Psychological interventions for non-ulcer dyspepsia

(Unknown)

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

This is a reprint of a Cochrane unknown, prepared and maintained by The Cochrane Collaboration and published in The Cochrane
Library 2004, Issue 1
http://www.thecochranelibrary.com

Psychological interventions for non-ulcer dyspepsia (Unknown)

Copyright © 2004 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 TABLE OF CONTENTS
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
SYNOPSIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
CRITERIA FOR CONSIDERING STUDIES FOR THIS REVIEW . . . . . . . . . . . . . . . . . . 2
SEARCH STRATEGY FOR IDENTIFICATION OF STUDIES . . . . . . . . . . . . . . . . . . . . 3
METHODS OF THE REVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
DESCRIPTION OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
METHODOLOGICAL QUALITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
REVIEWERS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
POTENTIAL CONFLICT OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Characteristics of included studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Characteristics of excluded studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
SUMMARY TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
COVER SHEET . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
GRAPHS AND OTHER TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
00 Psychotherapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
12 week data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
52 week data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Psychological interventions for non-ulcer dyspepsia i

Copyright ©2004 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd
Psychological interventions for non-ulcer dyspepsia

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

This Review should be cited as:

Soo S, Moayyedi P, Deeks J, Delaney B, Lewis M, Forman D. Psychological interventions for non-ulcer dyspepsia. The Cochrane
Database of Systematic Reviews 2004, Issue 1. Art. No.: CD002301.pub2. DOI: 10.1002/14651858.CD002301.pub2. This version
first published online: 26 January 2004 in Issue 1, 2004.
Date of most recent substantive amendment: 25 September 2003

ABSTRACT

Background
Studies have also shown that NUD patients have higher scores of anxiety, depression, neurotism, chronic tension, hostility, hypochondri-
asis, and tendency to be more pessimistic when compared with the community controls. However, the role of psychological interventions
in NUD remains uncertain.

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

Search strategy
Trials were located through electronic searches of the Cochrane Controlled Trials Register (CCTR), MEDLINE, EMBASE, CINAHL
and PsycLIT, using very broad subject headings and text words. Bibliographies of retrieved articles were also searched and experts in
the field were contacted.

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
identified.

Data collection and analysis

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

Main results
We identified only four trials, each using different psychological interventions and three presenting results in a manner, that did not
allow synthesis of the data to form a meta-analysis. All trials suggest that psychological interventions benefit dyspepsia symptoms and
this effect persists for one year. However, all trials use 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 of these papers was too small.
Unadjusted data was not statistically significant. The other problem of psychological intervention include low recruitment and high
drop out rate which has been shown to be greater in patients receiving group therapy.

Reviewers’ conclusions
There is currently insufficient evidence from this review to confirm the efficacy of psychological intervention in NUD. There is also no
evidence on the combined effects of pharmacological and psychological therapy. Nevertheless, if there are any benefits of psychological
therapies, they are likely to persist long-term and NUD is a chronic relapsing and remitting disorder. Psychological therapies may
therefore be offered to patients with severe symptoms that have not responded to pharmacological therapies.
Psychological interventions for non-ulcer dyspepsia 1
Copyright ©2004 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd
SYNOPSIS

Patients with negative investigations for dyspepsia are said to have non-ulcer dyspepsia (NUD). Previous studies have shown a higher
incidence of psychological disorders and also there is 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 in patients with NUD amongst other therapies
including H.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.

