Summary
A recently published randomised controlled trial has cast doubt on the efficacy of vaginal laser for the alleviation of vaginal symptoms associated with the menopause [1]. This study was a sham controlled, double blind randomised trial of the fractioned CO2 laser over 12 months. Participants had to be clearly postmenopausal with at least one vaginal symptom (dyspareunia, burning, itching or dryness) sufficient to seek further treatment. Other treatments may have been tried previously but had to have been discontinued for at least 6 months before hand. All enrolled women were randomised to either active CO2 microablative laser or sham laser treatment. Women and the outcome evaluators were blinded as to which treatment had been given. Three treatments were applied at 1 month intervals. The same procedure was performed in both groups with the laser group having standard energy settings and the sham group having minimal energy settings. All women received 4% topical anaesthetic cream. The primary outcome measures were symptom severity which were assessed at baseline, each treatment visit, 6 and 12 months using the visual analogue scale (VAS) and the Vulvovaginal Symptom questionnaire (VSQ). Secondary outcomes included: quality of life assessment, sexual satisfaction, vaginal health index (VHI) and vaginal histology 6 months post first treatment.
A total of 85 women were randomised and 78 completed the 12 month follow up. From baseline to 12 months there was no significant difference between the laser and the sham groups in terms of symptom severity (-17.2 vs -26.6) or in the VSQ score (-3.1 vs -1.6). Subgroup analyses found no difference between groups when comparing natural vs iatrogenic menopause. There were also no significant differences between groups for quality of life, sexual function and the VHI scores. Vaginal histology showed a shift from postmenopausal to premenopausal in 9% of the laser group and 12.5% of the sham group. Minor adverse events were common in both groups but no serious adverse events were reported. The authors conclude that treatment with the fractioned CO2 laser did not significantly improve vaginal symptoms after 12 months when compared with sham treatment.
Commentary
It is well recognized that whilst the current treatments (vaginal estrogens, DHEA, ospemifene) for the symptoms of vulvovaginal atrophy are effective for many women, there is a significant cohort of those in whom they are either not effective or not suitable. In addition, some women do not want the “inconvenience” of regular vaginal application or medication. Thus, since the first publication of its potential use 7 years ago [2], the vaginal laser has been heralded in some quarters as a possible alternative option. A plethora of short-term observational studies have demonstrated potential benefits of both the CO2 and Erbium YAG laser for various vaginal symptoms in postmenopausal women [3]. Despite these early positive reports, widespread caution and skepticism remains in the scientific community. This is due, at least in part, to the lack of appropriate randomized trials, the heavy marketing of these techniques for “vaginal rejuvenation”, the widespread uptake by health care professionals who do not normally treat these women and the blurring of the boundaries between what is cosmetic and what is a genuine treatment. As we highlighted in our editorial last year [4] there is an urgent need for robust data together with international standards, guidelines and training to ensure that those using these devices are appropriately trained and collect all their outcome data. A few randomized trials have started to emerge and recent systematic reviews have not found convincing evidence of any benefit over standard treatments [5,6].
This latest randomized trial from Jason Abbott’s group in Sydney [1] demonstrates that the evidence for vaginal laser is not clear cut. As the accompanying editorial states, there is a real need to pause the use of vaginal laser outside of research trials until clear high quality evidence on its efficacy and safety is available [7]. The key strengths of this study were that it was double blind and randomized with a sham arm in women who presented with troublesome symptoms. Outcomes were assessed by a variety of methods including, clinical, laboratory and patient reported tools. There are some limitations which the authors acknowledge but these are largely around the sample size. For example, although the study found no difference between treatments in the 50% of participants with previous breast cancer, it was not powered sufficiently to detect a difference. Equally the study was not powered to detect the risk of uncommon adverse events. Most of the minor complications noted were probably due to the insertion of the probe itself.
Either way this study has set the benchmark for future studies on vaginal laser and underlined the importance of proper evaluation of new treatments and procedures before widespread adoption. This point has been made repeatedly [4,8] and is again emphasized by the authors themselves and the accompanying editorial [7].
This study also raises interesting questions about the proposed mode of action of lasers. As the authors postulate, it is possible that the trauma of the insertion of a probe may in itself promote some degree of tissue repair. Vaginal laser may yet prove to have a beneficial role in the management in the symptoms of postmenopausal vaginal atrophy but until clear evidence of its benefits and safety is available, practitioners would be well advised to heed the advice of Adelman and Nygaard [7] and indeed NICE [8], and not to use these devices outside of clinical trials.
Tim Hillard
Consultant Gynaecologist
University Hospitals Dorset, Poole, UK
References
- Li FG, Maheux-Lacroix S, Deans R, et al. Effect of Carbon Dioxide Laser vs Sham treatment on Symptom Severity in women with postmenopausal vaginal symptoms. JAMA. 2021;326(14):1381-89.
https://pubmed.ncbi.nlm.nih.gov/34636862/ - Salvatore S, Nappi RE, Zerbinati N, et al. A 12-week treatment with fractional CO2 laser for vulvovaginal atrophy: a pilot study. Climacteric. 2014;17(4):363–9.
https://pubmed.ncbi.nlm.nih.gov/24605832/ - Pitsouni E, Grigoriadis T, Falagas ME, Salvatore S, Athanasiou S. Laser therapy for the genitourinary syndrome of menopause. A systematic review and meta-analysis. Maturitas. 2017;103:78-88.
https://pubmed.ncbi.nlm.nih.gov/28778337/ - Hillard TC, Nappi RE. The Heat is On. Climacteric. 2020;23(S1):1-2.
https://pubmed.ncbi.nlm.nih.gov/33124451/ - Preti M, Vieira-Baptista P, Digesu G, et al. The Clinical Role of LASER for Vulvar and Vaginal Treatments in Gynecology and Female Urology: An ICS/ISSVD Best Practice Consensus Document. J Low Genit Tract Dis. 2019;23(2):151–60.
https://pubmed.ncbi.nlm.nih.gov/30789385/ - Li FG, Picard-FortinV, Maheux-Lacroix S, et al. The efficacy of vaginal laser and other energy-based treatments on genital symptoms in postmenopausal women: a systematic review and meta-analysis. J Minim Invasive Gynecol. 2021;28(3):668-683.
https://pubmed.ncbi.nlm.nih.gov/32791349/ - Adelman M, Nygaard IE. Time for a “Pause” on the use vaginal laser. JAMA. 2021;326(14):1378-80.
https://pubmed.ncbi.nlm.nih.gov/34636870/ - NICE IPG 697. Transvaginal Laser therapy for urogenital atrophy. May 2021.
https://www.nice.org.uk/guidance/ipg697
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