Phase II clinical study of an association for the treatment of interstitial cystitis (Cystex®).
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Data
2012
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Resumo
Painful bladder syndrome associated with interstitial
cystitis (PBS/IC) is a clinical condition
characterized pelvic pain, urinary urgency, and
urinary frequency. In this study, 22 patients were
assigned to make two visits over a three weeks period.
The patients were randomly, double-blinded
assigned in two groups. The first group received
Cystex® capsules. The second group received
placebo capsules. Two capsules were taken three
times a day away from meals. The change from
baseline in the O’Leary-Sant IC symptom and
problem index was the primary outcome parameter.
Changes in functional bladder capacity and
intensity of pain and urgency have been chosen
as secondary outcome parameters. Mood as well
as physical and sexual activity were rated by 10
questions on a scale 0 to 6. The ratings were analyzed
and the average for each patient in both groups
Cystex® and placebo was determined as the quality
of life index. For the primary outcome there was a
statistically significant difference between the groups.
Mean symptom score-sum decreased from
28.4 to 20.5 in the Cystex® group compared with
29.5 to 26.8 in the placebo group (p<0.05). For the
secondary end points, pain and urgency intensity
improved statistically significantly in the Cystex®
group compared with the placebo group (p<0.05).
The frequency and functional bladder capacity
improved to greater degree in the Cystex® group.
The differences were statistically significant
for comparison of frequency (p<0.05) and not for
functional bladder capacity (p>0.05). In our study, Cystex® enhanced quality of life over the placebo
showing a statistically significant. This trial have
shown that the efficacy and safety of therapy with
Cystex® in the treatment of interstitial cystitis and
is an alternative for patients suffering from this
pathology. Therefore, it can be concluded that the
composition of Cystex®, increased the quality of
life in treated patients.
Descrição
Palavras-chave
Interstitial cystitis, Clinical trial, Painful bladder, Quality of life
Citação
SOUZA, G. H. B. et al. Phase II clinical study of an association for the treatment of interstitial cystitis (Cystex®). Healthmed, v. 6, p. 423-427, 2012. Disponível em: <http://connection.ebscohost.com/c/articles/73311336/phase-ii-clinical-study-association-treatment-interstitial-cystitis-cystex>. Acesso em: 10 jan. 2017.