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Alimentary Pharmacology & Therapeutics

Clinical trial: interferential electric stimulation in functional


dyspepsia patients a prospective randomized study
S. KO KLU *, G. KO KLU , E. O ZGU C LU , G. U. KAYANI, E. AKBAL* & Z. HASC ELIK

*Department of Gastroenterology,
Ankara Education and Research
Hospital, Ankara, Turkey;
Department of Physical Medicine
and Rehabilitation, Hacettepe
University School of Medicine,
Ankara, Turkey; Department of
Physical Medicine and Rehabilitation,
Ankara University School of
Medicine, Ankara, Turkey
Correspondence to:
Dr S. Koklu, Baglarbas mahallesi,
Duman sokak, 55 11, Kecioren,
Ankara, Turkey.
E-mail: gskoklu@yahoo.com

Publication data
Submitted 4 December 2009
First decision date 28 December 2009
Resubmitted 14 January 2010
Accepted 2 February 2010
Epub Accepted Article 5 February
2010

SUMMARY
Background
There are several studies reporting the beneficial effects of transcutaneous electrical stimulation in patients with gastroparesis and chronic
constipation.
Aim
To analyse whether transcutaneous electrical stimulation is an effective
procedure in functional dyspepsia patients.
Methods
Functional dyspepsia patients were randomly placed in vacuum interferential current (IFC) and placebo groups. Both treatments consisted of 12
sessions administered over 4 weeks. Upper gastrointestinal system
symptoms were documented at the beginning, during and after the
treatment sessions.
Results
Patients in therapy (23 cases) and placebo (21 cases) groups were homogeneous with respect to demographic data and upper gastrointestinal
system symptoms. In the therapy group, all symptoms other than early
satiation improved significantly during and after the treatment sessions,
whereas in the placebo group, symptoms including heartburn and vomiting did not change significantly. IFC therapy was superior to placebo
with respect to epigastric discomfort, pyrosis, bloating, early satiation
and postprandial fullness during the treatment sessions. One month
after the treatment sessions, vacuum IFC proved to be superior to placebo with regard to early satiation and heartburn.
Conclusions
Vacuum IFC is a non-invasive and effective therapy for functional dyspepsia. Transcutaneous electrical stimulation may represent a new treatment modality for drug-refractory functional dyspepsia patients.
Aliment Pharmacol Ther 31, 961968

2010 Blackwell Publishing Ltd


doi:10.1111/j.1365-2036.2010.04256.x

961

962 S . K O K L U et al.

INTRODUCTION

MATERIALS AND METHODS

Functional dyspepsia (FD) is a highly common and


problematic gastrointestinal disorder. For many sufferers, it presents a lower quality of life as well as
higher costs.1 It is characterized by persistent upper
gastrointestinal complaints for which adequate examination does not reveal a sufficient explanation
through a structural or specific pathology. As the
exact aetiology of FD remains unclear, curative treatment is not available and current treatment modalities are mainly directed against the predominant
symptoms.
A wide variety of treatments have been used in the
management of FD, including dietary and lifestyle
modifications, antacids, antisecretory agents, prokinetics, antidepressants, behavioural and complementary
and alternative therapies.2 Interferential therapy is a
form of transcutaneous electrical stimulation. Electrical stimulation at the applied site is likely to stimulate
local skin nerve fibres, as well as deeper stimulation
activating afferent and efferent parasympathetic outflow to the gastrointestinal tract.3, 4 In clinical practice, it is used for pain control, bladder overactivity
and chronic treatment-resistant constipation.57
Delayed gastric emptying and impaired postprandial
gastric accommodation have been considered the main
mechanisms that contribute to symptom generation in
patients with FD.8 Hence, electrical stimulation of the
upper gastrointestinal system might improve the
motility disorder. Gastric electrical stimulation has
been successfully tried over the last decade as a therapeutic option for a variety of gastrointestinal motility
disorders, especially gastroparesis and morbid obesity.4, 811 In a recent study, gastric electrical stimulation by a surgical approach has improved symptoms
in gastroparetic patients. McCallum et al. have suggested that improvement was achieved by electrical
stimulation of both afferent and efferent vagal pathways.4 In the pertinent literature, there are several
studies reporting the beneficial effects of transcutaneous electrical stimulation in patients with gastrointestinal tract dysfunction, including gastroparesis and
chronic constipation.3, 6, 7, 11 To our knowledge,
transcutaneous electrical stimulation has not been
tried in the management of FD before. In the present
study, we aimed to document the efficacy of vacuum
interferential current therapy, a non-invasive procedure for transcutaneous electrical stimulation in FD
patients.

