title: Rhodiola rosea versus sertraline for major depressive disorder: A randomized placebo-controlled trial.
abstract: BACKGROUND
  We performed a proof of concept trial to evaluate relative safety and efficacy of Rhodiola rosea (R. rosea) versus sertraline for mild to moderate major depressive disorder.
  
  
  OBJECTIVE
  We hypothesize that R. rosea would have similar therapeutic effects as sertraline but with less adverse events.
  
  
  METHODS
  Phase II randomized placebo controlled clinical trial.
  
  
  METHODS
  57 subjects were randomized to 12 weeks of standardized R. rosea extract, sertraline, or placebo. Changes over time in Hamilton Depression Rating (HAM-D), Beck Depression Inventory (BDI), and Clinical Global Impression Change (CGI/C) scores among groups were examined using mixed-effects models.
  
  
  RESULTS
  Modest, albeit statistically non-significant, reductions were observed for HAM-D, BDI, and CGI/C scores for all treatment conditions with no significant difference between groups (p = 0.79, p = 0.28, and p = 0.17, respectively). The decline in HAM-D scores was greater for sertraline (-8.2, 95% confidence interval [CI], -12.7 to -3.6) versus R. rosea (-5.1, 95% CI: -8.8 to -1.3) and placebo (-4.6, 95% CI: -8.6 to -0.6). While the odds of improving (versus placebo) were greater for sertraline (1.90 [0.44-8.20]; odds ratio [95% CI]) than R. rosea (1.39 [0.38-5.04]), more subjects on sertraline reported adverse events (63.2%) than R. rosea (30.0%) or placebo (16.7%) (p = 0.012).
  
  
  CONCLUSIONS
  Although R. rosea produced less antidepressant effect versus sertraline, it also resulted in significantly fewer adverse events and was better tolerated. These findings suggest that R. rosea, although less effective than sertraline, may possess a more favorable risk to benefit ratio for individuals with mild to moderate depression.
authors.affiliation: Department of Family Medicine & Community Health, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States; Department of Biostatistics and Epidemiology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States. Electronic address: jun.mao@uphs.upenn.edu.
authors.forename: Jun J
authors.initials: JJ
authors.lastname: Mao
authors.affiliation: Department of Biostatistics and Epidemiology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States.
authors.forename: Sharon X
authors.initials: SX
authors.lastname: Xie
authors.affiliation: Department of Biostatistics and Epidemiology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States.
authors.forename: Jarcy
authors.initials: J
authors.lastname: Zee
authors.affiliation: Department of Family Medicine & Community Health, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States; Depression Research Unit, Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States.
authors.forename: Irene
authors.initials: I
authors.lastname: Soeller
authors.affiliation: Department of Family Medicine & Community Health, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States; Depression Research Unit, Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States.
authors.forename: Qing S
authors.initials: QS
authors.lastname: Li
authors.affiliation: Investigational Drug Service, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States.
authors.forename: Kenneth
authors.initials: K
authors.lastname: Rockwell
authors.affiliation: Depression Research Unit, Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States.
authors.forename: Jay D
authors.initials: JD
authors.lastname: Amsterdam
mesh_terms: D000328:Adult; D000928:Antidepressive Agents / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D029771:Rhodiola / Q000737:chemistry*; D020280:Sertraline / Q000627:therapeutic use
chemical_list: D000928:Antidepressive Agents; D010936:Plant Extracts; D020280:Sertraline
keywords: Botanical psychopharmacology; Complementary and alternative medicine; Depression; Rhodiola rosea; Sertraline
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