Evidence Based Medicine Approach to Medical Cannabis. From Hype to Hope
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1 Evidence Based Medicine Approach to Medical Cannabis. From Hype to Hope Prof. Victor Novack, MD PhD Head, Research Authority and Cannabis Clinical Research Institute, Soroka University Medical Center Dean Advisor for Clinical Research, Faculty of Health Sciences, Ben-Gurion University of the Negev
2 Conflicts of Interest Consultant to Tikun Olam Pharma; Niamedic Keystone Heart; Celonova; Bi02; Merit; Meril; AlviMedica; Corindus; Eximo; CardioMed; Intensix; Robocath; Creavomedtech; Cardionovum; AdvancedBifuraction; Occlutech
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4 Five HIGHLY POPULAR THEMES Wearable Technologies and Internet of Things Precision Medicine Big Data Medical Cannabis Free Beer
5 Only One of Them in Medical Consensus as Beneficial to Health
6 Only One of Them in Medical Consensus as Beneficial to Health
7 Gartner Cycle of Hype
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11 Since Then Vitamin D Vitamin C Renal artery stenting for HTN Transmyocardial laser revascularization Many others
12 Aspirin vs. Cannabis ASPIRIN Cannabis Used by Humans Since ancient Egypt Even before that Established chemical compound Known Mechanism of Action V - V - Proven Efficacy V -/+ Proven Indications V -/+ Panacea Effect Expectations Money making potential expectations - VV - VVVVVVVVVVVVVVVVV
13 Evidence Based Medicine
14 What about evidence for MM? PubMed: "Cannabis["Mesh] OR " Medical Marijuana["Mesh] AND (Humans[Mesh] AND English[lang] papers
15 Publications Per Year
16 Quality Last 10 years - less than 100 trials, only 5 are good trials Evidence is ~reliable for : Pain reduction Nausea reduction Sleep disturbances Special type of epilepsy
17 Israel as a World Leader in Cannabis Research Superb Regulatory Basis Good research infrastructure Well established agricultural program Basic research going back 50 years Tightly regulated licensing No expectation for future recreational cannabis approval
18 MEDICAL CANNABIS TREATMENT Lihi Bar-Lev Schleider MA 1,2, Raphael Mechoulam PhD 3, Inbal Sikorin RN 2, Timna Naftali MD 4, Zvi Bentwich MD 2,5, Victor Novack MD PhD 1. 1 Clinical Research Center, Soroka University Medical Center and Faculty of Health Sciences, Ben-Gurion University of the Negev, Be'er-Sheva, Israel. 2 Research Department, Tikun Olam LTD. 3 School of Pharmacy, the Hebrew University of Jerusalem, Israel. 4 Department of Gastroenterology and Hepatology, Meir Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Kfar Saba. 5 Center for Emerging Tropical Diseases and AIDS, Faculty of Health Sciences, Ben- Gurion University of the Negev, Be'er-Sheva, Israel.
19 Number of Patients Indications for Medical Cannabis (N=2231)
20 Demographic characteristics Total (2231) Mean age (SD) 55.8 (19) Gender (male) 1144 (51.3%) Working (Yes) 528 (23.7%) Driving a car (Yes) 1165 (52.2%) Median Number of medications (IQR) Previous experience with cannabis (Yes) 4 (2-7) 681 (30.5%)
21 Disease Prevalence and Duration Total Responses (%) Median disease duration (IQR) in years Cancer 1332 (59.7%) 1 (1-3) Hypertension 298 (13.4%) 10 (5-21) Diabetes 216 (9.7%) 10 (5-21) Spinal Disk Herniation 185 (8.3%) 6 (3-13.2) Nonspecific Pain 164 (7.4%) 5 (2-10) Ischemic Heart Disease 136 (6.1%) 10 (4-18) Post-Traumatic Stress Disorder 130 (5.8%) 9 (3-15) Fibromyalgia 97 (4.3%) 6 (2-10) Parkinson's Disease and Parkinsonism 76 (3.4%) 7 (4.5-10) Arthritis 73 (3.3%) 10.5 (5-21) Epilepsy 63 (2.8%) 7 (3-11) Degenerative Disc Disease 52 (2.3%) 10 ( ) Depression 50 (2.2%) 7 (1.2-15) Crohn's Disease 44 (2%) 10 (3-15)
22 Pain Scale Before and During Treatment Before treatment After six months
23 Quality of Life Before and During Treatment Very bad Bad Not good nor bad Before treatment Good After six months 30 Very good
24 Percentage of Patients Side Effects Six Months Follow-up Safety 5.0% 4.5% 4.0% 3.5% 4.7% 3.7% 252 patients (21.6%) reported on 459 side effects 3.0% 2.5% 2.0% 1.7% 1.6% 1.6% 1.4% 1.5% 1.0% 1.2% 0.9% 0.7% 0.6% 0.6% 0.6% 0.5% 0.5% 0.5% 0.5% 0.5% 0.5% 0.3% 0.2% 0.0%
25 Cancer
26 Demographic Characteristics Total (2682) Mean age (SD) 59.9 (16.3) Gender (male) 1222 (45.5%) Working (Yes) 465 (17.3%) Driving a car (Yes) 1331 (49.6%) Median number of medications (IQR) Previous experience with cannabis (Yes) 4 (2-6) 577 (21.5%)
27 Population Flow Chart Screening 3,557 Intake 2,682 Responded to the questionnaire 3,357 Initiated treatment 67 - Died Refused treatment One month 2,983 Ongoing treatment 3 Switched supplier Died Stopped treatment Six months 1,152 Responded to the questionnaire 1,933 Ongoing treatment 35 Switched supplier Died Stopped treatment
28 Percentage of Patients Efficacy Estimation 60.0% Six-Month Follow-up Efficacy 50.0% 40.0% 95.3% reported improvement 36.9% 47.9% 30.0% 20.0% 10.0% 0.0% 0.0% 0.2% 0.3% 4.2% 10.5%
29 NUMBER OF PATIENTS Pain Scale Before and During Treatment Before treatment After six months
30 17 34 NUMBER OF PATIENTS Quality of Life Before and During Treatment Before treatment After six months VERY BAD BAD NOT GOOD OR BAD GOOD VERY GOOD
31 Elderly
32 From: The Increasing Use of Cannabis Among Older Americans: A Public Health Crisis or Viable Policy Alternative? Gerontologist. Published online January 11, doi: /geront/gnw166 Gerontologist The Author Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved.
