Raft Meet

Definition of GERD
• Symptoms or mucosal damage produced by the abnormal reflux of
gastric contents into the oesophagus
• Common symptoms most common when pH<4
• Heartburn
• Belching and regurgitation
• Hypersalivation
• May be episodic or nocturnal
• May be aggravated by meals and reclining position
 Global Epidemiology of GERD

GERD2
The global pooled prevalence of GERD was 13.98% and
varied considerably according to region and country.

Using the UN 2017 Revision of World Population

Prospects, nearly 1.03 billion individuals suffer from
GERD globally.

1. Xie X, et al. BMC Gastroenterol. 2022;22:58.

2. Nirwan JS, et al. Sci Rep. 2020;10:5814. DALY: Disability-adjusted life years; GERD: Gastroesophageal reflux disease; PUD: Peptic ulcer disease; UN: United Nati
 Prevalence of GERD in the Indian Population

The study cites the prevalence GERD in India

The pooled prevalence of GERD

in the Indian population is 15.6%
(95% CI 11.046–20.714).

Rai S, et al. Indian J Gastroenterol. 2021;40(2):209–219. CI: Confidence interval; GERD: Gastroesophageal reflux disease.
Symptoms of GERD
 Heartburn
 Acid regurgitation (backward flow of acid from stomach to esophagus)
 Occurs commonly with heart burn

 Bitter acid taste in the mouth.

 Dysphagia- difficulty in swallowing.

 Belching- Expulsion of gas from the stomach through the mouth

 Other symptoms like non cardiac chest pain, pulmonary symptoms like cough and
some ear, nose throat problems like pharyngitis, laryngitis, sinusitis, dental erosion
etc. also occur.
Dyspepsia

• Dyspepsia is defined as having one or more symptoms of

epigastric pain, burning, postprandial fullness, or early satiation.

• Dyspepsia is extremely common in the community; with

prevalence in excess of 30%. Up to 40% of sufferers will consult a
primary care physician

Ther Adv Gastroenterol (2010) 3(2) 8798

Symptoms of Dyspepsia

• Epigastric Pain: Persistent or recurrent

pain or discomfort centered in the upper
abdomen
• Heartburn
• Nausea
• Bloating (Abdominal Fullness)
• Early satiety and
• Flatulence.
Interview and Examination - Symptoms and Signs

Suggest GERD Functional Dyspepsia Ulcer

Heart burn Nausea Burning pain

Regurgitation Bloating Relief of pain with food
Reflux Early satiety Localised epigastric pain

Pain worse with food Nocturnal fasting pain

Lifestyle modifications – Tips & tricks to tackle reflux
Medical : Role of PPI in the management of
GERD and its challenges
PPIs – for GERD
• Over the years, PPIs have become the cornerstone of therapy
for
GERD and Peptic Ulcer Disease (Gastric & Duodenal Ulcers)
• Evolution of numerous molecules and entry into India:
• Omeprazole
• Lansoprazole
• Pantoprazole
• Esomeprazole
• Rabeprazole
• Dexlansoprazole
PPI and its challenges
Non compliance: Most common cause for PPI failure

 GERD is a symptom-driven disease

 By end of 6 months, 30% of patients still consume PPIs
 Factors of compliance
 Presence or absence of symptoms
 Severity of symptoms
 Personal preference
 Compliance should be assessed in all patients with refractory
GERD prior to ordering any evaluative test
Medication timing and adherence
 Poor compliance with proton pump inhibitor (PPI) timing
and adherence is an important cause for inadequate acid
suppression and refractory GERD.

 PPIs should be administered 30 to 60 minutes before

breakfast for maximal inhibition of proton pumps.
Residual acid reflux

• It has been documented in GERD patients with persistent heartburn

despite PPIs once or twice daily.

• In one study, 38.6% of patients with GERD undergoing pH testing for

persistent symptoms, while receiving standard dose PPIs once a day, had
an abnormal test.

Dig Dis Sci 2005;50:1909–15 .

Post prandial heart burn

• Acid pocket’, the phenomenon by which newly secreted gastric acid

layers on top of, rather than mixing with, the ingested meal.

• This puts acid in close proximity to the gastro-esophageal junction as

soon as 17 minutes after eating.

