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Laxatives for the treatment of hemorrhoids.

(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

Laxatives for the treatment of hemorrhoids. (Review)


Copyright 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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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Laxatives for the treatment of hemorrhoids. (Review)


Copyright 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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[Intervention Review]

Laxatives for the treatment of hemorrhoids.


Pablo Alonso-Coello1 , Gordon H Guyatt2 , Diane Heels-Ansdell3 , John F Johanson4 , Maite Lopez-Yarto5 , Ed Mills6 , Qi Zhuo7
1 Iberoamerican

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.

PLAIN LANGUAGE SUMMARY


Laxatives for the treatment of hemorrhoids
Symptomatic hemorrhoids are a common medical condition but what causes them is not completely understood. Minimizing constipation with its associated prolonged straining may affect both lifestyle measures and medicines used as treatments for symptomatic
hemorrhoids.
This systematic review suggests a beneficial effect of laxatives in the form of fiber for improving symptoms of hemorrhoids, especially
bleeding. The improvement, halving the risk of having overall symptoms, was consistent over up to three months follow up. The results
for other symptoms such as prolapse, pain or itching were not clear from the included trials.
The relatively small number of patients enrolled in trials to date could argue for the need for additional larger trials.

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

prevalence during pregnancy and in the postpartum period (Beck


1998). However, the pathophysiology is not completely understood other than that structural and vascular changes are involved
(Beck 1998); chronic straining is inconsistently associated with
symptomatic hemorrhoids (Johanson 1990).
Symptomatic hemorrhoids are generally considered a benign condition but can be bothersome for some patients. Bleeding and
prolapse represent the most common symptoms but patients may
also experience discomfort, pain, and soiling or mucous discharge
associated with local irritation and itching. Internal hemorrhoids
are usually painless and it is any bleeding or prolapse that takes a
person to the physician. Bleeding is usually described as bright red
spotting on toilet tissue, or dripping in the toilet bowl and occurs
at the end of defecation, separate from the stool. External hemorrhoids can be asymptomatic or associated with discomfort and

Laxatives for the treatment of hemorrhoids. (Review)


Copyright 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

acute pain in the case of a local thrombosis. All these symptoms


are, however, not specific for hemorrhoids and a diagnosis requires
clinical examination: anorectal examination, digital palpation, and
anoscopy or colonoscopy in some cases (Alonso-Coello 2003).
The decision whether or not to treat hemorrhoids depends on the
frequency and severity of symptoms. The initial approach usually takes place in primary care and for most people this is the
only treatment they need (Grades I to II). Traditional conservative
treatment to relieve symptoms includes increasing the amount of
fiber and water intake in the diet, fiber supplements, and topical
therapies (steroids, anesthetics). Some people may benefit from
avoiding certain foods or from a short course of venotonics (such
as flavonoids).
Clinicians may recommend either non-surgical treatment (for example rubber band ligation) or surgical interventions (hemorrhoidectomy) in people who do not improve with the initial treatments, or in people with a more significant degree of prolapse
(grades III to IV) (Abramowitz 2001; Brisinda 2000). These procedures fix the sliding hemorrhoidal tissue back onto the muscle
wall of the anal canal. Tissue fibrosis (for example sclerotherapy,
or infrared coagulation), or tissue destruction with subsequent
fibrosis (as with hemorrhoidectomy) can achieve tissue fixation
(Johanson 1992). Only about 10% of people require surgical treatment (hemorrhoidectomy) either due to the severity of the disease
or failure of conservative measures (Bleday 1992).
To minimize constipation, and the prolonged straining that may
be associated with it, is one of the main purposes of lifestyle measures and medical treatment. The initial approach is to increase the
amount of water and fiber in the diet, or to introduce a laxative.
Constipation may be due to low fluid intake (Petticrew 2001) but
the effectiveness of increasing fluid intake as a treatment for constipation remains unknown. Dietary fiber intake has been positively associated with increases in bowel movement frequency and
fecal mass among individuals with occasional or mild constipation
(Bennett 1996; Spiller 1994). In randomised trials other types of
laxatives (stimulant laxatives, osmotic agents, and fecal softeners)
have shown some effectiveness for the treatment of constipation
(Jones 2002; Kenny 2001; Petticrew 2001; Tramonte 1997) but
poor study methodology has not allowed clear evidence.
Several small clinical trials have evaluated the effect of fiber compared with placebo in people with hemorrhoids (Moesgaard 1982;
Perez-Miranda 1996). Authors of narrative reviews (Johanson
2002; Johanson 2002a) and clinical practice guidelines (Alonso
2002; Madoff 2004) have found the evidence inconclusive but
overall recommend the use of fiber due to its safety and low cost
(Johanson 2002a).
We have conducted a systematic review of the impact of laxatives
on a wide range of symptoms in people with symptomatic hemorrhoids in order to establish the strength of the available evidence.

