Yakhno 2006.
| Methods | RCT; double‐blind, double‐dummy; multicentre Follow‐up time: 7 days |
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| Participants |
Population: 220 participants, sex not mentioned. Mean age (SD): (i) 39.3 (9.1); (ii) 40.3 (9.7) Setting: 6 centres in Russia Inclusion criteria: age 18 to 55 years, nonspecific acute LBP, duration ≤ 5 days, pain score ≥ 5 on 11‐point NRS, requiring medical treatment Exclusion criteria: pregnant or breastfeeding women; previous episode of LBP within the last 6 months; specific spinal pathology or symptoms related to other pathologies; intake of analgesics ≤ 3 hrs preceding inclusion; intake of antiepileptics, antidepressants, barbiturates, anxiolytics, or muscle relaxants ≤ 24 hrs preceding inclusion; scheduled daily intake of one of the above medications; concomitant treatment with anticoagulants or platelet‐aggregation inhibitors; contraindication or allergy to study drugs; alcohol/drug abuse/dependency; episodes of GI disorders, oedema, dizziness, headache; history of aspirin‐induced asthma |
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| Interventions | NSAIDs (i): lornoxicam on day 1: 16 mg once a day and 8 mg once a day; day 2 to 7: 8 mg b.i.d.; 7 days (N = 110) + matching (diclofenac‐like) placebo NSAIDs (ii): diclofenac‐k on day 1: 100 mg once a day and 50 mg once a day; day 2 to 7: 50 mg b.i.d.; 7 days (N = 110) + matching (lornoxicam‐like) placebo | |
| Outcomes | Sum of pain intensity differences from baseline on day 1 to 6 (SE); (i, N = 109) 4.2 (0.17); (ii, N = 110) 3.8 (0.17); (i) significantly lower than (ii) P < 0.05 Adverse events (no of participants, %): (i) 27 participants (24.5%), 1 withdrew; (ii) 28 participants (25.5%), 1 withdrew |
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| Funding | Study was supported by an unrestricted grant from Nycomed, manufacturer of lornoxicam. | |
| Notes | Inadequate dosage of diclofenac‐k (50 mg b.i.d. instead of t.i.d.) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation schedule |
| Allocation concealment (selection bias) | Low risk | A computer‐generated randomisation schedule assigned treatments in equal ratio to sequential participants. Participants were assigned to the next consecutive participant number in a sequential ascending order. |
| 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: 1.4% (3/220) |
| Incomplete outcome data (attrition bias) All outcomes ‐ ITT analysis | Low risk | ITT analysis performed |
| Selective reporting (reporting bias) | Unclear risk | Study protocol registration not mentioned |
| Similarity at baseline characteristics | Low risk | Baseline characteristics similar |
| Co‐interventions avoided or similar | Unclear risk | Paracetamol (acetaminophen) was allowed as rescue medication. |
| Compliance acceptable | Unclear risk | Not mentioned |
| Timing outcome assessments similar | Low risk | Timing similar |
| Other bias | Low risk | None |