Diseases of the Esophagus (2015) ••, ••–••

DOI: 10.1111/dote.12390

Original article

Short-term and long-term effect of diaphragm biofeedback training in

gastroesophageal reflux disease: an open-label, pilot, randomized trial

X. Sun,1 W. Shang,2 Z. Wang,1 X. Liu,1 X. Fang,1 M. Ke1

1
Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical
Sciences & Peking Union Medical College, Beijing, and 2Department of Gastroenterology, Guangdong
Provincail Traditional Chinese Medicine Hosptial, Guangzhou, China

SUMMARY. This study investigated the effectiveness of diaphragm biofeedback training (DBT) for patients with
gastroesophageal reflux disease (GERD). A total of 40 patients with GERD treated at the Peking Union Medical
College Hospital between September 2004 and July 2006 were randomized to receive DBT and rabeprazole proton
pump inhibitor (PPI) or rabeprazole alone. The DBT + rabeprazole group received DBT during the 8-week initial
treatment; the rabeprazole group did not. During the 6-month follow up, all patients took acid suppression
according to their reflux symptoms, and the patients in the DBT + rabeprazole group were required to continue
DBT. The primary outcome (used for power analysis) was the amount of acid suppression used at 6 months.
Secondary outcomes were reflux symptoms, health-related quality of life (HRQL), and esophageal motility
differences after the 8-week treatment compared with baseline. Acid suppression usage significantly decreased in
the DBT + rabeprazole group compared with the rabeprazole group at 6 months (P < 0.05). At 8 weeks, reflux
symptoms and GERD-HRQL were significantly improved in both groups (P < 0.05), without difference between
them. Crural diaphragm tension (CDT) and gastroesophageal junction pressure (GEJP) significantly increased in
the DBT + rabeprazole group (P < 0.05), but without change in lower esophageal sphincter (LES) pressure. There
was no significant change in CDT, GEJP, and LES pressure compared with baseline in the rabeprazole group. In
conclusion, long-term DBT could reduce acid suppression usage by enhancing the anti-reflux barrier, providing a
non-pharmacological maintenance therapy and reducing medical costs for patients with GERD.
KEY WORDS: anti-reflux barrier, diaphragm biofeedback training, gastroesophageal reflux, manometry,
therapy.

