Objective: To determine the effect of a new venoactive ftav?no~d fraction (S 5682) in the treatment of symptomatic disturbances of the venolymphatic system.Design: Double-blind, randomized, placebo-controlled, parallel group trial conducted in two centres. P~nt~: One hundred and sixty patients with sympto-!1latlc disturbances of the venolymphatic system, includ-109 chronic venous insufficiency, were included in the stUdy.Interventions: Treatment lasted 8 weeks and consisted of the daily administration of two tablets of either S 5682 (n=8O) or placebo (n=80).
Main o.utcome "!easures:The primary end-point was the evolution of eight symptoms of disturbance of the Venolymphatic system over the 2-month observatioñ riod. The secondary end-point was the change of Clr~umference of each affected leg over the same observation period. es~/ts: When compared with placebo, S 5682 led to a Sl~mficant improvement in four symptoms (functional discomfort, sensation of heaviness, nocturnal cramps, sensation of swelling) at week 4 and in two additional symptoms (pain and sensation of heat or burning) at Correspondence and offprint requests to: Dr G. Pillion, IRIS, 6 place des Pleiades, 92415 Courbevoie Cedex, France.week 8. Similarly, S 5682 was associated with a significant decrease in calf muscle and supra malleolar circumferences at week 4 (p
In a randomized, single-dose, double-blind, parallel comparative trial of analgesic efficacy, 96 adult patients received either 10 mg ketorolac tromethamine or 400 mg glafenine orally the morning after surgery if they requested pain relief medication. Each patient provided a baseline pain assessment and then received the assigned medication. Patients assessed pain intensity and pain relief and reported any adverse events in interviews held 30 minutes after drug administration and then hourly for 6 hours. The demographic characteristics, baseline pain intensity, and surgical categories of the 47 patients who received ketorolac tromethamine and the 49 who received glafenine were similar. Both drugs provided prompt, sustained pain relief throughout the 6-hour observation period, and there were no statistically significant differences between the two groups in any of the efficacy measures analyzed. The global assessment recorded by patients suggested a slight clinical advantage for ketorolac tromethamine (32.6% of 'excellent' responses) as compared to glafenine (12.5% 'excellent'). The differences in overall response were statistically significant (p = 0.017). Fourteen (30%) patients who received ketorolac tromethamine and 17 (35%) who received glafenine reported adverse experiences that began or seemed to worsen after administration of the study drugs. The most prominent were drowsiness and sleeping, both of which are common in post-surgical patients.
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