Scandinavian Journal of Primary Health Care
ISSN: 0281-3432 (Print) 1502-7724 (Online) Journal homepage: http://www.tandfonline.com/loi/ipri20
Oestriol in the Prophylactic Treatment of Recurrent Urinary Tract Infections in Postmenopausal Women Anne Luise Kirkengen, Per Andersen, Einar Gjersøe, Grethe Riis Johannessen, Nils Johnsen & Egil Bodd To cite this article: Anne Luise Kirkengen, Per Andersen, Einar Gjersøe, Grethe Riis Johannessen, Nils Johnsen & Egil Bodd (1992) Oestriol in the Prophylactic Treatment of Recurrent Urinary Tract Infections in Postmenopausal Women, Scandinavian Journal of Primary Health Care, 10:2, 139-142, DOI: 10.3109/02813439209014051 To link to this article: http://dx.doi.org/10.3109/02813439209014051
© 1992 Informa UK Ltd All rights reserved: reproduction in whole or part not permitted Published online: 12 Jul 2009.
Submit your article to this journal
Article views: 117
View related articles
Citing articles: 3 View citing articles
Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=ipri20 Download by: [176.126.252.11]
Date: 22 March 2016, At: 18:09
Scand J Prim Health Care 1992; 10: 139-142
Oestriol in the Prophylactic Treatment of Recurrent Urinary Tract Infections in Postmenopausal Women ANNE LUISE KIRKENGEN', PER ANDERSEN', EINAR GJERSBE', GRETHE RIIS JOHANNESSEN3, NILS JOHNSEN4 and EGIL BODD3 'Department of Medicine, 'General Surgery, Red Cross Clinic; 'Private Practice and 'Frogner Public Healrh Center, Oslo, Norway
Downloaded by [176.126.252.11] at 18:09 22 March 2016
Kirkengen AL, Andersen P, G j e m E, Johannessen GR, Johnsen N, Bodd E. Oestriol in the prophylactic treatment of recurrent urinary tract infections in postmenopausal women. Scand J Prim Health Care 1992; 1 0 13942. A black randomized, double-blind, group-comparative, placebo-controlled study was conducted to assess the effect of oestriol on recurrent urinary tract infections in postmenopausal women. 40 women, median age 78 years (66-91), 20 in each group, were treated with oestriol three mg p.0. per day or corresponding placebo for four weeks, followed by one mg per day for eight weeks. The main response parameter was the number of urinary tract infections per week in the two treatment periods. Both oestriol and placebo reduced the number of infections per week significantly in both periods, compared with the pretreatment period. There was no difference between oestriol and placebo treatment in the first period. In the second period, however, oestriol treatment was significantly more effective than placebo (p = 0.05). Correspondingly, there was a significant difference between the two groups in the vaginal pH at the end of the study (p < 0.05). We conclude that oestriol reduces recurrent urinary tract infections in postmenopausal women. Key words: postmenopausal women, recurrent urinary tract infections, oestriol as prophylaxis. Anne Luise Kirkengen, MD, Behrensgt 8, 0257 Oslo, Norway.
Urogenital complaints such as vaginal dryness, itching, dyspareunia, urinary incontinence, and recurrent urinary tract infections (UTI) are frequent in elderly women. Iosif and Beckassy reported that one o r more of these symptoms were present in 50% of a cohort of 61-year-old Swedish women (1). The frequency of these symptoms also increases with increasing age (2). Urogenital complaints are caused by postmenopausal oestrogen deficiency, which leads to atrophy of the vaginal and urethral mucosa and to atrophy of the connective tissue in the lower abdominal area. Thereby the slightly acid environment in the vagina (normal during the fertile period) disappears, favouring good growing conditions for faecal gram negative bacteria (3). Oestriol is the dominant oestrogen in pregnant women. When used in recommended dosages, it does not have any effect on the endometrium. Seri-
ous side-effects have not been reported. A Swedish consensus meeting stated that there seemed to b e no contraindications to the use of oestriol in recommended dosages, with the possible exception of recently diagnosed breast cancer (4). This was confirmed by a Norwegian consensus conference (5), and it was suggested that use of oestriol without prescription should be discussed. Previous studies have documented that oestriol treatment reverses the atrophic changes described above (6). It has also been shown that oestriol treatment results in recolonization of the postmenopausal vagina by lactobacilli, and in reduced use of antibiotics in these women (7). A reduction in the number of UTI has also been reported (8). However, a prophylactic effect of oestriol on UTT in postmenopausal women has yet to be investigated in a doubleblind placebo-controlled trial. This was the aim of the present study. Scand I Prim Healrh Care 1992; I0
140
A. L. Kirkengen et al. study design
{
7
OESTRIOL 3 ma/W
L
~
0
~
1 ‘ 2
3
OESTRIOL 1 mg/day
4
~
5
1
1
6
7
8
1
9
1
1
1011
l
l
12weeks
{ PLACEBO 7PLACEBO -tablewday tabletlday 1
3
I
l
l
l
l
l
l
l
l
l
l
0
1
2
3
4
5
6
7
8
9
1011
Th ShldV dS0 IndUJed h
l
l 12weeks
4 P M m S nd
Fig. I. Distribution of oestriol and placebo in the two groups from week 0 to week 12.
