Short and long-term efficacy of combining Fuzhengliqi mixture with acupuncture in treatment of functional constipation
Authors: Guangyan Li
Xiaofeng Guo
Like Guo
Chaoxian Zhang
Xiaohe Guo
Journal: Journal of Traditional Chinese Medicine (2013)
Discipline: PHARMACOLOGY & TOXICOLOGY
Keywords: Fuzhengliqi mixture; acupuncture; functional constipation; combined therapy; efficacy

Abstract:  Objective: To explore the short and long-term efficacy of combining Fuzhengliqi mixture (FLM) with acupuncture in treating functional constipation (FC). Methods: The 560 patients with confirmed diagnosis of FC were randomly assigned to four groups: FLM group, acupuncture group, combined therapy group, and control group. There were 140 cases in each group. The FLM group was administered FLM 60 mL twice a day, while the acupuncture group was treated with acupuncture at acupoints Tianshu (ST 25), Shangjuxu (ST 37), Zusanli (ST 36), Dachangshu (BL 25), and Zhigou (TE 6) twice a day, the combined therapy group with FLM and acupuncture, and the control group was administered mosapride (5 mg thrice a day) and Macrogol 4000 (10 g twice a day). The treatment lasted 6 weeks. The defecation interval, stool property, constipation symptoms, and accompanying symptoms were recorded, graded, and scored. The gastrointestinal transit time (GITT) and motilin (MTL) level in serum and life quality score were detected at three time points (pre-treatment, at the end of treatment, and 60 weeks post-treatment). Moreover, the adverse reactions were also observed. Results: In the FLM group 2 cases were eliminated for not taking medication strictly according to the research plan and 1 case was lost to follow-up, while 2 cases in the acupuncture group and 2 cases in the combined therapy group were lost to follow-up. Compared with those detected pre-treatment, the defecation interval, stool property, constipation symptom grade, accompanying symptom grade, and GITT were all decreased markedly at the end of treatment in every group, while the MTL levels in serum and life quality score were increased markedly (P &lt; 0.01), the above-mentioned detecting indices were better in the combined therapy group than those in other groups (P &lt; 0.05). Compared with the end of treatment, above-mentioned detecting indices all recurred significantly in the FLM group and control group 60 weeks post-treatment (P &gt; 0.05), but these indices recurred insignificantly in the acupuncture and combined therapy groups (P &gt; 0.05). The short and long-term total effective rates in the combined therapy group were significantly different from those in other groups (P &lt; 0.05 or P &lt; 0.01). No serious adverse reactions were found in four groups. Conclusion: Both FLM and acupuncture can significantly shorten the defecation interval and GITT, increase MTL levels in serum, decrease the scores of stool property, constipation symptoms, and accompanying symptoms in patients with FC to increase their life quality. The combined therapy is much better in long-term efficacy and the safety is also good, worth spreading in clinical practice. 

Retracted: No

PubPeer comments:
 This is a randomized trial where participants are divided into four separate groups of around 140 participants each. A large number of variables are measured at three different times points. The first time point (at baseline) is denoted as T1. **Could the authors please explain why there is almost no variation between groups for the variables measured at baseline?** I have included some highlighted tables below, where the colours show the unexpectedly similar mean values across groups at T1. In Table 1 for example,  Defecation interval ,  Stool property ,  Constipation symptom , and  Accompanying symptom all have practically identical values in each group at T1, minor variation is consistently seen, but only in the third significant digit. The standard deviations do not seem to indicate that the data is clustered around the mean. I left a very similar comment on another paper by some of the same authors for the same reasons , could the authors provide the raw data to help explain the surprisingly similar means at baseline? ![file] ![file] ,