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Spivak L. et al., 2019: Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction in Diabetic Patients

Spivak L, Shultz T, Appel B, Verze P, Yagudaev D, Vinarov A.
Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia. Electronic address: .
Medispec Ltd., Gaithersburg, Maryland, USA.
Neuro-urology Unit, Rambam Healthcare Campus, Haifa, Israel.
Department of Neurosciences, Sciences of Reproduction and Odontostomatology, Urology Unit, University of Naples "Federico II", Naples, Italy.
Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.

Abstract

INTRODUCTION: The cause of erectile dysfunction (ED) in diabetic patients is complex and involves both neurogenic and vasculogenic components and is often hard to treat.AIM: To study the effect of low-intensity extracorporeal shock wave therapy (Li-ESWT) therapy ona subgroup of diabetic patients with ED who are responders (PDE5I-R) and non-responders (PDE5I-NR) to phosphodiesterase 5 inhibitors (PDE5I). METHODS: Analysis of pooled data from 5 double-blind, sham-controlled trials was performed. In this sub-analysis, of 350 patients in the PDE5I-R group and with vasculogenic ED, we found 61 patients with diabetes mellitus who underwent LI-ESWT. Another 48 patients (of 53) belonged to the PDE5I-NR group. Baseline efficacy was evaluated with the International Index of Erectile Function-Erectile Function domain questionnaire (IIEF-EF) for the PDE5I-R and with Erection Hardness Score, IIEF-EF, and flow-mediated dilation technique for the PDE5I-NR.MAIN OUTCOME MEASURES: Change in the IIEF-EF score after treatment of diabetes-induced ED with Li-ESWT in the PDE5i-R group vs the PDE5i-NR group. RESULTS: LI-ESWT therapy was found to be effective in both subgroups of diabetic patients. Minimally clinical important difference in IIEF-EF score was achieved in 50%, 79.5%, 77.3%, and 65.9% of the subjects in the active group in after the sixth shockwave (SW) treatment evaluation (just before initiating the seventh SW session) and at 1 month, 6 months, and 12 months after the last SW treatment, respectively. The difference among the groups was significant (P < .05) after the sixth treatment and in all the follow-up periods. In the PDE5I-NR group, 55% of the active group were converted to PDE5I-5-R after LI-ESWT. The difference between the active and sham groups was statistically significant in all the tested measures (P < .001). CONCLUSION: LI-ESWT is safe and effective for the treatment of ED in PDE5I-R and PDE5I-NR groups. Spivak L, Shultz T, Appel B, et al. Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction in Diabetic Patients. Sex Med Rev 2019;XX:XXX-XXX
Sex Med Rev. 2019 Aug 1. pii: S2050-0521(19)30072-1. doi: 10.1016/j.sxmr.2019.06.007. [Epub ahead of print]

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Comments 1

Peter Alken on Friday, December 20 2019 08:15

The conclusion is simple and straight forward: ”LI-ESWT is safe and effective for the treatment of ED in PDE5I-R and PDE5I-NR groups.”
This is a post-hoc analysis of pooled data of 5 different studies. Data dredging is another word used for statistic based reevaluation of data generated to verify or falsify a new, different hypothesis generated from the results.
One study the authors refer to is a systematic review and meta-analysis. One study concludes that diabetic patients were those who most frequently failed during long term follow up.
The results of sham treated patients are used after cross-over to active treatment to statistically secure results of active treatment:
“The second group included 48 patients in the PDE5I-NR group who were actively treated and 13 patients who received sham treatment in the same fashion as described above
All patients were offered a second course of 12 LI-ESWT active treatments before un-blinding after 1 month of follow-up. For the sake of statistical power, all patients who received full active treatment sessions (those who were previously treated with sham and those who were not) were considered as 1 group.” There is no way the reader can get an idea about confounding factors.

The author state:” Recent randomized controlled studies have shown that LI-ESWT may become the first choice in non-invasive treatment for patients with ED (1). The promising results after the extensive research in this field in the last decade have led to inclusion of LI-ESWT for ED in the 2018 European Association of the Urology guidelines for male sexual dysfunction.” And at another paragraph they state: “The meta-analysis performed by Clavijo and colleagues (2) concluded that the current evidence-based clinical level on electrohydraulic-induced SWs via the ED1000 device is 1A; therefore, the LI-ESWT applied via the ED1000 device based on hundreds of patients included in randomized controlled trials, as well as open-label trials, is safe and effective.”

The concluding statement in the guidelines is: However, the publication of unequivocal evidence from additional RCTs and longer-term follow-up would provide more confidence regarding the use of LI-SWT (including detailed number of pulses per patient, treatment protocols) for ED patients. Therefore clear and definitive recommendations cannot be given (1, 2).”
The references 1 and 2 are obviously interpreted very different by the present authors and in the guidelines.
The authors report no conflicts of interest. One of the authors who is the leading person in study conception and design and data acquisition is employee of the company producing the device used in all studies evaluated.

The interested reader should study the original publication and references himself because I confess that I dislike this publication and my comment may be unfair.

The conclusion is simple and straight forward: ”LI-ESWT is safe and effective for the treatment of ED in PDE5I-R and PDE5I-NR groups.” This is a post-hoc analysis of pooled data of 5 different studies. Data dredging is another word used for statistic based reevaluation of data generated to verify or falsify a new, different hypothesis generated from the results. One study the authors refer to is a systematic review and meta-analysis. One study concludes that diabetic patients were those who most frequently failed during long term follow up. The results of sham treated patients are used after cross-over to active treatment to statistically secure results of active treatment: “The second group included 48 patients in the PDE5I-NR group who were actively treated and 13 patients who received sham treatment in the same fashion as described above All patients were offered a second course of 12 LI-ESWT active treatments before un-blinding after 1 month of follow-up. For the sake of statistical power, all patients who received full active treatment sessions (those who were previously treated with sham and those who were not) were considered as 1 group.” There is no way the reader can get an idea about confounding factors. The author state:” Recent randomized controlled studies have shown that LI-ESWT may become the first choice in non-invasive treatment for patients with ED (1). The promising results after the extensive research in this field in the last decade have led to inclusion of LI-ESWT for ED in the 2018 European Association of the Urology guidelines for male sexual dysfunction.” And at another paragraph they state: “The meta-analysis performed by Clavijo and colleagues (2) concluded that the current evidence-based clinical level on electrohydraulic-induced SWs via the ED1000 device is 1A; therefore, the LI-ESWT applied via the ED1000 device based on hundreds of patients included in randomized controlled trials, as well as open-label trials, is safe and effective.” The concluding statement in the guidelines is: However, the publication of unequivocal evidence from additional RCTs and longer-term follow-up would provide more confidence regarding the use of LI-SWT (including detailed number of pulses per patient, treatment protocols) for ED patients. Therefore clear and definitive recommendations cannot be given (1, 2).” The references 1 and 2 are obviously interpreted very different by the present authors and in the guidelines. The authors report no conflicts of interest. One of the authors who is the leading person in study conception and design and data acquisition is employee of the company producing the device used in all studies evaluated. The interested reader should study the original publication and references himself because I confess that I dislike this publication and my comment may be unfair.
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