A research team in Israel has determined that medicinal cannabis delivered through metered-dose inhalation produces no meaningful differences in safety or effectiveness between male and female patients.
Prior clinical studies had identified higher rates of adverse events (AE) in women and stronger pain relief in men, with researchers attributing those gaps to biological and hormonal factors or to variations in the cannabis strains being used.
The team employed the SyqeAir Metered-Dose Inhaler alongside a single cannabis chemovar from Bedrocan to examine sex-related differences as well as long-term effectiveness and safety.
A total of 1,120 chronic pain patients qualified for clinical analysis, 54% of whom were women. Over 240 days of treatment, participants were evaluated on pain intensity via a numeric pain scale (NPS), along with sleep latency, duration, quality, and adverse events.
Delta-9 THC was used as a dosage marker for full-spectrum medicinal cannabis. No meaningful differences in doses between the sexes were observed beyond the first month of treatment, and doses were nearly identical once adjusted for body weight.
After the initial two weeks of treatment, no significant sex-related differences emerged in either the medicine's effectiveness or its safety profile.
Pain reduction and sleep improvement were comparable across both sexes. Within the first 30 days, 68% of patients reported a decrease in pain intensity of at least one NPS point, and 26% said their pain had dropped by 30% or more.
On average, sleep latency fell by three to 31 minutes, sleep duration rose by 30 to 120 minutes, and sleep quality improved considerably.
The overall AE rate was the same for men and women at 10%, with only 1.6% of the cohort experiencing psychoactive adverse events. The most commonly reported AEs were dizziness (4%), cough (3%), and headaches, sleeplessness, and sore throat (each at 2%).
A secondary pharmacokinetic analysis found no significant differences between the sexes in Delta-9 THC or its metabolite pharmacokinetics, cardiovascular measurements, 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."
