554 Journal of the Royal Society of Medicine Volume 83 September 1990
Comparison of a dimethicone/antacid (Asilone gel) with an alginate/antacid
(Gaviscon liquid) in the management of reflux oesophagitis
H L Smart DM MRCpl M Atkinson MD FRCp2 lDepartment of Medicine, University of Sheffield, Royal
Hallamshire Hospital, Sheffield SIO 2JF and 2Department of Surgery, University of Nottingham, University
Hospital, Queen's Medical Centre, Nottingham
Keywords: dimethicone/antacid; alginate/antacid; gastro-oesophageal reflux; endoscopic oesophagitis
Summary
Fifty-three patients with symptomatic reflux
oesophagitis were entered into a single centre
randomized study comparing the effects of a
dimethicone/antacid (Asilone Gel) and an alginate/
antacid (Gaviscon liquid) on symptoms and endoscopic
changes over an 8-week period. Both treatments
significantly improved heartburn, acid regurgitation
and flatulence. Dimethicone/antacid but not alginate/
antacid, produced a significant improvement in
oesophagitis, oesophageal ulceration and histological
grade of inflammation over the Sweek treatment
period so that 14 patients treated with dimethicone/
antacid and 10 with alginate/antacid had normal
endoscopic oesophageal appearances at the end of the
study. The difference in improvement between the two
patient groups did not reach significance however,
except for dimethicone/antacid improving histological
changes (P< 0.05). These findings suggest that
dimethicone/antacid and alginate/antacid are equally
effective in treating symptomatic reflux oesophagitis
although dimethicone/antacid may have an advantage
in improving oesophageal histological appearances.
Introduction
Antacids together with simple measures such as
control of smoking and weight reduction, form the
cornerstone of the medical treatment of symptomatic
gastro-oesophageal reflux'. There is some evidence to
suggest when combined with alginatee", or with
dimethicone" the efficacy of antacids is increased.
We have therefore compared two commonly prescribed
preparations, a dimethicone/antacid (Asilone gel) and
an alginate/antacid (Gaviscon liquid) in order to
determine the relative therapeutic value of these
combinations, the composition of which are shown in
Table 1.
Patients and methods
Fifty-three patients (24 men), all aged over 18 years
and suffering from symptomatic gastro-oesophageal
Table 1. Content of each 10 ml dose of the agents employed
in this study
Dimethicone! Alginate!
antacid antacid
Dimethicone 250mg
Sodium alginate 500mg
Sodium bicarbonate 267mg
Calcium carbonate 160mg
Aluminium hydroxide 840mg
Light magnesium oxide 140mg
reflux associated with endoscopic evidence of
oesophagitis were admitted into a double-blind trial.
Patients were excluded from the trial if pregnant, if
they had previously undergone gastric surgery, or if
they suffered from diabetes mellitus, rheumatoid
arthritis, peptic ulceration or any other serious
medical disorder. Diet, smoking and alcohol con-
sumption were not curtailed.
After a 2-week period taking no anti reflux
treatment patients were randomly allocated to receive
either dimethicone/antacid (DA) or alginate/antacid
(AA) 10 ml 4 times a day (half an hour after meals
and at night) for an 8-week treatment period. These
preparations were supplied in identical containers but
no attempt was made to alter their physical character-
istics. The randomization was stratified according to
the severity of endoscopic oesophagitis so that two
balanced patient-groups were obtained. Patients were
seen on entry to the trial, and after 4 and 8 weeks
of treatment. Endoscopy with oesophageal mucosal
biopsy was performed on entry to the study and after
8 weeks.
Symptomatic assessment was made on entry (0
weeks), and after 4 and 8 weeks of treatment when
heartburn, acid regurgitation and flatulence were
measured on a 5-point scale (Table 2) and the presence
of dysphagia was noted.
Endoscopic assessment at 0 and 8 weeks was based
on inflammation and ulceration (Table 3).
