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

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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.

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Abbreviations

ASMI:

Appendicular skeletal muscle mass index

DEXA:

Dual-energy X-ray absorptiometry

ED:

Erectile dysfunction

GAD:

Generalized anxiety disorder

IIEF:

International index of erectile function

q ADAM:

Quantitative androgen deficiency in the aging male questionnaire

PHQ:

Patient health questionnaire

SEP:

Sexual encounter profile

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Acknowledgements

The authors would like to acknowledge the contribution of Mr. Sandip Kumar from the information technology department of the Institute of Liver and Biliary sciences, for generating the allocation sequence on computer.

Funding

No funding was taken from any pharmaceutical company and funding was done by the Institute of Liver and Biliary Sciences research fund.

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Authors and Affiliations

  1. Department of Hepatology and Liver Transplantation, Institute of Liver and Biliary Sciences, D1 Vasant Kunj, New Delhi, 110070, India

    Rakesh Kumar Jagdish, Saggere Muralikrishna Shasthry, Rakhi Maiwall, Ankur Jindal, Ashok Choudhary, Vijayaraghavan Rajan, Vinod Arora, Manoj Kumar & Shiv K. Sarin

  2. Department of Urology, Institute of Liver and Biliary Sciences, New Delhi, India

    Ahmed Kamaal

  3. Department of Clinical Nutrition, Institute of Liver and Biliary Sciences, New Delhi, India

    Jaya Benjamin

  4. Department of Clinical Research, Institute of Liver and Biliary Sciences, New Delhi, India

    Ankit Bhardwaj

  5. Department of Biostatistics, Institute of Liver and Biliary Sciences, New Delhi, India

    Guresh Kumar

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  1. Rakesh Kumar Jagdish
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Contributions

RKJ, MK and SKS developed the protocol. RKJ, MK and AB enrolled participants in the study. SMS, AK, JB, RM, AJ, AC, VR and VA reviewed and provided inputs to the protocol and manuscript. Guresh Kumar helped with statistical analysis and protocol development.

Corresponding author

Correspondence to Manoj Kumar.

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Conflict of interest

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 have no conflicts of interest to disclose.

Ethical approval and registration

The study was approved by the Institutional Review Board (IRB) of the Institute of Liver and Biliary Sciences, New Delhi, India, where the study was conducted (Institutional ethical committee number: IEC/2018/60/MA04and the trial is registered at ClinicalTrials.gov with identifier number: NCT03566914.

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Informed consent was taken from the participants and the work was done in accordance with the declaration of Helsinki.

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Jagdish, R.K., Kamaal, A., Shasthry, S.M. et al. Tadalafil improves erectile dysfunction and quality of life in men with cirrhosis: a randomized double blind placebo controlled trial. Hepatol Int 17, 434–451 (2023). https://doi.org/10.1007/s12072-021-10264-w

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