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Psychological interventions for non-ulcer dyspepsia (Review)

  Soo S, Moayyedi P, Deeks JJ, Delaney B, Lewis M, Forman D  

  Soo S, Moayyedi P, Deeks JJ, Delaney B, Lewis M, Forman D.  

Psychological interventions for non-ulcer dyspepsia.
Cochrane Database of Systematic Reviews 2005, Issue 2. Art. No.: CD002301.
DOI: 10.1002/14651858.CD002301.pub4.

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Psychological interventions for non-ulcer dyspepsia (Review)
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TABLE OF CONTENTS
HEADER......................................................................................................................................................................................................... 1
ABSTRACT..................................................................................................................................................................................................... 1
PLAIN LANGUAGE SUMMARY....................................................................................................................................................................... 2
BACKGROUND.............................................................................................................................................................................................. 3
OBJECTIVES.................................................................................................................................................................................................. 3
METHODS..................................................................................................................................................................................................... 3
RESULTS........................................................................................................................................................................................................ 5
DISCUSSION.................................................................................................................................................................................................. 6
AUTHORS' CONCLUSIONS........................................................................................................................................................................... 6
ACKNOWLEDGEMENTS................................................................................................................................................................................ 6
REFERENCES................................................................................................................................................................................................ 7
CHARACTERISTICS OF STUDIES.................................................................................................................................................................. 9
DATA AND ANALYSES.................................................................................................................................................................................... 11
Analysis 1.1. Comparison 1 Psychotherapy, Outcome 1 12 week data.............................................................................................. 11
Analysis 1.2. Comparison 1 Psychotherapy, Outcome 2 52 week data.............................................................................................. 11
WHAT'S NEW................................................................................................................................................................................................. 12
HISTORY........................................................................................................................................................................................................ 12
DECLARATIONS OF INTEREST..................................................................................................................................................................... 12
SOURCES OF SUPPORT............................................................................................................................................................................... 12
INDEX TERMS............................................................................................................................................................................................... 12

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[Intervention Review]

Psychological interventions for non-ulcer dyspepsia

Shelly Soo1, Paul Moayyedi2, Jonathan J Deeks3, Brendan Delaney4, Maxine Lewis5, David Forman6

1Department of Medicine/Gastroenterology, South Tyneside District Hosiptal, South Shields, UK. 2Department of Medicine, Division of
Gastroenterology, McMaster University, Hamilton, Canada. 3Public Health, Epidemiology and Biostatistics, University of Birmingham,
Birmingham, UK. 4Division of Health and Social Care Research, King's College London, London, UK. 5Department of Psychiatry, St Joseph's
Hospital, Hamilton, Canada. 6Centre for Epidemiology and Biostatistics, University of Leeds, Leeds, UK

Contact address: Shelly Soo, Department of Medicine/Gastroenterology, South Tyneside District Hosiptal, Harton Lane, South Shields,
NE34 0PL, UK. Shelly.Soo@sthct.nhs.uk.

Editorial group: Cochrane Upper GI and Pancreatic Diseases Group

Publication status and date: Edited (no change to conclusions), published in Issue 11, 2010.

Citation: Soo S, Moayyedi P, Deeks JJ, Delaney B, Lewis M, Forman D. Psychological interventions for non-ulcer dyspepsia. Cochrane
Database of Systematic Reviews 2005, Issue 2. Art. No.: CD002301. DOI: 10.1002/14651858.CD002301.pub4.

Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT

Background
Studies have also shown that non-ulcer dyspepsia (NUD) patients have higher scores of anxiety, depression, neurotism, chronic tension,
hostility, hypochondriasis and tendency to be more pessimistic when compared with the community controls. However, the role of psy-
chological interventions in NUD remains uncertain.

Objectives
This review aims to determine the effectiveness of psychological interventions including psychotherapy, psychodrama, cognitive behav-
ioural therapy, relaxation therapy and hypnosis in the improvement of either individual or global dyspepsia symptom scores and quality
of life scores in patients with NUD.

Search methods
Trials were identified by searching the Cochrane Controlled Trials Register (Issue 3-1999), MEDLINE (1966-99), EMBASE (1988-99), PsycLIT
(1987-1999) and CINAHL (1982-99). Bibliographies of retrieved articles were also searched and experts in the field were contacted. Searches
were updated on 10 December 2002 and 21 January 2004. The searches were re-run on 24 January 2005 and 9 January 2006 and no new
trials were found

Selection criteria
All randomised controlled trials (RCTs) or quasi-randomised studies assessing the effectiveness of psychological interventions (including
psychotherapy, psychodrama, cognitive behavioural therapy, relaxation therapy and hypnosis) for non-ulcer dyspepsia (NUD) were iden-
tified.