Downloaded by [176.126.252.11] at 18:09 22 March 2016
PATIENTS AND METHODS Patients Two groups of postmenopausal women were included in the study: in-patients at the Red Cross Clinic and patients being treated by general practitioners in Oslo, referred to as GP-patients. The inclusion criteria were recurrent UTI (see below), alkaline vaginal pH, and treatment of current UTI with antibiotics (before inclusion). Patients with thromboembolic disease, known or suspected oestrogen-dependent tumours, or vaginal bleeding of unknown origin were not included in the study. Recurrent UTI was defined as at least one episode with a recidive within two weeks or at least three episodes during the previous year.
single morning dose, 3 mg/day during the first four weeks and 1 mg/day during the last eight weeks of the treatment period (Fig. 1). Before inclusion, the patients underwent cardiol l pulmonary, breast, and gynaecological examinations. These procedures were repeated after week 12 of the trial. Urine for bacteriological examination was sampled before inclusion and after weeks four, eight, and twelve. Vaginal p H was measured before inclusion, after four weeks’ treatment, and at the end of the treatment period. To ensure correct recruitment of available patients and a precise registration of infections, the nursing staff at the Red Cross Clinic and at the Home Services were informed about the study both at a staff meeting and by written instructions. The main response parameter was the number of bacteriologically verified UTI per week during the treatment period. Possible adverse effects were recorded after week four and twelve.
Study Design Any prophylactic treatment with chemotherapeutics was stopped at least two weeks before inclusion. After inclusion, the patients were block randomized and then followed during a four-week pretreatment period before they received oestriol o r matching placebo. Oestriol (Ovesterin “Organon”) was given as a
Statistical evaluation Both mean and median values were used to estimate distribution parameters. The 95% confidence limits for the mean value were estimated according to the Student procedure. Two-sided tests were used, and the chosen level of significance was similar to or less than 0.05. Sign tests were used to identify changes in number of infections. The chi-square test was used in the analysis of contingency tables. Fisher’s exact test was used to compare the change in the number of infections between oestriol and placebo. Changes in pH were tested by using the Wilcoxon rank test. Whenever hospitalized and GP-patients were analysed as one group, corrections were made for possible differences between the two groups.
Table I. Number of patients with 0, I or 2 UTI receiving oestriol (n = 20).
Table 11. Number of patients with 0, I or 2 UTI receivingplacebo (n = 20).
