ETHNOPHARMACOLOGICAL RELEVANCE: Shou Hui Tong Bian Capsules, rooted in traditional Chinese medicine (TCM), are designed to treat functional constipation (FC) by balancing Yin and Qi, which are often disrupted in middle-aged and elderly individuals. These capsules contain a combination of herbs historically used in TCM to promote digestive health and improve bowel movement regularity, providing a potential alternative to conventional treatments. AIM OF THE STUDY: The aim of this study was to evaluate the efficacy and safety of Shou Hui Tong Bian Capsules in treating functional constipation in middle-aged and elderly patients, compared with a conventional lactulose oral solution. MATERIALS AND

Methods: This multicenter, randomized, controlled trial was conducted across several centers affiliated with the Xiyuan Hospital of China Academy of Chinese Medical Sciences. In all, 292 middle-aged and older patients with FC associated with Qi and Yin deficiency were randomized 2:1 to receive either Shou Hui Tong Bian Capsules or a lactulose oral solution control. The primary outcomes were assessed over a 4-week treatment period with follow-ups extending to 12 weeks, focusing on bowel movement frequency, TCM syndrome efficacy, quality of life, and safety profiles.

Results: Participants treated with Shou Hui Tong Bian Capsules demonstrated a significantly higher total effectiveness rate (82.9 % in the full analysis set and 83.6 % in the per protocol set) compared to those in the control group (70.4 % and 71.3 %, respectively). Improvements were also noted in the frequency of complete spontaneous bowel movements and quality of life measures. The safety profiles were similar between the groups, with no significant differences in adverse events.

Conclusions: Shou Hui Tong Bian Capsules effectively improve bowel movement frequency and alleviate symptoms associated with FC in middle-aged and elderly patients, with a safety profile comparable to conventional treatments. This study supports the use of Shou Hui Tong Bian Capsules as a viable alternative to traditional treatments for FC, demonstrating the potential of TCM-based therapies in modern clinical settings.