© 2006 The Royal College of Psychiatrists
REVIEW ARTICLE |
Psychotherapy plus antidepressant for panic disorder with or without agoraphobia
Systematic review
Department of Psychiatry and Cognitive–Behavioural Medicine, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
Cochrane Collaboration Depression, Anxiety and Neurosis Review Group, Health Services Research Department, Institute of Psychiatry, London, UK
Correspondence: Professor Toshi A. Furukawa, Department of Psychiatry and Cognitive–Behavioural Medicine, Nagoya City University Graduate School of Medical Sciences, Nagoya City University Medical School, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Tel: +81 52 853 8271; fax: +81 52 852 0837; e-mail: furukawa{at}med.nagoya-cu.ac.jp
Declaration of interest T.A.F. has received research grants and fees for speaking from several pharmaceutical companies. These companies did not provide funding for the current study (see Acknowledgements).
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Background Panic disorder can be treated with psychotherapy, pharmacotherapy or a combination of both.
Aims To summarise the evidence concerning the short- and long-term benefits and adverse effects of a combination of psychotherapy and antidepressanttreatment.
Method Meta-analyses and meta-regressions were undertaken using data from all relevant randomised controlled trials identified by a comprehensive literature search. The primary outcome was relative risk (RR) of response.
Results We identified 23 randomised comparisons (21 trials involving a total of 1709 patients). In the acute-phase treatment, the combined therapy was superior to antidepressant pharmacotherapy (RR=1.24,95% CI1.02–1.52) or psychotherapy (RR=1.16,95% CI1.03–1.30). After termination of the acute-phase treatment, the combined therapy was more effective than pharmacotherapy alone (RR=1.61,95% CI1.23–2.11) and was as effective as psychotherapy (RR=0.96, 95% CI 0.79–1.16).
Conclusions Either combined therapy or psychotherapy alone may be chosen as first-line treatment for panic disorder with or without agoraphobia, depending on the patient’s preferences.
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Two categories of treatment have been shown to be effective in treating panic disorder with or without agoraphobia. One is psychotherapy and the other is pharmacotherapy using antidepressants and benzodiazepines (American Psychiatric Association, 1998; Nathan & Gorman, 2002). However, it is uncertain whether combining these two forms of treatment confers any additional benefit over and above either treatment alone, both in the short term and in the long term. The primary objective of this systematic review was therefore to review and synthesise evidence from randomised controlled trials that examined the short- and long-term benefits and adverse effects of a combination of psychotherapy and antidepressants compared with either therapy alone for the treatment of panic disorder. A separate review that focuses on the use of psychotherapy in combination with benzodiazepines is in preparation.
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Inclusion criteria
Randomised controlled trials that compared a combination of psychotherapy and antidepressant pharmacotherapy with either treatment alone for adult patients with panic disorder, with or without agoraphobia, were eligible for inclusion.
We included both individual and group formats of behaviour therapy involving some kind of exposure, cognitive therapy involving some kind of cognitive restructuring, cognitive–behavioural therapy involving elements of both cognitive and behavioural therapy, and other psychological approaches. All commonly prescribed antidepressants were eligible, including tricyclic antidepressants (TCAs) and selective serotonin reuptake inhibitors (SSRIs).
Studies in which there was irregular use of benzodiazepines or in which benzodiazepines were regularly administered at a constant dosage for long-term users were included, because it was considered that these did not undermine the comparability of the combined therapy with either monotherapy, and because such practices would reflect clinical reality more closely. The effect of this decision was examined in a sensitivity analysis. Studies in which benzodiazepines were combined with antidepressants as part of the study medication were excluded.
Identification of trials
We searched the Cochrane Collaboration Depression, Anxiety and Neurosis
Controlled Trials Register (CCDANCTR) with the keywords ANTIDEPRESSANT and
PANIC up to April 2003. The CCDANCTR is a study-based register of randomised
trials that incorporates the results of group searches of Medline (from 1966),
EMBASE (from 1980), CINAHL (from 1982), PsycINFO (from 1974), PSYNDEX (from
1977) and LILACS (from 1982 to 1999), and hand searches of major psychiatric
and medical journals, conference proceedings and trial registers. Two
additional searches of the Cochrane Central Register of Controlled Trials
(CENTRAL) and Medline were also undertaken. No language restrictions were
imposed on the search.