BACKGROUND
Dyspepsia is a common symptom. It comprises 30-40% of all
the abdominal complaints presented to the gastroenterologists.
However, 50-60% of these patients have negative investigations
or insignificant findings on endoscopy [Harvey 1983; Williams
1998]. These patients are given a diagnosis of functional or non-
ulcer dyspepsia (NUD).
NUD is a heterogeneous disorder and the pathophysiology is not
well established. We have reported that Helicobacter pylori is likely
to be implicated in a small proportion of patients with NUD
[Moayyedi 2003] but the cause in the remainder is uncertain and
is likely to be multifactorial.
Previous studies [Folks 1992; Switz 1976] and epidemiological ev-
idence have suggested that patients with NUD have a higher inci-
dence 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 pa-
tients with unexplained gastrointestinal complaints when com-
pared with controls [O’Malley 1998, Haug 1995, Talley 1986].
Studies have also suggested possible link between emotional fac-
tors and alteration in gut physiology, which might give rise to
abnormal gastric secretion and gut motility and function [Wolf
1981, Drossman 1997, Camilleri 1986, Rees 1980, Malagelada
1985].
Psychotherapy has been defined as an interpersonal process de-
signed to bring about modification of feelings, cognitions, atti-
tudes and behaviour which have proved troublesome to the patient
seeking help from a trained professional [Strupp 1978]. There are a
wide range of interventions which can be described as psychothera-
peutic including cognitive-behavioural psychotherapy, psychody-
namic psychotherapy and group therapies. Psychodynamic thera-
pies 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
therapy are effective in treating depression and anxiety disorders
[Shapiro 1994]. Patients with functional medical conditions may
Psychological interventions for non-ulcer dyspepsia
Copyright ©2004 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd
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
intervention remain unclear in NUD. We performed a system-
atic review to establish the evidence of the clinical effectiveness of
psychotherapy and hypnosis in NUD.
OBJECTIVES
1. To assess if psychological interventions improve either the in-
dividual or global dyspepsia symptom scores in patients NUD.
2. To assess if psychological interventions improve the quality of
life (QoL) in patients with NUD.
The psychological interventions included in this review are
a) psychodynamic psychotherapy
b) psychodrama
c) cognitive behavioural therapy
d) relaxation therapy
e) hypnosis
CRITERIA FOR CONSIDERING
STUDIES FOR THIS REVIEW
Types of studies
All parallel-group randomised controlled trials (RCTs) and quasi-
randomised studies were eligible for inclusion in the review.
Types of participants
Adult patients presenting to secondary care with dyspepsia with
negative or insignificant findings at endoscopy or barium studies.
Definitions of dyspepsia include any gastrointestinal symptoms
referable to the foregut. Patients that meet the Working Group
[Working Party 1988], Rome I [Talley 1991] and II [Talley 1999]
2
criteria are therefore included. Trials that recruit patients with only random
heartburn or reflux symptoms were excluded as gastro-oesophageal Research design
reflux disease would be over-represented in this group. Comparative Study
exp Evaluation Studies
Types of intervention
Follow-Up Studies
Comparison of psychological interventions including psychother- Prospective Studies
apy, psychodrama, cognitive behavioural therapy, relaxation ther- dyspepsia
apy and hypnosis versus no intervention in NUD. eructation
Types of outcome measures flatulence
The clinical benefits of the psychological interventions include heartburn
assessment of the following parameters: eructation
(1) Dyspepsia symptom scores indigestion
a) Improvement of individual dyspepsia symptom scores early satiety
- 12 individual dyspepsia symptom scores assessed were epigas- hiatus hernia
tric pain/discomfort, post-prandial fullness, early satiety, anorexia, gastroparesis
vomiting, bloating, flatulence, belching, eructation, heartburn and gastric emptying
acid regurgitation stomach paresis
b) Improvement of global dyspepsia symptom scores pyrosis
dyspep$
(2) Improvement of quality of life (QoL) as measured by any of (acid adj5 reflux)
the following: belch$
a) Generic QoL scores - e.g. Psychological Well Being (PGWB) bloat$
Index and Short Form 36 (SF36) burp$
b) Disease specific QoL scores (early adj5 satiety)
flatu$
pyro$
SEARCH STRATEGY FOR Stomach acid secretion
IDENTIFICATION OF STUDIES (gastric acid adj5 secretion)
(stomach acid adj5 secretion)
See: search strategy (gastric adj5 erosion$)
Searches were carried out using Cochrane Controlled Trials (stomach adj5 erosion$)
