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van der Kolk BA, Spinazzola J, Blaustein ME, et al. A randomized clinical trial of eye movement desensitization and reprocessing (EMDR), fluoxetine, and pill placebo in the treatment of posttraumatic stress disorder: treatment effects and long-term maintenance. J Clin Psychiatry 2007;68:37–46.
Randomised controlled trial.
Eight months (2 months’ treatment plus 6 months’ post-treatment follow-up).
Recruitment via newspaper ads, the Internet, and from medical and mental health professionals, USA; July 2000 to July 2003.
88 people aged 18–65 years old with current post-traumatic stress disorder (PTSD) (DSM-IV) and mixed trauma exposure at least one year before enrolment. Main exclusions: contraindication to study treatments, previous use of study treatments, Global assessment of functioning score <40, unstable medical comorbidity, psychotic or bipolar disorder, alcohol or substance abuse, high risk of suicide, ongoing trauma focused treatment, unstable living arrangements, involvement in trauma-related lawsuit, or receiving disability compensation for PTSD.
EMDR, fluoxetine (dose titrated to 60 mg/day as tolerated; mean dose 30 mg/day), or pill placebo for eight weeks. EMDR was aimed at memories of the primary trauma, and involved individual weekly 90-min sessions with trained clinicians, based on specially developed treatment manuals.
PTSD symptoms (clinician-administered PTSD Scale (CAPS), DSM-IV version; higher score indicates greater symptoms severity); asymptomatic function (CAPS score <20); PTSD diagnosis (Structured Clinical Interview for DSM-IV Axis I and Axis II Disorders); depressive symptoms (Beck Depression Inventory-II (BDI-II)).
86% completed treatment (100% included in post-treatment analyses), 66% completed follow-up (84% included in follow-up analyses).
After eight weeks of treatment, there was no significant difference between EMDR, fluoxetine and placebo in symptom scores, the proportion of people no longer meeting diagnostic criteria for PTSD or the proportion of people who were asymptomatic (see http://ebmh.bmj.com/supplemental for table). After six months of follow-up, EMDR significantly reduced PTSD and depressive symptoms, and proportion of people who were asymptomatic compared with fluoxetine (see table); there was no significant difference in the proportion of people no longer meeting diagnostic criteria for PTSD between EMDR and fluoxetine.
After eight weeks’ treatment, there is no difference in PTSD symptoms between EMDR, fluoxetine and placebo. Six months after the end of treatment, EMDR reduces PTSD symptoms compared with fluoxetine.
After post-treatment assessment, the placebo group were unblinded for ethical reasons and given of option of receiving either EMDR or fluoxetine. Therefore, placebo group data are not included in the follow-up analysis.
There is much debate regarding the relative efficacies of psychological treatments and pharmacological treatments in the management of post-traumatic stress disorder (PTSD). The UK’s National Institute for Health and Clinical Excellence rated trauma-focused psychological treatments superior to pharmacological treatments, recommending them for first line use for PTSD with pharmacological treatments being reserved as a second line treatment or for use when other indications are present.1
One of the biggest difficulties in determining the relative efficacies is the absence of head-to-head comparisons using an appropriate methodological design. This paper goes some way to addressing that, with PTSD sufferers being randomly allocated to receive the trauma-focused psychological treatment eye movement desensitisation and reprocessing (EMDR), fluoxetine or placebo. There are a few methodological issues worthy of mention. Fluoxetine was discontinued over a 10-day period following an eight-week intervention period which does not reflect usual practice. Typically, an individual who had responded would be continued on fluoxetine for a period of six months or more. Other issues are that the fluoxetine and placebo groups received less therapist input than the EMDR group, and that the initial scores in the fluoxetine group were higher than those in the EMDR group—although the analyses did control for this.
The results show that all three groups did well. Indeed, 65% of the placebo completers lost their diagnosis. The EMDR group fared significantly better than the fluoxetine group at follow-up, although this is not really surprising as the fluoxetine was stopped after eight weeks. This research will not make me change my practice from offering individuals trauma-focused psychological treatment as a first line treatment for PTSD. It supports previous work that suggests that fluoxetine should not be stopped after eight weeks if it has been helpful and that EMDR is an effective treatment for PTSD.
Source of funding: National Institute of Mental Health, USA.
Competing interests: None.