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.

Pharmacological interventions for somatoform disorders in adults.

Importance Primary care clinicians find managing chronic pain challenging. Evidence of long-term efficacy of opioids for chronic pain is limited. Opioid use is associated with serious risks, including opioid use disorder and overdose. Objective To provide recommendations about opioid prescribing for primary care clinicians treating adult patients with chronic pain outside of active cancer treatment, palliative care, and end-of-life care. Process The Centers for Disease Control and Prevention (CDC) updated a 2014 systematic review on effectiveness and risks of opioids and conducted a supplemental review on benefits and harms, values and preferences, and costs. CDC used the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework to assess evidence type and determine the recommendation category. Evidence Synthesis Evidence consisted of observational studies or randomized clinical trials with notable limitations, characterized as low quality using GRADE methodology. Meta-analysis was not attempted due to the limited number of studies, variability in study designs and clinical heterogeneity, and methodological shortcomings of studies. No study evaluated long-term (≥1 year) benefit of opioids for chronic pain. Opioids were associated with increased risks, including opioid use disorder, overdose, and death, with dose-dependent effects. Recommendations There are 12 recommendations. Of primary importance, nonopioid therapy is preferred for treatment of chronic pain. Opioids should be used only when benefits for pain and function are expected to outweigh risks. Before starting opioids, clinicians should establish treatment goals with patients and consider how opioids will be discontinued if benefits do not outweigh risks. When opioids are used, clinicians should prescribe the lowest effective dosage, carefully reassess benefits and risks when considering increasing dosage to 50 morphine milligram equivalents or more per day, and avoid concurrent opioids and benzodiazepines whenever possible. Clinicians should evaluate benefits and harms of continued opioid therapy with patients every 3 months or more frequently and review prescription drug monitoring program data, when available, for high-risk combinations or dosages. For patients with opioid use disorder, clinicians should offer or arrange evidence-based treatment, such as medication-assisted treatment with buprenorphine or methadone. Conclusions and Relevance The guideline is intended to improve communication about benefits and risks of opioids for chronic pain, improve safety and effectiveness of pain treatment, and reduce risks associated with long-term opioid therapy.

/pdf/cdc-guideline-for-prescribing-opioids-for-chronic-pain-j4r6nt5nmj.pdf

CDC Guideline for Prescribing Opioids for Chronic Pain—United States, 2016

/pdf/cdc-guideline-for-prescribing-opioids-for-chronic-pain-48d7kdjqlr.pdf

CDC guideline for prescribing opioids for chronic pain

Summary estimates of treatment effect from random effects meta-analysis give only the average effect across all studies. Inclusion of prediction intervals, which estimate the likely effect in an individual setting, could make it easier to apply the results to clinical practice

/pdf/interpretation-of-random-effects-meta-analyses-3wqyseoko4.pdf

Interpretation of random effects meta-analyses.

Importance Many people meditate to reduce psychological stress and stress-related health problems. To counsel people appropriately, clinicians need to know what the evidence says about the health benefits of meditation. Objective To determine the efficacy of meditation programs in improving stress-related outcomes (anxiety, depression, stress/distress, positive mood, mental health–related quality of life, attention, substance use, eating habits, sleep, pain, and weight) in diverse adult clinical populations. Evidence Review We identified randomized clinical trials with active controls for placebo effects through November 2012 from MEDLINE, PsycINFO, EMBASE, PsycArticles, Scopus, CINAHL, AMED, the Cochrane Library, and hand searches. Two independent reviewers screened citations and extracted data. We graded the strength of evidence using 4 domains (risk of bias, precision, directness, and consistency) and determined the magnitude and direction of effect by calculating the relative difference between groups in change from baseline. When possible, we conducted meta-analyses using standardized mean differences to obtain aggregate estimates of effect size with 95% confidence intervals. Findings After reviewing 18 753 citations, we included 47 trials with 3515 participants. Mindfulness meditation programs had moderate evidence of improved anxiety (effect size, 0.38 [95% CI, 0.12-0.64] at 8 weeks and 0.22 [0.02-0.43] at 3-6 months), depression (0.30 [0.00-0.59] at 8 weeks and 0.23 [0.05-0.42] at 3-6 months), and pain (0.33 [0.03- 0.62]) and low evidence of improved stress/distress and mental health–related quality of life. We found low evidence of no effect or insufficient evidence of any effect of meditation programs on positive mood, attention, substance use, eating habits, sleep, and weight. We found no evidence that meditation programs were better than any active treatment (ie, drugs, exercise, and other behavioral therapies). Conclusions and Relevance Clinicians should be aware that meditation programs can result in small to moderate reductions of multiple negative dimensions of psychological stress. Thus, clinicians should be prepared to talk with their patients about the role that a meditation program could have in addressing psychological stress. Stronger study designs are needed to determine the effects of meditation programs in improving the positive dimensions of mental health and stress-related behavior.