Register (CCTR), Medline (1966-March 2003), EMBASE (gastric emptying adj5 disorder$)
(1988- M arch 2003), PsycLIT (1987-March 2003) and (stomach emptying adj5 disorder$)
Cinahl (1982-March 2003). The searches were done using Epigastric adj5 pain$
a combination of subject headings and text words related to Epigastric adj5 discomfort
dyspepsia, its symptomatology and psychological interventions Stomach adj5 pain$
including psychodynamic psychotherapy, psychodrama, cognitive Stomach adj5 discomfort
behavioural therapy, relaxation therapy and hypnosis. A recursive Postprandial adj5 fullness
search of the bibliography of retrieved articles was also performed Abdominal adj5 distension
and experts in the field were contacted. Stomach adj5 distension
The subject headings and texwords used in this review include Stomach adj5 empty$
the following: Gastric acid adj5 secretion
randomized controlled trial Stomach acid adj5 secretion$
Randomized controlled trials Abdominal adj5 distension
Random Allocation Stomach adj5 distension
Double-Blind Method Postprandial adj5 fullness
Single-Blind Method Gastritis
clinical trial Atrophic gastritis
exp Clinical trials Chronic gastritis
(clin$ adj3 trial$) Erosive gastritis
((singl$ or doubl$ or treb$ or trip$) adj3 (blind$ or mask$)) behaviour therapy
Placebos behaviou$ adj5 therapy
placebo$
Psychological interventions for non-ulcer dyspepsia 3
Copyright ©2004 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd
behav$ adj therap$
psychotherapy
psychotherap$
psychoanalytic therapy
psychoanalytic adj5 therapy
psychotherapeutic processes
psychotherapeutic adj5 process$
group therapy
family therapy
psychodrama
cognitive therapy
relaxation training
hypnosis
hypno$
METHODS OF THE REVIEW
Selection Of Studies
One reviewer excluded papers from the initial searches unrelated
to dyspepsia based on the title or abstract if available. A second
reviewer independently checked a sample of this selection process.
The decision to include a study was made independently by
two reviewers according to the pre-stated eligibility criteria, and
recorded on a specially developed form. Disagreements were
reviewed, and a third reviewer consulted if they could not be
resolved.
Assessment of Study Quality
Trials meeting the eligibility criteria were assessed for quality
according to four characteristics:
Generation of the allocation schedule
(truly random, quasi-random, systematic, not stated/unclear)
Computer generated random numbers, coin toss, shuffles, etc
were defined as truly random, allocation according to birth-date,
patient number, etc were defined as quasi-random, whilst alternate
allocation and deterministic methods were classified as systematic.
Concealment of the treatment allocation
(adequate, inadequate, unclear)
If trialists were unaware of each participants allocation when
they were recruited the allocation was said to be adequately
concealed. Methods such as central randomisation systems or
serially numbered opaque envelopes fit this criteria. If the trialist
could have been aware of allocations at recruitment, as when the
participants birth-date or patient number is used for allocation,
the allocation was defined as inadequate.
Implementation of masking
When a placebo is used it is assumed that the participants were
masked to their treatment allocation.
Completeness of follow-up and intention to treat analysis
Drop-outs and missing data rates by group
Study quality was assessed by one reviewer and checked by a
second.
Data Extraction
Psychological interventions for non-ulcer dyspepsia
Copyright ©2004 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd
Data was extracted and recorded onto specially developed forms.
Extraction was undertaken by one reviewer and checked by a
second. Data entry into RevMan was also double-checked.
The following characteristics were recorded for each trial:
(a) details of the participants including demographic characteristics,
source of recruitment, criteria for diagnosis, and dyspeptic
symptoms on presentation. Trials were categorised according to the
most prevalent type of dyspepsia, whether ulcer-like, dysmotility-
like, reflux-like or non-specific, if possible.
(b) details of the experimental and control interventions including
intervention type where appropriate.
(c) the prevalence of individual dyspeptic symptoms before and
after the intervention, dyspeptic symptom scores and global
assessments of dyspeptic symptoms. 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 was also noted.
Data was extracted from intention to treat analyses if they were
presented.
Data Synthesis
Meta-analysis was not possible as the data were too heterogeneous
to synthesis in a single outcome measure as all trials identified used
different interventions and in four eligible papers the data could
not be extracted to provide a summary effect size.
