Diclofenac potassium for the treatment of traumatic joint distortions: an open multicentre study.

In an open multicentre study, 410 patients presenting with traumatic joint distortions, predominantly involving the ankle, were recruited for treatment with 50 mg diclofenac potassium given orally three times daily for 7 days. Due to various protocol violations, the number of patients eligible for efficacy and tolerability analysis were 340 and 344, respectively. Significant (P less than 0.001) improvement in mobility, swelling, local tenderness, functional impairment and pain intensity occurred after both 3 and 7 days of therapy. Overall efficacy was assessed as excellent/good in 83% and 87% of cases by the investigator and patient, respectively. Altogether, 66 (19.2%) patients complained of adverse effects, which were generally mild or moderate in severity. Gastrointestinal complaints accounted for around 70% of the reported side-effects. Premature discontinuation of therapy due to poor tolerability was necessary in 15 (4.4%) patients. In conclusion, diclofenac potassium was both effective and well-tolerated when used for the short-term treatment of traumatic joint distortions.