Sanren Runchang Formula Regulates Brain-gut Axis to Treat IBS-C： A Randomized Controlled Trial
10.13422/j.cnki.syfjx.20260395
- VernacularTitle:基于“脑肠同调”理论的三仁润肠方治疗便秘型肠易激综合征的随机对照试验
- Author:
Teng LI
1
;
Xinrong FAN
2
;
He YAN
1
;
Zhuozhi GONG
1
;
Mengxi YAO
3
;
Na YANG
1
;
Yuhan WANG
1
;
Huikai HU
1
;
Wei WEI
1
;
Tao LIU
1
Author Information
1. Wangjing Hospital， China Academy of Chinese Medical Sciences，Beijing 100102，China
2. Experimental Research Center， China Academy of Chinese Medical Sciences，Beijing 100010，China
3. Changping District Hospital of Traditional Chinese Medicine，Beijing 102200，China
- Publication Type:Journal Article
- Keywords:
constipation-predominant irritable bowel syndrome （IBS-C）;
regulation of brain-gut axis;
Sanren Runchang formula;
clinical efficacy;
neuroactive substances
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2026;32(2):154-161
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo observe the clinical efficacy of Sanren Runchang formula in treating constipation-predominant irritable bowel syndrome （IBS-C） by regulating the brain-gut axis and the effects of the formula on serum levels of 5-hydroxytryptamine （5-HT）， vasoactive intestinal peptide （VIP）， and substance P （SP）. MethodsA randomized controlled design was adopted， and 72 IBS-C patients meeting Rome Ⅳ criteria were randomized into observation and control groups （36 cases）.The observation group received Sanren Runchang formula granules twice daily， and the control group received lactulose oral solution daily for 4 weeks. IBS Symptom Severity Scale （IBS-SSS）， IBS Quality of Life Scale （IBS-QOL）， and Bristol Stool Form Scale （BSFS） were used to assess clinical symptoms， and bowel movement frequency was recorded. The Self-Rating Anxiety Scale （SAS） and Self-Rating Depression Scale （SDS） were employed to evaluate psychological status. ELISA was employed to measure the serum levels of 5-HT， VIP， and SP. ResultsThe total response rate in the observation group was 91.67% （33/36）， which was higher than that （77.78%， 28/36） in the control group （χ2=4.50， P<0.05）. After treatment， both groups showed increased defecation frequency and BSFS scores， decreased IBS-SSS total score， abdominal pain and bloating scores， IBS-QOL health anxiety， anxiety， food avoidance， and behavioral disorders scores， SAS and SDS scores， serum 5-HT and VIP levels， and increased SP levels （P<0.05， P<0.01）. Moreover， the observation group showed more significant changes in the indicators above than the control group （P<0.05， P<0.01）. The SP level showed no significant difference between the two groups. During the 4-week follow-up， the recurrence rate was 5.88% in the observation group and 31.25% in the control group. No adverse events occurred in observation group， and 2 cases of mild diarrhea occurred in the control group. ConclusionSanren Runchang formula demonstrated definitive efficacy in alleviating gastrointestinal symptoms and improving the psychological status and quality of life in IBS-C patients， with a low recurrence rate. The formula can regulate serum levels of neurotransmitters such as 5-HT and VIP， suggesting its potential regulatory effect on the brain-gut axis through modulating neurotransmitters and neuropeptides. However， its complete mechanism of action requires further investigation through detection of additional brain-gut axis-related biomarkers.
