Beruflich Dokumente
Kultur Dokumente
(Review)
Alonso-Coello P, Guyatt GH, Heels-Ansdell D, Johanson JF, Lopez-Yarto M, Mills E, Zhuo Q
This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library
2008, Issue 4
http://www.thecochranelibrary.com
TABLE OF CONTENTS
HEADER . . . . . . . . . .
ABSTRACT . . . . . . . . .
PLAIN LANGUAGE SUMMARY .
BACKGROUND . . . . . . .
OBJECTIVES . . . . . . . .
METHODS . . . . . . . . .
RESULTS . . . . . . . . . .
Figure 1.
. . . . . . . .
DISCUSSION . . . . . . . .
AUTHORS CONCLUSIONS . .
ACKNOWLEDGEMENTS
. . .
REFERENCES . . . . . . . .
CHARACTERISTICS OF STUDIES
DATA AND ANALYSES . . . . .
WHATS NEW . . . . . . . .
HISTORY . . . . . . . . . .
CONTRIBUTIONS OF AUTHORS
DECLARATIONS OF INTEREST .
SOURCES OF SUPPORT . . . .
INDEX TERMS
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[Intervention Review]
Cochrane Centre, Barcelona, Spain. 2 Health Sciences Centre, McMaster University, Hamilton, Canada. 3 Department
of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Canada. 4 College of Medicine, University of Illinois,
Rockford, Illinois, USA. 5 Obstetrics and Gynaecology, Instituto Universitario Dexeus, Barcelona, Spain. 6 Canadian College of Naturopathic Medicine, North York, Canada. 7 West China Hospital, Sichuan University, Chengdu, China
Contact address: Pablo Alonso-Coello, Iberoamerican Cochrane Centre, Hospital de la Santa Creu i Sant Pau, Sant Antoni Maria
Claret 171 (Casa de Convalescencia), Barcelona, 08041, Spain. palonso@santpau.es.
Editorial group: Cochrane Colorectal Cancer Group.
Publication status and date: Edited (no change to conclusions), published in Issue 4, 2008.
Review content assessed as up-to-date: 31 May 2005.
Citation: Alonso-Coello P, Guyatt GH, Heels-Ansdell D, Johanson JF, Lopez-Yarto M, Mills E, Zhuo Q. Laxatives for the treatment of
hemorrhoids.. Cochrane Database of Systematic Reviews 2005, Issue 4. Art. No.: CD004649. DOI: 10.1002/14651858.CD004649.pub2.
Copyright 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
ABSTRACT
Background
Symptomatic hemorrhoids are a common medical condition, which increase in prevalence in women during pregnancy and postpartum.
Although the evidence appears to be inconclusive, narrative reviews and clinical practice guidelines recommend the use of laxatives
(and fiber) for the treatment of hemorrhoids and relief of symptoms. This is due to their safety and low cost.
Objectives
To evaluate the impact of laxatives on a wide range of symptoms in people with symptomatic hemorrhoids.
Search methods
Search strategy
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2, 2005), MEDLINE (1966
to 2005), EMBASE (1980 to 2005), CINAHL (1982 to 2005), BIOSIS, and AMED (Allied and Alternative Medicine Database), for
eligible trials (including conference proceedings).
We sought missing and additional information from authors, industry, and experts in the field.
Selection criteria
We selected all published and unpublished randomised controlled trials that compared any type of laxative to placebo or no therapy in
any patient population.
Data collection and analysis
Two authors independently screened studies for inclusion and retrieved all potentially relevant studies. Data were extracted from
studies that met our selection criteria on study population, intervention used, pre-specified outcomes, and methodology. We extracted
methodological information for the assessment of internal validity: existence and method of generation of the randomization schedule,
and method of allocation concealment; blinding of caregivers and outcomes assessors; numbers of and reasons for participants lost to
follow up; and use of validated outcome measures.