Patients with FD were recruited from the out-patient


clinic at the clinic of Gastroenterology, Ankara Educational and Research Hospital in Ankara from February
2008 through July 2009. Patients with suspected FD
were enrolled in the study for evaluation and treatment. Patients were recruited both from a pool of FD
patients at our unit and from referrals from other physicians. Standardized work-up for all cases included an
upper gastrointestinal endoscopy, abdominal ultrasonography and laboratory tests. Functional dyspepsia
was defined as uninvestigated dyspepsia without findings of oesophagitis, peptic ulcer, coeliac disease, or
cancer and no evidence of other structural disease at
endoscopy that was likely to explain the symptoms.
All subjects were categorized into FD according to the
Rome III criteria by the same physician (S.K.). Each
patient had a history of chronic abdominal symptoms
for a long time and had medical treatments (proton
pump inhibitor, H2-receptor antagonists and antacids)
that did not overcome the dyspeptic symptoms. Subjects with concomitant irritable bowel syndrome
symptoms and who refused to participate in the treatment sessions were excluded. Patients with a history
of gastrointestinal or gynaecological surgery, gastrointestinal cancer, recent peptic ulcer disease and isolated
or predominant symptoms of gastro-oesophageal
reflux disease were also eliminated. Participants were
prohibited from using non-steroidal anti-inflammatory
drugs, antacids, proton pump inhibitors, H2-receptor
antagonists and antibiotics until the end of the study.
This was a prospective study and patients were randomized with a systematic random sampling method.
It was decided by the gastroenterologist (S.K.) whether
the patient fulfilled the criteria for randomization.
After informed consent was obtained from them,
patients were randomly assigned to the treatment and
control groups according to the basic random sampling method. Patients in the treatment and control
groups were unaware of their treatment allocation. In
each session, 15 min of vacuum interferential current
therapy (IFC) or sham IFC was applied to the patients.
Interferential current was supplied by the device,
Metron Medical Australia, Vectorpulse (Australia). The
skin of the paravertebral area of the thoracic 1012 was
cleaned with alcohol and the electrodes were applied in
a quadripolar manner to this area for an intersecting
electrical current to the projection of the stomach
(Figure 1). Electrodes were placed on the skin by suction
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Figure 1. Application of vacuum interferential current


therapy.

cups using vacuum. Interferential stimulators delivered


interferential current using four electrodes, with a carrier frequency of 4 kHz, an adjustable intensity and a
beat frequency sweep covering 80150 Hz. The intensity of the stimulator was increased gradually until the
patient reported that a further rise would cause discomfort. Individual pulses had a duration of 1 s.
In the control IFC group, bipolar flexible carbon
electrodes were used with the same device. Electrodes
were placed in the same area. Subjects in the control
group did not feel any electrical stimulation or vacuum sensation.
For 4 weeks, both the IFC and placebo groups
received 12 15 min sessions of real or placebo IFC,
respectively. The procedure was explained before therapy to all patients. In both groups, patients were not
allowed to take any medical treatment. Patients completed standard questionnaires just before beginning
the therapy sessions, during the treatment and after the
treatment sessions. The questionnaire was given to the
patients by the study physiotherapists and completed
before the treatment. In addition, the questionnaire
included questions on sociodemographic characteristics,
education status and the duration of the patients complaints. All patients were asked whether they had upper
gastrointestinal symptoms including epigastric discomfort, pyrosis, bloating, early satiation, postprandial fullness, belching, gastro-oesophageal reflux, heartburn,
nausea or vomiting before the treatment, at the 2nd
week, just at end of the therapy, and 1 month after
treatment. The questionnaire was administered by study
physiotherapists at face-to-face interviews before and
during treatment sessions and over the telephone
Aliment Pharmacol Ther 31, 961968
2010 Blackwell Publishing Ltd