OBJECTIVES
To evaluate the efficacy of laxatives for the treatment of symptomatic hemorrhoids.

METHODS

Criteria for considering studies for this review

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

Types of outcome measures


Any of the following outcomes as recorded in a study:
- individual or global symptom improvement;
-number of recurrences in a time period;
-change in the degree of prolapse;
-need for surgical treatment;
-adverse effects.
We contacted authors to obtain additional data and details about
the key validity methods.

Laxatives for the treatment of hemorrhoids. (Review)


Copyright 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Search methods for identification of studies


We searched the Cochrane Central Register of Controlled Trials
(CENTRAL) (The Cochrane Library Issue 2, 2005), the OVID
versions of MEDLINE (1966 to April Week 2 2005), EMBASE
(1980 to 2005, week 17), CINAHL (Cumulative Index to Nursing
& Allied Health Literature) (1982 to April Week 4 2005), limiting
our searches to randomised controlled trials using the Cochrane
highly sensitive search strategy (Appendix 1) (Dickersin 2002).
We modified the searches for the databases CENTRAL, BIOSIS,
and AMED (Allied and Alternative Medicine Database), also including conference proceedings. The contact author (PA) can provide the full details of search strategies. The authors screened reference lists from all retrieved articles, and from reviews and clinical practice guidelines (Alonso 2002; Johanson 2002; Johanson
2002a; Madoff 2004) to identify additional studies. Furthermore,
we sought additional trials from pharmaceutical companies and
experts in the field. Finally, we searched for on-going trials in the
Meta Register of Controlled Trials (mRCT), US NIH register, and
the Register of the Center for Clinical Trials and Evidence-Based
Healthcare.

Data collection and analysis


Data abstraction
Two authors (EM, PA) independently screened identified studies
for inclusion, and extracted data on study population, intervention, pre-specified outcomes, and methodology from included trials. In both phases, we resolved disagreements by consensus between authors, if unsolved after contacting study authors for further information. We used Cohens kappa to assess agreement between the two authors on the selection of articles for inclusion
(Fleiss 1973).
Validity assessment
We extracted methodological information for the assessment of
internal validity (Alderson 2004): existence and method of generation of the randomization schedule, and method of allocation
concealment (Juni 2001); blinding of caregivers and outcomes assessors; number and reasons of patients lost to follow-up; and use
of validated outcome measures.
Quantitative data synthesis
Trials did not consistently use the same symptom measures; all of
them, however, recorded the proportion of patients either free of
symptoms, with symptom improvement, or still symptomatic. We
considered the outcomes patients free of symptoms and patients
with symptomatic improvement as equivalent, and pooled each
outcome of interest based on the a priori expectation of a similar
magnitude and direction of treatment effect.
Results were presented as the relative risk of being symptomatic
and not having improved. We also calculated pooled risk differences for being symptomatic or persisting symptoms for the different outcomes. There was a pronounced heterogeneity in the trial

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.

Laxatives for the treatment of hemorrhoids. (Review)


Copyright 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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

between 28 and 92 with a mean of around 50 patients. We did not


locate any studies with thrombosed hemorrhoids or with a focus
on pregnant women.
Interventions

Laxatives for the treatment of hemorrhoids. (Review)


