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Referencias (11):
1. Angulo JC, Arance I, de Las Heras MM, Meilán E, Esquinas C, Andrés
EM. Efficacy of low-intensity shock wave therapy for erectile
dysfunction: A systematic review and meta-analysis. Actas Urol Esp.
2017 Oct;41(8):479-490. [Resumen] [Consulta: 29/06/2018]
2. Man L, Li G. Low-Intensity Extracorporeal Shock Wave Therapy for
Erectile Dysfunction: a Systematic Review and Meta-Analysis. Urology.
2017 Sep 26. pii: S0090-4295(17)30992-5. [Resumen] [Consulta:
29/06/2018]
3. Zou ZJ, Tang LY, Liu ZH, Liang JY, Zhang RC, Wang YJ, Tang YQ,
Gao R, Lu YP. Short-term efficacy and safety of low-intensity
extracorporeal shock wave therapy in erectile dysfunction: a
systematic review and meta-analysis. Int Braz J Urol. 2017 Sep-
Oct;43(5):805-821. [Resumen] [Texto Completo] [Consulta:
29/06/2018]
4. Lu Z, Lin G, Reed-Maldonado A, Wang C, Lee YC, Lue TF. Low-
intensity Extracorporeal Shock Wave Treatment Improves Erectile
Function: A Systematic Review and Meta-analysis. Eur Urol. 2017
Feb;71(2):223-233. [Resumen] [Consulta: 29/06/2018]
5. Clavijo RI, Kohn TP, Kohn JR, Ramasamy R. Effects of Low-Intensity
Extracorporeal Shockwave Therapy on Erectile Dysfunction: A
Systematic Review and Meta-Analysis. J Sex Med. 2017 Jan;14(1):27-
35. [Resumen] [Consulta: 29/06/2018]
6. Fojecki GL, Tiessen S, Osther PJ. Effect of Low-Energy Linear
Shockwave Therapy on Erectile Dysfunction-A Double-Blinded, Sham-
Controlled, Randomized Clinical Trial. J Sex Med. 2017 Jan;14(1):106-
112. [Resumen] [Consulta: 29/06/2018]
7. American Urological Association (AUA): Guideline on erectile
dysfunction (2018) [Texto Completo] [Consulta: 29/06/2018]
8. Guidelines on male sexual dysfunction. European Association of
Urology, 2017. [Texto Completo] [Consulta: 29/06/2018]
9. Fojecki GL, Tiessen S, Osther PJ. Extracorporeal shock wave therapy
(ESWT) in urology: a systematic review of outcome in Peyronie's
disease, erectile dysfunction and chronic pelvic pain. World J Urol.
2017 Jan;35(1):1-9. [Resumen] [Consulta: 29/06/2018]
10. Kalyvianakis D, Hatzichristou D. Low-Intensity Shockwave
Therapy Improves Hemodynamic Parameters in Patients With
Vasculogenic Erectile Dysfunction: A Triplex Ultrasonography-Based
Sham-Controlled Trial. J Sex Med. 2017 Jul;14(7):891-
897. [Resumen] [Consulta: 29/06/2018]
11. Khera M, Cunningham GR. Treatment of male sexual
dysfunction. This topic last updated: Jun 19, 2018. Snyder PJ, O'Leary
MP, eds. UpToDate. Waltham, MA: UpToDate Inc.
http://www.uptodate.com (Consultado el 29 junio 2018)
Efficacy and safety of shock wave treatment for
erectile dysfunction.
The literature search identified 5 meta-analyzes published
between January and October 2017 (1-5), which analyze the
effectiveness of low intensity shock wave therapy (OCBI) in
patients with erectile dysfunction (ED). In general, they agree
that OCBI therapy is effective, in the short term, for the
management of patients with ED (effectiveness measured
based on the changes observed in the international index of
erectile function [IIEF-EF]; in some studies, in the hardness
score in the erection [EHS]). However, the documents indicate
the need for randomized controlled trials with placebo
(RCTs), larger sample size than those published so far and
with long-term follow-up in order to confirm these findings.
In addition, the heterogeneity of the published studies does
not allow conclusions to be drawn regarding the short wave
application devices of choice and regarding the most effective
treatment protocols (number of pulses per patient, treatment
protocols, number of weekly sessions, Treatment duration,...).
Equally scarce is the available data regarding the safety of the
technique.
On the other hand, this effectiveness is not confirmed in an
RCT not included in the meta-analyzes (6) and two recent
clinical practice guidelines (CPG) (7,8) that address the
management of ED do not include the use of OCBI. among
the therapeutic measures to be adopted in these patients: one
of the guidelines considers it an experimental treatment (7)
and the other indicates that, based on the inconsistent
available evidence, no recommendations can be made
regarding its therapeutic role ( 8).
