PUBLISHED CLINICAL STUDIES

Over the last decade, our skilled team of scientists and nurses at Tikun Olam Israel have treated more than 20,000 patients, conducting laboratory research and clinical trials on medical cannabis therapy and the effectiveness of our strains. Below is an outline of our published studies and ongoing research.

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Autism,

Cannabidiol-Rich Cannabis in Children with Autism Spectrum Disorder and Severe Behavioral Problems

Journal of Autism and Developmental Disorders, 2019

A retrospective study assessing the tolerability and efficacy of CBD-rich cannabis in children with ASD.

Key Results:

  • Considerable improvement was reported in behavior (61%), communication (47%), and anxiety (39%), after at least 3 months of cannabis treatment

  • 33% of children reduced their other medication doses and 24% stopped taking medications altogether

Fibromyalgia,

Safety and Efficacy of Medical Cannabis in Fibromyalgia

Publisher: Journal of Clinical Medicine, 2019

This observational study investigated the characteristics, safety, and effectiveness of medical cannabis therapy for fibromyalgia. Patients studied were referred to cannabis after receiving traditional treatment for at least a year without improvement. The change in symptoms and quality of life was measured after six months of treatment.

Key Results:

  • 81.1% of patients reported overall treatment success – defined as experiencing at least moderate improvement in their condition without serious adverse effects

  • 73.4% of patients reported improved sleep; 13.2% reported their sleep problems were fully relieved

  • 80.8% of patients reported improved depression‐related symptoms

  • 61.9% of patients reported their quality of life (QOL) to be “good or very good,” whereas only 2.7% of patients rated their QOL at this level prior to beginning treatment; QOL components include appetite, sleep quality, and sexual activity

  • Overall pain intensity reduced from a median of 9.0 at baseline to 5.0 after six months

  • 22.2% of patients stopped or reduced their dosage of opioids; 20.3% reduced their dosage of benzodiazepines

Autism,

Real Life Experience of Medical Cannabis with Autism: Analysis of Safety and Efficacy

Scientific Reports, 2019

This observational study assessed the safety and efficacy of medical cannabis for the treatment of autism spectrum disorders (ASD), analyzing the change in symptoms after six months of using our CBD-rich cannabis oil.

Key Results:

  • 90.2% of patients reported an improvement in symptoms after six months treatment

  • Symptoms improved included depression (100%), restlessness (89.8%), rage attacks (89%), anxiety (88.8%), seizures (84.6%), agitation (83.8%), tics (80%), digestion problems (62.5%), constipation (62.5%), sleep problems (58.6%), and more

  • Good quality of life was indicated by 31.1% of patients at intake; at six months, QOL increased to 66.8%

  • Patients reported improvement in sleep, positive mood, and ability to dress and shower independently

  • 34.3% of patients decreased medication consumption, including antipsychotics, antiepileptics, antidepressants, hypnotics, and sedatives

  • 20% of patients stopped taking antipsychotics

  • Cannabis appears to be a well-tolerated, safe and effective option to relieve ASD symptoms

Tourette's Syndrome,

Single Center Experience with Medical Cannabis in Gilles De La Tourette Syndrome

Parkinsonism and Related Disorders, 2019

This study was conducted to assess the response and benefits of using cannabis to treat Tourette Syndrome.

Key Results:

  • The mean ranking of efficacy was 3.85 out of 5, indicating a positive response to medical cannabis

  • Patients reported reduction in tic severity, better sleep, and improved mood

Multiple Sclerosis,

Avidekel Cannabis Extracts and Cannabidiol are as Efficient as Copaxone in Suppressing EAE in SJS/J Mice

Inflammopharmacology, 2019

This study compared the efficacy of purified CBD, extracts of CBD-rich Avidekel, and Copaxone (glatiramer acetate), an immunosuppressive medication that is used to alleviate the symptoms of multiple sclerosis (MS).

Key Results:

  • CBD and Avidekel extracts are as efficient as Copaxone in alleviating the symptoms of EAE (animal model of brain inflammation) in lab mice.

