Summary
Background : Herbal medications have been used in many countries for the treatment of patients with irritable bowel syndrome. Controlled data supporting the efficacy of these treatments in patients with irritable bowel syndrome are lacking.
Aim : To assess the efficacy and safety of a commercially available herbal preparation (STW 5) (nine plant extracts), the research herbal preparation STW 5‐II (six plant extracts) and the bitter candytuft mono‐extract in patients with irritable bowel syndrome.
Methods : Two hundred and eight patients with irritable bowel syndrome were recruited after standardized diagnostic work‐up into a double‐blind, placebo‐controlled, multi‐centre trial and were randomly assigned to receive one of four treatments: commercially available herbal preparation STW 5 (n = 51), research herbal preparation STW 5‐II (n = 52), bitter candytuft mono‐extract (n = 53) or placebo (n = 52). The main outcome variables were the changes in total abdominal pain and irritable bowel syndrome symptom scores.
Results : Two hundred and three patients completed the trial. STW 5 and STW 5‐II were significantly better than placebo in reducing the total abdominal pain score (intention‐to‐treat: STW 5, P = 0.0009; STW 5‐II, P = 0.0005) and the irritable bowel syndrome symptom score (intention‐to‐treat: STW 5, P = 0.001; STW 5‐II, P = 0.0003) at 4 weeks. There were no statistically significant differences between the bitter candytuft mono‐extract group and the placebo group (P = 0.1473, P = 0.1207).
Conclusions : The commercially available herbal preparation STW 5 and its research preparation STW 5‐II are both effective in alleviating irritable bowel syndrome symptoms.
Our study shows for the first time that in all patients signs of primarily successful Hp-eradication treatment during the first days of treatment are consistently demonstrable and complete already after one week of therapy, irrespective of the subsequent cure or persistence of Hp-infection. In the patients with persistence of Hp-infection Hp-colonization and activity of gastritis quickly increased within 2-4 weeks after cessation of treatment. Checks to evaluate complete eradication or recrudescence of Hp-infection should be carried out not earlier than 28 days after cessation of treatment.
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