Copyright 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

All articles comparing laxatives evaluated the use of fiber versus


placebo. We did not identify any studies using other types of laxatives. The types of fiber studied were Ispaghula husk (three trials),
plantago ovata or psyllium (two trials), sterculia (one trial) and
unprocessed bran (one trial).
Outcomes
Most trials assessed the degree of improvement of individual
(bleeding, pain, itching, and prolapse) or overall symptoms, by
patient. Some of the studies used categorical scales (for example
no symptoms, better, same, or worse) (Broader 1974; Moesgaard
1982; Webster 1978), others used a visual analogue scale (VAS)
(Jensen 1988), or, as in the case of the included abstracts, did
not describe the outcome measures (Foster 1979; Hunt 1981).
Some studies provided absolute numbers by dichotomizing the
results and presenting the number of patients who were symptom
free, or lumping patients with no symptoms or better together
(Moesgaard 1982); while others provided the average number of
bleeding episodes for a certain time period (Perez-Miranda 1996).
In the first RCT describing the use of fiber for hemorrhoids,
Broader et al. randomised 40 unselected outpatients who had internal hemorrhoids with anal bleeding, prolapse, or discomfort to
a bulk-forming agent (sterculia) or a non-bulk forming placebo
(starch) (Broader 1974). Treatment duration was three months
and symptom assessment was performed every month. The outcomes included single symptom improvement (bleeding, prolapse,
or discomfort) measured monthly or patients overall impression.
Webster et al used a crossover design to evaluate the effect of ispaghula versus placebo and randomized 67 patients to two sixweek treatment periods. There was no reporting of a washout period (Webster 1978). Participants comprised those who were referred to an outpatient surgery clinic with symptomatic hemorrhoids (Grades I to III) and 43% of them had had their symptoms for more than a year. Concomitant laxatives were allowed.
Outcome assessment took place at six and 12 weeks and included:
individual symptoms and overall improvement (better, same or
worse), laxative use, ease of defecation, bowel habit, and palatability of the intervention. Six patients (11%) complained of constipation on admission to the trial.
Moesgaard et al. randomised 52 patients,with grades I to III hemorrhoids to psyllium seed dietary fiber versus placebo (12% patients with constipation at baseline) (Moesgaard 1982). Treatment
duration was six weeks. Symptoms (bleeding; pain at defecation;
a composite of pruritus, anal secretion, and prolapse) and endoscopic assessment took place at three and six weeks. Patient overall
assessment was a composite of the patients with no symptoms or
feeling better compared with the remainder of patients (same or
worse).
Perez-Miranda et al randomised 50 consecutive patients with
bleeding hemorrhoids to a preparation of plantago ovata or placebo
(vitamin B preparation) taken over 15 days (Perez-Miranda 1996).
The investigators assessed the number of rectal bleeding episodes
at 15, 30 and 45 days. During anoscopy, they assessed: the degree

of prolapse, presence of hemorrhoids bleeding on contact, and the


number of congested haemorrhoidal cushions. They also assessed
the degree of prolapse as the patient performed a Valsalva manoeuvre.
Foster et al published a study, only available as an abstract, where
they randomised 41 patients to ispaghula or a matching placebo.
Evaluation of overall symptom improvement and anal and rectal
pressure took place after one month of treatment (Foster 1979).
This was the only trial in which authors failed to respond to our
request for clarification and additional information.
Hunt et al randomised 28 patients with bleeding hemorrhoids
(grade I to II degree) to six weeks of treatment with ispaghula
Husk or placebo (Hunt 1981). The study was published originally
as an abstract (Hunt 1981a) and later the same year as a letter
by the same authors. One of the origional authors was unable to
provide any additional data. The outcomes assessed were: number of patients with rectal bleeding, severity of hemorrhoids, and
ease of defecation. Sixty eight per cent of patients presented with
constipation at baseline.
Jensen et al studied a different population from the rest of the studies (Jensen 1988). The authors randomized 92 patients with thirddegree hemorrhoids (grade III) to rubber band ligation (RBL) plus
bran versus RBL alone and followed patients for 18 months. An
independent observer assessed patients every six months using a
visual analogue scale (0 to 10, where 0 meant no symptoms and
10 severe symptoms). Authors considered the number of rubber
band ligations until disappearance of symptoms, recurrent symptoms (by individual symptoms and global number), and adverse
effects as the main outcomes

Risk of bias in included studies


The reported quality was generally low with very little detail provided concerning key validity methodologies such as allocation
concealment. When contacted directly the majority of authors
provided additional information that generally indicated they had
met methodological criteria. This finding is in agreement with
recent data suggesting authors typically use concealment of randomisation and blinding despite the failure to report these methods (Devereaux 2004). None of the included studies used validated questionnaires to assess study outcomes.
Randomisation and allocation concealment
Most studies provided additional information about the generation and method of randomisation. Four out of seven used an
adequate method of allocation concealment, one was inadequate
and two did not provide any information.
Blinding
Five studies used the term double blind. Out of these five, four
of them reported or informed us about the level of blinding. In
three trials, both patients and data collectors were blinded and in
another one data collectors and analysts (Perez-Miranda 1996).
One trial reported the use of an independent observer but did not
report blinding status of the rest of the participants (Jensen 1988).

