Study register · detail
No benefit demonstrated
GRADE
Moderate
203 citations
Samplen = 96 Pat.
Duration14 weeks
ControlDihydrocodeine, max. 240 mg/day, 6 weeks…
EndpointVAS
Blindingdoppelblind
DesignRandomized Controlled Trial (double-blind, crossover, multicenter)
Cannabinoidthc
Max. dose2.0 mg
Routeoral
Key finding
Nabilone was inferior to dihydrocodeine: the pain score was 6,0 mm higher under nabilone (worse pain relief), and nabilone caused more side effects.
Summary
n=96, double-blind crossover RCT (14 weeks, 3 UK centres); nabilone (max. 2 mg/d) vs. dihydrocodeine (max. 240 mg/d) in chronic neuropathic pain; mean VAS score 6,0 mm higher under nabilone (95% CI 1,4–10,5 mm; n=73 available-case); per-protocol analysis (n=64): 5,6 mm (95% CI 0,8–10,3 mm) — dihydrocodeine superior; side effects more frequent under nabilone.
P
PopulationAdults with chronic neuropathic pain, n=96, age 23–84 years
I
InterventionNabilone (synthetic cannabinoid), max. 2 mg/day, 6 weeks escalating dosage
C
ControlDihydrocodeine (weak opioid), max. 240 mg/day, 6 weeks escalating dosage
O
OutcomeMean VAS score 6,0 mm worse under nabilone vs. dihydrocodeine (95% CI 1,4–10,5 mm) in the available-case analysis; dihydrocodeine showed better pain relief
Confidence in the evidence
Moderate
The third of four GRADE levels, the effect estimate is probably reliable.
Downgraded for
Imprecision
Quality profile
Sample size
★★★★★
Blinding
Double-blind
Effect size
No benefit
Citations / year
★★★★★
Authors
DOI
10.1136/bmj.39429.619653.80↗
Design: Randomized Controlled Trial (double-blind, crossover, multicenter)
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Abstract
To compare the analgesic efficacy and side effects of the synthetic cannabinoid nabilone with those of the weak opioid dihydrocodeine for chronic neuropathic pain. Randomised, double blind, crossover trial of 14 weeks' duration comparing dihydrocodeine and nabilone. Outpatient units of three hospitals in the United Kingdom. 96 patients with chronic neuropathic pain, aged 23-84 years. 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. 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. 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.
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