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 controlled-trials.com] .
RCT Entities:
OBJECTIVE: To compare the analgesic efficacy and side effects of the synthetic cannabinoidnabilone 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 cannabinoidnabilone and had slightly fewer side effects, although no major adverse events occurred for either drug. TRIAL REGISTRATION: Current Controlled Trials ISRCTN15330757 controlled-trials.com] .
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