METHODOLOGY- CRITICAL READING

Ulipristal Acetate versus Placebo for Fibroid Treatment

before Surgery
by
Jacques Donnez, M.D., Ph.D., Tetyana F. Tatarchuk, M.D., Ph.D.,
Philippe Bouchard, M.D., Lucian Puscasiu, M.D., Ph.D.,
Nataliya F. Zakharenko, M.D., Ph.D., Tatiana Ivanova, M.D., Ph.D.,
Gyula Ugocsai, M.D., Ph.D., Michal Mara, M.D., Ph.D.,
Manju P. Jilla, M.B., B.S., M.D., Elke Bestel, M.D.,
Paul Terrill, Ph.D., Ian Osterloh, M.R.C.P.
and Ernest Loumaye, M.D., Ph.D., for the "PEARL I Study Group*"

Name: Berenstain Iosefina Francesca

Series: B
Group: 11
Date: 8.4.2016

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This article is an original article that presents a clinical trial that involves
treatment investigation. The characteristics of this type of article are the
following:
It is a research that includes 242 women divided in 3 groups
Try to answer to scientific question and find better ways to
prevent, diagnose or treat the disease: Is Ulipristal Acetate
effeciency as a treatment for uterine bleeding caused by
fibroides?
The text is limited to 2700 words
The article includes abstract
The article includes maximum 5 tables and figures
The article includes up to 40 references - there are 38 references

The study presents women with symptomatic fibroid, excessive uterine

bleeding and anemia who received a treatment with oral Ulipristal Acetate
in different doses and placebo. The aim was to control the bleeding and to
reduce the fibroid volume before surgery.
The 242 women that were randomly chosen were divided in 3 groups.
Two groups received a dose of 5 mg or 10 mg of the drug and the third
group received the placebo. The treatment was given for 13 weeks only.
At the end of week 13, it was noticed that the bleeding was controlled in
91% from women who received 5 mg Ulipristal Acetate, 92% from women
who received 10 mg Ulipristal Acetate and 19% from women who
received placebo. The volume of the fibroid was reduced by 21% in the
first group, 12% in the second group but in the third group it exceeded for
about 3%.
In conclusion, treatment with Ulipristal Acetate for 13 weeks before
surgery has a good influence on the possibility to control the uterine
bleeding as well as to reduce the fibroid volume.
It need to be pointed out that the study focused on the preoperative
treatment and did not assess long term treatment.

Title: it is informative, presents very precisely the disease and the

investigation that will be explained in the article.
Abstract: included but the structure is not optimal for understanding.

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Introduction:
Includes the definition, symptoms and possible therapy.
Presents what the article is going to present (the efficiency of
Ulipristal Acetate).
Presents an older study that was done about the same subject and
its disanvanteges compared to this study (a 3-month course of
Ulipristal Acetate at a dose of 10 mg per day or 20 mg per day).
Presets the hypothesis or the aim of the study.

Methods: there are presented the interventions, techniques, assessment

of adverse events and statistical analysis.
Results: there are tables and grafts that show the screening,
randomization and follow up of patients. All of them are understandable.
In addition, the author explains the safety and side effects profile that are
an important information regarding the success and efficiency of the
investigated drug.
This kind of information has a good impact on the reader. The reader can
evaluate the article from his point of view, to consider the advantages and
disadvantages for this kind of treatment.
Discussion: the author presents the study and its results as a
comparison to other studies and points the benefits of his study (why this
treatment is better and what are its limitations). At that point the reader
can, again, find this study reliable more than other studies.
In conclusion, I think that the article is very interesting and can be
understood by the readers due to its clear language. The medical
information is explained very well by making the connection between the
theoretical data and the specific mechanisms or effects of the treatment.
Those mechanisms and effects are explained through the theoretical data,
for example, the effect of the drug on specific receptors.
This article presents a new possibility of improvement in quality of life for
those women who suffer from severe uterine bleeding accompanied with
all the symptoms involved like weakness, discomfort and secondary
anemia due to iron deficiency. I think that this finding need to be taken
one step forward in order to create a long term treatment. A similar case
happened in my family and I am sure that this kind of preoperative
treatment could have had a great influence on the medical as well as on
the psychological aspect. This study has a lot in common with the
palliative care that, in my opinion, is already the future part of medicine.
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