Two reviewers examined the titles and abstracts of studies identified by the electronic search, and then checked the full articles for eligibility. To identify further trials, the references cited in these studies and in other review papers were also checked, relevant studies were subjected to SciSearch, and experts in the field were contacted.
Quality assessment and data extraction
Two independent reviewers assessed the methodological quality of the
selected studies according to the recommendations of the Cochrane
Reviewers’ Handbook 4.2.2
(Alderson et al,
2004), which emphasises allocation concealment (A, low risk of
bias; B, moderate risk of bias; C, high risk of bias). We also rated the study
as ‘blinded’ when at least one outcome measure was assessed by an
independent assessor who was masked to treatment allocation, and
‘unblinded’ when the outcomes were assessed by someone who was
aware of the allocated treatment.
In addition, we rated the adequacy of the psychotherapy as ‘good’ when the way in which psychotherapy was actually conducted was examined by a third reviewer by means of audiotapes, etc., and as ‘poor’ when the authors only provided a description of the therapy procedure.
Two reviewers independently extracted data from the original reports using standardised data-extraction forms. Our primary outcome was ‘response’ – that is, substantial improvement from baseline, such as ‘very much or much improved’ according to the Clinical Global Impression scale (CGI; Guy, 1976), a decrease of more than 40% in the Panic Disorder Severity Scale score (Shear et al, 1997), and a reduction of more than 50% in panic frequency or the Fear Questionnaire – Agoraphobia sub-scale (Marks & Mathews, 1979). Our secondary outcomes included global severity, frequency of panic attacks, phobic avoidance, general anxiety, depression, social dysfunction, patient satisfaction and cost-effectiveness. The total number of drop-outs for any reason was regarded as a proxy measure of the acceptability of treatment. Adverse effects were evaluated by examining the number of drop-outs due to adverse effects.
Any discrepancies were resolved by consensus between two or, where necessary, between all three reviewers. The decision to include in the meta-analysis studies that did not appropriately conceal allocation, that were ‘unblinded’ or that scored ‘poor’ with regard to adequacy of psychotherapy was examined in sensitivity analyses.
Data synthesis
Data were entered into Review Manager 4.2 (Windows software provided by the
Cochrane Collaboration and available at
http://www.cc-ims.net/RevMan)
and double-checked for accuracy. For dichotomous outcomes, relative risk (RR)
and 95% confidence intervals were calculated using a random-effects model,
which yields superior results in terms of clinical interpretability and
external generalisability compared with fixed-effects models and odds ratios
or risk differences (Furukawa et
al, 2002). For continuous outcomes, the standardised weighted
mean difference (SMD) and 95% confidence intervals were calculated using a
random-effects model.
For dichotomous outcomes, we used intention-to-treat analyses according to the following principle. When data on drop-outs were carried forward and included in the efficacy evaluation using the last-observation-carried-forward method, they were included as such. When drop-outs were excluded from any assessment in the primary studies (e.g. those who never returned for assessment after randomisation), they were considered to be non-responders in both active and comparison groups. The same principles were applied to outcomes after the end of continuation treatment.
Subgroup and sensitivity analyses
To investigate clinical heterogeneity, we planned three a priori
subgroup analyses: for types of psychotherapies; for classes of
antidepressants; and for patients with or without agoraphobia. Statistical
heterogeneity between studies was assessed with the I-squared
statistic and the Q statistic. If significant heterogeneity was noted
(I2>30% or P<0.10)
(Higgins et al,
2003), sources were investigated.
In addition, sensitivity analyses were performed, restricting the data syntheses to studies of higher quality in terms of allocation concealment, blinding, operational diagnosis, adequacy of psychotherapy and control of benzodiazepine co-intervention. Meta-regressions (Thompson & Sharp, 1999) were also performed to determine whether these variables had a significant effect on the pooled effect sizes.