Week Week0-4 -4-0 0 1 2
Week Week0-4 -4-0 0 1 2
0 1
2 Total
3 8 2 13
1 2 4 7
0 0 0 0
Total 4
10 6 20
Week Week 5-12 -4-0 0 1 2 0 1 2 Total
Scand J Prim Health Care 1992: 10
2 10 3 15
2 0 2 4
Total
0
4
0 1 1
10 6 20
0 1 2
Total
3 8 0 11
1 4 3 8
Total
0 4 1 1 3 0 3 1 20
Week Week 5-12 -4-0 0 1 2 0 1
2 Total
Total
4
0
8 0 12
4 0
0 4 1 1 3 3 3
4
4
20
Oestriol in rhe prophylactic treatment Table 111. Change in the number of UTI in the oestrio1 - (n = 20) and the placebo-treated group (n = 20). Week 0-4 More/
Week 5-12 More/
Fewer
Oestriol
Placebo Total
Fewer
Unchanged
Unchanged
6 9
14 11
5 12
15 8
15
25
17
23
RESULTS
Downloaded by [176.126.252.11] at 18:09 22 March 2016
44 patients entered the trial, but four dropped out for reasons not related to treatment: one was discharged from hospital without trial medication, one died of myocardial infarction four weeks after inclusion, and the scheduled follow up by the home nurse failed in the other two patients. Three of these patients, all in the hospital group, were receiving oestriol. The final analysis was therefore based on 40 patients, 19 in hospital and 21 GP-patients. Median age was 78 years (61-91 years). 20 patients, 9 hospitalized and 11 GP-patients, received oestriol. 20 patients, 10 hospitalized and 10 GP-patients, received placebo. There were no differences between the patients receiving oestriol or placebo regarding age, the mean age being 75.4 years (61-90) in the oestriol group and 79.9 years (64-91) in the placebo group. The frequency of UTI did not differ significantly between t h e oestriol and placebo groups in any of the registered periods of time, nor did it differ between hospitalized and GP-patients. In the pretreatment period, the total numbers of UTI were 22 in the oestriol group and 19 in the placebo group. Dur-
141
ing the first four weeks of treatment the number of episodes of UTI was seven in seven oestriol patients and ten in nine placebo patients. The corresponding numbers in the last eight weeks of treatment were six (in five oestriol patients) and 12 (in eight placebo patients). Table I shows the number of infections in the two treatment periods with oestriol related to the number of infections in the pre-treatment period. Corresponding figures for placebo are shown in Table 11. Both oestriol and placebo reduced the number of UTI significantly (p < 0.05) in both treatment periods, when compared with the pre-treatment period. The change in number of UTI in the oestriol and placebo treated groups from the pre-treatment period to the two periods of active treatment is shown in Table 111. No significant differences were found between oestriol and placebo in the change of number of infections from the pre-treatment period to the first period of active treatment. At the end of the second treatment period, however, 15 oestriol patients were improved and 5 were unchanged or worse, compared with the pre-treatment period. The corresponding figures for placebo were 8 and 12. The difference between oestriol and placebo was statistically significant (p = 0.05). Vaginal pH was measured in 13 patients treated with oestriol and 17 with placebo at the beginning of week 1 and at the end of week 12 of the trial. In the oestriol group pH decreased from 6.5 in week 1 to 5.5 in week 12. The corresponding changes for placebo were 6.6 and 6.5 (Table IV). The differences in pH between oestriol- and placebotreated patients were statistically significant both regarding the pH in week 12 (p < 0.01) and the difference in pH between week 1 and 12 (p = 0.04) (Fig. 2). No adverse reactions were reported.
Table IV. Vaginal pH measurements in oestriol and placebo patients pre- and post-treatment. Post-treatment
Pre-treatment Oestriol N Mean 95% C.I.M.
SD/SEM Median
Placebo
13 17 6.5 6.6 (6.0-7.0) (6.1-7.1) 0.8410.23 0.94/0.23 6.5 7.0 p = 0.42
Oestriol
13 5.5 (5.1-5.9) 0.61/0.17 5.5
Difference Placebo
17 6.5 (6.1-7.0) 0.9310.22 7.0 p < 0.01
Oestriol
13 1 .O (0.3-1.7) 1.08/0.30 1.o
Placebo
17 0.1 ( -0.4-0.5) 0.87/0.2 1 0.0 p = 0.04
Scand J Prim Health Care 1992; 10
142
A. L. Kirkengen et al.
-1
0 Oestrio’ Placebo
I
1 Iosif CS, Beckassy 2. Prevalence of urogenito-symp-
toms in the late menopause. Acta Obstet Gynecol Scand
7
1984;63: 257-60. 2. Molander U, Milsom I, Ekelund P, Mellstrom D. An epidemiological study of urinary incontinence and re-
0
a ? 6
% 5
I
I
I
Pretreatment
,
8
Post-treatment
I
Fig. 2. Mean values (95% confidence limits) of vaginal pH measurements pre- and post-treatment.
