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Combined pharmacotherapy and psychological therapies for post traumatic stress disorder (PTSD)


How Victims are Affected by Abuse - Post-Traumatic Stress Disorder (PTSD)

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Combined pharmacotherapy and psychological therapies for post traumatic stress disorder (PTSD)


Ruth Parslow, Rosemary Purcell, Belinda Garner, Sarah E Hetrick

ORYGEN Research Centre Melbourne Victoria Australia



Table of contents
  a.. Background
  b.. Objectives
  c.. Methods
  d.. Acknowledgements
  e.. History
  f.. Contributions of authors
  g.. Sources of support
  h.. References

--------------------------------------------------------------------------------

Background
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Description of condition
PTSD is an anxiety disorder related to exposure to a severe psychological trauma. The estimated life time prevalence is 7.8% and it affects women more than men. PTSD in men is more commonly related to combat exposure, and in women it is more commonly related to rape and sexual assault ( Kessler 1995). The reasons for higher rates in women are not fully understood but may be related to the type of trauma, younger age of exposure to trauma, stronger perceptions of threat and loss of control and biological reactions to trauma, to name a few (Olff 2007 ). On the other hand, gender differences have been noted for ICD-10 but not DSM-IV (APA 1994) diagnostic systems, due to the different endorsement of symptoms by males and females, and different configuration of symptoms in each diagnostic system (Peters 2006). There is some evidence of genetic vulnerability for PTSD (Yehuda 1999). The prognosis is often poor, with up to a third not recovering after many years (Kessler 1995).

PTSD was first brought to public attention by combat veterans and was formally recognised as a clinical disorder in 1980, when its description and diagnostic criteria were specified in the Diagnostic and Statistical Manual of Mental Disorders Version III (DSM-III) (APA 1980). The disorder stands alone in psychiatry in having the requirement of an external stimulus, the traumatic experience, which then results in PTSD symptoms, of which re-experience of the event is common to both major diagnostic systems (DSM and ICD). In DSM, both avoidance and arousal symptoms as well as distress or impairment are required, however, in ICD-10, avoidance and arousal symptoms are listed as common (Lopez-Ibor 2002). DSM is more strict in its definition of PTSD. It has been argued that these clinical decision rules for diagnosis of PTSD may be too restrictive and fail to recognise morbidity and associated impairment of functioning commonly reported by individuals with subthreshold symptoms, particularly those who have chronic PTSD (Mylle 2004).

Finally, PTSD has been differentiated from Acute Stress Disorder (ASD) in which distressing re-experiencing, avoidance and arousal symptoms are reported within two days to four weeks of experiencing a trauma, but persist for no longer than four weeks. For this reason, it is now recommended that treatment for PTSD should not be considered until four weeks after symptoms are first reported (Ballenger 2004).

Description of intervention
Treatments for PTSD were primarily focused on psychological interventions in the years immediately following its formal recognition. Clinicians of this orientation argued that relief of PTSD symptoms achieved with pharmacological interventions was superficial at best, and at worst, could hinder full resolution of the trauma. They also argued that it encouraged patients' early withdrawal from their longer-term psychological treatment ( Friedman 1988). Cognitive behavioural techniques, including exposure types, flooding and stress inoculation have the most empirical support, although interpersonal therapy is also used (Nemeroff 2006 ). Bisson 2005 in a Cochrane systematic review, concluded that trauma-focused cognitive behavioural therapy (CBT), as individual or group therapy, and stress management were effective in reducing PTSD symptoms.

Initially, pharmacological interventions, such as tricyclic antidepressants (TCAs) and mono-amine oxidase inhibitors (MAOIs), were seen only as an adjunct to long-term psychotherapy, usually to address the symptoms of co-morbid depression experienced by those with PTSD ( Boehnlein 1985). By 1992, this position had changed considerably. It was argued that effective treatment of PTSD often required use of pharmacological interventions, although clinicians' awareness of the efficacy of these treatments was generally limited (Davidson 1992 ). Antidepressants, particularly SSRIs, have been the most commonly used pharmacological intervention (Davidson 1999; Davidson 2000). While few RCTs exist, antipsychotic medication is also used, most often in the case of patients who do not respond adequately to antidepressants and psychotherapy (Hamner 2005 ). A Cochrane systematic review of pharmacotherapy concluded that pharmacotherapy can be effective in treating PTSD symptoms, and that SSRIs should be first line agents for this disorder (Stein 2006).

