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3 Evidence and Conclusions: Pharmacotherapy
Pages 55-92

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From page 55... ... , 13 studies were predominantly in veteran populations whose primary trauma was combat, 10 studies in civilian populations predominantly included victims of sexual abuse, and 14 studies had a mixed trauma type. The committee found that, in most cases, if the study was predominantly in a veteran population, the participants were mostly male, and if the study was predominantly in Some studies did not include sex and/or trauma type. Read the entire page →
From page 56... ... ALPHA-ADRENERGIC BLOCKERS The committee identified a small number of studies examining the effects of prazosin, an alpha-adrenergic blocker, on posttraumatic stress disorder (PTSD) Read the entire page →
From page 57... ... The main PTSD outcome measures used in the selective serotonin reuptake inhibitors (SSRIs) studies were CAPS-Total and SI-PTSD. Read the entire page →
From page 58... ... If only one trauma type is listed, at least 80% of the study population reported that type of trauma. bPTSD outcome measure change data were obtained either directly from the study, when provided, or by subtracting data reported at treatment completion (not follow-up data) Read the entire page →
From page 59... ... gResults for first half of study before crossover. NOVEL ANTIPSYCHOTIC MEDICATIONS The committee identified seven trials of novel antipsychotics olanzapine or risperidone in the treatment of individuals with PTSD (Bartzokis et al., 2005; Butterfield et al., 2001; Hamner et al., 2003; Monnelly et al., 2003; Padala et al., 2006; Reich et al., 2004; Stein et al., 2002) Read the entire page →
From page 60... ... If only one trauma type is listed, at least 80% of the study population reported that type of trauma. bPTSD outcome measure change data were obtained either directly from the study, when provided, or by subtracting data reported at treatment completion (not follow-up data) Read the entire page →
From page 61... ... and 40% using LOCF –42 -- 42% 21% Yes Duke Dropout 17% and 20% -- e Global Rating using LOCF; trial too -- 50% small to estimate effect 25% size scores for all arms are nearly the same; otherwise, baseline scores listed individually in order of arm. cITT population is reported at 38, with 19 in each treatment condition. Read the entire page →
From page 62... ... BENZODIAZEPINES The committee identified only one placebo-controlled RCT of alprazolam with a primary PTSD outcome, which showed that the drug was ineffective. The participants in the study suffered from three different trauma types: combat-related (40 percent) Read the entire page →
From page 63... ... . Synthesis: The committee found the overall body of evidence regarding benzodiazepines to be scant and low quality. Read the entire page →
From page 64... ... If only one trauma type is listed, at least 80% of the study population reported that type of trauma. bPTSD outcome measure change data were obtained either directly from the study, when provided, or by subtracting data reported at treatment completion (not follow-up data) Read the entire page →
From page 65... ... Principal Limitations Yes ~87c N/A Dropout 18% and 33% –30 Yes using LOCF with a –7 -- 15% differential Yes ~100 N/A Dropout 33% and 19% –14.3 Yes –4.6 -- Yes ~64 N/A No major limitations –29.6 Yes –18.6 -- Yes ~90 N/A Dropout 42% and 33% –9 No using LOCF –10.1 -- Yes ~71 N/A Dropout 12.5% in –10 Yes one arm; handling of –0.5 -- missing data unclear Yes ~85 N/A Dropout 30% and 22% –14.8 Yes using LOCF –2.67 -- Yes ~52 N/A Dropout 30% and 20% –20.5 No using LOCF -- cActual numbers not given -- read off of a line graph. dAdjunctiveto stable psychotropic Rx regimen. Read the entire page →
From page 66... ... If only one trauma type is listed, at least 80% of the study population reported that type of trauma. bPTSD outcome measure change data were obtained either directly from the study, when these trials ranged from 26 to 73 years. Read the entire page →
From page 67... ... SELECTIVE SEROTONIN REUPTAKE INHIBITORS The committee found that the literature on SSRIs was the most extensive for any of the pharmacotherapies, identifying 14 studies meeting inclusion criteria (Brady et al., 2000; Connor et al., 1999; Davidson et al., 2001a, 2006b; Friedman et al., 2007; Hertzberg et al., 2000; Marshall et al., 2001, 2007; Martenyi et al., 2002a; Tucker et al., 2001, 2003; van der Kolk et al., 1994, 2007; Zohar et al., 2002) Read the entire page →
