BACKGROUND AND PURPOSE:

• Efficacy of fractional carbon dioxide vaginal laser is not well established for postmenopausal symptoms
• Li et al. (JAMA, 2021) sought to determine the efficacy of fractional carbon dioxide laser for treatment of vaginal symptoms associated with menopause

METHODS:

• Double-blind, randomized, sham-controlled trial
• Participants
  • Postmenopausal women | Amenorrheic for at least 12 months,
  • Vaginal symptoms (≥ 1 symptoms including dyspareunia, burning, itching, or dryness) requiring medical treatment
• Interventions
  • Microablative carbon dioxide laser treatment 
  • Sham
• Study design
  • Laser treatment: 3 treatments | Performed 4 to 8 weeks apart | 12-month follow-up
  • Sham:  Minimal energy settings with no tissue effect | Visual and auditory effects from the laser were identical to that of treatment
• Sample size calculation
  • Minimal clinically important difference: 50% decrease in both
    • Visual analog scale (VAS; range, 0 to 100; 0 indicates no symptoms and 100 indicates most severe symptoms)
    • Vulvovaginal Symptom Questionnaire (VSQ; range, 0 to 20; 0 indicates no symptoms and 20 indicates most severe symptoms)
  • Assume 30% placebo effect
  • Sample size was increased to 78 to reduce the probability of a type II error and participant drop out
• Primary outcomes
  • Symptom severity at 12 months
    • VAS
    • VSQ
• Secondary outcomes
  • Quality of life (range 0 to 100)
  • Vaginal Health Index Score (range 5 to 25)
  • Vaginal histology (premenopausal or postmenopausal status)

RESULTS:

• 85 randomized participants
  • Mean (SD) age: 57 (8) years | 91.7% completed follow-up
• At 12 months, there was no significant difference between the groups in change in symptom severity
  • VAS score for overall vaginal symptoms
    • Laser: –17.2
    • Sham: –26.6
    • Difference 9.4 (95% CI, –28.6 to 47.5)
  • VAS score for the most severe symptom
    • Laser: –24.5
    • Sham: –20.4
    • Difference –4.1 (95% CI, –32.5 to 24.3)
  • VSQ score
    • Laser: –3.1
    • Sham: –1.6
    • Difference –1.5 (95% CI, –5.9 to 3.0)
• There were no significant differences between the laser and sham group in
  • Mean quality of life score
    • Laser: 6.3
    • Sham: 1.4
    • Difference 4.8 (95% CI, –3.9 to 13.5)
  • Vaginal Health Index Score
    • Laser: 0.9
    • Sham: 1.3
    • Difference –0.4 (95% CI, –4.3 to 3.6)
  • Histological comparisons
• Incidence of adverse events
  • Laser: 16 events
  • Sham: 17 events
  • There were no severe adverse events in either group
• Adverse events
  • Vaginal pain/discomfort
    • Laser: 44%
    • Sham: 68%
  • Spotting
  • Discharge
  • Lower urinary tract symptoms

CONCLUSION:

• There was no improvement in postmenopausal vaginal symptoms 12 months after fractional carbon dioxide laser treatment vs sham treatment
• The authors state

Clinical outcomes and cost-effectiveness of treatments, whether devices or drugs, should be evaluated rigorously prior to integration into routine treatment

The annual cost of laser treatment to the individual for management of vaginal menopausal symptoms was reported to be $2733.24 and because there is no demonstratable difference vs sham treatment, it cannot be considered to be cost-effective

Learn More – Primary Sources:

Effect of Fractional Carbon Dioxide Laser vs Sham Treatment on Symptom Severity in Women With Postmenopausal Vaginal Symptoms: A Randomized Clinical Trial

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