Zerbini 2005.
| Methods | RCT, double‐blind, double‐dummy, 'flare design' | |
| Participants | 446 participants, 320 women, 126 men; mean age (SD) 51.9 (13.8) Inclusion: age 19 to 85 years, with chronic low back pain, regular users of analgesic medication, pain without radiation to an extremity and without neurological signs or pain with radiation to an extremity, but not below the knee and without neurological signs, after 1 week washout period LBP intensity ≤ 80 mm on 100 mm VAS scale |
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| Interventions | NSAID (i) etoricoxib 60 mg/day, 4 weeks (N = 224) NSAID (ii) diclofenac 150 mg/day, 4 weeks (N = 222) |
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| Outcomes | Mean difference (95% CI) pain intensity scale (100 mm VAS) at 4 weeks: (i, N = 222 versus ii, N = 218) 2.51 (−1.50 to 6.51) Mean difference (95% CI) RDQ (0 to 24) over 4 weeks: (i versus ii) −0.23 (−1.14 to 0.67) Adverse events: (i) 79 participants (15 withdrew); (ii) 87 participants (12 withdrew) |
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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 | Not mentioned |
| Blinding (performance bias and detection bias): All outcomes ‐ Patients All outcomes | Low risk | Double dummy |
| Blinding (performance bias and detection bias): All outcomes ‐ Care providers All outcomes | Low risk | Care providers blinded |
| Blinding (performance bias and detection bias): All outcomes ‐ Outcome assessors All outcomes | Low risk | Outcome assessors blinded |
| Incomplete outcome data (attrition bias): All outcomes ‐ Drop‐outs All outcomes | Low risk | 9% and 11% drop out in both groups |
| Incomplete outcome data (attrition bias): All outcomes ‐ ITT analysis All outcomes | High risk | Per protocol analysis |
| Selective reporting (reporting bias) | Unclear risk | No study protocol |
| Similarity of baseline characteristics | Low risk | Similar baseline characteristics |
| Co‐interventions avoided or similar | Low risk | Paracetamol as rescue therapy |
| Compliance acceptable | Low risk | More than 95% compliance in both study groups |
| Timing outcome assessments similar | Low risk | Timing similar |
Abbreviations: ESR: erythorcyte sedimentation rate, LBP: low back pain, NSAID: non‐steroidal anti‐inflammatory drug, RCT: randomized controlled trial, RDQ: Roland Morris Disability Questionnaire, SD: standard deviation, VAS: visual analogue scale.