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Description of studies
The electronic search identified 139 studies from CCDANCTR, an additional 164 studies from CENTRAL and 35 studies from Medline. By browsing their titles and abstracts, the two independent reviewers identified 135 articles as possible candidates, and full copies of these articles were obtained. Two independent reviewers then examined the strict eligibility of these papers. As a result of a further reference search, SciSearch and personal contacts, we identified 21 studies which satisfied the strict eligibility criteria. The interrater reliability of the eligibility criteria was found to be 94%. Because two trials provided two comparisons each (Sheehan et al, 1980; Mavissakalian & Michelson, 1986), there were 23 randomised comparisons involving a total of 1709 participants (Table 1) (a more detailed version of Table 1 is presented as a data supplement to the online version of this paper).
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View this table: [in a new window] | Table 1 Characteristics of the studies included in the review |
The majority of the participants were women, and their average age was between 30 and 40 years. They had suffered from panic disorder for 5 to 10 years. Only one comparison focused on patients with panic disorder without agoraphobia, whereas 13 comparisons focused on patients with panic disorder with agoraphobia. The other studies were of mixed populations.
The typical length of the acute-phase active treatment was between 8 and 12 weeks. In total, 12 studies administered behaviour therapy that consisted of exposure and/or breathing retraining and/or relaxation exercises. None of the studies used narrowly defined cognitive therapy that relied only on cognitive restructuring. Nine studies administered cognitive–behavioural therapy that consisted of both behaviour and cognitive therapy elements. Two studies were categorised as ‘Other psychotherapies’. One of these used a mixture of cognitive–behavioural therapy and interpersonal psychotherapy (Berger et al, 2004) and the other used brief psychodynamic psychotherapy (Wiborg & Dahl, 1996). With regard to medications that were administered, 14 studies used TCAs (with an average dose of 146 mg/day of imipramine equivalents), 7 studies used SSRIs (average dose 32 mg/day fluoxetine equivalents) and 2 studies used monoamine oxidase inhibitors.
Response was defined in terms of the CGI scale in eight studies, in terms of the Fear Questionnaire Agoraphobia sub-scale in three studies, in terms of panic frequency in two studies, and in terms of other measures in 10 studies. In total, 13 studies reported continuous outcomes of global severity, 15 reported on panic frequency, 20 reported on agoraphobia, 18 reported on general anxiety, 18 reported on depression and 13 reported on social dysfunction. None of the studies reported on patient satisfaction or cost issues.
Six studies reported the results at the end of continuation treatment which lasted for between 3 and 9 months. Nine studies followed up the patients 6–24 months after termination of acute-phase and continuation treatments.
With regard to validity, all but four comparisons from three trials (Mavissakalian & Michelson, 1986; Wiborg & Dahl, 1996; Berger et al, 2004) scored B for allocation concealment. In total, 19 studies conducted blinded outcome assessments and four studies were unblinded (Mavissakalian et al, 1983; Spinhoven et al, 1996; Azhar, 2000; Berger et al, 2004). The interrater reliability of these two validity criteria was 94% for allocation concealment and 83% for outcome assessment.
Six studies reported that quality control of the psychotherapy was adequate (Zitrin et al, 1983; de Beurs et al, 1995; Fava et al, 1997; Loerch et al, 1999; Barlow et al, 2000; Kampman et al, 2002). Four studies acknowledged financial support from pharmaceutical companies (Fahy et al, 1992; de Beurs et al, 1995; Sharp et al, 1996; Loerch et al, 1999), and these companies marketed the drugs involved in the trials. Oehrberg et al (1995) did not acknowledge financial support from a drug company, but three of the co-authors of that study were company employees.
Psychotherapy plus antidepressant v. antidepressant treatment
Acute-phase treatment
Combining data from 11 studies involving 322 patients in the psychotherapy
plus antidepressant arm and 347 patients in the antidepressant arm showed that
the combination was 1.24 times (95% CI 1.02–1.52) more likely to produce
a response at the end of 2–4 months of acute-phase treatment compared
with the antidepressant alone (Fig.
1). There was moderate but statistically significant heterogeneity
(P= 0.05, I2=44.9%). Furthermore, the funnel plot
indicated that there was some publication bias, with one small study reporting
an extreme result (Telch et al,
1985). Subgroup analyses suggested that there was greater
heterogeneity in the ‘other psychotherapies’ category
(Wiborg & Dahl, 1996;
Berger et al, 2004).