Laxatives for the treatment of hemorrhoids. (Review)
Copyright 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Main results
Seven randomised trials enrolling a total of 378 participants to fiber or a non-fiber control were identified. Meta-analyses using randomeffects models showed that laxatives in the form of fiber had a beneficial effect in the treatment of symptomatic hemorrhoids. The
risk of not improving hemorrhoids and having persisting symptoms decreased by 53% in the fiber group (risk reduction (RR) 0.47,
95% CI 0.32 to 0.68). These results are compatible with large treatment effects regarding prolapse, pain, itching, although the pooled
analyses showed a tendency toward no-effect for these parametres.
The effect on bleeding showed a significant difference in favour of the fiber (RR 0.50, 95% CI 0.28 to 0.89).
Studies including data on multiple follow ups (usually after six weeks and three months) showed consistent results over time.
However, we have to stress two possible limitations of this review: the risk of publication bias, and only moderate study quality.
Authors conclusions
The use of fiber shows a consistent beneficial effect for relieving overall symptoms and bleeding in the treatment of symptomatic
hemorrhoids.
BACKGROUND
Hemorrhoidal tissue is a normal anatomic structure located in the
anal canal that plays a role in differentiating between liquids, solids,
and gas and maintaining anal continence (Beck 1998). Hemorrhoids are considered a medical condition only if symptomatic.
The dentate line divides the hemorrhoidal tissue into internal and
external hemorrhoids. Internal hemorrhoids are classically divided
into four categories depending on the degree of any prolapse (I to
IV). Recently it has been suggested that it is more appropriate to
classify internal hemorrhoids on the basis of presence or absence
of bleeding or prolapse (Abcarian 1994).
Symptomatic hemorrhoids are a common medical condition with
a prevalence ranging from 4.4% in the general population to
36.4% in general practice (Abramowitz 2001). It has been reported that one in three persons with symptomatic hemorrhoids
seek medical help (Johanson 1990). Women have an increased
OBJECTIVES
To evaluate the efficacy of laxatives for the treatment of symptomatic hemorrhoids.
METHODS
Types of studies
We considered published as well as unpublished randomised controlled trials that compared any type of laxative to placebo or no
therapy. We also considered crossover trials and quasi-randomised
methods of treatment allocation. There were no language restrictions.
Types of participants
1) People of both gender and all ages with symptomatic hemorrhoids
2) Pregnant women or women after delivery with symptomatic
hemorrhoids
Types of interventions
Any kind of laxative compared to placebo or no therapy.
Laxatives included:
1. fiber administered orally, where fiber included
- a high fiber diet, or
- bulking agents such as bran, ispaghula, psyllium
3. stimulant laxatives, for example senna and bisacodyl
4. faecal softeners, such as liquid paraffin, seed oils
5. osmotic agents, such as lactulose, magnesium hydroxide, sorbitol, and lactitol
reports on duration of follow-up, the number of discrete measurements they made, and the timing of their first follow -up measurement. Investigators first measurement of follow-up varied from
six weeks to three months - which was used for all our pooled analyses. In studies with multiple follow -ups we compared the different estimates across each study for consistency. We also included
the pooled relative risks of re-treatment, patient satisfaction, need
for additional treatment, and adverse effects.
We undertook the analysis using the intention-to-treat principle,
including all patients in the study arm to which they were originally allocated, as opposed to only those symptomatic at the start
of a study. We used Review Manager 4.2 (The Cochrane Collaboration, Oxford, UK) to aggregate data for each outcome using
a random effects model (DerSimonian 1986) We presented all
pooled effect estimates with 95% confidence intervals (CI); and
all P values were two sided.
