Efficacy and safety of Shouhui Tongbian Capsules, a traditional Chinese medicine, combined with 2L polyethylene glycol for bowel preparation before colonoscopy: a multicenter, randomized, single-blind, parallel-controlled clinical trial
Rattachement africain : cn, hk. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
Background: High-volume polyethylene glycol (PEG) solutions are commonly used for bowel preparation but are often poorly tolerated, reducing patient compliance. Shouhui Tongbian Capsules (SHTBC), a traditional Chinese medicine known to promote gastrointestinal motility, may offer an alternative approach. However, its role in bowel preparation remains unclear. Objectives: To evaluate the efficacy, safety, and tolerability of a novel bowel preparation regimen combining SHTBC with low-volume PEG (2L) compared to conventional high-volume PEG (3L). Design: Multicenter, randomized, single-blind, parallel-controlled trial. Methods: A total of 404 participants scheduled for colonoscopy across 34 medical centers in China were randomized into two groups: the experimental group (SHTBC + 2L PEG, n = 202) and the control group (3L PEG, n = 202). Bowel preparation quality was assessed using the Boston Bowel Preparation Scale (BBPS), with successful cleansing defined as a total BBPS score ⩾6. The secondary outcomes included time to adequate bowel movement, number of bowel movements, patient tolerance, acceptance, and incidence of adverse drug reactions (ADRs). Results: The success rate of bowel preparation was comparable between groups ( p = 0.7454). The experimental group had a slightly longer time to first adequate bowel movement on the day of colonoscopy ( p = 0.0013) but experienced fewer bowel movements the day before ( p < 0.0001). The experimental group reported significantly fewer ADRs ( p = 0.0311) and better tolerance, including reduced bloating, nausea, and sleep disturbance ( p < 0.01 for all). Patient acceptance was higher in the experimental group (92.89% vs 88.32%), although the difference was not statistically significant ( p = 0.4170). Conclusion: SHTBC combined with 2L PEG is a safe, effective, and better-tolerated alternative to 3L PEG for bowel preparation before colonoscopy, offering a promising strategy to improve patient compliance. Trial registration: Chinese Clinical Trial Registry: ChiCTR2300069962.
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Efficacy and safety of Shouhui Tongbian Capsules, a traditional Chinese medicine, combined with 2L polyethylene glycol for bowel preparation before colonoscopy: a multicenter, randomized, single-blind, parallel-controlled clinical trial
- Date Crossref
- 01/08/2025
- Éditeur
- SAGE Publications
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
-
Nanjing Medical University Department of Gastroenterology pays non établi dans la noticeUniversité ou école supérieure
-
Wenzhou Medical University pays non établi dans la noticeUniversité ou école supérieure
-
Dongyang People's Hospital pays non établi dans la noticeÉtablissement de santé
-
Hainan General Hospital Department of General Surgery pays non établi dans la noticeÉtablissement de santé
-
Lishui City People's Hospital pays non établi dans la noticeÉtablissement de santé
-
Dongfeng General Hospital Department of Colorectal and Anal Surgery pays non établi dans la noticeÉtablissement de santé
-
First Affiliated Hospital Zhejiang University pays non établi dans la noticeÉtablissement de santé
-
Chengdu Second People's Hospital Department of Gastroenterology and Hepatology pays non établi dans la noticeÉtablissement de santé
-
Yancheng Third People's Hospital pays non établi dans la noticeÉtablissement de santé
-
Yancheng Second People's Hospital pays non établi dans la noticeÉtablissement de santé
-
Integrated Chinese Medicine (China) pays non établi dans la noticeEntreprise
-
Hangzhou Hospital of Traditional Chinese Medicine pays non établi dans la noticeÉtablissement de santé
Department of Gastroenterology — Nanjing Medical University, Wenzhou Medical University et Dongyang People's Hospital, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.