Long-term treatment of chronic venous insufficiency of the leg with micronized purified flavonoid fraction in the primary care setting of India

Abstract

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.

Medicamentous treatment of chronic venous insufficiency using semisynthetic diosmin: A prospective study

“…The professions requiring long -lasting passive static load may be considered a significant risk factor for HVI. The duration of the symptoms of the patients included in our study varied (3 to 38 years), which is also consistent with other studies 9 . Similarly, HVI is more frequent among patients with a positive family history 2,5,11 .…”

“…Pinjala et al 9 reported that purified flavonoid fraction administered for 6 months to 308 patients with HVI resulted in regression of CEAP stage (53.9%), did not change CEAP stage but decreased the symptoms (29.5%), did not change CEAP but resulted in a deterioration of the symptoms (8.1%), and finally resulted in a progression of CEAP stage (8.5%). The results of this study show that semi synthetic diosmin significantly improves CEAP classification of HVI for patients treated for a month (Table 4, Graph 3), which is more beneficial compared with the research of purified flavonoid fraction 9 . It was also demonstrated that semi synthetic diosmin decreased the capillary filtration rate for patients with HVI, with consequent reduction of oedema and clinical improvement 12 .…”

A consensus statement – part I. Recommendations for the management of chronic venous disease (CVD) in India and the key role of primary care doctors

“…1) [9]. • In a prospective observational study of six months (No. of patients = 308) involving 11 major cities of India, it was found that CVD was more prevalent at the age of 42.9 ±11.5 years [10]. • Chronic venous disease tends to affect women more than men.…”

“…The prevalence of CVD in India is estimated at 42.4% in males and 57.6% in females (Fig. 2) [10]. • The most common symptoms at the time of presentation in CVI patients were lower limb pain, swelling, heaviness, and cramps.…”

“…• The most common symptoms at the time of presentation in CVI patients were lower limb pain, swelling, heaviness, and cramps. Observed symptom intensity was 1.5 ±0.8 for swelling, 1.5 ±0.8 for pain, 1.8 ±0.7 for heaviness, and 1.5 ±0.9 for cramps [10]. • Quality of life (QoL) can be considerably compromised in patients who are suffering from chronic venous insufficiency [11].…”