High microsatellite instability (MSI-H) is associated with distinct clinical and molecular characteristics and an improved survival in early Colon cancer (CC); real world data from the AIO molecular registry Colopredict Plus.

Colorectal cancer is one of the leading malignancies and still accounts for almost 25 000 deaths in Germany each year. Although there is accumulating data on the molecular basis, treatment and clinical outcome of patients within clinical trials evidence from the real-world setting is mostly lacking. We started the molecular registry trial Colopredict Plus in 2013 to collect clinical and molecular data from a real-world cohort of patients with early colon cancer stage II and III in 70 German colon cancer centers focusing on the prognostic impact of high microsatellite instability. In this interim report, we characterize a clinical cohort of 2615 patients, of whom 1787 tissue probes were analyzed. Microsatellite status was assessed using immunhistochemistry and fragment length analysis, with a concordance of 91.4 %. These established histopathological methods are sensitive and cost-effective. The median age was 72 years, significantly higher compared to clinical trial populations, with a median Charlson Comorbidity Index of 3. The stage-dependent incidence of microsatellite instability was 23.7 % and was associated with female gender, BRAF-mutation, UICC stage II and localization in the right colon. Survival calculated in disease free, relapse free and overall survival significantly differed between MSI-H and MSS, in favor of MSI-H patients. Multivariate age-adjusted analyses of relapse-free survival, disease-free survival, and overall survival highlighted microsatellite instability as a robust and positive prognostic marker for early colon cancer independent of age.

Optimal Cut Points for Remission and Response for the German Version of the Social Phobia Anxiety Inventory (SPAI).

OBJECTIVE: The German version of the Social Phobia and Anxiety Inventory (SPAI-G) is a validated measure for the detection of social anxiety disorder (SAD). The aim of the present study was to develop optimal cut points (OC) for remission and response to treatment for the SPAI-G. METHODS: We used Receiver Operating Characteristic methods and bootstrapping to analyse the data of 359 patients after psychotherapeutic treatment. OCs where defined as the cut points with the highest sensitivity and specificity after bootstrapping. RESULTS: For remission, an OC of 2.79 was found, and for response, a change in score from pre- to posttreatment by 11% yielded best results. CONCLUSIONS: The OC we identified for remissionmay be used to improve the diagnostic utility of the SPAI-G. However, the cut point for response achieved only borderline-acceptable levels of sensitivity and specificity, calling into doubt their utility in clinical and research setting.

Early response in cognitive-behavior therapy for syndromes of medically unexplained symptoms.

BACKGROUND: Early dramatic treatment response suggests a subset of patients who respond to treatment before most of it has been offered. These early responders tend to be over represented among those who are well at termination and at follow-up. Early response patterns in psychotherapy have been investigated only for a few of mental disorders so far. The main aim of the current study was to examine early response after five therapy-preparing sessions of a cognitive behavior therapy (CBT) for syndromes of medically unexplained symptoms (MUS). METHODS: In the context of a randomized, waiting-list controlled trial 48 patients who suffered from ≥3 MUS over ≥6 months received 5 therapy-preparing sessions and 20 sessions of CBT for somatoform disorders. They completed self-report scales of somatic symptom severity (SOMS-7 T), depression (BDI-II), anxiety (BSI), illness anxiety and behavior (IAS) at pre-treatment, after 5 therapy-preparing sessions (FU-5P) and at therapy termination (FU-20 T). RESULTS: The current analyses are based on data from the treatment arm only. Repeated measure ANOVAs revealed a significant decrease of depression (d = 0.34), anxiety (d = 0.60), illness anxiety (d = 0.38) and illness behavior (d = 0.42), but no change of somatic symptom severity (d = -0.03) between pre-treatment and FU-5P. Hierarchical linear multiple regression analyses showed that symptom improvements between pre-treatment and FU-5P predict a better outcome at therapy termination for depression and illness anxiety, after controlling for pre-treatment scores. Mixed-effect ANOVAs revealed significant group*time interaction effects indicating differences in the course of symptom improvement over the therapy between patients who fulfilled a reliable change (i.e., early response) during the 5 therapy-preparing sessions and patients who did not reach an early reliable change. Demographic or clinical variables at pre-treatment were not significantly correlated with differential scores between pre-treatment and FU-5P (-.23 ≤ r ≤ .23). CONCLUSIONS: Due to several limitations (e.g., small sample size, lack of a control group) the results of this study have to be interpreted cautiously. Our findings show that reliable changes in regard to affective-cognitive and behavioral variables can take place very early in CBT of patients with distressing MUS. These early changes seem to be predictive of the outcome at therapy termination. Future studies are needed in order to replicate our results, and to identify mechanisms of these early response patterns in somatoform patients. TRIAL REGISTRATION: ISRCTN. ISRCTN17188363 . Registered retrospectively on 29 March 2007.