INTRODUCTION PPIs, long-term maintenance therapy is still necessary

in most patients,4,5 with up to 50% of patients experi-
Gastroesophageal reflux disease (GERD) is a encing some GERD symptoms despite PPIs,6 and with
common chronic disorder1,2 that has a significant some patients failing to respond to PPIs.7,8 In fact, PPI
impact on patients’ quality of life and on the use of failure and PPI long-term maintenance have become
healthcare services.3 The most common treatment is common problems for patients with GERD and there
the use of proton pump inhibitors (PPI). Although is an increasing concern that their long-term use may
patients with GERD typically have a good response to cause side effects such as reduced bone mineral density
and bone fractures.9 It has been suggested that effec-
tive therapy for GERD should be based on alternative
Address correspondence to: Dr Meiyun Ke, MD, Department of
Gastroenterology, Peking Union Medical College Hospital, approaches in combination with drugs.10
Chinese Academy of Medical Sciences & Peking Union Medical Lifestyle changes also play an important role
College, Beijing 100730, China. Email: in GERD therapy and education of patients with
kemeiyunmedsci@126.com
The copyright line for this article was changed on 26 October GERD can help managing symptoms.11 Complemen-
2015 after original online publication tary and alternative medicine techniques such as acu-
Financial support: This work was supported by the Janssen puncture, aromatherapy, chiropractic, homeopathy,
Research Council Research Fund.
Conflict of interest: The authors declare that they have no hypnotherapy, and reflexology are becoming popular
conflict of interest. methods for the treatment of GERD.12
© 2015 The Authors
Diseases of the Esophagus published by Wiley Periodicals, Inc. on behalf of International Society for Diseases of the Esophagus 1
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and
distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
2 Diseases of the Esophagus
GERD is an upper gastrointestinal dysmotility dis-
order related to gastric acid reflux into the esophagus.
Gastroesophageal reflux results from a positive
abdomen-to-thoracic pressure gradient during rest
(e.g. in obesity), swallowing, respiratory and physical
exertion. The gastroesophageal junction (GEJ)
includes two fundamental components, the intrinsic
lower esophageal sphincter (LES) and extrinsic com-
pression by the crural diaphragm (CD), and is the
first and primary line of esophageal defense against
damage by acid reflux.13 Thus, a GEJ valve mecha-
nism exists between the esophagus and stomach,
formed by the LES, the CD, the His angle and
the phrenoesophageal membrane, which normally
prevents gastroesophageal reflux.14 Relaxation and
phasic tone of the CD contribute significantly
to the GEJ.14,15 There is a direct correlation
between intraluminal GEJ pressure and integrated
electromyography (EMG) spike activity of the CD.16
In addition, CD function is significantly reduced in
patients with GERD compared with healthy subjects
or patients with functional heartburn.17 Based on
those studies, we initiated a series of studies on the
anti-reflux function of CD in patients with GERD.
These studies demonstrated that the crural dia-
phragm tension (CDT) during abdominal deep inspi-
ration was significantly higher than that during
thoracic deep inspiration in both healthy subjects
and patients with GERD, and that CDT in patients
with GERD was significantly lower compared with
healthy subjects during the resting breathing.18
However, there was no significant difference between
patients with GERD and healthy subjects during
abdominal deep inspiration.
The CD is a skeletal muscle, and like any other
striated muscle, it should be amenable to improved
performance by physical exercise. A previous open-
label study from our group has shown that dia-
phragm biofeedback training (DBT) enhanced
CDT,19 strongly suggesting that DBT could be useful
in the therapy of GERD by improving the natural
defense against reflux and subsequent damage.
The hypothesis of the present study was that dual
therapy with DBT and PPI improve the GEJ anti-
reflux barrier and decrease the requirement for long-
term PPI use. The aim of the present study was to
investigate the effectiveness of long-term non-drug
therapy (i.e. DBT) for improving esophageal motility
for patients with GERD.
MATERIALS AND METHODS
Patients
A total of 40 patients with GERD were consecutively
enrolled from the outpatient department of the
Peking Union Medical College Hospital (urban ter-
tiary care hospital) between September 2004 and July
Diseases of the Esophagus published by Wiley Periodicals, Inc. on behalf of International Society for Diseases of the Esophagus
2006. The inclusion criteria were: (i) history of typical
reflux symptoms such as heartburn, acid reflux, and
regurgitation for a minimum of 6 months; (ii) aged
between 18 and 60 years; and (iii) requirement of
maintenance treatment using a PPI (i.e. that the
patient achieved a good response when taking a PPI,
but relapsed upon drug withdrawal). The exclusion
criteria were: (i) diabetes mellitus; (ii) scleroderma;
(iii) severe comorbidity (such as heart diseases,
chronic pulmonary disease, chronic liver disease,
chronic kidney disease, and brain diseases); (iv)
gastroparesis; (v) active peptic ulcer disease; (vi)
history of upper gastrointestinal surgery; or (vii)
women who were pregnant or lactating.
All eligible patients who provided a written
informed consent underwent an upper endoscopic
examination after an overnight fast to assess the
mucosal condition of esophagus, stomach, and proxi-
mal part of the duodenum. Patients were on their
usual PPI treatment for endoscopy. The extent of
reflux esophagitis (RE) was determined using the Los
Angeles Classification.20 Patients with non-erosive
reflux disease (NERD) who had good response to
PPIs presented normal esophagus under endoscopic
examination.
This study was approved by the Ethics Committee
of the Peking Union Medical College Hospital.
Written informed consents were obtained from all
patients.
Study design
In the present study, patients were randomized (1 : 1
ratio) to the DBT + rabeprazole group or the
rabeprazole alone group using computer-generated
random number table. The study included two
periods: an 8-week initial treatment period and a
6-month follow-up period. During the first 8-week
period, patients in the DBT + rabeprazole group
received DBT and rabeprazole (10 mg twice a day),
whereas patients in the rabeprazole group received
rabeprazole only (10 mg twice a day). During the
6-month follow-up period, all patients in both groups
took acid suppression (PPIs or histamine 2 receptor
antagonists [H2RAs]) on-demand, and patients in the
DBT + rabeprazole group were required to continue
DBT as instructed in the initial treatment period. The
study design is shown in Fig. 1.
The primary outcome of the study was the amount
of acid suppression used during the 6-month follow
up. Secondary outcomes were reflux symptoms,
health-related quality of life (HRQL), and esopha-
geal motility differences after the 8-week initial treat-
ment compared with baseline.
Diaphragm biofeedback training
It is well known that abdominal deep breathing is
completed by diaphragmatic muscle contraction.19
© 2015 The Authors
 DBT for treatment of GERD 3

