Beruflich Dokumente
Kultur Dokumente
I (1994) 4D-43
1994 The Venous Forum of the Royal Society
of Medicine and Societas Phlebologica Scandinavica
ABSTRACT
Introduction
Haemorrhoidal disease is characterized by recurrent
acute congestive episodes of the anal region. The onset
of these episodes is often triggered by mechanical and
vascular factors: arteriovenous shunts may open up
suddenly under certain conditions, such as ingestion of
highly spiced food, alcohol and substances altering the
vasomotor function in the gut and pelvis [1,2].
In addition to hygiene and dietary recommendations,
pharmacological treatment is aimed at treating the
acute haemorrhoidal crisis and preventing relapse [3].
Bioflavonoids, including diosmin, show specific efficacy
in the treatment of haemorrhoidal disease because of
their phlebotonic, capillaroprotective activity and antagonism of the biochemical mediators of inflammation
[4,5].
The present study was carried out to evaluate the
therapeutic efficacy and acceptability of Daflon 500
mg", a purified and micronized flavonoid fraction consisting of diosmin (90%) and hesperidin (10%), in the
treatment of symptoms and signs of a haemorrhoidal
crisis [6].
41
No. of patients
Sex
Age (years)
Mean (SEM)
Range
Weight (kg)
Mean (SEM)
Range
Height (em)
Mean (SEM)
Range
Homogeneity
Dation 500 mg
Placebo
50
27M, 23 F
50
22M, 28 F
44.6 (1.7)
(24-79)
42.6 (1.5)
(23-67)
p=0.389
NS
69.9 (1.6)
(45-103)
68.7 (1.9)
(45-115)
p=0.650
NS
167.5 (1.1)
(152-180)
168.9 (1.2)
(150-189)
p=0.404
NS
p=0.317
NS
Efficacy
M. Cospite
42
Table 5. Side-effects
Daflon 500 mg
Bleeding
0
1
2
3
Anal discomfort
0
1
2
3
Pain
0
1
2
3
Pruritus
0
1
2
3
Proctitis
0
1
2
3
Placebo
Comparison
of groups
Daflon
Placebo
3
2
500mg
19
1
0
0
95
5
0
0
9
4
4
1
50
22
22
6
p=0.OO6
19
26
3
1
39
53
6
2
3
25
16
5
6
51
33
10
p<O.OOl
42
5
2
1
84
10
4
2
8
24
15
3
16
48
30
6
p<O.OOl
21
5
0
0
81
19
0
0
30
48
22
0
p<O.OOl
27
18
2
0
57
38
4
0
17
56
23
4
p<O.OOl
11
5
0
Discussion
43
7. Duhault J, Crastes de Paulet A, et al. Daflon 500 mg: activite
protectrice vis-a-vis des mediateurs biochimiqucs irnpliques dans
la reaction inflammatoire (etudes de pharmacologie et de
pharmacocinetique. Compte rendu d'expertise). 1990.
8. Labrid C, Duhault J, Vix C. Proprietes pharmacologiqucs de
Daflon 500 mg. J Int Med 1987;85 (suppl.):3G-6.
9. Bertrand M, Genissel P, Francois-Bouchard M, Roussie M,
Bertrand M. Absorption de la diosmine chez Ie lapin: interete de
la micronisation. Arteres et Veines 1982;11:163-5.
10. Tsouderos Y. Efficacy of Daflon 500 mg in the treatment of
chronic venous insufficiency. Phlebology 1992;7:(suppI. 2):45-9.
11. Cospite M, Cospite V. Treatment of haemorrhoids with Daflon
500 mg. Phlebology 1992, 7 (suppl. 2): 53-6.