Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Efficacy, Safety, and Tolerability of THC:CBD Extract and THC Extract in Patients with Intractable Cancer-Related Pain

被引:428
作者
Johnson, Jeremy R. [2 ]
Burnell-Nugent, Mary [3 ]
Lossignol, Dominique [4 ]
Ganae-Motan, Elena Doina [5 ]
Potts, Richard [6 ]
Fallon, Marie T. [1 ]
机构
[1] Univ Edinburgh, Edinburgh Canc Res Ctr, St Columbas Hosp Chair Palliat Med, Edinburgh EH4 2XR, Midlothian, Scotland
[2] Severn Hosp, Shrewsbury, Shrops, England
[3] St Lukes Hosp, Plymouth, Devon, England
[4] ULB, Ctr Tumeurs, Assoc Hosp Brussels, Brussels, Belgium
[5] Hosp Sf Ioan Cel Nou, Emergency Dept, Suceava, Romania
[6] GW Pharma Ltd, Ely, Cambs, England
关键词
Cancer; pain; tetrahydrocannabinol; cannabidiol; Sativex (R); CANNABIS-BASED MEDICINE; MULTIPLE-SCLEROSIS; NEUROPATHIC PAIN; CONTROLLED-TRIAL; CLINICAL-TRIALS; RECEPTORS; CB1; DELTA-9-TETRAHYDROCANNABINOL; PHARMACOLOGY; CONSTITUENT;
D O I
10.1016/j.jpainsymman.2009.06.008
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
This study compared the efficacy of a tetrahydrocannabinol:cannabidiol (THC:CBD) extract, a nonopioid analgesic endocannabinoid system modulator, and a THC extract, with placebo, in relieving pain in patients with advanced cancer. In, total, 177 patients with cancer pain, who experienced inadequate analgesia despite chronic opioid dosing, entered a two-week, multicenter, double-blind, randomized, placebo-controlled, parallel-group trial. Patients were randomized to THC:CBD extract (n = 60), THC extract (n = 58), or placebo (n = 59). The primary analysis of change from baseline in mean pain Numerical Rating Scale (NRS) score was statistically significantly in favor of THC:CBD compared with placebo (improvement of -1.37 vs. -0.69), whereas the THC group showed a nonsignificant change (-1.01 vs. -0.69). Twice as many patients taking THC:CBD showed a reduction of more than 30% from baseline pain NRS score when compared with placebo (23 [43 %] vs. 12 [21%]). The associated odds ratio was statistically significant, whereas the number of THC group responders was similar to placebo (12 [23%] vs. 12 [21%]) and did not reach statistical significance. There was no change from baseline in median dose of opioid background medication or mean number of doses of breakthrough medication across treatment groups. No significant group differences were found in the MRS sleep quality or nausea scores or the pain control assessment. However; the results from the European Organisation for Research and Treatment of Cancer Quality of Life Cancer Questionnaire showed a worsening in nausea and vomiting with THC:CBD compared with placebo (P = 0.02), whereas THC had no difference (P = 1.0). Most drug-related adverse events were mild/moderate in severity. This study shows that THC:CBD extract is efficacious for relief of pain in patients with advanced cancer pain not fully relieved by strong opioids. J Pain Symptom Manage 2010;39:167-179. (C) 2010 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.
引用
收藏
页码:167 / 179
页数:13
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