When we omitted these studies, limiting the included studies to those that
employed behavioural or cognitive–behavioural therapies, the RR remained
the same (RR=1.28, 95% CI 1.08–1.52) and there was no longer statistical
heterogeneity (P=0.18, I2=30.5%) or funnel-plot
asymmetry.
 View larger version (33K): [in a new window] [as a PowerPoint slide] |
Fig. 1 Psychotherapy plus antidepressant v. antidepressant alone:
response at the end of acute-phase treatment. PT, psychotherapy; AD,
antidepressant; RR, relative risk.
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 View larger version (25K): [in a new window] [as a PowerPoint slide] |
Fig. 2 Psychotherapy plus antidepressant v. antidepressant alone:
response after termination of treatment. PT, psychotherapy; AD,
antidepressant; RR, relative risk.
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There were no differences in overall drop-outs or in drop-outs due to side-effects.
Continuation treatment
There was considerable statistical heterogeneity (P=0.005,
I2=76.8%). Limiting the studies to behaviour and
cognitive–behavioural therapies removed this heterogeneity
(P=0.55, I2=0%) and suggested that the
combination therapy was 1.63 (95% CI 1.21–2.19) times more likely to
produce a response than antidepressant treatment alone.
After termination of treatment
Figure 2 shows the findings
of five studies that reported outcomes after 6–24 months of naturalistic
follow-up. Combining outcomes based on 376 participants, the combination
therapy was still superior to antidepressant treatment alone (RR=1.61, 95% CI
1.23–2.11). No heterogeneity was noted (P=0.50,
I2=0%).
Psychotherapy plus antidepressant v. psychotherapy
Although the comparison of psychotherapy plus antidepressant with
psychotherapy alone is theoretically different from the comparison of
psychotherapy plus antidepressant with psychotherapy plus placebo
(Hollon & DeRubeis, 1981),
our meta-analytical summaries were remarkably similar for the acute phase and
follow-up evaluations. We therefore report here the aggregated results of
trials comparing psychotherapy plus antidepressant with psychotherapy alone
and psychotherapy plus placebo.
Acute-phase treatment
Combining data from 19 comparisons involving 592 patients in the
psychotherapy plus antidepressant arm and 665 patients in the psychotherapy
arm demonstrated that the combination was 1.16 times (95% CI 1.03–1.30)
more likely to produce a response at the end of acute-phase treatment than
psychotherapy alone (Fig. 3).
The test for heterogeneity was not significant.
 View larger version (39K): [in a new window] [as a PowerPoint slide] |
Fig. 3 Psychotherapy plus antidepressant v. psychotherapy alone: response
at the end of acute-phase treatment. PT, psychotherapy; AD; antidepressant;
RR, relative risk. 1. Comparison A of two from this study; 2. comparison B of
two from this study.
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Although the two arms did not differ in terms of overall drop-out rates, drop-outs due to side-effects were much more frequent in the combined therapy arm (RR=3.01, 95% CI 1.61–5.63).
 View larger version (28K): [in a new window] [as a PowerPoint slide] |
Fig. 4 Psychotherapy plus antidepressant v. psychotherapy alone: response
after termination of treatment. PT, psychotherapy; AD, antidepressant; RR,
relative risk. 1. Comparison A of two from this study; 2. comparision B of two
from this study.
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For as long as the treatments were continued, the advantage of the combination therapy appeared to persist, as the response rate at the end of continuation treatment still favoured the combination therapy (RR=1.23, 95% CI 1.00–1.51), and the global severity was significantly lower in the combination arm (SMD=–0.65, 95% CI –0.97 to –0.33).
After termination of treatment
In total, 658 patients from nine studies were assessed 6 to 24 months after
discontinuing treatment (Fig.
4). Neither the response rate nor the global severity measure
differed significantly between the two arms, which suggests that any advantage
of the combination therapy disappeared over time.
Subgroup and sensitivity analyses
Types of psychotherapy
For all the outcomes during the acute-phase or continuation treatments or
after termination of treatment, the confidence intervals of the pooled
estimates of the effectiveness of behaviour therapy and
cognitive–behavioural therapy overlapped to a significant degree (Figs
1,
2,
3,
4). Pooling these two types of
psychotherapy together seldom resulted in significant heterogeneity. The only
exception was the ‘other psychotherapies’ category for the
comparison of psychotherapy plus antidepressant with antidepressant treatment
alone. The results of these studies were sometimes directionally different
from those of the other studies in which behavioural or
cognitive–behavioural therapies were administered, and combining them
often resulted in significant heterogeneity.
