C19HERBAL MEDICINE

StudyParticipantsInterventions
Bensoussan et al, 1998; Trial held in australia; parallel trial; Setting: not statedInclusion & Exclusion criteria: Included: age 18-75, IBS by Rome Criteria, at least 3 months of IBS symptoms.
Excluded: breast feeding, pregnancy, medication, alcoholism, allergies, psychiatric illness, lactose intolerance, celiac disease, diabetes, cancers, ulcers. Type of IBS: Mixed; IBS definition: Authors’ def; Severity of IBS symptoms: Not stated; Bloating/flatus: Not stated; Post infective: not stated Age (range): 47 yrs (no range given); Gender (M/F): 64:52; Comorbidities: IBS definition was ‘Rome criteria’, but not stated I, II or III. Setting not stated, but could be ‘primary care’. Methods states many outcome measures
  1. Standard Chinese herbal preparation, Mei Yu Imports, Sydney (see paper for list of names of 20 herbs and their concentration) (compound Chinese herbal preparation); duration: 16 weeks; frequency/day: 3; amount 15 capsules (5 capsules 3 times daily) (n=43)
  2. Placebo “designed to taste, smell and look similar to Chinese herb formula” (placebo); duration: 16 weeks; frequency/day: 3; amount 15 capsules (n= 35) group C: individualised chinese herbal therapy. N= 38 Formula tailored to individual patient (irrespective of diagnosis), modified at different stages of illness. Dose: 5 capsules 3 times daily.
Brinkhaus et al, 2005; Trial held in Germany; parallel; trial; Setting: not statedInclusion & Exclusion criteria: Included:clinical diagnosis of IBS, aged 18-70, with certain IBS symptoms. Excluded: organic disease, allergies, cancer, coeliac disease, diabetes, hypo(er)thyrioidism, serious diseases, alcohol/drug abuse, psychiatric illness, pregnancy/breastfeeding. Type of IBS: Mixed; IBS definition: Authors’ def; Severity of IBS symptoms: severe; Bloating/flatus: Not stated; Post infective: not stated Age (range): 48 (no range); Gender (M/F): 39:67; comorbidities: Setting unclear. Mean duration of symptoms= 7 yrs.
  1. Curcuma xanthorizza tablets containing 20 mg spray dried extract of the herb (single non-chinese herbal preparation); duration: 18 weeks; frequency/day: 3; amount 60 mg (n=24)
  2. Placebo tablets (placebo); duration: 18 weeks; frequency/day: 3; amount 6 tablets (n=59) C; fumitory group, Fumaria Officinalis (1 tabled containing 250mg of an aqueous, spray dried extract of the herb. Including >=3.75 mg alkaloid. N=24. For 18 weeks, 2 tablets 3 times daily 1500 mg/day.
Leung et al, 2006; Trial held in China; parallel trial; Setting: not statedInclusion & Exclusion criteria: Included: IBS patients (aged 18-75) based on Rome II, with diarrhoea predominant symptoms (diarrhoea at least 75% of the time) with TCM syndrome. Excluded:constipation/alternating IBS type, organic/systemic diseases, preganat/lactating women. Type of IBS: Diarrhoea; IBS definition: Rome II; Severity of IBS symptoms: Not stated; Bloating/flatus: Not stated; Post infective: not stated Age (range): 45.4 yrs SD 11.9 yrs; Gender (M/F): 57:62; Comorbidities: Setting not stated, but could be ‘primary’. About half of the cases had IBS durations between 1 and 5 yrs. Dose of TCM
  1. Herbal TCM Traditional Chinese Medicine of ‘Tong Xie Yao Fang composition (see paper for list of names of 11 herbs and their concentration) (compound chinese herbal preparation); duration: 8 weeks; frequency/day: 2; amount see paper for preparation/dose of 11 herbs used (n=60)
  2. Placebo made of starch, glucose, lactose (<1% by weight), bitter, sucrose octaacetate (0.01% of weight) (placebo); duration: 8 weeks; frequency/day: 2; amount (n=59)
