Title: Nabilone for Chronic Pain: Clinical Effectiveness ...

Title: Nabilone for Chronic Pain: Clinical Effectiveness

Date: 21 December 2007

Context and policy issues:

Cannabis has been used medicinally for hundreds of years in countries such as China and India.1 In recent years, the pharmacology of cannabinoids has been investigated and synthetic cannabinoids developed. Anecdotal evidence has shown benefits with cannabis in chronic pain. In a survey of chronic pain clinic patients, 35% reported using marijuana with nearly one half of these patients citing pain relief as the reason.1

There is wide variation in the prevalence of chronic pain, ranging from 10% to 55%.2 In 2003, the Canadian Community Health Survey reported that 10.5% of the population had pain or discomfort that prevented them from doing few to most activities.3 In many cases chronic can be difficult to control, requiring multiple treatments and frequent visits to health care providers.1

Nabilone (Cesamet?) is an oral synthetic cannabinoid, approved for use in Canada for the management of severe nausea and vomiting associated with cancer chemotherapy.4

Research questions:

What is the evidence for the clinical effectiveness of nabilone in adults for chronic pain management?

Methods:

A limited literature search was conducted on key health technology assessment resources, including OVID MEDLINE, OVID EMBASE, The Cochrane Library (Issue 4, 2007), University of York Centre for Reviews and Dissemination (CRD) databases, ECRI, EuroScan, international HTA agencies, and a focused Internet search. Results include articles published between 2003 and the present, and are limited to English language publications only. No filters were applied to limit the retrieval by study type.

Disclaimer: The Health Technology Inquiry Service (HTIS) is an information service for those involved in planning and providing health care in Canada. HTIS responses are based on a limited literature search and are not comprehensive, systematic reviews. The intent is to provide a list of sources and a summary of the best evidence on the topic that CADTH could identify using all reasonable efforts within the time allowed. HTIS responses should be considered along with other types of information and health care considerations. The information included in this response is not intended to replace professional medical advice, nor should it be construed as a recommendation for or against the use of a particular health technology. Readers are also cautioned that a lack of good quality evidence does not necessarily mean a lack of effectiveness particularly in the case of new and emerging health technologies, for which little information can be found, but which may in future prove to be effective. While CADTH has taken care in the preparation of the report to ensure that its contents are accurate, complete and up to date, CADTH does not make any guarantee to that effect. CADTH is not liable for any loss or damages resulting from use of the information in the report.

Copyright: This report contains CADTH copyright material. It may be copied and used for non-commercial purposes, provided that attribution is given to CADTH.

Links: This report may contain links to other information on available on the websites of third parties on the Internet. CADTH does not have control over the content of such sites. Use of third party sites is governed by the owners' own terms and conditions.

Summary of findings:

Clinical studies assessing the efficacy of nabilone in patients with chronic pain were limited to two randomized controlled trials (RCTs) and one case series.

In the trial by Skrabek et al.5 40 patients with fibromyalgia and ongoing pain despite treatment were randomized to nabilone or placebo. Patients were treated for 4 weeks with an escalating dose of nabilone or placebo, and assessed at 2 weeks, 4 weeks and again 4 weeks after treatment was stopped. Patients and physicians were blinded to treatment allocation however some degree of un-blinding may have occurred due to the high incidence of adverse effects in the nabilone group. Twenty five percent of patients in the nabilone group (5/20) and 15% in the control group (3/20) stopped therapy by the first 2 weeks follow-up visit. Data from the remaining 33 patients were analyzed. At 4 weeks, the nabilone group showed statistically significant differences in two outcome measures; the change from baseline scores for pain and quality of life were significantly improved compared to placebo. No significant differences were detected at 4 weeks in the other outcomes measured (number of tender points, or the average tender point pain threshold). At the other time points measured, no significant differences were detected. Adverse effects were more common in the nabilone group (p ................
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