Diacerein as adjuvant to diclofenac sodium in osteoarthritis knee

• Published in: International journal of rheumatic diseases 2012-02, Vol.15 (1), p.69-77
• Main Authors: SINGH, Kuljinder, SHARMA, Rakesh, RAI, Jaswant
• Format: Article
• Language: English
• Subjects: Acetaminophen - therapeutic use; Adjuvants; Administration, Oral; Analgesics, Non-Narcotic - therapeutic use; Anthraquinones - administration & dosage; Anthraquinones - adverse effects; Anthraquinones - therapeutic use; Anti-Inflammatory Agents - administration & dosage; Anti-Inflammatory Agents - adverse effects; Anti-Inflammatory Agents - therapeutic use; Anti-Inflammatory Agents, Non-Steroidal - administration & dosage; Anti-Inflammatory Agents, Non-Steroidal - adverse effects; Anti-Inflammatory Agents, Non-Steroidal - therapeutic use; Arthralgia - diagnosis; Arthralgia - drug therapy; Arthralgia - etiology; Arthralgia - physiopathology; Capsules; Clinical trials; Controlled release; Delayed-Action Preparations; diacerein; Diclofenac; Diclofenac - administration & dosage; Diclofenac - adverse effects; Diclofenac - therapeutic use; diclofenac sodium; Double-Blind Method; Drug Therapy, Combination; Female; Humans; India; Knee; Knee Joint - drug effects; Knee Joint - physiopathology; Male; Middle Aged; nonsteroidal anti-inflammatory drugs; Osteoarthritis; Osteoarthritis, Knee - complications; Osteoarthritis, Knee - diagnosis; Osteoarthritis, Knee - drug therapy; Osteoarthritis, Knee - physiopathology; Pain; Pain Measurement; paracetamol; Placebos; Prospective Studies; Range of Motion, Articular; RCT; Recovery of Function; Sodium; Surveys and Questionnaires; SYSDOA; Tablets; Time Factors; Treatment Outcome
• ISSN: 1756-1841; 1756-185X
• DOI: 10.1111/j.1756-185X.2011.01648.x

Aim:  To evaluate clinical effectiveness of diacerein as an adjuvant to diclofenac sodium in treatment of Indian patients with symptomatic osteoarthritis (OA) knee. Methods:  This is a prospective, double‐blind, placebo‐controlled and intention‐to‐treat study. An initial washout period of 1 week, was followed by 3 months treatment period during which patients were randomly divided to receive either capsule diacerein 50 mg or matched placebo once daily for the first month and twice daily for the next 2 months with diclofenac sodium 75 mg sustained release tablet once daily given to both groups. Patients were observed for one more month, using paracetamol as rescue therapy. Treatment efficacy was assessed by a visual analogue scale (VAS) and the Western Ontario and McMaster University (WOMAC) Osteoarthritis Index, patient and physician global assessment of OA, daily paracetamol intake. Results:  Of 84 patients screened, 74 patients formed the intent‐to‐treat population (37 patients in each group). At baseline, both groups were comparable and at the third month functional index and pain intensity were better in the diacerein group (VAS 15.33 ± 5.07; WOMAC 15.9 ± 2.40) as compared to the placebo group (VAS 22.83 ± 6.90;WOMAC 36.8 ± 2.92; P