Maldonado-Valadez RE. et al., 2022: Efficacy of Adjuvant Tamsulosin for Improving the Stone-Free Rate after Extracorporeal Shock Wave Lithotripsy in Renal Stones: A Randomized Controlled Trial.
Maldonado-Valadez RE, Valdez-Vargas AD, Alvarez JA, Rodea-Montero ER.
Department of Urology, Hospital Regional de Alta Especialidad Del Bajío, Leon, Mexico.
Universidad de Guanajuato, Leon, Mexico.
Department of Research, Hospital Regional de Alta Especialidad Del Bajío, Leon, Mexico.
Abstract
Introduction: Extracorporeal shock wave lithotripsy (ESWL) is an effective treatment for urolithiasis. Tamsulosin is capable of causing dilation and facilitating the migration of stones. The aim of this study is to evaluate the efficacy of adjuvant treatment with tamsulosin for improving the stone-free rate after a single session of ESWL in the treatment of kidney stones.
Methods: This is a randomized, nonplacebo-controlled study with a sample of 60 adults with a single radiopaque kidney stone of 5-20 mm in diameter. After the ESWL session, the patients were divided into two groups. The control group received standard treatment for analgesia consisting of oral diclofenac (75 mg/12 h) as needed. The tamsulosin group received standard treatment for analgesia plus oral tamsulosin (0.4 mg/day) for eight weeks. In both groups, stone-free status was determined using a CT scan eight weeks after ESWL. The protocol of this study was registered with ClinicalTrials.gov, identifier: NCT04819828.
Results: Only 57 patients completed the study (28 tamsulosin and 29 control). Overall, the average stone diameter was 11.42 ± 4.52 mm. The stone-free rate was 50.88% (29 of 57) overall, 53.57% (15 of 28) for the tamsulosin group, and 48.27% (14 of 29) for the control group (p = 0.680). The estimated relative risk in favor of the tamsulosin group to achieve a stone-free status was 1.11 (95% CI 0.67-1.9). The estimated number needed to treat to achieve a single patient with renal stone-free status after eight weeks of ESWL adjuvant treatment with tamsulosin was 19.
Conclusion: Our findings suggest that tamsulosin as adjuvant treatment after a single ESWL session is well tolerated and safe, but it does not increase the stone-free rate in patients with a single radiopaque renal stone of 5-20 mm in diameter. Our results may support the use of tamsulosin with ESWL in the case of patients with a single radiopaque renal stone of 11-20 mm in diameter based on an apparent higher stone-free rate and a low rate of complications.
Int J Clin Pract. 2022 Jan 31;2022:3757588. doi: 10.1155/2022/3757588. eCollection 2022. PMID: 35685573 . Clinical Trial. FREE ARTICLE
Comments 1
The article is published in the International Journal of Clinical Practice, which formerly was an exclusive Wiley journal. It is now an open access journal in a cooperation between Wiley and Hindawi. The impact factor (2021) is 3.149.
For those interested to know how the open publishing business is developing, I recommend to read the author’s instructions (https://www.hindawi.com/journals/ijclp/). Difficult to understand that the acceptance rate is only 16%, which is much lower than that of some classical print journals I know. “Article processing charges (APCs) allow the publisher to make articles immediately available online to anyone to read and reuse upon publication.” The APC is 2100 $.
The present article was on a really fast publishing track: ”Received 11 November 2021; Revised 3 December 2021; Accepted 8 December 2021; Published 31 January 2022” So one would guess that it carries an important message. However, the story on α-blockers and ESWL is very old and such is the material of this study: participants were recruited between 2010 and 2016.
The last sentence of the conclusion on stones is daring. Based a non-significant (p = 0,198) difference of the stone free rate in 8 of 14 cases for the tamsulosin group and 5 of 15 for the control group the authors talk about an apparent higher stone free rate.
The results are neither new nor impressive but the paper may make it into guidelines because of the prospective nature of the study.
Peter Alken