Table 3.
Description of selected articles.
| Study Type | Objective | Type of Magistral Preparations Used and Comparator | n | Outcome | Adverse Event | Conclusions | Ref. |
|---|---|---|---|---|---|---|---|
| Indication 1: Anorexia and cachexia in HIV | |||||||
| Systematic Review | To assess whether cannabis (in its natural or artificial form), whether smoked or ingested, reduces morbidity or mortality in HIV-infected patients. | Cannabis smoked or ingested, THC ingested (dronabinol or any form produced). Compared to placebo, no medication, another form of cannabis. |
7 studies | Primary: Mortality (HIV-related, all causes) Secondary: Subjective and objective appetite experiences: 1. Cannabis vs placebo: Weight gain. Study number: 1, participants 88 OR (95% CI) 2.40 [0.70, 8.23] 2. Changes in appetite, food, and calorie intake: insufficient data do not allow for analysis of this measure. |
1 study: 1 subject discontinued the study for psychosis; 2 study: 2 discontinued the study due to sedation and changes in mood. |
Evidence on the efficacy and safety of cannabis and cannabinoids is lacking; most of the studies that were analyzed were of short duration, with a small number of patients, and focused on short-term efficacy measures; one of the most important limitations is not having long-term safety data. | [36] |
| Indication 2: Post-chemotherapy nausea and vomiting | |||||||
| RCT crossover | To determine formulation preference for THC vs Compazine. | THC (offered by NIDA and administered per body surface area as follows: 7.5 mg for 1.4 m2, 10 mg for 1.4–1.8 m2, 12.4 mg for >1.8 m2 vs. Compazine (10 mg prochlorperazine dose). | 139 (variety of neoplasms and different QT regimens) | Reported preference: 49% for THC, 43% for Compazine, 8% no preference. Nausea reduction: There was a reduction in both groups. |
Sedation and psychoactive effects were greater in the THC group. | The preference for THC was associated with more adverse events related to the magisterial preparation compared to Compazine. Most studies with THC exclude patients with emotional instability; however, it is a condition that is associated with cancer and that can interfere with the proper use of THC. |
[37] |
| RCT, double blind, randomized, crossover | To determine the degree of effectiveness of the oral THC formula in preventing nausea and vomiting associated with QT compared with the conventional antiemetic and placebo. | Oral THC at 7 mg/m2 every 4 h for 4 doses (NIDA), administered in 0.12 mL of sesame oil and supplied in gelatinous capsules; oral prochlorperazine at 7 mg/m2 every 4 h for 4 doses and placebo (administered 1 h prior to QT). | 55 | Absence of nausea in 40 of 55 patients receiving THC, 8 of 55 receiving prochlorperazine, and 5 of 55 receiving placebo. | THC group AEs were euphoria, sedation, and temporary loss of physical control; AEs in the chlorperazine group were excessive sleepiness and autonomic symptoms. | It concludes that the magistral preparations with THC seem to be more effective in controlling vomiting associated with cyclophosphamide, 5-fluorouracil, and doxorubicin, and less for nitrogen mustards and nitrosurea. | [38] |
| RCT, double blind, randomized, crossover | To observe the effect of THC as an antiemetic agent in cancer patients and to compare the antiemetic and AE effect of THC with those using prochlorpromazine. | THC: 15 mg orally 3 times per day vs. prochlorperazine 10 mg orally 3 times per day or placebo. | 116 | Occurrence of no nausea and vomiting events on days 2–4 (mild emetic stimulus): THC (57), prochlorperazine (72), placebo (53). | Greater degree of intolerable sedation in the THC group (5) vs. chlorperazine (2). 12 patients from the THC group (1 from pbo, 1 from chlorperazine) discontinued the study due to central intolerable symptoms. |
Concludes that the THC-rich magistral preparations had superior antiemetic activity compared to placebo, but had no advantages compared to prochlorperazine. Adverse events related to the central nervous system were more frequent and severe with THC, with the dose and scheme used in the elderly population; additionally, the use of the formula rich in THC resulted in unpleasant experiences compared to prochlorperazine and placebo. Describes that the formula used shows that it prevents post-chemotherapy nausea and vomiting, yet its role must be clarified before it is recommended for general use. |
[39] |
| Indication 3: Neuropathic pain in multiple sclerosis | |||||||
| None | |||||||
RCT: randomized clinical trial, AE: adverse events, CI: confidence interval, NIDA: National Institute on Drug Abuse, n: number, QT: chemotherapy, THC: tetrahydrocannabinol, HIV: human immunodeficiency virus.