Data collection and analysis

Data collected included both individual and global dyspepsia symptom scores and quality of life (QoL) scores.

Main results
We identified only four trials each using different psychological interventions; three presented results in a manner that did not allow syn-
thesis of the data to form a meta-analysis. All trials suggested that psychological interventions benefit dyspepsia symptoms and this effect
persists for one year. However, all trials used statistical techniques that adjusted for baseline differences between groups. This should
not be necessary for a randomised trial that is adequately powered suggesting that the sample size was too small. Unadjusted data was

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not statistically significant. The other problems of psychological intervention included low recruitment and high drop out rate, which has
been shown to be greater in patients receiving group therapy.

Authors' conclusions
There is insufficient evidence from this review to confirm the efficacy of psychological intervention in NUD.

PLAIN LANGUAGE SUMMARY

Psychological interventions for non-ulcer dyspepsia

People with unexplained gastrointestinal complaints and negative investigations for dyspepsia are said to have non-ulcer dyspepsia
(NUD). Previous studies have shown a higher incidence of psychological disorders and also a possible link between emotional factors and
alteration in gut physiology in patients with NUD. Psychological interventions have been used as a form of treatment as well as other
therapies including Helicobacter pylori eradication and pharmacological interventions. This review has shown benefit of psychological
interventions in NUD but the result has to be interpreted with caution due to paucity of trials in this area.

