outcomes, and better than CMT for two secondary outcomes. Given the rather inconsistent pattern of findings and the inherent risk of CMT,1,2 it is not clear that any marginal incremental
benefits of the combined treatment are worth the additional risk of adding CMT to LLLT. The authors conclusion that both therapies are indicated as potentially beneficial treatments for CFD is somewhat premature given the lack of a no-treatment condition or comparison group involving standard medical treatment. Until the effectiveness of CMT, LLLT, the combination treatment, and standard medical treatment are compared, patients committed to alternative treatments should consider LLLT rather than CMT or the combined treatment, due to its comparable effectiveness and lower risk profile.1,2,4
A Gilbey, Massey University, New Zealand E-mail: a.p.gilbey@massey.ac.nz

1 Ernst E. Deaths after chiropractic: a review of published cases. Int J Clin Pract 2010; 64: 11625. 2 Ernst E. Vascular accidents after neck manipulation: cause or coincidence? Int J Clin Pract 2010; 64: 6737. 3 Bjordal JM, Coupp C, Chow RT et al. A systematic review of low level laser therapy with location-specific doses for pain from joint disorders. Aust J Physiother 2003; 49: 107 16. 4 Hawkins D, Houreld N, Abrahamse H. Low level laser therapy (LLLT) as an effective therapeutic modality for delayed wound healing. Ann N Y Acad Sci 2005; 1056: 48693.
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Authors reply Historically, both CMT and LLLT have been viewed with a certain level of scepticism, mainly due to the lack of scientific evidence of efficacy. However, there has been a definite tendency to move towards more non-invasive therapies and an increase in the awareness of the side-effects of medications, such as anti-inflammatory drugs. This study attempted to, in a well-designed research project, using sound, established research methodology, investigate and compare these two therapeutic modalities as applied to a specific medical condition. As is the case with all research studies, all possible questions can never be answered in a single project, leaving the investigator the possibility of further research and subsequent more in-depth investigation of the subject. Qualitative, subjective (primary) and quantitative, objective assessments were used to determine the effectiveness of CMT and LLLT. Although the primary outcome measures consistently
showed the effectiveness of each treatment alone, as well as the combination of treatments, the secondary outcome measures were far more difficult to interpret in totality. The differences in the secondary measures with reference to the different therapies may be indicative of the underlying cellular and molecular effects and targets of the two different therapies, as well as the molecular responses to the different treatment regimes. However, irrespective of the difficulty in interpretation, this study served to invoke thought and interest in the use of CMT and LLLT for cervical facet dysfunction and other related conditions, and poise further research in the mechanisms involved in both CMT and LLLT. In addition, it has successfully highlighted the promise that non-invasive and non-chemical therapies hold for conditions such as cervical facet dysfunction.
H Abrahamse, University of Johannesburg, South Africa
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Massage therapy to improve sleep quality post coronary artery bypass graft surgery
DOI 10.1111/j.2042-7166.2011.01138_13.x
Nerbass FB, Feltrim MIZ, de Souza SA, Ykeda DS, Lorenzi-Filho G. Effects of massage therapy on sleep quality after coronary artery bypass graft surgery. Clinics 2010; 65: 110510.
Aim To evaluate whether massage therapy is an effective technique for improving sleep quality in patients following cardiopulmonary artery bypass graft surgery. Design Open-label, RCT with two parallel arms. Setting Heart Institute, University of So Paulo School of Medicine, So Paulo, Brazil. Participants Forty patients, aged between 40 and 80 years, who were waiting for elective coronary artery bypass graft (CABG) surgery at the Heart Institute, So Paulo, participated. Excluded were patients with a body-mass index 35 kg/m2, a history of regular alcohol consumption, chronic use of hypnotics, previous diagnosis of sleep disorders, surgery other than CABG performed within the last 24 months, illiteracy and patients who received combined valve and CABG surgery, a thoracic drain on return to the ward, or an intensive care unit stay longer than 5 days in the postoperative period. Intervention Subjects were randomly assigned to a control or massage therapy group on discharge from the intensive care unit. The massage therapy group received a neck, shoulder and back massage by a physiotherapist around 7pm (23 h before sleep) every night for three consecutive nights. The control group sat in comfortable chairs for three consecutive nights.