How the intervention might work
Clinical expert opinion on treatment of PTSD has been revised considerably during the past six years. A Consensus Statement on PTSD treatment in 2000 recommended psychotherapy (exposure therapy, stress inoculation training and cognitive therapy) for mild PTSD and a combination of psychotherapy and pharmacotherapy for moderate to severe cases of this disorder (Ballenger 2000). Recommendations made in the most recent update of this statement focus on early use of SSRIs and/or CBT within 3 to 4 weeks of presentation of substantial, persistent PTSD symptomatology. This revised statement advised that treatment for chronic PTSD may be most effective in the longer term when both SSRIs and CBT are included in the treatment plan ( Ballenger 2004). The combination of the two interventions may further enhance treatment outcomes, particularly in those with co-morbid conditions, with pharmacotherapy making exposure therapy more tolerable (Marshall 2000 ).

Why it is important to do this review
While recommended by clinical expert opinion, a systematic review of the literature is required to appraise and assemble the evidence for combination treatments for PTSD.

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Objectives
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The purpose of this review is to assess whether the combination of psychological therapy and pharmacotherapy provides a more efficacious treatment for PTSD than either of these interventions delivered separately, and whether combination treatment is tolerable to patients with diagnosed PTSD.

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Methods
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Criteria for considering studies for this review

Types of studies

Randomised controlled trials will be included.

Types of participants

Patients of any age or gender with a primary diagnosis of PTSD, diagnosed by a clinician using any diagnostic system will be included. Sub-clinical symptoms will be defined as participants who display at least one symptom in each of the three symptom clusters or any acceptable definition adopted by the trialist. Definitions will be noted and described.

Chronic (>2 years or as defined by trialist) and recent onset (<2 years or as defined by trialist) PTSD with any length of untreated illness, and of any severity (as defined by trialist usually as a score on a PTSD scale), arising from any type of event relevant to the diagnostic criteria, including interpersonal events, disaster or accidents, combat and witnessing an event, will be included. Those with comorbidity, except psychotic illness, will be included. These aspects of the population will be recorded, as they may have an effect on the treatment outcome.

Types of interventions

Intervention
Combination of any type of pharmacotherapy and any type of psychological therapy will be included. Categories of pharmacotherapy will include SSRIs, SNRIs, tricyclic antidepressants, anxiolytic medication, mood stabilizers, atypical antipsychotics and other. Categories of psychological therapy will comprise cognitive and/or behavioural approaches (including exposure therapy), EMDR, interpersonal therapy, supportive counselling and psychodynamic treatments.

Control conditions
1. Waitlist control
2. Placebo
3. Standard treatment
4. Pharmacotherapy alone
5. Psychological therapy alone (this may be the standard therapy)


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Re: Combined pharmacotherapy and psychological therapies for post traumatic stress disorder (PTSD)


Types of outcome measures

Primary outcome
1. Change from baseline to endpoint (or endpoint scores) of PTSD symptom severity (clinician rated standardised, validated, reliable rating scales)
2. Change from baseline to endpoint (or endpoint scores) of PTSD symptom severity (self-rated rated standardised, validated, reliable rating scales)
3. Change (or endpoint) in Global Functioning scores (standardised, validated, reliable rating scales)

Secondary outcomes
1. Change from baseline to endpoint (or endpoint scores) of comorbid depression/anxiety (standardised, validated, reliable rating scales)
2. Change from baseline to endpoint (or endpoint scores) of suicidal ideation
3. Suicide attempt (reported in number of events or on standardised, validated, reliable rating scales)
4. Comorbid substance use (reported in number of events or on standardised, validated, reliable rating scales)
5. Vocational and social functioning (either in number of events e.g. return to full time work or on standardised, validated, reliable rating scales)
6. Quality of life (standardised, validated, reliable rating scales)
7. Number of withdrawals due to adverse events (number of events)
8. Cost of treatment

