Reviewer ’s report  
 
Title: Effectivenes s of dienogest in improving quality of life in Asian women with endometriosis 
(ENVISIOeN): interim results from a prospective cohort study under real -life clinical practice  
 
Version: 1 Date: 02 Mar 2019  
 
Reviewer: Iztok Taka č 
 
Reviewer's report:  
 
BMWH -D-19-00048R1  
"Effectiveness of dienogest in improving quality of life in Asian women with endometriosis 
(ENVISIOeN): interim results from a prospective cohort study under real -life clinical practice"  
 
General remarks  
The authors performed a non -interventional, multicenter, prospective study which aimed to 
investigate the influence o f dienogest on health -related quality of life (HRQoL) in women with 
endometriosis. In this study Asian women received dienogest (2 mg/daily) and were followed for 
24 months. The effectiveness of dienogest to improve HRQoL and EAPP was assessed by 
patient -reported outcomes. HRQoL, especially the "pain" domain as primary endpoint, was 
evaluated with the Endometriosis Health Profile -30 (EHP -30) questionnaire. The numeric rating 
scale served to determine changes in the severity of endometriosis -associated pelvi c pain 
(EAPP). Within the presented interim analysis, the mean changes in EHP -30 and EAPP scores 
from baseline to 6 months upon availability of the data were evaluated. Treatment -emergent 
adverse events (TEAEs) and bleeding profiles were also documented. A uthors found out that 
dienogest therapy decreased EHP -30 scores in all assessed domains. Primarily, the "pain" 
domain was improved in 78.4% of patients. EAPP was reduced, highlighted by a mean reduction 
of the pain score by -4.5 points. Patients with a hig her EAPP score at baseline had an increased 
response to dienogest compared to patients with low baseline EAPP severity. Both surgically and 
clinically diagnosed patients described comparable pain reduction, as well as women with or 
without prior treatment.  
Drug -related TEAEs were documented for 31.5% of patients, with amenorrhoea (5.9%) and 
metrorrhagia (5.1%) being the most common events. The bleeding pattern was changed upon 
dienogest, characterized by decreased normal bleeding and increased amenorrhea at  6 months. 
Authors concluded that their data indicate an amelioration of HRQoL and EAPP upon dienogest 
therapy. No new safety signals were observed. Moreover, its use as first -line therapy for long -
term management of debilitating and chronic endometriosis -associated pain represents an 
interesting option that remains to be further investigated.  
The topis is very interesting and till now no such a large study in Asian population was 
performed.  
There are some corrections needed before the article is suitable f or publication, which are 
marked in the attached document.  
Are the methods appropriate and well described?  
If not, pl ease 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.  
 
Yes 
 
Are the conclusions drawn adequately supported by the d ata shown?  
If not, please explain in your comments to the authors.  
 
Yes 
 
Are you able to assess any statistics in the manuscript 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 written English  
Please indicate the quality of language in the manuscript:  
 
Acceptable  
 
Declaration of competing interests  
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