Department of Psychological Medicine, Institute of Psychiatry, London, and Istituto di Ricerche Farmacologiche "Mario Negri" Milan, and Dipartimento di Medicina e Sanità Pubblica, Sezione di Psichiatria, Università di Verona, Italy
Department of Psychological Medicine, Guy's, King's and St Thomas' Schools of Medicine, and Institute of Psychiatry, London
Correspondence: Dr Corrado Barbui, Istituto di Ricerche Farmacologiche "Mario Negri", Via Eritrea 62, 20157 Milano, Italy. Tel: 0039 02 39014 431; fax: 0039 02 33 2000 49; e-mail: barbui{at}marionegri.it
See editorial, pp. 99-100,
this issue.
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ABSTRACT |
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Aims To review the tolerability and efficacy of amitriptyline in the management of depression.
Method A systematic review of randomised controlled trials (RCTs) comparing amitriptyline with other tricyclics/heterocyclics or with an SSRI.
Results We reviewed 186 RCTs. The overall estimate of the efficacy of amitriptyline revealed a standardised mean difference of 0.147 (95% CI 0.05-0.243), significantly favouring amitriptyline. The overall OR for dropping out was 0.99 (95% CI 0.91-1.08) and that for side-effects was 0.62 (95% CI 0.54-0.70), favouring the control drugs. With drop-outs included as treatment failures, the estimate of the effectiveness of amitriptyline v. tricyclics/heterocyclics and SSRIs showed a 2.5% difference in the proportion of responders in favour of amitriptyline (number needed to treat 40, CI 21-694; OR 1.12 (95% CI 1.01-1.24)).
Conclusions Amitriptyline is less well tolerated than tricyclics/heterocyclics and SSRIs, but slightly more patients treated on it recover than on alternative antidepressants.
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INTRODUCTION |
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METHOD |
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Search strategy
Relevant studies were located by searching the Cochrane Collaboration
Depression, Anxiety and Neurosis Controlled Trials Register (CCDANCTR). This
specialised register is regularly updated by electronic (Medline, Embase,
PsycINFO, LILACS, Psyndex, CINAHL, SIGLE) and non-electronic literature
searches. The register was searched using the following terms:
AMITRIPTYLIN* or AMITRIL or ELATROL or
ELAVIL or EMITRIP or ENDEP or ENOVIL or
LAROXYL or LENTIZOL or LEVATE or MEVARIL
or NOVOTRIPTYN or SAROTEN or TRYPTAL or
TRYPTIZOL or TRIPTAFEN*. A specific electronic search was
also performed with Medline and Embase from 1966 to 1998. We used the search
term: AMITRIPTYLINE and RANDOMISED CONTROLLED TRIAL or
RANDOM ALLOCATION or DOUBLE-BLIND METHOD. Reference lists of relevant
papers and previous systematic reviews were hand searched for published
reports and citations of unpublished research. Finally, attempts were made to
obtain data through direct contact with the pharmaceutical industry.
Outcomes
Efficacy was evaluated using the following outcome measures:
Tolerability was evaluated using the following outcome measures:
Data extraction
Using a standard form two reviewers independently extracted information on
the year of publication, concealment of allocation, blindness, length of
treatment, inclusion criteria, age range, country and setting of the study and
type of pharmacological intervention. The number of patients undergoing the
randomisation procedure, the number of patients who failed to complete the
study (drop-outs) and that of patients complaining of side-effects were
recorded. For dichotomous outcomes the number of patients showing a 50%
reduction in score on the HDRS or MADRS scale was extracted; if these figures
were not available, we extracted the number of patients categorised as
much improved and improved on the Clinical Global
Impression scale (CGI; Guy,
1976), or the number of patients in the corresponding categories
of any other rating scale if the CGI was not used. For continuous outcomes the
mean scores at end-point on the HDRS and the number of patients included in
this analysis were recorded. If the HDRS was not employed, we extracted the
mean scores at end-point on the MADRS or on any other rating scale. Mean
scores were recorded with the standard deviation (s.d.) or standard error
(s.e.) of these values. When only the s.e. was reported, it was converted into
s.d. according to Altman & Bland
(1996).
Statistical analysis
Efficacy data were analysed in the following way. Responders to treatment
were calculated on an intention-to-treat (ITT) basis: drop-outs were always
included in this analysis. When data on drop-outs were carried forward and
included in the efficacy evaluation (last observation carried forward, LOCF),
they were analysed according to the primary studies; when drop-outs were
excluded from any assessment in the primary studies they were considered as
drug failures. Scores from continuous outcome scales could not
be analysed on an ITT basis. This approach was not feasible as most studies
performed only an end-point or LOCF analysis, which inevitably excluded most
drop-out patients. Therefore, scores from continuous outcomes were analysed on
an end-point basis, including only patients with a final assessment or with an
LOCF to the final assessment. Tolerability data were analysed by calculating
the proportion of patients who failed to complete the study and who
experienced adverse reactions out of the total number of randomised patients.
