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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
  1. CVI: Chronic venous insufficiency; SE: Standard error; *: SE estimated from published data on group size and standard deviation; pbo: placebo; CEAP: Clinical Etiological Anatomical Pathophysiological CVI classification; HCSE: Horse chestnut seed extract