Weber 1993.
| Methods | RCT; double‐blinded | |
| Participants | 214 outpatients, mean age 48 years (range 18 to 75 years) Inclusion criteria: radiating pain corresponding to L5/S1 root syndrome with/without sensory and/or motor deficits; positive straight leg raise test; radiating pain provoked by finger pressure; free from sciatica the previous 6 months. Exclusion criteria: cauda equina syndrome; "acute back"; progressive paresis; suspected tumour or local inflammation; ankylosing spondylitis; rheumatoid arthritis; history of peptic ulcer or severe dyspepsia; hypersensitivity to aspirin or other NSAIDs; any other known hematologic, hepatic, renal, pulmonary, cardiac, or systemic disease. Patients with severe psychiatric disease, drug addiction, or alcoholism were excluded |
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| Interventions | Treatment duration 14 days. Follow‐up duration 2 and 4 weeks, 12 months. No results reported for the respective treatment groups at 12 months. (i) NSAID group: piroxicam 20 mg day 1 to 2, 2 tablets OD; day 3 to 14, 1 tablet OD (ii) Placebo group: administered as in group (i) |
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| Outcomes | Pain: Marked reduction in pain (VAS 0 to 100) at 14 days and 4 weeks compared to baseline in both groups, but no significant difference between groups. Disability: Marked improved function (modified Roland Morris Disability Questionnaire 0 to 17) at 14 days and 4 weeks compared to baseline in both groups, but no significant difference between groups. Global improvement: No. Additional drug use: Additional analgesics as needed included paracetamol with or without codeine and/or levomepromazine. No other opioids were allowed. Other outcomes: At 4 weeks return to work 60%, at 12 months 92.5%. The mean duration of sick leave was 27.9 days. 62 participants were not sick‐listed at all. Adverse effects: 35 participants reported mainly mild to moderate side effects (22 in the piroxicam group, 13 in the placebo group) |
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| Notes | Withdrawal: 6 participants were dropped out at 4 weeks Funding: Pfizer A/S Norway provided piroxicam and placebo |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not reported, design was double blind |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo capsules of identical appearance were administered in the same manner as the active substance |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported how blinding was maintained throughout the trial |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No reporting on drop‐out or ITT analysis |
| Selective reporting (reporting bias) | Low risk | All outcomes defined in the methods section were reported |
| Group similarity at baseline | Unclear risk | Limited information on baseline characteristics reported |
| Influence of co‐interventions | Low risk | Additional analgesic use did not differ between the groups |
| Compliance with interventions | Low risk | Compliance 95% (piroxicam) and 98% (placebo) up until week 2 |
| Funding | Unclear risk | Pfizer A/S Norway provided piroxicam and placebo |
| Other bias | Unclear risk | Good sample size, did not report standard deviation and confidence interval |
BID: 2 times a day ITT: intention to treat LBP: low back pain LOCF: last observation carried forward NSAID: non‐steroidal anti‐inflammatory drug OD: once a day RCT: randomised controlled trial SD: standard deviation TID: 3 times a day VAS: visual analogue scale