Real Life Experience of Medical Cannabis Treatment in Autism: Analysis of Safety and Efficacy
Lihi Bar-Lev Schleider 1,2, Raphael Mechoulam3, Naama Saban2, Gal Meiri4,5& Victor Novack1
1Clinical Cannabis Research Institute, Soroka University Medical Center and Faculty of Health Sciences, Ben-Gurion University of the Negev, Be’er-Sheva, Israel; 2Research Department, Tikun Olam LTD, Tel Aviv-Yafo, Israel; 3Institute for Drug Research, School of Pharmacy, The Hebrew University of Jerusalem, Jerusalem, Israel; 4Negev Autism Centre, Ben-Gurion University of the Negev, Beer Sheva, Israel. 5Soroka University Medical and Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel
There has been a dramatic increase in the number of children diagnosed with autism spectrum disorders (ASD) worldwide. Recently anecdotal evidence of possible therapeutic effects of cannabis products has emerged, but clinical studies in the field are lacking. The aim of this prospective observational study, conducted in collaboration with Soroka University Medical Center and Ben-Gurion University, was to assess the safety and efficacy of Avidekel oil 30% CBD and Erez oil 3% THC for the treatment of ASD, analyzing the change in symptoms after six months of use.
STUDY POPULATION: 188 children with ASD (154 boys, mean age 12.9).
STUDY PRODUCT: Avidekel oil 30% CBD 1% THC. Erez oil 3% THC.
RESULTS:
- 33 (17.5%) children discontinued treatment during the 6 months of follow-up.
- General improvement – of the patients who answered the follow-up questionnaires (93 patients),90.2% of them reported an improvement in symptoms after six months treatment.
- Significant improvement in a large number of symptoms associated with ASD – symptoms improved included seizures (100%), tics (100%), depression (100%), restlessness (91.2%), rage attacks (90.5%), anxiety (88.8%), agitation (85.3%), sleep problems (78.3%), digestion problems (75%), constipation (75%), and more.
- Significant improvement in quality of life – good quality of life was indicated by 31.1% of patients at intake; by 66.8% at six months.
- Improvement in daily activities – patients reported improvement in sleep, positive mood, and ability to dress and shower independently.
- An overall decrease in drug use -34.3% of patients decreased medication consumption, including antipsychotics, antiepileptics, antidepressants, hypnotics, and sedatives.
- Decreased use of antipsychotic drugs -20% of patients stopped taking antipsychotics.
- The most common side effects, reported at six months by 23 patients (25.2%, with at least one side effect) were: restlessness (6 patients, 6.6%), sleepiness (3, 3.2%), psychoactive effect (3, 3.2%), increased appetite (3, 3.2%), digestion problems (3, 3.2%), dry mouth (2, 2.2%) and lack of appetite (2, 2.2%).
- Avidekel and Erez strains in ASD patients appears to be well tolerated, safe and an effective option to relieve symptoms associated with ASD.
