PROSPECTIVE ANALYSIS OF THE SAFETY AND EFFECTIVENESS OF MEDICAL CANNABIS TREATMENT AMONG A LARGE POPULATION OF MEDICAL CANNABIS PATIENTS
Lihi Bar-Lev Schleider1,2, Raphael Mechoulam3, Inbal Sikorin4, Timna Naftali5, Victor Novack1,6
1Clinical Research Center, Soroka University Medical Center and Faculty of Health Sciences, Ben-Gurion University of the Negev, Be’er-Sheva; 2Research Department, Tikun Olam – Cannbit Pharmaceuticals, Tel Aviv; 3School of Pharmacy, the Hebrew University of Jerusalem, Jerusalem; 4Hadarim Nursing Home, Naan; 5Department of Gastroenterology and Hepatology, Meir Medical Center, Kfar Saba and Faculty of Medicine, Tel Aviv University, Israel.
There is insufficient high-level clinical evidence for the effectiveness of medical cannabis treatment. Surveys of a large population of medical cannabis patients are very limited; none of them monitored patients before and after treatment, included a large amount of variables, or assessed the composition of cannabis consumed. The aim of this prospective study, conducted in collaboration with Soroka University Medical Center, was to analyze the epidemiological characteristics, safety, and efficacy of cannabis treatment among a large population of Tikun Olam’s patients.
In order to adjust the goals and plan of cannabis treatment, the patient is questioned prior to treatment regarding medical history, pain and other symptoms, regular medications, quality of life characteristics, and more. Depending on the patient’s individual characteristics, a cannabis strain, mode of consumption, initial dosage and titration, were recommended. One month after starting treatment, a reviewer called the patient and checked by a short questionnaire if there was an improvement in his condition. Six months after starting cannabis treatment, a reviewer conducted another questionnaire about the effect of cannabis on the patient diseases, symptoms, medications, pain, quality of life, consumed strains and side effects. Medical cannabis appears to be a safe and effective alternative with a high adherence to treatment, helping to improve quality of life and decrease the level of pain, with a low incidence of serious side effects.
STUDY POPULATION: 8,560 Tikun Olam’s patients (51.1% males, mean age 54.6)
STUDY PRODUCT: Various Tikun Olam’s varieties and products
RESULTS:
1,735 patients (17.3%) discontinued treatment during six months of treatment.
Overall improvement – 70.6% of patients reported a moderate (at least) improvement in their condition with no serious side effects
Improvement in rage attacks – There was a significant decrease of 91.5% in rage attacks following the treatment with cannabis.
Improvement in restlessness – There was a significant decrease of 89.5% in restlessness following the treatment with cannabis.
Improvement in sleep disturbances – There was a significant decrease of 89.1% in sleep disturbances following the treatment with cannabis.
Improvement in nausea – There was a significant decrease of 88.9% in nausea following the treatment with cannabis.
Decrease in pain intensity – The reporting of the pain intensity in a numeric rating scale (0 – no pain at all, 10 – the most horrible pain that can be described), decreased significantly. Prior to treatment, 62.0% of patients reported high pain-intensity (8 or more); after six months of treatment, this number decreased to only 5.0% of patients.
Improving quality of life – 69.9% of patients reported their quality of life to be “good or very good,” during half a year of active treatment, whereas only 12.9% of patients rated their quality of life at this level prior to beginning treatment.
Decreased drug use – 52.5% of patients stopped or reduced the dosage of opioids; 39.2% stopped or reduced the dosage of other analgesics and anti-pyretics; 36.9% of patients stopped or reduced the dosage of anti-psychotics; 35.7% of patients stopped or reduced the dosage of anti-epileptics; 35.3% of patients stopped or reduced the dosage of hypnotics and sedatives.
The most common side effects were mild and included dizziness (8.2%), dry mouth (6.7%), increased appetite (4.7%), sleepiness (4.4%), and psychoactive effect (feeling “high”) (4.3%).
The figure bellow presents the proportion of patients experiencing any side-effect, and ranges between 28.9% for Tourette syndrome to 40.0% in patients with epilepsy.
Medical cannabis appears to be a safe and effective alternative with a high adherence to treatment, helping to improve quality of life and decrease the level of pain, with a low incidence of side effects.
