Chouinard 2011
Chouinard 2011
Chouinard 2011
Revue
ABSTRACT Résumé
North American family physicians and dietitians commonly Il demeure assez courant pour les médecins de famille et
recommend psyllium fibre supplementation for treating les diététistes de l’Amérique du Nord de recommander une
symptoms of irritable bowel syndrome (IBS). In this review, supplémentation en fibres de psyllium pour le traitement des
evidence on the effectiveness of psyllium supplementation for symptômes du syndrome du côlon irritable (SCI). L’objectif de
diagnosed IBS symptoms was evaluated and summarized. A cette revue était d’évaluer et de résumer l’état des données
systematic search of MEDLINE, CINAHL, and Web of Science was probantes relativement à l’efficacité d’une supplémentation
conducted. Included were full-length, peer-reviewed, English- en psyllium sur les symptômes du SCI chez les personnes en
language articles in which psyllium ingestion was tested for its ayant reçu le diagnostic. Une recherche systématique dans
For personal use only.
effect on IBS symptoms. Quality of these articles also was MEDLINE, CINAHL et Web of Science a été menée. Les articles
assessed. Twelve met the criteria for complete data abstraction. intégraux, en langue anglaise et révisés par des pairs ont été
Seventy-five percent of the studies examined were of weak inclus lorsque l’ingestion de psyllium était évaluée afin de
quality. Study designs and methods were heterogeneous. déterminer ses effets sur les symptômes du SCI. Une évaluation
Patient-perceived global symptoms improved significantly in six de la qualité des articles satisfaisant aux critères ci-dessus a
of the nine studies measuring a global symptom outcome. In été effectuée. Douze articles satisfaisaient aux critères pour une
one study, significant improvements occurred in reported abstraction complète des données. Soixante-quinze pour cent
abdominal pain; in three, improvement did not occur. Quality of des études évaluées étaient de faible qualité. De plus, les plans
life and flatulence did not improve significantly in any studies in et méthodologies des études étaient hétérogènes. Une amé-
which these outcomes were examined. The results of this lioration globale significative de l’amélioration des symptômes
systematic review indicate limited and conflicting evidence to perçus par les patients a été notée dans six des neuf études
support the recommendation of psyllium supplementation for mesurant un résultat relatif aux symptômes globaux. Une étude
symptomatic IBS treatment. a rapporté des améliorations significatives quant à la douleur
abdominale rapportée, tandis que trois n’ont pas fait men-
(Can J Diet Pract Res. 2011;72:48)
tion de ce type d’amélioration. Dans les études examinant ces
(DOI: 10.3148/72.1.2011.48)
résultats, aucune amélioration significative n’a été rapportée
en matière de qualité de vie et de flatulences. Les résultats de
cette revue systématique indiquent qu’une quantité limitée de
données probantes contradictoires soutiennent la recomman-
dation d’une supplémentation en psyllium pour le traitement
des symptômes du SCI.
(Rev can prat rech diétét. 2011;72:48)
(DOI: 10.3148/72.1.2011.48)
Introduction
Irritable bowel syndrome (IBS) is a common gastrointestinal onstrated in IBS patients. Thus the diagnosis of IBS is symptom-
disorder characterized by recurrent abdominal pain, bloating, based and unstandardized. As there is no standardization of di-
distension, cramping, constipation and/or diarrhea, and flatu- agnostic criteria, prevalence estimates vary from 3% to 20% of
lence (1). Diagnosis of IBS can be difficult as no biochemical, the population (2-6). Most estimates, however, suggest a 10% to
structural, or physiological abnormalities are consistently dem- 15% prevalence.
Canadian Journal of Dietetic Practice and Research – Vol 72 No 1, Spring 2011 e107
Review
Revue
Dietary advice is often given for IBS management, and most consideration were identified. Reference lists of relevant articles,
family physicians recommend an increase in total dietary fibre as well as review articles, were hand searched to identify addi-
intake, usually in the form of insoluble fibres such as bran (7). tional publications.
