Evaluation of efficacy of Flexiqule (Boswellia Phyto Extract) in osteoarthritis of Knee

Osteoarthritis is major cause of morbidity and impaired quality of life among the elderly persons. The prolong use of NSAIDs in elderly, is required for constant relief of pain, but they are associated with adverse drug effects. Thus long term use of NSAIDs compromise with its safety profile.The present study was undertaken to evaluate the long term clinical efficacy and safety of Flexiqule(Boswellia phyto extract) , and comparison with Etoricoxib (ETX) as a remedial measure .Boswellia phyto extract ,a herbal extract contains Boswellic acid as active ingredient, which has exhibited anti inflammatory and analgesic effect.Etoricoxib is Cox 2 inhibitor, frequently used NSAIDs,but not without side effects. One hundred patients of either sex, in age group of 50 to 65 years ,with clinical and radiological evidence of Osteoarthritis of knee were selected for trial. Patients were randomly divided into two groups. Group A received capsule Flexiqule 300 per day and group B received Etoricoxib 90 mg per day. All symptoms along with severity and duration were recorded prior to start of drug treatment. Routine hematological and radiological assessment was done before and the end of treatment. The patients were followed up every 04 weekly for six months. Symptomatic assessment score was carried out to determine the clinical efficacy of Flexiqule as compared to Etoricaxib. The minimal level of significance was fixed at 95% confidence limits and a 2-sided p value of <0.05 was considered significant. Clinical Efficacy was assessed by decrease in total sign and symptom scores. Results revealed that the average symptom score for joints involved, before and after the treatment was 7.140 to 1.060 in Flexiqule group while in Etoricoxib group was 6.800 to 1.840. There was reduction in symptom score 86% in Flexiqule group and 82% in ETX group. Thus objective improvement was comparatively better in Flexiqule groups. As for the side effects, No Adverse Reaction(ADRs), was noted in Flexiqule group, While Etoricoxib group experienced side effects -gastrointestinal, neurological or dermatological symptoms, which required due care. Though there was no significant alteration in hematological level, there was significant lowering in SGOT and SGPT levels, which indicated hepatoprotective effect of Flexiqule, and also significant decrease in Creatinine level indicated its renoprotective effect. No Adverse drug side effects were positive factor for prolong usage of Flexiqule as compared to Etoricoxid group. This study indicates that Flexiqule (Boswellia Phyto Extract) has proved better symptom relief in terms of relief of pain and free mobility of joints, equally effective but a safe alternative for long -term use in management of mild to moderate osteoarthritis, in patients unwilling for surgery.