Table 2. Grading of symptoms in reflux oesophagitis
Grade
Heartburn 0 None
1 Occurring less than once a day
2 Occurring once a day or at night
3 Occurring more than once a day
4 Frequent and prolonged pain
Regurgitation 0 None
1 Less than once a day and clearly
precipitated, eg by stooping or lifting
2 Less than once a day with no
precipitating factors
3 More than once a day with or
without precipitating factors
4 Frequent or persistent regurgitation
Flatulence 0 None
1 Once a day or less 0141·0768/901
2 More than once a day 090554-03/$02.00/0
3 After every meal © 1990
4 Persistent and frequent with social The Royal
embarrassment Society of
Medicine

Table 3. Grading of endoscopic appearance of reflux
oesophagitis
Grade
Inflammation o Normal
1 Oedema and friability of the mucosa
involving less than 50% of the
circumference and restricted to the
lower 2 cm of the oesophagus
2 As 1, but involving most of the
circumference of the oesophagus
3 As 1 but extending above the lower
2 em of the oesophagus
4 As 3, but involving more than 50% of
Ulceration o
the oesophagus
Nil
1 Small superficial ulcers surrounded
by erythema, maximum of three in
number and restricted to the lower
2
2 cm of the oesophagus
As 1, but more than 3 ulcers
3 Superficial ulceration, but extending
above the lower 2 cm of the
oesophagus
4 Chronic peptic ulceration of the
oesophagus
Table 4. Grading of histological changes on oesophageal
biopsy in patients with reflux oesophagitis
o Normal
1 Occasional polymorphonuclear leukocytes around
submucosal papillae
2 As 1, but with scattered polymorphs in the
epithelium between papillae
3 Polymorphs conspicuous throughout fields of the
biopsy
4 Evidence of ulceration
Patients with grade 0, 1 or 2 oesophagitis and grade
o or 1 ulceration were classified as mild/moderate
disease, and the remainder as severe. The grading
scale for histological biopsies is shown in Table 4.
Compliance assessment was based on measurement
of the amount of liquid returned at 4 and 8 weeks.
Good compliance was defined as the consumption of
more than 75% of the calculated volume to be
consumed.
Statistical methods
For parametric data Student's t-test was used. The
Mann-Whitney U test was used to study differences
between treatment groups and the Wilcoxonmatched-
pairs signed rank test was used to compare changes
in symptoms and endoscopic measurements within
treatment groups. Chi-square analysis was used to
compare the changes in the proportion of patients
having a given grade of symptoms or endoscopic/
histological measures between and within patient
groups.
An 'intention to treat' analysis was employed.
Results
Of the 53 patients admitted to this trial 28 received
DA and 25 AA. Both treament groups were com-
parable for age, sex, alcohol and tobacco consumption
and the severity ofbaseline symptoms, endoscopicand
histological appearances <Tables 5 and 6}. Patients who
Journal of the Royal Society of Medicine Volume 83 September 1990 555
Table 5. Median symptom grades at entry to trial (0 weeks),
after 4 weeks and after 8 weeks of treatment
Dimethicone! Alginate!
antacid antacid
o 4 804 8
weeks weeks weeks weeks weeks weeks
P< 0.001 P< 0.001
Heartburn 3
~ 2 2
~322
~~ P<O.002 P<0.0025
P<O.Ol P<O.Ol
Acid regurgitation 3
~ 1 121
~ 1
~~
P<0.002 P<0.02
Flatulence 3 2 2 3 2 1.5
~~ P<0.05 P<0.05
received DA however were significantly heavier
(P< 0.01) than those who received AA (mean weight
73 kg and 68 kg, respectively).
Three of the 28 patients receiving DA with-
drew from the trial (two because of symptomatic
deterioration and one defaulted). Three of the 25
who received AA withdrew because of clinical
deterioration. Compliance was good in the remaining
patients.
After 4 and 8 weeks of therapy with DA, 11 and 16
patients respectively had minimal or no symptoms of
heartburn (Grades 1 and O); the corresponding figures
for AA were 10 and 10 patients. Acid regurgitation
was well controlled in 15 and 14 patients at weeks
4 and 8 respectively with DA and in 14 and 16
patients respectively receiving AA. Twelve patients
taking DA and 11 taking AA had grade 0 or 1
flatulence at the end of the trial. Table 5 shows that
after both 4 and 8 weeks of treatment, DA and AA
produced a significant improvement in the grade of
heartburn and acid regurgitation and that at 8 weeks
both led to a significant improvement in the grade
of flatulence. Dysphagia, present initially in 30% of
patients, was mild and did not improve significantly
with either treatment. The degree of improvement in
all these symptoms did not differ significantly
between the DA and the AA groups.
Significant improvement in the grade of endoscopic
inflammation was seen at 8 weeks with DA but not
with AA. (Table 6). However, the difference in the
degree of improvement between the two groups was
not significant. Endoscopic evidence of ulceration was
present at the commencement ofthe treatment period
in 50% of the DA group and 48% of the AA group.
Significant improvement in the grade of ulceration
was seen in the DA group at 8 weeks but not in
556 Journal of the Royal Society of Medicine Volume 83 September 1990
Table 6. Median endoscopic and histological gradings before
and after treatment
Dimethicone/ Alginate!
antacid antacid
Endoscopic
appearances o weeks 8 weeks 0 weeks 8 weeks
Inflammation 2 0 1 1
P<O.02
Ulceration 0.5 0 1 0 to cause a significant reduction in oesophageal
P<0.02
Biopsy histology 2 1 2 2
P<0.05
the AA group. Again, the difference in degree of
improvement between the two groups did not reach
statistical significance. Fourteen patients receiving
DA (50%)and 10 receiving AA (40%) had no evidence
of oesophagitis at the end ofthe study (Chi square 0.5;
P>OA).
