Reviewer's report
Title:Association between low-dose pulsed intravenous cyclophosphamide
therapy and amenorrhea in patients with systemic lupus erythematosus: A
case-control study
Version: 1Date:17 April 2011
Reviewer: HIROSHI KAJIYAMA
Reviewer's report:
Baba et al studied how IVCY affect ovary function in 45 year-old or younger
female Japanese patients with SLE, and clarified clinical parameters, which is
associated with amenorrhea after IVCY treatment by a single-center case-control
retrospective study.
General comments
Although there are some limitations such as selection bias and insufficiency of
subject number, the incidence for sustained amenorrhea by IVCY in Japanese
patient was described by retrospective study. Authors also clarified that even
low-dose IVCY caused transient amenorrhea, although it resumed in all 40
year-old or younger patients after IVCY, which might be interpreted as the one of
the benefits in IVCY for Japanese patients younger than 40 with SLE. It was
found in this study that 40 and older might be the risk factor for sustained
amenorrhea. Complying with the review guideline by the editorial team,
comments are categorized as follows:
Major Compulsory Revisions
1) Time between treatment and amenorrhea, duration of amenorrhea, and time
to resumption of menses were raised in “Data Collection” part. However, the data
were not presented anywhere. They are also important and helpful for physician
and patients to plan the treatment, and especially, time to resumption would be
one of the concerns for patients. Please consider describing these data.
Minor Essential Revisions
1) In Table 2 and 3, some parts show P value and OR comparing longitudinally
and the other parts showed them comparing transversally, and that makes
readers confusing. Please specify which data was subject to each univariate
analysis in an appropriate way.
One of the examples are as follows:
In “Associations between amenorrhea and clinical parameters” part, P value,
odds ratio and 95% CI (0.02, 3.5 (1.3-11.0) for the difference of amenorrhea
incidence between the IVCY group and the steroid group described in the text
are all same as what is described in the table 2 for amenorrhea incidence in the
IVCY group. When readers see table 2, they might think that 0.02 and
3.5(1.3-11.0) are the data comparing 17/26 and 12/36 within the IVCY group.
Regarding the data comparing amenorrhea cases between sujects <40 and
subjects 40 and older, it might be acceptable, since we could tell from the “raw”
data – 17 and 9, described both in table 2 and 3.
2) In the third paragraph of “Discussion” part, we see the sentence “ The
strongest risk factor for developing….”, and from the context, it could be known
that the sentence is describing your study, but it might puzzle some readers.
Some words or phrases might be added to this sentence to make readers
understand that it describes your data, not data previously reported.
3) “in a retrospective study” might be changed to “in a single center retrospective
study” in the beginning of the fifth paragraph of “Discussion” part.
4) “reported previously” might be added at the last of the sentence, “However,
the size of our study population was comparable to similar studies” in the fifth
paragraph of “Discussion” part.
Discretionary Revisions
1) If the incidence of pregnancy would be included in your database for this
study, that would be more helpful for clinician to offer IVCY to patients with SLE.
However, pregnancy itself is a risk factor for recurrence of lupus, and it might be
difficult to find such cases.
2) In “Discussion” part, comparison of your data and the previous data in
high-dose IVCY is described, and this might be presented as Table 7, since this
is also one of the most important parts, which makes your data valuable and
appealing to the readers.
Level of interest: An article of importance in its field
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests.