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THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE Volume 17, Number 8, 2011, pp.

741748 Mary Ann Liebert, Inc. DOI: 10.1089/acm.2010.0206

Acupuncture for Symptom Management in Hemodialysis Patients: A Prospective, Observational Pilot Study
1 1 1 Kun Hyung Kim, OMD, MS, Tae-Hun Kim, OMD, MS, Jung Won Kang, OMD, PhD, 2 1 3 1 Jae-Uk Sul, OMD, PhD, Myeong Soo Lee, PhD, Jong-In Kim, OMD, PhD, Mi Suk Shin, RN, MS, 1 1 1 1 So Young Jung, BSc, Ae Ran Kim, MS, Kyung Won Kang, MS, and Sun Mi Choi, OMD, PhD

Abstract

Objectives: Patients undergoing hemodialysis suffer from a variety of complications related to end-stage renal disease. This prospective, observational pilot study aims to determine the feasibility, safety, and possible benets of acupuncture for symptom management in patients undergoing hemodialysis. Methods: Twenty-four (24) patients undergoing hemodialysis received acupuncture treatment for their symptoms. Manually stimulated, individualized acupuncture treatments were provided twice a week for 6 consecutive weeks on a nondialysis day or on the day of hemodialysis prior to initiating treatment. Symptoms were evaluated using the Measure Your Medical Outcome Proles 2 questionnaire, and quality of life was measured by Kidney Disease Quality of Life-Short Form (KDQOL-SFTM) Version 1.3 at baseline, 7 weeks and 11 weeks from baseline. Statistical analysis was conducted on the basis of the intention-to-treat principle. Results: Twenty-one (21) patients (87%) completed the whole treatment course and follow-up evaluation. Three (3) patients dropped out due to increased fatigue (n 1), pancreatic and renal transplantation (n 1), and infections of the arteriovenous stula used for hemodialysis access (n 1). Patients experienced a signicant improvement of symptoms considered the most bothersome, reporting a decrease of 1.87 and 2.08 points on a 0 6 symptom scale at 7 weeks and 11 weeks, respectively (both p < 0.0001). Some subscales of KDQOL-SFTM showed signicant improvement at 7 weeks (effects of kidney disease, burden of kidney disease, role-limitations physical, emotional well-being, and energy/fatigue) and 11 weeks (physical functioning and energy/fatigue). No serious adverse events related to acupuncture occurred. Conclusions: Acupuncture seems feasible and safe for symptom management in patients undergoing hemodialysis. Future controlled trials are needed to conrm the benets of acupuncture.

Introduction

hronic kidney disease (CKD) and the ensuing endstage renal disease (ESRD) are major public health concerns, and the number of ESRD patients undergoing hemodialysis is increasing worldwide.13 Despite technical advances in the care of patients with ESRD, those undergoing hemodialysis suffer from a number of distressing symptoms, including bodily pain, poor mental health, fatigue, sleep disturbance and pruritus, which originate from this complex pathological condition.4 However, undertreatment of symptoms in the hemodialysis population is prevalent, which substantially increases patients symptom burden.5 Since
1 2 3

these complications negatively inuence health-related quality of life, and some of them result in increased mortality and more frequent hospitalization of patients undergoing hemodialysis.6,7 Thus, successful symptom management has been suggested as an important factor for improving patients health outcomes.8,9 In Korea, acupuncture has been used to manage a variety of chronic conditions including pain, stroke complication, facial palsy, and other diseases throughout its long history.10 Adjunctive use of acupuncture with conventional treatment has been suggested as a possible therapeutic option to achieve optimal care for patients who experience chronic illness or undergo palliative care.1113 Patients with chronic illness, but

Acupuncture, Moxibustion & Meridian Research Center, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea. Department of Oriental Rehabilitation Medicine, School of Oriental Medicine, Pusan National University, Pusan, Republic of Korea. Department of Acupuncture & Moxibustion, College of Oriental Medicine, Kyung Hee University, Seoul, Republic of Korea.

