Table 1 Studies with venoactive drugs using water displacement leg/foot volumetry as an efficacy endpoint
From: Water displacement leg volumetry in clinical studies - A discussion of error sources
First author, year of publ. | Patients | Centres | Drug/Reference (No. of patients with data) | Effect (volume) | Comments |
|---|---|---|---|---|---|
Casley-Smith 1988 [33] | CVI Grade [I-]* III (Widmer) * not clear whether I-II was included | Monocentre, hospital. One study country (Australia) | Calcium dobesilate (n = 15), placebo (n = 15). Treatment duration 6 weeks | -85 mL vs. pbo | Change pre-post 4 mL (pbo) SE ca. 27 mL |
Rudofsky 1990 [7] | CVI Grade I-II (Widmer) | Multicentre. One study country (Germany) | Ruscus + hesperidine-methylchalcone (n = 70), placebo (n = 71) Treatment duration 8 weeks | -47 mL vs. pbo (varicosis) -65 mL vs. pbo (postthrombotic syndrome) | Change pre-post ca. +30 mL (pbo) SE* ca. 6 mL |
Vanscheidt 2002a[10] | CVI Grade I-II (Widmer) | Multicentre. One study country (Germany) | Ruscus extract (n = 77), placebo (n = 71) Treatment duration 12 weeks | -21 mL vs. pbo. | Change pre-post +6 mL (pbo) |
Diebschlag 1994[5] | CVI Grade II (Widmer) | Monocentre. One study country (Germany) | Oxerutin 500 and 1000 mg (n = 2 × 20), placebo (n = 20). Treatment duration 12 weeks | -8 and -19 mL vs. pbo (500 and 1000 mg, resp.; corrected diff. vs. less affected leg) | Change pre-post ± 1 mL (pbo) SE* ca. 1 mL |
Unkauf 1996 [9] | CVI Grade II (Widmer) | Multicentre, outpatients. One study country (Germany) | Oxerutin (n = 64), placebo (n = 56); stockings in both groups. Treatment duration 12 weeks | -31 mL vs. pbo | Change pre-post -33 mL (pbo) |
Ihme 1996 [28] | CVI Grade I-II (Widmer) | Monocentre, hospital. One study country (Germany) | Buckwheat herb tea (n = 36), placebo (n = 31). Treatment duration 3 months | -78 mL vs. pbo | Change pre-post +110 mL (pbo) SE* ca. 56 mL. Volumes determined by two different volumetric measurements |
Vanscheidt 2002b[32] | CVI Grade C3-C5 (CEAP) | Multicentre, outpatients. Multinational (Germany, Austria, Switzerland) | Coumarin + troxerutin (n = 113), placebo (n = 113). Treatment duration 16 weeks | -30 mL vs. pbo | SE ca. 12 mL |
Diehm 1996 [6] | CVI mainly Grade I (Widmer) | Multicentre, hospital. Prob. one study country (Germany) | HCSE (n = 95), placebo (n = 46), compression (n = 99). Treatment duration 12 weeks | -54 mL vs. pbo | Change pre-post ca. +10 ± 15 mL (mean ± SE; pbo) and -47 ± 8 mL (compression) |
Diehm 2000 (not published, according to [8]) | CVI Grade II-III (Widmer) | Multicentre, hospital. Prob. one study country (Germany) | HCSE (n = 143), placebo (n = 70), compression (n = 142). Treatment duration 16 weeks | -20 mL vs. pbo | Change pre-post ca. +2 ± 10 mL (mean ± SE* pbo) and -89 ± 10 mL (compression) |
Danielsson 2002[14] | CVI Grade C2-C4 (-C6) (CEAP) | Monocentre, hospital. One study country (Sweden) | Flavonoids (n = 48), placebo (n = 49). Treatment duration 2 months | +7.5 mL vs. pbo | Change pre-post +4 mL (pbo) SE* ca. 4 mL. Volumetry after 20 knee bends |
Kiesewetter 2000 [19] | CVI Grade I-II (Widmer) | Multicentre, outpatients. One study country (Germany) | Red vine leaf extract (360 mg: n = 86; 720 mg: n = 84), placebo (n = 87). Treatment duration 12 weeks | -76 and -100 g vs. pbo (360 and 720 mg, respectively) | Change pre-post ca. +34 g (pbo). SE* ca. 10 g |