Metscher 2001.
| Methods | RCT; double‐blind, randomised, controlled, multicentre. Article in German. Randomisation procedure not described. Follow‐up time: 7 days (outcome measurements at baseline, after 3 and 7 days) |
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| Participants |
Population: 192 participants, 87 women, 105 men. Median age 47 years (range 20 to 70) Setting: 24 centres in Germany, from November 1998 until March 1999 Inclusion criteria: age 18 to 70 years; acute LBP; pain 100‐mm VAS ≥ 50 mm; onset within 48 hours; not indicated for other than analgesic treatment Exclusion criteria: not mentioned |
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| Interventions | NSAID (i): dexketoprofen‐trometamol 25 mg t.i.d.; 7 days (N = 97) Reference treatment (ii): tramadol hydrochloride 50 mg t.i.d.; 7 days (N = 95) | |
| Outcomes | Pain difference, mean changed score, 100‐mm VAS, after 7 days: (i, N = 81) vs (ii, N = 79) ‐6 (4) (P < 0.05) Adverse events: (i) 13 participants; (ii) 22 participants | |
| Funding | Not mentioned | |
| Notes | Unclear presentation of results (data on pain scores extracted from graph) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomisation procedure not described |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes ‐ participants | Unclear risk | Not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes ‐ careproviders | Unclear risk | Not mentioned |
| Blinding of outcome assessment (detection bias) All outcomes ‐ outcome assessors | Unclear risk | Not mentioned |
| Incomplete outcome data (attrition bias) All outcomes ‐ dropouts | Low risk | Dropout rate 17.1% (33/193 withdrew: 1 only baseline measurements; 10 stopped therapy prematurely or failed therapy; 22 protocol violations) |
| Incomplete outcome data (attrition bias) All outcomes ‐ ITT analysis | Unclear risk | Not mentioned |
| Selective reporting (reporting bias) | Unclear risk | No study protocol |
| Similarity at baseline characteristics | Unclear risk | Not mentioned, no table 1 |
| Co‐interventions avoided or similar | Low risk | Paracetamol was allowed as rescue medication, maximum 4 tablets of 500 mg |
| Compliance acceptable | Unclear risk | Compliance was assessed by the recordings in the participant diaries. Unused medication was not collected. |
| Timing outcome assessments similar | Low risk | Timing similar |
| Other bias | Low risk | None |