The use of medical grade cannabis (marijuana), its active ingredient or synthetic forms such as dronabinol has been advocated in patients with HIV/AIDS, in order to improve the appetite, promote weight gain and lift mood. Dronabinol has been registered for the treatment of AIDS-associated anorexia in some countries. However, the evidence for positive effects in patients with HIV/AIDS is limited, and some of that which exists may be subject to the effects of bias. Those studies that have been performed have included small numbers of participants and have focused on short-term effects. Longer-term data, and data showing a benefit in terms of survival, are lacking. There are insufficient data available at present to justify wide-ranging changes to the current regulatory status of cannabis or synthetic cannabinoids.
Despite dronabinol being registered by at least some medicines regulatory authorities for the treatment of AIDS-associated anorexia, and some jurisdictions making allowances for the “medical” use of marijuana and other areas with HIV/AIDS, evidence for the efficacy and safety of cannabis and cannabinoids in this setting is lacking. Such studies as have been performed have been of short duration, in small numbers of patients, and have focused on short-term measures of efficacy. Long-term data, showing a sustained effect on AIDS-related morbidity and mortality and safety in patients on effective antiretroviral therapy, has yet to be presented. Whether the available evidence is sufficient to justify a wide-ranging revisiting of medicines regulatory practice remains unclear.
The use of cannabis (marijuana) or of its psychoactive ingredient delta-9-tetrahydrocannabinol (THC) as a medicine has been highly contested in many settings.There have been claims that smoked or ingested cannabis, either in its natural form or artificial form (pharmaceutically manufactured drug such as dronabinol), improves the appetites of people with AIDS, results in weight gain and lifts mood, thus improving the quality of life.
The objectives of this review were to assess whether cannabis (in its natural or artificially produced form), either smoked or ingested, decreases the morbidityor mortality of patients infected with HIV. The search was conducted and based on that of the HIV/AIDS Research Group.
A total of seven relevant studies were included in the review, reported in eight publications. All were randomised controlled studies, with four utilising a parallel group design, two a within-subject randomisation and two a cross-over design. All studies were of a fairly short duration, ranging from 21 days to 84 days. In only four papers (in effect, three studies) were sequence generation and allocation concealment judged to be adequate. The use of cannabis and rapidly acting cannabinoids posed considerable challenges for blinding, as the psychoactive effects are expected to be quickly discernible to study participants, particularly those who have been previous users of such products. Dronabinol was expected to be more easily blinded. The outcomes measured were variable, including change in weight, change in body fat (measured as a percentage of total body weight), change in appetite (measured on a visual analogue scale), change in caloric intake, change in nausea and vomiting (measured on a visual analogue scale), change in performance (measured performance score or specific tests for memory and dexterity) and change in mood (measured on a visual analogue scale). The evidence for substantial effects on morbidity and mortality is currently limited. Marijuana use in many areas is high amongst HIV patients is very steady as data from only one relatively small study, conducted in the period before access to highly-active antiretroviral therapy showed that patients administered dronabinol were twice as likely to gain 2kg or more in body weight, but the confidence interval for this measure included unity. The mean weight gain in the dronabinol group, compared with a loss of the placebo group. However, the quality of sequence generation and allocation concealment in this study, in which participants were randomised, could not be assessed.
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