Main outcome measures The main outcome measures were the Epworth sleepiness scale, Pittsburgh Sleep Quality Index, Berlin Questionnaire, and VASs for pain and fatigue. Main results Fifty-seven cardiopulmonary artery bypass graft surgery patients were enrolled in the study during the preoperative period, 17 of whom were excluded due to postoperative complications. The remaining 40 participants (male: 67.5%, age: 61.9 years 8.9 years, body mass index: 27.2 kg/m2 3.7 kg/m2) were randomized into control (n=20) and massage therapy (n=20) groups. Pain in the chest, shoulders, and back decreased significantly in both groups from Day 1 to Day 3. The participants in the massage therapy group had fewer complaints of fatigue on Day 1 (P=0.006) and Day 2 (P=0.028) in addition, they reported a more effective sleep during all three days (P=0.019) when compared with the participants in the control group. Authors conclusion Massage therapy is an effective technique for improving patient recovery from cardiopulmonary artery bypass graft surgery because it reduces fatigue and improves sleep. Address F Nerbass, Sleep Laboratory, Pulmonary Division, Heart Institute, Faculty of Medicine, Clinics Hospital, University of So Paulo, So Paulo, Brazil. E-mail: fbnerbass@gmail.com
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Commentary This interesting study attempted to elucidate whether massage therapy has any beneficial effect on sleep quality in patients following CABG surgery. The study design was simple yet effective in testing the hypothesis that massage therapy improves sleep quality post-CABG. Postoperative sleep deprivation is a common problem that has often been overlooked by surgeons. Patients often do not complain about insomnia after surgery unless they are being asked by the clinical team. As mentioned by the authors, postoperative sleep depri-
vation is a stressful condition, which may lead to inappropriate activation of the hypothalamic pituitary adrenal axis and the subsequent release of cortisol. This study has demonstrated the role of massage therapy in patients post-CABG surgery; that is, to decrease fatigue and improve sleep. In todays clinical environment, most patients postCABG surgery would be placed on a patient controlled analgesia (PCA) machine for intermittent opioid administration during the postoperative period. It was not
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mentioned in the article whether any of the recruited subjects were placed on PCA while massage therapy was offered. Given that opioid medication can cause drowsiness and sleepiness, it would be useful to know if any of the subjects were exposed to opioid medication at the same time massage therapy was offered. In addition, there was no mention of whether the recruited subjects received short-acting sedative drugs or benzodiazepines (such as temazepam) after the massage therapy. These medications may also influence a patients sleep quality. It is certain that this study has contributed interesting and important knowledge about the postoperative care
of patients following CABG surgery. Further research is needed in this area to determine how massage therapy should be performed (e.g. intensity and frequency) in postoperative patients.
CE Danforn Lim, Faculty of Medicine, University of New South Wales, Sydney Australia E-mail: celim@unswalumni.com NCL Cheng, Calvary Hospital, Sydney, Australia
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Authors reply We are grateful for the reviewers interest in our work. We agree that sleep quality is a common problem that has been constantly overlooked by many surgeons, and that patients do not complain about insomnia after the surgery, unless they are asked by the clinical team. We thank FACT for the opportunity to clarify a few important points raised by Professors Lim and Cheng. In our study, the intervention only occurred after the patients had left the intensive care unit. In our sample, none of the enrolled participants received patient-controlled analgesia during the study period. Only two patients in each arm of the trial received benzodiazepines during the study period. We therefore believe that the use of these
medications did not influence the results of the study. Our RCT thus showed that massage reduces fatigue complaints and improves sleep. We agree that further studies are needed in this area, and we hope other centres could test similar approaches in these patients.
Flvia Baggio Nerbass, Physiotherapy Division; Sleep Laboratory, Clinics Hospital, University of So Paulo, So Paulo, Brazil Maria Ignez Zanetti Feltrim, Silvia Alves de Souza, Daisy Satomi Ykeda, Physiotherapy Division, Clinics Hospital, University of So Paulo, So Paulo, Brazil Geraldo Lorenzi-Filho, Sleep Laboratory, Clinics Hospital, University of So Paulo, So Paulo, Brazil
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Connective tissue reflex massage to improve peripheral circulation in type 2 diabetes mellitus
DOI 10.1111/j.2042-7166.2011.01138_14.x
Castro-Sanchez AM, Moreno-Lorenzo C, Mataran-Penarrocha GA, Feriche-Fernandez-Castanys B, Granados-Gamez G, Quesada-Rubio JM. Connective tissue reex massage for type 2 diabetic patients with peripheral arterial disease: randomized controlled trial. Evid Based Complement Altern Med 2011; Article ID 804321. doi:10.1093/ecam/nep171.
