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

Abstract

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.