Predictors of the application of exposure in vivo in the treatment of agoraphobia in an outpatient clinic: An exploratory approach.

OBJECTIVE: Although exposure in vivo is considered to be the most effective therapy component in the treatment of agoraphobia (AG), there is a remarkable lack of its application in psychotherapeutic routine care. We examined the severity of anxiety, psychological distress/comorbidity, therapeutic process/alliance, and sociodemographic status as potential predictors of in vivo exposure. METHOD: We applied correlational analyses and logistic regression analyses in a sample of N = 92 patients (main diagnosis AG) in an outpatient setting. RESULTS: Logistic regression analyses did not yield any significant single predictors, whereas a combination of a subset of predictors significantly predicted the application of exposure in vivo in the completer sample (R2 = .24, p = .041). CONCLUSION: The application of in vivo exposure may be predicted by a complex pattern of patient characteristics.

The predictive value of early response in patients with depressive disorders.

OBJECTIVE: Several randomized controlled trials have identified early response to psychotherapy as a predictor for later treatment outcome among patients with depressive disorders. However, supporting evidence under routine conditions is rare. This study evaluated the predictive value of early improvement for final outcomes in psychotherapy among depressive patients in the naturalistic setting of a German university outpatient clinic. METHOD: We used the method of percent symptom reduction to classify 639 patients with major depression or dysthymic disorder who underwent an average of 40.0 sessions (SD = 16.3) of naturalistic cognitive-behavioral therapy (CBT) as having either an early response or an early nonresponse. RESULTS: Early response was a good predictor for final response and remission regarding depressive symptoms (OR = 8.75 and OR = 5.32, respectively), as well as overall psychological distress (OR = 3.95 and OR = 3.16, respectively). Early nonresponse was distinctly associated with later deterioration of both depressive (OR = 9.56) and general psychological symptomatology (OR = 4.92). CONCLUSIONS: Early response to psychotherapy has high predictive qualities for positive later treatment outcome in depressive patients under routine CBT. Therefore, early treatment effects should be considered in clinical decision-making and treatment planning in everyday clinical practice.

Long-term cost-effectiveness of cognitive behavioral therapy versus psychodynamic therapy in social anxiety disorder.

BACKGROUND: To determine the cost-effectiveness of cognitive behavioral therapy (CBT) versus psychodynamic therapy (PDT) in the treatment of social anxiety disorder after a follow-up of 30 months from a societal perspective. METHODS: This analysis was conducted alongside the multicenter SOPHO-NET trial; adults with a primary diagnosis of social anxiety disorder received CBT (n = 209) or PDT (n = 207). Data on health care utilization and productivity loss were collected at baseline, after 6 months (posttreatment), and three further follow-ups to calculate direct and indirect costs. Anxiety-free days (AFDs) calculated based on remission and response were used as measure of effect. The incremental cost-effectiveness ratio (ICER) was determined. Net benefit regressions, adjusted for comorbidities and baseline differences, were applied to derive cost-effectiveness acceptability curves. RESULTS: In the descriptive analysis, the unadjusted ICER favored CBT over PDT and the adjusted analysis showed that CBT's cost-effectiveness relative to PDT depends on the willingness to pay (WTP) per AFD. As baseline costs differed substantially the unadjusted estimates might be deceptive. If additional WTPs for CBT of €0, €10, and €30 were assumed, the probability of CBT being cost-effective relative to PDT was 65, 83, and 96%. Direct costs increased compared to baseline across groups, whereas indirect costs did not change significantly. Results were sensitive to considered costs. CONCLUSIONS: If the society is willing to pay ≥€30 per additional AFD, CBT can be considered cost-effective, relative to PDT, with certainty. To further increase the cost-effectiveness more knowledge regarding predictors of treatment outcome seems essential.

