Effects of Estriol-Lactobacilli Combination Versus Polycarbophil-Based Vaginal Moisturizer on Post-Radiation Vaginitis in Women With Cervical Cancer: A Randomized Controlled Trial.
To compare the efficacy of an estriol-lactobacilli combination vaginal tablet (E3/L) and polycarbophil-based vaginal moisturizer (PBVM) in women with post-radiation vaginitis following cervical cancer treatment.
This open-label, randomized controlled trial recruited 34 women with Stages I-III cervical cancer who had completed pelvic radiotherapy and developed vaginal toxicity symptoms. Participants were randomized 1:1 to E3/L (Gynoflor) or PBVM (Regelle) for 4 weeks. The primary outcome was change in vaginal maturation value (VMV). Secondary outcomes included changes in vaginal pH, vaginal toxicity symptom scores, and Female Sexual Function Index (FSFI) scores.
The median improvement in VMV was significantly greater with E3/L than with PBVM (19.65 [IQR: 0-39.5] vs. 2.08 [IQR: 0-20.1] points; p = 0.035; 95% CI: 10.22-32.59). Vaginal dryness and inflammation improved significantly in the E3/L group. Changes in vaginal pH, dyspareunia, and vaginal pain were similar between groups. Although the FSFI change was greater with E3/L (median +6 vs. +2; p = 0.01), absolute FSFI scores at Week 4 were similar, and clinical significance is uncertain. Both treatments were well tolerated.
In women with cervical cancer and radiation-induced vaginitis, E3/L showed greater short-term improvements in vaginal epithelial maturation, dryness, and inflammation than PBVM over 4 weeks. These findings are exploratory given the modest sample size, open-label design, and short follow-up; larger double-blind randomized trials with extended follow-up are needed to confirm these results.
Thai Clinical Trials Registry: TCTR2024051001.
This open-label, randomized controlled trial recruited 34 women with Stages I-III cervical cancer who had completed pelvic radiotherapy and developed vaginal toxicity symptoms. Participants were randomized 1:1 to E3/L (Gynoflor) or PBVM (Regelle) for 4 weeks. The primary outcome was change in vaginal maturation value (VMV). Secondary outcomes included changes in vaginal pH, vaginal toxicity symptom scores, and Female Sexual Function Index (FSFI) scores.
The median improvement in VMV was significantly greater with E3/L than with PBVM (19.65 [IQR: 0-39.5] vs. 2.08 [IQR: 0-20.1] points; p = 0.035; 95% CI: 10.22-32.59). Vaginal dryness and inflammation improved significantly in the E3/L group. Changes in vaginal pH, dyspareunia, and vaginal pain were similar between groups. Although the FSFI change was greater with E3/L (median +6 vs. +2; p = 0.01), absolute FSFI scores at Week 4 were similar, and clinical significance is uncertain. Both treatments were well tolerated.
In women with cervical cancer and radiation-induced vaginitis, E3/L showed greater short-term improvements in vaginal epithelial maturation, dryness, and inflammation than PBVM over 4 weeks. These findings are exploratory given the modest sample size, open-label design, and short follow-up; larger double-blind randomized trials with extended follow-up are needed to confirm these results.
Thai Clinical Trials Registry: TCTR2024051001.
Authors
Koohachaiskun Koohachaiskun, Atjimakul Atjimakul, Peeyananjarassri Peeyananjarassri, Klangsin Klangsin, Kanjanapradit Kanjanapradit
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