1 month after treatment. All vacuum IFC and placebo


treatment sessions were applied by the same physiotherapist (vacuum IFC by G.K. and placebo by G.U.K).
Hence, each therapist was unaware of the results of the
other treatment group. Symptoms were questioned at
the beginning as present or absent. Later, the patients
were asked whether each symptom improved, remained
the same or increased when compared with the pretreatment status.
The primary outcome measures were a self-reported
change in major FD symptoms, including epigastric
discomfort, early satiation and postprandial fullness
during or after treatment sessions. Secondary outcome
measures were to evaluate changes in the remaining
upper gastrointestinal symptoms. All outcome measures were evaluated at baseline, in the middle of
treatment, at the end of treatment and 1 month after
IFC and placebo treatments.
Data analyses were performed using SPSS 15.0 (IBM,
Chicago, Illinois) for Windows. The continuous variables were presented as mean  standard deviation or
median (min-max), whereas categorical variables were
presented as percentage. MannWhitney tests were
used to determine if there were any significant differences between groups. Chi-square or Fishers exact test
were used for categorical comparisons.
Our planned sample size calculated for this study
was about 30 patients for each treatment arm to reach
more than 80% power. As one of the physiotherapists
had moved to another hospital before the end of the
study, we could not reach that number. The detected
power of this study was 73.8%.
We assessed the efficacy of IFC by a per-protocol
analysis (PP). We also gave the results according to an
intention-to-treat analysis (ITT). P < 0.05 was accepted
as statistically significant for the results.
Responders to therapy were identified using Jacobson
and Truax criteria for clinically significant change. This
change was determined by calculation of a reliable
change index (RC). This is the difference between pretest
and post-test scores divided by the standard error of the
difference. An RC larger than 1.96 indicates true change
in post-test vs. pretest scores.

RESULTS
Fifty patients were randomized into IFC and placebo
groups. Two and four patients dropped out of the
study because of non-medical reasons just after
beginning the treatment sessions in IFC and placebo

964 S . K O K L U et al.

groups respectively. There were 44 patients who


completed the therapy sessions (Figure 2). As FD
subgroups, one had epigastric pain syndrome, five
had postprandial distress syndrome and the remaining 19 had overlap in either group. The age-range
was between 19 and 70 years. Vacuum IFC and placebo groups included 23 and 21 FD patients respectively. Demographic characteristics of either group,
including age, gender, body mass index, smoking
habits, occupation, education level, marital status,

parity and number of admissions to a physician with


FD in the last year were comparable (Table 1). Both
groups had similar upper gastrointestinal system
symptoms frequency (Table 2). Epigastric discomfort and bloating were the two most common
complaints.
All symptoms other than heartburn (P = 0.11) and
vomiting (P = 0.20) in the placebo group decreased
significantly at the mid and end of the treatment, and
at the 1st month after treatment when compared with

100 patients
Met rome III criteria for FD

50 patients randomized to
interference current or placebo

50 patients had concomitant


IBS or declined to treatment
groups

25 patients

25 patients

Placebo group

Interference group

4 unable to complete treatment sessions

2 unable to complete treatment sessions

21 patients completed the sessions

23 patients completed the sessions

21 patients analyzed at the 1st month after treatment

23 patients analyzed at the 1st month after treatment

Figure 2. Patient flow showing the number of patients in the different phases of the study.

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Table 1. Demographic data of the patients


Variables
Age (year)
Body mass index (kg m2)
Gender (n, female)
Smoking (%)
Alcohol
Marital status (% married)
Occupation (% housewife)
Education level

Parity
*Attendance to a physician

Placebo

Interference

P values

37.1  17.9
26.3  5.9
20
13.6%
0
86.4%
81.8%
77.3% elementary school
18.2% high school
4.5% university
2 (05)
4 (120)

39.6  8.0
27.7  3.0
22
18.2%
0
90.9%
81.8%
68.2% elementary school
27.3% high school
4.5% university
2 (08)
2 (110)

0.42
0.20
0,98
0.68
1
0.63
1
0.89

0.56
0.11

* At the last year with the complaint of functional dyspepsia.


