Klinische Forschung zu Fuß und Sprunggelenk

Abstrakt

A Placebo-Controlled, Double Blind Study to Evaluate the Efficacy and Safety of a Combination of Mucopolysaccharides, Collagen Type-I and Vitamin C in Patients with Tendinopathy

Vikalp Vashishtha, Amit Pingat, Chirag Patel, Manoj Madini, Roshan Pawar, Abhijit Trailokya, Akhilesh Sharma

Background: Tendinopathy is the most common disorder of tendons. The aim of present study was to evaluate the efficacy and safety of combination of mucopolysaccharides, collagen type-I and vitamin C in patients with tendinopathy.

Methods: This placebo-controlled, double blind study was conducted in 100 patients (active-50, placebo-50); amongst them 50 patients each had Achilles tendinopathy and plantar fasciitis respectively. Patients received either active combination therapy or placebo capsules which was administered twice daily for 90 days. Rescue analgesic tablets were also dispensed for use as required. Patients were followed up on day 15, 30, 60 and 90. Efficacy assessments included 0-100 Visual Analogue Scale (VAS) score for pain on activity and at rest, VISA-A questionnaire and AOFAS scale score, rescue analgesic use and overall assessment of treatment by patients. Safety was based on reported Adverse Events (AEs).

Results: 97/100 patients completed the study. The scores of VAS for pain, VISA-A and AOFAS were comparable at baseline (P>0.05). There was gradual decline in VAS scores for pain and gradual improvement in VISA-A and AOFAS scores with change from baseline being significantly higher in active group at the end of study (P<0.05). The usage of rescue analgesic was significantly lesser for day 31-60 and day 61-90 in the active group (P<0.01). Trend on overall assessment also favored active drug. No treatment emergent AEs reported in the study.

Conclusion: The combination of mucopolysaccharides, collagen type-I and vitamin C can be considered a safe and effective supportive therapy in patients with tendinopathy.