Laxatives for the treatment of hemorrhoids. (Review)


Copyright 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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

Laxatives for the treatment of hemorrhoids. (Review)


Copyright 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

the treatment. Adverse effects were inconsistent with some studies


reporting a 50% incidence of bloating, the most common complaint, in the treatment group versus none in the placebo group
(Jensen 1988). Two of the studies did not observe any adverse effects (information provided by authors) (Hunt 1981; Moesgaard
1982)

we failed to identify additional unpublished studies with small or


absent treatment effects our results may represent an overestimate
of the true underlying effect of treatment. We believe, however,
that the limitations outlined above are relatively minor and that
the inferences drawn are moderately strong. In summary, fiber
shows a consistent beneficial effect for overall symptoms as well as
bleeding in the treatment of symptomatic hemorrhoids.

DISCUSSION

AUTHORS CONCLUSIONS

In this systematic review we found that fiber had a beneficial effect


in the treatment of symptomatic hemorrhoids. The risk of not
improving or having persisting symptoms decreased by 53% in
the fiber group (RR 0.47, 95% CI 0.32 to 0.68) and the risk of
bleeding showed a significant difference in favour of fiber (RR
0.50, 95% CI 0.28 to 0.89). We also found that in studies with
multiple follow ups, usually at six weeks and at three months, the
results for later time points were very similar to earlier time points.
Results are also compatible with large treatment effects in prolapse,
pain, itching, but even in the pooled analyses confidence intervals
were wide and compatible with no effect (RR=0.79, 95% CI 0.37
to 1.67; RR=0.33, 95% CI 0.07 to 1.65; and RR=0.71, 95% CI
0.24 to 2.10 respectively). Results showed a non-significant trend
toward increases in mild adverse events in the fiber group (RR=
6.0, 95% CI 0.57 to 64.8).
One of the few outcomes that failed to show a relative improvement with fiber was the degree of prolapse. This is not surprising
as prolapse, as opposed to bleeding or itching, involves a structural
change that is unlikely to improve with a change in the consistency
of feces or the frequency of defecation. In other words, damage
to the connective tissue that supports the hemorrhoidal cushions
resulting from chronic straining is not likely to improve with fiber
supplementation alone.
Fiber is generally used in patients suffering from first and seconddegree hemorrhoids, that is those with a lesser component of prolapse. Most trials evaluated grade I to II hemorrhoids, and the
studies that included mixed populations failed to provide data according to grade of severity. While fiber might also be effective in
people with more advanced stages of hemorrhoidal disease, this
remains largely unaddressed.
Moderate study quality and publication bias are potential limitations to this systematic review. We contacted authors and were
given access to the methodology for the majority of trials, which
improved the quality in comparison to the published articles. We
found too few trials for the funnel plot to be of use and the small
number and size of the trials raises the serious possibility of publication bias. On the other hand, our efforts to locate unpublished
studies by contacting authors, experts and the pharmaceutical industry and our success, we located two previously unpublished abstracts, make serious publication bias less likely. To the extent that

Implications for practice


Fiber seems an effective treatment for symptomatic hemorrhoids,
measuring overall symptom improvement and bleeding. Weaknesses are relatively minor (moderate study quality, use of unvalidated symptom ratings, and risk of publication bias), and inferences are therefore moderately strong.

Implications for research


Future trials should explore head-to-head comparisons with common first line treatments like venotonics (for example flavonoids)
or topical treatments (local anesthetics and/or steroids). Addressing prevention of recurrences over the long term would also be of
use. The consistent use of a small number of validated scales in
future trials would facilitate comparisons and increase the validity
of the results.
In future trials it is recommendable that randomisation should be
concealed, and followed by an analysis that adheres to the principle
of intention to treat; participants, caregivers, and those administering questionnaires and analyzing data must blind to allocation;
and investigators must use validated questionnaires addressing patients symptoms. Ideally, investigators in this area will adopt single rigorously-designed and validated questionnaires (or a single
questionnaire) that addressed each symptom complex. Such questionnaires are likely to work best using seven-point scales as response options. In addition, each investigation shoudl report the
number of patients bleeding or not bleeding at the time of each
assessment, the number of bleeding episodes in eacj time period,
and the duration of each bleeding episode.

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).

Laxatives for the treatment of hemorrhoids. (Review)


Copyright 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

We would like to thank all the authors of the studies included in


the review that provided information about their trials.

