A Human Study On The Uses Of Medicinal Cannabis In South Africa – Phase One

Commercial Research Study Report (21^st January 2021)

Contents

About

Authors
Title
Abstract

Introduction

Research question: background, importance, and relevance
Hypotheses
Timeline

Methods

Basic methodological framework / identification strategy intervention
Sample and statistical power
Data collection and processing
Variations from the intended sample size
Pilot Data
Statistical methods
Interpreting results
Dissemination of information
Study status

Data availability

Additional information

Funding
Ethics Policy
Competing interest
Systematic reviews
Acknowledgements

References
Reporting Checklist

About
People often use the words â€œcannabisâ€ and â€œdagga/marijuanaâ€ interchangeably, but they do not mean the same thing.
â€¢ The word â€œcannabisâ€ refers to all products derived from the plant Cannabis sativa.
â€¢ The cannabis plant contains about 540 chemical substances, of which Canabidiol (CBD) and tetrahydrocannabinol (THC) are the most well known and abundant in the plant material.
â€¢ The words â€œdagga/marijuanaâ€ refer to parts of or products from the plant Cannabis sativa that contain substantial amounts of THC. THC is the substance that is primarily responsible for the effects of marijuana on a person’s mental state.
â€¢ CBD has been declared safe and of medicinal benefit by the United Nations, the World Health Organisation and the European Union.
â€¢ Some cannabis plants contain small amounts of THC and are considered as â€œHempâ€. Some hemp plants are high in CBD and other non-psychoactive cannabinoids and are well suited for medicinal cannabis products.
Throughout the rest of this report, we use the term â€œcannabisâ€ to refer to the plant Cannabis sativa and products derived therefrom. For Phase One of this study we have not made a distinction about the ratios of cannabinoids present in the medicinal cannabis products used by participants and are examining medicinal cannabis as a whole.
Druids Garden (Pty) Limited
Motivation for the study has been determined and authorised as per the conditions of PERMIT NO. HEMP 024/2018/2019 (signed and issued to Cian McClelland on 4 April 2019).
â€œ(b) The cultivation of the registered Cannabis sativa cultivars shall be a research project to conduct commercial research trials to develop commercially viable products to test market readiness for medical dagga products in South Africa.â€ â€“ excerpt from the Permit.
SAHPRA has been advised of our intention to comply as per email communications on 3rd March 2020 and 11th December 2020.
The study protocol included the following elements:
â€¢ Description of the key background literature
â€¢ Motivation for the study, Hypotheses, Study procedures
â€¢ Statistical analysis procedures
â€¢ Pilot data

Title: (Phase One Report)
A HUMAN STUDY ON THE USES OF MEDICINAL CANNABIS IN SOUTH AFRICA: Successful Uses Reported by Existing Users
Authors: T/Dr. Cian McClelland, T/Dr. Simon Varrall, Qhuzulini Sithole and Gavin Tonks
Abstract
Cannabis has been known as a medicine for several thousands of years across many cultures. It reached a position of prominence within Western medicine in the nineteenth century but became mired in disrepute and legal controls early in the twentieth century.
Despite unremitting world-wide suppression, recreational cannabis exploded into popular culture in the 1960s and has remained easily obtainable on the black market in most countries ever since. This ready availability has allowed many thousands of patients to rediscover the apparent power of the drug to alleviate symptoms of some of the most cruel and refractory diseases known to humankind. Pioneering clinical research in the last quarter of the twentieth century has given some support to these anecdotal reports, but the methodological challenges to human research involving a pariah drug are formidable.
Studies have tended to be small, imperfectly controlled, and have often incorporated unsatisfactory synthetic cannabinoid analogues or smoked herbal material of uncertain composition and irregular quality and bioavailability. As a result, the scientific evaluation of medicinal cannabis in humans is still in its infancy.
New possibilities in human research have been opened by the discovery of the endocannabinoid system, a rapidly expanding knowledge of cannabinoid pharmacology, and a more sympathetic political environment in several countries. More and more scientists and clinicians are becoming interested in exploring the potential of cannabis-based medicines.
Future targets will extend beyond symptom relief into disease modification, and already cannabinoids seem to offer promise in the treatment of certain inflammatory and neurodegenerative conditions.
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OBJECTIVE To determine what ailments and/or disorders are being successfully treated through the use of medicinal cannabis by the South African adult public that have increasing access to medicinal and recreational cannabis products.
DESIGN: Open Study Phase One was a large retrospective case series of existing medicinal cannabis users to determine what ailments medicinal cannabis is successfully treating, either on its own or as an adjunct to usual treatment.
The retrospective chart review included documentation of the effectiveness of medicinal cannabis in 1,458 adult participants.
The design of the opening question was for a global feedback and generic capture of a wide group of people and the type of ailments they were experiencing, so as to begin a base line approach to our research.

