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Yao H. et al., 2022: Systematic Review and Meta-Analysis of 16 Randomized Controlled Trials of Clinical Outcomes of Low-Intensity Extracorporeal Shock Wave Therapy in Treating Erectile Dysfunction

Yao H, Wang X, Liu H, Sun F, Tang G, Bao X, Wu J, Zhou Z, Ma J.
Department of Urology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, China.
Department of Urology, Beijing TianTan Hospital, Capital Medical University, Fengtai District, Beijing, China.

Abstract

We conducted a meta-analysis to evaluate the efficacy of low-intensity extracorporeal shock wave therapy (LI-ESWT) in the treatment of erectile dysfunction (ED). From July 2011 to June 2021, we finally selected 16 randomized controlled trials (RCTs) including 1,064 participants to evaluate the efficacy of LI-ESWT in the treatment of ED from PubMed, EMBASE, and Cochrane databases. The data are analyzed by Review Manager Version 5.4. Fifteen articles mentioned International Index of Erectile Function (IIEF), in the follow-up of 1 month (mean difference [MD] = 3.18, 95% confidence interval [CI] = [1.38, 4.98], p = .0005), 3 months (MD = 3.01, 95% CI = [2.04, 3.98], p < .00001), and 6 months (MD = 3.20, 95% CI = [2.49, 3.92], p < .00001). After treatment, the improvement of IIEF in the LI-ESWT group was better than that in the control group. Besides, eight of the 16 trials provided data on the proportion of patients with baseline Erectile Hardness Score (EHS) ≤ 2 improved to EHS ≥ 3. The LI-ESWT group was also significantly better than the placebo group (odds ratio [OR] = 5.07, 95% CI = [1.78, 14.44], p = .002). The positive response rate of Questions 2 and 3 of the Sexual Encounter Profile (SEP) was not statistically significant (SEP2: OR = 1.27, 95% CI = [0.70, 2.30], p = .43; SEP3: OR = 4.24, 95% CI = [0.67, 26.83], p = .13). The results of this meta-analysis suggest that treatment plans with an energy density of 0.09 mJ/mm2 and pulses number of 1,500 to 2,000 are more beneficial to IIEF in ED patients. In addition, IIEF improvement was more pronounced in patients with moderate ED after extracorporeal shockwave therapy.
Am J Mens Health. Mar-Apr 2022;16(2):15579883221087532. doi: 10.1177/15579883221087532. PMID: 35319291. FREE ARTICLE

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Comments 1

Jens Rassweiler on Tuesday, 10 May 2022 10:30

The important mechanism of erectile dysfunction (ED) is vascular endothelial function injury or disorder. Low-intensity extracorporeal shock wave therapy (LI-ESWT) can stimulate the expression of angiogenesis-related factors, such as vascular endothelial growth factor (VEGF), so as to promote vascular regeneration. As a result, LI-ESWT has been widely used in clinical treatment of ED. However, until now, it has not yet been approved by the FDA or EMA. This meta-analysis summarizes the results of 16 randomized controlled trials (RCT) on the clinical outcome of Li-ESWT on ED out of a total of 318 publications. For evaluation of the success the International Index of Erectile Function (IIEF), the Erection Hardness Score (EHS) and Sexual Encounter Profile (SEP) were used. Moreover, the length of follow-up was taken into consideration. Finally impact of different levels of energy density (mJ/mm2) and number of impulses were analyzed.
LI-ESWT could significantly increase IIEF and EHS in all ED patients, especially in moderate ED group, but had no significant improvement in positive response rate of SEP2 and SEP3. The use of lower energy density (0.09 vs 0.1- 0.2 mJ/mm2) was better. Interestingly1500 – 2000 impulses should be applied rather than 600 or 3000 SW. The follow-up showed better results after 6 months versus only 1 months. However, long-term follow-up studies are needed.
This is a very interesting study, because it is able to answer various questions. The authors propose the Minimum Clinically Important Difference (MCID) as an ideal method to evaluate the real clinical efficacy and value of an intervention. Concerning the IIEEF score this should be a 4-point difference, which was not reached by all studies. On the other hand, due the design of an RCT-trial any statistical difference should be taken into consideration (see Forest Plot). It is a real dilemma, that despite the clear evidence about positive effects of Li-ESWT on ED, until now the treatment has not be approved by the health authorities.
For the design of future studies, it should be clarified, what parameters respectively MCID has to be evaluated with the required number of patients in both arms. Apart from this of course the impact age, hypertension, diabetes, hyperlipidemia, and coronary artery disease on ED treated by Li-ESWL might be interesting.

The important mechanism of erectile dysfunction (ED) is vascular endothelial function injury or disorder. Low-intensity extracorporeal shock wave therapy (LI-ESWT) can stimulate the expression of angiogenesis-related factors, such as vascular endothelial growth factor (VEGF), so as to promote vascular regeneration. As a result, LI-ESWT has been widely used in clinical treatment of ED. However, until now, it has not yet been approved by the FDA or EMA. This meta-analysis summarizes the results of 16 randomized controlled trials (RCT) on the clinical outcome of Li-ESWT on ED out of a total of 318 publications. For evaluation of the success the International Index of Erectile Function (IIEF), the Erection Hardness Score (EHS) and Sexual Encounter Profile (SEP) were used. Moreover, the length of follow-up was taken into consideration. Finally impact of different levels of energy density (mJ/mm2) and number of impulses were analyzed. LI-ESWT could significantly increase IIEF and EHS in all ED patients, especially in moderate ED group, but had no significant improvement in positive response rate of SEP2 and SEP3. The use of lower energy density (0.09 vs 0.1- 0.2 mJ/mm2) was better. Interestingly1500 – 2000 impulses should be applied rather than 600 or 3000 SW. The follow-up showed better results after 6 months versus only 1 months. However, long-term follow-up studies are needed. This is a very interesting study, because it is able to answer various questions. The authors propose the Minimum Clinically Important Difference (MCID) as an ideal method to evaluate the real clinical efficacy and value of an intervention. Concerning the IIEEF score this should be a 4-point difference, which was not reached by all studies. On the other hand, due the design of an RCT-trial any statistical difference should be taken into consideration (see Forest Plot). It is a real dilemma, that despite the clear evidence about positive effects of Li-ESWT on ED, until now the treatment has not be approved by the health authorities. For the design of future studies, it should be clarified, what parameters respectively MCID has to be evaluated with the required number of patients in both arms. Apart from this of course the impact age, hypertension, diabetes, hyperlipidemia, and coronary artery disease on ED treated by Li-ESWL might be interesting.
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