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BACKGROUND
Dyspepsia is a common symptom. It comprises 30 to 40% of all the
abdominal complaints presenting to gastroenterologists. Howev-
er, 50 to 60% of these patients have negative investigation results or
insignificant findings on endoscopy [Harvey 1983; Williams 1998].
These patients are given a diagnosis of functional or non-ulcer dys-
pepsia (NUD).
NUD is a heterogeneous disorder and the pathophysiology is not
well established. We have reported that Helicobacter pylori is like-
ly to be implicated in a small proportion of patients with NUD
[Moayyedi 2000] but the cause in the remainder is uncertain and is
likely to be multifactorial.
Previous studies [Folks 1992; Switz 1976] and epidemiological ev-
idence suggested that patients with NUD have a higher incidence
of psychological disorders than population controls [Alpers 2000]
and that symptoms of neurosis, anxiety, hypochondriasis, hostility
and depression were found to be more common in patients with un-
explained gastrointestinal complaints when compared with con-
trols [Haug 1995; O'Malley 1998; Talley 1986]. Studies also suggest-
ed possible links between emotional factors and alteration in gut
physiology which might give rise to abnormal gastric secretion, and
gut motility and function [Camilleri 1986; Drossman 1997; Malage-
lada 1985; Rees 1980; Wolf 1981].
Psychotherapy has been defined as an interpersonal process de-
signed to bring about modification of feelings, cognitions, attitudes
and behaviour which have proved troublesome to the patient seek-
ing help from a trained professional [Strupp 1978]. There are a wide
range of interventions which can be described as psychotherapeu-
tic including cognitive-behavioural psychotherapy, psychodynam-
ic psychotherapy, and group therapies. Psychodynamic therapies
focus on how maladaptive ideas and behaviours have emerged
whereas cognitive behavioural work concentrates on how mal-
adaptive ideas and belief systems are maintained by the patient's
environment.
Both cognitive behavioural therapy (CBT) and psychodynamic ther-
apy are effective in treating depression and anxiety disorders
[Shapiro 1994]. Patients with functional medical conditions may
suffer from psychiatric disorders [Talley 1986] and CBT has been
found to be effective in the treatment of patients with unexplained
physical symptoms [Speckens 1995] and chronic fatigue syndrome
[Butler 1991]. Stress management or behavioural therapies have
also been beneficial in irritable bowel syndrome and peptic ulcer
disease [Schwarz 1990]. However, the benefits of psychological in-
tervention remain unclear in NUD. We performed a systematic re-
view to establish the evidence for the clinical effectiveness of psy-
chotherapy and hypnosis in NUD.
OBJECTIVES
1. To assess if psychological interventions improve either individual
or global dyspepsia symptom scores in patients with NUD.
2. To assess if psychological interventions improve the quality of life
(QoL) in patients with NUD.
The psychological interventions included in this review were:
a) psychodynamic psychotherapy;
b) psychodrama;
c) cognitive behavioural therapy;
d) relaxation therapy;
e) hypnosis.
Psychological interventions for non-ulcer dyspepsia (Review)
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Cochrane Database of Systematic Reviews
METHODS
Criteria for considering studies for this review
Types of studies
All parallel-group randomised controlled trials (RCTs) and qua-
si-randomised studies were eligible for inclusion in the review.
Types of participants
Adult patients presenting to secondary care with dyspepsia asso-
ciated with negative or insignificant findings at endoscopy or with
barium studies.
Definitions of dyspepsia included any gastrointestinal symptoms
referable to the foregut. Patients that met the Working Group
[Working Party 1988], Rome I [Talley 1991] and II [Talley 1999] cri-
teria were therefore included. Trials that recruited patients with
only heartburn or reflux symptoms were excluded as gastro-oe-
sophageal reflux disease would be over-represented in this group.
Types of interventions
Comparison of psychological interventions, including psychother-
apy, psychodrama, cognitive behavioural therapy, relaxation ther-
apy and hypnosis, versus no intervention in NUD.
Types of outcome measures
The clinical benefits of the psychological interventions included as-
sessment of the following parameters.
(1) Dyspepsia symptom scores:
a) improvement of individual dyspepsia symptom scores
- the 12 symptom scores assessed were epigastric pain or discom-
fort, post-prandial fullness, early satiety, anorexia, vomiting, bloat-
ing, flatulence, belching, eructation, heartburn and acid regurgita-
tion;
b) improvement of global dyspepsia symptom scores.
(2) Improvement of quality of life (QoL) as measured by any of the
following:
a) generic QoL scores e.g. Psychological Well Being Index (PGWB)
and Short Form 36 (SF36);
b) disease-specific QoL scores.