REFERENCES

References to studies included in this review


Broader 1974 {published data only}
Broader JH, Gunn IF, Alexander-Williams J. Evaluation of a
bulk-forming evacuant in the management of haemorrhoids.
British Journal of Surgery 1974;61(2):14244.
Foster 1979 {published data only}
Foster GE, Bolwel JS, Wright J, Hardcastle JD. Controlled
trial of bulk forming evacuants in the treatment of patients
with haemorrhoids. GUT 1979;20(Suppl 2):A452.
Hunt 1981 {published data only}
Hunt PS, Korman MG. Fybogel in haemorrhoid treatment.
The Medical journal of Australia 1981;2(5):25658.
Jensen 1988 {published data only}
Jensen SL, Harling H, Tange G, Shokouh-Amiri MH,
Nielsen OV. Maintenance bran therapy for prevention
of symptoms after rubber band ligation of third-degree
haemorrhoids. Acta chirurgica Scandinavica 1988;154(5-6):
39598.
Moesgaard 1982 {published data only}
Moesgaard F, Nielsen ML, Hansen JB, Knudsen JT. Highfiber diet reduces bleeding and pain in patients with
haemorrhoids: a double-blind trial of Vi-Siblin. Diseases of
the Colon & Rectum 1982;25(5):4546.
Perez-Miranda 1996 {published data only}
Perez-Miranda M, Gomez-Cedenilla A, Leon-Colombo
T, Pajares J, Mate-Jimenez J. Effect of fiber supplements
on internal bleeding haemorrhoids. Hepatogastroenterology
1996;43(12):1504507..
Webster 1978 {published data only}
Webster DJ, Gough DC, Craven JL. The use of bulk
evacuant in patients with haemorrhoids. British Journal of
Surgery 1978;65(4):29192.

References to studies excluded from this review


Craven 1976 {published data only}
Craven JL. A controlled, double blind study of dietary fiber
in patients with hemorrhoids. Symposium on dietary fiber.
St James Hospital, Leeds 1976.

Australian & New Zealand Journal of Medicine 1981;11:


22122.
Mat 1996 {published data only}
Mat J, Gmez A, Correa JA, Len T, Prez M, Pajares
JM. Therapeutic Fiber and Bleeding Haemorrhoids. GUT
1996;39(3):A140.

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.

Gorgul 1999 {published data only}


Gorgul A. Mentes BB. Tascilar O. Ates Y. Kandilci U.
Tatlicioglu E. The results and comparison of rubber band
ligation and injection sclerotherapy supplemented by
high-fibre diet in the treatment of second-degree internal
hemorrihoids. Turkish Journal of Gastroenterology 1999;10
(1):6671.

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.

Hunt 1981a {published data only}


Hunt P, Stewardson A, Korman M. Double-blind trial of
fybogel (isphaghula husk) in the treatment of haemorrhoids.

Brisinda 2000
Brisinda G. How to treat hemorrhoids. British Medical
Journal 2000;321:58283.

Laxatives for the treatment of hemorrhoids. (Review)


Copyright 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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
2004;126(5):1463473.
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.
Petticrew 2001
Petticrew M, Rodgers M, Booth A. Effectivenes of laxatives
in adults. Quality in Health care 2001;10:26873.
Spiller 1994
Spiller RC. Pharmacology of dietary fiber. Pharmacology &
therapeutics 1994;62:40727.
Tramonte 1997
Tramonte SM, Brand MB, Mulrow CD, Amato MG,
OKeefe ME, Ramirez G. The treatment of chronic
constipation in adults: a systematic review. Journal of
General Internal Medicine 1997;12:1524.

Indicates the major publication for the study

Laxatives for the treatment of hemorrhoids. (Review)


Copyright 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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

40 outpatients with anal bleeding, prolapse or discomfort (I-III)

Interventions

Stercullia vs. placebo (starch, <20g/day)

Outcomes

-Bleeding, prolapse, discomfort


-Patient overall impression
-Adverse events
-Bowel habit

Notes
Risk of bias
Item

Authors judgement

Description

Allocation concealment?

Yes

A - Adequate

Foster 1979
Methods

Parallel randomised controlled trial


Poorly described methodology. No details about validity issues

Participants

41 patients with hemorrhoids

Interventions

Isphagula husk vs. placebo


One month of treatment

Outcomes

-Overall symptomatic improvement


-Anal and rectal pressure

Notes

Only abstract available


Authors provided additional information

Risk of bias
Item

Authors judgement

Description

Allocation concealment?

Unclear

B - Unclear

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Copyright 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

11

Hunt 1981
Methods

Parallel randomised controlled trial.