Fig. 1 Outline of the study design. The 40 patients with gastroesophageal reflux disease (GERD) were randomly allocated to two
groups: the DBT + rabeprazole group received diaphragm biofeedback training (DBT) and rabeprazole proton pump inhibitor (PPI),
whereas the rabeprazole group received rabeprazole alone. H2RA: histamine 2 receptor antagonist.

DBT is autonomously performed by contraction and
relaxation of the CD during abdominal deep breath-
ing. Myoelectrical activity of diaphragmatic muscle
and abdominal muscle were recorded respectively by
two channels connected to a biofeedback device
(Multi-modality Physiomonitoring System; Orion,
Dover, New Hampshire, USA). Myoelectrical activity
signals were converted into visual tracings by a com-
puter and shown on the monitor screen. The patients
were instructed to perform DBT while watching the
visual tracings under the therapist’s instruction. The
key point of DBT is abdominal breathing pattern
instead of mixed breathing or thoracic breathing
pattern. For each patient participating in DBT and
before beginning the study, we went through illustra-
tions showing the anatomy of the chest and abdomen
including the diaphragm, explaining to each patient
the mechanisms of pectoral and abdominal breathing,
and the role of the diaphragm in abdominal breathing.
Emphasis was made on the role of abdominal deep
breathing in the high-pressure zone of the GEJ. When
training before the study, we placed the patient’s
hands on his abdomen to make him feel the effect of
deep breathing on abdominal distension and expira-
tory muscle relaxation. Much care was taken to make
the patients breath correctly. Each patient was prop-
erly trained before beginning the study. A breath cycle
included 15 seconds for inhalation and 15 seconds for
expiration. Each DBT session lasted 30 minutes and
was performed in the fasting state. During each DBT
session, the therapist tried to achieve a good commu-
nication with the patient to facilitate good under-
© 2015 The Authors
Diseases of the Esophagus published by Wiley Periodicals, Inc. on behalf of International Society for Diseases of the Esophagus
standing and collaboration. Patients performed DBT
once a week in hospital during 8 weeks of the initial
treatment period, and practiced abdominal deep
breathing 20 minutes twice a day in the morning and
in the evening in the fasting state at home, by them-
selves. The visual tracing of a typical DBT session is
shown in Fig. 2.
The treating physicians who accepted to partici-
pate in the present study received formal training on
gastrointestinal motility studies. In addition, prior to
beginning the study, teachers who majored in teach-
ing of abdominal breathing were invited to train the
participating physicians. Each patient was supervised
by the same specialist throughout the whole study.
The training schedule of the patients at the hospital
and at home was managed by the technician.
Reflux symptom scores
All patients evaluated the frequency and severity of
their reflux symptoms including acid reflux, heart-
burn, and regurgitation using a self-reported daily
diary. Patients visited their physician every 2 weeks to
review the symptoms and their frequency. The sever-
ity of each symptom was determined as: 0 = no
symptom; 1 = mild, felt the symptoms but only when
thought about; 2 = moderate, symptom caused dis-
comfort but did not affect daily activities; 3 = severe,
symptom caused much discomfort and affected daily
activities. The frequency of each symptom was: 0 =
none; 1 = one to three episodes a week; 2 = four to six
episodes a week; 3 = every day. The total symptom
4 Diseases of the Esophagus
Fig. 2 The diaphragm biofeedback training (DBT). The figures represent an example of the visual traces obtained during DBT. The
patients watched the traces while undertaking DBT with instruction from a therapist. EMG, electromyography.