Phase Two will be a large active case study on the effectiveness of a variety of medical cannabis products for specific ailments within specific population demographic groups.
MAIN OUTCOME
Medicinal cannabis appears to be effective in addressing numerous ailments such as anxiety, inflammation, pain and a variety of neurological disorders, according to the case series.
MAIN OUTCOME MEASURES
Anxiety & stress, sleep and pain scores are the highest, using validated instruments at baseline and after medicinal cannabis treatment.
RESULTS The final sample consisted of 1,458 adults presenting with primary concerns of anxiety and stress (n = 886) poor sleep (n = 576) and pain (n = 451). Ailment scores decreased within the first month in 100% of participants and remained decreased during the study duration. Sleep scores improved within the first month in 100% of participants that listed sleep disorders as a concern.
Detailed breakdown of ailments listed by participants that they are successfully treating with medicinal cannabis, in descending order:
â€¢ Anxiety & stress: 886
â€¢ Poor sleep: 576
â€¢ Pain: 451 (108 for back pain, 96 for headaches & migranes and 47 for muscular)
â€¢ Depression: 160
â€¢ ADHD: 32
â€¢ Stop tobacco addiction: 31
â€¢ Appetite stimulant: 28
â€¢ Inflammation: 23
â€¢ PTSD: 20
â€¢ Bipolar: 19
â€¢ Blood disorders: 14 (7 for diabetes and 4 for high blood pressure)
â€¢ Asthma: 13
â€¢ Cancer: 10 (Nausea)
â€¢ Skin conditions: 9
â€¢ Epilepsy: 8
â€¢ Focus and concentration: 7
â€¢ IBS: 7
â€¢ Glaucoma: 6
â€¢ Lupus: 6
â€¢ ADD: 5
In this chart review, medicinal cannabis was well tolerated in all participants.
CONCLUSION
Participants concluded that continued use of medicinal cannabis improved the quality of their life considerably. Verbal and written reports from participants are increasingly showing that cannabis holds medicinal benefit for a wide variety of ailments, especially anxiety-related, pain and sleep disorders.

Controlled clinical studies are needed to unlock the full value of medicinal cannabis as an effective natural treatment for a wide variety of ailments, with little to no side effects. Future research should also include specific strains of cannabis that show increased efficacy with specific ailments.
2. Introduction
Due to the lack of verifiable local data on the current uses of medical cannabis, it is imperative to study existing cannabis users that are successfully treating a range of ailments by using cannabis based products that are currently available in South Africa.
When all Phases of this study are complete it will assist to build relevant data and models for cultivators, product producers and the cannabis industry as a whole. It will also assist the South African government with policy guidelines, educate the public and assist to advise the types of cannabis medicines proven to be effective, as well as the new product lines that need to be developed in line with current successes.
Phase One Research question
What medical ailments are you successfully treating with cannabis products?
Hypotheses
International studies have indicated that cannabis is effective as a general health tonic that helps to balance the endocrine system; and that it treats a wide variety of mild health related ailments, especially stress related conditions.
The primary outcomes of this study indicate that the South African public is successfully using cannabis products to address a wide range of mild health related ailments, especially anxiety, stress, pain & sleep related conditions.
The secondary outcomes of this study indicate that the South African public is successfully using cannabis products to treat a wide range of more serious health related conditions. However, clinical trials are required to further explore and study the exact nature of the successes stated by participants in this study for the more serious health related ailments.
Timeline
Participants were required to have been using cannabis products for a minimum period of two months to allow time for the products to work. Anecdotal evidence suggests that cannabis products take three to ten days to begin working and up to twenty-one days to become fully effective. This may be related to dosage and individual tolerance levels and requires further study.
3. Methods
Participants were identified from two different adults-only private membership-based networks of users of cannabis products that are currently available in South Africa.
The bulk of participants came from the membership base of the Tree of Life Wellness Group. Participants signed up to be part of the initial research study in the Tree of Life stores to assist with the creation of a base line study. They willingly provided information on their ailment and contact details.

