The proof of concept trial study is the first randomized, double-blind, placebo-controlled, comparison trial of oral R. rosea extract versus the conventional antidepressant therapy sertraline for mild to moderate major depressive disorder.
Depression is one of the most common and debilitating psychiatric conditions, afflicting more than 19 million Americans each year, 70 percent of whom do not fully respond to initial therapy. Costs of conventional antidepressants and their sometimes substantial side effects often result in a patient discontinuing use prematurely. Others opt to try natural products or supplements instead.
All of the study’s 57 adult participants, enrolled from December 2010 and April 2013, had a DSM IV Axis 1 diagnosis of MDD, meaning they exhibited two or more major depressive episodes, depressed mood and/or loss of interest or pleasure in life activities for at least 2 weeks, as well as symptoms including significant unintentional weight loss or gain, insomnia or sleeping too much, fatigue, and diminished ability to think or concentrate, and recurrent thoughts of death.
The participants received 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 (CGI) change scores were measured among groups.
Patients who took sertraline were somewhat more likely – as measured by Ham-D scores – to report improvement in their symptoms by week 12 of treatment than those who took R. rosea, although these differences were not found to be statistically significant. Patients taking R. rosea had 1.4 times the odds of improvement, and patients on sertraline had 1.9 times the odds of improvement versus those on a placebo. However, patients on sertraline experienced twice the side effects – most commonly nausea and sexual dysfunction — than those on R. rosea: 63 percent versus 30 percent, respectively, reported side effects. These findings suggest that R. rosea may possess a more favorable risk to benefit ratio for individuals with mild to moderate major depressive disorder.
“These results are a bit preliminary but suggest that herbal therapy may have the potential to help patients with depression who cannot tolerate conventional antidepressants due to side effects,” Mao said. “Larger studies will be needed to fully evaluate the benefit and harm of R. rosea as compared to conventional antidepressants.” The study done by Perelman School of Medicine at the University of Pennsylvania.