Downloaded by [176.126.252.11] at 18:09 22 March 2016
REFERENCES
DISCUSSION Both placebo and oestriol treatment reduced the number of infections in this trial. The good effect of placebo suggests that the pre-treatment period was too short. One infection during this period gives a frequency of 0.25 infections per week which is very high even in these patients. In the present study it was therefore mandatory to look at the difference between the oestriol- and the placebo-treated groups to measure t h e true effect of oestriol. This controlled double-blind trial has confirmed the results of two open studies (7,8) on the effect of oestriol treatment in recurrent UTI. Our results indicate that prophylactic treatment with oestriol reduces the frequency of recurrent UTI in postmenopausal women.
Scand J Prim Health Care 1992; 10
lated urogenital symptoms in elderly women. Maturitas 1990; 12: 51-60. 3. Heimer GM. The urogenital estrogen deficiency syndrome. In: Pharmacologicaltreatment of the climacteric syndrome. National Board of Health and Welfare. Drug, Information Committee, Sweden 1990;3: 23-7. 4. Pharmacological treatment of the climacteric syndrome. Recommendations from the group. In: Pharmacological treatment of the climacteric syndrome. National Board of Health and Welfare. Drug, Information Committee, Sweden 1990; 3: 157-66. 5. GunbjBrud AB,Aanderud SJ, Flottorp S et al. Bruk av astrogen i og etter overgangsalderen. Uttalelsen fra konsensuskonferansen om bruk av estrogen i og etter overgangsalderen. (Use of oestrogen during and after clirnacterium. Report from a consensus conference concerning use of oestrogen during and after climacterium). Soria Mona, Oslo, 27-29 November 1990. Tidsskr Nor Lregeforen 1991;111:75-7. 6 Heimer GM. Oestriol in the postmenopause. Thesis from the Faculty of Medicine, Uppsala University, Sweden 1986: 30. 7. Brandberg A, Mellstrorn D, Samsioe G. Peroral ostriolbehandling ti1 aldre kvinnor med urogenitala infektioner. (Peroral oestriol treatment of elderly women with urogenital infections). Ukartidningen 1985; 82: 3399-401. 8. Privette M, Cade R, Peterson J, Mars D. Prevention of recurrent urinary tract infections in postmenopausal women. Nephron 1988;50: 24-7.
Received February 1991 Accepted December 1991
ISSN: 0281-3432 (Print) 1502-7724 (Online) Journal homepage: http://www.tandfonline.com/loi/ipri20
Oestriol in the Prophylactic Treatment of Recurrent Urinary Tract Infections in Postmenopausal Women Anne Luise Kirkengen, Per Andersen, Einar Gjersøe, Grethe Riis Johannessen, Nils Johnsen & Egil Bodd To cite this article: Anne Luise Kirkengen, Per Andersen, Einar Gjersøe, Grethe Riis Johannessen, Nils Johnsen & Egil Bodd (1992) Oestriol in the Prophylactic Treatment of Recurrent Urinary Tract Infections in Postmenopausal Women, Scandinavian Journal of Primary Health Care, 10:2, 139-142, DOI: 10.3109/02813439209014051 To link to this article: http://dx.doi.org/10.3109/02813439209014051
© 1992 Informa UK Ltd All rights reserved: reproduction in whole or part not permitted Published online: 12 Jul 2009.
Submit your article to this journal
Article views: 117
View related articles
Citing articles: 3 View citing articles
Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=ipri20 Download by: [176.126.252.11]
Date: 22 March 2016, At: 18:09
Scand J Prim Health Care 1992; 10: 139-142
Oestriol in the Prophylactic Treatment of Recurrent Urinary Tract Infections in Postmenopausal Women ANNE LUISE KIRKENGEN', PER ANDERSEN', EINAR GJERSBE', GRETHE RIIS JOHANNESSEN3, NILS JOHNSEN4 and EGIL BODD3 'Department of Medicine, 'General Surgery, Red Cross Clinic; 'Private Practice and 'Frogner Public Healrh Center, Oslo, Norway
Downloaded by [176.126.252.11] at 18:09 22 March 2016
Kirkengen AL, Andersen P, G j e m E, Johannessen GR, Johnsen N, Bodd E. Oestriol in the prophylactic treatment of recurrent urinary tract infections in postmenopausal women. Scand J Prim Health Care 1992; 1 0 13942. A black randomized, double-blind, group-comparative, placebo-controlled study was conducted to assess the effect of oestriol on recurrent urinary tract infections in postmenopausal women. 40 women, median age 78 years (66-91), 20 in each group, were treated with oestriol three mg p.0. per day or corresponding placebo for four weeks, followed by one mg per day for eight weeks. The main response parameter was the number of urinary tract infections per week in the two treatment periods. Both oestriol and placebo reduced the number of infections per week significantly in both periods, compared with the pretreatment period. There was no difference between oestriol and placebo treatment in the first period. In the second period, however, oestriol treatment was significantly more effective than placebo (p = 0.05). Correspondingly, there was a significant difference between the two groups in the vaginal pH at the end of the study (p < 0.05). We conclude that oestriol reduces recurrent urinary tract infections in postmenopausal women. Key words: postmenopausal women, recurrent urinary tract infections, oestriol as prophylaxis. Anne Luise Kirkengen, MD, Behrensgt 8, 0257 Oslo, Norway.