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742 not CKD, value the multidimensional effects of acupuncture, which range from reduced physical symptoms to an improved social identity.14 Holistic approaches were also identied as a characteristic feature of acupuncture treatment by patients.15,16 Despite those benets of acupuncture for patients with chronic illness, little is known about the use of acupuncture in patients undergoing hemodialysis. Thus, the role of acupuncture in those populations is worth exploring. To this end, the study aimed to determine the feasibility, safety, and possible benets of acupuncture for symptom management in patients undergoing hemodialysis, via a patient-centered approach. Materials and Methods Study design and approval This study was conducted as a prospective, before-and-after study. The relevant criteria of the Standards for Reporting Interventions in Controlled Trials of Acupuncture were used for the design and report,17 and the trial was conducted in accordance with the Declaration of Helsinki. Written consent was obtained from each participant. The study was approved by the institutional review board of Daejeon University Hospital. Participant criteria Participants eligible for this study were patients undergoing hemodialysis 3 times a week for at least 3 months, 19 years of age or older, with [e, equilibrated; K, dialyzer clearance of urea; t, dialysis time; V, volume of distribution of urea] eKt/V ! 1.2, and who were willing to participate. Participants were excluded if they had acute/chronic liver disease, events of lifethreatening cardiovascular or neurological disease within the past 6 months, a history of cancer, hemorrhagic disorders, drug abuse/alcoholism, active tuberculosis or other infectious diseases, and a history of using of acupuncture, moxibustion, or prescribed herbal medications within the past month. Participant recruitment Participants were recruited between April and October 2009 at the Acupuncture, Moxibustion, and Meridian Clinical Research Center of the Korean Institute of Oriental Medicine (KIOM), Daejeon. Recruitment was conducted through newspaper advertisements, hospital postings, referrals from nephrologists and other physicians, and notications in the CKD patient community. Upon conrmation that participants met the inclusion criteria, they were enrolled in the study and underwent 6 weeks of acupuncture treatment. Blood samples were drawn at local hemodialysis centers and were analyzed at an independent central laboratory facility. Treatment interventions Eligible patients were instructed to visit the clinical research center of KIOM on a nondialysis day or before hemodialysis on the day of dialysis, and receive acupuncture treatments twice a week for 6 consecutive weeks. Acupuncture points were selected according to traditional Korean medicine (TKM) theory, focusing on a patients unique set of symptoms/conditions and individualizing diagnosis and treatments substantially based on the distinctive constitutional energy traits.18 The acupuncture needles used were sterile, disposable needles (0.2540 mm; Dongbang

KIM ET AL. Acupuncture Inc., Chungcheongnam-do, Korea). Ten (10) to 12 acupuncture needles were inserted on the body in several locations, including the extremities, trunk, and head, avoiding the arm(s) with an arteriovenous stula (AVF) for hemodialysis access. Acupuncture needles were manually stimulated when rst placed and 15 minutes after the initial insertion of needles to elicit a de-q sensation (a dull, aching sensation). Needles were kept in place for a total of 30 minutes. After needles were removed, patients were allowed to rest in bed if needed. Treatments were delivered by 1 qualied oriental medicine doctor with 6 years of clinical experience. During acupuncture treatment, infrared irradiation was delivered to gently warm the needled area because it is often used with acupuncture in the typical clinical practice. Open communication between patients and the practitioner about the patients symptoms and general conditions was encouraged to make the practitioner aware of how patients felt about the treatment and to help them make adjustments to optimize the treatment. Concomitant treatments Routine medications for maintenance hemodialysis were continued. The medication regimen was checked at every visit, and participants were asked to inform the study coordinator of any changes to their medication/supplement regimen. Additional acupuncture treatments, herbal prescriptions, or other therapeutic interventions by other TKM doctors were not allowed during the treatment period. Outcomes The primary outcome was the Measure Your Medical Outcome Prole 2 (MYMOP2), a validated patient-centered outcome measure.19 Self-reported symptoms, limitations in daily life by those symptoms, and general well-being were lled out in the patients own words and scored on a 06 scale (0 best condition; 6 worst condition). MYMOP2 prole scores were calculated using the mean of symptom 1, symptom 2, activity and well-being scores. Since the validated Korean version of MYMOP2 was not available, the MYMOP2 questionnaire was translated into the Korean language without proper validation and it was used in this study. The secondary outcome was the Kidney Disease Quality of Life-Short Form (KDQOL-SFTM ) Version 1.3, a validated health-related quality of life questionnaire for patients with kidney disease.20 The questionnaire is composed of 18 subscales: 8 for the SF-36 and 10 for kidney disease-specic QOL. Scores range between 0 and 100 in each subscale, and a higher score reects better QOL. Both outcomes were measured by patients under the guidance of an independent assessor, who was not involved in providing acupuncture treatment or patientpractitioner communication, at baseline, post-treatment (7 weeks from baseline), and follow-up (11 weeks from baseline). Patients expectations and credibility of acupuncture treatment were also measured by selected questions from the Devilly et al. questionnaire21 at baseline and post-treatment. Statistical analysis Statistical analyses were performed using the SAS statistical package, version 9.1.3 (SAS Inc., Cary, NC), and two-

