Literature Review
• There has been so many RCT, systemic review and metanalaysis on
this topic.Most of the studies shows superiority of Combined therapy
over monotherapy in case of GERD.but There are studies which shows
no added benefit of combined therapy over monotherapy.In such
situation PPI alone turn to be cost effective over combined therapy.
continue
• A systemic review and meta analysis of RCT conducted by Nurfatahu
Jamani et al shows a significant difference in reduction of symptoms
by combined therapy over PPI monotherapy:
Heart burn(MD =-1.73,95%CI from -2.67 to 0.78,P<0.00001)
Reflux time(MD=-1.82,95%CI from -2.36 to 1.28,P=0.0002)
Frequency(MD= -7.42 from -10.26 to -4.59,P<0.0001)
• KY Marakhousi etal phase 4 open label ,RCT shows
mean VAS score for heartburn severity as 1.7 ± 3.30 and 9.1 ± 6.48 (95% CI
of mean: 0.432-2.9 and 6.21-11.96; P = .000) for combined and Omepraole
groups, respectively after 8 weeks of treatment.
Combined therapy was accompanied by a significantly longer period of
heartburn-free days: 22.8 ± 3.0 days (95% CI = 21.6-23.9 days) vs
11.8 ± 4.3 days (95% CI = 10.2-13.4 days) on omeprazole (P = .00).
• Deepak kumar Khajuria et al a review of superior effect of comined
therapy vs monotherapy has explained in terms of management of
severe and resistant GERD, which, when treated medically, demands
aggressive acid suppression, usually through the use of PPIs and
prokinetic agents as a combination therapy, which seem to be the
most effective treatment of control and management of acid reflux as
compared to monotherapy with PPIs.
• A recent (2020) publication—“ACG Clinical Guideline for
the Diagnosis and Management of Gastroesophageal Reflux Disease”
—recommended against using any prokinetic agent for GERD treatment
unless there is objective evidence of gastro-paresis .
• The recommendation was based on low-grade evidence with a high
grade of recommendation strength.
Tarang Taghvaei Et al RCT double blind trial has following findings:
• Carlson Dennett and GERD questionnaire results revealed no
significant differences between two groups. This means that
application of domperidone was not effective in reducing reflux.
• Both groups could not show any valuable difference in SF-36
questionnaire results which reflect quality of life.
Rupranik Et al study study about pharmacoeconomic evaluation shows:
Cost-effectiveness ratio for combined vs monotherapy was calculated
by dividing the cost of treatment by its clinical outcome that is,
Frequency Scale for the Symptoms of GERD (FSSG) score.
the total improvement rate was found to be higher in combined group
than in monotherapy group (improvement score 12.93 vs 11.32 but
statistically not significant, p-0.21)
But Pantoprazole was found to be more cost effective than
Pantoprazole plus Domperidone group (ACER 9.7 vs 11.2).
• Gallusi Gulia et al does a systemic review of medical trials written in
English between 2000 and 2016 from pubmed and scopus which
showed trial of using double doses of PPI against alternative
medication where ist line fails.
• Though different systemic review and meta analysis has been done in
other parts of world showing PPI plus prokinetic superior in terms of
symptom reliefs, such study has not been conducted in developing
countries like Nepal where cost burden over the benefit and long
term compliance of the drug has to be considered in the population
and even in the European countries domperidone has not been used
as much due to its cardiac side effects.