[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]

التفاصيل البيبلوغرافية
العنوان: [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]
المؤلفون: Ping Han, Xiao-lin Xue, Yu Tang, Yan Zhao, Qing-bo Wang, Liu-xin Wu, Wen-ping Wang, Zhen Li, Run-shuan Zhao, Jia-jia Wang, Jian-min Xing, Tian-fang Wang, Ya-jing Zhang, Li Li, Shao-liang Ji, Xiu-yan Wu, Guan-ru Li
المصدر: Zhong xi yi jie he xue bao = Journal of Chinese integrative medicine. 9(5)
سنة النشر: 2011
مصطلحات موضوعية: Male, medicine.medical_specialty, Traditional Chinese medicine, Placebo, law.invention, Randomized controlled trial, Double-Blind Method, law, Internal medicine, medicine, Outpatient clinic, Humans, Prospective Studies, Medicine, Chinese Traditional, Prospective cohort study, Adverse effect, Fatigue, Traditional medicine, business.industry, Middle Aged, Clinical trial, Complementary and alternative medicine, Female, Phytotherapy, business, Drugs, Chinese Herbal, Follow-Up Studies
الوصف: 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
تدمد: 1672-1977
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2fa54951e2b3ac3a6060129570025d0e
https://pubmed.ncbi.nlm.nih.gov/21565137
رقم الأكسشن: edsair.doi.dedup.....2fa54951e2b3ac3a6060129570025d0e
قاعدة البيانات: OpenAIRE