ACUPUNCTURE FOR HEMODIALYSIS PATIENTS sided p < 0.05 was regarded as signicant. Post-treatment and follow-up outcomes were compared to baseline values using either paired t tests or Wilcoxon signed-rank tests, depending on whether or not the data were normally distributed. The main analysis was intention to treat, based on participants who had baseline values for within-group comparison in each outcome and received at least one session of acupuncture treatment. Results Participant ow and baseline characteristics Of the 34 patients willing to participate in this study from six local hemodialysis centers screened, 24 patients were eligible for study participation. Ten (10) patients did not meet inclusion criteria because of eKt/V values less than 1.2 (n 5), previous cardiovascular disease within 6 months (n 2), hepatitis C virus infection (n 1), post-surgical cancer (n 1), and being unable to participate in 6 weeks of acupuncture treatment (n 1). Of the 24 enrolled patients, 21 patients completed the 6-week acupuncture treatment and follow-up evaluation. Three (3) patients dropped out due to increased fatigue (n 1), renal and pancreatic transplantation (n 1), and admission to a tertiary hospital due to infection of the arteriovenous stula (AVF) used for hemodialysis access (n 1). Other baseline characteristics of the patients are listed in Table 1. Symptoms and difculties in activities at baseline are reported in Table 2. Treatment procedure The mean number of attended treatment sessions for each patient was 10.8. The mean number of needles used was 11.9 per session. The most frequently used acupuncture points were ST36, HT7, LR3, CV4, LI11, PC6, KI3, SP3, LU9, SP6, LI4, HT8, GB39, and BL23, which were all used more than 50 times in a total of 264 sessions. Each session was broken down into 1015 minutes for patientpractitioner communication prior to needling, 1015 minutes for selecting and needling acupuncture points, and 30 minutes for needle retention and manipulation. In total, 4560 minutes were required for the entire treatment procedure. Changes in MYMOP2 subscale scores Table 3 lists the means and standard deviations (SD) of baseline MYMOP2 subscale scores and the changes of those scores at weeks 7 and 11 from baseline values. At weeks 7, the mean changes of scores in symptoms 1, 2, and MYMOP2 prole showed statistical signicance. Scores for activity and well-being subscales were not signicantly changed at weeks 7 compared to baseline. However, activity scores were signicantly changed at weeks 11 compared to baseline. Changes in KDQOL subscale scores Table 4 and 5 show the means and SD of baseline KDQOL-SFTM subscale scores and changes in scores at weeks 7 and 11 from baseline values. At weeks 7, the mean changes in two subscales related to kidney diseasespecic QOL (effects of kidney disease and burden of kidney disease) and those in three subscales representing general QOL (roleTable 1. Baseline Characteristics of the Study Participants Characteristics Male/female Age Body weight (after hemodialysis) (kg) Occupation Exercise Disease underlying ESRDa Hypertension Diabetes mellitus Glomerulonephritis CKD duration (years) Hemodialysis duration (years) Symptom duration 04 weeks 412 weeks 3 months1 year 15 years Over 5 years Previous use of CAM Acupuncture Ginseng Omega-3 fatty acids Aloes Hemoglobin (g/dL) Albumin (g/dL) Calcium (mg/dL) Phosphate (mg/dL) iPTH (pg/ml) Urea (mg/dL) Creatinine (mg/dL) eKt/V

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Study participants (n 24) 14/10 51.87 (7.22) 60.10 (9.92) 14 (58%) 11 (45%) 14 7 4 15.39 11.33 1 2 11 9 1 7 5 3 2 11.19 4.13 9.29 5.01 262.59 66.61 10.68 1.38 (58%) (29%) (16%) (7.56) (6.49) (4%) (8%) (46%) (38%) (4%) (29%) (21%) (13%) (8%) (1.36) (0.20) (0.67) (1.54) (249.43) (18.32) (2.60) (0.17)

Data are presented as either mean standard deviation or n (%), where appropriate. a Seven (7) patients reported two comorbid diseases, thus percentage of underlying disease may exceed 100%. ESRD, end-stage renal disease; CKD, chronic kidney disease; CAM, complementary and alternative medicine; CVD, cardiovascular disease; iPTH, intact parathyroid hormone; eKt/V, equilibrated dialyzer clearance of urea, dialysis time/volume of distribution of urea.

limitations physical, emotional well-being, and energy/fatigue) were signicant. At weeks 11, the mean changes in two subscales representing general QOL (physical functioning and energy/fatigue) remained signicant. Other changes after acupuncture treatment Other changes perceived by patients after acupuncture treatment are described in Table 6. Changes of credibility and expectations for acupuncture treatment are reported in Table 7. Adverse events Of the 24 patients treated, four adverse events were occurred. One (1) patient experienced increased fatigue after acupuncture treatment and opted to drop out of the study. Two (2) patients quit the trial and were admitted to the tertiary hospital for surgery: 1 who had type I juvenile diabetes for renal and pancreatic transplantation and the other for infection of the AVF for hemodialysis access. One (1)

744 Table 2. Patient-Reported Symptoms and Difculties in Daily Activities at Baseline Study participants (n 24) Symptoms Pain Fatigue Sleep disturbance Erectile dysfunction Nausea and vomiting Gastric discomfort Peripheral numbness Difculty keeping legs still (restless legs) Hot ashes (female) Rhinorrhea Affected activitiesa Occupational activity Daily activity Traveling or hobbies Exercise Volunteering 10 3 3 2 1 1 1 1 (42%) (13%) (13%) (8%) (4%) (4%) (4%) (4%)

