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presentation
การฝึกงาน Ambulatory 2 โรงพยาบาลวังน้าเย็น ผลัดที่ 5
น้าเสนอโดย นศภ.ภัทรฤทัย หาญชิงชัย รหัส 541158

Table of Contents

Introduction Method 01
Introduction
Result Discussion

Heartburn or pyrosis is a burning or painful sensation in
the upper part of the digestive tract including the throat. It is
one of the most common gastrointestinal symptoms in pregnant
women. The symptoms of heartburn in pregnancy may be
frequent, severe and distressing, but serious complications are
rare. The worldwide incidence of heartburn in pregnancy is
17% to 80% and it can occur in all trimesters of pregnancy.
Common drugs used for the treatment of heartburn in pregnancy
• Antacids
• Sucralfate
• histamine 2-receptor antagonists
• promotility drugs
• proton pump inhibitors
• a raft-forming alginate reflux suppressant.
However, there has been no evidence-based recommendation
for the treatment of heartburn in pregnancy.
The pathogenesis of heartburn in pregnancy involves
• Decreasing lower esophageal sphincter pressure
• Increased circulating progesterone during pregnancy causes lower
esophageal sphincter relaxation
• The enlarging gravid uterus causes increased intra-abdominal
pressure
• The normal compensatory response of the lower esophageal
sphincter to accommodate this change is impaired during pregnancy
• Abnormal gastric emptying or delayed small bowel transit might also
contribute to heartburn in pregnancy
Alginate-based reflux suppressants
● licensed for use in pregnant women to combat the frequent
symptoms of heartburn and regurgitation
● There has been one multicenter, prospective, open-label, and
baseline-controlled study of liquid alginate-based reflux
suppressants in the treatment of heartburn in pregnant women. The
efficacy of the study medication was rated by the investigator
(primary endpoint) and patient. Treatment was deemed to be a
success in 91% of patients as judged by the investigator and 90%
when assessed by the patient themselves
 The primary aim of this study was to
compare the reduction of heartburn
frequency after treatment.
02
Secondary aims were to compare the
reduction of heartburn intensity, quality of Method
life, maternal satisfaction, maternal side
effects, pregnancy and neonatal outcomes.

● This study was a randomized, double blinded, controlled trial conducted Inclusion criteria Exclusion criteria
at the Department of Obstetrics and Gynecology, Faculty
● Pregnant women aged 18 to 40 years who
of Medicine, Chulalongkorn University, Bangkok, Thailand, • Pregnant women with medical diseases,
presented to antenatal care clinic in hospital
between June 1, 2015 and July 31, 2016. with the diagnosis of heartburn and less than
with study drug contraindications and
● This study was approved by the Research Ethics Committee of the allergies to alginate-based reflux
36 weeks of gestation.
Faculty of Medicine, Chulalongkorn University. suppressant and magnesium-aluminium
● Participants were advised to undergo
antacid gel were excluded.
● The methods were performed in accordance with approved guidelines. lifestyle modification including reducing risk
● Written informed consent was obtained from all participants. factors of heartburn symptoms. At 1-week
● This clinical trial was registered at ClinicalTrials.gov (Clinical trials
follow-up, participants who had persisting or
worsened symptoms
registration: NCT02470117 date June 5, 2015).
 Treatment And Control group.
● Alginate-based reflux suppressant was assigned to the treatment group
and magnesium-aluminium antacid gel to the control group.
● Drug dose was 15 ml oral three times after meal and before bedtime.
Treatment was continued for 2 weeks.
● A randomization scheme was generated by random number table using a
block-of-four technique.
• Alginate-based reflux suppressant and magnesium-aluminium antacid gel
were prepared prior to the study by a pharmacist who had no
involvement in the study.
• Put into 2 opaque bottles. The bottles were put into an opaque bag.
• Participants recorded details of heartburn (frequency and intensity) and
side effects in a diary chart.
• Participants were asked to return the bottles and diary chart at the end of
study to evaluate compliance.
• Pregnancy and neonatal outcomes were followed-up until delivery
Statistical analysis.
● SPSS version 22 (SPSS Inc, Chicago, IL, USA)
● Chi-square test and Fisher-exact test for categorical variables,
● independent t-test for continuous variables
● p< 0.05 was considered statistically significant
● Analysis of the trial was conducted in intent-to-treat (ITT) analysis.
 The primary outcome
03 • the reduction of heartburn frequency after treatment
Secondary outcomes
Result • the reduction of heartburn intensity measured by 100-mm
visual analogue scale after treatment
• health-related quality of life was self-evaluated using the
Optum™ SF-12v2® Health Survey (Thai version)
• maternal satisfaction
• maternal side effects
• pregnancy and neonatal outcomes.