Multicenter prospective evaluation of a new articulating 5-mm endoscopic linear stapler.

BACKGROUND: The objective of this study was to evaluate the safety and efficacy of a novel 5-mm laparoscopic linear stapler in clinical gastrointestinal surgical applications. METHODS: A prospective, single-arm study with an open enrollment of subjects requiring stapling of the gastrointestinal (GI) tract was performed. The study endpoints were the number of complications and technical failures associated with the use of a novel stapler when compared to similar events with conventional staplers as described in the medical literature. RESULTS: Seven centers enrolled 160 subjects, 150 of which were followed up to at least 30 days postoperatively. Intraoperative success: In 423 deployments, there were two staple line leaks and five staple line bleeds, all of which were intraoperatively resolved. In addition, incomplete staple lines were noted as a result of user error (n = 15) or device-related issues (n = 22), all of which were immediately resolved and none of which resulted in a complication or a change of the surgical procedure. Late outcomes: A total of 13 surgical complications in 160 patients were related to a GI transection or anastomosis, 12 of which related to a hand-sewn anastomosis or use of other commercially available staplers. One event (1/153, 0.065 %) on POD 1, involving bleeding of the staple line, was felt to be related to the use of the new stapler. CONCLUSION: The study confirmed that the new device was user-friendly (9 % incidence of problems firing the device), reliable (3 % device failures) and safe (<1 % complication rate related to the stapler). Based on these results, it would seem that this new 5-mm stapler is a safe and effective alternative to standard 12-mm staplers.

Psychosocial Profile of Women with Premenstrual Syndrome and Healthy Controls: A Comparative Study.

PURPOSE: According to modern bio-psychosocial theories of premenstrual syndrome (PMS), the aim of this study is to investigate systematically associations between selected psychosocial factors and premenstrual symptoms in different menstrual cycle phases. METHOD: Several psychosocial variables were assessed, in a sample of German women with PMS (N = 90) and without premenstrual complaints (N = 48) during the follicular and luteal phase of the menstrual cycle. Presence of PMS was indicated by analysis of contemporary daily ratings of premenstrual symptom severity and impairment for one menstrual cycle. RESULTS: Regarding perceived chronic stress (ƞ 2 = 0.34), self-efficacy (ƞ 2 = 0.12), and two dimensions of self-silencing (0.06 ≤ ƞ 2 ≤ 0.11) analyses revealed only a significant effect of group. Regarding body dissatisfaction and somatosensory amplification, a significant effect of group (0.07 ≤ ƞ 2 ≤ 0.16) and additionally a group by menstrual cycle phase interaction (ƞ 2 = 0.06) was identified. Regarding relationship quality, a significant effect of menstrual cycle phase (ƞ 2 = 0.08) and a group by menstrual cycle phase interaction (ƞ 2 = 0.06) was demonstrated. In respect to sexual contentment, acceptance of premenstrual symptoms, and the remaining two dimensions of self-silencing statistical analyses revealed no effects at all. Linear multiple regression analysis revealed that 20 % of the variance in PMS symptom severity was explained by the psychosocial variables investigated. Body dissatisfaction (ß = 0.26, p = 0.018) and the divided self-dimension of self-silencing (ß = 0.35, p = 0.016) were significant correlates of PMS severity. CONCLUSION: Results of this study are consistent with previous research and additionally show patterns of associations between specific psychosocial factors and PMS in dependence of menstrual cycle phase that have not been researched before. The role of the psychosocial variables we investigated in regard to the development and maintenance of PMS should be clarified in future research.

Baseline Patient Characteristics Predicting Outcome and Attrition in Cognitive Therapy for Social Phobia: Results from a Large Multicentre Trial.

