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 | |||||
© Sabinsa Corporation 2000