Urogenital complaints such as vaginal dryness, itching, dyspareunia, urinary incontinence, and recurrent urinary tract infections (UTI) are frequent in elderly women. Iosif and Beckassy reported that one o r more of these symptoms were present in 50% of a cohort of 61-year-old Swedish women (1). The frequency of these symptoms also increases with increasing age (2). Urogenital complaints are caused by postmenopausal oestrogen deficiency, which leads to atrophy of the vaginal and urethral mucosa and to atrophy of the connective tissue in the lower abdominal area. Thereby the slightly acid environment in the vagina (normal during the fertile period) disappears, favouring good growing conditions for faecal gram negative bacteria (3). Oestriol is the dominant oestrogen in pregnant women. When used in recommended dosages, it does not have any effect on the endometrium. Seri-
ous side-effects have not been reported. A Swedish consensus meeting stated that there seemed to b e no contraindications to the use of oestriol in recommended dosages, with the possible exception of recently diagnosed breast cancer (4). This was confirmed by a Norwegian consensus conference (5), and it was suggested that use of oestriol without prescription should be discussed. Previous studies have documented that oestriol treatment reverses the atrophic changes described above (6). It has also been shown that oestriol treatment results in recolonization of the postmenopausal vagina by lactobacilli, and in reduced use of antibiotics in these women (7). A reduction in the number of UTI has also been reported (8). However, a prophylactic effect of oestriol on UTT in postmenopausal women has yet to be investigated in a doubleblind placebo-controlled trial. This was the aim of the present study. Scand I Prim Healrh Care 1992; I0
140
A. L. Kirkengen et al. study design
{
7
OESTRIOL 3 ma/W
L
~
0
~
1 ‘ 2
3
OESTRIOL 1 mg/day
4
~
5
1
1
6
7
8
1
9
1
1
1011
l
l
12weeks
{ PLACEBO 7PLACEBO -tablewday tabletlday 1
3
I
l
l
l
l
l
l
l
l
l
l
0
1
2
3
4
5
6
7
8
9
1011
Th ShldV dS0 IndUJed h
l
l 12weeks
4 P M m S nd
Fig. I. Distribution of oestriol and placebo in the two groups from week 0 to week 12.
Downloaded by [176.126.252.11] at 18:09 22 March 2016
PATIENTS AND METHODS Patients Two groups of postmenopausal women were included in the study: in-patients at the Red Cross Clinic and patients being treated by general practitioners in Oslo, referred to as GP-patients. The inclusion criteria were recurrent UTI (see below), alkaline vaginal pH, and treatment of current UTI with antibiotics (before inclusion). Patients with thromboembolic disease, known or suspected oestrogen-dependent tumours, or vaginal bleeding of unknown origin were not included in the study. Recurrent UTI was defined as at least one episode with a recidive within two weeks or at least three episodes during the previous year.
single morning dose, 3 mg/day during the first four weeks and 1 mg/day during the last eight weeks of the treatment period (Fig. 1). Before inclusion, the patients underwent cardiol l pulmonary, breast, and gynaecological examinations. These procedures were repeated after week 12 of the trial. Urine for bacteriological examination was sampled before inclusion and after weeks four, eight, and twelve. Vaginal p H was measured before inclusion, after four weeks’ treatment, and at the end of the treatment period. To ensure correct recruitment of available patients and a precise registration of infections, the nursing staff at the Red Cross Clinic and at the Home Services were informed about the study both at a staff meeting and by written instructions. The main response parameter was the number of bacteriologically verified UTI per week during the treatment period. Possible adverse effects were recorded after week four and twelve.
