Researchers in Israel have found no sex-related differences in safety and efficacy among patients consuming medicinal cannabis via metered-dose inhalation.
Previous clinical studies have shown higher susceptibility to adverse events (AE) among women and greater analgesia among men using the medicine. They have attributed the differences to biological and hormonal factors or to differences in the strains being consumed.
The team used the SyqeAir Metered-Dose Inhaler and a single cannabis chemovar from Bedrocan to analyse sex-related differences as well as long-term effectiveness and safety.
A total of 1,120 chronic pain patients were deemed eligible for clinical analysis, 54% of whom were women. Participants were assessed for pain intensity using a numeric pain scale (NPS), sleep latency, duration and quality – as well as AEs – over 240 days of treatment.
Delta-9 THC served as a dosage marker for full-spectrum medicinal cannabis with no significant variations in doses between the sexes except in the first month of treatment and almost identical doses when adjusted for weight.
No significant sex-related differences were found in the effectiveness or safety of the medicine after the first two weeks of treatment.
Pain reduction and sleep improvement were similar for both sexes, with 68% of patients reporting a reduction in pain intensity of at least one NPS point and 26% saying their pain reduced by 30% or more after the first 30 days of treatment.
On average, sleep latency decreased by three to 31 minutes, sleep duration increased by 30 to 120 minutes and sleep quality improved significantly.
The overall rate of AEs was equal among men and women at 10%, with only 1.6% of the cohort reporting psychoactive AEs. The most frequent AEs were dizziness (4%), cough (3%), and headaches, sleeplessness and sore throat (all 2%).
A secondary analysis of pharmacokinetic data showed no significant difference between the sexes in Delta-9 THC and its metabolite pharmacokinetics, cardiovascular measures or AE severity.
The researchers conclude: “Medical cannabis (MC) treatment with the SyqeAir Inhaler demonstrated similar overall long-term pain reduction, and a superior AE profile with administration of high-dose MC by conventional routes. Sleep improvement was also reported.”
“Additionally, metered MC treatment… showed no sex differences in short-term effectiveness, safety and pharmacokinetics, nor in long-term effects under ‘real-life’ conditions.”
