Objective: This study investigates whether micronized purified flavonoid fraction (MPFF) is effective and acceptable without compression or surgical intervention for the management of chronic venous insufficiency of the leg (CVIL) in the primary care setting of a tropical country such as India. Methods: A prospective observational study on patients with early CVIL drawn from the clinical practice of randomly selected physicians distributed across India. Patients received MPFF 1000 mg/day for six months without compression stockings or surgery. The primary outcome was a change in their CEAP (clinical, aetiological, anatomical, pathophysiological) classification of CVIL severity. Secondary outcomes were changes in leg oedema, symptom intensity and quality of life. Results: Of the 308 patients recruited by 72 physicians, 166 (53.9%, 95% confidence interval (CI) 48.3-59.5) had regression in the CEAP severity stage. Mean leg circumference in those with oedema decreased by 2 cm (95% CI 1.7-2.3, P <0.05). Patient-assessed mean percentage decrease in symptom intensity was 32.3 for cramps (28.9-35.7, P <0.01); 32.4 for heaviness (29.8-35.7, P <0.01); 28.2 for pain (25.6-30.8, P <0.01); and 21.5 for swelling (18.7-24.3, P <0.01). Quality of life improved by 21.7% (16.9-26.5, P <0.01) in the physical domains, 25.9% (20.8-31.0, P <0.01) in the social domains, and 19.2% (14.7-23.7, P <0.01) in the psychological domains. Conclusions: When used alone, MPFF was effective and acceptable for the management of CVIL in primary care. This may be useful in tropical climates where compliance with compression stockings is poor and access to surgery limited.