KIM ET AL. and benecial results in this study. The patient recruitment goal was achieved within a reasonable duration, and a variety of symptoms known to be prevalent in the hemodialysis population was encompassed. The proposed treatment sessions were conducted in a consistent manner, and no patients experienced any interference with their regular hemodialysis treatment as a result of the adjunctive acupuncture treatment. Twenty-one (21) of 24 patients (87%) completed the full treatment course and follow-up evaluation. Changes in self-reported symptoms and quality of life were signicant, and some of those effects lasted until the nal assessment at weeks 11. Only 1 patient complained of increased fatigue after acupuncture and dropped out. Given that the minimal clinically important difference (MCID) of the MYMOP2, a 7-point scale questionnaire,19 is 1 point, changes of more than 1 points in symptom, activity and prole scores of MYMOP2 might imply the benecial effects of acupuncture in this study, and resonate with reported favorable effects of acupuncture in other previous trials for patients with ESRD.2231 However, neither previous studies nor this trial meet sufcient methodological standards; thus, their positive results should be carefully interpreted. Several factors may have contributed to the positive results of this study. Nonspecic effects of natural remission of symptoms and high expectations for acupuncture might be responsible for possible placebo effects in this trial. Heterogeneity of treated symptoms may have inuenced the treatment outcome differently.32 Open patientpractitioner communications aimed at tailoring acupuncture regimen based on prioritization of patients demands might affect treatment outcomes synergistically. Overall, the results of this study are likely to show possible overall benets of acupuncture when conducted in naturalistic settings, but unlikely to reect specic effects of intervention due to lack of a control group. In this study, two subscales related to compliance for dialysis treatment (dialysis staff encouragement and patient satisfaction) in KDQOL-SF showed negative changes after treatment, although there were no signicant differences and no participants interrupted their regular hemodialysis treatment during the study. Because good adherence to prescriptions and care provided by dialysis staffs are important factors for successful disease management in the ESRD

1 (4%) 1 (4%) 8 8 4 1 1 (33%) (33%) (16%) (4%) (4%)

Data are presented as n (%). a Two (2) patients lacked answers about difculties in daily activities.

patient experienced occasional inammation of the lower eyelid that subsided with antibiotics and anti-inammatory agents; however, he completed all of the treatment sessions and follow-up evaluation. Adverse events in 3 of these 4 patients other than in 1 who complained about the exacerbated fatigue were deemed unrelated to acupuncture because needles were not inserted on the AVF-located arm or acupuncture points near the lower eyelid, aseptic needling procedure was used, and sterile and single-use needles were employed. Mild and transient events, including minimal bleeding at an acupoint that were stopped in a second or small bruising, were commonly observed during the treatment phase; however, no complaints related to those events were reported by patients. Discussion It was found that acupuncture for symptom management in patients undergoing hemodialysis provided feasible, safe,

Table 3. Changes of MYMOP2 Scores from Baseline to Weeks 7 and 11a Baseline Mean (SD) Symptom 1 (n 24) Symptom 2 (n 9) Activity (n 22) Well-being (n 23) MYMOP2 prole (n 23) 4.83 4.55 4.09 3.13 4.04 (1.04) (1.13) (1.41) (1.68) (0.92) 95% CI (4.39, (3.68, (3.46, (2.40, (3.64, 5.27) 5.42) 4.71) 3.85) 4.44) Mean (SD) 1.87 1.44 0.90 0.39 1.14 (1.67) (1.81) (1.79) (1.37) (1.16) Weeks 7 95% CI (2.58, (2.83, (1.70, (0.98, (1.64, 1.16) 0.05) 0.11) 0.20) 0.64) p-Value
b

Weeks 11 Mean (SD) 2.08 1.88 1.72 0.47 1.53 (1.90) (1.16) (2.00) (1.12) (1.07) 95% CI (2.88, (2.78, (2.61, (0.96, (1.99, 1.27) 0.99) 0.83) 0.00) 1.0) p-Valueb p < 0.0001 p 0.0013 p 0.0042c p 0.2668c p < 0.0001

p < 0.0001 p 0.0436 p 0.0574c p 0.6072c p 0.0001

a Data are presented as mean (standard deviation [SD]). Some patients missed the baseline measurement and thus were excluded from analysis in relevant subscales. b Results from paired t-tests in terms of the mean reduction compared to baseline values. c Wilcoxon rank tests were used because data were not normally distributed. MYMOP, measure your medical outcome prole; CI, condence interval. p-Value of <0.05 is level of statistical signicance and is italicized in Table 3.