Aim To evaluate the effectiveness of connective tissue massage in improving blood circulation and intermittent claudication symptoms in patients with type 2 diabetes. Design Randomised, open-label, sham-controlled trial with two parallel arms. Setting Healthcare district in Southern Spain. Participants Ninety-eight patients aged 1865 years, with type 2 diabetes, stage I or II-a peripheral arterial disease (PAD) (according to Leriche-Fontaine classification), an anklebrachial index of 0.60.9, glycosylated haemoglobin of 710% and body mass index of 2735 kg/m2, were enrolled. Excluded were patients with PAD stage II-b or higher, peripheral venous insufficiency, cardiac, renal or hepatic insufficiency, uncontrolled hypertension, central or peripheral nervous system disorders, or myopathic or neurologic damage that impaired mobility. Intervention The massage group received a 1-hour session of connective tissue massage to the back and lower limbs twice a week for 15 weeks. The placebo group received a 30-minute session of sham (disconnected) magneto-
therapy to the lower back and popliteal regions (i.e. 15 min per zone) twice a week for 15 weeks. Main outcome measures The main outcomes were differential segmental arterial pressure, heart rate, skin temperature, oxygen saturation and skin blood flow. Main results After the 15-week program, the groups differed (P<.05) in differential segmental arterial pressure in right lower limb (lower one-third of thigh, upper and lower one-third of leg) and left lower limb (lower one-third of thigh and upper and lower one-third of leg). A significant difference (P<.05) was also observed in skin blood flow in digits 1 and 4 of right foot and digits 2, 4 and 5 of left foot. ANOVA results were significant (P<.05) for right and left foot oxygen saturation but not for heart rate and temperature. At 6 months and 1 year, the groups differed in differential segmental arterial pressure in upper third of left and right legs. Authors conclusion Connective tissue massage improves blood circulation in the lower limbs of type 2 diabetic patients at stage I or II-a and may be useful to slow the progression of PAD. Address AM Castro-Sanchez, Department of Nursing and Physical Therapy, University of Almeria, 04120 Almeria, Spain. E-mail: adelaid@ual.es
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Commentary This interesting study attempted to elucidate whether connective tissue massage therapy had any beneficial effect on peripheral vascular circulation in type 2 diabetic patients. The methodology of this study was simple yet effective to test the study hypothesis. The study clearly demonstrated that connective tissue massage improved peripheral blood flow in the lower limbs. However, it is questionable whether a similar effect also could have
been elicited using any passive form of physical exercise or remedial massage. As for the control, no intervention may have been used instead of using the disconnected magneto-therapy equipment. Authors performed a 1-year follow up and were able to demonstrate statistical differences between the intervention and placebo groups in the oxygen saturation in both feet. It would have been useful to know if this increase in oxygen saturation altered the need for
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surgical management in any of the patients involved. This piece of information would in no doubt be clinically important. It is certain that this study has contributed interesting and important knowledge towards the management of peripheral vascular disease in type 2 diabetes mellitus. Further research is needed in this area to determine how massage therapy should be performed (e.g. intensity
and frequency of massage therapy) and whether the approach used is superior to other forms of massage.
CE Danforn Lim, Faculty of Medicine, University of New South Wales, Sydney, Australia E-mail: celim@unswalumni.com NCL Cheng, Calvary Hospital, Sydney, Australia
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V I TA M I N S , M I N E R A L S A N D D I E TA R Y S U P P L E M E N T S Vaginal vitamin C tablets effective for bacterial vaginosis

DOI 10.1111/j.2042-7166.2011.01138_15.x
Petersen EE, Genet M, Caserini M, Palmieri R. Efcacy of vitamin C vaginal tablets in the treatment of bacterial vaginosis: a randomised, double blind, placebo controlled clinical trial. Arzneimittelforschung 2011; 61: 2605.
Aim To evaluate the efficacy and safety of vaginally administered vitamin C in women with bacterial vaginosis. Design Randomised, double-blind, placebo-controlled trial with two parallel arms. Setting Outpatient departments across 15 sites in Germany. Participants The trial recruited 277 women, aged 18 years or older, presenting with bacterial vaginosis and at least three of the following signs: white discharge that smoothly coats the vaginal walls, pH of vaginal fluid >4.5, a fishy odour of vaginal discharge before or after addition of 10% KOH, or the presence of clue cells on microscopic examination.
