CITATION:  Augustine, T.N. et al. 2018. Priority areas for cannabis and cannabinoid product research in South Africa. African Journal of Primary Health Care & Family Medicine, 10(1):1-3, doi:10.4102/phcfm.v10i1.1711.The original publication is available at https://phcfm.org/index.php/phcfmThe legalisation of cannabis for medicinal use is a contentious space both politically and in the
medical community. In 2014, the Medical Innovation Bill introduced by Mario Oriani-Ambrosini
MP, aimed to shift the political and legal positions of cannabis as an illegal substance to one
available for research and medical use. To date, progress on this has been slow. Cannabis and
cannabinoid products are currently available for medicinal use in several countries, including the
Netherlands and 29 states in the United States. Locally, anecdotal reports suggest that many of
our patients with chronic medical conditions are using cannabis and cannabis-derived or
cannabinoid products for symptom alleviation.https://phcfm.org/index.php/phcfm/article/view/1711Publishers versio

Augustine, Tanya N.

Cairns, Carel J.

Chetty, Sean

Dannatt, Lisa G.

Gravett, Nadine

Grey, Glenda

Grobler, Gerhard

Jafta, Zukiswa

Kamerman, Peter

Lopes, John

Matsabisa, Motlalepula G.

Mugabo, Pierre

Mulder, Michelle

Parry, Charles

Rataemane, Solomon

Siegfried, Nandi

Steenkamp, Vanessa

Thomas, Eileen

Van Zyl-Smit, Richard

Stellenbosch University SUNScholar Repository

http://www.phcfm.org Open AccessAfrican Journal of Primary Health Care & Family Medicine ISSN: (Online) 2071-2936, (Print) 2071-2928Page 1 of 3 EditorialRead online:Scan this QR code with your smart phone or mobile device to read online.Authors:Tanya N. Augustine1 Carel J. Cairns2 Sean Chetty3 Lisa G. Dannatt4 Nadine Gravett1 Glenda Grey5Gerhard Grobler6 Zukiswa Jafta7Peter Kamerman8,9 John Lopes10 Motlalepula G. Matsabisa11 Pierre Mugabo12 Michelle Mulder13 Charles Parry14,15 Solomon Rataemane16 Nandi Siegfried14,17 Vanessa Steenkamp18 Eileen Thomas19 Richard van Zyl-Smit20 Affiliations:1School of Anatomical Sciences, Faculty of Health Sciences, University of the Witwatersrand, South Africa2Department of  Anaesthesia, Grey’s Hospital, Pietermaritzburg, South Africa3Department of Anaesthesiology and Critical Care, Faculty of Medicine and Health Sciences, Stellenbosch University, South Africa4Department of Psychiatry and Mental Health, Faculty of Health Sciences, University of Cape Town, South Africa5South African Medical Research Council, Cape Town, South Africa6Department Psychiatry, Faculty of Health Sciences, University of Pretoria,  South Africa7Frere Hospital, East London, South AfricaThe legalisation of cannabis for medicinal use is a contentious space both politically and in the medical community. In 2014, the Medical Innovation Bill introduced by Mario Oriani-Ambrosini MP, aimed to shift the political and legal positions of cannabis as an illegal substance to one available for research and medical use. To date, progress on this has been slow. Cannabis and cannabinoid products are currently available for medicinal use in several countries, including the Netherlands and 29 states in the United States. Locally, anecdotal reports suggest that many of our patients with chronic medical conditions are using cannabis and cannabis-derived or cannabinoid products for symptom alleviation.In January 2016, the Alcohol, Tobacco and Other Drug Research Unit (ATODRU) of the South African Medical Research Council (SAMRC) produced a policy brief evaluating the findings of a published systematic review of current evidence to inform the discussion.1,2 The review identified moderate quality evidence to support the use of medicinal cannabis for chronic pain, chemotherapy-induced nausea, vomiting, and multiple sclerosis,1,2 but the many formulations, dosages and routes of administration limit recommendations.Subsequently, the SAMRC brought key stakeholders representing all nine faculties of health sciences at South African universities together on 08 February 2017 at the SAMRC Medicina Campus, Cape Town, to explore opportunities for conducting local research and clinical trials of medicinal cannabis and cannabinoids to inform local policy-making. The workshop identified three major research priorities:•	 Conduct a national, multisite clinical trial of cannabinoids following identification of the optimal formulations, dosage and relevant clinical indications from the current evidence base to inform trial protocol development.