Long-term
treatment of chronic venous insufficiency of the leg
with micronized purified flavonoid fraction in the primary
care setting of India
R K Pinjala, T K Abraham, S K Chadha, A A Hai, S A Hussain,
A K Moulik, L F Nagori, G Nayak, M D Patel, G Sen, S
V Shetty and K N Sinha
Abstract
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.
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, athophysiological)
classification of CVIL severity. Secondary outcomes
were changes in leg oedema, symptomintensity and quality
of life.
Of the 308 patients recruited by 72
physicians, 166 (53.9%, 95% confidence interval (CI)
48.3Ð59.5) had regression in the CEAP severity stage.
Mean leg circumference in those with oedema decreased
by 2 cm (95% CI 1.7Ð2.3, P<0.05). Patient-assessed
mean percentage decrease in symptom intensity was 32.3
for cramps (28.9Ð35.7, P<0.01); 32.4 for heaviness
(29.8Ð35.7, P<0.01); 28.2 for pain (25.6Ð30.8,
P<0.01); and 21.5 for swelling (18.7Ð24.3, P<0.01).
Quality of life improved by 21.7% (16.9Ð26.5, P<0.01)
in the physical domains, 25.9% (20.8Ð31.0, P<0.01)
in the social domains, and 19.2% (14.7Ð23.7, P<0.01)
in the psychological domains.
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 com- pression stockings
is poor and access to surgery limited.
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