title: Selective serotonin reuptake inhibitor combined with dengzhanshengmai capsule improves the fatigue symptoms: a 12-week open-label pilot study.
abstract: OBJECTIVE
  This study was to assess the efficacy and safety of selective serotonin reuptake inhibitor (SSRI) plus Dengzhanshengmai capsule in patients with chronic fatigue syndrome (CFS).
  
  
  METHODS
  SSRI at a moderate dose plus Dengzhanshengmai (n = 134) with SSRI alone (n = 134) were compared for the efficacy and safety in the treatment of CFS. The therapeutic efficacy and safety were evaluated.
  
  
  RESULTS
  As compared to monotherapy group, the efficacy in combined therapy group was better and characterized by the improvement of general fatigue (0.8±0.6 vs. 1.3±0.7), physical fatigue (0.6±0.3 vs. 1.0±0.4) and reduced activity (1.0±0.5 vs. 1.3±0.6) since the 2nd week (P<0.01) and in reduced motivation (2.1±0.8 vs. 2.4±1.0) since the 8th week (P<0.01) and the improvement continued thereafter. The mental fatigue score and HAD score were comparable between two groups (P>0.05). No significant difference was found in the drop-out rate between SSRI group (15.7%) and SSRI plus Dengzhanshengmai group (18.0%). The reasons for drop out were adverse events (7.5% vs. 9.7%), requests of the patients or career requirement (3.7% vs. 4.5%), loss to follow-up and others (2.2% vs. 3.0%) and lack of efficacy (2.2% vs. 0.7%). Although the patients in combined therapy group experienced a higher rate of hypertension than (5.8% vs. 1.5%), no significant difference was observed (P = 0.08).
  
  
  CONCLUSIONS
  SSRI combined with Dengzhanshengmai capsule may significantly improve the general fatigue, physical fatigue, reduced activity and reduced motivation of CFS patients as compared to monotherapy with SSRI. Furthermore, this combined therapy is safe and tolerable.
authors.affiliation: Department of Integrated Internal Medicine, The First Affiliated Hospital, College of Medicine, Zhejiang University Hangzhou 310003, Zhejiang, China.
authors.forename: De-Qiang
authors.initials: DQ
authors.lastname: Li
authors.affiliation: Department of Neurology, Tongde Hospital of Zhejiang Province Hangzhou, China.
authors.forename: Zhong-Chun
authors.initials: ZC
authors.lastname: Li
authors.affiliation: Department of Preventive Medicine, Xiaoying Street Community Health Center Hangzhou, China.
authors.forename: Zhi-Yuan
authors.initials: ZY
authors.lastname: Dai
keywords: SSRI; dengzhanshengmai; fatigue