Newswise — Ayurvedic drugs may be safer, and just as effective, as glucosamine and celecoxib in treating patients with knee osteoarthritis, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in San Francisco, Calif.
Osteoarthritis is the most common joint disease affecting middle-age and older people. It is characterized by progressive damage to the joint cartilage—the slippery material at the end of long bones—and causes changes in the structures around the joint. These changes can include fluid accumulation, bony overgrowth, and loosening and weakness of muscles and tendons, all of which may limit movement and cause pain and swelling.
Most commonly affected are the weight-bearing joints—the knees, hips and spine. Osteoarthritis in the knee and hip areas can generate chronic pain or discomfort during standing or walking. Deterioration of disks between spine vertebrae can cause back and neck stiffness and pain.
Ayurvedic (which, when translated, means "science of life" ) therapy is rooted in ancient Indian civilization and is considered to be the precursor to many other forms of Asian medicine. It is practiced popularly in India to treat several chronic disorders.
Researchers recently spent five years studying the safety and effectiveness of ayurvedic herbal drugs, in comparison to glucosamine and celecoxib, two commonly used treatments for OA. In this randomized, double-blind study, researchers followed 440 with painful knee OA. After dividing patients into one of four groups (two groups were placed on different types of ayurvedic therapy, one group was placed on glucosamine, and one group on celecoxib), researchers compared the effectiveness and safety of each therapy over a 24-week period by looking at active pain, difficulty and function, and side effects in the patients.
Twenty-eight percent of the patients withdrew from the study; withdrawals were equally spread among the four groups. Researchers found that none of the groups experienced serious side effects " those taking ayurvedic therapy showed even fewer side effects overall. The results showed ayurvedic treatments to be relatively safe and as effective as glucosamine and Celecoxib for improving pain and function in patients with OA.
OA is a difficult to treat disorder that has very few therapeutic options in modern medicine, explains Arvind Chopra, MD; Center For Rheumatic Diseases, Maharashtra, India, and lead investigator in the study. "This scientifically designed drug trial demonstrates the therapeutic usefulness of two standardized Ayurvedic derived purely herbal formulations in the symptomatic treatment of OA [in the] knees over 24-week period. The Ayurvedic drugs were equivalent to Glucosamine and Celecoxib, which are popularly used globally to treat OA. Documented historical use & our data confirm a potentially superior safety of Ayurvedic medicine," says Dr. Chopra.
Patients should consult their rheumatologists before taking this, or any, over-the-counter medication.
The ACR is an organization of and for physicians, health professionals, and scientists that advances rheumatology through programs of education, research, advocacy and practice support that foster excellence in the care of people with or at risk for arthritis and rheumatic and musculoskeletal diseases. For more information on the ACR's annual meeting, see www.rheumatology.org/annual.
Editor's Notes: Dr. Chopra will present this research during the ACR Annual Scientific Meeting at the Moscone Center from 3:45 " 4:00 PM on Tuesday, October 28, in Room 307.
Presentation Number: L16
A 24 Week RDB Multicentric Trial to Demonstrate Equivalence between Individual Drugs for Symptomatic Treatment of OA Knees: Ayurvedic (Indian Asian) , Glucosamine and Celecoxib
Arvind Chopra1, M. Saluja1, A. Venugopalan1, P. Naik1, G. Tillu2, S. Sarmukkaddam3, G. Narsimulu4, R. Handa5, A. Raut6, L. Bichile6, J. Patil1, B. Patwardhan2. 1Center for Rheumatic Diseases, Pune, India; 2Pune University, Pune, India; 3BJ MC, Pune, India; 4NIMS, Hyderabad, India; 5AIIMS, Delhi, India; 6KEMH, Mumbai, India
Purpose: Modern medicine is limited in several chronic disorders. Ayurvedic Herbal drugs (with long term human use) may prove beneficial. Our multidisciplinary project (2002-07) targets Ayurvedic medicines.
Methods: Two formulations [3/4 plants (T.Cordifolia- Z.officinale based) extracts], namely SG'C & SG'CG, were selected and standardized. A four arm [ 2 Ayurvedic, Glucosamine sulfate (GLU, 2 gm daily) and Celecoxib (CXB, 200 mg daily), RDB multicentric study (80% power, α=0.05) of 24 weeks tested equivalent efficacy using a-priori derived equivalence range (Bellamy et al. J Rheumatol 1992; 19:451-7 & experience) for difference in mean change by drug for primary efficacy variables (active pain VAS, Indian version WOMAC (W/ Likert version) pain and difficulty). Rescue paracetamol discouraged. Post consent, 440 eligible (active pain VAS> 4 cm) patients (median age /weight/active painVAS=55.5 yrs/65 kg/6.55cm) with OA knees (ACR classified) were enrolled and monitored as per protocol. Groups matched well at baseline. Within group, several variables improved significantly.NS: not significant
Results: (1) Difference in ANCOVA adjusted mean change score (Table: PP analysis; 75, 76, 86 & 79 patients in SG'C, SG'CG, GLU & CXB respective) fell within the target equivalence . ANOVA & an intent-to-treat analysis (LOCF) gave similar results.
[Table included with press release and full abstract at www.rheumatology.org.]
(2) None of the arms showed SAE. Ayurvedic arms showed less AE (NS)(3) Overall 28% patients withdrew (between group NS) (4) The mean (geometric) reduction in urinary CTX [C-telopeptide Collagen II; 1.63ng/mmol, 95% CI~ 1.04,2.54] in SG'CG was significant with minimal/nil change in controls(4) Randomly measured joint space (several points) in blinded X-Ray knees (weight bearing, baseline and completion) using validated manual technique consistently favored SG'CG (NS).
Conclusions: This first head to head study demonstrates equivalent efficacy (with better safety) between Ayurvedic drugs and glucosamine/celecoxib. The CTX and radiology data suggest a superior chondroprotective role for the Ayurvedic drug.Acknowledgement: A NMITLI arthritis project sponsored and funded by the Council of Science and Industrial Research, Govt of India using several other national research facilities (IIIM- Jammu, NBRI-Lucknow, ARI-Pune, IRSHA-Pune) and experts.
Disclosure Block: A. Chopra, None; M. Saluja, None; A. Venugopalan, None; P. Naik, None; G. Tillu, None; S. Sarmukkaddam, None; G. Narsimulu, None; R. Handa, None; A. Raut, None; L. Bichile, None; J. Patil, None; B. Patwardhan, None.
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