Search methods for identification of studies
Searches were conducted to identify all published and unpublished
randomised controlled trials.
Trials were identified by searching the Cochrane Controlled Trials
Register (Issue 3-1999), MEDLINE (1966-99), EMBASE (1988-99), Psy-
cLIT (1987-1999) and CINAHL (1982-99).
The following search strategy was constructed by using a combina-
tion of subject headings and textwords relating to the symptoms
of dyspepsia, its symptomatology and psychological interventions,
including psychodynamic psychotherapy, psychodrama, cognitive
behavioural therapy, relaxation therapy and hypnosis.
Medline search strategy
exp dyspepsia/
exp eructation/
exp flatulence/
exp heartburn/
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exp gastroparesis/ Searches were updated on 10 December 2002 and 21 January 2004.
exp gastric emptying/ The searches were re-run on 24 January 2005 and 9 January 2006
exp gastritis/ and no new trials were found.
exp Gastritis, Atrophic/
exp bile reflux/ Data collection and analysis
dyspep$.tw.
Selection of studies
(acid adj5 reflux).tw.
One reviewer excluded papers from the initial searches that were
belch$.tw.
unrelated to dyspepsia based on the title or abstract, if available. A
bloat$.tw.
second reviewer independently checked a sample of this selection
burp$.tw.
process.
gastric reflux.tw.
The decision to include a study was made independently by two re-
(early adj5 satiety).tw.
viewers according to the pre-stated eligibility criteria and recorded
eructation.tw.
on a specially developed form. Disagreements were reviewed and
flatu$.tw.
a third reviewer consulted if they could not be resolved.
heartburn.tw.
indigestion.tw. Assessment of study quality
pyro$.tw. Trials meeting the eligibility criteria were assessed for quality ac-
hiatus hernia.tw. cording to four characteristics:
(stomach adj5 paresis).tw.
gastritis.tw. (1) Generation of the allocation schedule
(gastric acid adj5 secretion).tw. (truly random, quasi-random, systematic, not stated/unclear).
(stomach adj5 secretion).tw. Computer generated random numbers, coin toss, shuffles, etc were
(gastric adj5 erosion).tw. defined as truly random; allocation according to birth date, patient
(stomach adj5 erosion$).tw. number, etc were defined as quasi-random; whilst alternate alloca-
(gastric emptying adj5 disorder$).tw. tion and deterministic methods were classified as systematic.
(stomach adj3 emptying adj5 disorder$).tw.
gastroparesis.tw. (2) Concealment of the treatment allocation
or/30-60 (adequate, inadequate, unclear).
exp psychoanalytic therapy/ If trialists were unaware of each participant's allocation when they
exp psychotherapeutic processes/ were recruited the allocation was said to be adequately concealed.
exp psychotherapy/ Methods such as central randomisation systems or serially num-
exp Psychotherapy, Brief/ bered opaque envelopes fit this criterion. If the trialist could have
exp Psychotherapy, Multiple/ been aware of allocations at recruitment, as when the participant's
Psychotherapy, rational-emotive/ birth date or patient number was used for allocation, the allocation
exp reality therapy/ was defined as inadequate.
exp socioenvironmental therapy/
exp autogenic training/ (3) Implementation of masking.
Behavior therapy/ When a placebo was used it was assumed that the participants were
exp gestalt therapy/ masked to their treatment allocation.
exp hypnosis/
(4) Completeness of follow up and intention to treat analysis.
(symptom adj5 score$).tw.
Drop-outs and missing data rates by group.
(psychoanalytic adj5 therapy).tw.
Study quality was assessed by one reviewer and checked by a sec-
(psychotherapeutic adj5 process).tw.
ond.
(socio$ adj3 environment adj5 therapy).tw.
psychotherapy.tw. Data Extraction
(autogenic adj5 training).tw. Data were extracted and recorded onto specially developed forms.
(behaviour$ adj5 therapy).tw. Extraction was undertaken by one reviewer and checked by a sec-
(gestalt adj5 therapy).tw. ond. Data entry into RevMan was also double-checked.
(reality adj5 therapy).tw.
(non?directive adj5 therapy).tw. The following characteristics were recorded for each trial:
hypnosis.tw. (a) details of the participants including demographic characteris-
or/62-84 tics, source of recruitment, criteria for diagnosis, and dyspeptic
61 and 85 symptoms on presentation; trials were categorised according to
86 and 29 the most prevalent type of dyspepsia, whether ulcer-like, dysmotil-
ity-like, reflux-like or non-specific, if possible;
In addition, members of the Cochrane UGPD Group, experts in the (b) details of the experimental and control interventions including
field of dyspepsia and pharmaceutical companies with an interest intervention type, where appropriate;
in gasteroenteology were contacted and asked to supply details of (c) the prevalence of individual dyspeptic symptoms before and af-
any outstanding clinical trials and relevant unpublished materials. ter the intervention, dyspeptic symptom scores and global assess-
ments of dyspeptic symptoms.