In crossover studies, we analysed the data in the same way as for
parallel group studies, by comparing treatment periods to control
periods. This analysis was conservative both because it ignored the
decrease in variance associated with the pairing, and because any
carry-over would have reduced the magnitude of effect. We tested
for between-study heterogeneity for each pooled comparison using
the Cochrane Q statistic. We also reported the I2 statistic, which is
the proportion of total variation among studies that is likely to be
explained by between-study heterogeneity rather than by chance
(Higgins 2003). Irrespective of the results of the formal statistical
test of heterogeneity we tested whether our a priori hypotheses
could explain variability in the magnitude of treatment effects
across studies. For each hypothesis, we tested the difference in
estimates of treatment effect between the two subgroups using a
Z test and considered P value<0.05 to be statistically significant
(Fleiss 1993)
Our a priori hypotheses to explain heterogeneity were: (1) severity: smaller treatment effect in hemorrhoids grade III to IV compared to grade I to II; (2) condition: smaller treatment effect in
thrombosed hemorrhoids versus non-thrombosed; (3) intervention: smaller treatment effect in studies that used another treatment for hemorrhoids in both treatment arms (for example venotonic in both arms comparing fiber versus no fiber or placebo) (4)
methodology: smaller treatment effect in studies with adequate
allocation concealment in studies with appropriate blinding of
caregivers and smaller treatment effect in cross-over compared to
parallel trials.
RESULTS
Description of studies
See: Characteristics of included studies; Characteristics of excluded
studies.
We excluded four identified studies for the following reasons: partial duplicate publication (Hunt 1981a, Mat1996), wrong topic
or retrospective study (Gorgul 1999).
Three studies were abstracts, of which two were published later also
as full text (Hunt 1981a, Mat1996) - and subsequently included,
whereas the trial by Craven was an abstract and apparently never
published as a full article (Craven 1976).
Type of studies
Seven studies comparing fiber versus placebo met the eligibility
criteria (see Figure 1). Six used a parallel group and one a crossover design (Webster 1978).
Figure 1. Trialflow.
Participants
All trials included adults with symptomatic hemorrhoids (grades
I to III) and most patients presented with rectal bleeding as their
main complaint. Mean age for the populations studied was approximately 40 years of age (range 23 to 71). Sample sizes varied
Loss to follow up
Four studies out of the seven provided appropriate detail of the
patients lost to follow up (range 2% to 21%)
Effects of interventions
The two review authors achieved good agreement in the initial
selection of trials for inclusion from the titles (k = 0.67, 95% CI
0.48 to 0.85) and excellent agreement on the final stage of inclusion from full-text articles (k = 1.0). Six out of the seven authors
responded positively to our request for additional information regarding key validity issues and provided it. In studies that measured symptoms on more than one visit, usually at six weeks and at
three months,the results for later time points were very similar to
earlier time points. We did not observe significant heterogeneity
in our comparisons for the overall assessment but I2 ranged from
1.1% to 45.6% (substantial heterogeneity exists when I2 exceeds
50%). None of our a priori hypotheses explained the variability in
results between the studies. Crossover estimates for the different
outcomes were consistently closer to one than the parallel group
estimates, suggesting a potential carryover effect that decreased the
size of the estimate.
Overall assessment
The pooled analysis for overall improvement showed a 53% reduction in the risk of not improving or not being asymptomatic
(RR 0.47, 95% CI 0.32 to 0.68) (Broader 1974; Foster 1979;
Hunt 1981; Moesgaard 1982; Webster 1978). Results were consistent across studies (heterogeneity P value 0.40, I2 1.1%). The
pooled risk difference for being symptomatic or having persisting
symptoms for the overall assessment was -24% (95% CI -0.37 to
-0.12). The range of absolute percentages between trials for those
not improved was 0.16 to 0.40 for fiber versus 0.23 to 0.61 for
placebo.
Bleeding
Four studies that compared fiber to placebo reported bleeding as an
individual outcome (Broader 1974; Hunt 1981; Moesgaard 1982;
Webster 1978). All results showed either a trend or a significant
difference in favour of the fiber group. The pooled analysis showed
a 50% relative risk reduction in the active treatment arm (RR 0.50,
95% CI 0.28 to 0.89) No statistically significant heterogeneity was
present but I2 was moderate (P value 0.14, I2 45.6%) Pooled risk
difference for being symptomatic and having persisting symptoms
of bleeding was -0.26 (95% CI -0.44 to -0.07). The range of
absolute percentages between trials of those being symptomatic or
having persisting symptoms was 0.07 to 0.31 for fiber versus 0.38
to 0.76 for placebo.