Canadian Journal of Dietetic Practice and Research Downloaded from dcjournal.ca.www.nrcresearchpress.com by University of Otago on 10/15/15
This is surprising, given the limited evidence for the role of in-
soluble fibre in alleviating IBS symptoms. Insoluble fibre under- Selection criteria and data extraction
goes minimal change in the digestive tract and increases fecal Full-length, English-language primary studies in peer-reviewed
mass. A systematic review of 17 clinical trials of patients with journals were included when psyllium ingestion had been tested
IBS indicated that insoluble fibre not only generally confers no for its effect on IBS symptoms. Study subjects were required to
benefit but, in many cases, may worsen IBS symptoms (8). In have been diagnosed with pre-existing IBS by any criteria, but
contrast, soluble fibre dissolves in water and forms a gel; it is the IBS could not be medication-induced for the purposes of the
fermented by colonic bacteria, forming short-chain fatty acids study. Medication trials were included as long as they contained
and gas, both of which may decrease gut transit time. Shortened analyses of psyllium ingestion effects, independent of the medi-
transit time may alleviate constipation and associated pain. cation. All study designs were considered. All searching and data
Psyllium fibre (also referred to as ispaghula) is derived from the extraction were conducted by the author.
husks of the seeds of Plantago ovata, and is one such soluble fi-
bre (9). Approximately 50% of IBS patients receive some form Study quality
of drug treatment, which often includes psyllium fibre supple- Each study was graded for quality, using the Quality Assessment
mentation (10). Tool for Quantitative Studies developed by the Effective Pub-
While pooled results of studies examining the effectiveness lic Health Practice Project team (17). This tool is used to assess
of soluble fibres (including psyllium) reveal an overall improve- quality of published quantitative studies on the basis of sample
ment in global symptom indices (8), most have severe meth- selection methods, study design, control for confounders, blind-
odological limitations such as inadequate outcome assessment ing, data collection, and withdrawals and dropouts. Studies are
tools or lack of placebo controls. Despite a lack of good quality ranked as weak, moderate, or strong, according to these criteria.
evidence, recommendation of psyllium-based bulk laxatives re-
For personal use only.
Figure 1
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Study selection process for systematic review of the effect of psyllium fibre supplementation on
irritable bowel syndrome symptoms
Excluded
n=45
Articles meeting criteria No report of effectiveness
for complete data of psyllium independent of
abstraction medication 1
n=12 Not primary sources 2
Duplication 41
Published as abstract only 1
Canadian Journal of Dietetic Practice and Research – Vol 72 No 1, Spring 2011 e109
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Table 1
Summary of studies on irritable bowel syndrome and psyllium fibre included in the literature review
Canadian Journal of Dietetic Practice and Research Downloaded from dcjournal.ca.www.nrcresearchpress.com by University of Otago on 10/15/15
Design
(quality Participants and
Study assessment) intervention Results Comments
Arthurs and Fielding, Randomized, Target: patients newly diagnosed with No significant difference Subjects were 61 females,
1983, Ireland (27) controlled trial irritable bowel syndrome (IBS) between groups; p values not 17 males, aged 15-50 years
(weak) described
Intervention: ispaghula/poloxamer
granules, dose not specified Subjects completing study:
78
Control: not specified
Duration: 4 weeks
Outcome measures: Patient report
of general symptoms as either mild,
moderate, or severe
Bijkerk et al., 2009, Randomized, Target: patients aged 18-65 years Significant improvement in Subjects were 94% white,
Netherlands (14) controlled trial diagnosed with IBS in last 2 years adequate symptom relief 78% female, mean age 34.4
(strong) with psyllium in 1st and 2nd years
Intervention: 10 g psyllium (form not month only (p<0.05); severity
identified) BID of symptoms was significantly Used intention-to-treat (ITT)
decreased (p<0.05); no change analyses
Control: bran or rice flour
in quality of life or abdominal
Duration: 12 weeks pain
Outcome measures: patient- Subjects completing study:
determined adequate symptom relief 164
(primary), quality of life, severity of
symptoms, abdominal pain (secondary)
Chapman et al., 1990, Controlled clinical Target: patients aged 18-75 years with No difference between Parallel group study, subjects
For personal use only.
