Ximenes 2007.
| Methods | RCT; double‐blind, double‐dummy; multicentre Follow‐up time: 7 days. Adverse events were monitored until 30 days after the final administration of the study drug. |
|
| Participants |
Population: 340 participants, 173 women, 167 men. Mean age (SD): (i) 41.6 (11.7), (ii) 40.1 (12.7) Setting: 31 centres in 9 Latin American countries (Brazil, Venezuela, Ecuador, Argentina, Chile, Mexico, Colombia, Costa Rica, and Peru), November 2002 to May 2003 Inclusion criteria: age 18 to 65 years, acute LBP, duration of ≤ 72 hours, no previous episodes of acute LBP in the previous 6 weeks, VAS pain score ≥ 50 mm (100‐mm scale) and moderate to severe pain (categorical scale) Exclusion criteria: back pain of neurologic etiology, back pain did not qualify as a Quebec Task Force class 1a or 2a; presence of inflammatory conditions (e.g. arthritis), conditions of chronic pain, malignancy or IBD; uncontrolled hypertensive, hepatic, or renal disorders; participants subject of active workers compensation or litigation cases; history of allergic reactions to NSAIDs or sulfonamides; pregnant or lactating women |
|
| Interventions | NSAIDs (i): valdecoxib 40 mg daily, with a second dose on day 1; 7 days (N = 170) NSAIDs (ii): diclofenac 75 mg b.i.d.; 7 days (N = 170) | |
| Outcomes | Mean difference (95% CI) pain intensity scale (100‐mm VAS) at 7 days; (i, N = 167 vs ii, N = 166) 0.26 (‐3.76 to 4.28)
Mean difference (95% CI) Oswestry LBPDQ (0 to 24‐point scale) at 7 days; (i vs ii) 0.02% (‐3.21 to 3.16) Adverse events (no of participants, % (95% CI)): (i, N = 170) 48 participants, 28.2% (21.7 to 35.7%), (0 withdrew); (ii, N = 170) 44 participants, 25.9% (19.6% to 33.3%), (4 withdrew) |
|
| Funding | Funded by Pfizer Inc., manufacturer of Valdecoxib. Editorial support provided by C. Scott, MD at Parexel, (biopharmaceutical R&D company). | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation schedule generated by the study sponsor before the start of the study; stratified by categorical baseline pain intensity (moderate or severe), 1:1 |
| Allocation concealment (selection bias) | Low risk | Computer‐generated randomisation schedule |
| Blinding of participants and personnel (performance bias) All outcomes ‐ participants | Unclear risk | Double‐blind concept, it was written that it was double‐dummy, but the frequency of administration differs between both types of NSAIDs (one or two times a day). It is unclear how "all patients and study personnel were blinded to the identity of the study medication." |
| Blinding of participants and personnel (performance bias) All outcomes ‐ careproviders | Unclear risk | Double‐blind concept, but unclear if it was double‐dummy. |
| Blinding of outcome assessment (detection bias) All outcomes ‐ outcome assessors | Unclear risk | Double‐blind concept, but unclear if it was double‐dummy. |
| Incomplete outcome data (attrition bias) All outcomes ‐ dropouts | Low risk | Low dropout rate: 7% (24/340 withdrew) |
| Incomplete outcome data (attrition bias) All outcomes ‐ ITT analysis | Low risk | MITT (modified intention‐to‐treat) analysis performed |
| Selective reporting (reporting bias) | Unclear risk | Study protocol not mentioned |
| Similarity at baseline characteristics | Low risk | Baseline characteristics similar |
| Co‐interventions avoided or similar | Unclear risk | Not mentioned |
| Compliance acceptable | Unclear risk | Not mentioned |
| Timing outcome assessments similar | Low risk | Timing similar |
| Other bias | Low risk | None |