Efficacy and Safety Evaluation of Myostaal Forte, a Polyherbal Formulation, in Treatment of Knee Osteoarthritis: A Randomised Controlled Pilot Study FC06-FC10
Dr. Pooja Harish Vaidya,
A-2/705, Vasundhara CHS, Lok-Rachna Complex, Amar Nagar, Mulund (W), Mumbai-400082, Maharashtra, India.
Introduction: Myostaal Forte, a proprietary poly-herbal formulation, is mixture of nine herbal plant extracts which possess analgesic, anti-inflammatory and chondroprotective properties.
Aim: A prospective, randomised, active controlled, 2-arm, parallel group, assessor blind study was planned to evaluate clinical efficacy and safety of Myostaal Forte in patients of knee osteoarthritis.
Materials and Methods: Idiopathic knee osteoarthritis cases as per American College of Rheumatology (ACR) clinical criteria were screened and recruited. A total of sixty patients were assigned to receive Myostaal Forte TDS (n=30) or Paracetamol 650 mg TDS (n=30) for six weeks. Naproxen was rescue analgesia. Modified Western Ontario and McMaster Universities Arthritis Index (WOMAC), Visual Analogue Scale (VAS), global assessment scores determined by orthopaedic physician at baseline, two, four, six weeks and telephonically at eight weeks. Safety was assessed through laboratory investigations at baseline and six weeks, adverse events and tolerability. Data were expressed as Mean±SD and analysed by Chi-square and unpaired t-test. p<0.05 was considered significant.
Results: Myostaal Forte and Paracetamol showed significant reduction in osteoarthritis disease activity. Myostaal Forte produced significant improvement compared to Paracetamol, in the pain, stiffness and physical function from baseline to eight weeks (p<0.05). Significant reduction in WOMAC pain score was seen within two weeks in Myostaal Forte group (p<0.05), but not in Paracetamol group. From baseline to two weeks, the pain severity reduced in 8/8 patients in Myostaal Forte group, whereas in 4/8 patients in Paracetamol group. After treatment cessation at six weeks, symptomatic relief was sustained over two weeks in Myostaal Forte group, whereas in Paracetamol, relapse of pain and physical disability occurred within two weeks (p>0.05). No significant adverse events, changes in the laboratory parameters and excellent compliance to treatment were seen in both the groups.
Conclusion: Earlier onset analgesic effect with sustained chondroprotection after treatment cessation makes Myostaal Forte, a safe and effective alternative for treatment of knee osteoarthritis.