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Where measurement scales were used it was noted whether or not
they were standard scales and whether they have been validated.
Assessments of quality of life and adverse events were also noted.
Data were extracted from intention to treat analyses if they were
presented.
Data Synthesis
Meta-analysis was not possible as the data were too heterogeneous
to synthesise in a single outcome measure. All trials identified used
different interventions and in the four eligible papers the data could
not be extracted to provide a summary effect size.
RESULTS
Description of studies
A total of 886 citations were obtained from the broad search terms
that we used. Eight trials evaluated psychological intervention in
NUD and only four of these met our eligibility criteria [Bates 1988;
Calvert 2002; Hamilton 2000; Haug 1994]. The other four studies
were excluded as one study investigated the effectiveness of a com-
bination of therapies including psychotherapy and psychotropic
drugs [Mine 1998], the second study investigated a combination of
psychotherapy with traditional Chinese medicine [Jiang 2000], the
third and fourth studies considered irritable bowel syndrome (IBS)
and NUD patients together [Arn 1989; Poitras 2002].
Risk of bias in included studies
One trial used adequate methods of randomisation and conceal-
ment [Hamilton 2000]. Two trials adequately masked both the pa-
tient and the investigator assessing the response to intervention
[Calvert 2002; Hamilton 2000]. The investigator administering the
intervention was not masked but this was not possible with this
type of intervention. The other two trials did not state the method of
randomisation or concealment, and there was no attempt to mask
the patient or investigator assessing outcome [Bates 1988; Haug
1994].
Effects of interventions
The four eligible trials assessed different outcome parameters and
used different psychological interventions. It was, therefore, not
possible to meaningfully pool the data. Three studies [Bates 1988;
Calvert 2002; Haug 1994] used mean dyspepsia symptom score as
an outcome measure but only one [Hamilton 2000] recorded the
standard deviation of the mean to allow results to be recorded in
this review. One study reported the percentage change in symptom
score from baseline [Calvert 2002]. We have, therefore, simply qual-
itatively described the design and results of the trials under five
sub-headings.
1. Mode of psychological intervention
Four different psychological interventions were used: relaxation
techniques, cognitive therapy, psychodynamic-interpersonal ther-
apy, and hypnotherapy.
Bates et al. [Bates 1988] used group therapy with emphasis on ap-
plied relaxation techniques. Each group consisted of 2 to 5 patients
attending eight sessions over 3 months, with each session lasting
90 minutes. The average number of sessions attended was 7.1.
Hamilton et al. used psychodynamic-interpersonal therapy aiming
to identify interpersonal difficulties and ways that these may be
Psychological interventions for non-ulcer dyspepsia (Review)
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modified [Hamilton 2000]. Patients individually received an initial
3-hour session followed by six 50-minute sessions over 12 weeks.
The control patients were given 'supportive therapy' consisting of
sympathy and support for the same duration of time as the inter-
vention arm but specific elements of psychodynamic-interperson-
al therapy were not introduced.
Calvert et al. used hypnotherapy induced using standard proce-
dures [Calvert 2002]. Tactile and visualisation methods were used
to suggest that positive effects on motor activity, sensitivity and
acid secretion could be achieved to improve symptoms. Patients
had twelve 30-minute sessions over 16 weeks. There were two con-
trol groups: one received 'supportive therapy' and placebo raniti-
dine, the other did not have any 'supportive therapy' but was given
active ranitidine, 150 mg twice daily.
2. Recruitment
Psychological therapies may not be suitable for all patients as
shown by a proportion who refused to participate in the trials. The
number of eligible patients agreeing to take part in these trials
was 100/143 (70%) [Haug 1994], 73/95 (77%) [Hamilton 2000], and
126/149 (85%) [Calvert 2002]. Bates et al. [Bates 1988] did not report
on the number/proportion of eligible patients that were recruited.
3. Compliance
There appeared to be fewer drop-outs in individual psychological
therapies compared with group therapy. The trial evaluating group
support reported a drop-out rate of 48% [Bates 1988] compared
with 14% [Haug 1994], 19% [Hamilton 2000] and 16% [Calvert 2002]
for individual psychological therapies.
4. Impact of psychological interventions on dyspepsia symptoms
All four studies reported a statistically significant reduction in dys-
pepsia symptoms in the intervention group compared with the con-
trol groups at the end of treatment, an effect that persisted for up
to one year follow up.
Bates et al. [Bates 1988] randomised 52 patients to group therapy
and 51 to a control group. Patients were interviewed at 12 and 52
weeks and completed a questionnaire that assessed pain intensi-
ty, pain duration, pain index and pain occasions. There was a sta-
tistically significant decrease in these parameters in the treatment
group compared to the control group at 12 and 52 weeks when
the data was log transformed and adjusted for baseline dyspepsia
scores using analysis of co-variance [Bates 1988]. For example, the
mean pain intensity score was 18 in the intervention group and 22
in the control group, which was reported as statistically significant
(p < 0.03). No further information on standard deviation, standard
errors or confidence intervals was given in the paper making the
magnitude of the benefit and the range of results achieved difficult
to interpret.
Haug et al. [Haug 1994] randomised 50 patients each to cognitive
therapy and control. The method of assessing symptoms was not
clear but the paper reported that patients receiving intervention
showed a statistically significant reduction in epigastric pain score
(mean score in intervention group of 1.9 versus 2.4 in the control
group; p = 0.003), nausea score (1.7 versus 1.8; p = 0.04), and bloat-
ing score (2.0 versus 2.0; p = 0.001) at one year; using repeated mea-
sures analysis of variance. Statistically significant effects were seen
even when the mean score was the same in each group due to dif-
ferences in baseline values. Again measures of spread of the data
were not provided.
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Hamilton et al. [Hamilton 2000] randomised 37 patients to psycho-
