Study register · detail
Mixed
GRADE
Moderate
118 citations
Samplen = 12 Pat.
DurationTwo five-week treatment periods…
ControlPlacebo
EndpointCaloric intake / body weight…
Blindingdoppelblind
DesignRCT (cross-over)
Cannabinoidthc
Max. dose10.0 mg
Routeoral
Key finding
Dronabinol significantly improved body fat percentage and symptom distress, but showed only non-significant trends for weight and prealbumin.
Summary
n=12 HIV patients with weight loss, dronabinol 5mg 2×daily vs. placebo (crossover); body fat +1% (p=0.04), symptom distress significantly reduced (p=0.04); weight gain +0.5kg (p=0.13, trend); high attrition (only 5/12 completed).
P
PopulationHIV-infected adults with weight loss (≥2,25 kg), n=12 randomised, n=5 protocol completers
I
InterventionDronabinol (Δ-9-THC) 5 mg twice daily orally before meals
C
ControlPlacebo
O
OutcomeSignificant increase in body fat percentage (+1%, p=0,04) and significant reduction in symptom distress (p=0,04); trends for weight gain (+0,5 kg, p=0,13) and prealbumin increase (+29,0 mg/L, p=0,11)
Confidence in the evidence
Moderate
The third of four GRADE levels, the effect estimate is probably reliable.
Downgraded for
Imprecision
Quality profile
Sample size
★★★★★
Blinding
Double-blind
Effect size
Mixed
Citations / year
★★★★★
Authors
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Abstract
<h4>Objective</h4>To examine the effect of dronabinol (delta-9-tetrahydrocannabinol) on appetite and nutritional status in patients with symptomatic HIV infection and weight loss.<h4>Design</h4>Double-blind, randomized, placebo-controlled, crossover trial with two five-week treatment periods separated by a two-week washout period. Patients received dronabinol 5 mg twice daily before meals or placebo.<h4>Setting</h4>A university-based HIV/AIDS clinic and a large infectious disease private practice largely devoted to care of patients with HIV.<h4>Participants</h4>Twelve HIV-infected patients who had had at least a 2.25-kg weight loss participated in the study. Five patients completed the protocol, and seven withdrew (two because of drug intolerance, two because of disease progression, two because of noncompliance, and one because of experimental antiretroviral therapy).<h4>Main outcome measures</h4>Main outcome measures included caloric intake, weight, percent body fat, serum prealbumin, and symptom distress.<h4>Results</h4>During dronabinol treatment, subjects experienced increased percent body fat (one percent, p = 0.04); decreased symptom distress (p = 0.04); and trends toward weight gain (0.5 kg, p = 0.13), increased prealbumin (29.0 mg/L, p = 0.11), and improved appetite score (p = 0.14).<h4>Conclusions</h4>In a selected group of HIV-infected patients with weight loss, short-term treatment with dronabinol may result in improvement in nutritional status and symptom distress.
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