Reviewer ’s report  
 
Title: Effect of a multi -ingredient based food supplement on sexual function in women with low 
sexual desire. Pilot study.  
 
Version: 1 Date: 17 Sep 2018  
 
Reviewer: Alan W Shindel  
 
Reviewer's report:  
 
The principle and most important limitation of this study is absence of a control group.  This, 
with small sample sizes, renders this study at best pilot data and not truly demonstrative of a 
clinical effect.  This may indeed be a good treatment for women in the future but this study alone 
cannot justify widespread use.  The authors must make this explicit in the abstract conclusion 
and the conclusions section of the paper.  
The authors should consider stating in the manuscript itself that one author has financial ties with 
Procare.  
I don't fully understand the low sexual desire cut off.  I ha ve traditionally seen the FSFI -total cut 
off of 26.55 promoted as the cut off for risk of sexual dysfunction, where did 25.83 come from?  
The authors should also clarify in the abstract hat the 25.83 is not specific to sexual desire but 
rather to sexual dy sfunction more broadly. MOST IMPORTANTLY, sexual dysfunction cannot 
be diagnosed by the FSFI as it does not contain a distress component in assessment.  The authors 
can speak of RISK of sexual dysfunction but should use caution in making an actual diagnosi s.  
The authors should also include several more citations in the methods to bolster their claims 
about the capabilities of the FSFI  
This study is hampered by absence  of a control group.  
A domain specific analysis should be considered and reported in t he abstract; what specifically 
got better for these women?  
The units of testosterone measurement are unusual.  Typically ng/dL or nmol/L are utilized as 
units, please consider.  
Please provide a citation for the statement that women produce higher amounts of estrogens than 
androgens.  I would also take issue with the statement that this fact demonstrates how important 
androgens are; this is supposition.  
The authors should condens e their background references in the introduction; one or two 
paragraphs can make the case for how prevalent the problem is.  The DSM section could 
similarly be shortened.  What should receive more attention is the data to suggest that these 
herbal prepara tions are helpful. Please discuss these in more detail, do not simply refer to 
existing studies en bloc and say they are helpful, provide the data to support this study on their 
efficacy in women.  
Please state a testable hypothesis in the introduction.  
Please provide more information about this herbal product.  How is quality control maintained?  
What I the dosing of these different components? From what source are they obtained?  Why 
these particular components and not others?   
Were all participants h eterosexual?  Was this a requirement?  What requirements existed 
regarding partner sexual function?  
How as normality of data determined?  This is essential to deciding between parametric and non -
parametric statistical tests.  
I believe "two tailed" is a b etter term than "bilateral" for hypothesis testing in the stats section.  
Be aware of and correct run on sentences.  The first, third, and fourth sentences of the discussion 
is an example, they need to be sub -divided.  In general it is not a good idea to h ave two or more 
commas in a sentence, unless one is making a list of considerations (e.g. as above when I state 
the specific problematic sentences).  
What does this study add to existing literature? The authors cite prior work that articulates the 
purporte d benefits of these  herbals in women; so what makes this current work novel and/or 
important?  
The specific limitations should be a separate paragraph, not buried at the end of a paragraph on 
hormone biology.  The authors should expound on what could be d one in the future to rectify 
these limitations in future work.  
The authors are making an assumption about how this compound works in the second to last 
paragraph of the discussion; are they certain that the "Domino effect" and increasing free T and 
vasodi lation are the drivers of these effects?  Without a specific study on the components they 
cannot attribute specific actions to the particular components of this herbal.  They may speculate 
but must be clear that it is speculation, not fact.  
I would also r ecommend more caution about the "truly objective" hormonal results.  
Measurement of androgens in women is fraught with potential for error given low concentrations 
and variation.  Until a control group of women is included the authors cannot conclusively 
demonstrate that their results are not all driven in some fashion by placebo effect.  
Units must be included in table 1 (e.g. years, kg, centimeters, etc). Since all women were 
Caucasian this could however be eliminated and just stated in text.  
What is mea nt by "studies" in table 1?  
Were all women post -menopausal?  This was not made clear.  Table 1 implies that all women 
had undergone menopause, how was this determined?  
The "no hysterectomy" row could be omitted as it is implied from the prior line.  
Was number of pregnancies assessed?  Number of deliveries  may be better presented as whole 
numbers or even median, depending on normality of data.  
The pie chart in figure 1 is relatively uninteresting. Would be better to include a domain -specific 
detail of FSFI changes.  
Consider changing the y axis in the chart on testosterone levels, a maximum of 1 pg/mL would 
permit more distinction  
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.  
 
No 
 
Are the conclusions drawn adequately supported by the data shown?  
If not, please explain in your comments to the authors.  
 
No 
 
Are you able to assess any statistics in the ma nuscript or would you recommend an  
additional statistical review?  
If an additional statistical review is recommended, please specify what aspects require further  
assessment in your comments to the editors.  
 
I am able to assess the statistics  
 
Quality of writ ten English  
Please indicate the quality of language in the manuscript:  
 
Acceptable  
 
  
Declaration of competing interests  
Please complete a declaration of competing interests, considering the following questions:  
 
1. Have you in the past five years received reim bursements, fees, funding, or salary from an  
organisation that may in any way gain or lose financially from the publication of this  
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3. Do you hold or are you currently applying for any patents relating to the content of the  
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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?  
 
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below.  If your reply is yes to any, please give details below.  
 
None  
 
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