Affiliation:
1. Department of Vascular Surgery, Shanghai Ninth People’s Hospital, School of Medicine, Shaihai JiaoTong Univeresity, Shanghai, China
2. Vascular Center of Shanghai JiaoTong University, Shanghai JiaoTong University, Shanghai, China
3. Drug Clinical Trial Institution, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai JiaoTong University, Shanghai, China
Abstract
Background Endovenous interventions and minimally invasive procedures are effective in the management of varicose veins. However, they can cause postoperative discomfort. Objective To evaluate the clinical efficacy of sodium aescinate (SA) in improving edema, pain, vein-specific symptoms, and quality of life in patients following endovenous laser ablation (EVLA) for varicose veins. Methods In this single-center randomized controlled trial (RCT), patients were allocated into two groups: in Group A, 60 mg SA was administered twice daily for 20 days, and in Group B (control), no venoactive drug was prescribed. The Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification system for chronic venous disorders was used to assess the varicose veins. The circumferences of the calf and ankle were recorded for evaluating edema. The 10-point Visual Analog Scale (VAS), Venous Clinical Severity Score (VCSS), and Aberdeen Varicose Veins Questionnaire (AVVQ) were used to measure the pain intensity, overall varicose vein severity, and patient’s quality of life, respectively. Results The study included 87 patients (mean age, 59.9 ± 10.7 years; 54 men) with CEAP class C2–C5 varicose veins who underwent EVLA and phlebectomy or foam sclerotherapy. The calf circumference recovered quicker in Group A than in Group B by days 10, 21, and 30 (difference from baseline was 1.04 ± 0.35 vs 2.39 ± 1.15 [ p < .001], 0.48 ± 0.42 vs1.73 ± 1.00 [ p < .001], and 0.18 ± 0.64 vs 0.82 ± 0.96 [ p < .001], respectively). The ankle circumference recovered quicker in Group A than in Group B by days 10 and 21 (the difference from baseline was 1.37 ± 0.52 vs 2.36 ± 0.93 [ p < .001] and 0.58 ± 0.60 vs 1.14 ± 0.88 [ p = .002], respectively). Pain relief was achieved quicker in Group A than in Group B (0.257 ± 1.097 [ p = .0863] vs 0.506 ± 1.250 [ p = .0168] by day 21). There were no significant differences in the VCSS and AVVQ scores between both groups. There were no drug-related adverse effects. Conclusions SA, in combination with compression therapy, can relieve edema and alleviate pain in patients following EVLA for varicose veins.
Funder
Fundamental Research Program of 9th People’s Hospital
Shanghai Science and Technology Innovation Action Plan
Shandong Luye Pharmaceutical Co., Ltd