Herrmann 2009.
Methods | Prospective, double‐blind, randomised, multicentre, placebo‐ and active‐controlled, parallel‐group trial | |
Participants | 171 outpatients (men 44%, women 56%), aged 18 to 70 years. Inclusion criteria: acute sciatica/lumbago‐sciatica with onset < 72 hrs; pain < 70 (VAS); previous episode > 3 months; pain radiating along the sciatic nerve (include below the knee); worsening with straight leg raise test (< 60 degrees). Lumbo‐sciatica defined as sciatica associated with paravertebral pain (superior spina iliaca and gluteal fold). Exclusion criteria: neurological symptoms of herniated disc (paraesthesia; muscular weakness; paralysis); cauda equina syndrome; ankylosing spondylitis; rheumatoid arthritis; significant disease, alcohol abuse; history of hospitalisation or bed rest; physiotherapy; hypersensitive of NSAIDs; use of other NSAIDs during last week; use of corticosteroids within 4 weeks; no narcotic analgesics within 12 hrs; anxiolytics, antidepressants and/or muscle relaxants, topical treatment with NSAIDs, anticoagulants, immunosuppressants; known adverse drug reaction to oxicam |
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Interventions | Treatment duration: 5 days, follow‐up duration/time of measurement: 3 and 8 hours, 2 and 3 days. (i) NSAID group 1: lornoxicam (LNX) day 1, 8 mg TID; day 2 to 4, 8 mg BID; day 5, 8 mg OD (ii) NSAID group 2: diclofenac day 1 and 5, 50 mg BID; day 2 to 4, 50 mg TID (iii) Placebo administrated as LNX |
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Outcomes | Pain: Pain reduction (VAS 0 to 100) significantly higher for LNX vs placebo from 3 to 8 hrs. No significant differences were seen for days 2 and 3 between the groups, no values for pain reduction reported. Disability: Not assessed. Global improvement: Overall efficacy rated as very good or good by the participants at day 2 to 4: 65% in the lornoxicam group, 72% in the diclofenac group, 56% in the placebo group. Additional drug use: Addditional analgesics were not permitted during study. Other outcomes: Not assessed Adverse effects: Mild to moderate adverse symptoms were reported by (i) n = 6; (ii) n = 7; (iii) n = 4. 2 participants reported severe nausea, abdominal pain, and dyspepsia |
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Notes | Withdrawal: 7 participants (4%) withdrew: due to early success (n = 1); due to insufficient efficacy (n = 3); result of adverse events (n = 3). Adherence: On day 5 47% of participants took capsules: (i) n = 20; (ii) n = 27; (iii) n = 33. Funding was reported. Nycomed Pharma Austria supplied the medication, and at least 1 author was employed at Nycomed Pharma |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomly assigned to treatment groups in blocks |
Allocation concealment (selection bias) | Low risk | Randomisation performed centrally |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo capsules were added to the LNX and diclofenac blister packs provided by the investigator to ensure blinding and correct dosage |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Randomisation was concealed until trial was completed |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention to treat (LOCF) |
Selective reporting (reporting bias) | Unclear risk | Reported all prespecified outcomes; no protocol |
Group similarity at baseline | Low risk | Similar baseline characteristics |
Influence of co‐interventions | Low risk | No rescue medication allowed, short follow‐up duration (5 days) |
Compliance with interventions | Unclear risk | Yes, 6 participants discontinued treatment in the placebo group due to insufficient efficacy, and 1 discontinued treatment in the diclofenac group due to side effects |
Funding | High risk | Nycomed Pharma Austria supplied the medication, and at least 1 author was employed at Nycomed Pharma |
Other bias | Low risk | Medium‐size trial. Well presented |