Search methods for identification of studies

For more information see Cochrane Depression, Anxiety and Neurosis Review Group (CCDAN) search strategy

1. Electronic searches
a) The register of trials kept by the CCDAN group will be searched by the Trials Search Co-ordinator (TSC) using the following terms:

CCDANCTR-Studies
Diagnosis = Post-Traumatic Stress Disorders
And
Intervention = "Combined Modality"

The TSC will screen search results to exclude studies which combine two pharmacological interventions within a trial or two psychological therapies within a trial. Studies will also be excluded where the combined treatment is usual care and psychological therapy or pharmacological therapy

CCDANCTR-References
Keyword = "stress disorder*"
Or
Full-text = PTSD or "trauma* stress"

Again, results will be screened in a similar way to above and references obviously not relevant will be excluded.

b) Bibliographic databases, including MEDLINE and PsycINFO, will be searched from 1950 to November 2007. The search strategy used for each database is included in an additional table Table 1.

c) National Research Register ([sign in to see URL]), Clinical Trials ([sign in to see URL]), the Australian Clinical Trials Register ([sign in to see URL]) and Current Controlled Trials ([sign in to see URL]) will be searched.

There will be no restrictions applied in the search in terms of date or language of publication. Any published (including Internet publication) or unpublished (including unpublished abstracts and reports) will be included.

2. Reference lists
The reference section of each included trial will be searched.

3. Hand searching
Conference abstracts for the following will be hand searched:
ASPR 1999-2001, and 2005
WPA, Epidemiology and Public Health, 2003
European Congress on Traumatic Stress, 2005

4. Personal Communication
In order to ensure that as many as possible RCTs are identified, the authors of the included trials and other experts in the field will be consulted to find out if they know of any published or unpublished RCTs in the area, and which were not yet identified.

Data collection and analysis

Selection of studies
Two review authors will independently select trials for possible inclusion in the study. Firstly, the titles and abstracts of trials identified from the search will be independently reviewed. Secondly, each review author will independently examine the full text of all studies that they consider to be of possible relevance. Each review author will compile a list of studies, which they believe meet the inclusion criteria. The contents of each review author's list will be compared, and any discrepancies discussed. Any disagreement will be resolved by discussion and consensus between all of the review authors.

Data extraction
Two review authors will independently extract data using specially developed data extraction forms. Information will be collected on:
1. Participants: age, gender, ethnicity, incident episode, length of time since episode, length of time since onset of PTSD, severity of PTSD, previous treatment for PTSD or other mental health disorders, type and severity of comorbid substance use disorder(s) and other psychiatric comorbidities and suicide-related behaviours.
2. Interventions and comparisons: description of medication including planned and actual dose, length of treatment and description of psychological intervention including type, whether it is delivered to groups or individuals, whether it is manualised, who delivers it and for how long, and the actual amount of therapy received. Information on other adjunctive interventions will also be collected. The number of participants randomised to each group, as well as total drop-outs and drop-outs due to adverse effects will be extracted.
3. Outcome measures: description of measures used, timing of administration, continuous/dichotomous nature, psychometric properties, references.
4. Results: point estimates and measures of variability and frequency counts for dichotomous variables.

One review author will compile all comparisons and enter outcome data into the Review Manager software program for meta-analysis. A second review author will perform double-data entry to ensure accuracy of results. Missing data will be obtained from trial authors wherever possible.


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Re: Combined pharmacotherapy and psychological therapies for post traumatic stress disorder (PTSD)


Assessment of risk of bias in included studies
Two review authors will independently assess the risk of bias of the included trials using a descriptive approach as advocated by the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2008 ). Potential for bias, including selection, performance, attrition and detection bias, will be considered using the following criteria:

1. Sequence generation
Was the allocation sequence adequately generated?

2. Allocation concealment
Was the allocation adequately concealed?

3. Blinding of participants, personnel and outcome assessors
Were the allocated interventions adequately blinded during the study? (participant/care provider)? How did you know that blinding was maintained? (In this review, given psychotherapy is one of the interventions, it is not possible for the participant and provider to be blinded). Were the outcome assessors adequately blinded to the allocated interventions?