dynamic psychotherapy and 36 patients to 'supportive therapy'.
Patients rated individual dyspepsia symptoms on a self-complet-
ed questionnaire and they were also assessed by a gastroenterol-
ogist. The specialist rated intervention patients as having statisti-
cally significantly less dyspepsia than control patients (mean 6.8 ±
5.1 (SD) versus 10.1 ± 3.2; p = 0.005) at the end of 12 weeks thera-
py. At one year, there was a statistically significant reduction in self-
rated global dyspepsia score in the intervention arm (mean score
7.8 ± 5 versus 9.9 ± 6.1; p = 0.037) using analysis of covariance once
patients with severe symptoms of heartburn were excluded. The
unadjusted data were not statistically significant (see forest plots 1
and 2) even when heartburn patients were excluded; the statistical
significance was achieved by adjusting for differences at baseline.
Calvert et al. [Calvert 2002] randomised 32 patients to hypnothera-
py; 48 to supportive therapy; and 46 to ranitidine, 150 mg twice dai-
ly. Symptoms were assessed by an adaptation of an IBS question-
naire that used visual analogue scales. At 56 weeks the total dys-
pepsia score was lower in the hypnotherapy group (median score
0.6; interquartile range 0.1 to 1.5), than the supportive therapy
group (median score 3.6; interquartile range 1.5 to 5.2), or the med-
ical therapy group (median score 2.9; interquartile range 1.4 to 3.7).
5. Impact of psychological interventions on quality of life and psy-
chological profile
One trial reported an improvement in psychological parameters
compared with the control group [Haug 1994] whereas another
found that the two groups had similar scores at one year [Hamilton
2000]. One trial [Calvert 2002] assessed quality of life and found that
the hypnotherapy group had a statistically significant improve-
ment in quality of life compared to medical therapy but not the sup-
portive group. The authors attributed the lack of statistical signif-
icance in the latter to five patients in the supportive therapy arm
receiving anti-depressants.
DISCUSSION
This review has revealed a paucity of randomised controlled trials
investigating psychological intervention in NUD. We identified on-
ly four trials each using different psychological interventions and
three of which presented results in a manner that did not allow
synthesis of the data. We, therefore, could only provide a qualita-
tive description of the results. All trials suggested that psychologi-
cal therapies benefit dyspepsia symptoms and this effect persists
for one year.
These data suggest that psychotherapeutic techniques benefit
NUD but this conclusion should be interpreted with caution. All
trials used statistical techniques that adjusted for baseline differ-
ences between groups. This should not be necessary for a ran-
domised trial that is adequately powered, suggesting that the sam-
Psychological interventions for non-ulcer dyspepsia (Review)
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cochrane Database of Systematic Reviews
ple size of these papers was too small. Unadjusted data was not sta-
tistically significant (see forest plots). Furthermore, the parametric
statistical tests used make assumptions regarding the distribution
of the data that may not hold for dyspepsia symptoms [Moayyedi
1998].
Further well-designed trials that are adequately powered are there-
fore required before we can be confident of the benefit of psy-
chotherapeutic techniques in NUD. Nevertheless, the findings of
these trials are consistent with the effect of psychotherapy [Guthrie
1991] and hypnotherapy [Vidakovic-Vukic 1999; Whorwell 1984] in
irritable bowel syndrome patients.
Psychotherapy techniques are time consuming for the patient and
healthcare practitioner and it is unlikely that this approach will be
useful for those with mild symptoms. This probably explains the
low recruitment rate reported in some trials. In those with severe
dyspepsia symptoms healthcare costs can be considerable [Ma-
son 2002] and even an expensive intervention may be an appro-
priate use of resources. Indeed, psychotherapy and hypnotherapy
have been shown to reduce healthcare costs in functional gastroin-
testinal disorders [Calvert 2002; Creed 2003]. Nevertheless, it is im-
portant to establish the least time-consuming psychotherapy tech-
nique that is effective in NUD. Group therapy is more efficient from a
healthcare perspective but the high drop-out rate in the trial [Bates
1988] evaluating this technique suggests it may not meet with pa-
tient satisfaction. Patients can be trained to induce self-hypnosis
with the aid of an audiotape [Palsson 2002] and this warrants fur-
ther evaluation in NUD.
AUTHORS' CONCLUSIONS
Implications for practice
There is currently insufficient evidence in this review to confirm the
efficacy of psychological intervention in NUD.
Implications for research
Further well-designed trials that are adequately powered are re-
quired before we can be confident of the benefit of psychothera-
peutic techniques in NUD. It would also be very important for future
studies to assess the improvement both in terms of the dyspepsia
symptom scores using standard validated questionnaire and the
impact of the treatment in terms of improvement of quality of life
scores. Long-term follow up of patients is essential to establish the
true efficacy of this mode of intervention as NUD is a chronic relaps-
ing disorder.
ACKNOWLEDGEMENTS
We would like to thank Dr. Cathy Bennett, Julie Rayworth, Janet Lil-
leyman, Iris Gordon and Gemma Sutherington for their help.
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Informed decisions.
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REFERENCES
References to studies included in this review
Bates 1988 {published data only}
Bates S, Sjoden P-O, Nyren O. Behavioral treatment of non-
ulcer dyspepsia. Scandinavian Journal of Behaviour therapy
1988;17(2):155-65.
Calvert 2002 {published data only}
Calvert EL, Houghton LA, Cooper P, Morris J, Whorwell PJ. Long-
term improvement in functional dyspepsia using hypnotherapy
[Long-term improvement in functional dyspepsia using
hypnotherapy]. Gastroenterology 2002;123:1778-85..
Hamilton 2000 {published data only}
Hamilton J, Guthrie E, Creed F, Thompson D, Tomenson B,
Bennett R, Moriarty K, Stephens W, Liston R. A randomized
controlled trial of psychotherapy in patients with chronic
functional dyspepsia. Gastroenterology 2000;119(3):661-9.
Haug 1994 {published data only}
Haug TT, Wilhelmsen I, Svebak S, Berstad A, Ursin H.
Psychotherapy in functional dyspepsia. Journal of
Psychosomatic Research 1994;38(7):735-44.
 