  • Avidekel may be useful in the treatment of MS symptoms.

Complex Motor Disorders,

Medical Cannabis for Pediatric Moderate to Severe Complex Motor Disorders

Journal of Child Neurology, 2019

A clinical random trial examining the effects of Avidekel oil on dystonia and spasticity in children who suffer from cerebral palsy or genetic impairment. Most participants reported significant improvement in spasticity and dystonia, sleep difficulties, pain severity, and quality of life.

Key Results:

  • CBD-enriched 5% cannabis oil with CBD:THC ratios of 6:1 and 20:1 are effective in reducing the severity of dystonia and spasticity, and improving motor function ability and quality of life

  • All patients demonstrated mood and appetite improvement

  • Patients treated with the 6:1 ratio oil demonstrated sleep improvement

  • Patients treated with the 20:1 ratio oil demonstrated improvement in constipation

Palliative Cancer Care,

Prospective Analysis of Safety and Efficacy of Medical Cannabis in Large Unselected Population of Patients with Cancer

European Journal of Internal Medicine, 2019

This study analyzed the data routinely collected as part of the treatment program of cancer patients treated with medical cannabis between 2015 and 2017. The most frequent types of cancer were breast (20.7%), lung (13.6%), pancreatic (8.1%) and colorectal (7.9%), and 51.2% of patients were at Stage 4. The main symptoms requiring therapy were sleep problems (78.4%), pain (77.7%; median intensity 8/10), weakness (72.7%), nausea (64.6%) and lack of appetite (48.9%). The study concluded that cannabis is a well-tolerated, effective and safe option to help patients cope with cancer-related symptoms.

Key Results:

  • 95.9% of patients reported an improvement in their condition

  • Prior to treatment, 52.9% of patients reported their pain in the 8-10 interval; after six months, only 4.6% of patients reported this intensity

  • Prior to treatment, only 18.7% of patients reported good quality of life; after six months, 69.5% of patients reported good quality of life

  • The most improved symptoms were nausea and vomiting (91%), sleep disorders (87.5%), restlessness (87.5%), anxiety and depression (84.2%), pruritus (82.1%) and headaches (81.4%)

  • 35.1% of patients decreased their drug consumption, including analgesics, sedatives, corticosteroids, and opioids

  • 36% of patients stopped taking opioids

Palliative Geriatric Care,

Epidemiological Characteristics, Safety and Efficacy of Medical Cannabis in the Elderly

European Journal of Internal Medicine, 2019

A prospective study that analyzed the use of cannabis treatment in the elderly, measuring for pain intensity, quality of life, and adverse effects at six months follow-up. The most common indications for cannabis treatment were pain (66.6%) and cancer (60.8%). The study found that the therapeutic use of cannabis is safe and efficacious in the elderly population.

Key Results:

  • Reported pain significantly reduced from a median of 8/10 to 4/10

  • Prior to treatment, 66.8% of patients reported high pain-intensity; at six months, this number decreased to only 7.6% of patients

  • 93.7% of patients reported that the cannabis treatment improved their condition

  • 35.1% of patients reported a decrease in the number of drugs taken or the dosage

  • 18.1% of patients stopped using opioid analgesics or reduced their dose

  • The most common reported side effects were dizziness (9.7%) and dry mouth (7.1%)

Parkinson's Disease,

Medical Cannabis in Parkinson’s Disease

Clinical Neuropharmacology, 2019

A retrospective questionnaire-based survey that examined the effects of cannabis on the motor and non-motor symptoms of patients with Parkinson’s Disease. The mean age of the patients was 64.2 +/- 10.8 years, the mean disease duration was 10.8 +/- 8.3 years, and the duration of cannabis use was 19.1 +/- 17 months.

