Lynch 2014.
Study characteristics | ||
Methods |
Purpose of the study: reducing chemotherapy‐induced neuropathic pain Study setting: participants were recruited through advertisements in the local paper and posters in oncology clinics at the university teaching hospital (Capital District Health Authority, Halifax, Nova Scotia, Canada) Study period: not reported Study design: double‐blind, randomised, placebo‐controlled, cross‐over design Study duration: no information on baseline period reported, 4 weeks each study period separated by a 2‐week wash‐out period |
|
Participants |
Type of cancer: ovary cancer (27.8%), uterus cancer (16.7%), lung cancer (16.7%), cervix cancer (11.1%), breast cancer (11.1%), blood/lymphoma (5.6%), lung cancer (5.6%), testicle cancer (5.6%) Inclusion criteria: neuropathic pain based on history and general physical examination along with specific quantitative sensory testing of the painful area; neuropathic pain persisting for 3 months after completing chemotherapy with paclitaxel, vincristine or cisplatin; mean 7‐day intensity of pain had to be ≥ 4 on an 11‐point NRS; concurrent analgesics had to be stable for 14 days before entry into the trial. Exclusion criteria: ischaemic heart disease, ongoing epilepsy, a personal or family history of schizophrenia, or psychotic disorder or substance abuse or dependency within the previous 2 years, pregnancy or other medical condition that might compromise safety in the trial. Nabiximols and placebo: 18 participants; 17% men; mean age 55 years; race not reported; type of cancer pain: neuropathic pain induced by chemotherapy; co‐medication: antidepressants (5.6%), NSAIDs (11.1%), opioids (11.1%); previous cannabis use: 27.8% |
|
Interventions |
Oromucosal spray THC/CBD extract, flexible dosage: THC 2.7 mg and CBD 2.5 mg, both per 100 µL (which equalled 1 pump action). Individually titration, maximum 12 pumps/day; mean 8 sprays/day (range 8–12) Oromucosal placebo spray, flexible dosage: individual titration, maximum 12 pumps/ day; mean 11 sprays/day Rescue medication: no details reported |
|
Outcomes |
Proportion of participants reporting no worse than mild pain on treatment at 14 days after start of treatment (typically < 30/100 mm on a 100‐mm VAS or < 3 on an 11‐point NRS): not assessed Patient impression to be much or very much improved: not assessed Withdrawal due to adverse events: no details of assessment reported Combined responder: not assessed Pain relief ≥ 30%: neuropathic pain score 7‐day mean; calculated by imputation method Pain relief ≥ 50%: neuropathic pain score 7‐day mean; calculated by imputation method Mean pain intensity: neuropathic pain score 7‐day mean Sleep problems: not assessed Depression: not assessed Anxiety: not assessed Daily maintenance opioid therapy dose: not assessed Daily breakthrough opioid therapy dose: not assessed Withdrawals due to lack of efficacy: not reported Nervous system disorders adverse effects: no details of assessment reported Psychiatric disorders adverse effects: no details of assessment reported Any serious adverse event: no details of assessment reported |
|
Notes |
Funding: none Conflicts of interest: authors declared no conflicts of interest. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No details reported. |
Allocation concealment (selection bias) | Unclear risk | No details reported. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No details reported. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details reported. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Last observation carried forward analysis. |
Selective reporting (reporting bias) | Unclear risk | No study protocol reported. |
Selection bias | Low risk | Identical baseline data of the study groups due to cross‐over design. |