Reviewer's report
Title:Does female sex hormone supplementation (FSHS), exercise or a
combination of both, improve pain and function in post-menopausal women with
greater trochanteric pain syndrome (GTPS)? A randomised controlled trial.
Version:3Date:7 March 2016
Reviewer: Mette Hansen
Reviewer's report:
In general, it is comprehensive study which is lined up. The study design will
adequately test the hypothesis outlined in the background which states that
supplemental hormones and exercise may be beneficial for reducing pain and
dysfunction measure by a clinical significant change in VISA-G scores, a
significant improvement in quality of life measured and decreasing tendon
abnormality assessed using US tissue characterization. Sufficient details are
provided to allow replication of the work or comparison with related analyses and
the manuscript does adhere to the relevant standards for reporting and data
deposition. Furthermore, the manuscript is well written.
No page numbers makes it difficult to refer to details in the text.
Major Compulsory Revisions:
Methods, Statistical Analysis:
US tissue characterization data will only be analyzed using a dependent samples
t-test - why?
Why will bonferroni adjustment not be made?
Methods, Recruitment:
Comment: The effect of HRT may depend on whether you have just turned into
menopause or you have been in the postmenopausal state for many years.
Therefore, I think it would be appropriate to specify the time-interval for
postmenopausal years (years since menopause).
Methods, Failure to improve:
Comment: The participants will be offered cross over to both active interventions
if their global ration of change scores is below 0. How will you handle this at
follow-up. If you transfer all "non-responders" in the control group there will be a
bias in regards to the effect of "control". Please clarify for the reader how you will
handle this at follow up
Minor Essential Revisions:
Background:
Ref 22: Since ref 22 is an unpublished manuscript and therefore I do not find it
suitable to use since the reader can't check the basis for the stated conclusion in
the systematic review of the literature
At the bottom of the first page in the background and the top of the following
page you write "injection". It may be obvious for you and me what you refer to,
but I would find it appropriate to specify if you refer only to cortisone injections or
any form of injection
Writing mistake: This response in similar to that seen --> This response is
similar...
Next line: "This review demonstrates that the role of exercise therapy in the
management of greater trochanteric pain syndrome needs investigation". I would
find it suitable to include "..needs further investigation".
Methods
Blood Sampling and Electrocardiography:
"Indicators for inclusion or exclusion of a participant will ....be... made on clinical
judgement..." (include be)
Intervention:
Just to be sure: Both groups will be informed about activities to avoid - which will
probably have an effect in both groups?
Female sex hormone supplementation transdermal cream:
Please refer to, which circulating concentrations of oestradiol is expected when
using the cream (in comparsion with the concentration levels during a normal
menstrual cycle in premenapusal women)
Discussion:
You write " In this program, all exercises aimed at loading the gluteal tendon
occur on a single leg as ....Comment: are you referring to the present study if
though you are writing "aimed"?
Discretionary Revisions
Secondary outcome measures:
Comment: Have you thought of including measurements of strength? Also to
check compliance to the home-exercise
Success of blinding
Comment: Do not be disappointed if the participants in the hormone groups are
able to guess that they have received hormonal treatment. We have just finished
a 8 week placebo-controlled intervention study where all the subjects who
received estrogen answered correct when asking the question about which group
they had been belonging to (placebo or estrogen)
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' below