Key Results:

  • 82.2% of patients reported that cannabis improved their overall symptoms

  • 81.4% of patients reported that their pain was reduced

  • 76.1% of patients reported an improvement in mood

  • 73.2% of patients reported tremor reduction

  • 72.7% of patients reported reduced muscle stiffness

  • 71.1% of patients reported an improvement in sleep quality

Pain & Inflammation,

Overcoming the Bell-Shaped Dose-Response of Cannabidiol by Using Cannabis Extract Enriched in Cannabidiol

Pharmacology & Pharmacy, 2019

This laboratory study was conducted on rodents to examine the effect of full-plant cannabis extract on inflammation and pain, in comparison with isolated CBD and commercial anti-inflammatory and anti-nociceptive drugs. Isolated CBD has been shown to have a bell-shaped dose-response, where healing is only observed within a very limited dose range, with no additional beneficial effect achieved at lower or higher doses. This trait of purified CBD poses challenges to clinical use; thus, this study aimed to find a CBD source that eliminates the bell-shaped dose response – and succeeded with Avidekel.

Key Results:

  • The full-plant extract of Avidekel, which is high in CBD and low in THC, provided a correlative anti-inflammatory and anti-pain dose-response (i.e. as the dose was increased, the pain and inflammation decreased in correlation), superior to the bell-shaped dose-response of isolated CBD, which exhibited less consistent anti-inflammatory and anti-pain properties at lower and higher doses

  • Avidekel extract exhibited superior anti-inflammatory effectiveness compared to tramadol (an opioid analgesic) and aspirin (a non-steroid anti-inflammatory)

Crohn's Disease,

Cannabis Induces a Clinical Response in Patients with Crohn’s Disease: A Randomized Placebo-Controlled, Double-Blind Study

Clinical Gastroenterology & Hepatology, 2019

In the world’s first randomized, placebo-controlled, double-blinded study of its kind, Dr. Naftali and a team of researchers used Tikun Olam’s Erez strain to produce dramatic results, with 45% of Crohn’s patients achieving “complete remission” and over 90% achieving substantial improvement – with no side effects witnessed.

Key Results:

  • Complete remission (CDAI score <150) was achieved by 5 of the 11 patients in the cannabis group

  • Clinical response (decrease in CDAI score of >100) was observed in 10 of the 11 patients

  • 3 of the 11 patients were weaned from steroid dependency

  • The cannabis group reported significantly less pain, and improved appetite and quality of life

Crohn's Disease,

Treatment of Crohn’s Disease with Cannabis: An Observational Study

The Israel Medical Association Journal, 2019

This retrospective study observed cannabis as treatment for Crohn’s Disease and found that cannabis use resulted in significant positive effects on the symptoms of the disease (number of bowel movements, quality of bowel activity, abdominal pain, and other complications).

Key Results:

  • 21 of the 30 patients improved significantly with cannabis treatment

  • The average Harvey Bradshaw Index improved from 14 +/- 6.7 to 7 +/- 4.7 (P<.001); the index measures general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and related complications

  • The mean number of bowel movements decreased from 8 to 5 per day

  • The need for other medication was significantly reduced; most notably, the number of patients needing steroid treatment reduced from 26 to 4

CLINICAL STUDIES IN PROGRESS

IBD,

Cannabis and IBD Data Collection

Large-scale long-term data collection study on patients using medical cannabis that suffer from inflammatory bowel disease (IBD), to determine the effect of cannabis use on the symptoms and adverse side effects of the disease.

colitis,

The Effects of Cannabis on Colitis

Clinical research comparing a group of Colitis patients who will be given Erez strain cannabis and a group who will be given placebo for a period of eight weeks, during which the effect of cannabis on blood inflammation indices, life quality, medicine consumption, and adverse side effects, etc., will be monitored.

Crohn's Disease,

The Effects of Cannabis on Crohn’s Disease

Clinical research comparing a test group, receiving the Avidekel strain, and a control group (placebo), to examine the effect of cannabis oil administered as treatment for inflammatory intestinal disease.

LABORATORY RESEARCH IN PROGRESS

immunology,

The Effects of Cannabis on Immune Response

A study analyzing the effect of extracts of Avidekel, Erez and Midnight on immune response in blood samples in which infection was induced. Preliminary results show a verification of a suppressing effect of natural cannabinoids on the release of inflammation triggering cytokines; indication of a possible inflammation preventing effect of CBD on the immune system.