One of the included studies provided the number of bleeding
episodes: during the first 15 days, from day 15 to 30, and from
30 to 45 days. These data could not be pooled with the rest of the
studies as the authors no longer had access to the raw data (PerezMiranda 1996). This study demonstrated a significant benefit in
the treatment group compared to placebo but only in the last two
periods (5.5 +/- 3.2 bleeding episodes versus 3.1 +/- 2.7 and 5.5+/
- 2.9 versus 1.1 +/- 1.4, respectively). There was no significant
difference in the number of patients with hemorrhoids bleeding
on contact, using an anoscope or finger (RR 0.13, 95% CI 0.01
to 2.29) (Perez-Miranda 1996).
Prolapse
The pooled analysis of the studies showed a non-significant difference between treatment and placebo for persistent prolapse (RR
0.79, 95% CI 0.37 to 1.67) (Broader 1974; Moesgaard 1982;
Webster 1978). The pooled risk difference for being symptomatic
or having persisting symptoms of prolapse was -0.08 (95% CI 0.22 to -0.06). The range of absolute percentages between trials of
those not improved was 0.03 to 0.35 for fiber versus 0.22 to 0.35
for placebo. No statistically significant heterogeneity was present
but I2 was moderate (P value 0.21, I2 35.7%). Perez-Miranda
et al likewise reported no differences in the degree of prolapse
compared with baseline, by hemorrhoidal grade (Perez-Miranda
1996).
Pain
We pooled together two studies evaluating pain or discomfort
(Broader 1974; Moesgaard 1982). The pooled estimate showed a
non significant trend in favour of fiber (RR=0.33, 95% CI 0.07
to 1.65). No statistically significant heterogeneity was present but
I2 was moderate (P value = 0.14, I2 =53%)
Itching
The two studies that evaluated itching did not find a significant
difference between the groups (RR 0.71, 95% CI 0.24 to 2.10)
(Moesgaard 1982; Webster 1978). One of the studies evaluated
a composite outcome with itching and anal secretion but authors could not provide the data for the individualcomponents
(Moesgaard 1982). No statistically significant heterogeneity was
present but I2 was moderate (P value 0.21, I2 36.4%). The range
of absolute percentages between trials of those being symptomatic
or having persisting symptoms was 0.03 to 0.40 for fiber versus
0.16 to 0.43 for placebo.
Recurrences or need for further treatment
Only one study comparing fiber with placebo looked at the number of recurrences in the long term (Jensen 1988). Jensen et al.
reported less overall recurrence in the fiber group (15% versus
45%) at 18 months in patients with third degree hemorrhoids
after rubber band ligation (RR 0.34, 95%CI 0.15, 0.77) During
the follow-up period there were fewer recurrent protrusions in the
treatment group (10%vs 38%) In the same study the number of
rubber band ligations required until disappearance of symptoms
was lower in the fiber group (median 2, range 1 to 4 versus 3,
range 1 to 5)
Adverse effects
The most common adverse effects with fiber consisted of gastrointestinal symptoms, typically starting at the beginning of the study,
and were generally not severe enough for participants to stop taking
DISCUSSION
AUTHORS CONCLUSIONS
ACKNOWLEDGEMENTS
The work of Dr Alonso-Coello is partly funded by grant 01/F070
of the Instituto de Salud Carlos III, Subdireccin General de Investigacin Sanitaria and by the Spanish Society of Family Practice
(semFYC). Dr. Alonso-Coello is a PhD candidate at the Pediatrics,
Obstetrics and Gynecology, and Preventive Medicine Department
(Universidad Autnoma de Barcelona, Espaa).
REFERENCES
Additional references
Abcarian 1994
Abcarian H, Alexander-Williams J, Christiansen J, Johanson
J, Killingback M, Nelson RL, Ries-Neto J. Benign anorectal
disease: definition, characterization and analysis of
treatment. American Journal of Gastroenterology 1994;89
(Suppl 8):S18293.
Abramowitz 2001
Abramowitz L, Godeberge P, Staumont G, Soudan D.