score was equal to the sum of the severity score and
the frequency score. Scores as baseline and at 8 weeks
were used for analysis. The maximal symptom score
was 18.21
Quality of life
GERD–health-related quality of life (GERD-
HRQL) was used to evaluate the quality of life spe-
cific to GERD symptoms at baseline and at 8 weeks.
This questionnaire has been shown to be reliable,
valid, and practical.22 The GERD-HRQL question-
naire evaluates heartburn-related symptoms by
patient satisfaction using a 0–5 visual analog scale.
The total GERD-HRQL scores are calculated by
summing the responses to nine questions. Scores
range from 0 (no symptoms) to 45 (worst possible
symptoms).22
Esophageal manometry
A four-channel 90° radially orientated catheter
(Medtronic; Fridley, MN, USA) was used with a low-
compliance pneumohydraulic capillary infusion
system with each side hole perfused with water at a
flow rate of 0.5 mL/min. The catheter was passed
transnasally into the stomach with patient seated.
The patient was then moved to a left supine position.
Intragastric pressure was determined as the baseline.
The GEJ pressure was calculated from the baseline to
the end of inspiration, LES pressure from baseline to
the end of expiration, and CDT from the end of
expiration to the end of inspiration. Ten water swal-
lows (5 mL each, 20–25°C) separated by 30 seconds
were performed at stable resting GEJ pressure.18
Diseases of the Esophagus published by Wiley Periodicals, Inc. on behalf of International Society for Diseases of the Esophagus
Follow up
Acid suppression usage
After the 8-week initial treatment period, patients in
the DBT + rabeprazole group continued to practice
abdominal deep breathing twice a day at home and
performed DBT in hospital once at a 2- to 3-week
interval (same method as the initial treatment
period). Patients in both groups took PPIs or H2RA
according to their reflux symptoms. Both groups
were prescribed PPI or H2RA by clinicians blinded to
the study groupings. Acid suppression usage was
described as discontinuance, on-demand, and con-
tinuance. Discontinuance of acid suppression was
defined as the symptoms being under complete remis-
sion without pharmacological intervention or occa-
sionally taking an antacid agent. On-demand was
defined as the symptoms being under control while
taking acid suppression (PPIs or H2RA) two to three
times a week. Continuance was defined as the symp-
toms being under control with daily intake of an
acid suppression medication during the 6-month
follow-up period.
Statistical analysis
Normally distributed continuous data were presented
as means ± standard deviation (SD) and were ana-
lyzed using the paired or unpaired Student’s t-test, as
appropriate. Categorical variables were presented as
proportions and were analyzed using the chi-square
or the Fisher’s exact test, as appropriate. P-values <
0.05 were considered significant. All analyses were
performed using SPSS 13.0 (SPSS Inc., Chicago, IL,
USA).
© 2015 The Authors
 DBT for treatment of GERD 5

Table 1 Demographic data and disease characteristics at baseline

DBT + rabeprazole group Rabeprazole group

(n = 20) (n = 20) P-value

Mean age (years) 48.90 ± 2.06 50.55 ± 2.28 0.590

Gender F : M 11 : 9 10 : 8 0.615
BMI (kg/m2) 27.90 ± 1.69 26.44 ± 1.78 0.140
Disease duration (months) 20.70 ± 1.04 18.61 ± 1.06 0.170
Reflux symptom score at baseline 12.50 ± 0.68 11.78 ± 0.63 0.450
GERD-HRQL at baseline 20.50 ± 1.47 18.94 ± 1.26 0.433
Endoscopic presentation 5:5:7:3 4:5:7:2 0.145
(NERD : LA-A : LA-B : LA-C)

Values are presented as means ± SD or numbers. BMI, body mass index; DBT, diaphragm biofeedback training; F, female; GERD-HRQL,
gastroesophageal reflux disease–health-related quality of life; LA-A, Los Angeles classification grade A; LA-B, Los Angeles classification
grade B; LA-C Los Angeles classification grade C; M, male; NERD, non-erosive reflux disease; SD, standard deviation.