Intervention Participants administered silicon-coated vitamin C (250 mg) or placebo tablets, vaginally, once daily for 6 days. Main outcome measures The primary endpoint was the bacterial vaginosis cure rate; defined as the recovery of all inclusion criteria. Main results In the intention-to-treat (ITT) population, cure was achieved by 55.3% of patients with Vit. C (n=141) and by 25.7% of patients with placebo (n=136). The betweengroup difference was 29.6% (P<0.001). Authors conclusion The results support an effective and safe use of siliconcoated vitamin C vaginal tablets in the management of bacterial vaginosis. Address E Petersen, University of Freiburg, Freiburg, Germany. E-mail: eiko.petersen@web.de
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Commentary Bacterial vaginosis affects up to one-third of postmenopausal women, often recurs and is usually treated with topical antibiotics. In terms of complementary and alternative therapies, a Cochrane review did not find probiotics to be a useful treatment. Previous studies have suggested that vaginal vitamin C may be a useful treatment, with a possible mechanism being that it increases local acidification, thereby making up for the decrease in hydrogen peroxide that often results from a reduction in the number of lactobacilli present. This study was a well-powered, well reported, doubleblind, parallel group, RCT. The strengths of the study were the placebo-controlled, double-blind design, the solid criteria for the diagnosis of the disease [i.e. the presence of at least three of four signs of bacterial vaginosis (Amsel criteria)], and the presence of few weaknesses. As well as efficacy, the study also demonstrated the safety of the
treatment, with few adverse events reported and little difference observed between the active and placebo groups. Based on the results of this study, vitamin C can be recommended for bacterial vaginosis, particularly for women in the first trimester of pregnancy for whom some topical antibiotics are contra-indicated. Future studies could assess whether a combination of vitamin C and topical antibiotics further increases the cure rate; head-to-head studies could also compare cure rates with conventional treatment.
S Holt, School of Biological Sciences, Victoria University of Wellington, Wellington, New Zealand E-mail: holtshaun@gmail.com
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Authors reply Women of fertile age are more exposed than post-menopausal women to the risk of being affected by bacterial vaginosis; this is likely due to a higher frequency of sexual activity and a greater number of sexual partners. Pregnant women are at most risk due to the increased amount of glycogen available for bacte-
rial growth. Use of vaginal vitamin C during pregnancy could be considered a safe therapeutic tool for mother and baby.
M Genet, Scientific Department, Polichem SA, Pazzallo, Switzerland
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Bisphosphonate and vitamin D supplementation for osteoporosis

DOI 10.1111/j.2042-7166.2011.01138_16.x
Ralston SH, Binkley N, Boonen S, Kiel DP, Reginster JY, Roux C, Chen L, Rosenberg E, Santora A. Randomized trial of alendronate plus vitamin D3 versus standard care in osteoporotic postmenopausal women with vitamin D insufciency. Calcif Tissue Int 2011; 88: 48594.
