A comparative evaluation of the effect of 2% Atorvastatin gel versus Diclofenac gel on clinical symptoms of patients with knee osteoarthritis

Study of topical Atorvastatin gel effect on clinical symptoms of patients with knee osteoarthritis

Parallel, drug-control, double blind, and randomized clinical trial

The statistical population included patients referred to the rheumatology clinic of Bou Ali hospital in Tehran. Patients were randomly divided into two groups: The first group received atorvastatin gel and the second group received diclofenac gel. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire was used to evaluate the pain, stiffness, physical function for a total period of 12 weeks.

Inclusion criteria: Diagnosis of mild to moderate knee osteoarthritis by a rheumatologist, No other topical treatment usage at least tow weeks before the study, No oral Atorvastatin usage, No other systemic analgesics or anti-inflammatory usage at least tow weeks before the study, Obtaining informed consent from the patients Patients aged between 40 and 75 years old; Exclusion criteria: Unwilling to continue or to participate in the study any further, Patients with other knee joint disorders: ( Rhumatoid Arthrities, Gout, Pseudo Gout, Infected Arthrities ), Knee corticosteroid injection in the past 3 months, Joint replacement, Pregnancy and lactation, Sensitivity to study drugs

Intervention group: Atorvastatin Gel prepared by researcher, Knee local use, 2 times a day, for 3 months Control group: Diclofenac Gel 1 % (Razak), 2 times daily, for 3 months

The WOMAC questionnaire was used to evaluate the pain, stiffness, physical function at the beginning of study,4weeks,8weeks,12weeks after treatment.

Sampling was done randomly so that 40 people were selected using the numbers table. These people were randomly assigned through "Random Sequence Generation" method by random numbers table in Excel software and were divided into two Atorvastatin and Diclofenac groups.

All patient who had the necessary condition to enter the study were assigned randomly into tow groups of drugs and drug-control. Patients and doctors were unaware of the medication or drug-control interventio, and patients and medication were coded by someone who did not intervene in the study.