This week, a clinical trial that was conducted by Soroka University Medical Center in conjunction with Tikun Olam-Cannbit in recent years to evaluate the safety and efficacy of treatment with medical cannabis, as well as epidemiological characteristics of the patient population was published in the leading medical journal, Frontiers in Medicine.
The study, which was conducted in recent years by Tikun Olam-Cannbit’s head of R&D, Lihi Bar-Lev Schleider, under the guidance of Prof. Victor Novack, Head of Soroka Clinical Research Center, on 8,500 Israeli male and female patients with an average age of 54.6 years, who are being treated with medical cannabis.
This is one of the farthest reaching and most comprehensive study ever conducted globally on follow-up of patients treated with medical cannabis. The study examined the efficacy and safety of treatment with Tikun Olam’s cannabis strains in providing relief for medical conditions and various symptoms.
Despite the extensive use of cannabis in medical treatment, there are not enough clinical studies or evidence of the efficacy of treatment with medical cannabis for various indications. For the most part, surveys of cannabis patients do not document the patient’s condition prior and subsequent to treatment. The aims of this study, were to analyze the epidemiological characteristics, safety and efficacy of the treatment with Tikun Olam strains in a large patient population.
Before starting treatment, patients were asked about diseases, pain and other symptoms, regular medications, quality of life characteristics, etc. According to the personal characteristics of each patient, treatment with a specific cannabis strain was recommended, particularly from among the following: Alaska, Erez and Avidekel, as well as the recommended mode of consumption. Six months after beginning treatment, another questionnaire was performed to examine the effect of treatment.
In general, medical cannabis appears to be a safe and effective alternative, with a high adherence to treatment, that improves quality of life and reduces the patient’s pain level. According to the study, there is a low incidence of side effects from treatment with medical cannabis.
Among the most remarkable findings of the study is that consumption of medications declined by over 50% 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-psychotics; 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.
Striking findings:
- 6% of patients reported a moderate (at least) improvement in their condition with no serious side effects.
- The indication with the highest percentage of improvement is PTSD, 90.8% of the patients who began treatment were classified as therapeutic success after six months.
- 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.
- 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%).
- 1,735 patients (17.3%) discontinued treatment during six months of treatment.
- 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.
Lihi Bar-Lev Schleider, Tikun Olam-Cannbit’s head of R&D, said, “In the past, we demonstrated that treatment with medical cannabis products relieves symptoms and improves quality of life for patients, but this is the first time that in-depth, organized and systematic analysis of a large amount of data on a very large group of patients was performed, and in which, with minimum bias as possible, the effect of treatment for various indications was examined. We found that the treatment with Tikun Olam strains is effective, safe and can be a therapeutic alternative for opioids in some patients. This publication mark a significant milestone for Tikun Olam and can hopefully help physicians and healthcare practitioners gain confidence in using medical cannabis as the alternative it is.”