Because it was a pilot study, we did not perform
a power analysis when we designed the study.
However, based on the final sample size (group 1 =
17, group 2 = 16), the incidence of primary end-point
events (P1 = 82.3%, P2 = 6.2%) and α = 0.05, and
using the software PASS 11.0 (NCSS, LLC,
Kaysville, UT, USA), we obtained a power of 0.9997,
indicating that the sample size was sufficient.
RESULTS
Baseline characteristics of the patients
A total of 40 patients were enrolled in the study. The
demographic and disease characteristics at baseline
between the two groups were comparable including
age, gender, body mass index (BMI), disease dura-
tion, reflux symptoms, GERD-HRQL, and endo-
scopic presentation (Table 1).
Overall, seven patients dropped out of the study:
two patients in the rabeprazole group did not com-
plete the 8-week initial treatment period (they chose
to drop out because their symptoms improved after
taking rabeprazole for 2 weeks), and five were lost
to follow up during the 6-month follow-up period
(three in the DBT + rabeprazole group and two in
the rabeprazole group because they were unable to
attend follow-up visits).
Acid suppression usage during the 6-month follow up
The primary outcome of this study was the use of acid
suppression during the 6-month follow-up period,
and the results are shown in Table 2. The rate of
follow up was 85% (17/20) and 89% (16/18) in the
DBT + rabeprazole and rabeprazole groups, respec-
tively. Whereas 82.3% (14/17) patients discontinued
acid suppression in the DBT + rabeprazole group,
only 6.2% (1/16) discontinued acid suppression in
the rabeprazole group; whereas 68.8% (11/16)
patients required continued acid suppression in the
rabeprazole group, only 5.9% (1/17) required contin-
ued acid suppression in the DBT + rabeprazole
group; there were 11.8% (2/17) and 25% (4/16)
patients who used acid suppression on-demand in the
DBT + rabeprazole and rabeprazole groups, respec-
tively (P < 0.05).
Reflux symptoms
Reflux symptoms were significantly improved at the
end of the 8-week initial treatment compared with
baseline in both the DBT + rabeprazole group (from
12.50 ± 0.68 to 3.45 ± 0.51, P < 0.001) and the
rabeprazole group (from 11.78 ± 0.63 to 4.05 ± 0.4,
P < 0.001). The reflux symptom scores were not sig-
nificantly different between the two groups (P = 0.37)
(Fig. 3A).
GERD-HRQL
GERD-HRQL was significantly improved at the end
of the initial 8-week treatment compared with the
scores at baseline in the DBT + rabeprazole group
(from 20.50 ± 1.47 to 8.10 ± 0.80, P < 0.001) and in the
rabeprazole group (from 18.94 ± 1.26 to 9.27 ± 0.52,
P < 0.001). There was no significant difference
between the two groups (P = 0.237) (Fig. 3B).

Table 2 Acid suppression usage during the 6-month follow up

Follow up (n) Discontinuance On-demand Continuance

DBT + rabeprazole group 17 (85%) 14 (82.3%) 2 (11.8%) 1 (5.9%)

Rabeprazole group 16 (89%) 1 (6.2%) 4 (25%) 11 (68.8%)

Chi-squared test, P < 0.001. DBT, diaphragm biofeedback training.