England (25) trial (weak) IBS groups (p=0.499); both treated with ispaghula +
groups improved significantly mebeverine or dietary advice
Intervention: ispaghula 3.5 g BID (p<0.001) + mebeverine
Control: high-fibre dietary advice Subjects completing study: Open study due to nature of
Duration: 8 weeks 103 control
Outcome measures: number and Unpalatability of ispaghula
severity of pain attacks, number of bowel described by many subjects
actions with stool consistency Subjects were aged 18-74
years; 76% female
Dettmar and Sykes, Controlled clinical Target: patients with IBS >1 year duration Significant reduction in Parallel group study, similar to
1999, United Kingdom trial (weak) physician-assessed abdominal Chapman et al.’s design (25);
(24) Intervention: ispaghula husk 3.5 g pain (p<0.01), as well as open study due to nature of
BID-TID physician-assessed (p<0.01) control
Control: high-fibre dietary advice and patient-assessed (p<0.05)
bowel function Subjects were 71% female;
Duration: 4 weeks ages ranged from 18-40
Subjects completing study: years; mean age 34 years
Outcome measures: physician and 110
patient assessments of number and
severity of episodes of pain and bowel
function
Golechha et al., 1982, Randomized, Target: IBS patients 13/26 reported improvement No description of data
India (20) controlled trial— with ispaghula versus 6/26 collection or assessment tools;
placebo- controlled Intervention: ispaghula husk powder, with placebo (p<0.05) no demographic information
crossover design no dose specified available
(weak) Subjects completing study:
Control: wheat flour 26
Duration: 3 weeks for each intervention,
6 weeks total
Outcome measures: patient-described
overall symptom improvement
Jalihal and Kurian, Controlled clinical Target: IBS >2 years Significant improvement in Subjects: 16 male, 4 female;
1990, India (22) trial— placebo- satisfaction with BMs with age range 17-56 years;
controlled crossover Intervention: 30 g ispaghula husk OD ispaghula (p<0.05); no change median age 38 years
design (weak) Control: not specified in pain, flatulence, number of
BMs, consistency of BMs, gut
Duration: 4 weeks treatment, 4 weeks transit time (p>0.05)
alternate therapy
Subjects completing study:
Outcome measures: patient reports 20
of pain, flatulence, number of bowel
movements (BMs), average consistency
of BMs, satisfaction with BMs, %
symptom improvement, gut transit time
Table 1 (cont’d.)
Summary of studies on irritable bowel syndrome and psyllium fibre included in the literature review
Canadian Journal of Dietetic Practice and Research Downloaded from dcjournal.ca.www.nrcresearchpress.com by University of Otago on 10/15/15
Design
(quality Participants and
Study assessment) intervention Results Comments
Kumar et al., 1987, Cohort (weak) Target: male patients with IBS Significant improvement in Study trying to determine
India (21) symptom score (p<0.01); optimum dosage of ispaghula
Intervention: processed ispaghula husk, significant increase in stool
10 g/20 g/30 g a day for each of 17 days weight (p<0.001) with best Subjects all male; no age
results at 20 g; no change to information provided
Control: N/A
transit time (p>0.05)
Duration: 51 days
Subjects completing study:
Outcome measures: patient reports of 10
symptoms, gut transit time by radio-
opaque markers, stool weight
Longstreth et al., Randomized, Target: Patients >18 years with IBS No significant improvement No descriptive statistics of
1981, United States controlled trial with intervention (p>0.05); study subjects
(18) (moderate) Intervention: Metamucil 6.4 g TID significant improvement with
Control: cornstarch, dextrose, and control substance
polyvinylpyrrolidone Subjects completing study:
Duration: 8 weeks 60
Outcome measures: stool consistency,
abdominal pain, gas, interference of
symptoms with activities of daily living
Nigam et al., 1984, Controlled clinical Target: IBS patients aged 16-68 years Significant improvement in No description of data
India (23) trial (weak) patient-described symptoms collection or assessment tools
Intervention: ispaghula husk, dose not
For personal use only.
