Dreiser 2001a.
| Methods | RCT; multicentre (79 centres), double‐blind, double‐dummy, placebo‐controlled trial. No description of the randomisation procedure | |
| Participants | 532 outpatients (male 44%, female 56%); 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 | Placebo‐controlled trial: treatment duration and follow‐up duration 7 days (i) NSAID group 1: meloxicam 7.5 mg once a day (n = 171) (ii) NSAID group 2: meloxicam 15 mg once a day (n = 181) (iii) Control group: placebo once a day (n = 180) |
|
| Outcomes | Pain: All groups improved significantly in spontaneous pain at 3 hours, 6 hours, 3 days, and 8 days compared to baseline. At day 7 pain decrease in the placebo group was ‐40 (±26.8), in group 1 ‐46 (±26.1), and in group 2 ‐45 (±26.9) on a 100 mm VAS scale. 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: Global efficacy was assessed at the end of treatment (day 7), by participant and investigator, using a 4‐point verbal rating scale (good, satisfactory, not satisfactory, bad), and the number of withdrawals due to lack of efficacy was monitored. The percentage of participants reporting a good or satisfactory response was 78% in group 1 and 76% in group 2. Additional drug use: Paracetamol daily use was lower for meloxicam 15 mg compared with placebo (P = 0.0320; mean (SD) daily use in the meloxicam 7.5 mg group was 939 (974) mg; meloxicam 15 mg group 869 (929) mg; placebo group 1110 (1022) mg). The number of participants who took paracetamol was lower in the meloxicam 15 mg group (105 participants; 58%) compared with the placebo group (128 participants; 71%; P = 0.033). Other outcomes: No difference in the daily standardised bed rest in hours (SD) between the treatment groups: meloxicam 7.5 mg 2.1 (2.1) hours, meloxicam 15 mg 2.2 (2.6) hours, and placebo group 2.5 (2.6) hours. Adverse effects: At least 1 adverse event occurred in 29 participants (17%) in the meloxicam 7.5 mg group , 35 participants (19%) in the meloxicam 15 mg group, and in 24 participants (13%) in the placebo group. The difference in the overall and treatment‐related adverse events was not statistically significant between the 3 treatment groups. Nausea, dyspepsia, and abdominal pain were the most common treatment‐related adverse events |
|
| Notes | Withdrawal 6%, no 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) | Unclear risk | Not addressed |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind, double‐dummy, placebo‐controlled trial |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not addressed, even if the design is double blinded, double dummy |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Drop‐out rate similar across groups (6%), reasons for drop‐out 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 | Low risk | 2 studies within 1 publication. Certain study‐specific information not reported; compliance not reported, additional interventions not reported |