Dataset Information

Xiaopiyishen Herbal Extract Granule Improves the Quality of Life among People with Fatigue-Predominant Subhealth and Liver-Qi Stagnation and Spleen-Qi Deficiency Syndrome.

ABSTRACT: To observe the effects of Xiaopiyishen Herbal Extract Granule (XPYS-HEG) on the quality of life in people with fatigue-predominant subhealth (FPSH) and liver-qi stagnation and spleen-qi deficiency syndrome, the participants were allocated randomly to the treatment group (XPYS, n = 100) and the control group (placebo, n = 100) in this study. The study period was 18 weeks (6 weeks for the intervention and 12 weeks for followup). The results show that there were no differences between the two groups for the scores of eight factors on the SF-36 (Chinese version of the SF-36 universal quality-of-life scale) at baseline. Compared with the baseline score, intervention with XPYS-HEG led to a significant increase in scores for the factor of bodily pain at the end of the 6th week. Compared with the score at the end of the 6th week, the score for the factor of mental health in the XPYS group significantly increased at the end of the 18th week. Therefore, XPYS-HEG could partially improve the quality of life for people with FPSH and liver-qi stagnation and spleen-qi deficiency syndrome, which can ease bodily pain, stimulate a positive mood, and ease a negative mood.

SUBMITTER: Xue XL

PROVIDER: S-EPMC3407644 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

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Xiaopiyishen Herbal Extract Granule Improves the Quality of Life among People with Fatigue-Predominant Subhealth and Liver-Qi Stagnation and Spleen-Qi Deficiency Syndrome.

Xue Xiao-Lin XL Wu Xiu-Yan XY Xing Jian-Min JM Li Li L Zhao Yan Y Wang Jia-Jia JJ Zhang Ya-Jing YJ Wang Qing-Bo QB Tang Yu Y Li Guan-Ru GR Han Ping P Li Zhen Z Wang Wen-Ping WP Wang Tian-Fang TF

Evidence-based complementary and alternative medicine : eCAM 20120718

To observe the effects of Xiaopiyishen Herbal Extract Granule (XPYS-HEG) on the quality of life in people with fatigue-predominant subhealth (FPSH) and liver-qi stagnation and spleen-qi deficiency syndrome, the participants were allocated randomly to the treatment group (XPYS, n = 100) and the control group (placebo, n = 100) in this study. The study period was 18 weeks (6 weeks for the intervention and 12 weeks for followup). The results show that there were no differences between the two group ...[more]

PMID: 22852022

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Project description:BackgroundIn Traditional Chinese Medicine (TCM) theory, functional dyspepsia (FD) can be divided into different syndromes according to different clinical symptoms and signs, and the most common one is spleen-deficiency and qi-stagnation syndrome that can be treated by Chinese traditional patent medicine--two kinds of Zhizhu pills, between which the primary difference in ingredients is that one contains immature orange fruit of Citrus aurantium L.(IFCA) and the other contains that of Citrus sinensis Osbeck (IFCS). The trial's objective was to compare the efficacy of two kinds of Zhizhu pills on symptom changes in patients with FD of spleen-deficiency and qi-stagnation syndrome.MethodsA randomized, group sequential, double-blinded, multicenter trial was conducted in patients with FD of spleen-deficiency and qi-stagnation syndrome at 3 hospitals in Beijing between June 2003 and May 2005. Participants were randomly allocated into two groups (IFCA group and IFCS group) in a 1:1 ratio, and respectively took one of the two kinds of Zhizhu pills orally, 6 g each time, 3 times a day, for 4 weeks. Statistical analysis was performed with use of a group sequential method, the triangular test (TT).ResultsA total of 163 patients were randomized, and 3 patients were excluded from analysis because of early dropouts, leaving 160 patients (IFCA group: n = 82; IFCS group: n = 78) for statistical analysis. Three interim analyses were done after 62, 116, and 160 patients had completed their 4-week treatment, respectively. At the third interim analysis, the sample path crossed the upper boundary and the trial was stopped, the cure-markedly effective rates were 45% for IFCS group and 67% for IFCA group, respectively, the one-sided p-value was 0.0036, the median unbiased estimate of the odds ratio (OR) for the benefit of IFCA relative to IFCS was 2.91 with 95%CI: 1.40 to 6.06.No adverse events were observed in the two groups.ConclusionsZhizhu pills containing IFCA was superior to Zhizhu pills containing IFCS in the treatment of FD of spleen-deficiency and qi-stagnation syndrome. The application of group sequential analysis in clinical trials of TCM may offer some financial and ethical benefits.Trial registrationChinese Clinical Trial Registry (ChiCTR): ChiCTR-TRC-00000485.

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Dataset Information

Xiaopiyishen Herbal Extract Granule Improves the Quality of Life among People with Fatigue-Predominant Subhealth and Liver-Qi Stagnation and Spleen-Qi Deficiency Syndrome.

Publications

Xiaopiyishen Herbal Extract Granule Improves the Quality of Life among People with Fatigue-Predominant Subhealth and Liver-Qi Stagnation and Spleen-Qi Deficiency Syndrome.

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