C3FIBRE

StudyParticipantsInterventions
Aller 2004; Trial held in Spain; parallel; trial; Setting: secondary careInclusion & Exclusion criteria: No spasmolytic agents were used by pts for 6 months prior to the study and during the trial. Patients with organic disease were excluded Type of IBS: Mixed; IBS definition: Rome II; Severity of IBS symptoms: Not stated; Bloating/flatus: Some people; Post infective: not stated Age (range): 46 yrs (SD12); Gender (M/F): 19:37; Comorbidities: None; Weight: assessed at 3 months Int 65.5kg SD12.1 Control: 66.6kg SD12.5 Smoking: Int:21% Control 32%
  1. Diet with 30.5 g fibre (4.11. Soluble, 25.08 insoluble; 13% soluble) (mixed fibre); duration: 12 weeks; frequency / day: daily; amount 30.5 g fibre per day (n=28)
  2. Diet with 10.4g fibre (1.97g soluble,8.13g insoluble; 19% soluble) (mixed fibre); duration: 12 weeks; frequency/day: daily; amount 10.4 g fibre per day (n=28)
Arthurs 1983; Trial held in Ireland; parallel; trial; Setting: secondary careInclusion & Exclusion criteria: not stated Type of IBS: Unclear; IBS definition: Other; Severity of IBS symptoms: Not stated; Bloating/flatus: Not stated; Post infective: Not stated; Age (range): Mean 28 (15–50); Gender (M/F): 17: 61; Comorbidities: amount 2 sachets / day (n=38 )
  1. Ispagula poloxamer 188 (2 sachets) + 30g fibre containing diet daily (soluble fibre); duration: 4 weeks; frequency / day: 2; amount 30g/day (n=40)
  2. Inert placebo +30g fibre containing diet daily (placebo); duration: 4 weeks; frequency/day: 2 times daily
Chapman 1990; Trial held in UK; parallel; trial; Setting: secondary careInclusion & Exclusion criteria: Exclusions: organic disease Type of IBS: Mixed; IBS definition: Manning; Severity of IBS symptoms: Not stated; Bloating / flatus: Not stated; Post infective: Not stated Age (range): 18–75; Gender (M/F): 25:78; Comorbidities: none; Duration of symptoms: median no. in months Int:20 Control:24
  1. Mebeverine 135mg TID + 3.5g IspaghulaBD (soluble fibre); duration: 8 weeks; frequency/day: 3 times day; amount 7–10.5g ispaghula + 405mg Mebeverine daily (n= 54)
  2. Mebeverine 405 mg + Dietary advice leaflet (mixed fibre); duration: 8 weeks; frequency/day: 3 times daily; amount 405mg mebeverine (n=49)
Cook 1990; Trial held in Canada; crossover; trial; Setting: secondary careInclusion & Exclusion criteria: Exclusion: previous dietary counselling, fibre supplementation, prior GI surgery, taking essential concurrent medication; Type of IBS: Constipation; IBS definition: Manning; Severity of IBS symptoms: Not stated; Bloating/flatus: Not stated; Post infective: not stated Age (range): 25.8(SD2.4)18–37 yrs; Gender (M/F): not stated; Comorbidities: none; IBS Symptom Questionnaire (scores 1–37); 4 week washout period
  1. 20g fibre cookies daily (insoluble fibre); duration: 12 weeks; frequency/day: 2 cookies twice daily; amount 20g per day (n=14 )
  2. Identical cookies with no fibre (placebo); duration: 12 weeks; frequency/day: 2 cookies twice daily; amount :0g per day (n=14)
Dettmar 1999; Trial held in UK; parallel; trial; Setting: primary careInclusion & Exclusion criteria: IBS unchanged for 12 months; organic disease excluded; Type of IBS: Unclear; IBS definition: Symptoms described; Severity of IBS symptoms: mixed; Bloating/flatus: Not stated; Post infective: Not stated; Age (range): mean 34 yr (18–40yr); Gender (M/F): 32:78; Comorbidities: Not stated
  1. Ispaghula husk 3.5g + mebeverine hydrochloride 135mg sachet (soluble fibre); duration: 4 weeks; frequency/day: twice daily; amount 7g fibre + 270mg mebeverine (n=56)
  2. Mebeverine hydrochloride 135mg tablets + high fibre dietary advice (Mebeverine); duration: 4 weeks; frequency/day: three times daily; amount 405mg mebeverine (n=54)
Fielding 1984; Trial held in Ireland; parallel; trial; Setting: secondary careInclusion & Exclusion criteria: not stated Type of IBS: Constipation; IBS definition: Authors' definition; Severity of IBS symptoms: Not stated; Bloating/flatus: Not stated; Post infective: n
Not stated; Age (range): 28 (15–46yrs); Gender (M/F): 18:37; Comorbidities: none
  1. 30g cereal fibre + 10g fruit fibre (mixed fibre); duration: 4 weeks; frequency/day: 40g fibre daily; amount 40g fibre daily (n=28 )
  2. 30g fruit & vegetable fibre +10g cereal fibre (mixed fibre); duration: 4 weeks; frequency/day: daily; amount 40g fibre daily (n= 27)