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; Hamilton 2000; Haug 1994]. The other four studies were
excluded as one study investigating 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 B] , the
third study and fourth study considered IBS and NUD patients
together [Arn 1989, Poitras 2002].
METHODOLOGICAL QUALITY
One trial used adequate methods of randomisation and conceal-
ment [Hamilton 2000]. Two trials also made adequate attempts
to mask the patient and the investigator assessing the response
to intervention [Hamilton 2000, Calvert 2002]. The investigator
administering the intervention was not masked but this is not pos-
sible 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
[Haug 1994; Bates 1988].
4
RESULTS
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 [Haug 1994;
Bates 1988; Calvert 2002]. 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 symp-
tom score from baseline [Calvert 2002]. We have therefore simply
qualitatively 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 2-5 patients,
attending 8 sessions over 3 months, with each session lasting 90
minutes. The average number of sessions attended was7.1.
Hamilton et al. used psychodynamic-interpersonal therapy that
aims to identify interpersonal difficulties and ways that these may
be modified [Hamilton 2000]. Patients individually received an
initial three-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 intervention arm but specific elements of psychodynamic-
interpersonal 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
control groups, one received “supportive therapy” and placebo
ranitidine the other did not have any “supportive therapy” but
was given active ranitidine 150mg twice daily.
2. Recruitment
Psychological therapies may not be suitable for all patients as a
proportion 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 of eligible patients that were recruited.
3. Compliance
There appears 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
Psychological interventions for non-ulcer dyspepsia
Copyright ©2004 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd
control groups at the end of treatment that persisted for up to one
year follow-up.
Bates et al. [Bates 1988] randomised 52 patients to group ther-
apy and 51 to a control group. Patients were interviewed at 12
and 52 weeks with a questionnaire that assessed pain intensity,
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 1988Bates 1988]. For
example the mean pain intensity score was 18 in the intervention
group and 22 in the control group, which was reported as statis-
tically 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 that paper reported that patients receiving intervention
showed a statistically significant reduction in epigastric pain score
(mean score in intervention group = 1.9 versus 2.4 in the con-
trol group; p=0.003), nausea score (1.7 versus 1.8; p=0.04) and
bloating score (2.0 versus 2.0; p=0.001) at one year using repeated
measures analysis of variance. Statistically significant effects were
seen even when the mean score was the same in each group due
to differences in baseline values. Again measures of spread of the
data were not provided.
Hamilton et al. [Hamilton 2000] randomised 37 patients to psy-
chodynamic psychotherapy and 36 patients to “supportive ther-
apy”. Patients rated individual dyspepsia symptoms on a self com-
pleted questionnaire and they were also assessed by a gastroen-
terologist. The specialist rated intervention patients as statistically
significantly less dyspepsia than control (mean = 6.8±5.1 (SD)
versus 10.1±3.2; p =0.005) at the end of 12 weeks therapy. 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 was not statistically significant (see Forrest plots 1 and 2) even
when heartburn patients were excluded and the statistical signifi-
cance was achieved by adjusting for differences at baseline.
Calvert et al. [Calvert 2002] randomised 32 patients to hypnother-
apy, 48 to supportive therapy and 46 to ranitidine 150 mg bd.
Symptoms were assessed by an adaptation of an IBS questionnaire
using visual analogue scales. 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 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
psychological profile
5
One trail 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 [Hamil-
ton 2000]. One trial [Calvert 2002] assessed quality of life and
found that the hypnotherapy group had a statistically significant
improvement in quality of life compared to medical therapy but
not the supportive group. The authors attributed the lack of sta-
tistical significance to five patients in the supportive therapy arm
receiving anti-depressants.
DISCUSSION
This review has revealed a paucity of randomised-controlled trials
in psychological intervention for NUD. We identified only four