Classes of antidepressants
We performed a meta-analysis of 14 studies in which TCAs were used and 7
studies in which SSRIs were used. The pooled estimates of the effect size of
these two meta-analyses were very similar both to each other and to the
overall results in terms of response or global severity
(Table 2).
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View this table: [in a new window] | Table 2 Subgroup analyses for different classes of antidepressants and for patients with and without agoraphobia |
Patients with and without agoraphobia
We performed a meta-analysis of 13 studies that focused on patients with
agoraphobia only. The results were very similar to the overall results, and
overlapped substantially with the results of the only study that focused on
patients without agoraphobia (Barlow et
al, 2000) (Table
2).
When only those studies that were of higher quality in terms of allocation concealment, blinding, diagnostic accuracy, adequacy of psychotherapy or control of benzodiazepine co-intervention were included, the pooled estimates that were obtained were virtually identical to the overall results. Meta-regression analysis did not reveal any significant contribution of these quality variables, either individually or in combination, which suggests that the overall findings are robust.
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Importance of the clinical problem in the context of previous reviews
There are a number of reasons why the clinical question concerning combined psychotherapy and antidepressant treatment is important. First, combination therapy is frequently provided in clinical practice, possibly because 30–50% of patients remain unimproved at the end of acute-phase treatment by either monotherapy. Second, it is now increasingly recognised that pharmacotherapy alone tends to result in substantial relapse rates not only when discontinued (Mavissakalian & Perel, 2002), but even when maintained at adequate dosage (Simon et al, 2002), whereas psychotherapy is associated with fewer relapses in the short term, but may not always be able to prevent them in the long term (Fava et al, 2001).
Several reviews of combination therapy can be found in the literature, but their conclusions have been variable, with some favouring the combination (Mattick et al, 1990; van Balkom et al, 1997), some favouring monotherapy (Gould et al, 1995; Taylor, 2000) and others drawing mixed or cautious conclusions (American Psychiatric Association, 1998; Schmidt et al, 2001). Most of these reviews have been either unsystematic or narrative only (American Psychiatric Association, 1998; Taylor, 2000; Schmidt et al, 2001) and, where meta-analytical summary was undertaken, this did not focus on head-to-head comparisons (Mattick et al, 1990; Gould et al, 1995; van Balkom et al, 1997), a practice that is known to be misleading (Song et al, 2003).
Current findings
This systematic review demonstrated that combining psychotherapy and
antidepressant treatment produced outcomes that were consistently superior to
either treatment alone for the acute-phase treatment, in terms of both the
response rates and the continuous outcomes measuring various aspects of the
disorder. Taking the average response rates of 50–70% for
single-modality treatments, the pooled RR of 1.2 for the combination therapy
is equivalent to a value for the number needed to treat of between 7 and 10.
During the acute-phase treatment, combination therapy resulted in more
drop-outs due to side-effects than psychotherapy alone, and the number needed
to harm was around 26.
The naturalistic follow-up of the randomised controlled trials that were included suggested that the combination therapy had a sustained advantage over antidepressant therapy. At 6–24 months after termination of treatment, the combined therapy still showed a number needed to treat of around 6 compared with antidepressant treatment alone. With regard to the comparison between the combination therapy and psychotherapy, there was no evidence of long-term benefit of the former compared with the latter. In this respect, it is interesting to note that, despite recent admonitions from several experts (Taylor, 2000; Schmidt et al, 2001; Foa et al, 2002), the combination therapy was found to have no disadvantage in the long term.
Strengths and limitations
This systematic review has several major strengths. First, we performed
systematic and comprehensive searches for relevant trials. We identified 23
randomised comparisons from 21 studies, whereas previous reviews included a
maximum of 13 studies. Second, we applied the intention-to-treat principle
when performing meta-analysis of dichotomous outcomes by counting all of the
drop-outs as non-responders. This policy is especially pertinent in the
context of the relative merits of the combination therapy over monotherapy in
the long term, because we are interested in the number of patients doing well
as a proportion of all those who started the acute-phase therapy, not just
those who successfully completed it. Finally, the a priori planned
heterogeneity and sensitivity analyses indicated that the results of the
analyses were quite robust.