References to studies excluded from this review
Arn 1989 {published data only}
Arn I, Theorell T, Uvnas-Moberg K, Jonsson C-O. Psychodrama
group therapy for patients with functional gastrointestinal
disorders - a controlled long-term follow-up study.
Psychotherapy and psychosomatics 1989;51:113-9.
Jiang 2000 {published data only}
Jiang B, Lin J, Zhang Y. Clinical observation on the mental
symptoms of functional dyspepsia and its treatment
[In Chinese]. Chung Kuo Chung Hsi I Chieh Ho Tsa Chih
2000;20:424-6..
Mine 1998 {published data only}
Mine K, Kanazawa F, Hosoi M, Kinukawa N, Kubo C. Treating
nonulcer dyspepsia considering both functional disorders of the
digestive system and psychiatric conditions. Digestive Diseases
and Sciences 1998;43(6):1241-7.
Poitras 2002 {published data only}
Poitras MR, Verrier P, So C, Paquet S, Bouin M, Poitras P.
Group counseling Psychotherapy for patients with functional
gastrointestinal disorders, Development of New Measures for
symptom severity and quality of life. Digestive Diseases and
Sciences 2002;47, No 6:1297-307.
 
Additional references
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CHARACTERISTICS OF STUDIES

Characteristics of included studies [ordered by study ID]

 
Bates 1988 
Methods RCT. Randomisation and allocation concealment not described. Patients and investigator not masked.

Participants Sweden. 103 patients with 2/12 dyspepsia. 52 assigned to Treatment group and 51 to Control group. In
the treatment group, 32 participated in 3 or more sessions and 20 did not participate. A group of 29 pa-
tients who declined the treatment served as an Extra Control group.
High dropout rates: Treatment group = 40% and Control group = 59%.

Interventions Treatment group:

Group support.
3/12 '"Psychosocial treatment of NUD" - 8 sessions each lasting 90 minutes.
Control group: No treatment but details of what happened in the OP follow-up were not given.

Outcomes Reductions of pain intensity and the number of pain episodes were statistically significantly greater
in the treated than control groups at 3 months. It is not clear whether this difference remained at 12
months. There were no differences between groups in pain index or duration of pain.

Notes Recorded pain intensity, pain duration, pain index and pain occasions.

Risk of bias

Bias Authors' judgement Support for judgement

Allocation concealment? Unclear risk B - Unclear

 
 
Calvert 2002 
Methods RCT.
Patients and assessor were blinded. Investigator not masked.

Participants UK. 126 patients divided into 3 groups: 32 patients to hypnotherapy, 48 to '"supportive therapy" and
placebo ranitidine and 46 to ranitidine 150 mg twice daily.

Interventions Hypnotherapy induced using standard procedures. Tactile and visualisation methods were used to
suggest that positive effects on motor activity, sensitivity and acid secretion could be achieved to
improve symptoms. Patients had twelve 30 minute sessions over 16 weeks. There were two control
groups, one received "supportive therapy" and placebo ranitidine the other did not have any "support-
ive therapy" but was given active ranitidine 150mg twice daily.

Outcomes At 56 weeks the total dyspepsia score was lower in the hypnotherapy group (median score = 0.6, in-
terquartile range = 0.1 to 1.5), than the supportive therapy group (median score = 3.6, interquartile
range = 1.5 to 5.2) or the medical therapy group (median score = 2.9, interquartile range = 1.4 to 3.7).

Notes  

Risk of bias

Bias Authors' judgement Support for judgement

Allocation concealment? Low risk A - Adequate

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Hamilton 2000 
Methods RCT.
Randomisation and allocation concealment described. Patients and investigator masked.

Participants England. 73 patients with 6/12 dyspepsia. 73/95 (77%) eligible patients participated in the trial. 37 as-
signed to intervention, 36 to control arm. There was a 15% drop out rate.

Interventions Treatment group: individual psychodynamic-

interpersonal psychotherapy for 12 weeks
Control: supportive therapy giving the patient the same contact time with the investigator as the inter-
vention arm

Outcomes Significant reduction in dyspepsia score at 12 weeks in the intervention arm after controlling for base-
line scores using ANOVA. No significant difference at one year.