Fowlie 1992; Trial held in UK; parallel; trial; Setting: secondary careInclusion & Exclusion criteria: Exclusion: use of dietary fibre supplements, laxatives or constipation medication. Psychiatric disorders. Type of IBS: Unclear; IBS definition: Symptoms described; Severity of IBS symptoms: mixed; Bloating/flatus: Not stated; Post infective: not stated Age (range): 40 (18–65)yrs; Gender (M/F): 17:32; Comorbidities: none; 24hr recall of CHO, Fat protein & Fibre assessed by dietitian blind to symptom score
  1. Fibre tablet-44% of its 624mg fibre + daily supplement of 4.1gm fibre (mixed fibre); duration: 12 weeks; frequency/day: 5 tablets TDS; amount 10g fibre/daily (n=25 )
  2. Placebo tablet-starch, calcium phosphate & lactose with 29mg fibre + daily supplement 0.4g fibre (placebo); duration: 3 months; frequency/day: once daily; amount 1gm fibre/daily (n= 24)
Kruis 1986; Trial held in Germany; parallel; trial; Setting: secondary careInclusion & Exclusion criteria: Exclusion: other medication Type of IBS: Mixed; IBS definition: Symptoms described; Severity of IBS symptoms: Not stated; Bloating/flatus: Some people; Post infective: not stated Age (range): 42 (19–71yrs); Gender (M/F): 47:73; Comorbidities: none; Weight, Length of time since diagnosis, duration of symptoms, ethnicity, socio-economic group
  1. 3 times 5g daily commercially available wheatbran (insoluble fibre); duration: 16 weeks; frequency/day: 3 times day; amount 15mg/day (n=40)
  2. 4 times 100mg daily Placebo mebeverine (usual diet); duration: 16 weeks; frequency/day: three time daily; amount: 0mg daily (n= 40)
  3. 4 times daily Mebeverine Placebo(n=40)
Longstreth 1981; Trial held in USA; parallel; trial; Setting: secondary careInclusion & Exclusion criteria: Exclusion: other GI disease, pregnancy, liver or gallbladder disease, previous use of psyllium Type of IBS: Mixed; IBS definition: Symptoms described; Severity of IBS symptoms: mixed; bloating/flatus: Some people; Post infective: not stated Age (range): not given; Gender (M/F): not given; Comorbidities: none
  1. 6.4g sachet of psyllium in water (soluble fibre); duration: 8weeks; frequency/day: 3 times daily; amount 19g/day (n=40)
  2. Corn starch and polyvinylprrrolidone -inactive agent to replace psyllium (placebo); duration: 8 weeks; frequency/day: 3 times daily; amount 3 times daily (n= 37)
Lucey 1987; Trial held in UK; crossover; trial; Setting: secondary careInclusion & Exclusion criteria: None stated; Type of IBS: Mixed; IBS definition: 'Had IBS'; Severity of IBS symptoms: Not stated; Bloating/flatus: Not stated; Post infective: not stated Age (range): 32 (22–78yrs); Gender (M/F): 9:19; Comorbidities: None; frequency/day: 12 biscuits/ day; amount : 2.76g fibre daily (n=28 )
  1. Normal diet + 12 bran biscuits containing 1.3g fibre each (insoluble fibre); duration: 12 weeks; frequency/day: 12 biscuits per day; amount 12.8g fibre daily (n=28)
  2. Normal diet +12 placebo biscuits each with 0.23g fibre (placebo); duration: 12
Manning 1977; Trial held in UK; parallel; trial; Setting: secondary careInclusion & Exclusion criteria: Exclusion|: taking drugs known to modify bowel motility, organic disease Inclusion: normal barium studies, Type of IBS: Mixed; IBS definition: 'Had IBS'; Severity of IBS symptoms: Not stated; bloating/flatus: Not stated; Post infective: not stated Age (range): 20–60 yrs; Gender (M/F): 14:12; Comorbidities: none
  1. Whole wheat bread +/or unprocessed wheat bran (insoluble fibre); duration: 6 weeks; frequency/day: 20g fibre daily; amount 20g wheat bran daily in divided doses (n=14 )
  2. Exclusion of all wholegrain cereals + only moderate intake of fruit & vegetables (no fibre); duration: 6 weeks; frequency/day: daily; amount not stated (n= 12)
Parisi 2002; Trial held in Italy; parallel; trial; Setting: secondary careInclusion & Exclusion criteria: Exclusions: Patients with systemic GI disease, psychiatric disease 10 days before commencing study asked to stop all medication. Type of IBS: Mixed; IBS definition: Rome I; Severity of IBS symptoms: mixed; Bloating/flatus: Not stated; Post infective: not stated Age (range): 40.3(+/−14.6); Gender (M/F): 49:139; Comorbidities: none; Patients could switch treatments after 4 weeks Separate Data available.
