Appendix 1

Controlled trials of HCSE in the management of CVI 17,2

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 ml in 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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