Ritchie and Truelove, Randomized, Target: not described 33/48 patients reported Factorial design, along
1980, England (19) controlled trial improvement with ispagula vs. with muscle relaxants and
(weak) Intervention: ispaghula husk (Fybogel) 23/48 with bran (p<0.05) psychotropic drugs
3.5 g BID
Subjects completing study: Authors describe likely
Control: coarse natural bran 96 synergy between treatments
Duration: 12 weeks No description of data
Outcome measures: patient-described collection or assessment tools
overall symptom improvement Subjects: mean age 39 years;
range 14-82 years; 74%
female
Canadian Journal of Dietetic Practice and Research – Vol 72 No 1, Spring 2011 e111
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overall symptom relief with psyllium administration (14,28), while IBS. Negative impacts of IBS on quality of life have been report-
one showed no significant improvement in any symptoms, but ed in numerous studies (33-36). Further, research teams in the
rather an advantage with the control substance over psyllium (18). United Kingdom and the United States have recently demon-
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IBS symptoms,” employed by the majority of studies in this re- als (31), blinding may be difficult in trials including dietary in-
view, is associated with a greater placebo response rate than is terventions. When a placebo is chosen, it must be one believed
measured improvement in individual symptoms (29). This may to lack any specific effect that would change the outcome being
in part explain the inability to detect significant difference be- measured. In some studies, bran or wheat flour was used as a
tween treatment groups for this outcome in some of the studies control substance, which may not be appropriate as increased
reviewed. A number of the studies were classified as “weak” in insoluble fibre may worsen IBS symptoms in some patients (8).
quality partly because of the lack of evidence for reliability and/ Factorial designs were employed in three of the 12 studies
or validity of the outcome measures used. reviewed (19,25,26). These studies were considered appropriate
for inclusion in this review because all treatments had distinct
Adequate relief mechanisms of action and treatments were assigned so that
Before 1998, no accepted or widely used measures were avail- simple effects of each treatment, as well as possible synergies be-
able for outcome assessment in IBS treatment trials. In 1998, tween treatments, could be detected (31).
the measure of “adequate relief” was validated as a clinically Sample size was variable (10 to 168 subjects) among stud-
meaningful outcome measure. “Adequate relief” is defined as a ies, and methods for determining sample size were not routinely
patient’s report of adequate relief of abdominal pain and dis- outlined. Smaller sample sizes have less power than larger ones
comfort (30). Patients are considered responders to treatment to reveal significant outcomes, and can result in type II statistical
if they report adequate relief during at least 50% of the weeks error (38). For clinical trials with multiple outcome measures,
of the treatment trial. The Design of Treatment Trials Commit- a sample size that can provide at least 90% power for each end
tee (DTTC) of the American Gastroenterological Association point should be employed (39).
has since endorsed this outcome (31). Physician assessment of Intention-to-treat analysis was used in only two of the 12
symptom improvement was employed as an outcome measure studies. This type of analysis is now considered the standard for
in one study (24), but has since been associated with greater the transparent reporting of clinical trial results (40), and it is
measurement error than is patient report (32). The DTTC now recommended for use in IBS treatment trials specifically (31).
exclusively endorses the use of patient-reported measures (31). As with study design and outcome measures, study duration
and psyllium doses were variable. Psyllium doses ranged from 7
Quality of life g a day to as much as 30 g a day in the seven studies detailing the
Quality-of-life assessments are considered important outcome dose. In only one small study (n=10) did the investigators at-
measures but should be secondary to patient-reported physical tempt to determine the optimal dose of psyllium effective in im-
symptom outcomes because they are considered more respon- proving symptoms and increasing stool weight. They concluded
sive to treatment (31). While not as easily measured in the set- that 20 g of psyllium a day is likely the preferred dose (21). The
ting of a treatment trial, quality-of-life assessments are likely to remaining study groups that outlined intervention doses did not
be clinically relevant and important to individuals living with publish the justifications for the dose chosen. This is a signifi-
Dis Sci.1997;42:2585-90.
demographic variability of study participants included in this 3. Drossman DA, Li Z, Andruzzi E, Temple RD, Talley NJ, Thompson WG, et al.
review. Although female IBS sufferers predominate in the gen- U.S. householder survey of functional gastrointestinal disorders. Prevalence,
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Poor acceptability and tolerance of psyllium therapy were re- comparison of the Rome and Manning criteria for case identification in epi-
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ingly, this study employed the smallest dose of psyllium, only 2000;95:2816-24.
3.5 g twice a day. This is in contrast to a more recent lipid study 6. Thompson WG, Irvine EJ, Pare P, Ferrazzi S, Rance L. Functional gastro-
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larger 10-g dose of psyllium versus placebo (14). More work is ritable bowel syndrome in primary care: the patients’ and doctors’ views on
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