 MannWhitney U-test.
 Chi Square test.

Table 2. Frequencies of gastrointestinal symptoms in the


patients
Variables
Epigastric discomfort (%)
Pyrosis (%)
Bloating (%)
Early satiation (%)
Postprandial fullness (%)
Belching (%)
Gastro-oesophageal reflux (%)
Heartburn (%)
Nausea (%)
Vomiting (%)

Placebo Interference P value


95.2
71.4
100
90.4
90.4
90.4
71.4
66.6
76.1
14.2

91.3
82.6
91.3
60.8
82.6
69.5
73.9
57.1
56.5
21.7

0.72
0.05
0.23
0.29
0.67
0.70
0.49
0.53
0.33
0.69

the pre-treatment status. P values for each symptom


were as follows: <0.01 for epigastric discomfort, pyrosis, bloating, postprandial fullness and gastro-oesophageal reflux; 0.01 for early satiation, belching and
nausea. When ITT analysis was applied, there was a
significant difference regarding epigastric discomfort
and gastro-oesophageal reflux (P < 0.01 for both),
bloating (P = 0.01) and nausea (P = 0.03). Other symptoms did not change significantly (Table 3).
In the vacuum IFC group, all symptoms other than
early satiation (P = 0.05) improved at the 2nd and 4th
week of therapy and 1 month after treatment when
compared with pre-treatment evaluation. P values were
<0.01 for epigastric discomfort, pyrosis, bloating,
postprandial fullness, gastro-oesophageal reflux and
Aliment Pharmacol Ther 31, 961968
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nausea; 0.01 for belching; 0.03 for heartburn and vomiting. In ITT analysis, all symptoms other than postprandial fullness improved significantly (P values were
<0.01 for epigastric discomfort, pyrosis, bloating, heartburn, vomiting and gastro-oesophageal reflux; 0.01 for
early satiation and nausea, and 0.03 for belching
(Table 3).
At the 2nd week of therapy, vacuum IFC was superior
to placebo with respect to decreased epigastric discomfort (P = 0.01), bloating (P = 0.01), early satiation
(P = 0.01) and pyrosis (P = 0.04). In ITT analysis, bloating (P = 0.02) and early satiation (P = 0.04) improved
significantly in IFC as compared with the placebo group.
Pyrosis, bloating, early satiation and postprandial
fullness decreased more prominently in the vacuum
IFC group as compared with the placebo group at the
end of treatment sessions (P values were 0.04, < 0.01,
< 0.01 and 0.02, respectively). In ITT analysis, bloating
and early satiation improved significantly in IFC as
compared with the placebo group (P = 0.02 for both).
At the 1st month after therapy, when vacuum IFC
and placebo groups were compared, IFC was superior
to placebo with regard to early satiation and heartburn
(P < 0.01 for both). ITT analysis was also similar
(P = 0.04 and 0.02 respectively) (Table 3).
There were significant differences between vacuum
IFC and placebo groups with respect to early satiation,
bloating and heartburn. According to the Jacobson and
Truax criteria for bloating, 15 (63%) of treated patients
vs. 7 (29%) of placebo showed significant improvement

* There is significantly difference between interference and placebo groups at the 2nd and 4th week of treatment sessions (P = 0.02 for both).
 There is significantly difference between interference and placebo groups at the 2nd and 4th week of treatment sessions and after treatment (P = 0.04, 0.02 and 0.04 respectively).
 There is significant difference between interference and placebo groups at the post-treatment evaluation (P = 0.02).
P values were for ITT analysis.

