C9ANTISPASMODICS

StudyParticipantsInterventions
Berthelot 1981 Trial held in France parallel trialInclusion & Exclusion criteria: Type of IBS: Unclear; IBS definition: ‘Had IBS’; Severity of IBS symptoms:----; bloating/flatus:---; Post infective: --- Age (range): ; Gender (M/F): ; Comorbidities: Study in French - no English abstract
  1. Mebeverine (duspatalin) (Antispasmodic); duration: 8 weeks; frequency/day: once; amount 400mg (n=36)
  2. Placebo (placebo); duration: 8 weeks; frequency/day: once; amount n/a (n=33)
Carling 1989 Trial held in Sweden crossover first period trial Setting: secondary careInclusion & Exclusion criteria: Inclusions: active IBS; Exclusions: liver disease, active peptic ulcer disease, previous gastrectomy or vagotomy. Pregnant or nursing women, patients taking anticholinergics or antidepressants. Type of IBS: Mixed; IBS definition: Symptoms described; Severity of IBS symptoms: Not stated; Bloating/flatus: All patients; Post infective: not stated Age (range): 43 (18–63); Gender (M/F): 7:19; Comorbidities: none stated History of IBS 8.9 and 9.3 y. One week run-in. 1st period data IBS-C or IBS-A; active IBS symptoms
  1. Hyoscamine (Egazil) 1–2 tablets; 0.2 mg + 1–2 placebo capsules (Antispasmodic); duration: 2 weeks; frequency/day: 3 times; amount 0.6 to 1.2 mg (n=13)
  2. Peppermint oil capsules (Colpermin) 1–2 x 0.2 ml + 1–2 placebo tablets (Antispasmodic); duration: 2 weeks; frequency/day: 3 times; amount 0.6 to 1.2 ml (n=13 )
  3. Placebo capsules and placebo tablets; 2 weeks; 3 times/day (n=14)
Czalbert 1990 Trial held in Hungary parallel trial Setting: not statedInclusion & Exclusion criteria: Can’t translate Type of IBS: Unclear; IBS definition: ‘Had IBS’; Severity of IBS symptoms: Not stated; Bloating/flatus: Some patients; Post infective: not stated Age (range): 48 (34–79); Gender (M/F): 8:26; Comorbidities: unclear Hungarian language, much missing information. From Cochrane review. Randomisation unclear.
  1. Peppermint oil (Colpermin) 0.2ml (Antispasmodic); duration: 6–12 weeks; frequency/day: 3 times; amount 0.6 ml (n=17)
  2. Placebo (placebo); duration: 6–12 weeks; frequency/day: unclear; amount (n=17)
Gilbody 2000 Trial held in UK parallel trial Setting: primary careInclusion & Exclusion criteria: Rome criteria of 1992 (?Rome II?) and VAS for global abdominal pain>40mm Type of IBS: Unclear; IBS definition: Rome II; Severity of IBS symptoms: Not stated; Bloating/flatus: Not stated; Post infective: not stated Age (range): median around 33 (18–68); Gender (M/F): 39:143; Comorbidities: not stated primary endpoint of study to establish equivalence between 2 doses of mebeverine
  1. Mebeverine hydrochloride MR (Antispasmodic); duration: 8 weeks; frequency/day: bd; amount 400mg/day (n=92)
  2. Mebeverine hydrochloride (Antispasmodic); duration: 8 weeks; frequency/day: tds; amount 405mg/day (n=92)
Inauen 1994 Trial held in Switzerland parallel trial Setting: secondary careInclusion & Exclusion criteria: <18 yr, tumour or inflammation of g-I tract, pregnancy, already treated with antispasmodic Type of IBS: Mixed; IBS definition: Authors’ def; Severity of IBS symptoms: mixed; Bloating/flatus: Some patients; Post infective: not stated Age (range): 18+; Gender (M/F): ; Comorbidities: not stated
  1. Mebeverine slow release (Antispasmodic); duration: 3 weeks; frequency/day: bd; amount 400mg/day (n=26)
  2. Mebeverine (Antispasmodic); duration: 2 weeks; frequency/day: tds; amount 405mg/day (n=28)
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 patients; Post infective: not stated Age (range): 42 (19–71 yrs); Gender (M/F): 47:73; Comorbidities: none
  1. 4x100mg daily mebeverine (Antispasmodic); duration: 16 weeks; frequency/day: 3 X day; amount 400mg daily (n=40)
  2. 4x0mg daily Placebo mebeverine (placebo); duration: 16 weeks; frequency/day: 3 xday; amount 0mg daily (n=40)
Lech 1988 Trial held in Denmark parallel trial Setting: secondary careInclusion & Exclusion criteria: Unclear Type of IBS: unclear; IBS definition: Symptoms described; Severity of IBS symptoms: Not stated; Bloating/flatus: Not stated; Post infective: not stated Age (range): 43 (20–72) years; Gender (M/F): 10:32; Comorbidities: unclear In Danish, from Cochrane Review. Many details unclear. Outpatients
  1. Peppermint oil in gelatine 4 capsules (200mg) half hour before each main meal (Antispasmodic); duration: 4 weeks; frequency/day: 3 times; amount 600 mg (n=19)