Aim To compare the effectiveness of alendronate plus vitamin D with standard care in the treatment of osteoporosis. Design International, multicentre, randomised, open-label, activecontrolled trial with two parallel arms. Setting Hospitals, medical centres and research centres across multiple countries. Participants Altogether 515 post-menopausal women 65 years of age, with vitamin D insufficiency (i.e. serum 25hydroxyvitamin D level between 8 and 20 ng/ml), low bone mineral density and increased risk of falls, were recruited. Excluded were women using medications affecting bone metabolism, requiring assistance walking or standing up, demonstrating abnormal laboratory safety screening tests or electrocardiogram, or with a history of malignancy within the previous 5 years, malabsorption syndrome, uncontrolled upper gastrointestinal disorders, cardiovascular disorders, hyperparathyroidism, thyroid disease or renal disease. Intervention Participants received oral alendronate 70 mg plus vitamin D3 140 mg (5600 IU, ALN/D5600) once a week (as a combination tablet), or standard osteoporosis care, for 12 months. Main outcome measures The primary outcome was the proportion of patients with serum 25-hydroxyvitamin D levels <20 ng/ml at 6 and 12
months. Secondary outcomes were percentage change in bone mineral density (BMD; spinal and total hip) and markers of bone turnover at 12 months, rate of falls and adverse events. Main results The proportion of participants with serum 25hydroxyvitamin D levels <20 ng/ml at 6 months was 8.6% in the ALN/D5600 group vs. 31% in the active control group. At 12 months, the proportion changed to 11.3% in the ALN/D5600 group vs. 36.9% in the active control group. A significantly greater reduction in markers of bone turnover and a significant increase in bone mineral density was observed in the ALN/D5600 group when compared to the active control group at 12 months. There were no significant differences in the number of falls, adverse effects or withdrawals between the two groups. Authors conclusion Based on the finding that ALN/D5600 was more effective than standard care at correcting vitamin D insufficiency, increasing BMD, and reducing BTMs in this patient group, greater attention needs to be directed toward optimizing the treatment of osteoporosis and correcting vitamin D deficiency in postmenopausal women. Address S Ralston, Rheumatic diseases unit, Molecular medicine centre, Institute of Genetics and Molecular Medicine, Western General Hospital, University of Edinburgh, Edinburgh, UK. E-mail: stuart.ralston@ed.ac.uk
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Commentary In 2010, the Food and Nutrition Board of the US NIH increased the recommended daily allowance (RDA) for vitamin D to 15 mg (600 IU) for people under 69 years and 20 mg (800 IU) for people over 70 years; a level of intake that is not achievable without taking supplements.1,2 This paper reports the results of an intervention trial of alendronate (70 mg) plus vitamin D (140 mg or 5600 IU), administered weekly [equivalent to 20 mg (800 IU) per day], to a group of post-menopausal
women with osteoporosis, whose plasma 25hydroxyvitamin D levels were initially above the threshold for deficiency (8 ng/ml) but below the level considered to be acceptable (20 ng/ml). The results in terms of bone mineral density and markers of bone turnover are difficult to interpret since patients in the active control group received a variety of treatments; half received alendronate and most received supplements of calcium and vitamin D, although few received as much vitamin D as the intervention group.
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There was an increase in mean serum 25hydroxyvitamin D in both groups but, as expected, this was greater in those receiving the dose of vitamin D equal to the new RDA for elderly people. What is surprising is that even at this level of supplementation (in addition to vitamin D from foods and sunlight exposure), 8.6% of the patients at 6 months still had a serum 25-hydroxyvitamin D level below 20 ng/ml, rising to 11.3% at 12 months. This may suggest that the new RDA is still too low, or it may suggest that weekly consumption of a supplement differs from a daily supplement. The latter is unlikely, since it is well known that summertime sunlight exposure leads to elevated serum 25-hydroxyvitamiun D levels that persist through winter.3 Unfortunately, we are not given any information about the seasonality of the study, although it is unlikely that all subjects would have commenced and finished the 12-month trial at the same time of year. Neither is there any information about compliance with treatment. The increase in the proportion of subjects with inadequate serum 25-hydroxyvitamin D
levels from 6 to 12 months suggests a falling off in compliance.

DA Bender, Emeritus Professor of Nutritional Biochemistry, University College London, London, UK E-mail: david.bender@btinternet.com

1 Institute of Medicine, Food and Nutrition Board. Dietary Reference Intakes for Calcium and Vitamin D [online book]. Washington, DC: National Academy Press, 2010. <http:// www.iom.edu/Reports/2010/Dietary-Reference-Intakes-forCalcium-and-Vitamin-D.aspx>, accessed August 5, 2011. 2 Office of Dietary Supplements. Dietary Supplement Fact Sheet: Vitamin D [online factsheet]. Besthesda, MD: National Institutes of Health, 2011. <http://ods.od.nih.gov/ factsheets/vitamind/>, accessed August 5, 2011. 3 Bender DA. Nutritional Biochemistry of the Vitamins. Cambridge: Cambridge University Press, 2003.
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Clinical efficacy of a Phaseolus vulgaris and Cynara scolymus mixture on satiety

DOI 10.1111/j.2042-7166.2011.01138_17.x
Rondanelli M, Giacosa A, Orsini F, Opizzi A, Villani S. Appetite control and glycaemia reduction in overweight subjects treated with a combination of two highly standardized extracts from Phaseolus vulgaris and Cynara scolymus. Phytother Res 2011; 25: 127582.