UNLABELLED: We examined the role of baseline patient characteristics as predictors of outcome (end-state functioning, response and remission) and attrition for cognitive therapy (CT) in social anxiety disorder (SAD). Beyond socio-demographic and clinical variables such as symptom severity and comorbidity status, previously neglected patient characteristics (e.g., personality, self-esteem, shame, interpersonal problems and attachment style) were analysed. METHOD: Data came from the CT arm of a multicentre RCT with n = 244 patients having DSM-IV SAD. CT was conducted according to the manual by Clark and Wells. Severity of SAD was assessed at baseline and end of treatment with the Liebowitz Social Anxiety Scale (LSAS). Multiple linear regression analyses and logistic regression analyses were applied. RESULTS: Up to 37% of the post-treatment variance (LSAS) could be explained by all pre-treatment variables combined. Symptom severity (baseline LSAS) was consistently negatively associated with end-state functioning and remission, but not with response. Number of comorbid diagnoses was negatively associated with end-state functioning and response, but not with remission. Self-esteem was positively associated with higher end-state functioning and more shame with better response. Attrition could not be significantly predicted. CONCLUSIONS: The results indicate that the initial probability for treatment success mainly depends on severity of disorder and comorbid conditions while other psychological variables are of minor importance, at least on a nomothetic level. This stands in contrast with efforts to arrive at an empirical-based foundation for differential indication and argues to search for more potent moderators of therapeutic change rather on the process level. KEY PRACTITIONER MESSAGE: Personality, self-esteem, shame, attachment style and interpersonal problems do not or only marginally moderate the effects of interventions in CT of social phobia. Symptom severity and comorbid diagnoses might affect treatment outcome negatively. Beyond these two factors, most patients share a similar likelihood of treatment success when treated according to the manual by Clark and Wells. Copyright © 2014 John Wiley & Sons, Ltd.

The Role of Dysfunctional Cognitions in Patients With Chronic Tinnitus.

OBJECTIVES: The present study investigates the role of dysfunctional cognitions in patients with chronic tinnitus. To explore different dimensions of tinnitus-related thoughts, a 22-item self-report measure, the "Tinnitus Cognitions Scale" (T-Cog), is presented. Furthermore, dysfunctional cognitions are examined as a possible mediator of the relation between tinnitus distress and depression. DESIGN: The present study analyzes the cross-sectional data of 373 patients with chronic tinnitus. Parallel analysis and principal axis factoring are used to identify the factor structure of the T-Cog. Assumed mediating effects are tested using the asymptotic and resampling procedure. RESULTS: Factor analysis reveals two factors interpreted as "tinnitus-related catastrophic thinking" and "tinnitus-related avoidance cognitions." Internal consistency is sufficient with a Cronbach's α of 0.88 for the total scale and 0.74 and 0.87 for the subscales. The authors find high associations between the T-Cog and other measures of tinnitus distress, depression, anxiety, and tinnitus acceptance, indicating convergent validity. With the exception of neuroticism, low correlations with personality factors are found, indicating discriminant validity. Patients with moderate or severe tinnitus distress report significantly higher scores of dysfunctional cognitions than patients with mild tinnitus distress. Tinnitus-related catastrophic thinking and tinnitus-related avoidance cognitions partially mediate the relation between tinnitus distress and depression. CONCLUSIONS: Dysfunctional cognitions can play an important role in the degree of tinnitus distress. Catastrophic and avoidant thoughts contribute to the explanation of depression among tinnitus patients. The T-Cog is a reliable and valid questionnaire for the assessment of different dimensions of cognitions. Its use could provide information for identifying tinnitus patients who are particularly suitable for cognitive-behavioral therapy.

The changeability and predictive value of dysfunctional cognitions in cognitive behavior therapy for chronic tinnitus.

BACKGROUND: Multidimensional tinnitus models describe dysfunctional cognitions as a complicating factor in the process of tinnitus habituation. However, this concept has rarely been investigated in previous research. PURPOSE: The present study investigated the effects of two cognitive-behavioral treatments on dysfunctional tinnitus-related cognitions in patients with chronic tinnitus. Furthermore, dysfunctional cognitions were examined as possible predictors of the therapeutic effect on tinnitus distress. METHOD: A total of 128 patients with chronic tinnitus were randomly assigned to either an Internet-delivered guided self-help treatment (Internet-based cognitive-behavioral therapy, ICBT), a conventional face-to-face group therapy (cognitive-behavioral group therapy, GCBT), or an active control group in the form of a web-based discussion forum (DF). To assess tinnitus-related dysfunctional thoughts, the Tinnitus Cognitions Scale (T-Cog) was used at pre- and post-assessment, as well as at the 6- and 12-month follow-up. RESULTS: Multivariate ANOVAs with post hoc tests revealed significant and comparable reductions of dysfunctional tinnitus-related cognitions for both treatments (GCBT and ICBT), which remained stable over a 6- and 12-month period. Negative correlations were found between the catastrophic subscale of the T-Cog and therapy outcome for ICBT, but not for GCBT. This means a higher degree of catastrophic thinking at baseline was associated with lower benefit from ICBT directly after the treatment. Hierarchical regression analysis confirmed catastrophizing as a predictor of poorer therapy outcome regarding emotional tinnitus distress in ICBT. No associations were detected in the follow-up assessments. CONCLUSION: Both forms of CBT are successful in reducing dysfunctional tinnitus-related cognitions. Catastrophizing significantly predicted a less favorable outcome regarding emotional tinnitus distress in ICBT. Clinical implications of these results are described. Dysfunctional cognitions could be targeted more intensively in therapy and in future research on tinnitus.

