Hickey 1982.
| Methods | RCT, double‐blind | |
| Participants | 30 participants, 26 women, 4 men Inclusion: incapacity due to low back pain, duration ≥ 6 months, age 21 to 75 years Exclusion: pain from intervertebral disc prolapse, suspected neoplastic disease, neurological disease, pregnancy, peptic ulceration or gastrointestinal haemorrhage, current treatment with systemic corticosteroids or anticoagulants, liver or kidney disease, haemopoietic disorders, history of sensitivity to salicylates or paracetamol, psychiatric problems |
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| Interventions | NSAID (i): Diflunisal 1000 mg/day, 4 weeks (N = 16) Reference treatment (ii): paracetamol 4000 mg/day, 4 weeks (N = 14) |
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| Outcomes | Number of participants with none or mild low back pain after 2 and 4 weeks: (i) 11, 13 (ii) 9, 7. Significantly more participants in (i) (10 out of 16) considered the therapy as good or excellent than in (ii) (4 out of 12). Adverse events: (i) 2 participants (ii) 1 participants |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomization prior to the trial |
| Allocation concealment (selection bias) | Low risk | Code‐labelled drugs, code was not broken |
| Blinding (performance bias and detection bias): All outcomes ‐ Patients All outcomes | Low risk | Patients were blinded |
| Blinding (performance bias and detection bias): All outcomes ‐ Care providers All outcomes | Low risk | Care providers were blinded |
| Blinding (performance bias and detection bias): All outcomes ‐ Outcome assessors All outcomes | Low risk | Outcome assessors were blinded |
| Incomplete outcome data (attrition bias): All outcomes ‐ Drop‐outs All outcomes | Low risk | Sixteen out of 16 participants and 13 out of 14 participants completed the trial |
| Incomplete outcome data (attrition bias): All outcomes ‐ ITT analysis All outcomes | High risk | Two participants in the paracetamol group were not analysed in their allocation group |
| Selective reporting (reporting bias) | Unclear risk | No protocol |
| Similarity of baseline characteristics | Unclear risk | No baseline characteristics were shown |
| Co‐interventions avoided or similar | Low risk | Only anti‐hypertensive drug therapy was allowed, other drugs were forbidden |
| Compliance acceptable | Unclear risk | Compliance was not mentioned |
| Timing outcome assessments similar | Low risk | Timing similar |