Driessens 1994.
| Methods | RCT, double‐blind, double‐dummy | |
| Participants | 62 participants, 33 women, 29 men; mean age (SD) 52.6 (14.3) Inclusion: hospital outpatients, chronic back pain for at least 4 weeks and required NSAID treatment Exclusion: acute or chronic infections, neoplasm or metastases, other severe intercurrent systemic disease, sciatica, referred pain from other organs or believed to be of psychogenic origin, treatment with local corticosteroid injection within 4 weeks of study commencement, pregnancy, lactation, contraindications for NSAID therapy |
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| Interventions | NSAID (i): ibuprofen sustained‐release 1600 mg, plus placebo, 14 days (N = 30) NSAID (ii): diclofenac sustained‐release 100 mg, plus placebo, 14 days (N = 32) |
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| Outcomes | Mean (SD) overall change in clinical condition compared to baseline on a 9‐point scale: (i) 6.0 (1.4) (ii) 5.3 (1.5) Adverse events: (i) 4 participants, (ii) 16 participants (P = 0.002) |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomization procedure not described |
| Allocation concealment (selection bias) | Unclear risk | Allocation procedure not described |
| 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 | High risk | 25% of the participants in the diclofenac dropped out |
| Incomplete outcome data (attrition bias): All outcomes ‐ ITT analysis All outcomes | High risk | Withdrawn participants were not analysed |
| Selective reporting (reporting bias) | Unclear risk | No study protocol |
| Similarity of baseline characteristics | Low risk | Baseline characteristics similar |
| Co‐interventions avoided or similar | Low risk | Rescue analgesia: 500 mg paracetamol with a maximum dose of 4000 mg/day |
| Compliance acceptable | High risk | 12 participants withdrew during treatment period |
| Timing outcome assessments similar | Low risk | Timing similar |