An enriched-enrolment,randomized withdrawal,flexible-dose,double-blind,placebo-controlled,parallel assignment efficacy study of nabilone as adjuvant in the treatment of diabetic peripheral neuropathic pain |
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Authors: | Cory Toth Shefina MawaniShauna Brady Cynthia ChanCaiXia Liu Essie MehinaAlexandra Garven Jennifer BestardLawrence Korngut |
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Affiliation: | The Department of Clinical Neurosciences, the Hotchkiss Brain Institute, and the University of Calgary, Calgary, Alberta, Canada |
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Abstract: | Cannabinoids are emerging as potential options for neuropathic pain treatment. This study evaluated an oral cannabinoid, nabilone, in the treatment of refractory human diabetic peripheral neuropathic pain (DPN). We performed a single-center, randomized, double-blind, placebo-controlled, flexible-dose study with an enriched enrolment randomized withdrawal design. DPN subjects with a pain score ?4 (0-10 scale) continued regular pain medications and were administered single-blinded adjuvant nabilone for 4 weeks. Subjects achieving ?30% pain relief (26/37) were then randomized and treated with either flexible-dose nabilone 1-4 mg/day (n = 13) or placebo (n = 13) in a further 5-week double-blind treatment period, with 30% (11/37) of subjects deemed run-in-phase nabilone nonresponders. For nabilone run-in-phase responders, there was an improvement in the change in mean end-point neuropathic pain vs placebo (mean treatment reduction of 1.27; 95% confidence interval 2.29-0.25, P = 0.02), with an average nabilone dose at end point of 2.9 ± 1.1 mg/day, and improvements from baseline for the anxiety subscale of the Hospital Anxiety and Depression Scale, the Medical Outcomes Study sleep scale problems index, and the European Quality of Life-5-Domains index score (each P < 0.05). Nabilone run-in-phase responders reported greater global end-point improvement with nabilone than with placebo (100% vs 31%; P < 0.05). Medication-related confusion led to discontinuation in 2/37 subjects during single-blind nabilone treatment. Potential unmasking occurred in 62% of both groups. Flexible-dose nabilone 1-4 mg/day was effective in relieving DPN symptoms, improving disturbed sleep, quality of life, and overall patient status. Nabilone was well tolerated and successful as adjuvant in patients with DPN. |
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Keywords: | Diabetic peripheral neuropathy Neuropathic pain Pharmacotherapy Nabilone |
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