Rhodiola rosea versus sertraline for major depressive disorder: A randomized placebo-controlled trial
- Received 27 January 2015, Accepted 29 January 2015, Available online 23 February 2015
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.
Hypothesis: We hypothesize that R. rosea would have similar therapeutic effects as sertraline but with less adverse events.
Study design: 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.
Keywords
- Rhodiola rosea;
- Sertraline;
- Depression;
- Complementary and alternative medicine;
- Botanical psychopharmacology
- Trial Registration – Rhodiola rosea therapy of major depressive disorder, NCT01098318.
- Corresponding
author at: Department of Family Medicine and Community Health,
University of Pennsylvania, 227 Blockley Hall, 423 Guardian Drive,
Philadelphia, PA 19104-6021, United States. Tel.:
+1 215 746 2481.
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