Random list prepared by throwing a coin*. Sealed envelopes*.
Everyone blinded except Head pharmacist who was aware of the list* (Described as double blind)

Participants

28 patients with bleeding hemorrhoids (I-II)

Interventions

Isphaghula husk vs. placebo Six weeks of treatment

Outcomes

-Symptomatic improvement
-Proctoscopic improvement
-Bowel habit
-Overall symptomatic improvement

Notes

Only abstract and a letter describing the main results available


Authors provided additional information.

Risk of bias
Item

Authors judgement

Description

Allocation concealment?

Yes

A - Adequate

Jensen 1988
Methods

Parallel randomised controlled trial


Poorly described methodology
Evaluation of follow-up by independent observer

Participants

92 patients with hemorrhoids grade III


Median age 47, 47% women

Interventions

Unprocessed bran (20g/day) vs. no treatment


18 months of treatment

Outcomes

Number or recurrences after RBL


Severity of symptoms
Laxatives intake
Adverse events

Notes

Open study

Risk of bias
Item

Authors judgement

Description

Allocation concealment?

Unclear

B - Unclear

Laxatives for the treatment of hemorrhoids. (Review)


Copyright 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

12

Moesgaard 1982
Methods

Parallel randomised controlled trial


Randomization schedule (table)*
Sealed envelopes*
Patients and investigators blinded*
Treatment and placebo looked alike*

Participants

52 outpatients with symptomatic hemorrhoids (I-II)


Mean age 54, 26% of women.

Interventions

Psyllium seed dietary fiber (20g/day) vs. placebo


Six weeks of treatment

Outcomes

Bleeding
Pain at defecation
Pruritus and/or anal secretion
Prolapse
Overall assessment
Adverse events*

Notes

Funding: industry provided medication

Risk of bias
Item

Authors judgement

Description

Allocation concealment?

Yes

A - Adequate

Perez-Miranda 1996
Methods

Parallel randomised controlled trial


Computer generated list*
Endoscopist and analyst blinded*.
Health providers and patients not blinded (Patients not aware of therapeutic effect*)

Participants

50 outpatients with internal bleeding hemorrhoids (I-IV) referred to colorectal outpatient clinic
Mean age 48, 42% women

Interventions

Plantago ovata (11.6 g/day vs. placebo (vitamin B preparation)


40 days of treatment

Outcomes

-Average number of bleeding episodes


-Number of congested hemorrhoidal cushions
-Hemorrhoids bleeding on contact
-Degree of prolapse
-Adverse events

Notes

Undertaken without funding*

Laxatives for the treatment of hemorrhoids. (Review)


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13

Perez-Miranda 1996

(Continued)

Risk of bias
Item

Authors judgement

Description

Allocation concealment?

No

C - Inadequate

Webster 1978
Methods

Cross-over randomised controlled trial


Randomization centrally and placed in sequentially numbered envelopes by sponsor*
Sealed envelopes (opened when patient agreed to enter study)*
Surgeons and patients blinded*

Participants

67 outpatients with symptomatic hemorrhoids referred to an outpatient surgery clinic (I-III)


Age 23-71, 37% women

Interventions

Isphaghula husk (7g/day) vs. placebo


6 weeks of treatment (Assessment at six and 12 weeks)

Outcomes

-Pruritus, prolapse, bleeding and overall symptoms


-Days of laxatives used
-Consistency of faeces
-Frequency of defaecation
-Proctoscopic evaluation

Notes

Cross-over with 2 periods of 6 weeks of treatment


Funding: industry provided medication

Risk of bias
Item

Authors judgement

Description

Allocation concealment?

Yes

A - Adequate

* Information provided by authors

Characteristics of excluded studies [ordered by study ID]

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Copyright 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

14

Study

Reason for exclusion

Craven 1976

Abstract from a symposium, and apparently never published as a full article

Gorgul 1999

Retrospective study

Hunt 1981a

Abstract of a full text article

Mat 1996

Abstract of a full text article

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15

DATA AND ANALYSES


This review has no analyses.

WHATS NEW
Last assessed as up-to-date: 31 May 2005.

Date

Event

Description

5 August 2008

Amended

Converted to new review format.

HISTORY
Protocol first published: Issue 1, 2004
Review first published: Issue 4, 2005

Date

Event

Description

1 June 2005

New citation required and conclusions have changed

Substantive amendment

CONTRIBUTIONS OF AUTHORS
None mentioned

DECLARATIONS OF INTEREST
None known.

SOURCES OF SUPPORT

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Copyright 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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

MeSH check words


Humans

Laxatives for the treatment of hemorrhoids. (Review)


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17