© 2015 The Authors
Diseases of the Esophagus published by Wiley Periodicals, Inc. on behalf of International Society for Diseases of the Esophagus
6 Diseases of the Esophagus

Fig. 3 Changes from baseline after the 8-week initial treatment in the two groups: the diaphragm biofeedback training (DBT) +
rabeprazole group (n = 20) and the rabeprazole group (n = 18). (A) Reflux symptom scores. (B) gastroesophageal reflux
disease–health-related quality of life (GERD-HRQL) assessment scores.

of patients with GERD and using a slightly different

Esophageal manometry
Table 3 shows the results of esophageal manometry
at baseline and at the end of the 8-week initial treat-
ment. At baseline, there was no difference in LES
pressure, CDT, and GEJ pressure between the two
groups. In the DBT + rabeprazole group, there were
significant increases in CDT and GEJ pressures com-
pared with baseline (P < 0.01), but there was no sig-
nificant change in LES pressure (P > 0.05). In the
rabeprazole group, there was no significant difference
in LES pressure, CDT, or GEJ pressure after the
8-week treatment compared with baseline (P > 0.05).
DISCUSSION
The results of the present study showed that DBT +
rabeprazole resulted in significantly lower acid
suppression usage during the 6-month follow up
compared with rabeprazole alone, suggesting that
DBT + rabeprazole may be an effective treatment for
GERD. This study also suggests that DBT signifi-
cantly enhanced the function of the anti-reflux barrier
by increasing CDT and GEJ pressure, and long-term
DBT decreased the dependence upon acid suppres-
sion during follow up.
The improved outcome for the DBT + rabeprazole
group in the present study is supported by another
randomized study performed on a smaller population
training method.23 After long-term follow up, they
observed that quality of life scores and PPI usage
improved with breathing exercise. The present study
aimed to further test the effect of DBT on a group of
patients with GERD that required long-term acid
suppression maintenance therapy without anatomi-
cal abnormalities because abdominal deep breathing
would be ineffective in these patients due to a loss of
CD on the LES. Age, gender, BMI, disease duration,
GERD-HRQL, and endoscopic presentation were
comparable in both groups at baseline. After 8 weeks
of initial treatment, CDT and GEJ pressure were sig-
nificantly increased in the DBT + rabeprazole group,
whereas they showed no changes in the rabeprazole
group. Normal GEJ pressure has been shown to
range from 15 ± 11 mmHg at the end of expiration to
40 ± 13 mmHg at the end of inspiration mainly as a
result of the diaphragmatic contribution.24 This result
indicated an increase of CDT and GEJ pressure
because of the 8-week DBT. A similar result in
improving GEJ pressure was observed using another
method of inspiratory muscle training used by Nobre
e Souza et al.,25 on a small population of patients with
GERD and healthy controls. They also found that
GERD symptoms were reduced, but did not evaluate
PPI usage. In addition, the present study showed that
although DBT could not significantly change LES
pressure, LES pressure presented an increasing trend
after the 8-week DBT period (from 6.25 ± 1.0 to 7.44

Table 3 Esophageal manometry values at baseline and at the end of initial 8-week treatment

DBT + rabeprazole group (n = 20) Rabeprazole group (n = 18)

Baseline Treatment 8-week P Baseline Treatment 8-week P

LES pressure 6.25 ± 1.0 7.44 ± 0.71 0.200 6.4 ± 1.1 6.2 ± 0.63 0.827
CDT 16.81 ± 1.08 25.27 ± 1.31 <0.001 17.96 ± 1.55 18.79 ± 1.37 0.690
GEJ pressure 23.21 ± 1.28 31.76 ± 1.92 0.001 25.41 ± 1.78 26.45 ± 1.87 0.691

Measurements are in mmHg and are presented as means ± SD. CDT, crural diaphragm tension; DBT, diaphragm biofeedback training;
GEJ, gastroesophageal junction; LES, lower esophageal sphincter.
© 2015 The Authors
Diseases of the Esophagus published by Wiley Periodicals, Inc. on behalf of International Society for Diseases of the Esophagus