Insulinoma as rare cause of severe post-partum hypoglycemia.

Post-partum hypoglycemia in non-diabetic women is a rare condition. We report the exceptional case of a 38-year-old obese woman who experienced recurrent neuroglycopenia 3 weeks after delivery. Corresponding to severe hypoglycemia with blood glucose levels of <30 mg/dL, there was no suppression of insulin or C-peptide. Through endoscopic ultrasound we detected a hypoechoic lesion of 8 × 9 mm localized in the head of the pancreas. Thus, the diagnosis of insulinoma was most probable. Complete surgical enucleation of the insulinoma resulted in immediate and permanent resolution of hypoglycemia. The postoperative course was complicated by recurrent episodes of pancreatitis requiring endoscopic ultrasound-guided punctures of pseudocysts and temporary stenting of the pancreatic duct. In conclusion, insulinoma is a very rare, nonetheless important, differential diagnosis of post-partum hypoglycemia.

The affective response to health-related information and its relationship to health anxiety: an ambulatory approach.

Affective reactions to health-related information play a central role in health anxiety. Therefore, using ambulatory assessment, we analysed the time course of negative affect in a control group (CG, n = 60) which only rated their negative affect and an experimental group (EG, n = 97) which also rated the presence of somatic symptoms (e.g., back pain). By means of mixed regression models, we observed a decline of negative affect following the symptom self-ratings in the EG and a stable affect in the CG. The decline of negative affect was not moderated by the degree of health anxiety. Our findings might indicate that evaluating one's health status leads to a general reduction of negative affect in healthy individuals. The results of the study are in line with a bidirectional symptom perception model and underline the crucial role of affect regulation in the processing of health-related information.

The impact of hyperacusis and hearing loss on tinnitus perception in German teachers.

Recent research indicates that a notable number of teachers are concerned with conditions of auditory impairment such as tinnitus, hyperacusis, and hearing loss. Studies focussing on characteristics and interdependencies of single hearing disorders (HD) are rare. This explorative study examines tinnitus, hyperacusis, hearing loss, and all possible combinations (tinnitus + hyperacusis; tinnitus + hearing loss; hyperacusis + hearing loss; tinnitus, hyperacusis + hearing loss) in German teachers. The impact of single HD on perceived distress, depending on the number and kind of comorbid HD, was of special interest. Information was collected via online survey and includes self-reported data as well as data from the Mini-Tinnitus Questionnaire (Mini-TQ). Results show that most of the 1468 participants (45%) suffered from two HD in different combinations, and the fewest (25%) were afflicted with only one HD. Considering the seven HD groups, most teachers (30%) suffered from all three HD. Across all groups, tinnitus was present in 1096, hyperacusis in 988, and hearing loss in 937 teachers. Multiple intergroup comparisons revealed that self-rated tinnitus-related distress rose significantly with the increasing number of HD. No significant differences were found for distress ratings of hyperacusis between the four groups including hyperacusis and between the four groups with hearing loss. In the Mini-TQ, groups including hyperacusis scored considerably higher than those excluding hyperacusis. The frequent prevalence of HD in German teachers points to a need of better noise prevention in German schools as one priority of occupational safety.

Clinical Profiles of Premenstrual Experiences Among Women Having Premenstrual Syndrome (PMS): Affective Changes Predominate and Relate to Social and Occupational Functioning.