Study Design Any prophylactic treatment with chemotherapeutics was stopped at least two weeks before inclusion. After inclusion, the patients were block randomized and then followed during a four-week pretreatment period before they received oestriol o r matching placebo. Oestriol (Ovesterin “Organon”) was given as a
Statistical evaluation Both mean and median values were used to estimate distribution parameters. The 95% confidence limits for the mean value were estimated according to the Student procedure. Two-sided tests were used, and the chosen level of significance was similar to or less than 0.05. Sign tests were used to identify changes in number of infections. The chi-square test was used in the analysis of contingency tables. Fisher’s exact test was used to compare the change in the number of infections between oestriol and placebo. Changes in pH were tested by using the Wilcoxon rank test. Whenever hospitalized and GP-patients were analysed as one group, corrections were made for possible differences between the two groups.
Table I. Number of patients with 0, I or 2 UTI receiving oestriol (n = 20).
Table 11. Number of patients with 0, I or 2 UTI receivingplacebo (n = 20).
Week Week0-4 -4-0 0 1 2
Week Week0-4 -4-0 0 1 2
0 1
2 Total
3 8 2 13
1 2 4 7
0 0 0 0
Total 4
10 6 20
Week Week 5-12 -4-0 0 1 2 0 1 2 Total
Scand J Prim Health Care 1992: 10
2 10 3 15
2 0 2 4
Total
0
4
0 1 1
10 6 20
0 1 2
Total
3 8 0 11
1 4 3 8
Total
0 4 1 1 3 0 3 1 20
Week Week 5-12 -4-0 0 1 2 0 1
2 Total
Total
4
0
8 0 12
4 0
0 4 1 1 3 3 3
4
4
20
Oestriol in rhe prophylactic treatment Table 111. Change in the number of UTI in the oestrio1 - (n = 20) and the placebo-treated group (n = 20). Week 0-4 More/
Week 5-12 More/
Fewer
Oestriol
Placebo Total
Fewer
Unchanged
Unchanged
6 9
14 11
5 12
15 8
15
25
17
23
RESULTS
Downloaded by [176.126.252.11] at 18:09 22 March 2016
44 patients entered the trial, but four dropped out for reasons not related to treatment: one was discharged from hospital without trial medication, one died of myocardial infarction four weeks after inclusion, and the scheduled follow up by the home nurse failed in the other two patients. Three of these patients, all in the hospital group, were receiving oestriol. The final analysis was therefore based on 40 patients, 19 in hospital and 21 GP-patients. Median age was 78 years (61-91 years). 20 patients, 9 hospitalized and 11 GP-patients, received oestriol. 20 patients, 10 hospitalized and 10 GP-patients, received placebo. There were no differences between the patients receiving oestriol or placebo regarding age, the mean age being 75.4 years (61-90) in the oestriol group and 79.9 years (64-91) in the placebo group. The frequency of UTI did not differ significantly between t h e oestriol and placebo groups in any of the registered periods of time, nor did it differ between hospitalized and GP-patients. In the pretreatment period, the total numbers of UTI were 22 in the oestriol group and 19 in the placebo group. Dur-
141
ing the first four weeks of treatment the number of episodes of UTI was seven in seven oestriol patients and ten in nine placebo patients. The corresponding numbers in the last eight weeks of treatment were six (in five oestriol patients) and 12 (in eight placebo patients). Table I shows the number of infections in the two treatment periods with oestriol related to the number of infections in the pre-treatment period. Corresponding figures for placebo are shown in Table 11. Both oestriol and placebo reduced the number of UTI significantly (p < 0.05) in both treatment periods, when compared with the pre-treatment period. The change in number of UTI in the oestriol and placebo treated groups from the pre-treatment period to the two periods of active treatment is shown in Table 111. No significant differences were found between oestriol and placebo in the change of number of infections from the pre-treatment period to the first period of active treatment. At the end of the second treatment period, however, 15 oestriol patients were improved and 5 were unchanged or worse, compared with the pre-treatment period. The corresponding figures for placebo were 8 and 12. The difference between oestriol and placebo was statistically significant (p = 0.05). Vaginal pH was measured in 13 patients treated with oestriol and 17 with placebo at the beginning of week 1 and at the end of week 12 of the trial. In the oestriol group pH decreased from 6.5 in week 1 to 5.5 in week 12. The corresponding changes for placebo were 6.6 and 6.5 (Table IV). The differences in pH between oestriol- and placebotreated patients were statistically significant both regarding the pH in week 12 (p < 0.01) and the difference in pH between week 1 and 12 (p = 0.04) (Fig. 2). No adverse reactions were reported.