Clinical practice guidelines for the treatment of hemorrhoid
disease. Gastroenterologie clinique et biologique 2001;25(67):674702.
Alderson 2004
Alderson P, Green S, Higgins JPT, editors. Cochrane
Reviewers Handbook 4.2.2 [updated March 2004]..
Cochrane Database of Systematic Reviews 2004, Issue 1.
Alonso 2002
Alonso P, Marzo M, Mascort JJ, Hervas A, Vinas L, Ferrus
J, et al.Clinical practice guidelines for the management of
patients with rectal bleeding Gastroenterol Hepatol. 2002
Dec;25(10):605-32.. Gastroenterologia y hepatologia 2002;
25(10):60532.
Alonso-Coello 2003
Alonso-Coello P, Marzo M. Office evaluation and treatment
of hemorrhoids. Office evaluation and treatment of
hemorrhoids. The Journal of family practice 2003;52:
36674.
Beck 1998
Beck DE. Hemorrhoidal disease. In: Beck DE, Wexner SD
editor(s). Fundamentals of anorectal surgery. 2nd Edition.
London: WB saunders edition, 1998:23753.
Bennett 1996
Bennett WG, Cerda JJ. Dietary fiber: fact and fiction.
Digestive Disease 1996;14:4358.
Bleday 1992
Bleday R, Pena JP, Rothenberger DA, Goldberg SM, Buls
JG. Symptomatic hemorrhoids: current incidence and
complications of operative therapy. Diseases of the Colon &
Rectum 1992;35:477481.
Brisinda 2000
Brisinda G. How to treat hemorrhoids. British Medical
Journal 2000;321:58283.
DerSimonian 1986
DerSimonian R, Laird N. Meta-analysis in clinical trials.
Controlled Clinical Trials 1986;7:17788.
Devereaux 2004
Devereaux PJ, Choi PT, El-Dika S, Bhandari M, Montori
VM, Schunemann HJ, Garg AX, et al.An observational
study found that authors of randomized controlled trials
frequently use concealment of randomization and blinding,
despite the failure to report these methods. Journal of
Clinical Epidemiology 2004;57(12):123236.
Dickersin 2002
Dickersin K, Manheimer E, Wieland S, Robinson KA,
Lefebvre C, McDonald S. Development of the Cochrane
Collaborations CENTRAL Register of controlled clinical
trials. Evaluation & the health professions 2002;25(1):3864.
Fleiss 1973
Fleiss JL, Cohen J. The equivalence of weighted kappa
and the intraclass correlation coefficient as measures of
reliability. Educational and Psychological Measurement 1973;
33:61319.
Fleiss 1993
Fleiss JL. The statistical basis of meta-analysis. Statistical
methods in medical research 1993;2:12145.
Higgins 2003
Higgins JP, Thompson SG, Deeks JJ, Altman DG.
Measuring inconsistency in meta-analyses. British Medical
Journal 2003;327:55760.
Johanson 1990
Johanson JF, Sonnenberg A. The prevalence of hemorrhoids
and chronic constipation. An epidemiologic study.
Gastroenterology 1990;98(2):38086.
Johanson 1992
Johanson JF, Rimm A. Optimal nonsurgical treatment
of hemorrhhoids: a comparative analysis of infrared
coagulation, rubber band ligation,and injection
sclerotherapy. American Journal of Gastroenterology 1992;
87:1600606.
Johanson 2002
Johanson JF. Evidence-based approach to the treatment
of hemorrhoidal disease. Evidence-Based Gastroenterology
2002;3(1):2631.
Johanson 2002a
Johanson JF. Nonsurgical treatment of hemorrhoids.
Journal of Gastrointestinal Surgery 2002;6(3):29094.
Jones 2002
Jones MP, Talley NJ, Nuyts G, Dubois D. Lack of objective
evidence of efficacy of laxatives in chronic constipation.
Digestive diseases and sciences 2002;47:2222230.
Juni 2001
Juni P, Altman DG, Egger M. Systematic reviews in health
care: assesing the quality of controlled clinical trials. British
Medical Journal 2001;323:4246.
