Reviewer’s report
Title: 
Anastrozole and Levonorgrestrel-Releasing Intrauterine Device in the
Treatment of Endometriosis: A Randomized Clinical Trial.
Version: 
1 
Date: 
04 Oct 2020
Reviewer's report:
Dear Authors,thank you very much for the opportunity to review your
manuscript. The article reports the results of a randomized trial regarding the use
of anastrazole .
First of all, the main concern regards the enrollment criteria, in fact, giving only
the lower boundaries of the criteria the population can be very heterogeneous,
for example, the CA125 can be either 36 or 190, the OMA can be either 4 cm or
7 cm, and these situations are very different. Similarly can be said for VAS 5 or
VAS 10.
Moreover the history and duration of symptomps can impact treatment as well
and this sentence "These patients could have a previous diagnosis and treatment
(medical and/or surgical) of endometriosis, but they should not have received
medical treatment in the last 3 months." is not enough to avoid a bias.
There is no mention regarding the randomization process and the calculation of
the sample size, and no data has been reported to describe the main outcome of
the study (beside the cited studies). The authors reports too many groups in a
very small population, in fact there are 4 independent variables tested. The
problem is related to the embalacing derived from the multiple subgrouping and
the total lack of statistical power, owing to inconclusive results, and not even
suitable for post-hoc hypotesis.
The incipit of the discussion "Our study shows that oral administration of 1
mg/day Anastrozole for 6 months, beginning before CS intervention of
endometriosis, reduces or improves significantly the symptoms associated with
the
disease (especially dysmenorrhea and CPP) during and after treatment. No other
significant advantages
over the single insertion of LNG-IUD (Mirena®), prior to CS, were observed.
The recurrence and
reoperation rates were similar at 2 years with or without Anastrozole that were
adversely influenced by
the performance of TUGPA." van't be written as it is given only 31 patients
enrolled. A similar limitation can be raised for this sentence "Clearly, the worst
result in short and long term was the performance of TUGPA (instead of CS),
independently of the use of Anastrozole and Mirena®." because authors report
group crossed TUGPA results in even a smaller population, without not even a
sample size or a prespecified subgrouping, and obiously, this sentence can't be
"Clearly", but it's almost an impression.
The authors define this study a pilot study, and hence I strongly suggest to
change the title and to decrease the importance of the findings and to rewrite the
discussion to put the basis of a rationale for a future study, highlight that
TUGPA should not be used to avoid jeopardization of the results. Moreover I
strongly suggest to report the sample size calculation and the main outcome
expected. 
Also the highlights are too much for the study, for example point 3, 4 and 5 are
well far to be declared from the results of the study, since this points are
subjective comments and not based on a sample size calculation or a post hoc
hypotesis.
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Declaration of competing interests
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Is the study design appropriate to answer the research question (including the use
of appropriate controls), and are the conclusions supported by the evidence
presented?
No
Are the methods sufficiently described to allow the study to be repeated?
No
Is the use of statistics and treatment of uncertainties appropriate?
Yes
Is the presentation of the work clear?
Yes
Are the images in this manuscript (including electrophoretic gels and blots) free
from apparent manipulation?
Yes