This study intends to design and conduct a prospective, multicenter, randomized, parallel-controlled, superiority trial to evaluate the symptom-relieving effects of Shouhui Tongbian Capsule on opioid-induced constipation (OIC) in cancer patients, including defecation frequency, stool consistency, symptom scores, quality of life and other indicators, and to systematically observe its safety in clinical application. Through analysis of intestinal flora, the mechanism of Shouhui Tongbian Capsule in regulating intestinal function will be revealed. By screening the optimal population for Shouhui Tongbian Capsule in the treatment of OIC, evidence will be provided for optimizing individualized medication.
The primary efficacy endpoint is the proportion of responders at week 2 of treatment, defined as an increase of ≥1 in the average weekly number of spontaneous bowel movements (SBMs) compared with baseline and at least one SBM during that week. Secondary endpoints include weekly number of SBMs, weekly number of complete spontaneous bowel movements (CSBMs), Bristol Stool Form Scale score, straining score, Patient Assessment of Constipation-Symptoms (PAC-SYM) score, and Patient Assessment of Constipation-Quality of Life (PAC-QOL) score.
Safety endpoints mainly include the incidence of adverse events and changes in vital signs, electrocardiography, routine blood and urine tests, as well as liver and renal function before and after treatment. Meanwhile, based on clinical study data, the characteristics of the optimal population for Shouhui Tongbian Capsule in treating OIC will be identified to further enrich the application scenarios of this capsule for OIC.