Porcine Large Intestine-Processed Dahuang Pill （肠制大黄丸） for Type 2 Diabetes Mellitus Complicated by Chronic Constipation：A Randomized Controlled Trial
10.13288/j.11-2166/r.2026.21.011
- VernacularTitle:肠制大黄丸治疗2型糖尿病合并慢性便秘的随机对照试验
- Author:
Jie XU
1
;
Hongjia SONG
1
;
Hongyue ZHAN
1
;
Yinghua YAO
1
;
Xiaohan LIN
1
;
Chao CHEN
1
Author Information
1. Shantou Hospital of Traditional Chinese Medicine/ Shantou Hospital Affiliated to Guangzhou University of Chinese Medicine，Shantou，515040
- Publication Type:Journal Article
- Keywords:
type 2 diabetes mellitus;
chronic constipation;
dahuang （Radix et Rhizoma Rhei）;
porcine large intestine;
traditional Chinese medicine processing;
randomized controlled trial
- From:
Journal of Traditional Chinese Medicine
2026;67(21):2319-2324
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo investigate the efficacy and safety of porcine large intestine-processed Dahuang Pill （肠制大黄丸） in the treatment of type 2 diabetes mellitus （T2DM） complicated by chronic constipation. MethodsA total of 80 patients with T2DM complicated by chronic constipation were enrolled and randomly divided into a control group and a treatment group， with 40 cases in each group. All patients received routine basic treatment. The control group was treated with oral lactulose solution 10 ml once daily， while the treatment group was administered with oral porcine large intestine-processed Dahuang Pill 3 g once daily. The treatment course was 4 weeks for both groups. The primary outcome was the score of the Wexner Constipation Scale score. The secondary outcomes included fasting blood glucose （FBG）， 2-hour postprandial blood glucose （2 hPG）， glycated hemoglobin A1c （HbA1c）， Patient Assessment of Constipation Quality of Life （PAC-QOL） score， traditional Chinese medicine （TCM） syndrome score， and clinical effective rate before and after treatment. TCM syndrome efficacy was evaluated in both groups after treatment， and safety was assessed simultaneously. ResultsSeventy-five subjects completed the study， including 37 in the treatment group and 38 in the control group. After treatment， the Wexner Constipation Scale score， FBG， 2 hPG， HbA1c， PAC-QOL score and TCM syndrome score all significantly decreased in both groups （P＜0.01）. In intergroup comparison， the treatment group showed significantly superior improvements in the Wexner Constipation Scale score， FBG， HbA1c， PAC-QOL score and TCM syndrome score relative to the control group （P＜0.05 or P＜0.01）. No significant difference in 2 hPG was observed between groups （P＞0.05）. The total clinical effective rate of TCM syndrome efficacy was 91.89%（34/37）in the treatment group， which was higher than 63.16%（24/38） in the control group. No adverse events occurred in either group， and all safety indicators were within the normal range. ConclusionPorcine large intestine-processed Dahuang Pill can effectively relieve clinical symptoms， synergistically improve glucose metabolism and quality of life in patients with T2DM complicated by chronic constipation， which possesses good clinical safety.
