Arzneimittelforschung. 2003 ; 53(4): 243-6.

Oedema protective properties of the red vine leaf extract AS 195 (Folia vitis viniferae) in the treatment of chronic venous insufficiency. A 6-week observational clinical trial.

Schaefer E, Peil H, Ambrosetti L, Petrini O.

Boehringer Ingelheim GmbH, Medicine Consumer Health Care, 55216 Ingelheim/Rhein, Germany. eckhard.schaefer@ing.boehringer-ingelheim.com

The characteristic components of the pure plant-based extract AS 195 (Folia vitis viniferae) are flavon(ol)-glycosides and glucuronides with quercetin-3-O-beta-D-glucuronide (main flavonoid) and isoquercitrin (quercetin-3-O-beta-glycoside; a secondary flavonoid). In previous clinical studies AS 195 (hard gelatine capsules) has shown oedema-preventing and subjective symptoms alleviating properties in patients with chronic venous insufficiency (CVI). The aim of the present open-label, multicentre, observational trial was to assess tolerability and efficacy of AS 195 (Antistax film-coated tablets). The reduction of the subjective CVI-related symptoms was measured on a 10-cm visual analogue scale. For the global assessment of efficacy and tolerability by the patient and the investigator a 4-point verbal rating scale was used. Sixty-five male and female patients aged 25-82 years with CVI grade I or II (Widmer classification) received AS 195, two film-coated tablets once daily for 42 days (360 mg/day). At the end of the study, all subjective symptoms of CVI (tired, heavy legs, sensation of tension in the legs, tingling sensations in the legs, pain in the legs) were statistically significantly improved. The global assessment of efficacy by the patients and by the investigators was rated as good or satisfactory in most of the patients. AS 195 filmcoated tablets were very well tolerated during the whole trial, as their global tolerability was assessed for most patients as good or satisfactory by both the patients and investigators. Six patients experienced adverse events potentially causally related to trial medication. Four of them reported gastrointestinal problems. The present study showed a marked improvement of subjective symptoms associated with CVI grade I or II, as well as a good or satisfactory global assessment of efficacy and tolerability by the patients and the investigators. Thus, AS 195 film-coated tablets can be considered as effective and safe in patients with CVI grade I or II.