  1. 30g wheat bran (insoluble fibre); duration: 4 weeks; frequency/day: daily; amount 30g/day (n=94)
  2. PHGG partially hydrolized Guar Gum (soluble fibre); duration: 4 weeks; frequency/day: daily; amount 5g in 60 mls apple juice (n= 94)After 4 weeks patients could change groups if their symptoms were worse, groups further divided into fibre - phgg ans phgg-fibre groups.
Parisi 2005; Trial held in Italy; parallel; trial; Setting: secondary careInclusion & Exclusion criteria: Ex: systemic, GI & psychiatric disease. 10 days before joining study all medication stopped. Type of IBS: Mixed; IBS definition: Rome II; Severity of IBS symptoms: mixed; Bloating/flatus: Not stated; Post infective: not stated Age (range): 45(SD13.6); Gender (M/F): 22:64; Comorbidities: none; BMI measured at baseline
  1. 10g partially hydrolyzedGuar Gum (soluble fibre); duration: 12 weeks; frequency/day: once daily; amount 10g/day (n=40)
  2. 5g partially hydrolyzed Guar Gum (soluble fibre); duration: 12 weeks; frequency/day: once daily; amount 5g/day (n= 46)
Prior & Whorwell 1987; Trial held in UK; parallel; trial; Setting: Secondary careInclusion & Exclusion criteria: Exclusions: None stated Type of IBS: Mixed; IBS definition: Symptoms described; Severity of IBS symptoms: mixed; Bloating/flatus: All patients; Post infective: not stated Age (range): 18–63yrs; Gender (M/F): 8:72; Comorbidities: none
  1. I sachet of 56% ispaguhla (soluble fibre); duration: 12 weeks; frequency/day: 1+ sachet 3 x daily; amount 11g per day (n=40)
  2. 1 sachet 3x daily (placebo); duration: 12 weeks; frequency/day:3/day; amount 0g 3x daily (n=40)
Rees 2005; Trial held in UK; parallel; trial; Setting: secondary careInclusion & Exclusion criteria: Negative investigations, no other bowel disorder/ serious illness; stools<1/day or variable or 1–2/day and hard, pellety, variable or straining. Excl if pregnant/surgery in last 6 months, on diet or medication Type of IBS: Constipation; IBS definition: Rome I; Severity of IBS symptoms: Not stated; Bloating/flatus: Not stated; Post infective: not stated Age (range): 18–70yr; Gender (M/F): 3:24; Comorbidities: not stated
  1. Coarse wheat bran (insoluble fibre); duration: 8–12 weeks; frequency/day: once; amount 10g x 4 weeks, increased if poss weeks 5–8 (n=14)
  2. Placebo (placebo); duration: 8–12 weeks; frequency/day: once; amount - (n=14)
Ritchie 1979; Trial held in UK; parallel; trial; Setting: secondary careInclusion & Exclusion criteria: Investigations negative for organic disease Type of IBS: Unclear; IBS definition: 'Had IBS'; Severity of IBS symptoms: Not stated; Bloating/flatus: Not stated; Post infective: not stated Age (range): mean 38 yr (16–69 yr); Gender (M/F): 22:74; Comorbidities: Not stated
  1. Ispaghula (Fybogel) (soluble fibre); duration: 3 months; frequency/day: twice daily; amount 2 sachets (n=48)
  2. Placebo (placebo); duration: 3 months; frequency/day: twice daily; amount 2 sachets (n=48)factorial design trial also looking at real or dummy lorazepam, and real or dummy hyoscine
Ritchie 1980; Trial held in UK; parallel; trial; Setting: secondary careInclusion & Exclusion criteria: Organic disease excluded Type of IBS: Unclear; IBS definition: 'Had IBS'; Severity of IBS symptoms: Not stated; Bloating/flatus: Not stated; Post infective: not stated Age (range): mean 39 yr (14–82 yr); Gender (M/F): 25:71; Comorbidities: not stated