  2. Placebo capsules filled with soyabean oil as intervention (placebo); duration: 4 weeks; frequency/day: 3 times; amount (n=23)
Liu 1997 Trial held in Taiwan parallel trial Setting: secondary careInclusion & Exclusion criteria: Exclusions: hepatic, renal or cardiac disease, anaemia or other GI disease; history of recent weight loss or rectal bleeding; medication with hypnotics, tranquilisers, laxatives, antacids, anticholinergics or antispasmodics, pregnancy /breast feeding Type of IBS: Unclear; IBS definition: ‘Had IBS’; Severity of IBS symptoms: Not stated; Bloating/flatus: Some patients; Post infective: not stated Age (range): 18–70; Gender (M/F): 66:44; Comorbidities: about half patients had symptoms of non-ulcer dyspepsia Outpatients; active symptoms of IBS; nb no side effects apart from difficulty swallowing capsules
  1. Copermin enteric coated capsule containing 187 mg peppermint oil in thixotropic gel (Antispasmodic); duration: 4 weeks; frequency/day: 3 to 4 times 30 min before meals; amount 561–748 mg (n=55 )
  2. Identical capsule containing an inert oil (placebo); duration: 4 weeks; frequency/day: 3 to 4 times 30 min before meals; amount (n=55 )
Mitchell 2002 Trial held in UK parallel trial Setting: secondary careInclusion & Exclusion criteria: alcohol/drug abuse, breastfeeding, concomitant disease with abdominal symptoms/constipation, uncontrolled endocrine disorders, history of abdominal surgery, significant renal/ hepatic/cardiac/ systemic disease Type of IBS: Mixed; IBS definition: Rome I; Severity of IBS symptoms: mixed; Bloating/flatus: Not stated; Post infective: not stated Age (range): mean 39.6 (15.0), range 19–73; Gender (M/F): 21:86; Comorbidities: Weight mean 68.3kg, ethnicity 100% Caucasian
  1. Alverine citrate capsule (Antispasmodic); duration: 12 weeks; frequency/day: tds; amount 360mg (n=53)
  2. placebo (placebo); duration: 12 weeks; frequency/day: tds; amount n/a (n=54)
Page 1981 Trial held in USA parallel trial Setting: secondary careInclusion & Exclusion criteria: Type of IBS: Constipation; IBS definition: Authors’ def; Severity of IBS symptoms: Not stated; Bloating/flatus: Not stated; Post infective: not stated Age (range): 36.7yr, 18–65yr; Gender (M/F): 12:59 completers; Comorbidities: Duration of symptoms <5 yr, median 2 yr. 26 of original 97 pts assessed excluded during 1 week run in period, mostly because of no pain
  1. Dicyclomine bromide (Antispasmodic); duration: 2 weeks; frequency/day: qds; amount 160mg (n=34)
  2. placebo (placebo); duration: 2 weeks; frequency/day: qds; amount n/a (n=37)
Nigam 1984 Trial held in India parallel trial Setting: secondary careInclusion & Exclusion criteria: not stated Type of IBS: Unclear; IBS definition: Authors’ def; Severity of IBS symptoms: Not stated; Bloating/flatus: Not stated; Post infective: not stated Age (range): 34.5 (5.7) 16–68 yr; Gender (M/F): 92:76; Comorbidities: not stated Complicated factorial design but can be treated as parts
  1. Hyoscine (Antispasmodic); duration: 3 months; frequency/day: not stated; amount not stated (n= 21)
  2. Placebo (placebo); duration: 3 months; frequency/day: not stated; amount n/a (n=21)
Ritchie 1979 Trial held in UK parallel trial Setting: secondary careInclusion & Exclusion criteria: Excluded: patients with 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): all pts 38 (16–69); Gender (M/F): all pts 22:74; Comorbidities: not Stated Factorial design. Six other treatments with various combinations of lorazepam, hyoscine and ispaghula with corresponding placebos
  1. Hyoscine butylbromide (Buscopan) 10mg (Antispasmodic); duration: 3 months; frequency/day: 4 times; amount 40 mg (n=12 )
  2. Placebo (placebo); duration: 3 months; frequency/day: not stated; amount not stated (n=12)
Schafer 1990 Trial held in Germany parallel trial Setting:----Inclusion & Exclusion criteria: Type of IBS:----; IBS definition: ‘Had IBS’; Severity of IBS symptoms:----; bloating/flatus:---; Post infective:---Age (range): ; Gender (M/F): 256:456; Comorbidities: Study in German - English abstract
  1. Hyoscine plus paracetamol (Antispasmodic); duration: 4 weeks; frequency/day: tds; amount 30mg + 1500mg (n=177)
  2. Placebo (placebo); duration: 4 weeks; frequency/day: tds; amount n/a (n=178)
  3. Hyoscine alone;
  4. Paracetamol alone

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.

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.