title: [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].
abstract: 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).
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Diagnostics of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100029, China. tianfangwang2000@yahoo.com.cn
authors.forename: Tian-fang
authors.initials: TF
authors.lastname: Wang
authors.forename: Xiao-lin
authors.initials: XL
authors.lastname: Xue
authors.forename: Ya-jing
authors.initials: YJ
authors.lastname: Zhang
authors.forename: Ping
authors.initials: P
authors.lastname: Han
authors.forename: Zhen
authors.initials: Z
authors.lastname: Li
authors.forename: Wen-ping
authors.initials: WP
authors.lastname: Wang
authors.forename: Jian-min
authors.initials: JM
authors.lastname: Xing
authors.forename: Qing-bo
authors.initials: QB
authors.lastname: Wang
authors.forename: Yu
authors.initials: Y
authors.lastname: Tang
authors.forename: Li
authors.initials: L
authors.lastname: Li
authors.forename: Jia-jia
authors.initials: JJ
authors.lastname: Wang
authors.forename: Guan-ru
authors.initials: GR
authors.lastname: Li
authors.forename: Shao-liang
authors.initials: SL
authors.lastname: Ji
authors.forename: Liu-xin
authors.initials: LX
authors.lastname: Wu
authors.forename: Yan
authors.initials: Y
authors.lastname: Zhao
authors.forename: Xiu-yan
authors.initials: XY
authors.lastname: Wu
authors.forename: Run-shuan
authors.initials: RS
authors.lastname: Zhao
mesh_terms: D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005221:Fatigue / Q000175:diagnosis / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008516:Medicine, Chinese Traditional; D008875:Middle Aged; D008517:Phytotherapy; D011446:Prospective Studies
chemical_list: D004365:Drugs, Chinese Herbal; C525740:yishen