Authors' reply re: Vaginal Er:YAG laser application in the menopausal ewe model: a randomised estrogen and sham‐controlled trial

Mackova, Katerina; Deprest, Jan

doi:10.1111/1471-0528.16652

Cited by 1 publication

(1 citation statement)

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“…Again, this is in line with previous trials including sham controls, both on laser therapy, as well as repeated vaginal estrogen applications. 3,12,13,[26][27][28][29][30] Sham vaginal manipulations also induce measurable effects on vaginal biopsies in different animal models, including in a recent study in the [31][32][33][34] Since the start of our trial, five other clinical RCTs have compared the effect of laser and sham manipulation, though four of them have notable limitations. [10][11][12][13][14] Ruanphoo and Bunyavejchevin 10 and Salvatore et al 11 reported improvement either in the VHIS or VAS after laser, but only in the short term (16 weeks from baseline).…”

Section: Discussionmentioning

confidence: 99%

Laser versus sham for genitourinary syndrome of menopause: A randomised controlled trial

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Verbakel

Verhaeghe

et al. 2022

BJOG

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Objective To assess whether CO2 laser treatment is more effective than sham application in relieving the most bothersome symptom (MBS) in women with genitourinary syndrome of menopause (GSM). Design Single‐centre, sham‐controlled, double‐blind, randomised trial. Setting A tertiary centre in Belgium. Population Sixty women with moderate to severe GSM symptoms. Methods All participants eventually received three consecutive laser and three consecutive sham applications, either first laser followed by sham, or conversely. Main outcome measures The primary outcome was the participant‐reported change in severity of the MBS at 12 weeks. Secondary outcomes included subjective (patient satisfaction, sexual function, urinary function) and objective (pH, Vaginal Health Index Score, in vivo microscopy) measurements assessing the short‐term effect and the longevity of treatment effects at 18 months after start of the therapy. Adverse events were reported at every visit. Results The MBS severity score decreased from 2.86 ± 0.35 to 2.17 ± 0.93 (−23.60%; 95% CI −36.10% to −11.10%) in women treated with laser compared with 2.90 ± 0.31 to 2.52 ± 0.78 (−13.20%; 95% CI −22.70% to −3.73%) in those receiving sham applications (p = 0.13). There were no serious adverse events reported up to 18 months. Conclusions In women with GSM, the treatment response 12 weeks after laser application was comparable to that of sham applications. There were no obvious differences for secondary outcomes and no serious adverse events were reported.

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