Our objective for this study was to examine symptom severity among women suffering from premenstrual syndrome as well as associations between symptom severity and impairment. In a one-cycle prospective study, various premenstrual symptoms of 91 women were assessed. Tension and irritability were the most severe symptoms. Headache, irritability, self-deprecating thoughts, and depressed mood were the symptoms that were subjectively rated as the most burdensome. Significant correlations were found between the mean premenstrual severity and functional impairment. The severity of premenstrual affective symptoms was related to social impairment. The severity of psychological symptoms was correlated with occupational impairment. These findings confirm the prominent role of premenstrual affective symptoms and support classification guidelines focusing on both affective and physical changes.

Internet-based guided self-help versus group cognitive behavioral therapy for chronic tinnitus: a randomized controlled trial.

BACKGROUND: The aim of this randomized controlled trial was to investigate the effects of conventional face-to-face group cognitive behavioral therapy (GCBT) and an Internet-delivered guided self-help treatment (Internet-based CBT, ICBT) on tinnitus distress. METHODS: A total of 128 adults with at least mild levels of chronic tinnitus distress were randomly assigned to GCBT (n = 43), ICBT (n = 41), or a web-based discussion forum (DF) that served as a control condition (n = 44). Standardized self-report measures [the Tinnitus Handicap Inventory (THI), Mini-Tinnitus Questionnaire (Mini-TQ), Hospital Anxiety and Depression Scale, Insomnia Severity Index and Tinnitus Acceptance Questionnaire] were completed at the pre- and post-assessments and at the 6-month follow-up. RESULTS: Repeated-measures ANOVAs revealed significant time × group interaction effects on the primary outcomes (THI and Mini-TQ scores) in favor of both CBT interventions compared with the DF at post-assessment (0.56 ≤ g ≤ 0.93; all p ≤ 0.001). There were no significant differences between GCBT and ICBT (all p > 0.05) and the treatment effects remained stable at the 6-month follow-up. CONCLUSIONS: This study provides evidence that ICBT might be an equally effective alternative to conventional CBT in the management of chronic tinnitus. Despite encouraging results, further research is necessary to determine the actual potential of ICBT as a viable alternative to CBT, and under which circumstances it is effective.

Reducing symptoms of major depressive disorder through a systematic training of general emotion regulation skills: protocol of a randomized controlled trial.

BACKGROUND: Major Depressive Disorder is one of the most challenging mental health problems of our time. Although effective psychotherapeutic treatments are available, many patients fail to demonstrate clinically significant improvements. Difficulties in emotion regulation have been identified as putative risk and maintaining factors for Major Depressive Disorder. Systematically enhancing adaptive emotion regulation skills should thus help reduce depressive symptom severity. However, at this point, no study has systematically evaluated effects of increasing adaptive emotion regulation skills application on symptoms of Major Depressive Disorder. In the intended study, we aim to evaluate stand-alone effects of a group-based training explicitly and exclusively targeting general emotion regulation skills on depressive symptom severity and assess whether this training augments the outcome of subsequent individual cognitive behavioral therapy for depression. METHODS/DESIGN: In the evaluation of the Affect Regulation Training, we will conduct a prospective randomized-controlled trial. Effects of the Affect Regulation Training on depressive symptom severity and outcomes of subsequent individual therapy for depression will be compared with an active, common factor based treatment and a waitlist control condition. The study sample will include 120 outpatients meeting criteria for Major Depressive Disorder. Depressive symptom severity as assessed by the Hamilton Rating Scale will serve as our primary study outcome. Secondary outcomes will include further indicators of mental health and changes in adaptive emotion regulation skills application. All outcomes will be assessed at intake and at 10 points in time over the course of the 15-month study period. Measures will include self-reports, observer ratings, momentary ecological assessments, and will be complemented in subsamples by experimental investigations and the analysis of hair steroids. DISCUSSION: If findings should support the hypothesis that enhancing regulation skills reduces symptom severity in Major Depressive Disorder, systematic emotion regulation skills training can enhance the efficacy and efficiency of current treatments for this severe and highly prevalent disorder. TRIAL REGISTRATION: This study is registered with ClinicalTrials.gov, number NCT01330485.

Pharmacological interventions for somatoform disorders in adults.

