Effect of Fractional Carbon Dioxide vs Sham Laser on Sexual Function in Survivors of Breast Cancer Receiving Aromatase Inhibitors for Genitourinary Syndrome of Menopause: The LIGHT Randomized Clinical Trial
An erratum to this article was published (JAMA Netw Open, 1 Mar 2023 ↗)
Authors' conclusion
In this randomized clinical trial, vaginal laser treatment was found to be safe after 6 months of follow-up, but no statistically significant differences in efficacy were observed between CLT and SLT.
Study context
- Population
- Survivors of breast cancer with genitourinary syndrome of menopause (GSM) receiving aromatase inhibitors; mean (SD) age 52.6 (8.3) yearsall analyzed
- Participants
- 72 survivors
- Comparison
- Fractional CO2 laser therapy vs sham laser therapy, both with first-line treatment (nonhormonal moisturizers and vaginal vibrator stimulation)
- CO2 laser therapy (CLT)n = 35
- Sham laser therapy (SLT)n = 37reference
- Primary endpoint
- Sexual function, Female Sexual Function Index (FSFI) score
- Follow-up
- 6 months
Methodological detailsprospective, double-blind, sham-controlled, two parallel groups, tertiary referral hospital, October 2020 to March 2022
- Prospective
- Double-blind
- Sham-controlled
- Two parallel groups
- Tertiary referral hospital
- October 2020 to March 2022
Primary result
As reported in the abstract
FSFI improvement (baseline to 6 months)
CLT
5.2
mean · SD 1.5 · points
SLT
7.9
mean · SD 1.2 · points
P = 0.15
Further findings
Mean difference, points
| Outcome | CLT | SLT | P value |
|---|---|---|---|
| FSFI improvement, excluding women not sexually active · 6 monthsNo significant difference | 2.9 (SD 1.4) | 5.5 (SD 1.1) | P = 0.15 |
- Dyspareunia (VAS) improvement · 6 months · no difference
- P = 0.73
- Vaginal Health Index improvement · 6 months · no difference
- P = 0.17
- Body image improvement · 6 months · no difference
- P = 0.35
- Quality of life (SF-12) improvement · 6 months · no difference
- P = 0.39
- Vaginal pH improvement · 6 months · no difference
- P = 0.29
- Vaginal maturation index improvement · 6 months · no difference
- P = 0.15
- Vaginal epithelial thickness improvement · 6 months · no difference
- P = 0.30
- Vaginal epithelial elasticity improvement · 6 months · no difference
- P = 0.64
Overall analysis regardless of group
- Significant improvements in many outcomes regardless of group
Safety
Mean
| Outcome | CLT | SLT | P value |
|---|---|---|---|
| Tolerance (Likert scale)Tolerance significantly lower with CLT | 3.3 (SD 1.3) | 4.1 (SD 1.0) | P = 0.007 |
Complications and serum estradiol
- No differences in complications or serum estradiol levels
Original publication
Effect of Fractional Carbon Dioxide vs Sham Laser on Sexual Function in Survivors of Breast Cancer Receiving Aromatase Inhibitors for Genitourinary Syndrome of Menopause: The LIGHT Randomized Clinical Trial. JAMA Netw Open. Published 1 February 2023. doi:10.
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