Madisch et al., 2004; Trial held in Germany; parallel trial; Setting: primary careInclusion & Exclusion criteria: Included: cases with IBS (def: abdominal pain of >=3 months during last 12 months, and associated with disturbances of bowel habit).
Excluded: structural lesions, organic diseases, history/current gastrointestinal diseases.
Type of IBS: Mixed; IBS definition: Authors’ def; Severity of IBS symptoms: Not stated; Bloating/flatus: Some patients; Post infective: not stated Age (range): mean 43.6 yrs SD 12.9 yrs (No range); Gender (M/F): 84:124; Comorbidities: Dose per day: No details given about concentration of the herbs. Also not clear whether the dose per day was 20 drops or 60 drops: paper states “3
  1. STW 5 bitter candytuft, chamomile flower, peppermint leaves, caraway fruit, liquorice root, lemon balm leaves, celandine herbs, angelica root, milk thistle fr. (compound non-Chinese herbal preparation); duration: 4 weeks; frequency/day: 3; amount 3 times daily 20 drops (n=51)
  2. Placebo (placebo); duration: 4 weeks; frequency/day: 3; amount 3 times daily 20 drops (n=52) B: STW 5-II: bitter candytuft, chamomile flower, peppermint leaves, caraway fruit, liquorice root, lemon balm leaves. 3x/day, 20 drops 4 wks. Group C: bitter candytuft mono extract. 3x/day (20 dr) 4 wks.
Wang 2006; Trial held in China; parallel trial; Setting: secondary careInclusion & Exclusion criteria: Excl: IBS drugs; allergy to food additive, drug or TXNG; inflammatory bowel disease; alcohol/drug abuse; psychiatric illness/dementia; pregnancy/breastfeeding; serious disease; other study in last 6 mo Type of IBS: Diarrhoea; IBS definition: Rome II; Severity of IBS symptoms: Not stated; Bloating/flatus: Not stated; Post infective: not stated Age (range): mean 37 yr; range 18-65yr; Gender (M/F): 26:31; Comorbidities: none
  1. Tong-xie-ning granule (TXNG): Baishao, Baizhu, Qingpi, Xiebai (compound chinese herbal preparation); duration: 3 weeks; frequency/day: 3; amount 15g/day (n=30)
  2. Placebo (placebo); duration: 3 weeks; frequency/day: 3; amount 15g (n=30)
Yadav et al, 1989; Trial held in India; parallel trial; Setting: not statedInclusion & Exclusion criteria: Included: patients (age 10- 60) with IBS using Sandler et al, 1984 criteria i.e. symptoms (including pain, loose stools, mucus) are chronic (> 1yr), occurring more than 25% of time. Excluded: organic gastrointestinal diseases and parasitic infestations. Type of IBS: Mixed; IBS definition: Symptoms described; Severity of IBS symptoms: Not stated; Bloating/flatus: Some patients; Post infective: not stated Age (range): mean 28.4 yr (13-55); Gender (M/F): 147:22; comorbidities: Setting unclear: paper states “patients from Gatroenterology Dept”. Age range below 18 included in this study. Mean
  1. Compound Ayurvedic preparation with Aegle marmelos correa + Bacopa monniere Linn (compound non- chinese herbal preparation); duration: 6 weeks; frequency/day: 3 (times 5 g); amount 15 g (n=57)
  2. Placebo: corn starch+ exciepient containing polyvinylpyrrolodone (glucose anhydrous, citric acid, green colour) (placebo); duration: 6 weeks; frequency/day: 3 (times 5 g); amount 15 g (n= 52) Part B, C, and D are IBS subtypes of overall. B. Diarrhoea IBS cases (n=55). C: Constipation IBS cases (n=33) D: Alternating IBS cases (n=49). B,C,D:Intervention time 6 wks Dose: 3 times 5 g daily.

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.

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