4. Incomplete outcome data
Were dropouts and exclusions adequately addressed? (Were losses to follow-up described?) Were intention-to-treat analyses used?

5. Selective outcome reporting
7. Have authors reported on all the outcomes they set out to? To assess reporting bias, we will record which of the review outcomes were available with usable data from each included trial as well as noting which of the review outcomes were only reported in terms of whether there were significant differences between groups. Additionally the other outcomes (not collected for the review) reported by the trialists in the paper publication(s) will be compiled.

6. Other sources of bias
Was the study apparently free of other problems that could mean a high risk of bias e.g. early stopping, baseline imbalance, choice of design, evidence of carry over effect, funding?

Each criterion will be graded as yes, no or unclear, and will be scored as adequate (A), unclear (B) or inadequate (C), according to the guidelines in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2008 ). When criteria are scored as unclear, one review author will attempt to obtain further information from the authors of the trial. The review authors will discuss any disagreement in the assessment of risk of bias to reach a consensus.

Data analysis
Review Manager software will be used for statistical analysis.

Measures of treatment effect
For dichotomous outcomes, such as 'response', results from each trial will be expressed as a Risk Ratio (RR) with 95% confidence intervals, and combined in meta-analysis.

Continuous outcomes, such as symptom measures, may be presented in several ways. When absolute values of post-treatment means and standard deviations (SD) are given, using the same rating scale across studies, these will be used to calculate the mean difference (MD) and 95% confidence intervals. If different scales are used to measure the same outcomes the standardised mean difference (SMD) will be calculated with 95% confidence intervals and then combined for meta-analysis.

Unit of analysis issues
Cross-over trials will be included only when it is possible to extract data from the first treatment period; or when inclusion of data from both treatment periods is justified by a sufficiently long wash-out period to minimise the effects of 'carry-over'. Data from both periods can only be included when it is possible to determine the correlation between participants' responses to interventions in the different phases ( Elbourne 2002).

Review authors will also check for and report where skewed data exist and it may be appropriate to report these in additional tables.

Dealing with missing data
Authors will be contacted for any missing data. If necessary, missing data will be imputed (e.g. calculating SDs from standard errors and p-values) and this will be clearly documented in the review. Data from intention-to-treat (ITT) will be extracted in the first instance with the type of imputation carried out by trialists noted. Where possible, observed case (OC) data will also be extracted and results compared with ITT data. The assumptions inherent in both these types of data will be discussed.

Assessment of heterogeneity
Clinical homogeneity will be satisfied when participants, interventions and outcome measures are considered to be similar. All of the analyses will be stratified by medication category. For trials that are clinically heterogeneous or present insufficient information for pooling, a descriptive analysis will be performed. Statistical homogeneity will be assessed using the I-squared (I2) statistic (Higgins 2003).

Assessment of reporting biases
We will investigate the potential for publication bias using a funnel plot for the primary outcomes relating to PTSD diagnosis and/or symptoms. Publication bias has long been associated with funnel plot asymmetry, however, asymmetry may be due to reasons other than publication bias and is difficult to assess in the case of a small number of trials. For this reason, an assessment of the risk of reporting bias will also be included as stated above.

Data synthesis
For all meta-analyses a fixed effects (Mantel 1959) meta-analysis will be used in the first instance. If statistical heterogeneity is found, it will be examined by subgroup and sensitivity analyses. If this does not account for heterogeneity, we will use random effects models (DerSimonian 1986 ). When the pooled summary statistic differs clinically between models, this will be reported.

