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[Treatment of chronic ischemia of the lower extremities with complex herbal preparation]
1Oddziału Klinicznego Chorób Zawodowych Instytutu Farmakologii i Toksykologii Pomorskiej Akademii Medycznej.
Insights
PADMA-28 significantly improved walking distance for patients with chronic lower extremity ischemia. This herbal preparation also positively impacted blood lipid profiles and platelet aggregation without adverse effects.
Area of Science:
- Vascular Medicine
- Pharmacology
- Herbal Medicine
Background:
- Chronic ischemia of lower extremities, often due to atherosclerosis, causes intermittent claudication.
- Current treatments for intermittent claudication may lead to adverse therapeutic effects.
- PADMA-28 is a vegetable preparation investigated for its efficacy in managing chronic lower extremity ischemia.
Purpose of the Study:
- To evaluate the efficacy and safety of PADMA-28 in patients with chronic lower extremity ischemia (Fontaine stage II).
- To assess the impact of PADMA-28 on claudication distance and key biochemical markers.
- To compare the effects of PADMA-28 with a placebo in a double-blind, randomized study.
Main Methods:
- A double-blind, randomized study involving 100 patients with Fontaine stage II chronic lower extremity ischemia.
- Participants were treated with either PADMA-28 (n=50) or placebo (n=50) for 16 weeks.
- Claudication distance was measured on a standardized ergometer-treadmill; biochemical parameters (lipid profile, platelet aggregation) were assessed.
Main Results:
- PADMA-28 significantly increased claudication distance compared to placebo.
- Treatment with PADMA-28 led to a decrease in platelet aggregation, cholesterol, triglycerides, total lipids, and beta-lipoproteins.
- An increase in alpha-lipoproteins was observed in the PADMA-28 group.
- No undesirable effects were reported, and drug tolerance was excellent.
Conclusions:
- PADMA-28 demonstrates significant efficacy in improving walking capacity for patients with chronic lower extremity ischemia.
- The preparation positively modulates lipid metabolism and reduces platelet aggregation.
- PADMA-28 is a safe and well-tolerated adjuvant therapy for chronic lower extremity ischemia (Fontaine stage II).
Abstract:
Chronic ischemia of the lower extremities with atherosclerosis background is being manifested by intermittent claudication. For treating the intermittent claudication many drugs are used, which may give rise to therapeutical side effects. In 50 patients with diagnosed arteriosclerosis affecting the lower extremities in II stage according to Fontain, a vegetable preparation PADMA-28 was applied for 16 weeks. A marked, statistically significant elongation of the claudication distance was achieved. That was measured, under standardized condition, on an ergometer-treadmill. Moreover, there was also a decrease in the index of blood platelets aggregation, a drop in the level of cholesterol, triglycerides, total lipids, beta lipoproteins, and an increase in ++alpha lipoproteins. Also 50 patients were receiving placebo for 16 weeks, but no positive results were observed in comparison with preparation PADMA-28. The studies were carried out by the method of double blind test, the latter was accomplished by randomized method. Observation, the performed biochemical examinations did not reveal any undesirable effect. Drug tolerance was excellent. The positive influence of the drug may result from summed action of components contained in the preparation namely: bioflavonoides, salicylates, valepotriates, tannins, phenol acids, ethereal oils and esters of acids. PADMA-28 may be a useful adjuvant to therapeutic methods with regard to chronic ischemia of the lower extremities in II stage, according to Fontain.