Pohjolainen 2000.
| Methods | RCT; double‐blind, double‐dummy, multicentre. Randomised according to a list in permutation blocks, concealed allocation Follow‐up time: 10 days |
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| Participants |
Population: 104 participants, sex unknown. Mean age 42 years (range 19 to 63) Setting: 1 hospital outpatient clinic and 1 occupational health care centre, both in Helsinki Inclusion criteria: age 18 to 65 years; acute LBP, onset within 30 days Exclusion criteria: chronic LBP for more than 4 weeks; sciatica syndrome (LBP with radiation to an extremity below the knee); secondary cause of LBP; osteoporotic fracture or a history of lumbar spine surgery; pregnancy or lactation; significant systematic disease; history of peptic ulceration; allergy to NSAIDs |
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| Interventions | NSAID (i): nimesulide 100 mg b.i.d. + placebo once a day; 10 days (N = 52) NSAID (ii): ibuprofen 600 mg t.i.d.; 10 days (N = 52) | |
| Outcomes | Oswestry LBP disability questionnaire, pre‐mean (SD), post‐mean day 10 (SD): (i, N = 52) 35.8 (15.0), 10.0 (10.8); (ii, N = 52) 35.1 (19.1), 16.5 (19.0), (i) vs (ii) significantly lower (P < 0.05)
Average pain intensity and relief scores (100‐mm VAS), pre‐mean (SD), post‐mean day 10 (SD): (i, N = 52) 57.9 (20.6), 12.8 (15.4); (ii, N = 52) 55.2 (21.4), 18.5 (19.9). No significant differences Adverse events: (i) 7 participants = 13% (2 withdrew); (ii) 11 participants = 21% (1 withdrew) |
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| Funding | Partially supported by Rhône‐Poulenc, a pharmaceutical company. Drugs supplied by Helsinn Healthcare SA, patent holder of nimesulide. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomised according to a list prepared in permutation blocks, random allocation |
| Allocation concealment (selection bias) | Low risk | Concealed allocation, sealed envelopes |
| Blinding of participants and personnel (performance bias) All outcomes ‐ participants | Low risk | Double‐blind, double‐dummy |
| Blinding of participants and personnel (performance bias) All outcomes ‐ careproviders | Low risk | Double‐blind, double‐dummy |
| Blinding of outcome assessment (detection bias) All outcomes ‐ outcome assessors | Low risk | Double‐blind, double‐dummy |
| Incomplete outcome data (attrition bias) All outcomes ‐ dropouts | Low risk | Low dropout rate: 4.8% (5/104 withdrew) |
| Incomplete outcome data (attrition bias) All outcomes ‐ ITT analysis | Unclear risk | Not mentioned |
| Selective reporting (reporting bias) | Unclear risk | Trial registration not mentioned |
| Similarity at baseline characteristics | Low risk | Baseline characteristics similar |
| Co‐interventions avoided or similar | Low risk | No therapy other than the study medication was permitted during the trial. No analgesics, muscle relaxants, topical preparations, local injections or non‐drug therapies (e.g. physiotherapy, massage, or bedrest) were permitted. |
| Compliance acceptable | Unclear risk | Participants were asked to return any unused medication. The monitor counted the numbers of unused pills and decided whether the participant had been compliant. Compliance criteria were assessed by the following: instances of not appearing for visits, incomplete diaries, or medication not taken according to the protocol. |
| Timing outcome assessments similar | Low risk | Timing similar |
| Other bias | Low risk | None |