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Kim KS. et al., 2019: Electromagnetic Low-Intensity Extracorporeal Shock Wave Therapy in Patients with Erectile Dysfunction: A Sham-Controlled, Double-Blind, Randomized Prospective Study

Kim KS, Jeong HC, Choi SW, Choi YS, Cho HJ, Ha US, Hong SH, Lee JY, Lee SW, Ahn ST, Moon DG, Bae WJ, Kim SW.
Department of Urology, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Department of Urology, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.
Department of Urology, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Department of Urology, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Department of Urology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Department of Urology, Hanyang University College of Medicine, Seoul, Korea.
Department of Urology, Korea University College of Medicine, Seoul, Korea.
Catholic Integrative Medicine Research Institute, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Catholic Integrative Medicine Research Institute, College of Medicine, The Catholic University of Korea, Seoul, Korea.

Abstract 

PURPOSE:
The aim of the present study was to evaluate the efficacy and safety of the electromagnetic-type low-intensity extracorporeal shock wave therapy (Li-ESWT) in patients with erectile dysfunction (ED).

MATERIALS AND METHODS:
The randomized, sham-controlled, double-blind prospective study was performed at two referral hospitals. Participants were randomized in a 1:1 ratio to receive sham or Li-ESWT for 6 weeks. ED was evaluated at screening and at 4 and 7 weeks after treatment. Participants were asked to complete the international index of erectile function-erectile function (IIEF-EF) domain questionnaire, erection hardness scale (EHS), and sexual encounter profile questionnaire (SEPQ 2 and 3). The development of complications was investigated.

RESULTS:
Eighty-one of 96 patients completed the study. The median change in the IIEF-EF score in the Li-ESWT and sham groups was 5.1 and -2.2 (p<0.001), respectively, at the 7-week follow-up; 47.4% (18/38) patients had EHS <3, of which 77.8% (14/18) showed significant improvement in virtue of Li-ESWT treatment (p=0.001). A significant improvement was observed in the percentage of "Yes" responses to SEPQ2 and 3 in the Li-ESWT group vs. sham group from baseline to 7-week follow-up (91.3% vs. 69.4%; p=0.008 and 50.0% vs. 14.3%; p=0.002, respectively). No patients reported pain or other adverse events during treatment or follow-up.

CONCLUSIONS:
Thus, Li-ESWT could have a role in improving erectile function. Furthermore, it is safe. We believe that Li-ESWT is an attractive new treatment modality for patients with ED.
2019 Nov 19. doi: 10.5534/wjmh.190130. [Epub ahead of print] FREE ARTICLE

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Comments 1

Peter Alken on Friday, March 06 2020 08:30

Hmm!? Good conclusion.
It is common to present data in a way that they make a good impression
The Erection Hardness Score (EHS) (1) uses a 5 point scale:
0: Penis does not enlarge.
1: Penis is larger but not hard.
2: Penis is hard but not hard enough for penetration.
3: Penis is hard enough for penetration but not completely hard.
4: Penis is completely hard and fully rigid. ≥ 3
In the present study there was a positive effect in the treatment group.
EHS Li-ESWT
n = 38 Sham
n = 43 p-value
Baseline 0.194
of the patients had a baseline value equivalent to the value achieved after the treatment. So why were they treated?
In addition I was surprised not to see a positive placebo effect in something so delicate like erectile dysfunction. Rhinoceros powder is said to have a good placebo effect. Here there was a deterioration of the EHS and the IIEF-EF in the sham group. The IIEF-EF decreased from 16.7±3.2 at baseline to 14.5±5.4 at 7 weeks.

The group has also published a paper on the positive effects of ESWT and/or a Korean herbal compound on ED in animal experiments (2).

1. Mulhall JP et al. Validation of the erection hardness score. J Sex Med. 2007 Nov;4(6):1626-34
2. Jeong HCet al. Synergistic effects of extracorporeal shockwave therapy and modified Ojayeonjonghwan on erectile dysfunction in an animal model of diabetes. Investig Clin Urol 2019;60:285-94.

Hmm!? Good conclusion. It is common to present data in a way that they make a good impression The Erection Hardness Score (EHS) (1) uses a 5 point scale: 0: Penis does not enlarge. 1: Penis is larger but not hard. 2: Penis is hard but not hard enough for penetration. 3: Penis is hard enough for penetration but not completely hard. 4: Penis is completely hard and fully rigid. ≥ 3 In the present study there was a positive effect in the treatment group. EHS Li-ESWT n = 38 Sham n = 43 p-value Baseline 0.194 of the patients had a baseline value equivalent to the value achieved after the treatment. So why were they treated? In addition I was surprised not to see a positive placebo effect in something so delicate like erectile dysfunction. Rhinoceros powder is said to have a good placebo effect. Here there was a deterioration of the EHS and the IIEF-EF in the sham group. The IIEF-EF decreased from 16.7±3.2 at baseline to 14.5±5.4 at 7 weeks. The group has also published a paper on the positive effects of ESWT and/or a Korean herbal compound on ED in animal experiments (2). 1. Mulhall JP et al. Validation of the erection hardness score. J Sex Med. 2007 Nov;4(6):1626-34 2. Jeong HCet al. Synergistic effects of extracorporeal shockwave therapy and modified Ojayeonjonghwan on erectile dysfunction in an animal model of diabetes. Investig Clin Urol 2019;60:285-94.
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