Activity ID
11876Expires
October 12, 2024Format Type
Journal-basedCME Credit
1Fee
$30CME Provider: JAMA
Description of CME Course
Importance Postmenopausal vaginal symptoms are common and frequently detrimental to a woman’s quality of life. Fractional carbon dioxide vaginal laser is increasingly offered as a treatment, but the efficacy remains unproven.
Objective To determine the efficacy of fractional carbon dioxide laser for treatment of vaginal symptoms associated with menopause.
Design, Setting, and Participants A double-blind, randomized, sham-controlled trial with 12-month follow-up was undertaken at a single tertiary referral hospital in Sydney, Australia. Enrollment commenced on September 19, 2016, with final follow-up on June 30, 2020. Participants were postmenopausal women with vaginal symptoms substantive enough to seek medical treatment. Of 232 participants approached, 85 were randomized.
Interventions Three treatments using a fractional microablative carbon dioxide laser system performed 4 to 8 weeks apart, with 43 women randomized to the laser group and 42 to the sham group.
Main Outcomes and Measures The co–primary outcomes were symptom severity assessed using a visual analog scale (VAS; range, 0-100; 0 indicates no symptoms and 100 indicates the most severe symptoms) and the Vulvovaginal Symptom Questionnaire (VSQ; range, 0-20; 0 indicates no symptoms and 20 indicates the most severe symptoms) at 12 months. The minimal clinically important difference was specified as a 50% decrease in both VAS and VSQ severity scores. There were 5 prespecified secondary outcomes, including quality of life (range, 0-100; higher scores indicate better quality of life), the Vaginal Health Index Score (range, 5-25; higher scores indicate better health), and vaginal histology (premenopausal or postmenopausal status).
Results Of 85 randomized participants (mean [SD] age, 57 [8] years), 78 (91.7%) completed the 12-month follow-up. From baseline to 12 months, there was no significant difference between the carbon dioxide laser group and the sham group in change in symptom severity (VAS score for overall vaginal symptoms: –17.2 vs –26.6; difference, 9.4 [95% CI, –28.6 to 47.5]; VAS score for the most severe symptom: –24.5 vs –20.4; difference –4.1 [95% CI, –32.5 to 24.3]; VSQ score: –3.1 vs –1.6; difference, –1.5 [95% CI, –5.9 to 3.0]). There were no significant differences between the laser and sham group in the mean quality of life score (6.3 vs 1.4; difference, 4.8 [95% CI, –3.9 to 13.5]) and Vaginal Health Index Score (0.9 vs 1.3; difference, –0.4 [95% CI, –4.3 to 3.6]) or in histological comparisons between laser and sham treatment groups. There were 16 adverse events in the laser group and 17 in the sham group, including vaginal pain/discomfort (44% vs 68%), spotting, discharge, and lower urinary tract symptoms. No severe adverse events were reported in either group.
Conclusions and Relevance Among women with postmenopausal vaginal symptoms, treatment with fractional carbon dioxide laser vs sham treatment did not significantly improve vaginal symptoms after 12 months.
Trial Registration Australian and New Zealand Clinical Trials Registry: ACTRN12616001403426
Disclaimers
1. This activity is accredited by the American Medical Association.
2. This activity is free to AMA members.
ABMS Member Board Approvals by Type
ABMS Lifelong Learning CME Activity
Allergy and Immunology
Anesthesiology
Colon and Rectal Surgery
Family Medicine
Medical Genetics and Genomics
Nuclear Medicine
Ophthalmology
Orthopaedic Surgery
Pathology
Physical Medicine and Rehabilitation
Plastic Surgery
Preventive Medicine
Psychiatry and Neurology
Radiology
Thoracic Surgery
Urology
Commercial Support?
NoNOTE: If a Member Board has not deemed this activity for MOC approval as an accredited CME activity, this activity may count toward an ABMS Member Board’s general CME requirement. Please refer directly to your Member Board’s MOC Part II Lifelong Learning and Self-Assessment Program Requirements.
Educational Objectives
To learn whether fractional carbon dioxide laser is superior to a sham treatment for vaginal symptoms associated with menopause.
Keywords
Medical Education, Hypertension
Competencies
Medical Knowledge
CME Credit Type
AMA PRA Category 1 Credit
DOI
10.1001/jama.2021.14892