Table 4. Changes of Disease-Specic KDQOL Subscale Scores from Baseline to Weeks 7 and 11a Baseline Mean (SD) 75.43 68.32 33.33 52.08 81.94 77.22 69.23 64.89 69.44 82.29 57.91 59.72 (13.34) (16.28) (28.35) (40.32) (12.96) (14.30) (23.72) (20.63) (27.65) (22.69) (23.58) (23.52) (69.79, (61.44, (21.36, (35.05, (76.47, (71.18, (54.89, (56.18, (57.76, (72.70, (47.95, (49.78, 81.06) 75.19) 45.30) 69.11) 87.41) 83.26) 83.56) 73.60) 81.12) 91.87) 67.87) 69.65) 3.47 5.87 12.76 6.25 3.05 1.66 2.25 4.37 2.08 4.16 3.75 2.08 (12.15) (12.90) (25.83) (22.42) (14.30) (16.59) (23.26) (16.03) (22.68) (20.74) (22.42) (24.23) (1.66, 8.60) (0.42, 11.32) (1.85, 23.66) (3.21, 15.71) (2.98, 9.09) (5.34, 8.67) (12.53, 17.03) (2.39, 11.14) (7.49, 11.66) (12.92, 4.59) (5.71, 13.21) (12.31, 8.14) 0.1751 0.0358 0.0238 0.3750c 0.0636c 0.6274c 0.7439 0.1945 1.0000c 0.3438c 0.3018c 1.0000c 5.03 4.94 6.51 2.08 3.05 0.27 4.77 6.97 2.08 3.12 1.66 4.86 (11.09) (14.90) (20.89) (31.20) (15.09) (20.84) (27.43) (16.74) (31.20) (21.25) (16.06) (17.36) 95% CI Mean (SD) 95% CI p-Valueb Mean (SD) 95% CI (0.35, 9.71) (1.34, 11.24) (2.31, 15.33) (11.09, 15.25) (3.31, 9.43) (8.52, 9.08) (13.65, 23.20) (0.09, 14.05) (11.09, 15.25) (12.10, 5.85) (5.11, 8.44) (12.19, 2.47) Weeks 7 Weeks 11 p-Valueb 0.5034c 0.1176 0.1405 1.0000c 0.1796c 0.9485 1.0000c 0.0963c 0.7539c 0.5488c 0.2668c 0.5488c

Subscales

Symptom/problem list Effects of kidney disease Burden of kidney disease Work status Cognitive function Quality of social interaction Sexual function Sleep Social support Dialysis staff encouragement Overall health Patient satisfaction

Data are presented as mean (standard deviation [SD]). Results from paired t-tests in terms of the mean reduction compared to baseline values. c Wilcoxon rank tests were used because data were not normally distributed. KDQOL, Kidney Disease Quality of Life. p-Value of <0.05 is level of statistical signicance and is italicized in Table 4.

745 Table 5. Changes of General KDQOL Subscale Scores from Baseline to Weeks 7 and 11a Baseline Mean (SD) 68.95 53.12 62.70 41.66 63.50 72.22 71.87 46.45 (20.95) (42.54) (25.06) (29.03) (18.92) (38.90) (23.95) (19.41) (60.11, (35.15, (52.12, (29.40, (55.51, (55.79, (61.75, (38.25, 77.80) 71.09) 73.29) 53.92) 71.48) 88.65) 81.99) 54.65) 4.79 23.95 11.04 0.62 7.83 12.50 6.25 14.37 (11.37) (38.64) (20.02) (23.92) (17.98) (35.18) (28.55) (21.12) 95% CI Mean (SD) Weeks 7 95% CI (0.00, 9.59) (7.63, 40.27) (2.58, 19.49) (9.47, 10.72) (0.23, 15.42) (2.35, 27.35) (5.80, 18.30) (5.45, 23.29) p-Valueb 0.1435c 0.0063 0.3323c 0.6476c 0.0437 0.1094c 0.3018c 0.0029 Mean (SD) 5.20 17.70 8.85 4.16 3.16 2.77 7.81 10.41 (10.05) (35.72) (29.59) (22.63) (18.83) (32.47) (23.83) (22.35) Weeks 11 95% CI (0.96, 9.45) (2.62, 32.79) (3.64, 21.35) (5.39, 13.72) (4.78, 11.11) (16.49, 10.93) (2.25, 17.87) (0.97, 19.85) p-Valueb 0.0184 0.1094c 1.0000c 0.3765 0.8145c 1.0000c 0.1220 0.0320

Subscales

Physical functioning Role-limitations physical Pain General health Emotional well-being Role-limitations emotional Social function Energy/fatigue

Data are presented as mean (standard deviation [SD]). Results from paired t-tests in terms of the mean reduction compared to baseline values. c Wilcoxon rank tests were used because data were not normally distributed. KDQOL, Kidney Disease Quality of Life; CI, condence interval. p-Value of <0.05 is level of statistical signicance and is italicized in Table 5.