trials each using different psychological interventions and three
presenting results in a manner, that did not allow synthesis of the
data. We therefore could only provide a qualitative description of
the results. All trials suggest that psychological therapies benefit
dyspepsia symptoms and this effect persists for one year.
These data suggest the psychotherapeutic techniques benefit NUD
but this should be interpreted with caution. All trials use statistical
techniques that adjusted for baseline differences between groups.
This should not be necessary for a randomised trial that is ad-
equately powered suggesting that the sample size of these papers
was too small. Unadjusted data was not statistically significant (see
Forest plots). Furthermore these are parametric statistical tests and
make some 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 pyschotherapy
[Guthrie 1991], and hypnotherapy [Whorwell 1984; Vidakovic-
Vukic 1999] in irritable bowel syndrome patients.
Psychotherapy techniques are time consuming for the patient and
health care 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 trails. In those with severe
dyspepsia symptoms health care costs can be considerable [Mason
2002] and even an expensive intervention may be an appropriate
use of resources. Indeed psychotherapy and hypnotherapy have
been shown to reduce health care costs in functional gastroin-
testinal disorders [Calvert 2002.; Creed 2003]. Nevertheless it is
important to establish the least time consuming psychotherapy
technique that is effective in NUD. Group therapy is more effi-
cient from a health care perspective but the high drop-out rate in
the trial [Bates 1988] evaluating this technique suggests it may not
Psychological interventions for non-ulcer dyspepsia
Copyright ©2004 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd
meet with patient satisfaction. Patients can be trained to induce
self-hypnosis with the aid of an audiotape [Palsson 2002] and this
warrants further evaluation in NUD.
REVIEWERS’ CONCLUSIONS
Implications for practice
There is currently insufficient evidence from this review to con-
firm the efficacy of psychological intervention in NUD. There is
also no evidence on the combined effects of pharmacological and
psychological therapy. Nevertheless, if there are any benefits of psy-
chological therapies, they are likely to persist long-term and NUD
is a chronic relapsing and remitting disorder. Psychological ther-
apies may therefore be offered to patients with severe symptoms
that have not responded to pharmacological therapies.
Implications for research
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. It would also be very impor-
tant for the future studies to assess the improvement both in terms
of the dyspepsia symptom scores using standard validated ques-
tionnaire and also the asssess 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 relapsing disorder.
ACKNOWLEDGEMENTS
We would like to thank Dr. Cathy Bennett, Julie Rayworth, Janet
Lilleyman, Iris Gordon and Gemma Sutherington for their help.
POTENTIAL CONFLICT OF
INTEREST
None known.
SOURCES OF SUPPORT
External sources of support
• UK NHS Health Technology Assessment Programme UK
Internal sources of support
• No sources of support supplied
6
 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):155–165.
Calvert 2002 {published data only}
Calvert EL, Houghton LA, Cooper P, Morris J, Whorwell
PJ. Long-term improvement in functional dyspepsia using
hypnotherapy. Gastroenterology 2002;123:1778–1785.
Hamilton 2000 {published data only}
Hamilton J, Guthrie E, Creed F, Thompson D, Tomenson
B, Bennett R, Moriarty K, Stephens W, Liston R. A ran-
domized controlled trial of psychotherapy in patients with
chronic functional dyspepsia. Gastroenterology 2000;119(3):
661–669.
Haug 1994 {published data only}
Haug TT, Wilhelmsen I, Svebak S, Berstad A, Ursin H. Psy-
chotherapy in functional dyspepsia. Journal of Psychosomatic
Research 1994;38(7):735–744.
References to studies excluded from this review
Arn 1989
Arn I, Theorell T, Uvnas-Moberg K, Jonsson C-O. Psy-
chodrama group therapy for patients with functional gas-
trointestinal disorders - a controlled long-term follow-up
study. Psychotherapy and psychosomatics 1989;51:113–119.
Jiang B
Jiang B, Lin J, Zhang Y. Clinical observation on the mental
symptoms of functional dyspepsia and its treatment. Chung
Kuo Chung Hsi I Chieh Ho Tsa Chih 2000;20:424–426.
Mine 1998
Mine K, Kanazawa F, Hosoi M, Kinukawa N, Kubo C. Treat-
ing nonulcer dyspepsia considering both functional disorders
of the digestive system and psychiatric conditions. Digestive
Diseases and Sciences 1998;43(6):1241–1247.
Poitras 2002
Poitras MR, Verrier P, So C, Paquet S, Bouin M, Poitras P.
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∗
Indicates the major publication for the study