33 Baseline demographic characteristics Age (years) Male BMI Driving a car Variable Approved monthly dosage of cannabis (grams) Approved way of administration Previous experience with cannabis Cigarettes smokers Number of regularly used medications Number of days hospitalized in the past 6 months 74.7 ± 7.5 All patients (N=2,312) 1,082 (46.8%) 25.1 ± (35.5%) 28.2 ± 13.7 Oil (27.5%) Inflorescence (20.2%) Oil + Inflorescence (51.6%) 409 (17.4%) 354 (15.3%) 6 (3,9) 1 (1,10)
34 Number of patients Quality of Life global assessment Quality of life prior and six months after the initiation of cannabis treatment, p< Very bad Bad Not good nor bad Before treatment Good 22 6 months after treatment 78 Very good
35 Number of patients Cannabis general effect Perception about the general effect of cannabis on the patient's condition after 6 months
36 Adverse events 288 (32.1%) of the responders reported experiencing any adverse event due to cannabis use. 45 (5%) stopped the treatment due to adverse events. Adverse event Number of patients (N=898) Dizziness 92 (10.2%) Dry mouth 53 (5.9%) Somnolence 32 (3.6%) Weakness 24 (2.7%) Psychoactive effect 24 (2.7%) Nausea 21 (2.3%) Cough 19 (2.1%) Confusion and disorientation 15 (1.7%) Hallucinations 13 (1.4%) Drop in sugar levels 12 (1.3%) Restlessness 10 (1.1%) Vomiting 10 (1.1%)
37 Fibromyalgia 367 fibromyalgia treated with cannabis between 2015 and Main outcome: Treatment response which was defined as at least moderate or significant improvement in the patient condition at six months follow-up and no cessation of treatment or serious side effects
38 Fibromyalgia Mean age was 52.9±15.1, 301 (82.0%) were women. 28 patients (7.6%) stopped the treatment prior to the six months follow-up. Pain intensity (scale 0-10) reduced from a median of 9.0 at baseline to 5.0 (p<0.001), and 194 patients (81.1%) achieved treatment response. In a multivariate analysis age above 60 years (OR 0.34, 95% C.I ), concerns about cannabis treatment (OR 0.36, 95% C.I ), spasticity (OR 2.26, 95% C.I ) and previous use of cannabis (OR % C.I ) were associated with treatment outcome. The most common adverse effects were mild and included dizziness (7.9%), dry mouth (6.7%) and gastrointestinal symptoms (5.4%).
39 Autism We analyzed the data of 188 ASD patients treated with medical cannabis between 2015 and Results: The average age was 12.9±7.0 years (82.8% under the age of 18), 81.9% boys and 14.4% of the patients reported comorbidity of epilepsy. The main symptoms were: restlessness (90.4%), rage attacks (79.8%) and agitation (78.7%).
40 Autism After six months of follow up, 23 patients (12.2%) stopped the treatment. 30.1% reported significant improvement, 53.7% reported moderate improvement and 6.4% reported only slight improvement, 8.6% reported no change in their condition. Twenty-three patients (25.2%) reported experiencing at least on side effect; the most common was restlessness (6, 6.6%).
41 Another Thought Cannabis Opiates From plant + + Existing body chemical analogues + + Treats pain Expectations for panacea effects + + +
42 What did we learn? Our population is really sick Less than 25% had previous experience with cannabis Cannabis treatment is safe It is efficacious (pain, quality of life)* Inherent limitations of the observational studies Limited idea what actually was taken by the patient and how it worked
43 Next Steps RCT for acute migraine RCT for autism RCT for opioids cessation in patients with chronic pain Study of the cardiovascular effects (HTN, glucose, lipids) Effect on ADL in elderly
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