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Based on clinical trials conducted under protocols consistent with U.S. Food and Drug Administration (FDA) and American College of Rheumatology ("ACR") criteria and guidelines, Bioved Pharmaceuticals believes that ARTREX is an effective and safe, natural supplement for long-term use in Bones and Joint considerations*.
Bioved Pharmaceuticals, Inc. completed a large double blind, placebo controlled trial in Rheumatoid arthritis patients, in India, of ARTREX's efficacy and safety using ACR criteria and FDA guidelines. One hundred and eighty two (182) patients participated in the study. This study was comprised of two parts: a 16 week, double-blind, placebo-controlled, trial, followed by an open label but closely monitored study, over a long term of three years, in all of these patients. Of the 182 patients, 165 patients completed the first 16 weeks of the study. The protocol for this trial was prepared by the Clinical Director, Arthritis unit of Massachusetts General Hospital, and the statistical analysis and reports were performed by Averion Inc., Massachusetts, a well known clinical research organization. Both are prestigious institutions, affiliated with Harvard Medical School.
Results obtained at the conclusion of the 16-week study, indicated that patients on ARTREX did better than the placebo group in many clinical and lab parameters. Statistical significance, as defined by the ACR and FDA, was obtained in two important clinical parameters - joint count (how many joints were affected) and score (severity) for swelling, and two lab indicators (of inflammation and disease) - rheumatoid factor and hemoglobin count.
However, after 32 weeks of participation in the study, patients showed statistically significant improvement from the start of the trial, in all clinical criteria and, most importantly, in the important laboratory blood testing criteria: (Interleukin-6, C-Reactive protein and Erythrocyte sedimentation rate). These patients were further followed for one year (145 patients), two years (130 patients), and three years (122 patients) in an open treatment regimen. Results analyzed from this data are statistically significant for keeping patients free from signs and symptoms of their arthritic conditions without any significant side effects. These patients continued to have (over such a long period), stable, normal blood counts, serum electrolytes, renal and liver function tests, which are all well known measures of safety and tolerance.
Bioved Pharmaceuticals also completed a 32-week double-blind, placebo-controlled clinical trial with ARTREX in patients with established Osteoarthritis of the knee. The objective of the study was to evaluate the pain control, efficacy and safety of ARTREX compared to placebo in patients with OA of the knee.
Both the treatment group and the placebo group, were well matched in clinical, laboratory and radiographic characteristics. Dosing was at two capsules twice a day. No escape medicine or any analgesic (pain killer) was permitted. Therefore, patients who claimed poor efficacy had to leave the study as their only alternative.
The protocol and study design was developed by the Clinical Director of the Arthritis Unit, Massachusetts General Hospital, Boston, MA. Biostatistical analysis was conducted at Averion Inc. in Framingham, Massachusetts, a well known and highly regarded statistical institution affiliated with Harvard University School of Medicine. All patients in the study had to be 35 years or older, with symptomatic and radiographically confirmed OA of the knee, and on stable doses of NSAIDs for at least 1 month.
The criteria for evaluation were pain, stiffness and difficulty using standard methods commonly used to test pain and arthritis products. The same joint (or joints) was evaluated throughout the study.
No pain medication and treatment other than the study drug was used by subjects during the course of the study, since these might have influenced the outcome. It is possible, however, that subjects could have had concurrent illnesses that required prescriptions of over-the-counter medication during the course of the study. In any event, an accurate record was kept of all medications and treatments used during the course of the study, including the drug name, dosage, duration and indication for use. Laboratory Studies were done at entry and final visit or completion of 32 weeks in the double-blind period. These included: Hematology, Chemistry, Urinalysis and Urine Pregnancy Test (for all women of child-bearing potential).
Patients on ARTREX showed statistically significant improvement in most of the major criteria under study. There was significant improvement in pain 3 weeks after start of therapy. In addition, there was statistically significant improvement in stiffness, difficulty and quality of life measures.
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