•	 Support exploratory research to quantify the prevalence and qualify the current use of extracts (e.g. oils) in the community to alleviate pain and other symptoms; methods to include are as follows, (1) community- or clinic-based cross-sectional surveys or online survey of general public, (2) cross-sectional surveys of practising general practitioners and/or specialists in pain clinics with respect to their knowledge of patient use of cannabis extracts through patient disclosure.•	 Conduct qualitative evaluation(s) of possible barriers and facilitators to medical practitioners prescribing cannabis or cannabinoids for medicinal purposes, should it be legalised in the future.Further to this meeting, an SAMRC-supported team of researchers evaluated the evidence for a trial of a cannabinoid for the management of pain related to HIV associated sensory neuropathy Priority areas for cannabis and cannabinoid  product research in South Africa8Brain Function Research Group, Faculty of Health Sciences, University of the Witwatersrand, South Africa9School of Biomedical Sciences, Curtin University, Australia10Department of Biomedical Sciences, Faculty of Medicine and Health Sciences, Stellenbosch University, South Africa11Department of Pharmacology, Faculty of Health Sciences, University of Free State, South Africa12School of Pharmacy, Faculty of Natural Sciences, University of the Western Cape, South Africa13Grants Innovation and Product Development, Strategic Health Innovation Partnerships, South African Medical Research Council, South Africa14Alcohol and Tobacco and Other Drug Research Unit, South African Medical Research Council, South Africa15Department of Psychiatry, Faculty of Medicine and Health Sciences, Stellenbosch University, South Africa16Department of Psychiatry, School of Medicine, Sefako Makgatho Health Sciences University, South Africa17Department of Psychiatry and Mental Health, Faculty of Health Sciences, University of Cape Town, South Africa18Department of Pharmacology, Faculty of Health Sciences, University of Pretoria, South Africa19Department of Psychiatry, Faculty of Medicine and Health Sciences, Stellenbosch University, South Africa20Lung Institute and Division of Pulmonology, Faculty of Health Sciences, University of Cape Town, South AfricaCorresponding author: Nandi Siegfried, nandi.siegfried@gmail.comHow to cite this article: Augustine TN, Cairns CJ, Chetty S, et al. Priority areas for cannabis and cannabinoid product research in South Africa. Afr J Prm Health Care Fam Med. 2018;10(1), a1711. https://doi.org/10.4102/phcfm.v10i1.1711Copyright: © 2018. The Authors. Licensee: AOSIS. This work is licensed under the Creative Commons Attribution License.Page 2 of 3 Editorialhttp://www.phcfm.org Open Access(HIV-SN). The team selected painful HIV-SN as the condition based on: (1) the high burden of HIV and HIV-SN in the South African population, despite availability of improved antiretroviral drug regimens, and (2) the absence of empirical evidence supporting the efficacy of pharmacological agents typically recommended for the management of neuropathic pain in this population group. They limited their assessment to high-quality trials of greater than 12 weeks duration, included participants with at least moderate intensity pain at baseline and who met current recommendations for trial design in the field of chronic pain.3 Only three studies, all using a fixed dose combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) delivered via oromucosal spray were identified, and the results of the GRADE4 assessment are shown in Table 1.The team concluded that clinical equipoise5 exists for a fixed dose THC:CBD oromucosal cannabinoid spray trial for the management of painful HIV-SN. This was based on  the GRADE assessment, the absence of demonstrably effective alternative therapies for painful HIV-SN and the clinical need in people living with HIV. The team is currently working on a study protocol for a multisite trial that conforms with the current highest standards for trials of analgesic agents for chronic pain.3,5 The SAMRC will be releasing a Request for Applications (RFA) from groups interested in participating in trials in due course.In medical practice, there is a balance between early adoption of new innovation and a slower, more considered approach prioritising evidence and safety over potential benefit. Though there are some clear areas where evidence supports the use of medicinal cannabis (as reviewed in the SAMRC policy brief), this should not imply that cannabis is a panacea for all ails or that it should be freely available without due control of production quality, disease indications and specific dosing recommendations. Research is urgently needed and regulatory changes will promote and allow for high priority, locally relevant research