Editor-in-Chief,
Journal of Endocrinology
We changed and completed items in our manuscript entitled “:Effect of Orlistat on weight loss, hormonal and metabolic profiles in women with polycystic ovarian syndrome: a randomized double-blinded placebo-controlled trial.” according to the editors’ opinions as we described in following explanations
The Abstract has been deleted. Why ?This is a research letter and has no abstract.
The Authors reported very briefly thatwomen with PCOS presented with oligomenorrhea and menometrorrhagia. Please, specify the percentage of women with normal menses, oligomenorrhea and menometrorrhagia, respectively. Eventual changes in menstrual pattern after therapy/placebo should be given in Results section. These data were in original article and had been omitted in research letterand now we added it.
Table 1 and 2 have been grouped in a new table 1. However, the mean age in the two groups is not shown. Please, report the age of the two groups.We reporte the mean age in table now.
The Authors reported that in both groups physical activity was encouraged. Please, report the number of subjects engaged in physical activity, if any, in Results section.
Participants completed weekly exercise diaries to monitor the compliance. The consistency in exercise was 77% in control group and 74.8% in case group.
There are two different ranges of testosterone levels (0.14-0.9 ng/ml or 14-90 ng/ml ?)14-90ng/dl
Insulin levels: mu/ml ?It is corrected
SD of mean weight in control group before and after treatment in the text are not given. Please, report also mean weight and SD in the treatment group in the text (or in table). We add it in table.
Discussion section and conclusions remain very poor.We performed some changes in discussion
Reviewers' comments:
Reviewer #1:
1. The authors conclude on biochemical hyperandrogenism based solely on total testosterone levels. However, the latter should always be reported together with SHBG and/or free androgen index.
2. The evaluation of insulin resistance could be better presented in the form of HOMAIR and or QUICKI indices.
We present insulin resistance in the form of HOMAIR in table now.
In brief, the present manuscript has limited impact on the available knowledge and cannot be accepted for publication in its current form. However, if the authors could modify the endpoints of the study (e.g. in the direction of measuring serum adipokine or gut hormone levels or even novel molecules implicated in energy homeostasis and metabolic control), the manuscript would gain significant interest.
As the study finished several months ago it is impossible to involved measurement of other hormones or molecules in the study. But we believed that knowing the common potential effects and side effects of this drug which is easily available and frequently used would help physician and patient for proper choice.
Reviewer #3:
1. Introduction sentence 2 line 17 page 2 is not true - PCOS is a obesity complicance not is associated with obesity. In PCOS commonly are observed metabolic syndrom components as a complicance of obesity and insulin resistnce.
In the United States, some studies report that the prevalence of overweight and obesity in women with PCOS is as high as 80%. Outside the U.S., the prevalence of obesity in affected women is lower, although it has increased over time, with studies reporting rates as low as 20%. This observation suggests that environmental factors, such as lifestyle, contribute to development of obesity in PCOS.
2. The role of hormonal disturbances of adiposse tissue in PCOS pathogenesis should be mentioned.
It is added now.
3. The aim of the study should be described better.
It is rewritten now.
Material and methods
4. Please explein the reason of 30% fat content in the recomendeddiet,according to numerous guidelines it should be 25% and protein 20%.
This is monounsaturated fatty acid (MUFA) diet- one of the diet protocols which is used in PCOS. (Parillo M, Rivellese AA, Ciardullo AV, Capaldo B, Giacco A, Genovese S, et al. A highmonounsaturated-fat/low-carbohydrate diet improves peripheral insulin sensitivity in non-insulindependentdiabetic patients. Metabolism. 1992; 41(12):1373–8.
Garg A, Bonanome A, Grundy SM, Zhang Z, Unger RH. Comparison of a high-carbohydrate dietwith a high-monounsaturated-fat diet in patients with non-insulin-dependent diabetes mellitus.New Engl J Med. 1988; 319:829–34.
Douglas CC, Gower BA, Darnell BE, Ovalle F, Oster RA, Azziz R. Role of diet in the treatment of polycystic ovary syndrome.
Fertil Steril. 2006 Mar;85(3):679-88.
5. Please add the guidelines for physical acctivity, 30 minutes of walking per day, only.
Five or Six session of walking per week is a common protocol for aerobic exercise.(R.L. Thomson, G.D. Brinkworth, M. Noakes, P.M. Clifton, R.J. Norman, and J.D. Buckley.The effect of diet and exercise on markers of endothelial function in overweight and obese women with polycystic ovary syndrome. Human Reproduction, Vol.27, No.7 pp. 2169–2176, 2012)
6. BMI is not measured but calculated. It is corrected.
7. The statistical analysis should be repeated, and differences before and after treatment between groups should be compared. In addition the percentage of intial body mass reduction schould be added and correlations between weight loss and study parameters should be analyzed.
The differences before and after treatment between groups shown in table previously.the percentage of intial body mass reduction and correlations between weight loss and study parameters was added.Some of these data were in original article and had been omitted in research letter.
Results
8. The reasons of treatment discontinuation should be added.
It was added. These data were in original article and had been omitted in research letter
9. The results should be described again after adequate statistical analysis.
Some of these data were in original article and had been omitted in research letter
Discussion
10. This section should be rewriten after new results description. The lack of results in control group should be better explained. Conclussions should be added.
English is very poor.We edited the article and performed some changes in discussion.
Best Regards
ReihanehHosseini
7/4/2014