Abstract | OBJECTIVES: MATERIALS AND METHODS: A parallel group, double-blind, randomized controlled trial was conducted with ambulatory patients over 50 years age suffering from knee osteoarthritis causing pain of at least moderate intensity. Patients were randomized to receive either oxaceprol 200 mg thrice daily or tramadol 50 mg thrice daily for 12 weeks. The primary efficacy variable was symptom relief as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) version 3.1 for pain, stiffness, and physical function. Responder rate (50% pain relief), patient's Clinical Global Impression (CGI), and rescue medication use were other outcomes measured. Vital signs, routine blood counts, tests of hepatorenal function and treatment-emergent adverse events were recorded for safety assessment. RESULTS: From 91 patients recruited, 43 on oxaceprol and 36 on tramadol were evaluable. The WOMAC scores declined significantly from baseline in each arm but remained comparable between groups throughout the 12-week study period. The CGI ratings and 50% responder rates were also comparable at the final visit. Differences in dose up-titration and rescue medication requirements were statistically nonsignificant. So also were the adverse event counts. Compliance was satisfactory in both groups. CONCLUSIONS:
|
Authors | Kaushik Mukhopadhyay, Parasar Ghosh, Partha Ghorai, Avijit Hazra, Amal Kanti Das |
Journal | Indian journal of pharmacology
(Indian J Pharmacol)
2018 Sep-Oct
Vol. 50
Issue 5
Pg. 266-272
ISSN: 1998-3751 [Electronic] India |
PMID | 30636830
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)
|
Chemical References |
- Analgesics, Opioid
- Tramadol
- oxaceprol
- Hydroxyproline
|
Topics |
- Aged
- Analgesics, Opioid
(adverse effects, therapeutic use)
- Double-Blind Method
- Female
- Humans
- Hydroxyproline
(adverse effects, therapeutic use)
- Male
- Middle Aged
- Osteoarthritis, Knee
(complications, drug therapy)
- Pain
(drug therapy, etiology)
- Pain Measurement
- Tramadol
(adverse effects, therapeutic use)
|