• High-resolution postprandial pH recordings 4 have confirmed that

the acid pocket is the source of postprandial acid reflux
Nocturnal acid breakthrough

• Nocturnal acid breakthrough (NAB) has been defined as the

presence of gastric pH,4 for at least 1 h during the night in patients
with persistent heartburn on standard dose PPIs twice daily.

• It has been suggested that this gastric physiological phenomenon

causes failure of PPI treatment by promoting gastro-oesophageal
reflux during sleep.
Challenges in Treating NERD patients
• The NERD population includes patients who do not have acid reflux
as a cause of their symptoms.
• Moreover, it includes patients with hypersensitivity, an irritable
esophagus, and concurrent irritable bowel syndrome (IBS).
• Their symptoms may present with reflux-type symptoms, but without
acid being the cause.
• Due to this heterogeneity, acid-suppressive medications have a lower
response in this patient population.
Concept of Acid pockets
 Acid Pocket
 Essentially, the food that a person
eats neutralizes gastric acid, but
soon afterward—within 15 minutes
—the stomach secretes acid in
response to that food. Post meal reflux
“Local area of gastric acidity
 Thisthat escapes buffering effect
newly secreted acid layers on Acid pocket
Of food, thereby causing
top of the meal; it does not mix with
postprandial acidic reflux”
the meal, resulting in a region on
top of the food— the acid pocket—
that is highly acidic.
Buffered food

Am J Gastroenterol 2013; 108:1058–1064; doi: 10.1038/ajg.2013.132; p

Post Meal Acid Pocket Formation

Before meal After a meal

FORMATION
During the meal

Turk J Gastroenterol 2019; 30(Suppl 2): S109-36

Post-prandial reflux acid pockets

Because of its proximity to the

EGJ, the acid pocket has
pathophysiological relevance in
GERD:
1) it is the likely origin of
postprandial acidic reflux,

2) it can form a reservoir for

acid reflux
 Assessment of the ability of an alginate / antacid formulation to neutralize and / or
displace the acid pocket

Acidified segment

Manometrically monitored esophagogastric

junction (EGJ) is shown during fasting and
postprandially, before and after dosing with the
alginate / antacid combination.

Sodium alginate antacid neutralized the acidified segment, eliminating the acid pocket in the majority of the
GERD patients, indicated by the significant relocation of the pH transition point away from the EGJ.
Am J Gastroenterol 2013; 108:1058–1064;
 An alginate-antacid formulation can eliminate the
postprandial “acid pocket” in symptomatic GERD patients

After ingestion of the Alginate

antacid the acidified segment was
no longer detected either in the
proximal stomach or the EGJ
(bottom panel)
Aliment Pharmacol Ther. 2011 July ; 34(1): 59–66.
Sodium Alginate Antacid
Combination of two antacids and
Sodium alginate causes a viscous
gel (or raft) to form
• Sodium alginate IP..250mg
• Sodium bicarbonate IP..133.5mg
• Calcium carbonate IP 80mg.
Mechanism of action of Sodium Alginate Antacid

• Calcium carbonate neutralises

gastric acid to provide fast
relief from indigestion and
heartburn.

Neutralisation of acid
Mechanism of action of Sodium Alginate Antacid

• On ingestion, the medicinal product

reacts rapidly with gastric acid to
form a protective barrier (raft) of
alginic acid gel having a near
neutral pH and which floats on the Raft
formation
stomach contents.

Raft formation
Mechanism of action of Sodium Alginate Antacid

• Sodium Bicarbonate in the

presence of gastric acid is
converted to carbon dioxide
which get entrapped with the
gel and converted in to the
foam which floats on the
surface of gastric content like a
raft and prevent the reflux.

Prevention of post meal

reflux
Onset and duration of action
• Faster Action:  Long Lasting Relief:
 Action Lasting Relief Up to 4 Hrs
• Relief in just 3 minutes
The Journal of International Medical Research 2010; 38: 449 – 457 Aliment Pharmacol Ther 14,
669±690
Indication

• Symptomatic treatment of gastro-oesophageal reflux such

as acid regurgitation, heartburn related to post meal
• As an adjunct therapy with PPIs
• GERD during pregnancy.
Posology and method of administration

 For oral administration.

 Adults and children 12 years and over: 10-20 ml after

meals and at bedtime, up to four times per day.