Table IV. Vaginal pH measurements in oestriol and placebo patients pre- and post-treatment. Post-treatment
Pre-treatment Oestriol N Mean 95% C.I.M.
SD/SEM Median
Placebo
13 17 6.5 6.6 (6.0-7.0) (6.1-7.1) 0.8410.23 0.94/0.23 6.5 7.0 p = 0.42
Oestriol
13 5.5 (5.1-5.9) 0.61/0.17 5.5
Difference Placebo
17 6.5 (6.1-7.0) 0.9310.22 7.0 p < 0.01
Oestriol
13 1 .O (0.3-1.7) 1.08/0.30 1.o
Placebo
17 0.1 ( -0.4-0.5) 0.87/0.2 1 0.0 p = 0.04
Scand J Prim Health Care 1992; 10
142
A. L. Kirkengen et al.
-1
0 Oestrio’ Placebo
I
1 Iosif CS, Beckassy 2. Prevalence of urogenito-symp-
toms in the late menopause. Acta Obstet Gynecol Scand
7
1984;63: 257-60. 2. Molander U, Milsom I, Ekelund P, Mellstrom D. An epidemiological study of urinary incontinence and re-
0
a ? 6
% 5
I
I
I
Pretreatment
,
8
Post-treatment
I
Fig. 2. Mean values (95% confidence limits) of vaginal pH measurements pre- and post-treatment.
Downloaded by [176.126.252.11] at 18:09 22 March 2016
REFERENCES
DISCUSSION Both placebo and oestriol treatment reduced the number of infections in this trial. The good effect of placebo suggests that the pre-treatment period was too short. One infection during this period gives a frequency of 0.25 infections per week which is very high even in these patients. In the present study it was therefore mandatory to look at the difference between the oestriol- and the placebo-treated groups to measure t h e true effect of oestriol. This controlled double-blind trial has confirmed the results of two open studies (7,8) on the effect of oestriol treatment in recurrent UTI. Our results indicate that prophylactic treatment with oestriol reduces the frequency of recurrent UTI in postmenopausal women.
Scand J Prim Health Care 1992; 10
lated urogenital symptoms in elderly women. Maturitas 1990; 12: 51-60. 3. Heimer GM. The urogenital estrogen deficiency syndrome. In: Pharmacologicaltreatment of the climacteric syndrome. National Board of Health and Welfare. Drug, Information Committee, Sweden 1990;3: 23-7. 4. Pharmacological treatment of the climacteric syndrome. Recommendations from the group. In: Pharmacological treatment of the climacteric syndrome. National Board of Health and Welfare. Drug, Information Committee, Sweden 1990; 3: 157-66. 5. GunbjBrud AB,Aanderud SJ, Flottorp S et al. Bruk av astrogen i og etter overgangsalderen. Uttalelsen fra konsensuskonferansen om bruk av estrogen i og etter overgangsalderen. (Use of oestrogen during and after clirnacterium. Report from a consensus conference concerning use of oestrogen during and after climacterium). Soria Mona, Oslo, 27-29 November 1990. Tidsskr Nor Lregeforen 1991;111:75-7. 6 Heimer GM. Oestriol in the postmenopause. Thesis from the Faculty of Medicine, Uppsala University, Sweden 1986: 30. 7. Brandberg A, Mellstrorn D, Samsioe G. Peroral ostriolbehandling ti1 aldre kvinnor med urogenitala infektioner. (Peroral oestriol treatment of elderly women with urogenital infections). Ukartidningen 1985; 82: 3399-401. 8. Privette M, Cade R, Peterson J, Mars D. Prevention of recurrent urinary tract infections in postmenopausal women. Nephron 1988;50: 24-7.
Received February 1991 Accepted December 1991
