Weber 1980.
Methods | RCT; double blind | |
Participants | 59 inpatients (32 male, 27 female), aged 16 to 69 years Inclusion criteria: acute and subacute sciatica, admitted consecutively to a hospital. Clinical symptoms and signs due to fifth lumbar and/or first sacral root lesion. Exclusion: Patients with indication for immediate surgical intervention; contraindication to NSAIDs, previous history of dyspepsia or tuberculosis |
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Interventions | Treatment started on day 2 of admission. Treatment duration 5 days. Follow‐up duration 5 days (?) (i) NSAID group: Butazolidin Alka 200 mg TID for 3 days, 100 mg TID for 2 days (ii) Placebo group: administered as in group (i) |
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Outcomes | Pain: Not reported. Disability: Not reported. Global improvement: Global effect as definite positive effect or indefinite at day 5; immediate result showed a trend in pain relief in favour of the NSAID group, but not significantly: 14/27 and 8/30 scored a definite positive effect. No difference in straight leg raise test following treatment. Additional drug use: Additional drugs were given on request: paracetamol, codeine, and promethazine. The use of additional drugs was not recorded. Other outcomes: None. Adverse effects: No side effects reported. |
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Notes | Withdrawal: 2 participants were excluded from the trial (1 male, 1 female) because they withheld information on contraindications | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | High risk | Outcome not reported for all participants (reported for 30 and 27 out of 59 included participants) |
Selective reporting (reporting bias) | Low risk | All outcomes defined in the methods section were reported |
Group similarity at baseline | Unclear risk | Limited information on baseline characteristics presented |
Influence of co‐interventions | Low risk | Use of additional analgesics reported |
Compliance with interventions | Unclear risk | Not addressed |
Funding | Unclear risk | Not reported |
Other bias | Unclear risk | Small trial, numbers without standard deviation or confidence intervals reported |