 Children aged 6 -12 years: 5-10 ml after meals and at bed

time.
 Children aged < 6 years – Not recommended

 Elderly: No dose modifications necessary for this age

group
 • Alginate antacid is more effective than antacid in controlling post-
prandial oesophageal acid exposure in GERD patients

Alginate antacid
After the first 30 min, the
nadir pH of refluxate was
significantly less acidic during
the alginate antacid studies
and this effect persisted until
150 min.
(P < 0.05, paired t-test).

Aliment Pharmacol Ther 2014; 40: 531–537

Meta-analysis for alginate therapy versus placebo or antacid.

Alginate therapy was uniformly favoured over placebo or antacids

Diseases of the Esophagus (2017) 30, 1–9
Studies on the efficacy of alginates in the reduction of regurgitation

Turk J Gastroenterol 2019; 30(Suppl 2): S109-36

Alginate Antacid as an adjunct to
PPI Therapy
 Alginate antacids + PPIs add on therapy

• A recent systematic review reported breakthrough symptoms in 30%-60%

of PPI-treated patients in primary care and community-based studies.
• In some cases, unresolved symptoms, particularly regurgitation, can have a
significant impact on social and physical functioning, sleep quality and
missed work.
• In untreated individuals, the “acid pocket” forms on top of food-buffered
gastric contents and acts as a highly acidic source of postprandial reflux.
• A postprandial layer of gastric secretion also exists in PPI-treated patients;
it is less acidic than the acid pocket (~pH 3.9 vs ~0.9) but remains the
source of reflux after meals.

Aliment Pharmacol Ther. 2017;45:1524–1533

Alginate antacids + PPIs add on therapy

• Alginates are interesting candidates for use as an add-on

therapy as they act in a complementary way to PPIs by directly
capping postprandial reflux.
• The alginate-antacid formulation has been shown to co-localise
and eliminate the acid pocket in GERD patients.
• Alginate antacid 10ml after meals and at bedtime added to
their existing PPI regimen.

Aliment Pharmacol Ther. 2017;45:1524–1533

The role of alginates combined with PPIs in patients with severe or PPI-
unresponsive gastroesophageal reflux disease

 Omeprazole (20 mg once daily) plus

sodium alginate (30 mL four times a
day) (group A) or omeprazole (20 mg
once daily) alone (group B).
 76 patients were randomly assigned
to group A (n = 36) or group B (n =
40).
 Complete resolution of heartburn for
at least 7 consecutive days by the end
of treatment was significantly more
common in group A (56.7%) than in
Rate of complete resolution of heartburn for 7 consecutive days up group B (25.7%).
to the last day of medication. There were significantly more
responders in group A than in group B.
Diseases of the Esophagus (2012) 25, 373–380
 Heartburn-free days (%) during the 28-day
observation period was 54.9% in group A
versus 35.9% in group B.

The rate was significantly higher in group A

than in group B

Diseases of the Esophagus (2012) 25, 373–380

Heartburn-free days (%) during the 28-day observation
period. The rate was significantly higher in group A than in
group B

For patients with partial response to PPIs, the addition of alginate antacids serves as a
useful adjunct.
Prevalence of GERD in the Pregnancy
 Alginate in Pregnant Women with GERD

Multicenter, prospective, open- Liquid Gaviscon 10–20 mL as required to a

144 pregnant women
label maximum of 80 mL per day, for 4 weeks

The severity of daytime and nocturnal heartburn

experienced by pregnant women at baseline and after
prn treatment with Liquid Gaviscon for 4 weeks. (ITT)

Liquid Gaviscon is both safe and highly efficacious in the treatment of heartburn and GER in pregnancy. There were no safety concerns for the
mother or unborn child and serum sodium levels.
Strugala V, et al. ISRN Obstet Gynecol. 2012;2012:481870.
GER: Gastroesophageal reflux; ITT: Intention-to-treat; Prn: As required.
Preferred treatment
algorithm for GERD
during pregnancy
 Immediate onset
of therapeutic
effect faster than
that of a PPI or
H2RA

Alginate added
to PPI Safe in pregnant
effectively women and
controls acid children due to
breakthrough non- systemic
and night time nature
symptoms Alginate Antacids

Effective control
Longer duration
of heartburn and
of action as
other symptoms
compare to
associated with
antacids
GERD
Thank You!