746 Table 6. Other Changes After Acupuncture Treatment Measured by MYMOP2 Number of responses Current user of prescribed conventional medications at baseline Cutting down your medication is very important A bit important Changes of prescribed medications in respondersa Reduced medication at week 7 Dropped out Perceived changes after acupuncture at weeks 7 or 11b Symptom relief Increased self-condence Having a positive attitude Improved systemic circulation Beginning exercise No benecial effect 5 4 1 2a 3 15 8 3 1 1 1 1

KIM ET AL. be addressed when designing an acupuncture regimen. For instance, it would be recommended to select acupuncture points other than an AVF-located arm as was done in this trial to prevent potential risks of acupuncture-associated infection at AVF, or to adjust the intensity of stimulation or depth of needling according to patients response rather than xed intensity of acupuncture. Further clinical data are needed to conrm the safety of acupuncture in patients undergoing hemodialysis. Assuming that acupuncture affects symptom relief in patients undergoing hemodialysis, the potential mechanism of acupuncture may be of interest. As chronic inammation in CKD and dialysis patients has been suggested to be associated with several symptoms including fatigue,39 sleep disturbance,40 and depression,41 and with decreased survival,42 anti-inammatory effects of acupuncture based on experimental and clinical research may be one possible explanation for symptom relief in patients undergoing hemodialysis.43,44 Opioid-regulation effects of acupuncture may inuence pain and pruritus in patients undergoing hemodialysis, as both conditions have similar patterns of activation45 and can be treated by opioid-regulative interventions.46,47 However, none of the suggested theories is fully established, and the myriad complex contributors of symptoms in hemodialysis prevents clear speculation about the mechanism by which acupuncture might affect those conditions.38 Major limitations in this study include lack of a control group and heterogeneity of treated symptoms. Because the main purpose was not to show net efcacy of acupuncture treatment for specic symptoms but to identify whether acupuncture treatment was feasible and acceptable for management of various symptoms in the hemodialysis population, those shortcomings should be addressed by a further controlled trial called for by the preliminary results. Short duration of follow-up prevents considering the longterm effects of acupuncture in this population, and longer follow-up periods are needed in future trials. Translation of MYMOP2 into the Korean language without proper validation might cause undesirable misunderstandings of original questions in the English version, and affect outcome measurements. Another aw might refer to possible diversity of dialysis delivery and general management by nephrologists. Patients were from six different local dialysis centers; thus, different dialysis-related factors such as dialysates, dialyzermembranes and units might affect study results and be a source of bias. Nevertheless, patients were enrolled who were receiving regular hemodialysis 3 times a week and whose Kt/V is the same or more than 1.2 to ensure that

Data are presented as numbers. a One for sleep medication and the other for analgesics. b Patients own responses to an open-ended question in MYMOP2 (Measure Your Medical Outcome Prole) were summarized.

population,33 attention should be paid not to violate relationships between dialysis patients and their staff when considering complementary and alternative treatments in research circumstances or clinical practices. Potential risks of CAM therapies in patients with CKD has previously been discussed in the literature.34,35 The most concerning risk of CAM therapies is the potential harm of herbs/supplements due to the lack of renal excretory capacity.35 However, acupuncture is a non-pharmacological intervention and, therefore, is unlikely to involve altered pharmacokinetics or drug interactions of patients undergoing hemodialysis, which limits the conventional use of both drug and herbal remedies in the general population. It has also been found that acupuncture is a safe therapeutic modality when practiced by qualied practitioners with relevant medical experience using disposable and sterile needles.36,37 Nevertheless, patients undergoing hemodialysis are exposed to increased risk of local inammation due to routine access of dialysis through AVF and altered innate immune activity.38 Some patients with altered autonomic nerve function by chronic uremia might be oversensitive to acupuncture stimulation. To minimize those risks of acupuncture-associated adverse events, special concerns should

Table 7. Credibility and Patient Expectations of Acupuncture Treatment at Baseline and Week 7a Questionsb Q 1. Q 2. Q 3.c
a b

Baseline

Weeks 7

How logical does it seem that acupuncture treatment would be offered to you? 6.50 (1.66) 6.61 (2.26) How condent would you be in recommending this treatment to a friend 6.50 (1.56) 6.42 (2.20) undergoing hemodialysis? How helpful do you think this acupuncture treatment will be in reducing your symptoms? 6.20 (1.71) 6.95 (2.37)

Data are presented as mean (standard deviation [SD]). Q 1. and Q 2. refer to credibility and Q 3. to patients expectations of acupuncture, respectively. Scoring of each question is based on a 19 scale, with higher scores reecting higher credibility or expectation. c Tenses were converted appropriately to reect the timing of the measurements (at baseline and weeks 7).