From page 68... ... If only one trauma type is listed, at least 80% of the study population reported that type of trauma. bPTSD outcome measure change data were obtained either directly from the study, when provided, or by subtracting data reported at treatment completion (not follow-up data) Read the entire page →
From page 69... ... Principal Limitations Yes ~80 N/A Dropout data –27.18 Yes aggregated with 30% –24.68 -- overall dropout using LOCF Yes ~81 N/A Dropout ~30% using –41.6 No LOCF –30.2 -- Yes ~33.5 N/A Dropout data –13.6 Yes aggregated with 48% –9.1 Yes overall dropout using –1.7 -- LOCF Yes ~20e N/A Dropout data –7 No aggregated with 33% –6.8 -- overall dropout with unclear handling of missing data scores for all arms are nearly the same; otherwise, baseline scores listed individually in order of arm. cTrycyclic antidepressant. Read the entire page →
From page 70... ... Of the 14 trials, 7 were judged weakly informative with respect to efficacy because of study limitations such as high differential and/or total dropout rates and weak or absent treatment of missing values (Connor et al., 1999; Davidson et al., 2006b; Hertzberg et al., 2000; Marshall et al., 2001, 2007; Tucker et al., 2001; van der Kolk et al., 1994) Read the entire page →
From page 71... ... Therefore the committee's conclusion echoes those of other recent evidence-based assessments such as that of the Cochrane systematic review (Stein et al., 2006) and the 2007 Australian Guidelines for the Treatment of Adults with Acute Stress Disorder and Posttraumatic Stress Disorder. While recognizing that Please refer to Dr. Read the entire page →
From page 72... ... . See Table 3-6 for a summary of the 14 included clinical trials. Read the entire page →
From page 73... ... Two hundred and fifty patients were entered into the continuation phase, of which approximately 50 percent had been in each the treatment and placebo conditions in the initial study. Only the 128 patients who had been in the treatment condition (sertraline) Read the entire page →
From page 74... ... 68% PL (27) 48% van der Female, S&NS Total (88) Read the entire page →
From page 75... ... Principal Limitations Yes ~72 >30% CAPS-2 Dropout 30% and 17% –13.1 No reduction using LOCF –15.4 -- 34.5% 42.7% Yes ~83 N/A Dropout 32% and 52% –25.7 Yes with a 20% differential –6.3 -- Yes NR Loss of PTSD No major limitations –33.23 No diagnosis –39.15 No 73% –30.95 -- 76% 59% Yes ~82 CAPS-SX ≤ 20 Dropout data –41.51 Yes (remission) aggregated with 35% –39.44 No 30.2% overall dropout using –34.17 -- 24.3% mainly LOCF 19.6% Yes ~90 N/A Dropout of 20%, 36%, –30.72 Yes and 30% using LOCF –41.82 Yes –13.6 -- Yes ~80.5 >50% reduction in Actual dropout rates –34.6 Yes TOP-8 and CGI-S not provided; used –26.8 -- of 1 or 2 LOCF 59.9% 43.8% Yes ~92 >30% CAPS-2 Dropout ~26% using –18.7 No reduction and LOCF –13.5 -- CGI-I of 1 or 2 41% 20% Yes ~80 >30% CAPS-2 Dropout 30% and 33% –33 Yes reduction and CGI using LOCF –26.2 -- score of 1 or 2 60% 38% continued Read the entire page →
From page 76... ... If only one trauma type is listed, at least 80% of the study population reported that type of trauma. bPTSD outcome measure change data were obtained either directly from the study, when provided, or by subtracting data reported at treatment completion (not follow-up data) Read the entire page →
From page 77... ... Principal Limitations Yes ~75 Global Dropout 33%, 38%, –39.6 Yes improvement score and 35% using LOCF –37.9 Yes 1 = very much –25.3 -- improved, 2 = much improved 62% 54% 37% Yes 74.3, 73.2 <20 CAPS score = Dropout ~38% and –35.5 Yes remission 40% using LOCF –24.7 -- 30% 20% Yes ~75 >30% decrease in Dropout 31% and 28% 33 Yes CAPS-2 score and using LOCF 23.2 -- CGI-I of 1 or 2 53% 32% Yes ~108 Duke Global Rating Dropout ~17% in –3 No 17% one arm with a ~17% –9 -- 33% differential dropout; completer analysis only Yes Baseline NR Responder (Duke Dropout ~22% and Score of 1: cutoff of 1–2) ~42% with a 20% 59% Yes 85% differential using LOCF 19% 62% Yes ~82 N/A Dropout ~36% and –35 Yes ~13% with a 23% –12 No differential and no –17 -- handling of missing –3 -- data and not the maintenance phase, which only included patients who were "much improved" or "very much improved." dSeven dropped out before receiving study drug. Read the entire page →
From page 78... ... The committee identified one RCT of mirtazapine, showing a modest benefit of treatment; but the study was small and did not use a robust method for handling the dropout rates and managing missing values ( Davidson et al., 2003) Read the entire page →