Treatment with DA but not AA led to significant
improvement in the grade of biopsy histology after
8 weeks (Table 6). Five patients treated by DA but
none treated with AA had a normal oesophageal
mucosal at biopsy at the end of the treatment period
(Chi square 4.9; P<0.03).
Discussion
This study shows that the antacid combinations DA
and AA are both equally effective in providing relief
of symptoms of gastro-oesophageal reflux. Since about
50% of patients with reflux symptoms do not have
clear endoscopic evidence of cesophagitis", these
agents will often suffice alone to provide effective
symptomatic treatment. Previous studies have given
conflicting evidence about the value ofDA in relieving
flatulencev' but in this study both it and AA gave
significant relief of these symptoms.
Under the conditions of this trial DA but not
AA significantly improved the grade of endoscopic
oesophagitis and oesophageal ulceration, although the
proportion of patients with a normal endoscopic
oesophageal appearance at trial conclusion did not
differ significantly between groups. This may be a real
finding or related to the small numbers of patients
studied inducing a type 2 error. With DA the healing
rate for oesophagitis of 50% compares favourably with
that reported for simple antacids and the H2 receptor
antagonist cimetidine of 35% and 63% respectively 7•
Symptomatic response and endoscopic healing rates
of oesophagi tis with omeprazole, a proton pump
inhibitor, are significantly higher than with antacids
or H 2 receptor antagonists8•9, indicating the impor-
tance of adequate gastric acid suppression in the
treatment of reflux disease.
The alginate preparation (AA) has much less
acid neutralizing capacity than the dimethicone
preparation (DA) which has also been reported in
having local mucosal protective properties", It seems
possible that the superiority of DA in healing
oesophagitis may be explained at least in part on this
basis. Alginate preparations with a greater antacid
content are now available and these might be
expected to give better symptomatic relief in gastro-
oesophageal reflux.
The influence ofDA on oesophageal acidity has not
been studied by pH monitoring; AA has been found
acidity 2.10 but others have been unable to confirm
these findings!'. Further pH studies would provide
objective evidence about the relative efficacy of DA
and AA in controlling acid reflux into the oesophagus,
but the different properties of these preparations
might reduce mucosal damage even with free reflux
of acid gastric contents into the oesophagus.
Acknowledgment: We would like to thank Rorer Health Care
Limited who supplied the antacid preparations and also
provided financial support for the study.
References
1 Castell DO. Medical therapy for reflux esophagitis: 1986
and beyond. Ann Intern Med 1986;104:112-14
2 Stanciu C, Bennett JR. Alginate/antacid in the reduction
of gastro-oesophageal reflux. Lancet 1974;i:l09-11
3 McHardy GA. A multicentre randomised clinical trial
of Gaviscon in reflux. South Med J 1978;71:16-21
4 Ogilvie AL, Atkinson M. Does dimethicone increase the
efficacy of antacids in the treatment of reflux oeso-
phagitis? J R Soc Med 1986;79:584-7
5 Rokkas T, Sladen GE. Ambulatory esophageal pH
recording in gastro-esophageal reflux: Relevance to the
development of esophagitis. Am J Gastroenteroll988;
83:629-32
6 Birtley RDN, Burton JS, Kellett DN, Oswald BJ,
Pennington JL. The effect of free silica on the mucosal
protective and anti-flatulent properties of polymethyl
siloxone. J Pharm Pharmacal 1973;25:859-63
7 Tytgat GNJ. Assessment of the efficacy of cimetidine
and other drugs in oesophageal reflux disease. In: Baron
JR, ed. Cimetidine in the 80s. Edinburgh: Churchill
Livingstone, 1981:153-66
8 Dent J, Hetzel DJ, Reed WD, Narielvala FM, Mitchell
BL, McCarthy JR. Healing of peptic esophagitis with
omeprazole. Gastroenterology 1986;90:1392
9 Klinkenberg-Knol EC, Jansen JMBJ, Festen HPM,
Meuwissen SGM, Lamers CBHW. Double blind multi-
centre comparison of Omeprazole and Ranitidine in the
treatment of reflux oesophagitis. Lancet 1987;i:349-51
10 Branicki FJ, Evans DF, Jones JA, Atkinson M,
Hardcastle JD. A controlled trial of liquid gaviscon in
gastro-oesophageal reflux using a portable pH sensitive
radiotelemetry system. J Ambulatory Monitoring
1988;1:61-72
11 Johnson LF, DeMeester TH. Evaluation of elevation of
the head of the bed, bethanecol and antacid foam tablets
on gastro-esophageal reflux. Dig Dis Sci 1981;26:673-80
(Accepted 18 April 1990)