Aceclofenac vs paracetamol in the management of symptomatic osteoarthritis of the knee: a double-blind 6-week randomized controlled trial.
OBJECTIVE
To evaluate the efficacy and tolerability of aceclofenac, 200 mg/day, and paracetamol, 3000 mg/day, in the treatment of osteoarthritis (OA) of the knee.


METHODS
This was a double-blind, parallel-group, multicentre clinical trial involving patients with symptomatic OA of the knee, conducted in Spain. Patients were randomly allocated to aceclofenac 100 mg twice daily (n=82) or paracetamol 1000 mg three times daily (n=86). Patients were assessed at baseline and 6 weeks. Primary efficacy measures were severity of pain (visual analogue scale, VAS), Lequesne OA knee index, and patient's and physician's global assessment of disease activity. Severity of knee pain at rest or walking, stiffness, knee swelling and tenderness, and assessment of health-related quality of life (Health Assessment Questionnaire, Western Ontario and McMaster Universities Osteoarthritis Index, and Short Form 36) were included as secondary endpoints.


RESULTS
Both treatment groups showed significant improvement compared with their baseline values in the four primary endpoints. Mean between-treatment differences favoured aceclofenac over paracetamol on pain (VAS, 7.64 mm [95% confidence interval (CI), 0.44-14.85 mm]), Lequesne OA index (1.41 [95% CI, 0.45-2.36]), and patient's (0.33 [95% CI, 0.06-0.61]) and physician's (0.23 [95% CI, 0.01-0.47]) global assessments. Adverse events were similar for both drugs (paracetamol, 29% patients vs aceclofenac, 32%; P=0.71). Four patients withdrew in each group due to adverse events. Patients tended to prefer aceclofenac to paracetamol (P=0.001), and more treated with paracetamol withdrew from the study due to lack of efficacy (n=8 vs n=1, P=0.035, for paracetamol and aceclofenac, respectively).


CONCLUSIONS
At 6 weeks, patients with symptomatic OA of the knee showed a greater improvement in pain and functional capacity with aceclofenac than paracetamol with no difference in tolerability.
Batlle-Gualda
E
E
Rheumatology Unit, Hospital General Universitario, Alicante, Spain. battle_enr@gva.es
Román Ivorra
J
J
Martín-Mola
E
E
Carbonell Abelló
J
J
Linares Ferrando
L F
LF
Tornero Molina
J
J
Raber Béjar
A
A
Fortea Busquets
J
J
D000082:Acetaminophen / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D000368:Aged; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage* / Q000009:adverse effects; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D004008:Diclofenac / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000188:drug therapy*; D016896:Treatment Outcome
D018712:Analgesics, Non-Narcotic; D000894:Anti-Inflammatory Agents, Non-Steroidal; D004008:Diclofenac; D000082:Acetaminophen; C056498:aceclofenac