using regionally sourced products.It is imperative that the medical and scientific community – both practitioners and researchers – are involved in informing and developing evolving cannabis policies. Much confusion exists between medical versus recreational usage, the legal statutes of medical and recreational possession and usage, and the scientific evidence compared to impassioned anecdotal reports of its efficacy in addressing a host of medical conditions. We owe it to our patients to offer the best relief of suffering with all available therapies based on the rational assessment of benefit, cost and potential harms of cannabis and cannabinoid products for medicinal use.AcknowledgementsThe authors thank the South African Medical Research Council (SAMRC) Alcohol, Tobacco and Other Drug Research Unit, and the SAMRC Strategic Health Innovation TABLE 1: GRADE assessment for nabiximol versus placebo for chronic pain.Quality assessmentNumber of patientsEffectQualityImportanceNumber of studiesDesignRisk of biasInconsistencyIndirectnessImprecisionOther considerationsCannabisPlaceboRelative %95% CIAbsoluten%n%3†Randomised trialsSerious‡Number of serious inconsistencies§No serious indirectnessNumber of serious imprecisionsNone172/43939.20155/43735.50RR 1.130.86% –1.5%46 more per 1000 (from 50 fewer to 177 more)ModerateCriticalNote: Pain relief (follow-up: 14 weeks –15 weeks).†, Included studies: GW Pharma (EudraCT number: 2004-002530-20): 297 patients with diabetic peripheral neuropathy; Langford et al.6: 339 patients with multiple sclerosis; Serpell et al.7: 303 patients with at least one of the following underlying conditions which caused their peripheral neuropathy: post-herpetic neuralgia, peripheral neuropathy, focal nerve lesion, radiculopathy or complex regional pain syndrome (CRPS) type 2. All trials evaluated the effects of Sativex (THC or CHB oromucosal spray); ‡, Risk of bias: Graded as serious. High risk of attrition in GW Pharma. Allocation concealment unclear in Langford and Serpell; §, Inconsistency: I2 was 47.6% indicating moderate heterogeneity. However, we did not downgrade the inconsistency as the inconsistency may be explained by the different population groups included in each trial.Page 3 of 3 Editorialhttp://www.phcfm.org Open AccessPartnerships Division for their financial and administrative support.Competing interestsThe authors declare that they have no financial or personal relationships that may have inappropriately influenced them in writing this article.Authors’ contributionsAll authors are members of the South African Cannabis Network and provided input to and/or attended an SAMRC Workshop held in February 2017 on which this article is based. All authors contributed to the draft manuscript. S.C., P.K. and N.S. developed the GRADE table. R.V.Z.S. and C.P. led the revision of the final manuscript.References1. Siegfried N, Parry C, Myers B. Cannabinoids for medicinal use 2016 [homepage on the Internet]. [cited 2017 Nov 17]. https://www.health-e.org.za/wp-content/uploads/2016/01/Cannabinoids.pdf2. Whiting PF, Wolff RF, Deshpande S, et al. Cannabinoids for Medical Use: A systematic review and meta-analysis. JAMA. 2015;313:2456–2473. https://doi.org/10.1001/jama.2015.63583. Dworkin RH, Turk DC, Peirce-Sandner S, et al. Considerations for improving assay sensitivity in chronic pain clinical trials: IMMPACT recommendations. Pain. 2012;153:1148–1158. https://doi.org/10.1016/j.pain.2012.03.0034. Guyatt GH, Oxman AD, Vist GE, et al. GRADE: An emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008;336:924–926. https://doi.org/10.1136/bmj.39489.470347.AD5. Hey SP, Truog RD. The question of clinical equipoise and patients’ best interests. AMA J Ethics. 2015;17:1108–1115. https://doi.org/10.1001/journalofethics. 2015. 17.12.ecas1-15126. Langford RM, Mares J, Novotna A, et al. A double-blind, randomized, placebo-controlled, parallel-group study of THC/CBD oromucosal spray in combination with the existing treatment regimen, in the relief of central neuropathic pain in patients with multiple sclerosis. J Neurol. 2013;260(4):984–997. https://doi.org/ 10.1007/s00415-012-6739-47. Serpell M, Ratcliffe S, Hovorka J, et al. A double-blind, randomized, placebo-controlled, parallel group study of THC/CBD spray in peripheral neuropathic pain treatment. Eur J Pain. 2014;18(7):999–1012. https://doi.org/10.1002/ j.1532-2149. 2013.00445.x

Priority areas for cannabis and cannabinoid product research in South Africa

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Priority areas for cannabis and cannabinoid product research in South Africa

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