Comparison of Topical Fractional CO2 Laser and Vaginal Estrogen for the Treatment of Genitourinary Syndrome in Postmenopausal Women

A Randomized Controlled Trial

Paula Fernanda Santos Pallone Dutra, MD; Thais Heinke, MD, PhD; Stella Catunda Pinho, MD; Gustavo Rubino Azevedo Focchi, PhD; Fernanda Kesselring Tso, MD, PhD; Bruna Cristine de Almeida, PhD; Ivaldo Silva, PhD; Neila Maria Góis Speck, MD, PhD

Disclosures

Menopause. 2021;28(7):756-763. 

In This Article

Results

Of the 25 participants in this study, 12 (48.0%) were allocated to the TE group and 13 (52.0%) to the LT group; one participant was excluded from the study due to her altered cytology (Figure 1). The mean age of the participants was 55.3 ± 4.3 years, and the mean age at menopause was 46.2 ± 5.8 years old. Clinical features such as age (P = 0.880), body mass index (P = 0.591), number of deliveries (P = 0.881), and age at menopause (P = 0.366) were homogeneous between the groups, with no significant differences.

Figure 1.

Flow diagram of study design with details of number of participants.

We observed that 10 (83.3%) participants in the TE group had an increased epithelium thickness, 1 (8.3%) had a decreased thickness, and another (8.3%) had no change in thickness. In the LT group, 10 (76.9%) participants had an increase in epithelium thickness, whereas 3 (23.1%) did not show any change.

To compare the proportion of deep cells, we used the Frost index, and our findings showed that 1 (8.3%) participant in the TE group had an increase and 11 (91.7%) had a decrease in the deep cells. In the LT group, four (30.8%) participants showed an increase, five (38.5%) had a decrease, and four (30.8%) showed no changes in deep cells.

In the TE group, nine (75.0%) participants had an increase in intermediate cells, two (16.7%) had a decrease of the same, and only one (8.3%) had no change. In the LT group, five (38.5%) participants showed an increase in intermediate cells, and the other eight (61.5%) showed a decrease.

An increase in superficial cells was observed in eight (66.7%) participants, one (8.3%) showed a decrease in these cells, and the other three (25.0%) participants had no change in the TE group. We noted that six (46.2%) participants had an increase in the proportion of superficial cells, three (23.1%) had a decrease, and four (30.8%) had no change in the LT group (Table 1).

In the inferential comparison between the two groups, the epithelial thickness (in mm) was statistically the same at both the baseline (P = 0.19) and at the end of the treatment (P = 0.316), increasing over time in both the TE (P = 0.001) and LT (P < 0.001) groups (Figure 2A). Figure 2B to E shows an increase in glycogen-rich cells as well as an increase in the intermediate and superficial layers of the VE in both groups.

Figure 2.

Comparison of epithelial thickness between participants of TE and LT groups: (A) One-dimensional scatter plot showing increase in epithelial thickness (mm) in both the groups. Photomicrographs of histological sections of the vaginal wall biopsies of a participant who underwent fractional LT. Photomicrograph of biopsies from the proximal third of the right lateral vaginal wall: (B) before treatment, and (C) after treatment with fractional LT. Photomicrographs of histological sections of vaginal wall biopsies of a participant who underwent treatment with TE. Photomicrograph of biopsies from the proximal third of the right lateral vaginal wall: (D) before treatment, and (E) after treatment with TE therapy. Hematoxylin and eosin staining was performed for histology sections.(Magnification: ×200). LT, laser therapy; TE, topical estrogen.

To evaluate the Frost index, we performed an analysis of epithelial layer cells. At baseline, the number of parabasal (P = 0.100), intermediate (P = 0.253), and superficial cells (P = 0.595) was statistically similar between the groups. The TE group showed a decrease in parabasal cells at the end of treatment (P < 0.001); however, the same was not observed in the other LT group (P = 0.948). With regard to the intermediate cells, we noted an increase in the TE group (P = 0.002) but not in the LT group (P = 0.432). In addition, the TE group showed an increasing trend for superficial cells (P = 0.092), whereas the LT group showed no statistically significant changes (P = 0.471; Figure 3A).

Figure 3.

Comparisons between different parameters of TE and LT groups: (A) One-dimensional scatter plot showing increase in maturation index at the end of treatment, by group; (B) One-dimensional scatter plot showing increase in female sexual quotient (SQ-F) at the end of treatment, by group. Images of the cervix obtained by an imaging system (Diagnose) before treatment (C) and 30 days after the last fractional LT session (D). Images of the vaginal mucosa obtained by an imaging system (Diagnose) before (E) and after (F) treatment with TE.

The Meisel index was also compared between the two groups. We found that 11 (91.7%) participants had an increase in this index in the TE group, whereas 8 (61.5%) of the participants had an increase in the LT group (P = 0.160). The inferential results revealed that, at the beginning, the maturation index was statistically similar in both groups (P = 0.379). There was a tendency for the TE group to present a higher maturation index than the LT group at the end of treatment (P = 0.073). At the beginning of the current study, the TE group had a lower maturation index than that noted at the end of the study (P = 0.003). On the other hand, the LT group did not demonstrate a significant change in the index between the two time points (P = 0.734).

All participants in both groups had an increase in the SQ-F. The LT group had an average increase of 27.84, whereas the TE group showed an average increase of 18.83 of SQ-F. We observed that the SQ-F was statistically similar between the two groups at both the baseline and the end of the study (P = 0.368). In addition, SQ-F was found to increase over time in both the TE (P < 0.001) and LT (P < 0.001) groups (Figure 3B).

Subjective evaluation through physical examination, as shown in Figure 3C to F, revealed clear signs of atrophy initially, such as pallor in the vaginal mucosa and petechiae. However, after LT, there was a marked improvement in the brightness and color of the vaginal mucosa, increased exudate, and absence of petechiae.

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