However, several potential limitations of this study must be acknowledged. First, the comparability of the treatment arms after termination of acute-phase and continuation treatments may be compromised by the naturalistic nature of the follow-up. Participants were usually free to seek further treatment between the termination of treatment and the follow-up assessments, and 30–77% of them received additional therapies. Unfortunately, inadequate reporting of additional therapies precluded further examination of this issue across studies. If the published studies had reported the number of patients who did well without further treatment, the interpretation of the relative merits of the combination therapy v. monotherapies would have been more straightforward. Second, funnel-plot analyses suggested the possibility of publication bias. However, the exclusion of outliers did not affect the pooled estimates. Third, we must point out that until recently there have been no widely accepted and validated rating scales for panic disorder, and that some of the studies that were included used the authors’ original scales. One study indicated that rating scales which have not been validated or standardised are more likely to report statistically significant findings (Marshall et al, 2000). Fourth, owing to this lack of accepted assessment methods for panic disorder, the definition of response (our primary outcome) had to be operationalised by a variety of measures. However, these overall results were corroborated by analyses that focused on specific aspects of the symptoms of panic disorder.
It must be noted that our review does not address the relative merits of combination therapy compared with sequential treatments. Given the present findings, some might argue for psychotherapy alone as first-line treatment, only considering combination therapy if psychotherapy fails. Although this appears to be a viable option, such a practice cannot be informed by the data available from these trials.
Clinical implications and future research
The current findings from the best available evidence suggest that either
combined therapy or psychotherapy alone may be chosen as first-line treatment
for panic disorder with or without agoraphobia. Treatment decisions may depend
on the patient’s preferences and values. Antidepressant pharmacotherapy
alone is not to be recommended as first-line treatment where appropriate
resources are available. Although none of the studies included in this review
examined cost issues, economic consideration of the costs of years of
medication compared with ‘one-off’ psychological treatment would
also favour the use of psychotherapy (Otto
et al, 2000).
Several issues warrant further investigation. First, in the acute-phase treatment, if we adhere to the strict intention-to-treat principle, the response rates are only slightly above 50% for combination therapy and slightly below 50% for psychotherapy alone. Therefore additional strategies may be required to deal with partial and nonresponders to these therapies. Second, there are currently only limited data available on the effects of combining antidepressants with non-cognitive–behavioural therapies, such as psychodynamic and interpersonal therapies. In this review, the only available trial that involved psychodynamic therapy showed increased benefit when combined with antidepressants. This suggests the potential value of future trials designed to investigate this type of combination in the treatment of panic disorder.
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CLINICAL IMPLICATIONS
- Combined psychotherapy plus antidepressant therapy is more effective than
either therapy alone for the acute-phase treatment of panic disorder with or
without agoraphobia (number needed to treat 7–10). Combined therapy
produces more drop-outs due to side-effects than psychotherapy alone (number
needed to harm around 26).
- Combined therapy is as effective as psychotherapy and more effective than
antidepressant pharmacotherapy after discontinuation of the acute-phase
treatment (number needed to treat around 6).
- The evidence was most consistent for behavioural therapy and
cognitive–behavioural therapy.
LIMITATIONS
- The comparability of the treatment arms after termination of the
acute-phase and continuation treatments may be compromised by the naturalistic
nature and inadequate reporting of the follow-up.
- Older studies did not use standardised assessment measures.
- This systematic review cannot address the relative merits of combination
v. sequential treatments by psychotherapy and pharmacotherapy
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This systematic review was conducted within the framework of the Cochrane Collaboration Depression, Anxiety and Neurosis Group, and we acknowledge their help and support. It was supported in part by a Health and Labour Sciences Research Grant (Research on Health and Technology Assessment) H13-018 from the Ministry of Health, Labour and Welfare, Japan.
T.A.F. has received research grants and/or fees for speaking from: Asahi Kasei, Astellas, Dai-Nippon, Eisai, Eli Lilly, GlaxoSmithKline, Janssen, Kyowa Hakko, Meiji, Organon, Tsumura and Yashitomi.
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