An Israeli clinic is experiencing encouraging results with the use of medical cannabis to treat children with autism spectrum disorder (ASD), according to a safety and efficacy study.
The two-year study, “Real Life Experience of Medical Cannabis Treatment in Autism; Analysis of Safety and Efficacy,” was conducted at the Soroka University Medical Center, which treats 15,000 of the 35,000 patients currently using medicinal cannabis in Israel.
Caregivers of 78 of the 188 children receiving the treatment, or 41.5 percent of participants, reported moderate or significant improvements in their condition after the patients were prescribed a high-cannabidiol (CBD)/low-THC dose of cannabis oil produced by Tikun Olam Ltd., the largest supplier of medical research cannabis in Israel. The cannabis oil goes by the brand name Avidekel.
Reported improvements included alleviation of common ASD symptoms such as restlessness, self-injury, rage attacks, agitation, and sleep problems.
The study, published in Nature Research's Scientific Reports, evaluated 30-day and six-month caregiver assessments. Twenty-three patients, or 17.5 percent of participants, dropped out before the end of the six-month study period, and 10 switched suppliers. The rate of response to the assessments among the 155 remaining was 66.4 percent after one month and 60 percent after six months, so the real percentage of improvement in symptoms may be higher.
Other Medications Used Less
Participating families also reported some reductions in the use of other medications during the cannabis trial. For example, 11 of 55 patients using anti-psychotic drugs at the outset of the study, or20 percent, had stopped those medications after the six-month follow-up.
The research was undertaken without funding as part of a doctoral dissertation at Soroka's Negev Autism Center, said Na'ama Saban, one of the study's co-authors and a registered nurse.
“The research began as an experimental treatment for children with autism,” Saban said. “Then because of its successful results, the study expanded while maintaining personalized treatment for each patient.”
The reported side effects to cannabis treatment were minimal, Saban said, with the most common at six months reported as restlessness (by 6.6 percent ), sleepiness (3.2 percent), and psychoactive effects (3.2 percent). Co-author Dr. Gal Mieri, head of the Preschool Psychiatry Unit at the Soroka Medical Center in the Negev desert region, wrote in an email to Weedmaps News that the researchers recently received a grant from the Ministry of Science to establish a National Knowledge Center for Autism.
“We plan to collect data about children with ASD and their families from all over Israel in order to have bigger studies about risk factors to autism and possible treatments,” Mieri said. “Meanwhile, this study gives hope to autism patients for safe treatment and relief for some of their most difficult symptoms.”
One limitation of the study is that families themselves could adjust dosages according to the patients' reactions. This flexibility resulted in a wide range of dosing strategies among users, from one to 20 sublingual drops three times daily. Dr. Meiri didn't see that as a problem but rather a challenge to take on in the future.
“Our aim was to get some data about 'real-world' use. We are now preparing a prospective study to look at dosing in a more accurate way,” Meiri said. “We hope this is only the beginning — since the Ministry of Health in Israel gave permission to children and people with autism to use medical cannabis.”
Patients Often Accepted for Cannabis Trials
Autism has not been officially listed by the Israeli Ministry of Health as a condition to be treated with medical cannabis. However, given the high success rates, applications for a cannabis license for low-functioning patients are often accepted.
Dr. Annabelle Manalo, a scientific adviser to Tikun Olam, celebrated the study results while recognizing the limitations of an observational study.
“It is early in the industry, and we have to take what we can get. When you're treating children, the urgent priority is to get them out of pain,” Manalo, who holds a Ph.D. in developmental biology, told Weedmaps News.
She became active in the field after developing cannabis products to treat her own son who is at risk of ASD because of brain loss.Manalo said Tikun Olam, after nearly a decade of testing and research on illnesses such as autism, Crohn's disease, Parkinson's, epilepsy and fibromyalgia, among others, the company is now bringing its medical marijuana products to the United States. On January 27, 2019, Israel approved the export of medical cannabis.
Saban, who works in the pediatric nursing division of Tikun Olam in Israel, is optimistic about future autism research.
“With the advancements made in therapy and the accumulated knowledge that was acquired during this study, I am confident further research will deepen our understanding and help us improve treatment as best and as precisely as possible,” Saban said.