  1. Ispaghula (Fybogel) (soluble fibre); duration: frequency/day: twice daily; amount 7g (n=48)
  2. Coarse natural bran (bran); duration: frequency/day: daily; amount 20g (n=48)factorial design trial also looking at lorazepam, hyoscine, mebeverine and Motival
Soltoft 1976; Trial held in Denmark; parallel; trial; Setting: secondary careInclusion & Exclusion criteria: Inclusion: over 14yrs, no other disease present. Type of IBS: Mixed; IBS definition: Symptoms described; Severity of IBS symptoms: Not stated; Bloating/flatus: Not stated; Post infective: not stated Age (range): 40 (18–73)yrs; Gender (M/F): 21:38; Comorbidities: none; Weight, Length of time since diagnosis, duration of symptoms, ethnicity, socio-economic group
  1. 10gm bran fibre biscuits containing 85% miller's wheat bran 10g 3 x day (insoluble fibre); duration: 6 weeks; frequency/day: TDS; amount 30g bran daily (n= 322)
  2. Wheat biscuits of same size & appearance containing no bran- (placebo); duration: 6 weeks; frequency/day: three times daily; amount 0g brantds (n=27)
Tarpila 2004; Trial held in Finland; parallel; trial; Setting: not statedInclusion & Exclusion criteria: Exclusions – patients with colitis ulcerosa, Crohn's disease or malignancies of any kind or any abnormality in the screening lab tests. Systematic use of other bulk laxatives forbidden. Type of IBS: Constipation; IBS definition: Authors' def; Severity of IBS symptoms: Not stated; Bloating/flatus: All patients; Post infective: not stated Age (range): 45.5 (sd 12); Gender (M/F): 5:50; Comorbidities: none Weight: 63 kg(sd 13.5) dietary fibre intake was monitored by food questionnaire completed weekly
  1. Foil sachets of 6g Flax seed (mixed fibre); duration: 3 months; frequency/day: 2–4 times/day; amount 12- 24g/day (n=26)
  2. Foil sachets of 6g psyllium fibre (mixed fibre); duration: 3 months; frequency/day: 2–4 times /day; amount 12–24g/day (n=29)
Villagrasa 1991; Trial held in Spain; parallel; trial; Setting: secondary careInclusion & Exclusion criteria: Exclusion: Other systemic disease, pregnancy, abnormal faecal analysis Inclusion: medical history of IBS for>3 yrs Type of IBS: Mixed; IBS definition: 'Had IBS'; Severity of IBS symptoms: Not stated; Bloating/flatus: Some patients; Post infective: not stated Age (range): 20–76yrs; Gender (M/F): 62:52; Comorbidities: none socio-economic group: stated as education level & occupation Clinical evaluation 3mths: bariu
  1. High fibre diet 20gm + 10gm bran supplement (mixed fibre); duration: 2 years; frequency/day: once daily; amount 30g fibre daily (n=53)
  2. Normal diet(10–15gm fibre)+ 120mg otilonium bromide (usual diet); duration: 24 months; frequency/day: once daily; amount 10–15gm fibre + 120mg otilium (n= 61)

From: Appendix C, Characteristics of included studies

Cover of Irritable Bowel Syndrome in Adults
Irritable Bowel Syndrome in Adults: Diagnosis and Management of Irritable Bowel Syndrome in Primary Care [Internet].
NICE Clinical Guidelines, No. 61.
National Collaborating Centre for Nursing and Supportive Care (UK).
Copyright © 2008, Royal College of Nursing.

PubMed Health. A service of the National Library of Medicine, National Institutes of Health.