A multicenter, randomized, open, controlled trial to evaluate the efficacy of Honglilai Vaginal Cream and Premarin Vaginal Cream for Genitourinary Syndrome of Menopause in different subgroups of Chinese postmenopausal women

Abstract

Aim

In a randomized, multicenter, open, controlled trial, we compared the effects of Honglilai Vaginal Cream and Premarin Vaginal Cream in different age subgroups and menopausal year subgroups (trial registration numbers: 02003L00493).

Methods

Postmenopausal women with Genitourinary Syndrome of Menopause (GSM) were divided into Honglilai group (n = 319) and Premarin group (n = 116), while subgroups were divided according to their different characteristics of age and menopausal years. Honglilai Vaginal Cream (0.625 mg/g) or Premarin Vaginal Cream (0.625 mg/g) once daily for 3 weeks.

Results

In the subgroup of participates >60 years, there were no significant differences of Vaginal Cell Maturation Index (VMI) between the two groups after treatment (p = .171). In the subgroup of 50–59 years, the VMI of Honglilai group was significantly lower than Premarin group (Honglilai group: 74.37 ± 22.76; Premarin group: 80.06 ± 16.15; p = .02). There were no significant differences of Vaginal symptom scores between Honglilai group and Premarin group in every sub-group (p > .05).

Conclusions

Honglilai Vaginal Cream had comparable efficacy with Premarin Vaginal Cream in Chinese women older than 60 years.

摘要

目的

采用随机、多中心、开放、对照的方法, 比较不同年龄亚组和绝经年限亚组（试验注册号：02003100493）应用红丽来和倍美力阴道乳膏的疗效。

方法

将绝经后女性生殖道综合征（GSM）患者分为红丽来组（319例）和倍美力组（116例）, 并根据年龄和绝经年限分为不同亚组。红丽来阴道乳膏（0.625 mg/g）或倍美力阴道乳膏（0.625 mg/g）每日1次, 疗程3周。

结果

在年龄>60岁的受试者中, 两组治疗后阴道细胞成熟指数（VMI）差异无统计学意义（P=.171)。在50∼59岁亚组中, 红丽来组的VMI显著低于倍美力组（红丽来组：74.37±22.76；倍美力组：80.06±16.15；P=0.02）。在各个亚组中, 红丽来组与倍美力组的阴道症状评分差异无统计学意义（p>0.05）。

结论

红丽来阴道乳膏与倍美力阴道乳膏对中国60岁以上女性的疗效相当。

Keywords:

• Genitourinary Syndrome of Menopause
• Vaginal Maturation Index
• Honglilai Vaginal Cream
• Premarin Vaginal Cream
• age

关键词:

• 绝经后泌尿生殖综合征
• 阴道成熟指数
• 红丽来阴道乳膏
• 倍美力阴道乳膏
• 年龄

Acknowledgments

Thanks to professor Shouqing Lin for her contributions as the leader of this multi-center study.

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

This research was supported by the Beijing Hospitals Authority Clinical Medicine Development of Special Funding Support (Code: ZYLX202112), the Major Science and Technology Projects of the Xinjiang Uygur Autonomous Region (Code: 2017A01002-4).