17.3 28 (7 25)
17.3 32 (8 25)
8.6 8 (2 25)
21.7 36 (9 25)
13.0 28 (7 25)
0 25
26.0 36 (9 25)
26.0 40 (10 25)
0 25
57.1 64 (16 25)
56.5 68 (17 25)
21.7 20 (5 25)
61.9 60 (15 25)
38.0 40 (10 25)
4.7 4 (1 25)
52.3 52 (13 25)
33.3 36 (9 25)
4.7 4 (1 25)
57.1 56 (14 25)
38.0 40 (10 25)
4.7 4 (1 25)
66.6 64 (16 25)
76.1 72 (18 25)
14.2 12 (3 25)

(10 25)
(11 25)
(9 25)
(8 25)
(11 25)
(10 25)
(6 25)
26 40
30.4 44
21.7 36
17.3 32
30.4 44
26.0 40
8.6 24
(5 25)
(8 25)
(6 25)
(8 25)
(6 25)
(11 25)
(6 25)
4.3 20
4.3 32
8.6 24
17.3 32
8.6 24
30.4 44
8.6 24
9 24
17.3 32
21.7 36
30.4 44
30.4 44
39.1 44
30.4 36
40.9 44
40.9 44
76.1 68
76.1 72
61.9 60
66.6 64
23.8 28

Epigastric discomfort
Pyrosis
Bloating*
Early satiation
Postprandial fullness
Belching
Gastro-oesophageal
reflux
Heartburn
Nausea
Vomiting

(24 25)
(17 25)
(24 25)
(21 25)
(21 25)
(21 25)
(17 25)
95.2 96
71.4 68
100 96
90.4 84
90.4 84
90.4 84
71.4 68

(11 25)
(11 25)
(17 25)
(18 25)
(15 25)
(16 25)
(7 25)

18.1 24
27.2 44
57.1 56
66.6 64
57.1 56
57.1 56
19.0 24

(6 25)
(11 25)
(14 25)
(16 25)
(14 25)
(14 25)
(6 25)

27.2 32
36.3 40
52.3 52
61.9 60
52.3 52
61.9 60
23.8 28

(8 25)
(10 25)
(13 25)
(15 25)
(13 25)
(15 25)
(7 25)

91.3 96
82.6 92
91.3 96
60.8 72
82.6 92
69.5 80
73.9 84

(24 25)
(23 25)
(24 25)
(18 25)
(23 25)
(20 25)
(21 25)

(6 25)
(8 25)
(9 25)
(11 25)
(11 25)
(11 25)
(9 25)

4th week
2nd week
Pre-treatment
2nd week
Variables (%, PP ITT)
(ITT, proportion)

Pre-treatment

4th week

Post-treatment

Interference
Placebo

Table 3. Documentation of all upper gastrointestinal symptoms before, during and after treatments

Post-treatment

966 S . K O K L U et al.

at the 2nd week of therapy; 18 (75%) of treated patients


vs. 10 (42%) of placebo showed significant improvement at the 4th week of therapy. For early satiation, 7
(38%) of treated patients vs. 3 (14%) of placebo showed
significant improvement at the 2nd week of therapy; 10
(55%) of treated patients vs. 5 (24%) of placebo showed
significant improvement at the 4th week of therapy; 10
(55%) of treated patients vs. 6 (29%) of placebo showed
significant improvement at 1 month after therapy. For
heartburn, 9 (56%) of treated patients vs. 1 (6%) of placebo showed significant improvement at 1 month after
therapy. RCI was significant for early satiation and
heartburn, but not for bloating.
There were no adverse events due to either vacuum
IFC or placebo.

DISCUSSION
The present study is the first time to report on the
beneficial application of vacuum inferential current
therapy in FD patients. Both placebo and vacuum IFC
were effective in the treatment. Vacuum IFC was more
effective with respect to improving symptoms of FD as
compared with placebo.
Functional dyspepsia is characterized by the presence of gastroduodenal symptoms in the absence of
any organic disease that may explain the symptoms.
Patients with FD have a diminished health-related
quality of life and it is also often difficult for doctors
to treat and expensive for society.1 The aetiology of
FD is not clear though several pathophysiological
mechanisms, including delayed gastric emptying,
impaired gastric accommodation, visceral hypersensitivity, nervous system dysregulation and psychological
stress have been implicated.12
As the exact pathophysiological mechanisms causing symptoms in an individual patient cannot be
delineated, there is no standard treatment modality for
patients with FD. Hence, numerous treatment options
have been described, including dietary and lifestyle
modifications, various pharmacological agents and,
recently, complementary and alternative treatments.2
There is no single available therapy that consistently
provides relief to the majority of FD patients, demonstrating the heterogeneity of this disorder. Hence, one
cannot generalize the therapeutic approach for these
patients and cannot predict the degree of response.
Delayed gastric emptying has been considered one
of the mechanisms contributing to symptoms of
gastrointestinal motility disorders. Delayed gastric
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emptying has been reported in more than one-third of