From page 79... ... OTHER DRUGS The committee identified studies of naltrexone, cycloserine, and i nositol, but not all met inclusion criteria. An RCT of naltrexone, an opioid antagonist, was conducted in patients with alcohol dependence, approximately one-third of whom also had PTSD, finding reductions in alcohol intake and improvements in CAPS scores (Petrakis et al., 2006) Read the entire page →
From page 80... ... If only one trauma type is listed, at least 80% of the study population reported that type of trauma. bPTSD outcome measure change data were obtained either directly from the study, when provided, or by subtracting data reported at treatment completion (not follow-up data) Read the entire page →
From page 81... ... Improvement (%) Principal Limitations Yes ~22 Yes Response rate Dropout data –7 -- 67% aggregated with 31% –7 22% overall dropout using LOCF provided, or by subtracting data reported at treatment completion (not follow-up data) Read the entire page →
From page 82... ... If only one trauma type is listed, at least 80% of the study population reported that type of trauma. bPTSD outcome measure change data were obtained either directly from the study, when provided, or by subtracting data reported at treatment completion (not follow-up data) Read the entire page →
From page 83... ... Principal Limitations Yes ~82 CAPS ≤20 Dropout of 30% and –51.8 Yes 50.9% 33% using LOCF –44.8 -- 37.5% Yes ~82 CAPS-SX ≤20 Dropout data –41.51 Yes (remission) aggregated with 35% –39.44 No 30.2% overall dropout using –34.17 -- 24.3% mainly LOCF 19.6% baseline data (before treatment began) Read the entire page →
From page 84... ... If only one trauma type is listed, at least 80% of the study population reported that type of trauma. bPTSD outcome measure change data were obtained either directly from the study, when provided, or by subtracting data reported at treatment completion (not follow-up data) Read the entire page →
From page 85... ... 2004. Practice guideline for the treatment of patients with acute stress disorder and posttraumatic stress disorder. Read the entire page →
From page 86... ... 2000. Efficacy and safety of sertraline treatment of posttraumatic stress dis order: A randomized controlled trial. Read the entire page →
From page 87... ... 2006a. Treatment of posttraumatic stress disorder with venlafaxine ex tended release: A 6-month randomized controlled trial. Read the entire page →
From page 88... ... 1987. Posttraumatic stress disorder in Israeli combat veterans. Read the entire page →
From page 89... ... 2006. A comparative study of fluoxetine, moclobemide, and tianeptine in the treatment of posttraumatic stress disorder following an earth quake. Read the entire page →
From page 90... ... 2006. Daytime prazosin reduces psychological distress to trauma specific cues in civilian trauma posttraumatic stress disorder. Read the entire page →
From page 91... ... , fluoxetine, and pill placebo in the treatment of posttraumatic stress disorder: Treatment effects and long-term maintenance. Journal of Clinical Psy chiatry 68(1) Read the entire page →
From page 92... ... KEY for Tables 4-1 through 4-9: BEP = brief eclectic psychotherapy N/A = not available CBT = cognitive behavior therapy NR = not reported CS = coping skills; examples: ns = not significant CS-B = biofeedback OT = other therapy DO = dropout rate PCT = present-centered therapy (active E = exposure control) E+CR = exposure plus cognitive PE = prolonged exposure restructuring PTSD outcome measures -- refer to list of E+CS = exposure plus coping skills acronyms in Appendix E for full name EMDR = eye movement desensitization of measure and reprocessing S&NS assault = sexual and nonsexual assault F = female Ss = subjects ITT = intent-to-treat analysis SSRI = selective serotonin reuptake inhibitor LOCF = last observation carried forward Tx = treatment MC = minimum care UC = usual care MVA = motor vehicle accident WL = wait list 92 Read the entire page →

From page 55...

... , 13 studies were predominantly in veteran populations whose primary trauma was combat, 10 studies in civilian populations predominantly included victims of sexual abuse, and 14 studies had a mixed trauma type. The committee found that, in most cases, if the study was predominantly in a veteran population, the participants were mostly male, and if the study was predominantly in Some studies did not include sex and/or trauma type.

3 Evidence and Conclusions: Pharmacotherapy Pages 55-92

3 Evidence and Conclusions: Pharmacotherapy
Pages 55-92