± 0.71 mmHg). LES would not be influenced by the
abdominal breathing exercise, because it is a smooth
muscle, but long-term DBT may benefit LES pres-
sure. Unfortunately, esophageal manometry could
not be re-tested at the end of the 6-month follow up.
A previous study by our group showed that the extent
of the abnormalities observed in the parasympathetic
system was correlated with the degree of the reflux
symptoms.18 In the future, we plan to explore the
effect of DBT on upper gastrointestinal motility such
as LES pressure, transit LES relaxation (TLESR),
and proximal stomach emptying using more detailed
measurements including the nervous system.
It is widely accepted that patients with GERD,
similar to patients with other chronic diseases, expe-
rience decrements in HRQL compared with the
general population.26 In the present study, reflux
symptoms and GERD-HRQL were significantly
improved in both groups after the 8-week initial treat-
ment, and there was no significant difference between
the two groups. This is probably because most of
the enrolled patients had RE (75% in the DBT +
rabeprazole group and 80% in the rabeprazole group)
and therefore had a good response to the rabeprazole
treatment.27 A previous study has shown that success-
ful reflux symptom resolution results in improve-
ments of HRQL.28
We observed that long-term DBT could signifi-
cantly decrease acid suppression usage: 82.3% (14/17)
of patients discontinued acid suppression in the DBT
+ rabeprazole group, whereas only 6.2% (1/16) in the
rabeprazole group did after 6 months. These results
led to our hypothesis that DBT provided GERD
patients with a non-pharmacological long-term main-
tenance therapy by enhancing the anti-reflux barrier.
Limitations
First, we did not collect data for autonomic nerve
function and especially esophageal manometry at the
end of the 6-month follow up. We may hypothesize
that these parameters could be even better after 6
months compared with the control group. Second, we
were not sure when and how long DBT had to be
undertaken for long-term maintenance therapy for
patients GERD because the present study was only a
pilot clinical trial. In the present study, the patients
received DBT during fasting to avoid inducing reflux
after eating. Ding et al.29 reported that performing
DBT after a meal decreased esophageal acid exposure
and accelerated proximal stomach emptying, espe-
cially 1 hour after a meal. In the future, we will design
a rational protocol to explore those problems. Third,
it is difficult encouraging patients with GERD to
perform long-term DBT, especially in terms of prac-
ticing at home. In this study, an appointed technician
interviewed the patients in the DBT + rabeprazole
group two to three times a week by telephone to
© 2015 The Authors
Diseases of the Esophagus published by Wiley Periodicals, Inc. on behalf of International Society for Diseases of the Esophagus
DBT for treatment of GERD 7
assess compliance with home practice and to verify if
the patients had any question regarding DBT. Nev-
ertheless, we had to rely on the truthfulness of the
patients. In the future, it could be possible for
patients with GERD to use a portable DBT device
with audio training, so patients can take the device
home and practice. Fourth, the patients in the present
study who did not receive DBT should have under-
gone a mock or sham DBT session. It has been
established that psychoeducation facilitates patient’s
self-management, which could improve GERD
symptoms.11 Therefore, we need to ensure that this
psychoeducation was not the cause of the improve-
ment seen in the present study in future investiga-
tions. Fifth, the number of patients with GERD
investigated in this study was quite low, but larger
than some recent similar studies. Finally, we did not
assess the quality of life at 6 months. Nevertheless,
there is a wealth of available data showing that
improvements of reflux symptoms are positively
correlated with quality of life. Therefore, we may
hypothesize that long-term DBT can significantly
improve the quality of life in patients with GERD
since reflux symptoms are improved. A larger popu-
lation would add more weight to these results and the
statistical analysis.
In conclusion, our study showed that DBT could
improve function of anti-reflux barrier by enhancing
CDT and GEJ pressure. Long-term biofeedback
training significantly reduced acid suppression usage,
which could provide a non-pharmacological mainte-
nance therapy and reduce the medical cost for
patients with GERD. In a further study, we should
evaluate the gastroesophageal anti-reflux mechanism
of DBT, such as the effect of diaphragm biofeedback
on TLESR and gastric emptying, and the effect of
long-term DBT on symptoms, HRQL, and acid sup-
pression dependence.
Acknowledgment
The authors would like to thank the staff at the
Department of Gastroenterology at the Peking
Union Medical College for their help in the collection
of data.
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