Efficacy and Safety of Maxing Xianchang Su in the Treatment of Functional Constipation: A Randomized Controlled Trial

Mi Li; Lijuan Zhao; Li Ma; Wen Zhang; Hua Huang; Jun Wei; Jun Sun; Fenying Lu; Lijiang Ji

doi:10.1155/2021/3685440

Efficacy and Safety of Maxing Xianchang Su in the Treatment of Functional Constipation: A Randomized Controlled Trial

Evid Based Complement Alternat Med. 2021 Nov 25:2021:3685440. doi: 10.1155/2021/3685440. eCollection 2021.

Authors

Mi Li¹, Lijuan Zhao², Li Ma³, Wen Zhang³, Hua Huang¹, Jun Wei¹, Jun Sun⁴, Fenying Lu⁵, Lijiang Ji¹

Affiliations

¹ Changshu Hospital Affiliated to Nanjing University of Chinese Medicine, Changshu 215500, Jiangsu, China.
² Yueyang Hospital of Integrative Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China.
³ Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China.
⁴ Jingjiang People's Hospital, Jingjiang 214500, Jiangsu, China.
⁵ The No. 2 People's Hospital of Changshu, Changshu 215500, Jiangsu, China.

Abstract

Background: Functional constipation (FC) is one of the prevalent gastrointestinal disorders that affect people of all ages. Long-term FC has significant effects on the quality of life of patients. Although commonly used drugs have reliable short-term effects, they are easily addictive and have side effects. Therefore, pursuing a convenient drug-food homogenous program is critical for FC patients. Maxing Xianchang Su is a functional food based on traditional Chinese medicine. To investigate the efficacy and safety of Maxing Xianchang Su in FC treatment, we conducted a randomized controlled trial.

Methods: We carried out a prospective multicenter randomized parallel controlled study in three hospitals in Jiangsu Province, China, from January 2020 to March 2021, which included 206 FC patients. All patients were arbitrarily assigned into a treatment group and a control group at a ratio of 1 : 1; 103 cases in each group. The treatment group was given oral Maxing Xianchang Su, whereas the control group was treated with lactulose oral solution. The course of treatment was two weeks. The two groups of patients were evaluated after six weeks for symptom improvement before and after taking the drug. Furthermore, the safety of Maxing Xianchang Su was assessed.

Results: Both groups of patients successfully completed the study without shedding cases. The effective rates of the treatment group and control group after two weeks were 90.6% and 67.0%, respectively. The treatment group had a better curative effect than the control group (P < 0.05). The symptom score of the two groups improved compared with that before the treatment. The difference between the two groups was statistically significant (P < 0.05). During the treatment process, neither group experienced abnormal changes in blood lipid, blood glucose, routine hematuria, or liver and kidney functions. There were no adverse reactions in both groups.

Conclusion: Maxing Xianchang Su has a positive effect on FC treatment with reliable mid-term effect and a high level of safety.