FD patients.2 There are no effective therapeutic options
that optimally improve gastric emptying and hence
further research is ongoing. Gastric electric stimulation
is a novel experimental and clinical approach to the
treatment of patients with gastrointestinal motility disorders. While performing gastric electrical stimulation
for patients who have gastroparesis, temporary or permanent improvement of constipation in almost all of
the patients has been noted.7 It has been reported that
although the gastric emptying rate could not be
improved, electric stimulation improved symptoms in
gastroparesis.13, 14 Low-frequency gastric electrical
stimulation normalizes gastric dysrhythmia, resulting
in improvement of gastric emptying. On the other
hand, high frequency stimulation improves symptoms
although it cannot accelerate gastric emptying.15 A
current study suggests that electrical stimulation activates both afferent and efferent vagal pathways, and
finally decreases gastric sensitivity to volume distention, which enhances postprandial gastric stimulation.4
Interferential therapy is a form of non-invasive transcutaneous electrical stimulation. It produces sinusoidal
currents that cross within the body. It has been applied to
the treatment of several disorders, including muscle
strengthening, soft-tissue mobilizing, detrusor instability
and slow transit constipation.3, 6, 7 When interferential
therapy has been used clinically to treat urinary incontinence due to bladder overactivity, diarrhoea occurred as
a side effect of IFC, suggesting an increase in bowel
motility.5 Afterwards, IFC has been tried in patients with
chronic constipation. Electrical stimulation at the applied
site is likely to stimulate local skin nerve fibres, vagal
symphathetic and parasympathetic outflow to the gastrointestinal tract, and nerves within the gut.3 Improvement
of constipation in previous reports and symptoms of FD
in the present study may be due to neuromodulation of
excitatory and inhibitory neural control by a supraspinal
or a spinal pathway.7 To our knowledge, interferential
therapy has not previously been applied to patients with
FD. As in the present study, studies have not reported any

REFERENCES
1 Henningsen P, Zipfel S, Herzog W. Management of functional somatic syndromes.
Lancet 2007; 369: 94655.

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2010 Blackwell Publishing Ltd

adverse effects of interferential treatment. It is non-invasive, painless and relatively inexpensive. Although it
requires trained physiotherapists, home-use, portable
units have become available recently.6
In the present study, patients were homogeneous
regarding age, gender, educational and occupation status. Most of the patients suffering from FD are women.
This study reports the outcomes of women with a low
education status. More research is needed not only to
test these results but also to extend the range of participants, for instance, to male patients and those with
different occupations. Actually, patients included in
this study were from the hard-to-treat group, as they
were all unresponsive to pharmacological treatment.
Although significantly lower than interferential treatment in several symptoms of FD, a higher response
rate for placebo in the present study supports the psychological aspect of FD.
A limitation of the study was the questionnaire used
to assess responses. Using validated questionnaires,
such as a visual analogue score, would have been better.
However, any change in each symptom at the middle
and end of treatment, and after the treatment sessions
was compared with the basal status of each symptom
and our expectations for the answers (the same,
decreased or increased) were to reflect the definite
changes. Another limitation of the study was a lower
number of patients than we had planned. As each study
physiotherapist carried out treatment sessions of IFC
and placebo groups separately, continuing with a new
physiotherapist would have given several biases.
In conclusion, this preliminary study demonstrates
that vacuum interference electrical stimulation is a
promising alternative therapy for FD. It seems beneficial, free of adverse effects and may be applied at least
when the symptoms of FD are aggravated or are unresponsive to medical treatment.

ACKNOWLEDGEMENT
Declaration of personal and funding interests: None.

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