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Original Article

An Open Study to Assess the Safety and Efficacy of Aesculus hippocastanum Tablets (Aesculaforce® 50 mg) in the Treatment of Chronic Venous Insufficiency

(Clinical Researcher) , (Clinical Trial Department Manager) , (Clinical Researcher) , (Head) & (Director)
Pages 19-32 | Published online: 20 Aug 2009
 

Abstract

An open study was carried out to assess, primarily, the safety and tolerability of Aesculus hippocastanum in the treatment of CVI. Patients underwent 8 consecutive weeks of treatment and were asked to take one 50 mg Aesculus hippocastanum tablet, twice daily. In total, 91 adverse events were reported, of which only 4 were rated as probably related to the study drug. Patients judged the tolerability of the study medication in the majority of the cases at visits 2 and 3 (90 and 95%, respectively) to be ‘good’ or ‘fairly good.’ Only 2 patients rated tolerability as poor at visit 3. For each of the symptoms investigated the difference in the median value between baseline and visit 3 was found to be statistically significant and both the ankle and lower leg circumference decreased. The PPG measurements were rejected after analysis since validation measurements carried out after the trial showed that the PPG technique had an internal error of around 30%. Nevertheless, the majority of patients rated efficacy to be ‘very good’ or ‘good,’ with only 10 patients reporting no effect by the end of the study. The results of this study indicate that Aesculaforce(r) 50 mg tablets are a safe, well-tolerated and efficacious treatment for Widmer stage I and II CVI.

Additional information

Notes on contributors

Sylvia Dickson

F. U. Alakbarov is Head Scientific Officer, expert in the Oriental and Folk Medicine, Institute of Manuscripts of the Azerbaijan Academy of Sciences, 8 Istiglaliyat str., Baku, 370001, Azerbaijan.

At the time of writing Liya Davydov was PharmD candidate, College of Pharmacy and Allied Health Professions, St. John’s University. Currently, she is Pharmacy Practice Resident, Mount Sinai Medical Center, New York, NY.

Ila Mehra Harris is Assistant Professor, Department of Pharmaceutical Care & Health Systems, College of Pharmacy, and Clinical Assistant Professor, Department of Family Practice & Community Health, Medical School, University of Minnesota, Minneapolis, MN.

Colin J. Briggs is Professor of Pharmacy, Faculty of Pharmacy, University of Manitoba. Recently he completed a secondment to Health Canada, as Senior Science Advisor in the Therapeutics Products Programme with special responsibility for complementary medicines.

Gemma Briggs is Research Assistant, IMPACT, The Injury Prevention Centre of Children’s Hospital, 501G-715 John Buhler Research Centre, Winnipeg, MB, Canada.

Mary Chavezis Professor of Pharmacy Practice, Director of Complementary Medicine Education and Research, The Center for the Advancement of Pharmacy Practice, Midwestern University, College of Pharmacy Glendale, Glendale, AZ 85308.

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