In the most recent meta-analysis of publication (1), 12 studies
were included (with a total of 636 patients) of which 8 were
prospective open clinical trials and 4 placebo-controlled
RCTs. These studies used different shock wave generators
and different therapeutic protocols (in terms of energy flow
density, number of weekly sessions and duration of
treatment).
The analysis of the 9 studies that allow to evaluate the active
treatment with OCBI, the standard deviation of the grouped
mean (DME) shows a significant increase of the IIEF-EF at
the first month with respect to the baseline situation (SMD = -
2.92; confidence [CI] 95%: -3.17 to -2.67, p = 0.000). The
effect associated with placebo is described in 3 of the studies
and the grouped SMD also shows an increase in FEI-EF at the
first month compared to baseline for patients treated with
placebo (SMD = -0.99, 95% CI: -1 , 31 to -0.67, p = 0.000).
However, the authors of the meta-analysis point out that,
although both active treatment and placebo improve the
IIEF-EF with respect to the baseline situation, the difference
produced by OCBI was greater.
In addition, the effectiveness of active treatment is maintained
over time: the IIEF-EF at 3-6 months for patients treated with
OCBI was also significantly higher than at the beginning of
the study (SMD = -2.78, 95% CI: -3.03 to -2.53, p = 0.000).
Only 2 studies compared the efficacy of placebo at 3-6 months
on baseline, but one of them does not provide the numerical
data; the other shows a significant improvement over baseline
(SMD = -9.14, 95% CI: -11.28 to -7.01).
The direct comparison of the effect on IIEF-EF between
OCBI and placebo is available only in 3 studies, and in 2 of
them only after one month of treatment. According to the
standard deviation of the pooled average, active treatment is
effective on placebo (SMD = 2.53, 95% CI: 2.11-2.95, p =
0.000) at the first month. There are not enough data to be able
to evaluate the placebo response in the medium or long term.
The meta-analysis also comments on the safety of the
treatment, indicating that the available evidence on this
aspect is less consistent: 9 studies showed no findings
regarding patient safety (there is no mention of a possible
adverse effect); one study reveals mild allergic reaction to the
gel in a case of 29 (3.5%); another study specifies pain in the
penis in one of 18 patients (5.6%); and finally, another study
reports mild adverse effects in 4 of 58 (6.9%) patients
evaluated, but does not indicate what type of adverse effects
are treated.
The authors of the meta-analysis conclude that "in light of the
results described, we can verify the existence of an
improvement effect in the IIEF-EF, both at the month of
treatment and at 3-6 months. This short-term improvement is
superior to that achieved by the placebo effect in the few
available controlled studies. " However, there is a lack of
multicenter studies and long-term studies, and more studies
are needed to answer the many questions that allow
optimizing the use of this therapy (including wave generator
system, dose and frequency of treatment). In the rest of the
meta-analyzes (2-5) an improvement in the IIEF-EF after the
treatment with OCBI is also described and that this
improvement seems to be maintained after 3 months of the In
one of these meta-analyzes (3) no significant difference was
found when comparing the results in the IIEF-EF of patients
receiving OCBI (n = 121) and patients with sham treatment (n
= 89): to 3 RCTs, the relative risk (RR) of effective treatment
with OCBI was 2.50 (95% CI): 0.74-8.54), approximately 1
month after the last session. In contrast, in terms of EHS (4
RCTs of 277 patients) the RR of effective treatment with
OCBI was 8.31 (95% CI: 3.88-17.78). Also in these documents
it is stated that publication is necessary of additional RCTs
that provide robust evidence regarding the use of OCBI in
patients with ED, that perform a longer-term follow-up and
that allow comparing different devices and protocols. This
potential positive effect of treatment with OCBI is not
confirmed in a systematic review also from 2017 (9). The
review, focused on the evaluation of the use of extracorporeal
shock wave therapy (ECT) in urology (Peyronie's disease, ED
and chronic pelvic pain), evaluated the results of 4 RCTs with
337 patients with vascular SD. After the individual analysis of
the studies, it was concluded that the effects of this therapy
for ED are inconsistent and that valid long-term data are
necessary before TEOC can be recommended as a standard
treatment for DE.Y two RCTs, not included in the previous
synthesis documents report contradictory results: • One of the
RCTs (6) included 126 men with ED and a score lower than
25 points in the erectile function domain of the IIEF-EF.
Subjects were assigned to receive OCBI once a week for 5
weeks or sham treatment once a week for 5 weeks. After a 4-
week break, the two groups received active treatment once a
week for 5 weeks. The mean scores of IIEF-EF in the
simulated group were 11.5 at the beginning of the study (95%
CI = 9.8-13.2) and 13 after five simulated sessions (95% CI =
11-15). ; After another five sessions of active treatment in the
second stage, the mean score was 12.6 (95% CI = 10.6-14.6).
