Feng Ye, Ni Guo, Yaping Wang, Baochun Wang, Chunyan Niu, Zujin Ji, Ming Guo, Yilin Hou, Yi Jian, Jianhua Cui, Dazhi Chen, Shuhui Li, Dongxia Wang, Hongping Guo, Junlei Jiu, Chunlei Qiu, Hui Cao, Ying He, Ming Chen, Hua Li, Xuezhi Xin, Rongjuan Zheng, Wei Chen, Dongya Chen, Lingyun Niu, Zhenqin Cui, Zhanquan Zou, Bin Jia, Leyao Zhang, Yinming Bai, Wanyu Li, Xiaojun Yang, Min Hua, Shaoming Long, Guoliang Cheng, Zhiyan Huang, Enhua Yang, Jinjin Shi, Guoxin Zhang
{"title":"中药寿会通便胶囊联合2L聚乙二醇用于结肠镜前肠道准备的疗效及安全性：多中心、随机、单盲、平行对照临床试验","authors":"Feng Ye, Ni Guo, Yaping Wang, Baochun Wang, Chunyan Niu, Zujin Ji, Ming Guo, Yilin Hou, Yi Jian, Jianhua Cui, Dazhi Chen, Shuhui Li, Dongxia Wang, Hongping Guo, Junlei Jiu, Chunlei Qiu, Hui Cao, Ying He, Ming Chen, Hua Li, Xuezhi Xin, Rongjuan Zheng, Wei Chen, Dongya Chen, Lingyun Niu, Zhenqin Cui, Zhanquan Zou, Bin Jia, Leyao Zhang, Yinming Bai, Wanyu Li, Xiaojun Yang, Min Hua, Shaoming Long, Guoliang Cheng, Zhiyan Huang, Enhua Yang, Jinjin Shi, Guoxin Zhang","doi":"10.1177/17562848251378043","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objectives: </strong>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).</p><p><strong>Design: </strong>Multicenter, randomized, single-blind, parallel-controlled trial.</p><p><strong>Methods: </strong>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, <i>n</i> = 202) and the control group (3L PEG, <i>n</i> = 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).</p><p><strong>Results: </strong>The success rate of bowel preparation was comparable between groups (<i>p</i> = 0.7454). The experimental group had a slightly longer time to first adequate bowel movement on the day of colonoscopy (<i>p</i> = 0.0013) but experienced fewer bowel movements the day before (<i>p</i> < 0.0001). The experimental group reported significantly fewer ADRs (<i>p</i> = 0.0311) and better tolerance, including reduced bloating, nausea, and sleep disturbance (<i>p</i> < 0.01 for all). Patient acceptance was higher in the experimental group (92.89% vs 88.32%), although the difference was not statistically significant (<i>p</i> = 0.4170).</p><p><strong>Conclusion: </strong>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.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry: ChiCTR2300069962.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251378043"},"PeriodicalIF":3.4000,"publicationDate":"2025-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12477385/pdf/","citationCount":"0","resultStr":"{\"title\":\"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.\",\"authors\":\"Feng Ye, Ni Guo, Yaping Wang, Baochun Wang, Chunyan Niu, Zujin Ji, Ming Guo, Yilin Hou, Yi Jian, Jianhua Cui, Dazhi Chen, Shuhui Li, Dongxia Wang, Hongping Guo, Junlei Jiu, Chunlei Qiu, Hui Cao, Ying He, Ming Chen, Hua Li, Xuezhi Xin, Rongjuan Zheng, Wei Chen, Dongya Chen, Lingyun Niu, Zhenqin Cui, Zhanquan Zou, Bin Jia, Leyao Zhang, Yinming Bai, Wanyu Li, Xiaojun Yang, Min Hua, Shaoming Long, Guoliang Cheng, Zhiyan Huang, Enhua Yang, Jinjin Shi, Guoxin Zhang\",\"doi\":\"10.1177/17562848251378043\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Objectives: </strong>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).</p><p><strong>Design: </strong>Multicenter, randomized, single-blind, parallel-controlled trial.</p><p><strong>Methods: </strong>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, <i>n</i> = 202) and the control group (3L PEG, <i>n</i> = 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).</p><p><strong>Results: </strong>The success rate of bowel preparation was comparable between groups (<i>p</i> = 0.7454). The experimental group had a slightly longer time to first adequate bowel movement on the day of colonoscopy (<i>p</i> = 0.0013) but experienced fewer bowel movements the day before (<i>p</i> < 0.0001). The experimental group reported significantly fewer ADRs (<i>p</i> = 0.0311) and better tolerance, including reduced bloating, nausea, and sleep disturbance (<i>p</i> < 0.01 for all). Patient acceptance was higher in the experimental group (92.89% vs 88.32%), although the difference was not statistically significant (<i>p</i> = 0.4170).</p><p><strong>Conclusion: </strong>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.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry: ChiCTR2300069962.</p>\",\"PeriodicalId\":48770,\"journal\":{\"name\":\"Therapeutic Advances in Gastroenterology\",\"volume\":\"18 \",\"pages\":\"17562848251378043\"},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2025-09-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12477385/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Therapeutic Advances in Gastroenterology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/17562848251378043\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic Advances in Gastroenterology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/17562848251378043","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
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.
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).
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.
期刊介绍：
Therapeutic Advances in Gastroenterology is an open access journal which delivers the highest quality peer-reviewed original research articles, reviews, and scholarly comment on pioneering efforts and innovative studies in the medical treatment of gastrointestinal and hepatic disorders. The journal has a strong clinical and pharmacological focus and is aimed at an international audience of clinicians and researchers in gastroenterology and related disciplines, providing an online forum for rapid dissemination of recent research and perspectives in this area.
The editors welcome original research articles across all areas of gastroenterology and hepatology.
The journal publishes original research articles and review articles primarily. Original research manuscripts may include laboratory, animal or human/clinical studies – all phases. Letters to the Editor and Case Reports will also be considered.
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