BACKGROUND: Somatoform disorders are characterised by chronic, medically unexplained physical symptoms (MUPS). Although different medications are part of treatment routines for people with somatoform disorders in clinics and private practices, there exists no systematic review or meta-analysis on the efficacy and tolerability of these medications. We aimed to synthesise to improve optimal treatment decisions. OBJECTIVES: To assess the effects of pharmacological interventions for somatoform disorders (specifically somatisation disorder, undifferentiated somatoform disorder, somatoform autonomic dysfunction, and pain disorder) in adults. SEARCH METHODS: We searched the Cochrane Depression, Anxiety and Neurosis Review Group's Specialised Register (CCDANCTR) (to 17 January 2014). This register includes relevant randomised controlled trials (RCTs) from The Cochrane Library (all years), MEDLINE (1950 to date), EMBASE (1974 to date), and PsycINFO (1967 to date). To identify ongoing trials, we searched ClinicalTrials.gov, Current Controlled Trials metaRegister, the World Health Organization International Clinical Trials Registry Platform, and the Chinese Clinical Trials Registry. For grey literature, we searched ProQuest Dissertation & Theses Database, OpenGrey, and BIOSIS Previews. We handsearched conference proceedings and reference lists of potentially relevant papers and systematic reviews and contacted experts in the field. SELECTION CRITERIA: We selected RCTs or cluster RCTs of pharmacological interventions versus placebo, treatment as usual, another medication, or a combination of different medications for somatoform disorders in adults. We included people fulfilling standardised diagnostic criteria for somatisation disorder, undifferentiated somatoform disorder, somatoform autonomic dysfunction, or somatoform pain disorder. DATA COLLECTION AND ANALYSIS: One review author and one research assistant independently extracted data and assessed risk of bias. Primary outcomes included the severity of MUPS on a continuous measure, and acceptability of treatment. MAIN RESULTS: We included 26 RCTs (33 reports), with 2159 participants, in the review. They examined the efficacy of different types of antidepressants, the combination of an antidepressant and an antipsychotic, antipsychotics alone, or natural products (NPs). The duration of the studies ranged between two and 12 weeks.One meta-analysis of placebo-controlled studies showed no clear evidence of a significant difference between tricyclic antidepressants (TCAs) and placebo for the outcome severity of MUPS (SMD -0.13; 95% CI -0.39 to 0.13; 2 studies, 239 participants; I(2) = 2%; low-quality evidence). For new-generation antidepressants (NGAs), there was very low-quality evidence showing they were effective in reducing the severity of MUPS (SMD -0.91; 95% CI -1.36 to -0.46; 3 studies, 243 participants; I(2) = 63%). For NPs there was low-quality evidence that they were effective in reducing the severity of MUPS (SMD -0.74; 95% CI -0.97 to -0.51; 2 studies, 322 participants; I(2) = 0%).One meta-analysis showed no clear evidence of a difference between TCAs and NGAs for severity of MUPS (SMD -0.16; 95% CI -0.55 to 0.23; 3 studies, 177 participants; I(2) = 42%; low-quality evidence). There was also no difference between NGAs and other NGAs for severity of MUPS (SMD -0.16; 95% CI -0.45 to 0.14; 4 studies, 182 participants; I(2) = 0%).Finally, one meta-analysis comparing selective serotonin reuptake inhibitors (SSRIs) with a combination of SSRIs and antipsychotics showed low-quality evidence in favour of combined treatment for severity of MUPS (SMD 0.77; 95% CI 0.32 to 1.22; 2 studies, 107 participants; I(2) = 23%).Differences regarding the acceptability of the treatment (rate of all-cause drop-outs) were neither found between NGAs and placebo (RR 1.01, 95% CI 0.64 to 1.61; 2 studies, 163 participants; I(2) = 0%; low-quality evidence) or NPs and placebo (RR 0.85, 95% CI 0.40 to 1.78; 3 studies, 506 participants; I(2) = 0%; low-quality evidence); nor between TCAs and other medication (RR 1.48, 95% CI 0.59 to 3.72; 8 studies, 556 participants; I(2) =14%; low-quality evidence); nor between antidepressants and the combination of an antidepressant and an antipsychotic (RR 0.80, 95% CI 0.25 to 2.52; 2 studies, 118 participants; I(2) = 0%; low-quality evidence). Percental attrition rates due to adverse effects were high in all antidepressant treatments (0% to 32%), but low for NPs (0% to 1.7%).The risk of bias was high in many domains across studies. Seventeen trials (65.4%) gave no information about random sequence generation and only two (7.7%) provided information about allocation concealment. Eighteen studies (69.2%) revealed a high or unclear risk in blinding participants and study personnel; 23 studies had high risk of bias relating to blinding assessors. For the comparison NGA versus placebo, there was relatively high imprecision and heterogeneity due to one outlier study. Although we identified 26 studies, each comparison only contained a few studies and small numbers of participants so the results were imprecise. AUTHORS' CONCLUSIONS: The current review found very low-quality evidence for NGAs and low-quality evidence for NPs being effective in treating somatoform symptoms in adults when compared with placebo. There was some evidence that different classes of antidepressants did not differ in efficacy; however, this was limited and of low to very low quality. These results had serious shortcomings such as the high risk of bias, strong heterogeneity in the data, and small sample sizes. Furthermore, the significant effects of antidepressant treatment have to be balanced against the relatively high rates of adverse effects. Adverse effects produced by medication can have amplifying effects on symptom perceptions, particularly in people focusing on somatic symptoms without medical causes. We can only draw conclusions about short-term efficacy of the pharmacological interventions because no trial included follow-up assessments. For each of the comparisons where there were available data on acceptability rates (NGAs versus placebo, NPs versus placebo, TCAs versus other medication, and antidepressants versus a combination of an antidepressant and an antipsychotic), no clear differences between the intervention and comparator were found.Future high-quality research should be carried out to determine the effectiveness of medications other than antidepressants, to compare antidepressants more thoroughly, and to follow-up participants over longer periods (the longest follow up was just 12 weeks). Another idea for future research would be to include other outcomes such as functional impairment or dysfunctional behaviours and cognitions as well as the classical outcomes such as symptom severity, depression, or anxiety.

