Comparison of a Chinese Herbal Medicine (CCH1) and Lactulose as First-Line Treatment of Constipation in Long-Term Care: A Randomized, Double-Blind, Double-Dummy, and Placebo-Controlled Trial.

Many institutionalized patients and their healthcare providers are dissatisfied with current laxative therapy. This study compared therapeutic efficacy, safety, and laxative cost of an herbal formula (CCH1) and lactulose for long stay patients with constipation. In this double-blind, double-dummy, and placebo-controlled trial, we randomized 93 residents with chronic constipation from two long-term care facilities in Taiwan to receive either CCH1 with lactulose placebo or CCH1 placebo with lactulose for 8 weeks, then followed up for 4 weeks without study medication. Both treatments were effective and well tolerated for patients, but CCH1 produced more spontaneous bowel movements, less rectal treatments, less amount of rescue laxative, and lower laxative cost than lactulose during treatment. No significant differences were found in stool consistency, stool amount, global assessment, and safety concerns. In conclusion, our results suggest that CCH1 may have better efficacy and could be used as an alternative option to lactulose in the treatment of constipation in long-term care.