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*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
961
962 S . K O K L U et al.
INTRODUCTION
C L I N I C A L T R I A L : I N T E R F E R E N T I A L E L E C T R I C S T I M U L A T I O N I N F U N C T I O N A L D Y S P E P S I A 963
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.
100 patients
Met rome III criteria for FD
50 patients randomized to
interference current or placebo
25 patients
25 patients
Placebo group
Interference group
Figure 2. Patient flow showing the number of patients in the different phases of the study.
C L I N I C A L T R I A L : I N T E R F E R E N T I A L E L E C T R I C S T I M U L A T I O N I N F U N C T I O N A L D Y S P E P S I A 965
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
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
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.
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
Aliment Pharmacol Ther 31, 961968
2010 Blackwell Publishing Ltd
C L I N I C A L T R I A L : I N T E R F E R E N T I A L E L E C T R I C S T I M U L A T I O N I N F U N C T I O N A L D Y S P E P S I A 967
REFERENCES
1 Henningsen P, Zipfel S, Herzog W. Management of functional somatic syndromes.
Lancet 2007; 369: 94655.
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.
968 S . K O K L U et al.
4 McCallum RW, Dusing RW, Sarosiek I,
Cocjin J, Forster J, Lin Z. Mechanisms of
symptomatic improvement after gastric
electrical stimulation in gastroparetic
patients. Neurogastroenterol Motil 2010;
22: 1617, e501.
5 Emmerson C. A preliminary study of the
effect of interferential therapy on detrusor
instability in patients with multiple sclerosis. Aust J Physiother 1987; 33: 645.
6 Clarke MCC, Chase JW, Gibb S, et al.
Decreased colonic transit time after transcutaneous interferential electrical stimulation in children with slow transit
constipation. J Ped Surg 2009; 44: 408
12.
7 Clarke MCC, Chase JW, Gibb S, Hutson
JM, Southwell BR. Improvement of quality of life in children with slow constipation after treatment with transcutaneous
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