Dreiser 2001b.

Methods	RCT; multicentre, double‐blind, double‐dummy, placebo‐controlled trial. No randomisation procedures described
Participants	489 outpatients (male 53%, female 47%); age older than 18 years. Inclusion criteria (the same for the placebo‐controlled and the diclofenac‐controlled trials): common sciatica with at least 5 out of 8 criteria: radiculalgia with LBP; sudden onset during exertion or wrong movement; mechanical pain; absence of progressive aggravation; history of LBP; antalgic spine deviation or stiffness; sciatica pain exacerbated by pressure of segments L4‐5, L5‐S1; sciatica pain exacerbated by coughing/defecation. Other inclusion criteria were: onset of pain within 3 days; pain intensity of > 50 on VAS; positive straight leg raise ≦ 60°, and a requirement of NSAIDs. Exclusion criteria: treatment with any NSAID within 3 days; adverse effects of NSAIDs; hypersensitive to analgesics, antipyretics or NSAIDs; other NSAIDs or analgesic agents; previous or active peptic ulcer; former lumbar surgery or symptomatic sciatica during the previous 6 months; cauda equina syndrome; paralysing sciatica; sciatica requiring surgery; hyperalgic sciatica; bilateral swing sciatica; truncular sciatica; sciatica due to tumour; spondylolisthesis or known lumbar narrowing
Interventions	Diclofenac‐controlled trial, treatment duration and follow‐up 14 days: (i) Meloxicam 7.5 mg once a day (n = 489) (ii) Meloxicam 15 mg once a day (n = 163) (iii) Diclofenac 50 mg 3 times a day (n = 162)
Outcomes	Pain: In all groups significant decrease in pain (VAS, 0 to 100) from baseline to follow‐up (at 3 hours, 6 hours, 7 and 14 days) with no between‐group differences. Disability: Not investigated. No differences in clinical findings between the groups, including Schober's test, fingers‐to‐floor test, straight leg raise test. Global improvement: No significant difference in proportion of participants experiencing pain relief between the groups. Additional drug use: The mean daily paracetamol consumption and number of participants who took paracetamol was comparable between the groups. The mean (SD) daily paracetamol use was 751 (890) mg, 748 (869) mg, and 727 (871) mg for participants on meloxicam 7.5 mg, meloxicam 15 mg, and diclofenac 150 mg, respectively. Other outcomes: Daily standardised bed rest hours (SD were similar in each group, 2.6 (2.5) for meloxicam 7.5 mg, 2.8 (2.8) for meloxicam 15 mg, and 2.7 (2.8) for diclofenac 150 mg. Adverse effects: No significant difference between groups ((i) 13%; (ii) 17%; (iii) 17%) for the overall or treatment‐related side effects (nausea, dyspepsia, and abdominal pain most common side effects)
Notes	Withdrawal 12%, no significant difference between groups. Unclear whether the trial was funded
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not addressed
Allocation concealment (selection bias)	Low risk	Double‐blind, double‐dummy trial
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not reported
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	Drop‐out rate similar across groups (12%), reasons given
Selective reporting (reporting bias)	Low risk	No previous protocol, but reported all prespecified outcomes
Group similarity at baseline	Low risk	Comparable groups at baseline
Influence of co‐interventions	High risk	Not reported
Compliance with interventions	Unclear risk	Not addressed
Funding	Unclear risk	Unclear whether the trial was funded
Other bias	Unclear risk	2 studies within 1 publication. Additional interventions not reported