CLINICAL TRIAL GUIDELINES
Recommendations for Conducting Clinical Trials in Osteoarthritis
May issue of Osteoarthritis and Cartilage, 23/5, available online now at
Eleven separate working groups composed of OARSI members have developed guidelines for conducting clinical trials in the areas of:
- Osteoarthritis of the knee, hip and hand
- Surgical trials
- Non pharmacologic therapies including Diet/Exercise, Injury Prevention, and Post Surgery Rehabilitation
- Imaging/radiology of knee, hip, hand
- Biostatistical issues
This initiative is a good example of OARSI endeavors that aim for collaborative and fruitful discussions involving academic and industry members. OARSI Clinical Trial Guidelines are used by scientists, graduate students and clinical investigators worldwide and serve as the benchmark trial design. Guideline authors serve as authoritative leaders, mentors and collaborators for researchers developing progressively more advanced levels of investigation.
For the first time, OARSI has developed guidelines for the non-surgical treatment of osteoarthritis of the knee that are stratified to each of four patient groups: patients with knee-only OA and no comorbidities, patients with knee-only OA with comorbidities, patients with multi-joint OA and no comorbidities, and patients with multi-joint OA with comorbidities. Comorbities included diabetes, hypertension, cardiovascular disease, renal failure, GI bleeding, depression, or a physical impairment limiting activity, including obesity.
After a comprehensive review of the current scientific evidence, each working group member gave each treatment a score for appropriateness, therapeutic benefit, and overall risk for each of the four different patient populations. These scores were converted into a recommendation category of either “appropriate”, “not appropriate”, or “uncertain” and a composite risk-benefit score.
It is important to note that an “uncertain” recommendation is NOT a negative recommendation, nor is it meant to rule out the use of a therapy. Instead, this category means that the working group found too little scientific evidence to support a recommendation or that a treatment has a moderately high risk profile coupled with low efficacy. As such, “uncertain” treatments should be weighed by physicians and patients for merit in specific, individual circumstances.
The new guidelines recommend a set of non-pharmacological core treatments as appropriate for all individuals (listed in order from highest benefit-to-risk score to lowest): land-based exercise, weight management, strength training, water-based exercise, and self-management and education. For weight management, the OARSI guidelines make a specific recommendation of achieving a 5% weight loss within a 20-week period to be effective at treating knee OA.
Key Updates to the 2010 OARSI Guidelines:
- Topical NSAIDs are recommended as appropriate for all patients with knee-only OA and in a scientific review, were found overall to be safer and better tolerated compared to oral NSAIDs.
- The prescription drug duloxetine was evaluated for the first time and found to be an appropriate treatment for knee-only OA patients without comorbidities and all multi-joint OA patients.
- Due to increased safety concerns about toxicity, acetaminophen/paracetamol was given an “uncertain” recommendation for all patients with comorbidities.
- Oral and transdermal opioid painkillers were given an “uncertain” recommendation for all patient groups due to concerns about increased risks for adverse and serious adverse events.
- Glucosamine and chondroitin were both found to be “not appropriate” for all patients when used for disease modification and “uncertain” for all patients when used for symptom relief.
- Balneotherapy, defined as using baths containing thermal mineral waters, was evaluated for the first time and found to be an appropriate therapy for patients with multi-joint OA and comorbidities, as this group has few other treatment options.