Dronabinol led to a significant weight gain of 0,73 kg over placebo (p < 0,01) without serious adverse events, but without significant improvement of psychopathological features (EDI-2).
Summary
n=24 (double-blind crossover RCT), dronabinol 2×2,5 mg/day over 4 weeks in severe, long-standing anorexia nervosa: weight gain +0,73 kg vs. placebo (t=2,86, df=22, p<0,01); no significant psychotropic side effects, good tolerability.
P
PopulationWomen with severe, long-lasting anorexia nervosa (≥5 years), n=24 (evaluated), age >18 years
I
InterventionDronabinol 2,5 mg twice daily orally as add-on, 4 weeks
C
ControlMatched placebo, 4 weeks (crossover with 4-week wash-out phase)
O
OutcomeWeight gain under dronabinol +0,73 kg versus placebo (t=2,86, df=22, p<0,01); EDI-2 subscales no significant changes
Confidence in the evidence
Very lowLowModerateHigh
Moderate
The third of four GRADE levels, the effect estimate is probably reliable.
The evidence for pharmacological treatment of severe, longstanding anorexia nervosa (AN) is sparse and the few controlled pharmacologic studies have focused on a narrow range of drugs. The aim of the present study was to investigate the effects of treatment with a synthetic cannabinoid agonist on body weight and eating disorder-related psychopathological personality traits in women with severe, enduring AN. This add-on, prospective, randomized, double blind, controlled crossover study was conducted between 2008 and 2011 at a specialized care center for eating disorders. Twenty-five women over 18 years with AN of at least 5 years duration were randomized to treatment with either dronabinol-placebo or placebo-dronabinol. In addition to the standardized baseline therapeutic regime, the participants received dronabinol, 2.5 mg twice daily for 4 weeks and matching placebo for 4 weeks, separated by a 4-week wash-out period. Primary outcome was the mean change in body weight. Secondary outcome was score changes on the Eating Disorder Inventory-2 (EDI-2). Data were analyzed for the 24 patients who completed the trial. During dronabinol treatment, participants gained 0.73 kg (t = 2.86, df = 22, p < 0.01) above placebo without significant psychotropic adverse events. Dronabinol significantly predicted weight gain in a multiple linear regression including EDI-2 body dissatisfaction score and leptin. EDI-2 subscale scores showed no significant changes over time. Dronabinol therapy was well tolerated. During four weeks of exposure it induced a small but significant weight gain in the absence of severe adverse events.