Study register · detailProspektive Beobachtungsstudie · Cancer · 2022
Adherence, Safety, and Effectiveness of Medical Cannabis and Epidemiological Characteristics of the Patient Population: A Prospective Study
Bar-Lev Schleider et al.·Frontiers in MedicineImpact 2.3
Clear benefitGRADELow42 citations
Samplen = 10.000 Pat.
Duration6 months
EndpointTreatment success
Blindingn.a.
DesignProspektive Beobachtungsstudie
Cannabinoidvollspektrum
”Key finding
Supervised medical cannabis was associated with treatment success and improved quality of life in 70,6% of patients after 6 months.
Summary
Israeli prospective study with approx. n=10.000 patients on prescribed medical cannabis; cancer was the most common primary indication at 49,1%; 70,6% of patients achieved treatment success after 6 months; most common side effects: dizziness (8,2%), dry mouth (6,7%), increased appetite (4,7%); 1.938 (19,4%) patients died during the observation period.
P
PopulationAdult patients with medical cannabis prescription (predominantly cancer 49,1% and non-specific pain 29,3%), n≈10.000, mean age 54,6 years
I
InterventionMedical cannabis (prescription-based, regulated, various applications), observation over 6 months
O
Outcome70,6% of patients achieved treatment success after 6 months; frequent side effects in 34,2% (dizziness 8,2%, dry mouth 6,7%); significant predictors of treatment success: smoking, prior experience with cannabis, active driving, employment and young age
Confidence in the evidence
Very lowLowModerateHigh
Low
The second of four GRADE levels, the effect estimate is of limited reliability.
Quality profile
Sample size★★★★★
Blinding—
Effect sizeClear benefit
Citations / year★★★★★
Authors
Bar-Lev Schleider L, Mechoulam R, Sikorin I et al.
<h4>Background</h4>Despite the absence of rigorous prospective studies, there has been an increase in the use of cannabis-based medicinal products. During the study period, the use of medical cannabis in Israel was tightly regulated by national policy. Through a prospective study of approximately 10,000 patients, we aimed to characterize the medical cannabis patient population as well as to identify treatment adherence, safety, and effectiveness.<h4>Methods and findings</h4>In this study of prescribed medical cannabis patients, adherence, safety, and effectiveness were assessed at 6 months. Treatment adherence was assessed by the proportion of patients purchasing the medication out of the total number of patients (excluding deceased cases and patients transferred to another cannabis clinic). Safety was assessed by the frequency of the side-effects, while effectiveness was defined as at least moderate improvement in the patient condition without treatment cessation or serious side-effects. The most frequent primary indications requiring therapy were cancer (49.1%), followed by non-specific pain (29.3%). The average age was 54.6 ± 20.9 years, 51.1% males; 30.2% of the patients reported prior experience with cannabis. During the study follow-up, 1,938 patients died (19.4%) and 1,735 stopped treatment (17.3%). Common side-effects, reported by 1,675 patients (34.2%), were: dizziness (8.2%), dry mouth (6.7%), increased appetite (4.7%), sleepiness (4.4%), and psychoactive effect (4.3%). Overall, 70.6% patients had treatment success at 6 months. Multivariable logistic regression analysis revealed that the following factors were associated with treatment success: cigarette smoking, prior experience with cannabis, active driving, working, and a young age. The main limitation of this study was the lack of data on safety and effectiveness of the treatment for patients who refused to undergo medical assessment even at baseline or died within the first 6 months.<h4>Conclusions</h4>We observed that supervised medical-cannabis treatment is associated with high adherence, improvement in quality of life, and a decrease in pain level with a low incidence of serious adverse events.