For each outcome measure three separate meta-analyses were planned. The first
compared amitriptyline with tricylic/heterocyclic antidepressants, the second
amitriptyline with SSRIs and the third analysis summarised the overall
comparison of amitriptyline with both tricyclic/heterocyclic drugs and
SSRIs.
Dichotomous outcomes were summarised by calculating a Peto-weighted odds
ratio for each study, together with the 95% CI. An overall odds ratio was then
calculated as a summary measure. The number of patients who need to be treated
(NNT) with amitriptyline rather than the control antidepressants for one
additional patient to benefit (NNTB) or be harmed (NNTH) was calculated with
the 95% CI (Altman, 1998).
Heterogeneity of treatment effects between studies was tested using the
2 statistic. Continuous outcomes were analysed by calculating
a standardised weighted mean difference (SMD) for each study. This measure
gives the effect size of an intervention in units of standard deviation so
that scores from different outcome scales can be combined into an overall
estimate of effect. A random effects model, which takes into consideration any
between-study variation, was adopted to combine the effect sizes. Calculations
were performed using the RevMan software provided by the Cochrane
Collaboration (Review Manager,
1999).
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RESULTS |
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Although all trials reported that patients had been randomly allocated, in six cases the concealment of allocation was inadequate with some bias possible. In four studies only physicians, but not patients, were blind to treatments, in nine cases neither physicians nor patients were blind, while the other 173 studies were double-blind. The median sample size was 50 patients (10% percentile 24, 25% percentile 40, 75% percentile 80, 90% percentile 153; range 10-531). The median length of trials was four weeks (25% percentile 4, 50% percentile 4, 75% percentile 6; range 3-12); the number of studies with more than four weeks of follow-up increased from 28 (30%) to 62 (67%) after 1980. In 67 trials (36%) authors adopted diagnostic criteria and a specification of severity of depression to enrol patients; in 55 trials (30%) authors adopted only a specification of severity, while in the remaining 34% of studies patients were enrolled on the basis of physicians' implicit criteria to define patients with depression or because they were judged to require antidepressant therapy. Fifty-nine per cent of studies published before 1980 used implicit criteria v. 9.6% of those published after this date. Overall, 108 trials (60%) used operational criteria for depression. Nearly half of the studies (47%) provided a comprehensive description of patients' side-effects, while 23 (12%) trials gave inadequate details. The outcome assessment was performed with valid and reliable instruments in 70% of the sample; the use of valid instruments in studies published before and after 1980 increased from 51 (55%) to 81 (86%).
Efficacy of amitriptyline
Data extracted from 82 RCTs showed that the proportion of patients who
responded to amitriptyline was 2.4% higher than for control TCA/heterocyclic
antidepressants (NNTB 42, 95% CI NNTH 357 to to NNTB 20) (see
Table 2). This difference
corresponds to an overall odds ratio which favoured amitriptyline (Peto odds
ratio 1.11, 95% CI 0.99-1.25), but with only borderline statistical
significance. The estimate of the efficacy of amitriptyline and control
TCAs/heterocyclic antidepressants on a continuous outcome, performed on 699
and 661 patients respectively, revealed an effect size which also
significantly favoured amitriptyline (SMD=0.177, 95% CI 0.005-0.350).
Head-to-head comparisons indicated that amitriptyline, in comparison with
imipramine, is associated with a greater proportion of responders; in
comparison with dothiepin, however, the proportion of responders was
significantly lower (see Table
2).
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Data from 17 RCTs showed that the proportion of patients who responded to
amitriptyline was 2.8% higher than for SSRIs (NNTB 35, 95% CI NNTH 53 to
to NNTB 13) (see Table
3). This difference corresponded to an overall odds ratio which
favoured amitriptyline (Peto odds ratio 1.14, 95% CI 0.92-1.38), but not
significantly. The estimate of the efficacy of amitriptyline and SSRIs on a
continuous outcome, performed on 1041 and 1061 patients, respectively,
revealed a small effect size which significantly favoured amitriptyline
(SMD=0.106, 95% CI 0.02-0.19). No significant differences emerged from direct
comparisons between amitriptyline and one of the SSRIs (see
Table 3).
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Tolerability of amitriptyline
Data from 125 RCTs showed that 20% of patients treated with amitriptyline
failed to complete the study, in comparison with 21.5% of patients who
received another tricyclic/heterocyclic antidepressant (NNTB=69, 95% CI NNTH
385 to to NNTB 32). This difference corresponded to an overall odds
ratio non-significantly favouring amitriptyline (Peto odds ratio 1.09, 95% CI
0.98-1.22) (see Table 4).
However, the estimate of the proportion of patients who experienced
side-effects during the study was 13% higher for amitriptyline than for
control TCAs/heterocyclic antidepressants (NNTH=7.6, 95% CI NNTH 6 to NNTH 11)
(see Table 4), corresponding to
an odds ratio which significantly favoured the control TCAs/heterocyclic
antidepressants. Head-to-head comparisons failed to detect statistically
significant differences in terms of drop-outs between amitriptyline and one of
the TCA/heterocyclic antidepressants (see
Table 4). However,
amitriptyline was associated with more side-effects than dothiepin,
maprotiline, mianserin, minaprine and nortriptyline (see
Table 4).