The mean scores in the active treatment group were,
respectively, 10.9 (95% CI = 9.1-12.7), 13.1 (95% CI = 9.3-
13.4) and 11, respectively. 8 (95% CI = 9.3-13.4). Success rates
based on the IIEF-EF were 38.3% in the simulated group and
37.9% in the active group (odds ratio [OR] = 0.95, 95% CI =
0.45-2.2 , P = 0.902). Success rates based on the EHS score
were 6.7% in the sham group and 3.5% in the active group
(OR = 0.44, 95% CI = 0.08-2.61, P = 0.369 ). The predicted
change over time (evaluation at 18 weeks) in the IIEF-EF did
not show statistically significant differences between the
treatment groups • In the other RCT (10), 46 patients with ED
were randomized to receive OCBI ( n = 30) or sham treatment
(n = 16) and were evaluated at month of treatment and every
3 months up to 12 months later. At the beginning of the study
and at 1, 3, 6, 9 and 12 months after the last treatment, the
IIEF-EF scores in the active treated group were 13.8 ± 3.6,
18.46 ± 3.6, 18 , 46 ± 3.5, 19.0 ± 3.3, 18.63 ± 3.0 and 19.1 ± 2.8,
respectively. The IIEF-EF scores in the simulated treatment
group were 14.6 ± 3.4, 16.43 ± 3.5, 15.93 ± 3.6, 16.12 ± 2.6,
16.00 ± 3 , 0 and 16.00 ± 2.8, respectively. A clinically
important minimum difference was observed in the IIEF-EF
score for the active treatment compared to the simulated
group of 56.7% vs 12.5% (P = 0.005) in 1 month, 56.7% vs
12.5% (P = 0.003) in 3 months, 63.3% vs. 18.8% (P = 0.006) at
6 months, 66.7% vs. 31.3% (P = 0.022) at 9 months, and from
75 % versus 25% (P = 0.008) at 12 months.Regarding the role
in clinical practice of treatment with OCBI in patients with
ED: • In the 2018 update of the CPG of the "American
Urological Association" (7) It is established that for men with
ED, extracorporeal therapy with OCBI should be considered
in the research phase. (Conditional recommendation, level of
evidence: Grade C) * Refers to 4 of the meta-analyzes
discussed (1,3-5) indicating that their results are compromised
by conceptual weaknesses such as the lack of management of
the substantial heterogeneity of the studies suggesting
erroneous conclusions or clustering of trials in groups of non-
comparable patients (ED), chronic pelvic pain, patients in
whom erectile function was measured in an unassisted
manner, and patients in whom erectile function was measured
in response to inhibitors of erectile dysfunction.
phosphodiesterase (IFD), separate analyzes for active and
simulated groups). Therefore, it is considered that collectively
these documents offer little information on this topic. In
addition, it reports that the available RCTs varied in inclusion
criteria and in the form of evaluation of the effect, their
findings were inconsistent and the sample sizes were small • In
another CPG, published by the "European Association of
Urology" in 2017 (8 ), it is established that the use of
extracorporeal therapy with OCBI has been proposed in the
last decade as a treatment for ED and that, in general, most
studies reported encouraging results (in patients with mild ED
and even in patients with severe ED who do not respond to
DFI or who respond inadequately), regardless of the variation
in shock wave configuration parameters or treatment
protocols. However, similar to the aforementioned, the
authors of the guide consider it necessary to publish
unambiguous evidence of additional RCTs, with longer-term
follow-up, and that until then, clear and definitive
recommendations can not be made regarding the use of OCBI
in patients with ED.Finally note that the summary of evidence
of Uptodate on the management of male sexual dysfunction
(11) catalogs the treatment with OCBI as an emerging
technology to treat ED. He says that the studies reported that
the use of OCBI induces angiogenesis, stimulates
neovascularization in the penile tissue, improves blood flow of
the penis and endothelial function, and converts patients who
do not respond to DFIs in responders. However, it points out
that this treatment has not been shown to be effective in
clinical trials (7)
.References (11):
-1. Angulo JC, Arance I, from Las Heras MM, Meilán E, Esquinas C,
Andrés EM. Efficacy of low-intensity shock wave therapy for erectile
dysfunction: A systematic review and meta-analysis. Actas Urol Esp.
2017 Oct; 41 (8): 479-490. [Abstract] [Query: 06/29/2018]
-3. Zou ZJ, Tang LY, Liu ZH, Liang JY, Zhang RC, Wang YJ, Tang
YQ, Gao R, Lu YP. Short-term efficacy and safety of low-intensity
extracorporeal shock wave therapy in erectile dysfunction: a
systematic review and meta-analysis. Int Braz J Urol. 2017 Sep-Oct; 43
(5): 805-821. [Abstract] [Full text] [Query: 06/29/2018]