Notes  

Risk of bias

Bias Authors' judgement Support for judgement

Allocation concealment? Low risk A - Adequate

 
 
Haug 1994 
Methods RCT.
Randomisation and allocation concealment not described. Patients and investigator not masked.

Participants Norway. 100 patients with 3/12 of epigastric pain and some with endoscopic erosive prepyloric
changes. 50 patients in each arm.
Recruitment rate = 70%.
Dropout rate was 14% for the Treatment group and 10% for the Control group.

Interventions Treatment group:

Individual cognitive therapy.
4 months of 10 sessions cognitive therapy.
"Booster therapy'" at 6/12.
Control group:
No treatment but the therapist called the patients every second month throughout the year and spent
5 minutes talked about dyspeptic symptoms

Outcomes There were significantly greater reductions at 1year in days of epigastric discomfort, heartburn, diar-
rhoea and constipation with treatment, but not bloating or lower abdominal pain.

Notes Recorded reduction in the number of days of epigastric discomfort and also mean symptoms of 4 dys-
peptic symptoms.

Risk of bias

Bias Authors' judgement Support for judgement

Allocation concealment? Unclear risk B - Unclear

Psychological interventions for non-ulcer dyspepsia (Review) 10

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Characteristics of excluded studies [ordered by study ID]

 
Study Reason for exclusion

Arn 1989 This study was not randomised but used an historical control group. A mixture of NUD and irritable
bowel syndrome patients were recruited.

Jiang 2000 This study investigated a combination of psychotherapy with traditional Chinese medicine in pa-
tients with functional dyspepsia

Mine 1998 Randomised only one group of their seriously ill NUD patients, and investigated the effectiveness
of a combination of therapies, which included psychotherapy and psychotropic drugs.

Poitras 2002 Not RCT. It studied a total of 47 patients, 40 of these patients have IBS, only 5 have functional dys-
pepsia and 2 have oesophageal problems.

 
DATA AND ANALYSES
 
Comparison 1.   Psychotherapy

Outcome or subgroup title No. of No. of Statistical method Effect size

studies partici-
pants

1 12 week data 1 68 Mean Difference (IV, Fixed, 95% CI) -1.5 [-4.33, 1.33]

2 52 week data 1 58 Mean Difference (IV, Fixed, 95% CI) -0.60 [-3.70, 2.50]

 
 
Analysis 1.1.   Comparison 1 Psychotherapy, Outcome 1 12 week data.
Study or subgroup Treatment Control Mean Difference Weight Mean Difference
  N Mean(SD) N Mean(SD) Fixed, 95% CI   Fixed, 95% CI
Hamilton 2000 37 10.9 (6.4) 31 12.4 (5.5) 100% -1.5[-4.33,1.33]
   
Total *** 37   31   100% -1.5[-4.33,1.33]
Heterogeneity: Not applicable  
Test for overall effect: Z=1.04(P=0.3)  

Favours treatment -10 -5 0 5 10 Favours control

 
 
Analysis 1.2.   Comparison 1 Psychotherapy, Outcome 2 52 week data.
Study or subgroup Treatment Control Mean Difference Weight Mean Difference
  N Mean(SD) N Mean(SD) Fixed, 95% CI   Fixed, 95% CI
Hamilton 2000 31 8.7 (5.8) 27 9.3 (6.2) 100% -0.6[-3.7,2.5]
   
Total *** 31   27   100% -0.6[-3.7,2.5]

Favours treatment -10 -5 0 5 10 Favours control

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Study or subgroup Treatment Control Mean Difference Weight Mean Difference

  N Mean(SD) N Mean(SD) Fixed, 95% CI   Fixed, 95% CI
Heterogeneity: Not applicable  
Test for overall effect: Z=0.38(P=0.7)  

Favours treatment -10 -5 0 5 10 Favours control

 
WHAT'S NEW
 
Date Event Description

5 October 2010 Amended Contact details updated.

 
HISTORY
Protocol first published: Issue 1, 2000
Review first published: Issue 4, 2001

 
Date Event Description

30 October 2008 Amended Converted to new review format.

24 January 2005 New citation required and conclusions Substantive amendment

have changed

 
DECLARATIONS OF INTEREST
None known.

SOURCES OF SUPPORT

Internal sources
• No sources of support supplied

External sources
• UK NHS Health Technology Assessment Programme, UK.

INDEX TERMS

Medical Subject Headings (MeSH)

*Psychotherapy;  Dyspepsia  [psychology]  [*therapy];  Randomized Controlled Trials as Topic

MeSH check words

Humans

Psychological interventions for non-ulcer dyspepsia (Review) 12

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