Evaluation of Naproxen-Ginger and Diacerein- Ginger in Treating Knee Osteoarthritis

Abstract

Brief Background: Osteoarthritis, an inflammatory, degenerative disease of joints mostly affects weight bearing joints in old age. Most commonly involved joint is knee. As long term treatment is required for this chronic and debilitating disease; people are now seeking use of herbal medicines for effective relieve of the symptoms. This is on account of easy availability, low cost and fewer adverse effects. Objectives:  To evaluate and compare, the clinical efficacy of Naproxen-ginger (A) with Naproxen and Diacerein-ginger (B) with Diacerein.  To observe adverse effects of these regimens. Subject, Materials and Methods: The study was conducted in National Medical Center, Karachi on 120 diagnosed patients of knee osteoarthritis. Male and female patients ≥ 50 years of age, fulfilling criteria of knee OA (American College of Rheumatology) and category 1 to 3 (Kallgren Lawrence grading system) were included in the study. They underwent knee radiograph and investigations including CBC, serum ALT, bleeding time, serum creatinine, blood urea, fasting blood sugar, and serum uric acid levels. After written informed consent each patient experienced a wash-out period of 72 hours. These patients were systematically randomized into 4 groups each having 30 members. Group A: tablet Naproxen 500mg + capsule Ginger 550 mg BD, group B: capsule Diacerein 50mg + capsule Ginger 550mg BD, group C: tab. Naproxen 500mg BD and group D: capsule Diacerein 50mg BD, for 12 weeks. Parameters that were checked at 0, 6 and 12 weeks were: WOMAC index, pain at rest and movement (Visual Analogue Scale), walking time, tenderness, swelling, limitation of movement, and safety profile (serum creatinine, ALT and bleeding time). Adverse effects were also observed during the study. Comparison of the four groups was done by one way ANOVA and comparison of the study group with its control group was done by independent t-test. 2 Results: 120 patients of knee osteoarthritis were included in the study; 30 patients in each of the four groups. 37 (30.8 %)were males and 87(69.2%) were females. 5 patients in group A, 4 in B, 5 in C and 4 in group D dropped out during the study, hence 102 patients completed the study. Comparison of the four groups showed highly significant results (Pvalue < 0.001) in all parameters. However maximum decrease in mean from day 0 to 6th and 12th week was observed in group A and minimum decrease was observed in patients treated with diacerein (group D). Comparison of group A with its control group C showed significant difference that is Pvalue < 0.05 in all parameters. Whereas decrease in WOMAC score, pain at movement and rest scores, and swelling in group A as compared to C showed highly significant difference (P-value < 0.001). Comparison of group B with its control showed highly significant difference that is P-value < 0.001inall parametersexcept limitation of movement. Comparison of lab parameters (safety profile) showed no significant difference (P-value >0.05) among the groups at all visits, moreover mean values of the parameters within groups showed no significant difference from day 0 to 6th and 12th week follow-ups. Among gastrointestinal adverse symptoms, which were more common in this study; 10.78 % patients suffered from nausea/ vomiting, 24.51% suffered from diarrhea, 17.65 % complained about heart burn and 1.96% had increase in flatulence. Gastrointestinal adverse effects were highest in group C (naproxen alone). Conclusion: Ginger with naproxen or diacerein is clinically effective in management of knee osteoarthritis as compared to naproxen or diacerein (alone) respectively. Moreover Ginger when administered with naproxen or diacerein did not produce added adverse effects.