Volume 17, Issue 1 (8-2023)                   Qom Univ Med Sci J 2023, 17(1): 369-377 | Back to browse issues page

Ethics code: IR.SBMU.RETECH.REC.1401.025
Clinical trials code: IRCT20200926048841N


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Barati B, Goljanian Tabrizi A, Asadi M, Moghadam K. Evaluating the Effectiveness of Intranasal Estrogen on Nasal Obstruction in Menopausal Women: A Randomized Clinical Trial Study. Qom Univ Med Sci J 2023; 17 (1) : 2770.1
URL: http://journal.muq.ac.ir/article-1-3609-en.html
1- Hearing Disorders Research Center, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
2- Department of Otolaryngology and Head and Neck Surgery, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
3- Department of Otolaryngology and Head and Neck Surgery, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran. , mahboobeh_farvardin@yahoo.com
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Menopausal women often experience a decrease in nasal function, both in terms of smell sensation and nasal airflow, even in the absence of mucosal swelling or morphological changes. Estrogen may directly or indirectly change the function of the nasal mucosa by affecting the vessels of the basal layer of the nasal epithelium and the secretion of the mucous glands. Also, the decrease in the production of female hormones during this period explains the increase in the prevalence of nasal function disorders. Thus, nasal obstruction is a common complaint in menopausal women. In this study, we aimed to investigate topical estrogen's effect on nasal obstruction in menopausal women.
Methods
This study is a three-blind, placebo-controlled, randomized clinical trial conducted on menopausal women with nasal obstruction referred to Taleghani Hospital, Tehran City, Iran, in 2020. Menopausal women without diseases causing secondary amenorrhea, who had passed 12 months since their last menstrual bleeding and complained of nasal obstruction, were included in the study. Patients were randomly assigned to the intranasal estrogen group (intervention) and intranasal lanolin group (placebo or control) by the block randomization method. The intervention group was treated with conjugated estrogen ointment for three months (50 mg daily, which contains 300 µg of estrogen and is equivalent to 2 puffs of the spray daily). The placebo group was treated for three months with lanolin, the base ingredient for estrogen ointment, at the same dose. The patients were evaluated at the beginning of the study and in the third month after the intervention with nasal endoscopy, nasal obstruction severity scale (visual analog scale: VAS), and rhinomanometry test. The data obtained were analyzed using the t-test in SPSS software, version 21.
Results
A total of 46 menopausal patients with a complaint of nasal obstruction, a mean age of 52.58±0.667 years, and a mean body mass index (BMI) of 23.33±3.42 kg/m2 (23 in the intervention group and 23 in the placebo group) were included. There was no significant difference between the groups in demographic data. All patients showed significant improvement in symptom severity and rhinomanometry results post-intervention visits. The mean score of nasal obstruction based on the visual analog scale (VAS) was 7.29±0.39 in the intervention group and 6.89±0.16 in the placebo group (P=0.063). The mean score of nasal obstruction in the third month of follow-up was 44 ±0.745 in the intervention group and 4.81±0.612 in the placebo group (P=0.000). There was no significant difference in the basic rhinomanometry score (P=0.841). In the third month after the intervention, the average nasal airflow measured by rhinomanometry increased significantly in the estrogen group compared to the placebo (P=0.000). During the follow-up of the patients, no obvious drug side effects, such as epistaxis, were observed in any patient.
Conclusion
Evaluating the severity of symptoms based on the VAS scale and rhinomanometry results showed that intranasal estrogen was more effective than placebo in reducing the severity of nasal obstruction in menopausal women. Thus, intranasal estrogen ointment is recommended for nasal obstruction in menopausal women who do not have anatomical or functional nasal abnormalities that explain their symptoms.
Ethical Considerations
Compliance with ethical guidelines
The study was approved by the Ethics Committee of Beheshti University of Medical Sciences (Code: IR.SBMU.RETECH.REC.14091.025) and the Iranian Clinical Trial Center (Code: IRCT20200926048841N). The study intervention was explained to the patients, and their informed written consent was obtained.
Funding
This research did not receive any grant from funding agencies in the public, commercial, or non-profit sectors.
Authors contributions
All authors equally contributed to preparing this article
Conflicts of interest
The authors declared no conflict of interest.
Acknowledgements
The authors thank the Hearing Disorders Research Center of Loghman Hakim Hospital, Shahid Beheshti Medical Sciences University, and all the patients who helped us in this research.

 
Type of Study: Original Article | Subject: گوش ،حلق ، بینی
Received: 2022/11/19 | Accepted: 2023/02/5 | Published: 2023/08/1

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