Treatment of constipation in long-term care with chinese herbal formula: A randomized, double-blind placebo-controlled trial

Objectives: This study is aimed to evaluate the therapeutic efficacy and safety of CCH1, modified from an ancient herbal formula in Traditional Chinese Medicine, for the residents with constipation in long-term care. Methods: In this randomized, double-blind, placebo-controlled trial, 90 residents from three long-term care units were randomized to 8 weeks of treatment with CCH1 or placebo and then the subjects were followed up for an additional 4 weeks. Results: The mean numbers of weekly spontaneous bowel movement in the CCH1 group were greater than in the placebo group during the treatment phase of 8 weeks (p?€?<?€?0.05); the greatest difference was during weeks 1-4 (6.2±2.2 versus 3.4±2.1, p<0.001). Smaller mean numbers of weekly rectal treatments were observed with CCH1 compared with placebo during weeks 1-8 (p<0.05). The mean numbers of weekly rescue laxative tablets of magnesium oxide were significantly less in the CCH1 group than in the placebo group during the entire 12-week period (p<0.01), with the greatest difference during weeks 5-8 (14.4±16.3 versus 33.4±23.5, p<0.001). No significant safety concerns were noted. Conclusions: The six-herb formula (CCH1), compared with placebo, is effective on the treatment of constipation in long-term care. However, its maintenance effect needs further trial. Comparison of efficacy or cost-effectiveness with current laxatives is encouraged. ? 2011 Mary Ann Liebert, Inc.