TABLES

Characteristics of included studies

Study 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 patients
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.

Allocation concealment B

Study 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 bd.

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 “supportive 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, 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 medical therapy group (median score = 2.9, interquartile range = 1.4 to 3.7).

Notes

Allocation concealment A

Study Hamilton 2000

Methods RCT.
Randomisation and allocation concealment described. Patients and investigator masked.
Psychological interventions for non-ulcer dyspepsia 9
Copyright ©2004 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd
Characteristics of included studies (Continued )
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 intervention
arm
Outcomes Significant reduction in dyspepsia score at 12 weeks in the intervention arm after controlling for baseline
scores using ANOVA. No significant difference at one year.

Notes

Allocation concealment A

Study 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, diarrhoea
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 dyspeptic
symptoms.

Allocation concealment B

Characteristics of excluded studies

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 B This study investigated a combination of psychotherapy with traditional Chinese medicine in patients with
functional dyspepsia

Mine 1998 Randomised only one group of their seriously ill NUD patients, and investigated the effectiveness of a combi-
nation of therapies, which included psychotherapy and psycho-tropic drugs.

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

SUMMARY TABLES

Psychological interventions for non-ulcer dyspepsia 10

Copyright ©2004 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd
00 Psychotherapy
Outcome title No. of studies No. of participants Statistical method Effect size
12 week data 1 68 Weighted Mean Difference (Fixed) 95% CI -1.50 [-4.33, 1.33]
52 week data 1 58 Weighted Mean Difference (Fixed) 95% CI -0.60 [-3.70, 2.50]
COVER SHEET
Title Psychological interventions for non-ulcer dyspepsia
Reviewers Soo S, Moayyedi P, Deeks J, Delaney B, Lewis M, Forman D
Contribution of reviewer(s) Information not supplied by reviewer
Issue protocol first published /
Review first published /
Date of most recent amendment 26 November 2003
Date of most recent 25 September 2003
SUBSTANTIVE amendment
Most recent changes 3 new trials identified and only one trial is eligible and included in the review. The conclusion
of the review however remain unchanged
Date new studies sought but Information not supplied by reviewer
none found

Date new studies found but not Information not supplied by reviewer
yet included/excluded

Date new studies found and 23 September 2003

included/excluded

Date reviewers’ conclusions 23 September 2003

section amended
Contact address Dr Soo Shelly
Gastroenterology Dept
South Tyneside District Hospital
Harton Lane
South Shields
NE34 0PL
UK
Cochrane Library number CD002301
Editorial group Cochrane Upper Gastrointestinal and Pancreatic Diseases Group
Editorial group code HM-UPPERGI

Psychological interventions for non-ulcer dyspepsia 11

Copyright ©2004 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd
 GRAPHS AND OTHER TABLES

Fig. 00 Psychotherapy
01.12 week data
Review: Psychological interventions for non-ulcer dyspepsia
Comparison: 01 Psychotherapy
Outcome: 01 12 week data

Study Treatment Control Weighted Mean Difference (Fixed) Weight Weighted Mean Difference (Fixed)
N Mean(SD) N Mean(SD) 95% CI (%) 95% CI

Hamilton 2000 37 10.90 (6.40) 31 12.40 (5.50) 100.0 -1.50 [ -4.33, 1.33 ]

Total 37 31 100.0 -1.50 [ -4.33, 1.33 ]

Test for heterogenity: not applicable
Test for overall effect z=1.04 p=0.3

-10.0 -5.0 0 5.0 10.0

Favours treatment Favours control

01.52 week data

Review: Psychological interventions for non-ulcer dyspepsia
Comparison: 01 Psychotherapy
Outcome: 02 52 week data

Study Treatment Control Weighted Mean Difference (Fixed) Weight Weighted Mean Difference (Fixed)
N Mean(SD) N Mean(SD) 95% CI (%) 95% CI

Hamilton 2000 31 8.70 (5.80) 27 9.30 (6.20) 100.0 -0.60 [ -3.70, 2.50 ]

Total 31 27 100.0 -0.60 [ -3.70, 2.50 ]

Test for heterogenity: not applicable
Test for overall effect z=0.38 p=0.7

-10.0 -5.0 0 5.0 10.0

Favours treatment Favours control

Psychological interventions for non-ulcer dyspepsia 12

Copyright ©2004 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd