Comparison of analgesic effects and patient tolerability of nabilone and dihydrocodeine for chronic neuropathic pain: randomised, crossover, double blind studyBMJ 2008; 336 doi: https://doi.org/10.1136/bmj.39429.619653.80 (Published 24 January 2008) Cite this as: BMJ 2008;336:199
- B Frank, research registrar1,
- M G Serpell, consultant in pain management2,
- J Hughes, consultant in pain management3,
- J N S Matthews, professor of medical statistics4,
- D Kapur, consultant in pain management5
- 1Pain Management Unit, Royal Victoria Infirmary, Newcastle upon Tyne NE1 4LP
- 2University Department of Anaesthesia and Pain Management, Gartnavel General Hospital, Glasgow G12 0YN
- 3Department of Anaesthesia, James Cook University Hospital, Middlesbrough TS4 3BW
- 4School of Mathematics and Statistics, University of Newcastle, Newcastle upon Tyne NE1 7RU
- 5Pain Management Unit, Flinders Medical Centre, Bedford Park, SA 5155, Australia
- Correspondence to: B Frank
- Accepted 7 November 2007
Objective To compare the analgesic efficacy and side effects of the synthetic cannabinoid nabilone with those of the weak opioid dihydrocodeine for chronic neuropathic pain.
Design Randomised, double blind, crossover trial of 14 weeks’ duration comparing dihydrocodeine and nabilone.
Setting Outpatient units of three hospitals in the United Kingdom.
Participants 96 patients with chronic neuropathic pain, aged 23-84 years.
Main outcome measures The primary outcome was difference between nabilone and dihydrocodeine in pain, as measured by the mean visual analogue score computed over the last 2 weeks of each treatment period. Secondary outcomes were changes in mood, quality of life, sleep, and psychometric function. Side effects were measured by a questionnaire.
Intervention Patients received a maximum daily dose of 240 mg dihydrocodeine or 2 mg nabilone at the end of each escalating treatment period of 6 weeks. Treatment periods were separated by a 2 week washout period.
Results Mean baseline visual analogue score was 69.6 mm (range 29.4-95.2) on a 0-100 mm scale. 73 patients were included in the available case analysis and 64 patients in the per protocol analysis. The mean score was 6.0 mm longer for nabilone than for dihydrocodeine (95% confidence interval 1.4 to 10.5) in the available case analysis and 5.6 mm (10.3 to 0.8) in the per protocol analysis. Side effects were more frequent with nabilone.
Conclusion Dihydrocodeine provided better pain relief than the synthetic cannabinoid nabilone and had slightly fewer side effects, although no major adverse events occurred for either drug.
Trial registration Current Controlled Trials ISRCTN15330757.
Contributors: BF helped design the trial, analyse the data, write the initial draft of the article, and conduct the trial. MGS referred the Glasgow patients and helped design the trial and write the article. JH referred the Middlesbrough patients and helped design the trial and write the article. JNSM wrote the statistical part of the article and helped design the trial and analyse the data. DK designed the trial, was the principal investigator, and referred the Newcastle patients. BF is guarantor.
Funding: This trial was supported by a grant from Cambridge Laboratories. The sponsors had no role in study design, data collection, data analysis, data interpretation, or writing of the report.
Competing interests: BF’s salary was provided as part of the above research grant although he was employed by the Newcastle upon Tyne University Hospitals Trust. None of the other authors have any competing interests.
Ethical approval: The joint ethics committee for the Newcastle and North Tyneside Health Authority, the west ethics committee for the Northern Glasgow University Hospitals NHS Trust, and the South Tees local research committee in Middlesbrough.
Provenance and peer review: Not commissioned; externally peer reviewed.
- Accepted 7 November 2007