These members were contacted by email to provide information and request feedback on the effects of medicinal cannabis for the ailments that they noted on their forms as the reason for participating in the research study. This is an ongoing process and new members are encouraged to join daily.
Leafolo was also requested to approach members over 18 years old that are using medicinal cannabis products on a regular basis to complete the research questionnaire.
For both groups there was no stipulation on the type or severity of ailments and as broad a cross section of ailments as possible was encouraged. Due to legal implications, participants were not required to disclose the brand names or ratios of cannabinoids in the products being used.
The Covid-19 virus has impacted on face-to-face information gathering and we have relied on email and telephonic data gathering. Completed questionnaires from participants that were sourced from both membership bases were captured on a database and reviewed to ensure that they had been completed in full with all relevant information and that participants were adults over 18.
1,475 participants responded with sufficient detail to be included in the study results and 17 were disqualified due to incomplete information.
The lead author of this study then analysed the data and separated the responses into specific ailments and created tables for each type of ailment listed. There were over 115 ailments listed but many were similar and were then combined into groups. Eg anxiety & stress.
Sample and statistical power
Individual existing medicinal cannabis users were identified through two private membership based organisations. Over 2,000 medicinal cannabis users were requested to participate in this study. 1,475 people responded and 1,458 of the responses qualified for data capturing.
Data collection and processing
The data was collected over a 6 month period from May to October 2020 by way of email and telephonic feedback from participants. The submitted responses were captured by a Druids Garden administrator into an Excel spreadsheet for analysis by the research team during late November and December 2020.
We are currently refining our data collection methodology and developing an App to encourage and enable participants to capture data more accurately and thereby participate in the study more effectively.
Variations from the intended sample size
The study targeted to attract over 2,000 participants and fell short. However, the quality of the data collected was substantive and sufficient to conduct the intended research.
Pilot Data
A multitude of international studies have produced significant data on the effects of medicinal cannabis for treating a broad range of health ailments.
It is the authors collective view that clinical studies for Schedule 0 CBD products that have valid and verifiable COA’s (potency, heavy metals & pesticides) should not have to be subject to medical trials. These products should receive special dispensation and be registered with SAHPRA on the basis of their independent quality certifications.

Statistical methods
The captured data was sorted into the 114 listed ailments being treated with medicinal cannabis. These were then further grouped into 18 broader ailment groupings such as â€œPainâ€ that covers 28 types of pain listed by the participants.
Statistical model
To date, studies on the therapeutic efficacy of Cannabis in certain pathologies have yielded results that are, at best, contradictory and, generally, inconclusive given that the studies were carried out on inhomogeneous populations, used differing extraction processes, and administered differing dosages (Bar-Lev et al., 2018). Moreover, the experiments were performed without proper control procedures and were administered by different routes.
These uncertainties stem in part from legislative restrictions that, over time, have severely hindered the performance of rigorous clinical studies under controlled and comparable conditions. The legalization of Cannabis for medical use can pave the way for the gathering of reliable clinical and epidemiological dataâ€”fundamental for a clear definition of the clinical efficacy and the inherent risks, in a medical environment, of Cannabis.
The model used for this study targeted existing medicinal cannabis and all participants except for three responded that they were satisfied with the efficacy of the medicinal cannabis they were using.
It was surprising that so few participants gave a negative review of the usage of medicinal cannabis to address their ailments.
Multiple outcome and multiple hypothesis testing
Participants were requested to answer truthfully and there is no valid reason for them to have submitted false data. It is the opinion of this research team that any participants who were not satisfied would have mentioned that in their submission.
Interpreting results
The results indicate that medicinal cannabis does work as a natural, safe & effective treatment for a wide variety of mild medical conditions experienced by the South African public.
The results provide local verification for a multitude of peer reviewed international studies that have already been completed. This data should give confidence to the South African government that medicinal cannabis is a safe and effective treatment that warrants further research trials.
Dissemination of information
This report will be disseminated to the CSIR, SAHPRA, Department of Health and the Druids Garden, Tree of Life and Leafolo membership base.
Study status
Phase One of the study has been completed. Druids Garden will now apply to SAHPRA for registered trials that focus on the medicinal benefits of different Druids Garden CBD products for specific ailments.
4. Data availability
The data is available from Cian McClelland at Druids Garden by written request. It is date stamped and securely stored on a Druids Garden backup drive.
5. Additional information
Funding
The authors declared that no grants were involved in supporting this work. All costs were borne by Druids Garden & Tree of Life.
Ethics Policy
All research has been conducted within an appropriate ethical framework.
Competing interest
No competing interests were disclosed.
Acknowledgements
Special acknowledgement to the following participating external organisations that allowed access to their private membership base to conduct the research trials.
â€¢ Tree of Life Wellness Group
â€¢ Tinie Terblanche â€“ Tree of Life Communications
â€¢ Leafolo â€“ herbal (non-tobacco) smoking blend