Dual Release Paracetamol in Osteoarthritis of Knee: A Randomized Controlled Clinical Trial
Background: Paracetamol is recommended as first line agent for pain management in osteoarthritis (OA) by various guidelines. The main problem associated with management of osteoarthritis is long term patient compliance to paracetamol due to its frequent dosing. Objective: To evaluate the effica...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
JCDR Research and Publications Private Limited
2014-11-01
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| Series: | Journal of Clinical and Diagnostic Research |
| Subjects: | |
| Online Access: | https://jcdr.net/articles/PDF/5197/10052_F(T)_PF1(PU_Sh)_PFA(Sh).pdf |
| Summary: | Background: Paracetamol is recommended as first line agent
for pain management in osteoarthritis (OA) by various guidelines.
The main problem associated with management of osteoarthritis
is long term patient compliance to paracetamol due to its frequent
dosing.
Objective: To evaluate the efficacy and safety of Paracetamol
650 mg dual release tablet twice daily (PCM 650 dual release)
compared to paracetamol 500mg immediate release tablet thrice
daily (PCM 500 IR) in the treatment of Knee OA.
Materials and Methods: In this randomized, open label, parallel,
active controlled clinical study, 250 patients of OA knee meeting
inclusion criteria were randomized to receive either PCM 650
dual release two times daily or PCM 500 IR three times daily for
6 weeks. Patients were assessed at baseline, 2, 4 and 6 weeks.
Primary efficacy measures were severity of pain (Visual Analogue
Scale) and Knee injury and osteoarthritis outcome score (KOOS)
subscale for pain at week 2, 4 and 6. Other KOOS subscales
(symptoms other than pain, function in daily living, function in
sport and recreation, quality of life) and patient’s and physicians
global assessment of therapy were included as secondary
endpoints.
Results: Both treatment groups showed improvement in primary
endpoints at each evaluation visit. Patients receiving PCM 650
dual release showed significant improvement of pain in both
primary endpoints at each study visit compared to patients
receiving PCM 500 IR (p<0.001). PCM 650 dual release was
significantly superior to PCM 500 IR for improvement in all KOOS
subscales at each study visit (p<0.01).
Less number of patients required additional rescue analgesics in
PCM 650 dual release group (16% patients vs 26%, PCM 500 IR;
p>0.05). Adverse effects were significantly less in PCM 650 dual
release group (6% vs. 14% in PCM 500 IR; p<0.05). Patient’s
and physician’s global assessment of therapy favoured PCM 650
dual release than PCM 500 IR (p<0.001).
Conclusion: Patients with symptomatic OA of the knee showed
a greater improvement in pain and functional capacity with PCM
650 dual release than PCM 500 IR with better tolerability. |
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| ISSN: | 2249-782X 0973-709X |