Aim To evaluate the efficacy of a Phaseolus vulgaris (Pv) and Cynara scolymus (Cs) blend on the feeling of satiation in overweight subjects. Design Randomised, double-blind, placebo-controlled trial with two parallel arms. Setting Outpatient Dietetic and Metabolic Unit, Azienda di Servizi alla Persona, University of Pavia, Italy. Participants Altogether 40 overweight adults (20 in the Pv+Cs group and 20 in the placebo group), aged between 18 and 50 years, with body-mass indexes (BMI) ranging between 25 and 35 kg/m2, were randomised. Excluded were patients with critical alterations in lipid and carbohydrate metabolism, acute or disabling conditions, endocrinological, neoplastic or autoimmune diseases, heart disease, major depressive disorder, bulimia, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, bipolar I or II disorder, schizophrenia, or using psychoactive or anti-obesity drugs. One patient from the placebo group dropped out. Intervention Patients assigned to the Pv+Cs group received one tablet of BONVIT, three times a day for 8 weeks; with each tablet containing 100mg Pv and 200mg Cs. The placebo group received one placebo tablet, three times a day for 8 weeks. All patients were instructed on how to maintain
a daily energy intake 3344 kJ/day lower than the daily requirement specified by World Health Organization criteria. Main outcome measures The primary outcome, satiating capacity, was assessed using Habers scale, a VAS ranging from -10 (representing extreme hunger: painfully hungry) to +10 (representing extreme satiety: full to nausea). Secondary outcomes included variations in glucose and lipid patterns, anthropometric parameters and psychodynamic test scores. Main results At the end of treatment, the net change of the Habers mean score increased significantly in the intervention group. The net change of the glycaemia and of the dietary restriction score of the three factor eating questionnaire (TFEQ), were reduced significantly only in the intervention group. Moreover, in the supplemented group, the homeostasis model assessment, the body mass index and the susceptibility-to-hunger score of the TFEQ, decreased significantly after intervention; these parameters did not change in the controls. Authors conclusion The treatment appears potentially useful in the management of overweight and dysglycaemia. Address M Rondanelli, Department of Health Sciences, Section of Human Nutrition, Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona, University of Pavia, Pavia, Italy. E-mail: mariangela.rondanelli@unipv.it
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Commentary The authors refer to the term highly standardized extract; yet this term does not exist. When good manufacturing practice (GMP) guidelines are applied to the production of a standardised extract, all steps in the preparation, manufacture and distribution of a product are documented, including the quantity and quality of the starting material. These records enable one to access the complete history of a batch. Any deviations from protocol need to be documented and investigated. Many countries, including Italy where the patented extract is avail-
able, have legislated the GMP guidelines to ensure the safe manufacture of pharmaceutical products, including extracts. The details of the extract were not stated in the article; this is required if one is to better understand the effectiveness of the extract. What can be determined is that the aqueous extract of Phaseolus vulgaris (white bean) had a drug extract ratio of 1:1, an a-amylase inhibitor content of 714% (high-performance liquid chromatography) and a haemoagglutinin activity of 1230 HAU/mg. The 70%
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ethanolic extract of the flowering heads of Cynara scolymus (artichoke) had a drug extract ratio of 1:0.25, a caffeoylquinic acid content of 3060%, and a luteolin glycoside content of 25% (see WO 2008/107184 A1). Thus, the content of markers in the daily dose of the blend were as follows: a-amylase inhibitor 30 mg, haemoagglutinin activity 36009000 HAU/mg, caffeoylquinic acids 270 mg and luteolin glycosides 15 mg. Dietary supplements containing a-amylase and glucosidase inhibitors, so-called starch blockers, help to slow the intestinal absorption of carbohydrates.1 A specific proprietary product from the P.vulgaris (Phase 2 Carb Controller, Pharmachem Laboratories, Kearny, New Jersey, USA), at doses of 5003000 mg per day, in either a single or divided dose, has been shown to cause weight loss and reduce the postprandial spike in blood glucose levels.2 However, it remains unclear what dose is the optimum dose for weight reduction (i.e. closer to 500 mg or closer to 3000 mg/day), and what adverse events are expected with higher doses of P. vulgaris. Haemagglutinin