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MINERVA ORTOPEDICA E TRAUMATOLOGICA
A Journal on Orthopedics and Traumatology
Minerva Ortopedica e Traumatologica 2003 August;54(4):337-43
language: English, Italian
Clinical efficacy and tolerability of diclofenac foam in musculoskeletal diseases
Istituto Clinico San Siro, Milan, Italy
Aim. The aim of the study was to determine the tolerability and therapeutic safety of a new formulation of 1% diclofenac foam in patients with mild/moderate musculoskeletal disorders.
Methods. Fifty-six patients of both sexes (29 females, 27 males, mean age 47.8 years) with a diagnosis of musculoskeletal disease basically involving inflammation/pain were included in the study. The patients were treated for 1 week with 1% diclofenac foam twice daily, morning and evening. Endpoint criteria for efficacy, evaluated at baseline and after 1 week, were as follows: passive pain, oedema, impaired joint function, pain on contraction and muscle pain. The following were determined at the end of the treatment: the doctor’s opinion on the efficacy of the treatment; the patient’s opinion on the acceptability/cosmetic validity; and the patient’s preference compared to other topical treatments.
Results. There was an improvement in disappearance of passive pain in 94.4% of cases, oedema in 79.3%, impaired joint function in 75.5%, pain on contraction in 80.8% and muscle pain in 76.9%. Tolerability according to the patients was excellent. The product was described as better than previous topical treatments known to the patient in 55.4% of cases.
The doctor’s opinion on the overall efficacy of the treatment was positive in 94.6% of cases and acceptability according to the patients was positive in 98.2% of cases.
Conclusion. It can be confirmed that 1% diclofenac foam by topical route shows excellent acceptability in mild/moderate clinical conditions, with an excellent risk/benefit ratio.