Subgroup analysis and investigation of heterogeneity
If statistical heterogeneity is found, it will be examined by the following subgroup analyses, should there be a sufficient number of studies.
1. Newly developed vs short term (acute) vs chronic PTSD
2. Mild vs severe PTSD
3. Children/adolescents vs adults
4. Comorbid substance use disorders (SUD) vs no comorbid SUD

Sensitivity analyses
Sensitivity analyses will be performed to assess the effect of risk of bias. The following groups will be defined:
1. Allocation concealment is rated as inadequate, not used or unclear (and attempts to clarify with authors fail) (A)
2. Blinding of outcome assessment is not done or unclear (and attempts to clarify with authors fail) (B)
3. Intention-to-treat analysis is not done or probably not done (and attempts to clarify with authors fail) (C).

These criteria for assessing the risk of bias have been shown to influence estimates of treatment effect (Juni 2001). Sensitivity analyses will be performed in which studies categorised as A, B or C are excluded.

If statistical heterogeneity is found, it will be examined using the above sensitivity analyses, should there be a sufficient number of studies.

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Re: Combined pharmacotherapy and psychological therapies for post traumatic stress disorder (PTSD)


Acknowledgements
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Potential conflict of interest

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History
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Protocol first published: Issue 3, 2008


--------------------------------------------------------------------------
     
           Date
           Event
           Description
          

--------------------------------------------------------------------
          
           7 March 2007
           New citation required and major changes
           Substantive amendment
          
     

--------------------------------------------------------------------------
     


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Contributions of authors
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Ruth Parslow conceived the review and is guarentor. Ruth Parslow co-ordinated the development of the protocol with all authors contributing equally to the design and development of the protocol.

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Sources of support
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Internal sources

      •
     ORYGEN Research Centre, University of Melbourne, Australia.

External sources

      •
     No sources of support supplied

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<td><b>Combined pharmacotherapy and psychological therapies for post traumatic stress disorder (PTSD)</b></td> <td>
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<b>MEDLINE</b><br>
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<b>PscyINFO</b><br>
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<td align="left" valign="top">1. Stress Disorders, Post-Traumatic/<br>2. (stress disorder$ or trauma$ stress or ptsd or post-trauma$ or posttraum$).tw.<br>3. 1 or 2<br>4. Combined Modality Therapy/<br>5. (combined modality or combined therapy or combined treatment or multimodal treatment or multimodal therapy).tw.<br>6. 4 or 5<br>7. 3 and 6<br>8. exp Psychotherapy/<br>9. exp Psychotropic Drugs/<br>10. 8 and 9<br>11. 3 and 10<br>12. 7 or 11<br>13. clinical [sign in to see URL].<br>14. clinical trial$.mp.<br>15. random$.mp.<br>16. [sign in to see URL],ab.<br>17. [sign in to see URL],ab.<br>18. or/13-17<br>19. 12 and 18<br>
</td> <td align="left" valign="top">1. Posttraumatic Stress Disorder/
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<td> <hr size="2" noshade>
          
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<tr> <td colspan="4">
          
           </td>
         
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<td colspan="4"> <p>
<br><i>Cochrane Database of Systematic Reviews</i><br><i>Published by John Wiley & Sons, Ltd</i></p> </td>
         
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References
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Additional references