Kenny 2001
Kenny KA, Dkelly JM. Dietary fiber for constipation in
older adults: a systematic review. Clinical Effectiveness in
Nursing 2001;5:12028.
Madoff 2004
Madoff RD, Fleshman JW, Clinical Practice Committee,
American Gastroenterological Association. American
Gastroenterological Association technical review on the
diagnosis and treatment of hemorrhoids. Gastroenterology
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Perez-Miranda 1996
Perez-Miranda M, Gomez-Cedenilla A, Leon-Colombo
T, Pajares J, Mate-Jimenez J. Effect of fiber supplements
on internal bleeding hemorrhoids. Hepatogastroenterology
1996;43:1504507.
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Petticrew M, Rodgers M, Booth A. Effectivenes of laxatives
in adults. Quality in Health care 2001;10:26873.
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Tramonte SM, Brand MB, Mulrow CD, Amato MG,
OKeefe ME, Ramirez G. The treatment of chronic
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10
CHARACTERISTICS OF STUDIES
Characteristics of included studies [ordered by study ID]
Broader 1974
Methods
Randomization schedule
Patients and observer blinded Treatment and placebo looked alike
Participants
Interventions
Outcomes
Notes
Risk of bias
Item
Authors judgement
Description
Allocation concealment?
Yes
A - Adequate
Foster 1979
Methods
Participants
Interventions
Outcomes
Notes
Risk of bias
Item
Authors judgement
Description
Allocation concealment?
Unclear
B - Unclear
11
Hunt 1981
Methods
Participants
Interventions
Outcomes
-Symptomatic improvement
-Proctoscopic improvement
-Bowel habit
-Overall symptomatic improvement
Notes
Risk of bias
Item
Authors judgement
Description
Allocation concealment?
Yes
A - Adequate
Jensen 1988
Methods
Participants
Interventions
Outcomes
Notes
Open study
Risk of bias
Item
Authors judgement
Description
Allocation concealment?
Unclear
B - Unclear
12
Moesgaard 1982
Methods
Participants
Interventions
Outcomes
Bleeding
Pain at defecation
Pruritus and/or anal secretion
Prolapse
Overall assessment
Adverse events*
Notes
Risk of bias
Item
Authors judgement
Description
Allocation concealment?
Yes
A - Adequate
Perez-Miranda 1996
Methods
Participants
50 outpatients with internal bleeding hemorrhoids (I-IV) referred to colorectal outpatient clinic
Mean age 48, 42% women
Interventions
Outcomes
Notes
13
Perez-Miranda 1996
(Continued)
Risk of bias
Item
Authors judgement
Description
Allocation concealment?
No
C - Inadequate
Webster 1978
Methods
Participants
Interventions
Outcomes
Notes
Risk of bias
Item
Authors judgement
Description
Allocation concealment?
Yes
A - Adequate
14
Study
Craven 1976
Gorgul 1999
Retrospective study
Hunt 1981a
Mat 1996
15
WHATS NEW
Last assessed as up-to-date: 31 May 2005.
Date
Event
Description
5 August 2008
Amended
HISTORY
Protocol first published: Issue 1, 2004
Review first published: Issue 4, 2005
Date
Event
Description
1 June 2005
Substantive amendment
CONTRIBUTIONS OF AUTHORS
None mentioned
DECLARATIONS OF INTEREST
None known.
SOURCES OF SUPPORT
16
Internal sources
Centro Cochrane Iberoamericano (Barcelona), Spain.
Hospital de la Santa Creu i Sant Pau (Barcelona), Spain.
External sources
Instituto de Salud Carlos III. Subdireccin General de Investigacin Sanitaria, Ministerio de Sanidad y Consumo (Madrir),
Spain.
INDEX TERMS
Medical Subject Headings (MeSH)
Cathartics [ therapeutic use]; Dietary Fiber [ therapeutic use]; Hemorrhoids [complications; therapy]; Pruritus [etiology; therapy];
Randomized Controlled Trials as Topic
17