Jochimsen 1978.
Study characteristics | ||
Methods |
Purpose of the study: to assess the analgesic activity of a synthetic THC analogue at 2–4 mg Study setting: 1 university hospital in USA Study period: not reported Study design: double‐blind, randomised, placebo‐controlled, cross‐over design Study duration: 1 day each. Regular medication was stopped 4 hours before the intake of the medication |
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Participants |
Type of cancer: no details reported Inclusion criteria: pain related to malignancies and history of frequent analgesic use, though 1 had received large doses of narcotics Exclusion criteria: conditions interfering with drug metabolism, severe organic disease other than cancer, pregnancy or major psychiatric disorders Synthetic THC analogue: 35 participants; 17% men; aged 38–77 years; race: not reported; type of cancer pain: not reported; pain medication: not reported; previous cannabis use: not reported |
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Interventions |
Synthetic nitrogen‐containing benzopyran derivative (modification of delta‐I‐trans‐THC): 2 mg and 4 mg single, fixed dosage PO Codeine: 60 mg and 120 mg single, fixed dosage PO Placebo: PO Rescue medication: none Allowed cotherapies: no details reported |
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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%: not reported; imputation method not applicable because baseline pain scores not reported. Number of participants with moderate pain relief reported Pain relief ≥ 50%: reported Mean pain intensity: hourly ratings of the severity of pain (0, absent; 1, mild; 2, moderate; 3, severe) were used to determine hourly pain reduction scores 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: at hourly intervals, the participant completed an 11‐item subjective effects questionnaire, designed to quantify certain psychic manifestations of the test preparations. Data provided not suited for analysis. Psychiatric disorders adverse effects: at hourly intervals, the participant completed an 11‐item subjective effects questionnaire, designed to quantify certain psychic manifestations of the test preparations. Data provided not suited for analysis. Any serious adverse event: not assessed |
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Notes |
Funding: grant RR‐59 from the General Clinical Research Canters Program Division of Research Resources, National Institutes of Health and Abbott Laboratories. Conflicts of interest: not declared |
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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 | Low risk | Quote: "Identical appearing capsules." |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details reported. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Responder analysis. |
Selective reporting (reporting bias) | Unclear risk | No prepublished study protocol available. |
Selection bias | Low risk | Identical baseline parameters of the study groups due to cross‐over design. |