• APA 1980 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 3rd Edition. Washington, DC: American Psychiatric Association, 1980.
• APA 1994 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th Edition. Washington, DC: American Psychiatric Association, 1994.
• Ballenger 2000 Ballenger JC, Davidson JR, Lecrubier Y, Nutt DJ, Foa EB, Kessler RC, et [sign in to see URL] Statement on Posttraumatic Stress Disorder from the International Consensus Group on Depression and Anxiety. Journal of Clinical Psychiatry 2000;61 Suppl 5:60-6. Links
• Ballenger 2004 Ballenger JC, Davidson JR, Lecrubier Y, Nutt DJ, Marshall RD, Nemeroff CB, et [sign in to see URL] Statement update on posttraumatic stress disorder from the International Consensus Group on Depression and Anxiety. Journal of Clinical Psychiatry 2004;65 Suppl 1:55-62. Links
• Bisson 2005 Bisson J, Andrew M. Psychological treatment of posttraumatic stress disorder (PTSD). Cochrane Database of Systematic Reviews 2005, Issue 3. Links
• Boehnlein 1985 Boehnlein JK, Kinzie JD, Ben R, Fleck J. One-year follow-up study of posttraumatic stress disorder among survivors of Cambodian concentration camps. American Journal of Psychiatry 1985;142:956-9. Links
• Davidson 1992 Davidson J. Drug therapy for post-traumatic stress disorder. British Journal of Psychiatry 1992;160:309-14. Links
• Davidson 1999 Davidson JR, Connor KM. Management of posttraumatic stress disorder: Diagnostic and therapeutic issues. Journal of Clinical Psychiatry 1999;60 Suppl 18:33-8. Links
• Davidson 2000 Davidson JR. Pharmacotherapy of posttraumatic stress disorder: Treatment options, long-term follow-up, and predictors of outcome. Journal of Clinical Psychiatry 2000;61 Suppl 5:52-6. Links
• DerSimonian 1986 DerSimonian R, Laird N. Meta-analysis in clinical trials. Controlled Clinical Trials 1986;7:177-88. Links
• Elbourne 2002 Elbourne DR, Altman DG, Higgins JP, Curtin F, Worthington HV, Vail A. Meta-analyses involving cross-over trials: methodological issues. International Journal of Epidemiology 2002;31(1):140-9. Links
• Friedman 1988 Friedman MJ. Toward rational pharmacotherapy for posttraumatic stress disorder: An interim report. American Journal of Psychiatry 1988;145:281-285. Links
• Hamner 2005 Hamner MB, Robert S. Emerging roles for atypical antipsychotics in chronic post-traumatic stress disorder. Expert Review of Neurotherapeutics 2005;5(2):267-75. Links
• Higgins 2003 Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ 2003;327(7414):557-60. Links
• Higgins 2008 Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version [sign in to see URL] [Updated February 2008]. The Cochrane Collaboration 2008. Available from [sign in to see URL].
• Juni 2001 Juni P, Altman DG, Egger M. Assessing the quality of controlled clinical trials. BMJ 2001;323:42-6. Links
• Kessler 1995 Kessler RC, Sonnega A, Bromet E, Hughes M, Nelson CB. Posttraumatic stress disorder in the National Comorbidity Survey. Archives of General Psychiatry 1995;52(12):1048-60. Links
• Lopez-Ibor 2002 Lopez-Ibor JJ. The classification of stress-related disorders in ICD-10 and DSM-IV. Psychopathology 2002;35(2/3):107-11. Links
• Mantel 1959 Mantel N, Haenszel W. Statistical aspects of the analysis of data from retrospective studies of disease. Journal of the Nationall Cancer Institute 1959;22:719-48. Links
• Marshall 2000 Marshall RD, Cloitre M. Maximizing treatment outcome in post-traumatic stress disorder by combining psychotherapy with pharmacotherapy. Current Psychiatry Reports 2000;2:335-40. Links
• Mylle 2004 Mylle J, Maes M. Partial posttraumatic stress disorder revisited. Journal of Affective Disorders 2004;78:37-48. Links
• Nemeroff 2006 Nemeroff CB, Bremmer JD, Foa EB, Mayberg HS, North CS, Stein MB. Posttraumatic stress disorder: A state-of-the-science review. Journal of Psychiatric Research 2006;40:1-21. Links
• Olff 2007 Olff M, OLangeland W, Draijer N, Gersons BPR. Gender differences in posttraumatic stress disorder. Psychological Bulletin 2007;133(2):183-204. Links
• Peters 2006 Peters L, Issakidis C, Slade T, Andrews G. Gender differences in the prevalence of DSM-IV and ICD-10 PTSD and ICD-10 PTSD. Psychological Medicine 2006;36:81-9. Links
• Stein 2006 Stein DJ, Ipser JC, Seedat S. Pharmacotherapy for posttraumatic stress disorder (PTSD). Cochrane Database of Systematic Reviews 2006, Issue 1. Links
• Yehuda 1999 Yehuda R. Biological factors associated with susceptibility to posttraumatic stress disorder to posttraumatic stress disorder Biological factors associated with susceptibility to posttraumatic stress disorder. Canadian Journal of Psychiatry 1999;44(1):34-9. Links


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