Hosie 1993.
| Methods | RCT; multicentre, double‐blind, double‐dummy. Randomisation procedure not described Follow‐up time: 2 weeks |
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| Participants |
Population: 287 participants, 136 women, 151 men. Aged 18 to 63 years Setting: 28 general practices in the UK Inclusion criteria: acute low back injury/LBP, onset less than 1 month ago Exclusion criteria: sciatica, 2 or more episodes of LBP in the previous 6 months, nerve root pressure, previous vertebral fractures, spinal stenosis, spondylolisthesis, marked scoliosis, ankylosing spondylitis, osteoarthritis, Paget's disease, metabolic bone disease, systemic connective tissue disorders, malignancy, infection, referred pain from intra‐abdominal or intra‐pelvic disease, pregnancy, lactation, allergy to NSAIDs, history of bronchial asthma or peptic ulcer, gastrointestinal, renal, hepatic, cardiovascular, metabolic, haematological, or dermatological disease |
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| Interventions | NSAID (i): ibuprofen (capsules, 400 mg) 3 times daily + placebo foam 3 times daily, 14 days (N = 147) NSAID (ii): felbinac (foam, 3%) 3 times daily + placebo capsules 3 times daily, 14 days (N = 140) | |
| Outcomes | Participants (%) reporting none or mild severity after 1 and 2 weeks (i) 84, 92 (ii) 76, 88. No significant differences between the groups Adverse events (EA): No. of side effects (i) 22 AEs reported by 21 participants (8 withdrew), (ii) 26 AEs reported by 22 participants (3 withdrew) |
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| Funding | Not mentioned. However, the address for correspondence is the Medical Department, Lederle Laboratories, and Traxam (felbinac) was a registered trademark of Lederle Laboratories, UK. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomisation procedure not described |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes ‐ participants | Low risk | Blinding was achieved by double‐dummy approach. |
| 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 | Dropout rate 18% (52/287 withdrew) |
| Incomplete outcome data (attrition bias) All outcomes ‐ ITT analysis | High risk | ITT analysis performed, based on available data, but for ITT‐analysis dropout too high (analysis based on 172 participants). |
| Selective reporting (reporting bias) | Unclear risk | No study protocol |
| Similarity at baseline characteristics | Low risk | Baseline characteristics similar |
| Co‐interventions avoided or similar | Low risk | participants were instructed not to use any other oral, injectable, or topical analgesic or antiinflammatory medication, and to continue any ongoing physiotherapy without change. |
| Compliance acceptable | Unclear risk | Not mentioned |
| Timing outcome assessments similar | Low risk | Timing similar |
| Other bias | Low risk | None |