Primary studies included in this broad synthesis

loading
7 articles (7 References) loading Revert Studify

Primary study

Unclassified

Nabiximols for opioid-treated cancer patients with poorly-controlled chronic pain: a randomized, placebo-controlled, graded-dose trial.

Journal The journal of pain : official journal of the American Pain Society
Year 2012
Links Pubmed DOI

This article is included in 30 Systematic reviews Systematic reviews (30 references) 3 Broad syntheses Broad syntheses (3 references)

Loading references information
UNLABELLED: Patients with advanced cancer who have pain that responds poorly to opioid therapy pose a clinical challenge. Nabiximols (Nabiximols is the U.S. Adopted Name [USAN] for Sativex [GW Pharma Ltd, Wiltshire, U.K.], which does not yet have an INN), a novel cannabinoid formulation, is undergoing investigation as add-on therapy for this population. In a randomized, double-blind, placebo-controlled, graded-dose study, patients with advanced cancer and opioid-refractory pain received placebo or nabiximols at a low dose (1-4 sprays/day), medium dose (6-10 sprays/day), or high dose (11-16 sprays/day). Average pain, worst pain and sleep disruption were measured daily during 5 weeks of treatment; other questionnaires measured quality of life and mood. A total of 360 patients were randomized; 263 completed. There were no baseline differences across groups. The 30% responder rate primary analysis was not significant for nabiximols versus placebo (overall P = .59). A secondary continuous responder analysis of average daily pain from baseline to end of study demonstrated that the proportion of patients reporting analgesia was greater for nabiximols than placebo overall (P = .035), and specifically in the low-dose (P = .008) and medium-dose (P = .039) groups. In the low-dose group, results were similar for mean average pain (P = .006), mean worst pain (P = .011), and mean sleep disruption (P = .003). Other questionnaires showed no significant group differences. Adverse events were dose-related and only the high-dose group compared unfavorably with placebo. This study supports the efficacy and safety of nabiximols at the 2 lower-dose levels and provides important dose information for future trials. PERSPECTIVE: Nabiximols, a novel cannabinoid formulation, may be a useful add-on analgesic for patients with opioid-refractory cancer pain. A randomized, double-blind, placebo-controlled, graded-dose study demonstrated efficacy and safety at low and medium doses.

Primary study

Unclassified

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.

blocked
Journal Journal of pain and symptom management
Year 2010
Links Pubmed DOI

This article is included in 30 Systematic reviews Systematic reviews (30 references) 3 Broad syntheses Broad syntheses (3 references)

Loading references information
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 NRS 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.Copyright © 2010 by Elsevier Inc.

Primary study

Unclassified

Adjunctive nabilone in cancer pain and symptom management: a prospective observational study using propensity scoring.

Journal The journal of supportive oncology
Year 2008
Links Pubmed

This article is included in 2 Systematic reviews Systematic reviews (2 references) 3 Broad syntheses Broad syntheses (3 references)

Loading references information
A prospective observational study assessed the effectiveness of adjuvant nabilone (Cesamet) therapy in managing pain and symptoms experienced by advanced cancer patients. The primary outcomes were the differences between treated and untreated patients at 30 days' follow-up, in Edmonton Symptom Assessment System (ESAS) pain scores, and in total morphine-sulfate-equivalent (MSE) use after adjusting for baseline discrepancies using the propensity-score method. Secondary outcomes included other ESAS parameters and frequency of other drug use. Data from 112 patients (47 treated, 65 untreated) met criteria for analyses.The propensity-adjusted pain scores and total MSE use in nabilone-treated patients were significantly lower than were those found in untreated patients (both P < 0.0001). Other ESAS parameters that improved significantly in patients receiving nabilone were nausea (P < 0.0001), anxiety (P = 0.0284) and overall distress (total ESAS score; P = 0.0208). The nabilone group showed borderline improvement in appetite (P = 0.0516). When compared with those not taking nabilone, patients using this cannabinoid had a lower rate of starting nonsteroidal anti-inflammatory agents, tricyclic antidepressants, gabapentin, dexamethasone, metoclopramide, and ondansetron and a greater tendency to discontinue these drugs.

Primary study

Unclassified

Effect of benzopyranoperidine, a delta-9-THC congener, on pain.

Journal Clinical pharmacology and therapeutics
Year 1978
Links Pubmed DOI

This article is included in 9 Systematic reviews Systematic reviews (9 references) 1 Broad synthesis Broad syntheses (1 reference)

Loading references information
In a double-blind, 5-way crossover designed study, single doses of placebo, 2 doses of codeine sulfate (60 and 120 mg), and 2 doses of benzopyranoperidine (2 and 4 mg) were administered orally to 35 patients who required analgesics for chronic pain due to malignancies. Benzopyranopyridine is an analogue of delta-9-tetrahydrocannabinol and was chosen on the basis of its sedative, hypnotic, and analgesic properties in animals. Pain relief scores indicated a degree of relief of clinical significance with 120 mg of codeine but no consistent difference between placebo and any other active agent. On the basis of the data, bezopyranoperidine (2 or 4 mg) is not as effective as codeine (120 mg or 60 mg) and not more effective than placebo in relieving pain due to cancer; indeed, pain perception appeared to be augmented by both doses.

Primary study

Unclassified

Effect of a nitrogen analog of tetrahydrocannabinol on cancer pain.

Authors Staquet M , Gantt C , Machin D
Journal Clinical pharmacology and therapeutics
Year 1978
Links Pubmed DOI

This article is included in 9 Systematic reviews Systematic reviews (9 references) 2 Broad syntheses Broad syntheses (2 references)

Loading references information
Two consecutive, randomized, double-blind trials were performed to test the analgesic properties of a synthetic nitrogen analog of tetrahydrocannabinol (NIB). In the first trial, the test preparation was superior to placebo and approximately equivalent to 50 mg of codeine phosphate. In the second study, the tetrahydrocannabinol analog was superior to placebo and to 50 mg secobarbital. NIB is not useful clinically because of the frequency of side effects.

Primary study

Unclassified

Analgesic effect of delta-9-tetrahydrocannabinol.

Authors Noyes R , Brunk SF , Baram DA , Canter A
Journal Journal of clinical pharmacology
Year 1975
Links Pubmed DOI

This article is included in 16 Systematic reviews Systematic reviews (16 references) 2 Broad syntheses Broad syntheses (2 references)

Loading references information
A preliminary trial of oral delta-9-tetrahydrocannabinol (THC) demonstrated an analgesic effect of the drug in patients experiencing cancer pain. Placebo and 5, 10, 15, and 20 mg THC were administered double blind to ten patients. Pain relief significantly superior to placebo was demonstrated at high dose levels (15 and 20 mg). At these levels, substantial sedation and mental clouding were reported.

Primary study

Unclassified

The analgesic properties of delta-9-tetrahydrocannabinol and codeine.

Authors Noyes R , Brunk SF , Avery DA , Canter AC
Journal Clinical pharmacology and therapeutics
Year 1975
Links Pubmed DOI PubMed Central

This article is included in 18 Systematic reviews Systematic reviews (18 references) 3 Broad syntheses Broad syntheses (3 references)

Loading references information
The administration of single oral doses of delta-9-tetrahydrocannabinol (THC) to patients with cancer pain demonstrated a mild analgesic effect. At a dose of 20 mg, however, THC induced side effects that would prohibit its therapeutic use including somnolence, dizziness, ataxia, and blurred vision. Alarming adverse reactions were also observed at this dose. THC, 10 mg, was well tolerated and, despite its sedative effect, may analgesic potential.