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Man L et al, 2017: Low-Intensity Extracorporeal Shock Wave Therapy for Erectile Dysfunction: a Systematic Review and Meta-Analysis.

Man L, Li G.
Department of Urology, Beijing Jishuitan Hospital, Beijing, 100035, China.

Abstract

OBJECTIVE: To use systematic review and meta-analysis to assess the efficacy of low-energy extracorporeal shockwave therapy (LI-ESWT) for erectile dysfunction (ED) was undertaken with a meta-analysis to identify the efficacy of the treatment modality.
METHODS: A comprehensive search of the PubMed, Cochrane Register and Embase databases to March 2017 was performed for randomized controlled trials reporting on patients with ED treated with LI- ESWT. The International Index of Erectile Function (IIEF) and the Erection Hardness Score (EHS) were the most commonly used tools to evaluate the therapeutic efficacy of LI-ESWT.
RESULTS: There were 9 studies including 637 patients from 2005 to 2017. The meta-analysis revealed that LI-ESWT could significantly improve IIEF (mean difference [MD]: 2.54; 95% CI, 0.83-4.25; p= 0. 004) and EHS (risk difference [RD]: 0.16; 95% CI, 0.03-0.28; p = 0.01)). Therapeutic efficacy could last at least 3 mo (MD: 4.15; 95% CI, 1.40-6.90; p =0.003). Lower energy density(0.09mj/mm2, MD: 4.14; 95% CI, 0.87-7.42; p = 0.01) increased number of pulses (3000 pulses per treatment, MD: 5.11; 95% CI, 3.18-7.05, p < 0.0001) and shorter total treatment courses( <6 weeks, MD: 3.73; 95% CI, 0.54-6.93; p = 0.02) resulted in better therapeutic efficacy.
CONCLUSIONS: These studies suggest that LI-ESWT could significantly improve the IIEF and EHS of ED patients. The publication of robust evidence from additional RCTs and longer-term follow-up would provide more confidence regarding use of LI-ESWT for ED patients.

Urology. 2017 Sep 26. pii: S0090-4295(17)30992-5. doi: 10.1016/j.urology.2017.09.011. [Epub ahead of print]

 

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Comments 1

Peter Alken on Wednesday, 04 April 2018 10:17

In the discussion it says: “Most of the included RCTs did not describe the details of randomization or blinding, and the potential biases involved are unclear. Many studies did not do an analysis of positive results among all participants and rather only evaluated those participants who finished the course of treatments. This effect may have skewed the results to look more favorable since subject dropouts often are those who are not responsive to treatment; such an intent-to-treat analysis was not uniformly done in all of the studies. Thus, their findings are concerning and could impact the results of the meta-analysis as well.”
For a statistician this remark would qualify this metaanalysis as meaningless as the material included did not allow drawing a reliable conclusion.
It is equally difficult to align the two conclusions offered by the authors in the abstract and in the text:
Abstract: “Conclusions: These studies suggest that LI-ESWT could significantly improve the IIEF and EHS of ED patients. The publication of robust evidence from additional RCTs and longer-term follow-up would provide more confidence regarding use of LI-ESWT for ED patients.”
Text: “Conclusion: In this meta-analysis of randomized controlled trials evaluating the effect of LI-ESWT on ED, the improvement in IIEF-EF scores was statistically significant for men who underwent LI-ESWT compared with those who underwent sham therapy. From our review, LI-ESWT may have the potential to be the first-line noninvasive therapy for patients with ED in the near future.” This last sentence has nearly become a standard formula in many superficial research papers.
“… may have the potential … in the near future …” Who would pay for this fortune telling?
As a consequence new metaanalysis on the same topic - which inevitably are bound to come - should only be done - and read! - if and when a new RCT with reliable data is published. The reader is able to identify a good-quality metaanalysis by reading the introduction. There the authors should comment the last available metaanalysis and justify the new, present one by the publication of new available reliable data. This is lacking in the introduction of this paper. Reading is a waste of time.
I recommend instead reading: Fode M, Hatzichristodoulou G, Serefoglu EC, Verze P, Albersen M, Young Academic Urologists Men's Health Group. Low-intensity shockwave therapy for erectile dysfunction: is the evidence strong enough? Nat Rev Urol. 2017 Oct;14(10):593-606
and
Fojecki GL, Tiessen S, Sloth Osther PJ. Effect of Linear Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction-12-Month Follow-Up of a Randomized, Double-Blinded, Sham-Controlled Study. Sex Med. 2017 Dec 21. doi:10.1016/j.esxm.2017.09.002.
This publication should be added to the next metaanalysis on this topic.

In the discussion it says: “Most of the included RCTs did not describe the details of randomization or blinding, and the potential biases involved are unclear. Many studies did not do an analysis of positive results among all participants and rather only evaluated those participants who finished the course of treatments. This effect may have skewed the results to look more favorable since subject dropouts often are those who are not responsive to treatment; such an intent-to-treat analysis was not uniformly done in all of the studies. Thus, their findings are concerning and could impact the results of the meta-analysis as well.” For a statistician this remark would qualify this metaanalysis as meaningless as the material included did not allow drawing a reliable conclusion. It is equally difficult to align the two conclusions offered by the authors in the abstract and in the text: Abstract: “Conclusions: These studies suggest that LI-ESWT could significantly improve the IIEF and EHS of ED patients. The publication of robust evidence from additional RCTs and longer-term follow-up would provide more confidence regarding use of LI-ESWT for ED patients.” Text: “Conclusion: In this meta-analysis of randomized controlled trials evaluating the effect of LI-ESWT on ED, the improvement in IIEF-EF scores was statistically significant for men who underwent LI-ESWT compared with those who underwent sham therapy. From our review, LI-ESWT may have the potential to be the first-line noninvasive therapy for patients with ED in the near future.” This last sentence has nearly become a standard formula in many superficial research papers. “… may have the potential … in the near future …” Who would pay for this fortune telling? As a consequence new metaanalysis on the same topic - which inevitably are bound to come - should only be done - and read! - if and when a new RCT with reliable data is published. The reader is able to identify a good-quality metaanalysis by reading the introduction. There the authors should comment the last available metaanalysis and justify the new, present one by the publication of new available reliable data. This is lacking in the introduction of this paper. Reading is a waste of time. I recommend instead reading: Fode M, Hatzichristodoulou G, Serefoglu EC, Verze P, Albersen M, Young Academic Urologists Men's Health Group. Low-intensity shockwave therapy for erectile dysfunction: is the evidence strong enough? Nat Rev Urol. 2017 Oct;14(10):593-606 and Fojecki GL, Tiessen S, Sloth Osther PJ. Effect of Linear Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction-12-Month Follow-Up of a Randomized, Double-Blinded, Sham-Controlled Study. Sex Med. 2017 Dec 21. doi:10.1016/j.esxm.2017.09.002. This publication should be added to the next metaanalysis on this topic.
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