[Effectiveness of Troxerutin in association with Pycnogenol in the pharmacological treatment of venous insufficiency].
OBJECTIVE
The purpose of our study was to assess the different effectiveness of Troxerutin in association with Pycnogenol compared to the effects obtainable with the same pharmacological principle in monotherapy in patients suffering from venous insufficiency.


METHODS
Seventy patients with venous insufficiency of the lower extremities at the first stages of the CEAP classification (Cs1,3; Es; As 1; invalidity score 2, clinical score 1-2) were selected and subdivided into 2 groups: one of 50 and one of 20. All patients reported the following symptoms either associated or in isolation: heaviness, cramps, pruritus and pain at palpation. Evaluation of the degree of venous insufficiency was carried out by means of echo-Doppler at recruitment. The 1st group received Troxerutin (470 mg) associated with Pycnogenol (20 mg) in a dose of 1 g/day per os for 60 days; the 2nd group Troxerutin alone (300 mg) in a dose of 2 tablets twice a day per os for 60 days. Controls were set up at 30 and 60 days from the start of treatment and after a period of 3 months from the end of treatment to assess the effects on the symptomatology over time. The effectiveness of the drugs on symptomatology reported by both groups was assessed by means of an analysis of the qualitative variation of the symptoms using the score-scales method: 3=severe; 2=moderate; 1=slight; 0=absent and this variation was expressed as a percentage decrease and analysed using Student's test.


RESULTS
The results of our study after 30 days of treatment highlighted a clinical improvement in all patients with the disappearance of symptoms (score from 3 to 1) in 50% of patients in the 1st group and in 35% in the 2nd with a peak of 96% in patients of the 1st group and 80% in the 2nd at the end of treatment (60 days). This result held stable in the course of follow-up for 96% of patients in the 1st group (p<0.001) and for 50% of those in the 2nd group (p<0.005).


CONCLUSIONS
Comparison between the 2 groups showed that the group which received Troxerutin associated with Pycnogenol reported greater therapeutic effectiveness than the control group as regards both the rapidity of disappearance of the symptoms and as regards maintenance of the cure obtained.
Riccioni
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C
Unità Operativa Complessa di Angiologia, Ospedale Nuovo Regina Margherita, Roma. camriccioni@tiscalinet.it
Sarcinella
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R
Izzo
A
A
Palermo
G
G
Liguori
M
M
D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000284:Administration, Oral; D000328:Adult; D000704:Analysis of Variance; D003627:Data Interpretation, Statistical; D004359:Drug Therapy, Combination; D005260:Female; D005419:Flavonoids / Q000008:administration & dosage*; D005500:Follow-Up Studies; D006801:Humans; D006896:Hydroxyethylrutoside / Q000008:administration & dosage* / Q000031:analogs & derivatives; D008297:Male; D008875:Middle Aged; D010936:Plant Extracts; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome; D014662:Vasoconstrictor Agents / Q000008:administration & dosage*; D014689:Venous Insufficiency / Q000175:diagnosis / Q000188:drug therapy*
D000276:Adjuvants, Immunologic; D005419:Flavonoids; D006896:Hydroxyethylrutoside; D010936:Plant Extracts; D010975:Platelet Aggregation Inhibitors; D014662:Vasoconstrictor Agents; C024070:pycnogenols; C005865:troxerutin