ACUPUNCTURE FOR HEMODIALYSIS PATIENTS standard hemodialysis treatments were provided. In a future trial, controlling dialysis-related factors to minimize their potential inuences on the study would be needed, if possible. Conclusions In conclusion, this preliminary study showed the feasibility and possible benets of individualized acupuncture treatment for symptom management of patients undergoing hemodialysis in the context of a patient-centered approach. Reducing complications and symptoms as well as improving whole-body care by collaboration across different health care disciplines were prioritized research topics by CKD patients,48 and partially administered by this pilot trial. Nevertheless, this small, uncontrolled pilot study has substantial sources of bias. Hence, well-designed, larger controlled trials are needed to conrm the benets of acupuncture in patients undergoing hemodialysis. Acknowledgments We thank the patients who participated in this research. We also thank the local dialysis staffs for their help in the study. Hee Jung Jung contributed to this research by conducting data input. Seung Yeon Na, MD, gave helpful comments for the manuscript preparation. Professor Se Hyun Kim provided helpful comments for the use of KDQOL-SF questionnaire. We are thankful to Dr. Charlotte Paterson for her helpful advice on the use and analysis of MYMOP2. This study was supported by the Development of Acupuncture, Moxibustion and Meridian Standard Health Technology Project (K10010) of the Korea Institute of Oriental Medicine. Trial Registration at http:/ /clinicaltrials.gov (identier: NCT00883831). Disclosure Statement No competing nancial interests exist. References
1. Zoccali C, Kramer A, Jager K. The databases: Renal replacement therapy since 1989. The European Renal Association and European Dialysis and Transplant Association (ERA-EDTA). Clin J Am Soc Nephrol 2009;S18S22. 2. Meguid El Nahas A, Bello AK. Chronic kidney disease: The global challenge. Lancet 2005;365:331340. 3. U.S. Renal Data System. USRDS 2009 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2009. 4. Tong A, Sainsbury P, Chadban S, et al. Patients experiences and perspectives of living with CKD. Am J Kidney Dis 2009;53:689700. 5. Claxton RN, Blackhall L, Weisbord SD, Holley JL. Undertreatment of symptoms in patients on maintenance hemodialysis. J Pain Symptom Manage 2010;39:211218. 6. Lopes AA, Bragg J, Young E, et al. Depression as a predictor of mortality and hospitalization among hemodialysis patients in the United States and Europe. Kidney Int 2002; 62:199207. 7. Elder SJ, Pisoni RL, Akizawa T, et al. Sleep quality predicts quality of life and mortality risk in haemodialysis patients: 21. 9. 10.

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Results from the Dialysis Outcomes and Practice Patterns Study (DOPPS). Nephrol Dial Transplant 2008;23:9981004. Mapes DL, Lopes AA, Satayathum S, et al. Health-related quality of life as a predictor of mortality and hospitalization: The Dialysis Outcomes and Practice Patterns Study (DOPPS). Kidney Int 2003;64:339349. Rastogi A, Linden A, Nissenson AR. Disease management in chronic kidney disease. Adv Chronic Kidney Dis 2008;15:1928. Kim YS, Jun H, Chae Y, et al. The practice of Korean medicine: An overview of clinical trials in acupuncture. Evid Based Complement Alternat Med 2005;2:325352. Standish LJ, Kozak L, Congdon S. Acupuncture is underutilized in hospice and palliative medicine. Am J Hosp Palliat Care 2008;25:298308. Johnstone PA, Polston GR, Niemtzow RC, Martin PJ. Integration of acupuncture into the oncology clinic. Palliat Med 2002;16:235239. Greco CM, Kao AH, Maksimowicz-McKinnon K, et al. Acupuncture for systemic lupus erythematosus: A pilot RCT feasibility and safety study. Lupus 2008;17:11081116. Paterson C, Britten N. Acupuncture for people with chronic illness: Combining qualitative and quantitative outcome assessment. J Altern Complement Med 2003;9:671681. Gould A, MacPherson H. Patient perspectives on outcomes after treatment with acupuncture. J Altern Complement Med 2001;7:261268. Paterson C, Britten N. The patients experience of holistic care: Insights from acupuncture research. Chronic Illn 2008;4:264277. MacPherson H, White A, Cummings M, et al. Standards for reporting interventions in controlled trials of acupuncture: The STRICTA recommendations. Complement Ther Med 2001;9:246249. Lee MS, Shin BC, Choi SM, Kim JY. Randomized clinical trials of constitutional acupuncture: A systematic review. Evid Based Complement Alternat Med 2009;6(suppl 1):5964. MYMOP. Online document at: http:/ /sites.pcmd.ac.uk/ mymop/ Accessed April 27, 2011. Park HJ, Kim S, Yong JS, et al. Reliability and validity of the Korean version of Kidney Disease Quality of Life instrument (KDQOL-SF). Tohoku J Exp Med 2007;211:321329. Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry 2000;31:7386. Gao H, Zhang W, Wang Y. Acupuncture treatment for 34 cases of uremic cutaneous pruritus. J Tradit Chin Med 2002;22:2930. Rui H, Lin W, Sha J. Observation on therapeutic effect of 80 cases of uremic cutaneous pruritus treated with acupuncture. Zhongguo Zhen Jiu 2002;22:235256. Che-yi C, Wen CY, Min-Tsung K, Chiu-Ching H. Acupuncture in haemodialysis patients at the Quchi (LI11) acupoint for refractory uraemic pruritus. Nephrol Dial Transplant 2005;20:19121915. Jedras M, Bataa O, Gellert R, et al. Acupressure in the treatment of uremic pruritus. Dial Transplant 2003;32:810. Zhu LF, Pan XH, Zhou C, Huang KQ. Effects of adjunctive acupressure for muscle cramps of lower extremities in patients undergoing hemodialysis. Mod J Integr Tradit Chin West Med 2006;17:23472348. Dai XJ, Xing XY, Shi Y, et al. Lower extremity point massage for improving quality of sleep in patients with end-stage renal disease: A clinical study of 42 cases. J Tradit Chin Med 2007;48:4446.