Health anxiety, cognitive coping, and emotion regulation: a latent variable approach.

BACKGROUND: Health anxiety, the fear or conviction of suffering from a severe disorder, represents a dimensional and multifactorial construct consisting of cognitive, behavioral, affective, and perceptual components. It has recently been proposed that dysfunctional emotion regulation strategies contribute to health anxiety, but the empirical evidence for this claim is sparse. PURPOSE: The current research was aimed at broadly exploring and clarifying possible relationships between dimensions of health anxiety and cognitive coping and emotion regulation strategies. METHOD: In two studies with non-clinical samples (n study 1 = 172; n study 2 = 242), health anxiety, cognitive coping, and emotion regulation strategies were assessed using multidimensional self-report measures. Functional (e.g., reappraisal) and dysfunctional (e.g., rumination) cognitive coping and emotion regulation strategies were differentiated. RESULTS: Using structural equation modeling, the results of Study 1 revealed significant and consistent associations between the dimensions of health anxiety and dysfunctional coping and emotion regulation strategies. Study 2 replicated and extended the main findings of Study 1 by demonstrating that the associations between health anxiety and strategies of coping and emotion regulation were independent of the current level of depressive symptoms. CONCLUSION: Health anxiety was found to be associated with dysfunctional coping and emotion regulation strategies (e.g., suppression). The positive associations between behavioral dimensions of health anxiety (e.g., seeking reassurance) and dysfunctional coping strategies may suggest that behavioral dimensions of health anxiety serve as a compensatory strategy to overcome difficulties in cognitive coping.

Tinnitus-related distress and the personality characteristic resilience.

It has been suggested that personality traits may be prognostic for the severity of suffering from tinnitus. Resilience as measured with the Wagnild and Young resilience scale represents a positive personality characteristic that promotes adaptation to adverse life conditions including chronic health conditions. Aim of the study was to explore the relation between resilience and tinnitus severity. In a cross-sectional study with a self-report questionnaire, information on tinnitus-related distress and subjective tinnitus loudness was recorded together with the personality characteristic resilience and emotional health, a measure generated from depression, anxiety, and somatic symptom severity scales. Data from 4705 individuals with tinnitus indicate that tinnitus-related distress and to a lesser extent the experienced loudness of the tinnitus show an inverse correlation with resilience. A mediation analysis revealed that the relationship between resilience and tinnitus-related distress is mediated by emotional health. This indirect effect indicates that high resilience is associated with better emotional health or less depression, anxiety, and somatic symptom severity, which in turn is associated with a less distressing tinnitus. Validity of resilience as a predictor for tinnitus-related distress is supported but needs to be explored further in longitudinal studies including acute tinnitus patients.