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Data from 40 RCTs comparing amitriptyline and SSRIs showed that 29.8% of
patients treated with amitriptyline failed to complete the study, in
comparison with 27.7% of patients treated with SSRIs (NNTH=49, 95% CI NNTB 180
to to NNTH 22). This difference corresponds to an overall odds ratio
of 0.86 (95% CI 0.75-0.98), which significantly favoured SSRIs (see
Table 5). The estimate of the
proportion of patients who experienced side-effects during the study was 11.6%
higher for amitriptyline than for SSRIs (NNTH=8.6, 95% CI NNTH 6 to NNTH 15)
(see Table 5), corresponding to
an odds ratio which significantly favoured the SSRIs.
|
Overall efficacy and tolerability of amitriptyline in comparison with
all antidepressant drugs
A funnel plot (Fig. 1)
showed no evidence of publication bias being a problem in the data collected.
The overall estimate of the efficacy of amitriptyline in comparison to
TCAs/heterocyclic drugs and SSRIs showed a 2.5% difference in the proportion
of responders in favour of amitriptyline (NNTB=40, 95% CI NNTB 21 to NNTB 694)
(see Fig. 2), which
corresponded to an intention to treat odds ratio of 1.12 (95% CI 1.01-1.24).
The estimate of the efficacy of amitriptyline and control antidepressants on a
continuous outcome confirmed the slightly superior efficacy profile of
amitriptyline: the estimate of the SMD significantly favours amitriptyline
(see Fig. 2).
|
|
The drop-out rate in patients taking amitriptyline and the control antidepressants was very similar, yielding an overall odds ratio of 0.99 (95% CI 0.91-1.08). However, the estimate of the proportion of patients who experienced side-effects during the study was 13.1% higher for amitriptyline than control antidepressants (NNTH=7.6, 95% CI NNTH 6 to NNTH 10), corresponding to an odds ratio which significantly favoured the control antidepressants (see Fig. 2).
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DISCUSSION |
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Methodological concerns
There are reasons for interpreting these results with caution. Included
studies are heterogeneous in terms of selection criteria, allocation
concealment, setting and out-come measures. A certain variability in the
overall quality of the primary research might therefore have influenced the
overall comparison. This systematic review did not investigate heterogeneity
by grouping trials according to patient characteristics or trial quality and
performing subgroup analyses. This approach was not adopted because it would
have inevitably decreased the power of the analysis, thus providing ambiguous
results; in addition, increasing the number of comparisons would have
increased the possibility of detecting significant differences only by chance.
The present analysis, which pools data from different trials carried out in
many populations, has the advantage of generating information which can be
applied to a very diverse range of patients
(Oxman et al,
1994).
Implications for practice
How should these data be translated into clinical practice? It certainly
seems reasonable to conclude that amitriptyline is as good as if not
better than the other TCAs and heterocyclic antidepressants, with the
possible exception of dothiepin (Eccles
et al, 1999). It seems reasonable to suggest that either
amitriptyline or dothiepin should remain the first-line TCA. More
controversial is the role of TCAs alongside SSRIs. The results from randomised
trials suggest that amitriptyline probably has the edge in terms of efficacy
over SSRIs. Given that publication bias is likely to work in favour of newer
compounds, it is possible that unpublished data would further improve
amitriptyline's position. Those who advocate first-line use of an SSRI point
to two additional strands of evidence the danger of TCAs in overdose
and the fact that they are often in practice prescribed at sub-therapeutic
doses. Although the widespread prescribing of SSRIs has to be viewed as a
public health measure to prevent suicide, it is likely to be prohibitively
expensive; in addition, data showing that the widespread use of SSRIs
decreases suicide rates are lacking (Barbui
et al, 1999). The advice should probably remain that
SSRIs are the first-line treatment to be given to patients at high risk of
committing deliberate self-harm. The problems of TCAs being prescribed in low
doses has attracted considerable attention, as evidence suggests that in real
situations TCAs are rarely taken appropriately. However, the guidelines on
adequate dosing which suggest at least 125 mg of
amitriptyline have to be prescribed for it to be effective are
themselves based on inadequate research. Recent systematic reviews indicate
that low-dose TCAs are as effective as SSRIs in treating depression
(Canadian Coordinating Office for Health
Technology Assessment, 1997a), and studies directly
comparing low- and high-dose TCAs show only very modest benefits of high doses
(Bollini et al,
1999).
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Clinical Implications and Limitations |
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LIMITATIONS
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ACKNOWLEDGMENTS |
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APPENDIX: Potentially relevant studies identified by the electronic search and subsequently excluded from the meta-analysis |
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APPENDIX: Randomised controlled trials included in the meta-analysis |
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Received for publication January 31, 2000. Revision received May 19, 2000. Accepted for publication May 19, 2000.