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. 2023 Jun 5;2023(6):CD014915. doi: 10.1002/14651858.CD014915.pub2

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.