Dronabinol führte zu einem signifikanten Gewichtszuwachs von 0,73 kg über Placebo (p < 0,01) ohne schwerwiegende unerwünschte Ereignisse, jedoch ohne signifikante Verbesserung der psychopathologischen Merkmale (EDI-2).
Zusammenfassung
n=24 (doppelblinder Crossover-RCT), Dronabinol 2×2,5 mg/Tag über 4 Wochen bei schwerer, langjähriger Anorexia nervosa: Gewichtszunahme +0,73 kg vs. Placebo (t=2,86, df=22, p<0,01); keine signifikanten psychotropen Nebenwirkungen, gute Verträglichkeit.
P
PopulationFrauen mit schwerer, lang andauernder Anorexia nervosa (≥5 Jahre), n=24 (ausgewertet), Alter >18 Jahre
I
InterventionDronabinol 2,5 mg zweimal täglich oral als Add-on, 4 Wochen
C
KontrolleMatched Placebo, 4 Wochen (Crossover mit 4-wöchiger Wash-out-Phase)
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OutcomeGewichtszunahme unter Dronabinol +0,73 kg gegenüber Placebo (t=2,86, df=22, p<0,01); EDI-2-Subskalen keine signifikanten Veränderungen
Vertrauen in die Evidenz
Sehr niedrigNiedrigModeratHoch
Moderat
Dritte von vier GRADE-Stufen, die Effektschätzung ist wahrscheinlich verlässlich.
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.