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Preliminary assessment of the efficacy, tolerability and safety of a cannabis-based medicine (Sativex) in the treatment of pain caused by rheumatoid arthritis
Abstract
OBJECTIVES: To assess the efficacy of a cannabis-based medicine (CBM) in the treatment of pain due to rheumatoid arthritis (RA). METHODS: We compared a CBM (Sativex) with placebo in a randomized, double-blind, parallel group study in 58 patients over 5 weeks of treatment. The CBM was administered by oromucosal spray in the evening and assessments were made the following morning. Efficacy outcomes assessed were pain on movement, pain at rest, morning stiffness and sleep quality measured by a numerical rating scale, the Short-Form McGill Pain Questionnaire (SF-MPQ) and the DAS28 measure of disease activity. RESULTS: Seventy-five patients were screened and 58 met the eligibility criteria. Thirty-one were randomized to the CBM and 27 to placebo. Mean (S.D.) daily dose achieved in the final treatment week was 5.4 (0.84) actuations for the CBM and 5.3 (1.18) for placebo. In comparison with placebo, the CBM produced statistically significant improvements in pain on movement, pain at rest, quality of sleep, DAS28 and the SF-MPQ pain at present component. There was no effect on morning stiffness but baseline scores were low. The large majority of adverse effects were mild or moderate, and there were no adverse effect-related withdrawals or serious adverse effects in the active treatment group. CONCLUSIONS: In the first ever controlled trial of a CBM in RA, a significant analgesic effect was observed and disease activity was significantly suppressed following Sativex treatment. Whilst the differences are small and variable across the population, they represent benefits of clinical relevance and show the need for more detailed investigation in this indication.
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“Although these five studies found improvements in nausea with cannabis use, other studies found nausea to be an adverse event associated with cannabis use among some participants.”
From Clinical Practice Guidelines for Cannabis and Cannabinoid-Based Medicines in the Management of Chronic Pain and Co-Occurring Conditions (2024) · cites this paper as [48]
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Metadata
- Authors
- Blake, D. R., Robson, P., Ho, M., Jubb, R. W., & McCabe, C. S.
- Affiliations
- Royal National Hospital for Rheumatic Diseases (GB)
- University of Oxford (GB)
- Northampton General Hospital (GB)
- Selly Oak Hospital (GB)
- Corresponding author
- Blake, D. R.
- ORCID
- McCabe, C. S.
- Venue
- Rheumatology
- Publisher
- Oxford University Press (OUP)
- Published
- 2005-11-09
- Volume
- 45
- Issue
- 1
- Pages
- 50-52
- ISSN
- 1462-0324 (ISSN-L)
- 1462-0332
- OpenAlex
- W2155565260
- Cited by
- 433
- References
- 10
- Citations by year
- 2026: 16 · 2025: 24 · 2024: 25 · 2023: 19 · 2022: 45 · 2021: 34 · 2020: 37 · 2019: 35 · 2018: 31 · 2017: 19 · 2016: 22 · 2015: 14 · 2014: 18 · 2013: 11 · 2012: 16
- FWCI
- 6.37
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Lara D. Veeken (publishedVersion)
- PubMed (publishedVersion)
- Funders
- GW Pharmaceuticals
- Topics
- Health Sciences › Medicine › Pharmacology (medical) › Cannabis and Cannabinoid Research
- Health Sciences › Medicine › Rheumatology › Rheumatoid Arthritis Research and Therapies
- Health Sciences › Medicine › Complementary and alternative medicine › Natural Compounds in Disease Treatment
- Keywords
- Sativex, cannabis-based medicines, rheumatoid arthritis, pain, oromucosal spray, analgesia, disease activity, sleep quality, morning stiffness, tolerability, adverse effects
- MeSH terms
- Administration, Oral, Analgesics, Arthritis, Rheumatoid, Cannabidiol, Double-Blind Method, Drug Combinations, Female, Humans, Male, Middle Aged, Pain, Pain Measurement, Plant Extracts, Dronabinol, Treatment Outcome
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