Reviewer’ s report
Title: Effects of vaginal administration of conjugated estrogens tablet on sexual function in
postmenopausal women with sexual dysfunction: a double-blind, randomized, placebo-controlledtrial
Version: 0Date: 14 Apr 2020
Reviewer: R. Y. K. Cheung
Reviewer's report:
Thanks very much for preparing this study. This study is interesting that it aim to study the effect
of oral estrogen tablet to be used in vaginal route in postmenopausal women for sexual function.I would like to have the following comment:1. the study design and methodology:-this is a well designed and well planned study to achieve double blinding.-for the inclusion and exclusion criteria: there are a number of exclusion criteria, including thevaginal pH of >5. As we know estrogen has direct effects on genital anatomy, enhancingperipheral blood flow and peripheral nerve function and improving vaginal lubrication. vaginal pHmay not be the only factor reflecting estrogen status and this will lead to selection bias.-besides the listed demographic, the background co-morbidity, including diabetes, neurologicaldiseases, smoking status should be included-any reference of the regime of 3 weeks of daily dose and followed by 9 weeks of twice weeklydose?-the outcome measure of Thai version of FSFI, is it validated in Thai language? please included inthe reference list
-is the drug compliance checked in all subjects?
Results:
-please describe in detail about the ANCOV A test, what are the confounders that have beenincluded in the analysis? from Table 3, the change of mean change of FSFI score in treatmentgroup and placebo group is 5 and 2 respectively, it there a significant difference of the meandifference in 2 groups?
Discussion:
- what are the clinical significance of the change of vaginal pH and VMV?- current literature had some proven effects of vaginal estrogen in sexual function within similarstudy period ( Menopause. 2016 Jan;23(1):47-54. ) More discussion and comparison will beexpected on this aspect. How to compare the current result with those in current literature?- Is it possible to have insignificant different of the sexual function/ FSFI due to the absorption ofthe oral estrogen tablet in vagina? The preparation of estrogen may be the most important factorthat affect the insignificant result here.
Are the methods appropriate and well described?
If not, please specify what is required in your comments to the authors.
Yes
Does the work include the necessary controls?
If not, please specify which controls are required in your comments to the authors.
YesAre the conclusions drawn adequately supported by the data shown?
If not, please explain in your comments to the authors.
NoAre you able to assess any statistics in the manuscript or would you recommend an
additional statistical review?If an additional statistical review is recommended, please specify what aspects require furtherassessment in your comments to the editors.
I am able to assess the statistics
Quality of written English
Please indicate the quality of language in the manuscript:
Needs some language corrections before being publishedDeclaration of competing interests
Please complete a declaration of competing interests, considering the following questions:
1. Have you in the past five years received reimbursements, fees, funding, or salary from an
organisation that may in any way gain or lose financially from the publication of thismanuscript, either now or in the future?
2. Do you hold any stocks or shares in an organisation that may in any way gain or lose
financially from the publication of this manuscript, either now or in the future?
3. Do you hold or are you currently applying for any patents relating to the content of the
manuscript?
4. Have you received reimbursements, fees, funding, or salary from an organization that holds
or has applied for patents relating to the content of the manuscript?
5. Do you have any other financial competing interests?6. Do you have any non-financial competing interests in relation to this paper?
If you can answer no to all of the above, write 'I declare that I have no competing interests' below.
If your reply is yes to any, please give details below.
'I declare that I have no competing interests'
I agree to the open peer review policy of the journal. I understand that my name will be included
on my report to the authors and, if the manuscript is accepted for publication, my named reportincluding any attachments I upload will be posted on the website along with the authors'responses. I agree for my report to be made available under an Open Access Creative CommonsCC-BY license (http://creativecommons.org/licenses/by/4.0/). I understand that any commentswhich I do not wish to be included in my named report can be included as confidential commentsto the editors, which will not be published.
I agree to the open peer review policy of the journal