Randomized Controlled Trial
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World J Gastroenterol. Nov 28, 2014; 20(44): 16739-16744
Published online Nov 28, 2014. doi: 10.3748/wjg.v20.i44.16739
Xiaoyao pill for treatment of functional dyspepsia in perimenopausal women with depression
Han-Guang Du, Li Ming, Shu-Jiao Chen, Can-Dong Li
Han-Guang Du, Li Ming, Shu-Jiao Chen, Can-Dong Li, Research Base of Traditional Chinese Medicine Syndrome, Fujian University of Traditional Chinese Medicine, Fuzhou 350122, Fujian Province, China
Author contributions: Li CD, Du HG and Chen SJ designed the research; Du HG and Ming L analyzed the data; and Du HG and Ming L wrote the paper.
Supported by A grant from the National Physical Science Major Project, No. 81230087
Correspondence to: Can-Dong Li, MD, Professor, Research Base of Traditional Chinese Medicine Syndrome, Fujian University of Traditional Chinese Medicine, No. 1 Qiuyang Street, Fuzhou 350122, Fujian Province, China. fjzylcd@126.com
Telephone: +86-591-22861513 Fax: +86-591-22861513
Received: March 29, 2014
Revised: July 2, 2014
Accepted: July 24, 2014
Published online: November 28, 2014
Processing time: 247 Days and 12.4 Hours
Abstract

AIM: To evaluate the efficacy and safety of the Xiaoyao pill for treatment of functional dyspepsia (FD) associated with perimenopausal depression.

METHODS: This was a double-blind, randomized, controlled trial including 180 patients with FD accompanied by depression that were divided into two groups of 90. Patients in the treatment group received oral administration of the Xiaoyao pill for soothing the liver and activating the spleen, and patients in the control group received a placebo. This trial included an 8-wk therapy period with a follow-up period of 6 mo. The total efficacy and degree of depression, as assessed by the Hamilton Rating Scale for Depression (HRSD), were evaluated. Plasma levels of motilin and gastrin were measured and a gastric emptying test was conducted in each participant.

RESULTS: The Xiaoyao pill had a good therapeutic effect and improved the symptoms in patients with perimenopausal FD as assessed by the HRSD score, motilin and gastrin levels, and rate of gastric emptying. The total effective rate of the Xiaoyao pill in the treatment group was significantly superior to that of the placebo in the control group. In the control group, the initial HRSD score was 12.12 ± 2.29 and decreased to 7.14 ± 1.67 after therapy (P < 0.01). In the treatment group, the initial HRSD score was 11.44 ± 2.15, which significantly decreased to 6.20 ± 2.08 after therapy (P < 0.01). Moreover, the HRSD score in the treatment group was significantly lower than in control group after 8 wk (P < 0.01). Motilin and gastrin levels in both groups were significantly increased after the 8-wk therapy (P < 0.05). The gastric emptying rate was also improved in both groups after therapy (P < 0.05), and the improvement was significantly better in the treatment group compared to the controls (P < 0.05). These results confirm the therapeutic effects of the Xiaoyao pill in perimenopausal FD patients and indicate that it is worthy of clinical promotion.

CONCLUSION: The Xiaoyao pill is effective and safe for the treatment of perimenopausal women with FD associated with depression.

Keywords: Chinese herbal medicine; Functional dyspepsia; Perimenopausal women; Xiaoyao pill

Core tip: This study observed the clinical effects of the Xiaoyao pill for treatment of perimenopausal women with functional dyspepsia (FD) and depression. The Xiaoyao pill improved patient symptoms as assessed by the Hamilton rating scale for depression and gastric emptying rate. The mechanism of these effects may be related to the observed increases in plasma motilin and gastrin levels, which can accelerate gastric emptying and improve propulsion through the small intestine.