activity is expressed as the reciprocal of the highest dilution causing agglutination (HAU/ml) multiplied by the initial dilution factor of the sample to give HAU/g dry bean weight. An activity of 1600 HAU/g has been defined as slightly raised, and may cause toxic effects.3 Is the daily consumption of lectin, with a haemagglutinin activity of 3600 9000 HAU/g, considered a safe dose, and will it be associated with toxic effects (e.g. nausea, vomiting, diarrhoea) in the long-term? Because weight reduction is measured over prolonged periods, preclinical safety studies are urgently required to rule out any harm to patient health following the long-term use of lectin. The European Scientific Cooperative on Phytotherapy monograph on Cynarae folium recommends the use of artichoke preparations for digestive complaints (e.g. stomach ache, nausea, vomiting, feeling of fullness, flatulence) and hepatobiliary disturbances. Artichoke preparations are also recommended as an adjuvant to a low-fat diet in the treatment of mild to moderate hyperlipidaemia.4 Human pharmacological studies have demonstrated that the co-active marker compounds of leaf extracts (chlorogenic acid derivatives),5 and of cooked edible heads of C. scolymus,6 but not those of luteolin derivatives, are absorbed in clinically relevant concentrations. A recent Cochrane systematic review found in three clinical studies that artichoke preparations decreased cholesterol by 4% (after 12 weeks); 9% more than placebo (after 6 weeks) in a sub-group of patients with baseline total cholesterol levels of more than 230 mg/dl.7 The patients included in the study by Rondanelli and co-workers had normal triglyceride levels and slightly elevated total and LDL cholesterol, but also slightly elevated HDL cholesterol. Some patients might have suffered from a familial lipid disorder, but this is not stated. The result table shows that the artichoke component of the mixture had no effect on the lipid levels in the per protocol
analysis. Although the authors observed a statistically significant reduction in blood glucose, this was not clinically relevant as blood glucose was normal before and after the intake of the herbal mixture. It is difficult to imagine from the description of the diet how many calories patients consumed per day. Did the patients weigh the food to ensure total caloric intake was restricted to 800 kcal? Men and women have different caloric requirements, and caloric requirements decrease with age.8 Participants ranged between 18 and 50 years of age, but was participant age and gender equally distributed across the verum and placebo groups? Since weight loss did not differ between the verum and placebo groups, it seems likely that the weight reduction was caused by caloric restriction, and that the appetite control of the herbal mixture had no significant impact on weight loss; despite the statistically significant increase in satiety. Satiety was measured on a scale ranging from -10 to 10. Is a 10% or even 15% difference in satiety (i.e. a change of 23 points from 20 points) clinically relevant in light of the fact that there is no direct relationship between satiety and caloric intake? Patients who had an afternoon snack and increased satiety did not consume less calories for dinner than those who had spared the afternoon snack.9 In summary, this 8-week randomised, double-blind, placebo-controlled study with a confirmatory study design suggests that the standardised extracts of P. vulgaris and C. scolymus have only cosmetic effects but no clinical efficacy in overweight patients.
S Chrubasik, Institute of Forensic Medicine, University of Freiburg, Freiburg, Germany E-mail: sigrun.Chrubasik@klinikum.uni-freiburg.de

1 Preuss HG. Bean amylase inhibitor and other carbohydrate absorption blockers: effects on diabesity and general health. J Am Coll Nutr 2009; 28: 26676. 2 Barrett ML, Udani JK. A proprietary alpha-amylase inhibitor from white bean (Phaseolus vulgaris): a review of clinical studies on weight loss and glycemic control. Nutr J 2011; 10: 24. 3 Rodhouse JC, Haugh CA, Roberts D, Gilbert RJ. Red kidney bean poisoning in the UK: an analysis of 50 suspected incidents between 1976 and 1989. Epidemiol Infect 1990; 105: 48591. 4 Anon. Cynarae folium. In: ESCOP (Ed). ESCOP Monographs. Stuttgart: Thieme, 2003. 5 Wittemer SM, Ploch M, Windeck T et al. Bioavailability and pharmacokinetics of caffeoylquinic acids and flavonoids after oral administration of artichoke leaf extracts in humans. Phytomedicine 2005; 12: 2838. 6 Azzini E, Bugianesi R, Romano F et al. Absorption and metabolism of bioactive molecules after oral consumption of cooked edible heads of Cynara scolymus L. (cultivar Violetto di Provenza) in human subjects: a pilot study. Br J Nutr 2007; 97: 9639.