Characteristics
 04
Discussion

● The improvement of heartburn frequency in this study was 80% in alginate-based

reflux suppressant group. This result was similar to previous studies
This study showed no difference in the improvement of heartburn
● performed a multicentre, prospective, open-label, and baseline-controlled study
frequency between alginate-based reflux suppressant and magnesium-
of Liquid Gaviscon in the treatment of heartburn in pregnant women
aluminium antacid gel groups. Similar results were found in terms of the
● No neonatal complications occurred in both alginate-based reflux suppressant and
improvement of heartburn intensity, quality of life, maternal satisfaction,
magnesium-aluminium antacid gel groups.
maternal side effects and neonatal outcomes.
● This confirmed the safety of alginate-based reflux suppressant use in pregnancy as
reported from previous studies
 In conclusion, there was no difference between the
efficacy of alginate-based reflux suppressant and
CASP
magnesium-aluminium antacid gel in the treatment of
heartburn in pregnancy.
Checklist

Section A : Did the trial address a clearly focused issue? Section A : Did the trial address a clearly focused issue?
1. Are the results of the trial valid ? Yes Can’t tell No 2. Was the assignment of patients to treatments randomized?
Population Pregnant women aged 18 to 40 years who presented to antenatal care clinic in Yes Can’t tell No
our hospital with the diagnosis of heartburn and less than 36 weeks of
gestation
Intervention Alginate-based reflux suppressant
Comparison magnesium-aluminium antacid gel
Outcome primary outcome was to assess the reduction of heartburn frequency after
treatment.
Secondary outcomes were to assess the reduction of heartburn intensity
measured by 100-mm visual analogue scale after treatment, health-related
quality of life was self-evaluated using the Optum™ SF-12v2® Health Survey
(Thai version), maternal satisfaction, maternal side effects, pregnancy and
neonatal outcomes.
Section A : Did the trial address a clearly focused issue? Section A : Did the trial address a clearly focused issue?
3. Were all of the patients who entered the trial properly accounted for at its conclusion? 4. Were patients, health workers and study personnel ‘blind’ to treatment?
Yes Can’t tell No Yes Can’t tell No

Section A : Did the trial address a clearly focused issue? Section A : Did the trial address a clearly focused issue?
5. Were the groups similar at the start of the trial? 6. Aside from the experimental intervention, were the groups treated equally?
Yes Can’t tell No
Yes Can’t tell No
 Section B : What are the results? Section B : What are the results?
7. How large was the treatment effect? 8. How precise was the estimate of the treatment effect?

Yes Can’t tell No Yes Can’t tell No

Statistical analysis.
• SPSS version 22 (SPSS Inc, Chicago, IL, USA)
• Chi-square test and Fisher-exact test for categorical variables,
• independent t-test for continuous variables
• p< 0.05 was considered statistically significant
• Analysis of the trial was conducted in intent-to-treat (ITT)
analysis.

Section C : Will the results help locally ? Section C : Will the results help locally ?
9. Can the results be applied to the local population, or in your context? 10. Were all clinically important outcomes considered?
Yes Can’t tell No
Yes Can’t tell No
• primary outcome was to assess the reduction of heartburn frequency
after treatment.
• Secondary outcomes were to assess the reduction of heartburn
intensity measured by 100-mm visual analogue scale after treatment,
health-related quality of life was self-evaluated using the Optum™
SF-12v2® Health Survey (Thai version), maternal satisfaction,
maternal side effects, pregnancy and neonatal outcomes.
Section C : Will the results help locally ?
11. Are the benefits worth the harms and costs?
Yes Can’t tell
The strength
• this study was the first randomized, double blinded, controlled trial conducted
to evaluate the efficacy of alginate-based reflux suppressant and magnesium-
No aluminium antacid gel for treatment of heartburn in pregnancy.
• that we were able to assess patient quality of life before and after treatment,
which has yet to be assessed in any current or previous studies.

The limitations
• this study were that it was a short period of treatment (2-week) and it was
underpowered to evaluate some secondary outcomes.

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