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Journal of Chinese Integrative Medicine ›› 2011, Vol. 9 ›› Issue (5): 515-524.doi: 10.3736/jcim20110508

• Original Clinical Research • Previous Articles     Next Articles

Effects of Xiaopi Yishen herbal extract granules in treatment of fatigue-predominant subhealth due to liver-qi stagnation and spleen-qi deficiency: A prospective, randomized, placebo-controlled and double-blind clinical trial

Tian-fang Wang1(), Xiao-lin Xue1, Ya-jing Zhang1, Ping Han2, Zhen Li3, Wen-ping Wang4, Jian-min Xing5, Qing-bo Wang6, Yu Tang7, Li Li8, Jia-jia Wang1, Guan-ru Li1, Shao-liang Ji1, Liu-xin Wu9, Yan Zhao1, Xiu-yan Wu1, Run-shuan Zhao2   

  1. 1. Department of Diagnostics of Traditional Chinese Medicine, Preclinical School, Beijing University of Chinese Medicine, Beijing, 100029, China
    2. Health Examination Center, Beijing Xiaotangshan Hospital, Beijing 102211, China
    3. Department of Endocrinology, the First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, Henan Province, China
    4. Clinical Trial Institution, the Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang 110032, Liaoning Province, China
    5. Center of Evidence-based Medicine,Preclinical School, Beijing University of Chinese Medicine, Beijing 100029, China
    6. Department of Acupuncture and Moxibustion, the First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, Henan Province, China
    7. Department of Rehabilitation Medicine, the Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang 110032, Liaoning Province, China
    8. Preventive Treatment and Health Management Center, the First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, Henan Province, China
    9. Aeromedicine Institute of Peopled Liberation Army, Beijing 100142, China
  • Received:2010-12-15 Accepted:2010-12-28 Online:2011-05-20 Published:2011-05-15
  • Contact: Wang Tian-fang E-mail:tianfangwang2000@yahoo.com.cn

Background: The demand for effective intervention for subhealth conditions is growing with increasing numbers of people being in a state of subhealth with a poor quality of life. Future research and evaluation of the treatment methods for subhealth conditions from the perspective of traditional Chinese medicine (TCM) may provide an important direction for developing effective management of these conditions.
Objective: To evaluate the efficacy and safety of Xiaopi Yishen herbal extract granules (XPYS-HEG), a compound traditional Chinese herbal medicine for relieving fatigue and promoting a cheerful spirit for the treatment of people with fatigue-predominant subhealth due to liver-qi stagnation and spleen-qi deficiency.
Design, setting participants and interventions: A multi-center, randomized, double-blinded, placebo-controlled clinical study was undertaken. The study period was 18 weeks, including 6 weeks for intervention and 12 weeks for follow-up. Participants were recruited from medical center and outpatient clinics of three hospitals in China, i.e. Xiaotangshan Hospital of Beijing, the First Affiliated Hospital of Henan University of TCM and the Affiliated Hospital of Liaoning University of TCM. Two hundred participants who met the criteria of fatigue-predominant subhealth and liver-qi stagnation and spleen-qi deficiency in TCM were allocated randomly to the treatment group (XPYS, n=100) and control group (placebo, n=100).
Main outcome measures: The total score of Fatigue Scale-14 (FS-14) was used to evaluate the fatigue status of subjects and the extent of liver-qi stagnation and spleen-qi deficiency syndrome was also recorded.
Results: Three cases in the XPYS group withdrew from the trial. There were 200 subjects who entered to full analysis set (FAS) analysis and 197 subjects fitted in the per-protocol set (PPS) analysis. (1) According to the score changes of FS-14, the effectiveness rates in the XPYS and placebo group were as follows: 14.0% vs 9.0% (FAS) and 14.4% vs 9.0% (PPS) for complete remission, 19.0% vs 15.0% (FAS) and 19.6% vs 15.0% (PPS) for obvious effects, 39.0% vs 26.0% (FAS) and 39.2% vs 26.0% (PPS) for effective, and 72.0% vs 50.0% (FAS) and 73.2% vs 50.0% (PPS) for complete efficacy. The efficacy of XPYS-HEG was superior to the placebo statistically (P<0.05). (2) According to the score changes of TCM syndrome, the effectiveness rates in the XPYS group and placebo group were as follows: 1.0% vs 0.0% (FAS) and 1.0% vs 0.0% (PPS) for complete remission, 20.0% vs 7.0% (FAS) and 19.6% vs 7.0% (PPS) for obvious effects, 29.0%vs 24.0% (FAS) and 29.9% vs 24.0% (PPS) for effective, and 50.0% vs 31.0% (FAS) and 50.5% vs 31.0% (PPS) for complete efficacy. The efficacy of XPYS-HEG was superior to that of placebo statistically (P<0.05). (3) The follow-up results at 12 weeks and 18 weeks showed that the efficacy of XPYS-HEG was superior to that of placebo statistically (P<0.05). (4) No adverse effects were found in the XPYS group.
Conclusion: It can be concluded that XPYS-HEG is effective and safe for the treatment of people with fatigue-predominant subhealth due to liver-qi stagnation and spleen-qi deficiency.

Key words: drugs,Chinese herbal, fatigue, subhealth, symptom complex, randomized controlled trial, double-blind method, placebo, prospective studies

Figure 1

Flow chart of this randomized trial"

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