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.