Comment on ‘Efficacy of Tadalafil Monotherapy Versus Combination Therapy with Tamsulosin for Medical Expulsive Therapy of Ureteric Calculi: A Prospective Randomized Study’

Main Article Content

Priti Dhande https://orcid.org/0000-0002-5981-8080
Shuktika Mishra https://orcid.org/0009-0000-3133-0967
Jayshree Dawane https://orcid.org/0000-0002-1170-0454
Sonali Suryawanshi https://orcid.org/0000-0002-5504-5666

Keywords

Tadalafil, Tamsulosin, Ureteric calculi

Abstract

We read with interest the article authored by Joy et al entitled ‘Efficacy of Tadalafil Monotherapy Versus Combination Therapy with Tamsulosin for Medical Expulsive Therapy of Ureteric Calculi: A Prospective Randomized Study.’ [1] The study explores an important clinical question and adds to the existing literature on the effectiveness of medical expulsive therapy (MET) for ureteric calculi. However, certain methodological and reporting aspects require further clarification to facilitate appropriate interpretation of the findings. The study does not provide Institutional Ethics Committee approval details and whether consent was obtained from all participants before enrolment. Inclusion of these details is essential to ensure compliance with accepted ethical reporting standards. [2] The process of randomization, allocation concealment, and implementation has not been described in sufficient detail. The manuscript does not specify how the study medications were procured, whether identical formulations were used across treatment groups, or whether any financial support was received. Furthermore, the manuscript does not describe how the sample size of 165 participants was determined or provide a sample size calculation or power analysis, making it difficult to determine whether the study was adequately powered. These details are important for assessing the potential risk of bias. [3]  The manuscript does not specify statistical tests used for data analysis, despite reporting multiple p-values throughout the results section. Clearly describing the statistical methods is essential for readers to assess the appropriateness, validity, and reproducibility of the findings. [3] The pain score values reported in the discussion section do not appear to correspond with those presented in Table 3. This discrepancy makes it difficult to interpret the findings and raises uncertainty regarding which values were used for interpreting the results and drawing conclusion of the study. Clarification of these inconsistencies would improve the accuracy and transparency of the reported results. Also, lower pain scores generally indicate less pain and better clinical outcomes; however, the discussion appears to interpret these findings in the opposite direction. [4] Table 6 contains an asterisk (*) in the p-value column without any explanatory footnote. In addition, the methods section states that patients who failed to pass the stone after two weeks underwent ureteroscopy, whereas the primary follow-up period described in the study was only ten days. Clarification regarding the follow-up schedule and the criteria used to determine the need for ureteroscopy would improve quality of the manuscript. Several figures appear to duplicate information already presented in the tables, thereby providing limited additional scientific value. According to the International Committee of Medical Journal Editors (ICMJE), figures should complement rather than duplicate tabulated data and should be sufficiently self-explanatory, with detailed legends that enable independent interpretation. In the present study, the figures lack adequate descriptive legends, making them difficult to interpret without referring to the main text. [4] We also observed that the comparison of stone expulsion rates according to stone location presented in Table 6 was reported to be statistically non-significant. However, this finding is not acknowledged in the discussion or conclusion, which primarily emphasize the overall superiority of the intervention. As conclusions should accurately reflect both statistically significant and non-significant findings, acknowledging this result would provide a more balanced interpretation of the study outcomes and help avoid overstatement of the treatment effect. [5] In conclusion, clarification of the statistical methodology, ethical reporting, study conduct, sample size determination, funding and drug procurement, outcome reporting, and presentation of results would strengthen the transparency and scientific rigor of the study. Addressing these issues would improve readers' confidence in the validity and interpretation of the findings.

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References

1. Joy J, Kulkarni PM, Raghunandan M. Efficacy of tadalafil monotherapy versus combination therapy with tamsulosin for medical expulsive therapy of ureteric calculi: a prospective randomized study. J Popul Ther Clin Pharmacol 2026;33(2):34-41
2. World Medical Association. World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human participants. JAMA 2024;332(24):2191-2198.
3. Hopewell S, Chan AW, Collins GS, et al. CONSORT 2025 statement: updated guideline for reporting randomised trials. BMJ 2025;389:e081123.
4. Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, et al. Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage 2011;41(6):1073-1093.
5. International Committee of Medical Journal Editors. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals [Internet]. Updated 2025. Available from: https://www.icmje.org/icmje-recommendations.pdf