8.

11.

12.

13.

14.

15.

16.

17.

18.

19. 20.

22.

23.

24.

25. 26.

27.

748
28. Tsay S, Rong J, Lin P. Acupoints massage in improving the quality of sleep and quality of life in patients with end-stage renal disease. J Adv Nurs 2003;42:134142. 29. Cho Y, Tsay S. The effect of acupressure with massage on fatigue and depression in patients with end-stage renal disease. J Nurs Res 2004;12:5159. 30. Tsay SL, Cho YC, Chen ML. Acupressure and transcutaneous electrical acupoint stimulation in improving fatigue, sleep quality and depression in hemodialysis patients. Am J Chin Med 2004;32:407416. 31. Tsay S. Acupressure and fatigue in patients with end-stage renal disease: A randomized controlled trial. Int J Nurs Stud 2004;41:99106. 32. Krogsbll LT, Hrobjartsson A, Gtzsche PC. Spontaneous improvement in randomised clinical trials: Meta-analysis of three-armed trials comparing no treatment, placebo and active intervention. BMC Med Res Methodol 2009;9:1. 33. Loghman-Adham M. Medication noncompliance in patients with chronic disease: Issues in dialysis and renal transplantation. Am J Manag Care 2003;9:155171. 34. Markell MS. Potential benets of complementary medicine modalities in patients with chronic kidney disease. Adv Chronic Kidney Dis 2005;12:292299. 35. Duncan HJ, Pittman S, Govil A, et al. Alternative medicine use in dialysis patients: Potential for good and bad! Nephron Clin Pract 2007;105:c108c113. 36. MacPherson H, Thomas K, Walters S, Fitter M. The York acupuncture safety study: Prospective survey of 34,000 treatments by traditional acupuncturists. BMJ 2001;323:486487. 37. Ernst G, Strzyz H, Hagmeister H. Incidence of adverse effects during acupuncture therapy: A multicentre survey. Complement Ther Med 2003;11:9397. 38. Bergstrom J, Lindholm B, Lacson E Jr, et al. What are the causes and consequences of the chronic inammatory state in chronic dialysis patients? Semin Dial 2000;13:163175. 39. Jhamb M, Weisbord SD, Steel JL, Unruh M. Fatigue in patients receiving maintenance dialysis: A review of denitions, measures, and contributing factors. Am J Kidney Dis 2008;52:353365.

KIM ET AL.
40. Chen HY, Chiang CK, Wang HH, et al. Cognitive-behavioral therapy for sleep disturbance in patients undergoing peritoneal dialysis: A pilot randomized controlled trial. Am J Kidney Dis 2008;52:314323. 41. Cukor D, Cohen SD, Peterson RA, Kimmel PL. Psychosocial aspects of chronic disease: ESRD as a paradigmatic illness. J Am Soc Nephrol 2007;18:30423055. 42. Cohen SD, Phillips TM, Khetpal P, Kimmel PL. Cytokine patterns and survival in haemodialysis patients. Nephrol Dial Transplant 2010;25:12391243. 43. Garcia GE, Ma S, Feng L. Acupuncture and kidney disease. Adv Chronic Kidney Dis 2005;12:282291. 44. Kavoussi B, Ross BE. The neuroimmune basis of anti-inammatory acupuncture. Integr Cancer Ther 2007;6:251 257. 45. Yosipovitch G, Greaves MW, Schmelz M. Itch. Lancet 2003;361:690694. 46. Zhao ZQ. Neural mechanism underlying acupuncture analgesia. Prog Neurobiol 2008;85:355375. 47. Wikstrom B, Gellert R, Ladefoged SD, et al. Kappa-opioid system in uremic pruritus: Multicenter, randomized, doubleblind, placebo-controlled clinical studies. J Am Soc Nephrol 2005;16:37423747. 48. Tong A, Sainsbury P, Carter SM, et al. Patients priorities for health research: Focus group study of patients with chronic kidney disease. Nephrol Dial Transplant 2008;23:32063214.

Address correspondence to: Sun Mi Choi, OMD, PhD Acupuncture, Moxibustion & Meridian Research Center Korea Institute of Oriental Medicine 461-24, Jeonmin-dong, Yuseong-gu Daejeon 305-811 Republic of Korea E-mail: smchoi@kiom.re.kr

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