7 Wider B, Pittler MH, Thompson-Coon J, Ernst E. Artichoke leaf extract for treating hypercholesterolaemia. Cochrane Database Syst Rev 2009; 4: CD003335. 8 Wakimoto P, Block G. Dietary intake, dietary patterns, and changes with age: an epidemiological perspective. J Gerontol A Biol Sci Med Sci 2001; 56: 6580.
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9 Schusdziarra V, Erdmann J, Schick RR. Neuroendocrine feeding regulation in the perspective of modern food supply lessons for obesity treatment. In: Parsons WV, Taylor CM (Eds). New Research on Morbid Obesity. New York: Nova Science Publishers, 2008.
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Authors reply According to Italian and European laws, adherence to good manufacturing practice guidelines is not required for the preparation of botanical derivatives for dietary supplements. Nevertheless, the company that produced the supplement for our study is strictly committed to upgrading the quality standards for these products; the term highly standardized extracts reported in the paper is related to this approach, which depicts qualified batches with full traceability. All the details of the extract have been previously described by Fantini et al,1,2 who conducted the animal experiments prior to the human study. According to a recent review,3 we have selected a range of doses of PHA that are demonstrated to actively modulate spontaneous food intake in experimental animals without inducing measurable undesired effects.1 Safety data of this supplement have also been evaluated in preclinical toxicological studies.1 None of the patients had familial lipid disorder and only some of the patients were mildly hypercholesterolaemic; for this reason, we observed a decrease in mean cholesterol level that was not statistically significant. The statistically significant reduction in glycaemia was clinically relevant due to the specific effect observed in the group of 10 patients with impaired fasting glycaemia. The five hyperglycaemic patients in the treatment group reported a net change of -22.8 11.12 mg/dl as compared to -8.0 5.65 mg/dl in the placebo group. The significant increase in satiety appears clinically relevant also because it is associated with a reduction in caloric intake, as observed in experimental animal studies with the same supplement.1,2 Age and gender were equally distributed between groups and all patients followed a personalised hypocaloric diet according to the following formula: (Harris Benedict valuephysical activity level)3344 kJ. Appetite control is a key point during a weight-loss programme because it favours compliance to diet and reduces dropout.46 While both groups lost weight at the end of the intervention, the net weight change in the supplemented group was almost twice the net-change observed in the placebo group thus showing a more favourable trend toward weight loss in the verum group. The target of the study was satiety control, not weight loss;
thus the duration of the study and the number of enrolled patients was calculated on the basis of the former end-point. On the basis of all these considerations, our study shows that supplementation with Phaseolus vulgaris and Cynara scolymus extracts plays an interesting role in the clinical management of overweight patients due to its effect on satiety.
Mariangela Rondanelli, Department of Health Sciences, Section of Human Nutrition, Pavia, University of Pavia, Pavia, Italy Attilio Giacosa, Department of Gastroenterology and Clinical Nutrition, Policlinico di Monza, Milan, Italy Francesca Orsini, Department of Health Sciences, Section of Epidemiology and Medical Statistics, University of Pavia, Pavia, Italy Annalisa Opizzi, Department of Health Sciences, Section of Human Nutrition, University of Pavia, Pavia, Italy Simona Villani, Department of Health Sciences, Section of Epidemiology and Medical Statistics, University of Pavia, Pavia, Italy
References
1 Fantini N, Cabras C, Lobina C et al. Reducing effect of a Phaseolus vulgaris dry extract on food intake, body weight, and glycemia in rats. J Agric Food Chem 2009; 57: 9316 23. 2 Fantini N, Colombo G, Giori A et al. Evidence of glycemia lowering effect by a Cynara scolymus L. extract in normal and obese rats. Phytother Res 2011; 3: 4636. 3 Pusztai A, Bardocz S, Ewen SWB. Use of plant lectins in bioscience and biomedicine. Front Biosci 2008; 13: 1130 340. 4 Melin I, Reynisdottir S, Berglund L et al. Conservative treatment of obesity in an academic obesity unit. Long-term outcome and drop-out. Eat Weight Disord 2006; 11: 2230. 5 Teixeira PJ, Going SB, Houtkooper LB et al. Pretreatment predictors of attrition and successful weight management in women. Int J Obes Relat Metab Disord 2004; 28: 1124 33. 6 Teixeira PJ, Palmeira AL, Branco TL et al. Who will lose weight? A reexamination of predictors of weight loss in women. Int J Behav Nutr Phys Act 2004; 1: 12.

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