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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