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Hepatology International
Published in: Hepatology International 2/2023

14-11-2021 | Erectile Dysfunction | Original Article

Tadalafil improves erectile dysfunction and quality of life in men with cirrhosis: a randomized double blind placebo controlled trial

Authors: Rakesh Kumar Jagdish, Ahmed Kamaal, Saggere Muralikrishna Shasthry, Jaya Benjamin, Rakhi Maiwall, Ankur Jindal, Ashok Choudhary, Vijayaraghavan Rajan, Vinod Arora, Ankit Bhardwaj, Guresh Kumar, Manoj Kumar, Shiv K. Sarin

Published in: Hepatology International | Issue 2/2023

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Abstract

Background and aims

Patients with cirrhosis have high prevalence of erectile dysfunction (ED). The aim of this study was to study the efficacy and safety of tadalafil for ED in patients with cirrhosis.

Methods

140 cirrhotic males with ED were randomized into tadalafil 10 mg daily (n = 70) or placebo (n = 70) for 12 weeks. ED was diagnosed if erectile function (EF) domain score was < 25 in International Index of Erectile Function (IIEF) questionnaire. The erectile function domain consists of six questions concerning erection frequency, erection firmness, frequency of partner penetration, frequency of maintaining erection after penetration, ability to maintain erection to completion of intercourse and confidence in achieving and maintaining erection. Primary outcome was proportion of patients having an increase in > 5 points in EF domain of the IIEF. Generalized Anxiety Disorder 7 (GAD-7) questionnaire was used for screening and severity measuring of GAD. The presence of depression was screened using the Patient Health Questionnaire (PHQ-9) and the assessment of health related quality of life was done using the Short Form (36) Health Survey.

Results

At the end of 12 weeks, more patients in tadalafil group achieved > 5 points increase in the EF domain of the IIEF when compared with the placebo group [44(62.9%) vs. 21(30%), p < 0.001]. At the end of 12 weeks, patients receiving tadalafil had significantly more change in scores on the erectile function domain, orgasmic function domain, intercourse satisfaction domain, overall satisfaction domain, erection vaginal penetration rates and successful intercourse; significantly more decline in the GAD-7 and PHQ-9 scores; significantly more improvement in scores of five of the eight domains of SF-36 (general health perception, vitality score, social functioning, role emotional and mental health) and the mental component summary rates when compared with placebo. The development of side effects and the changes in HVPG were not significantly different between the two groups.

Conclusions

Tadalafil therapy may enhance erectile function, improve anxiety, depression and quality of life; and is well tolerated by men with cirrhosis (CTP score < 10) and ED. However, further larger and long-term studies are needed to confirm these results and look for rarer side effects of using tadalafil in patients with cirrhosis.

Trial registration

ClinicalTrials.gov identifier number NCT03566914; first posted date: June 25, 2018.
Appendix
Available only for authorised users
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Metadata
Title
Tadalafil improves erectile dysfunction and quality of life in men with cirrhosis: a randomized double blind placebo controlled trial
Authors
Rakesh Kumar Jagdish
Ahmed Kamaal
Saggere Muralikrishna Shasthry
Jaya Benjamin
Rakhi Maiwall
Ankur Jindal
Ashok Choudhary
Vijayaraghavan Rajan
Vinod Arora
Ankit Bhardwaj
Guresh Kumar
Manoj Kumar
Shiv K. Sarin
Publication date
14-11-2021
Publisher
Springer India
Published in
Hepatology International / Issue 2/2023
Print ISSN: 1936-0533
Electronic ISSN: 1936-0541
DOI
https://doi.org/10.1007/s12072-021-10264-w

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