A cannabis oracle? Delphi method not a substitute for randomized controlled trials of cannabinoids as therapeutics

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Abstract

Background

With millions of people using cannabinoids to treat a host of medical conditions, clinicians want guidance on how to utilize cannabinoids as pharmacotherapy in their practices. The Delphi method is a systematic, interactive forecasting method that aims to develop consensus best practices where guidelines are not available.

Body

A multidisciplinary group of global cannabinoid experts utilized a modified Delphi process to develop three protocols for the dosing and administration of cannabinoids to treat chronic pain. Two protocols recommend cannabidiol (CBD), for which there is limited evidence as an analgesic, starting well below doses required for other indications. Guidance on prescribing CBD for pain may demonstrate consensus recommendations based upon suboptimal evidence.

Conclusion

Consensus processes like the Delphi method are well-meaning, but they are not a substitute for rigorous RCTs with large sample sizes, adequate duration, and standardized outcome measures.

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Most cited references 10

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Cannabidiol: State of the art and new challenges for therapeutic applications.

Simona Pisanti, Anna Maria Malfitano, Elena Ciaglia … (2017)

Over the past years, several lines of evidence support a therapeutic potential of Cannabis derivatives and in particular phytocannabinoids. Δ(9)-THC and cannabidiol (CBD) are the most abundant phytocannabinoids in Cannabis plants and therapeutic application for both compounds have been suggested. However, CBD is recently emerging as a therapeutic agent in numerous pathological conditions since devoid of the psychoactive side effects exhibited instead by Δ(9)-THC. In this review, we highlight the pharmacological activities of CBD, its cannabinoid receptor-dependent and -independent action, its biological effects focusing on immunomodulation, angiogenetic properties, and modulation of neuronal and cardiovascular function. Furthermore, the therapeutic potential of cannabidiol is also highlighted, in particular in nuerological diseases and cancer.

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Initial experiences with medicinal extracts of cannabis for chronic pain: results from 34 'N of 1' studies.

William Notcutt, Mario Price, Roy M. Miller … (2004)

Three Cannabis Based Medicinal Extracts (CBMEs) for sublingual use became available in 2000. A total of 34 'N of 1' studies were undertaken using this novel therapy for patients with chronic, mainly neuropathic, pain and associated symptoms to explore efficacy, tolerability, safety and dosages. Three CBMEs (Delta9 Tetrahydrocannabinol (THC), Cannabidiol (CBD) and a 1:1 mixture of them both) were given over a 12-week period. After an initial open-label period, the CBMEs were used in a randomised, double-blind, placebo controlled, crossover trial. Extracts which contained THC proved most effective in symptom control. Regimens for the use of the sublingual spray emerged and a wide range of dosing requirements was observed. Side-effects were common, reflecting a learning curve for both patient and study team. These were generally acceptable and little different to those seen when other psycho-active agents are used for chronic pain. These initial experiences with CBME open the way to more detailed and extensive studies.

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An experimental randomized study on the analgesic effects of pharmaceutical-grade cannabis in chronic pain patients with fibromyalgia

Tine van de Donk, Marieke Niesters, Mikael Kowal … (2019)

Supplemental Digital Content is Available in the Text. This experimental highly controlled trial in 20 patients with fibromyalgia shows that the cannabinoid THC, but not CBD, is effective in the treatment of fibromyalgia pain.

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Author and article information

Contributors

Kevin P. Hill: Khill1@bidmc.harvard.edu

Donald I. Abrams: Donald.abrams@ucsf.edu

Journal

Journal ID (nlm-ta): J Cannabis Res

Journal ID (iso-abbrev): J Cannabis Res

Title: Journal of Cannabis Research

Publisher: BioMed Central (London )

ISSN (Electronic): 2522-5782

Publication date (Electronic): 2 July 2021

Publication date PMC-release: 2 July 2021

Publication date Collection: 2021

Volume: 3

Electronic Location Identifier: 23

Affiliations

[1 ]GRID grid.239395.7, ISNI 0000 0000 9011 8547, Division of Addiction Psychiatry, , Beth Israel Deaconess Medical Center, ; Grzymish 133, 330 Brookline Avenue, Boston, MA 02215 USA

[2 ]GRID grid.38142.3c, ISNI 000000041936754X, Department of Psychiatry, , Harvard Medical School, ; Boston, USA

[3 ]GRID grid.266102.1, ISNI 0000 0001 2297 6811, Department of Medicine, , University of California, ; San Francisco, USA

Article

Publisher ID: 74

DOI: 10.1186/s42238-021-00074-0

PMC ID: 8254257

PubMed ID: 34215325

SO-VID: 7cfc3e83-8000-4ade-8c5a-da5b900cb87a

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

History

Date received : 30 April 2021

Date accepted : 14 May 2021

Custom metadata

Keywords: medical cannabis,chronic pain,cannabidiol,cbd,tetrahydrocannabinol,thc,delphi process

Data availability:

Keywords: medical cannabis, chronic pain, cannabidiol, cbd, tetrahydrocannabinol, thc, delphi process

A cannabis oracle? Delphi method not a substitute for randomized controlled trials of cannabinoids as therapeutics

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Abstract

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Aging Pathobiology and Therapeutics

Most cited references 10

Cannabidiol: State of the art and new challenges for therapeutic applications.

Initial experiences with medicinal extracts of cannabis for chronic pain: results from 34 'N of 1' studies.

An experimental randomized study on the analgesic effects of pharmaceutical-grade cannabis in chronic pain patients with fibromyalgia

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