Appendix 1

Number of Patients Entered/Number of Drop Outs Daily Dosage of medication Study design Treatment Period (weeks) Results Reference
40/1 HCSE (100 mg escin) – 1 capsule each containing 50 mg escin twice a day Double-blind, randomized; two parallel groups 4 Significant reduction in leg volume of 44 ml in the HCSE group compared to 34 ml reduction for the placebo (P< 0.001) 28
24/2 HCSE (100 mg escin)- 2 capsules each containing 50 mg escin once a day Double-blind, randomized, Crossover NA Significant reduction in Capillary Filtration Coefficient by 22% in the HCSE group compared to placebo (P=0.006) 29
30/2 HCSE (100 mg escin)- 1 capsule each containing 50 mg escin twice a day Double-blind, randomized; Two parallel groups 20 days Significant reduction in leg circumference of 0.8 cm in the HCSE compared to placebo (P< 0.05) 30
40/1 HCSE (150 mg escin) -1 capsule each containing 75 mg escin twice a day Double-blind, randomized; Two parallel groups 6 Significant reduction in leg volume of 84 mlin the HCSE group compared to a reduction of 4 ml in the placebo group (p< 0.01) 31
118/23 HCSE (100mg escin) - 1 capsule each containing 50 mg escin twice a day Double-blind, randomized; Crossover 20 days Significant reduction of calf spasm, pain,fatigue, tenseness for HCSE group as compared to placebo (p< 0.05) 32
80/6 HCSE (100 mg escin)- 1 capsule each containing 50 mg escin twice a day Double-blind, randomized; Two parallel groups 8 Significant reduction in leg volume of 16.5 ml in the HCSE group compared to 3.8 ml in the placebo group. 33
233/7 HCSE (100mg escin)- 1 capsule each containing 50 mg escin twice a day Double-blind, randomized; Crossover 20 days Significant reduction (P<0.05) of edema,leg pain and pruritus with HCSE, as compared to placebo 34
20/n.r. HCSE (100 mg escin)- 1 capsule each containing 50 mg escin twice a day Double-blind, randomized; crossover 2 Reduction in leg volume of 114 ml in the HCSE group compared to 1 ml reduction in the placebo group (P=0.009) 35
Comparison with reference medications
33/3 HCSE (50 mg escin)- 1 capsule once a dayHR* 500 mg/day Double-blind, randomized; two parallel groups 8 Reductions of 0.2 cm and 0.18 cm for ankle circum-ference and calf circum-ference, respectively, for HCSE similar to HR 36
155/18 HCSE (100 mg escin) Vs. HR* (1000mg/d) / HR(1000/500 mg/d) Double-blind, randomized; three-armed parallel groups 12 Reduction in leg volume of 28 ml for HCSE, 58 ml for HR 1000 and 40 ml for HR 1000/500. 37
240/n.r.** HCSE (50 mg escin) Vs. compression therapy/placebo Double-blind, randomized; two parallel groups 12 Reduction in leg volume of 43.8 ml, 46.7 ml,and -9.8 in HCSE, comp-ression and placebo group respectively. 19
30/n.r. HCSE (100 mg escin), reference medication was not defined Double-blind, randomized; two parallel groups 4 Reduction in leg circumference by 0.4 cm in the HCSE compared to a reduction of 0.4 cm for rutosides 38
40/n.r. HCSE (150 mg escin) Vs. HR (2000mg/d) Double-blind, randomized; two parallel groups 8 Significant inhibition of edema after provocation in the HCSE group, p value not reported 39
* HR: O-(b-hydroxyethyl)-rutosides, **n.r: not reported



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