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.
Must meet the diagnostic criteria for **opioid-induced constipation (OIC) according to the Rome IV Criteria**.
Patients enrolled in the trial must have a history of OIC symptoms for at least 1 week.
Patients must be aged ≥ 18 years and ≤ 85 years.
Patients must have stable cancer status with a life expectancy of more than 6 months.
Patients diagnosed with clinically significant defecation disorders at enrollment caused by structural abnormalities of the gastrointestinal tract and other gastrointestinal-related tissues (excluding OIC): inflammatory bowel disease, rectal prolapse, gastrointestinal obstruction, peritoneal metastasis or peritoneal tumors.
Patients with a history of gastrointestinal surgery, abdominal surgery or abdominal adhesions within 1 month before screening; or a history of intestinal obstruction within 3 months before screening.
Diagnosis of active diverticular disease; or severe hemorrhoids; or anal fissure; or artificial rectum or anus.
Patients with intra-abdominal catheters or feeding tubes.
Parallel
the Shouhui Tongbian Capsule
DrugAdministered orally: Shouhui Tongbian Capsule (specification: 0.35 g per capsule), 2 capsules each time, 3 times daily
Lactulose
DrugLactulose Oral Solution (specification: 100mL: 66.7 g), administered orally, 15 mL each time, twice daily.
SBM
Responders were defined as having at least three spontaneous bowel movements (SBMs) per week and an increase of at least one SBM from baseline for at least 6 out of the 8 treatment weeks. An SBM was defined as a bowel movement occurring within the preceding 24 hours without any medications or interventions to facilitate defecation. Bowel movements occurring within 24 hours of using rescue laxatives or other adjunctive defecation methods were not considered SBMs.
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