https://jamanetwork.com/journals/jamainternalmedicine/articlepdf/1809754/ioi130131.pdf

Meditation Programs for Psychological Stress and Well-being: A Systematic Review and Meta-analysis

The aim of this study was to determine if ileal pouch-anal anastomosis in patients with ulcerative colitis is a psychologic burden for patients, the frequency of mental disorders, the amount of psychologic distress, and their possible disease-related determinants. These factors were studied in patients with ulcerative colitis after ileal pouch anal anastomosis and were compared with ulcerative colitis patients without ileal pouch-anal anastomosis and the general German population. A total of 37 patients with ulcerative colitis after ileal pouch-anal anastomosis (age 46.8 ± 11.8 years; 35 percent female) and 62 patients with ulcerative colitis without ileal pouch-anal anastomosis (age 44.4 ± 13.9 years; 37 percent female) completed the following questionnaires: medical and sociodemographic questionnaire of the German Competence Network “Inflammatory Bowel Diseases” and the German version of the Hospital Anxiety and Depression Scale. Disease activity was measured in patients with ileal pouch-anal anastomosis by the Pouch Disease Activity Index and in patients without ileal pouch-anal anastomosis by the German Inflammatory Bowel Disease Activity Index. Psychologic distress was assessed by the subscale scores of the Hospital Anxiety and Depression Scale. A probable mental disorder was identified if a patient scored 11 or higher in at least one subscale of the Hospital Anxiety and Depression Scale. The frequency of a probable psychiatric disorder in patients with ileal pouch-anal anastomosis (16 percent) and without ileal pouch-anal anastomosis (23 percent) did not differ from that in the general German population (17 percent). Ulcerative colitis patients with or without ileal pouch-anal anastomosis did not differ in the amount of psychologic distress. Ileal pouch-anal anastomosis patients had higher levels of anxiety than the general population (P
 < 0.01). Regression models of disease-related factors predicting mental disorder and psychologic distress showed no significant results. Ileal pouch-anal anastomosis neither increases nor decreases the frequency of mental disorders or the amount of psychologic distress in ulcerative colitis patients.

Mental Disorder and Psychologic Distress in Patients With Ulcerative Colitis After Ileal Pouch-Anal Anastomosis

Einleitung: Patientenzentrierung und eine gute Arbeitsallianz sind zentrale Merkmale der hausarztlichen Behandlung. Umfragen zeigen, dass die meisten Deutschen mit der Beziehung zu ihrem Hausarzt zufrieden sind. Jedoch ist offen, welche Faktoren die Qualitat der Beziehung zum Hausarzt beeinflussen. Diese Studie hat daher zum Ziel, patientenbezogene Pradiktoren der Qualitat der Beziehung zwischen Hausarzt und Patient zu identifizieren. Material und Methoden: Personen einer reprasentativen Stichprobe der deutschen Allgemeinbevolkerung wurden im Rahmen einer Querschnittstudie mit standardisierten Fragebogen untersucht. Die Qualitat der Hausarzt-Patient-Beziehung wurde mit der deutschen Version des Patient-Doctor Relationship Questionnaire (PDRQ-9) erfasst. Mogliche Assoziationen von demografischen und klinischen Variablen (somatische Komorbiditat, korperliche und psychische Symptombelastung) mit der Qualitat der Hausarzt-Patient-Beziehung wurden mittels einer hierarchischen linearen Regressionsanalyse uberpruft. Ergebnisse: 2 278 Probanden (91,9%) gaben an, einen Hausarzt zu haben. Der Gesamtmittelwert im PDRQ-9 war hoch (M=4,12, SD=0,70). Das finale Regressionsmodell zeigte, dass hoheres Alter, weibliches Geschlecht und vor allem geringere somatische und depressive Symptombelastung als Pradiktoren einer guten Hausarzt-Patient-Beziehung fungierten. Der initiale Effekt der somatischen Komorbiditat verschwand, nachdem die korperliche Symptombelastung in die Regression aufgenommen wurde. Die erzielte Varianzaufklarung von 11% entspricht einem kleinen Effekt. Schlussfolgerung: Das subjektive Erleben von Beschwerden stellt den relevanten patientenseitigen Einflussfaktor fur die von Patienten wahrgenommene Qualitat der Beziehung zum Hausarzt dar.

[The Quality of the Family Physician-Patient Relationship. Patient-Related Predictors in a Sample Representative for the German Population].

Eine symptombasierte Diagnose des Fibromyalgiesyndroms (FMS) ohne Tenderpointuberprufung ist fur die arztliche Primarversorgung sinnvoll. Wir uberpruften, ob eine symptombasierte Diagnose eines FMS auf die Intensitat der Symptome „Gliederschmerzen“ sowie „Erschopfung“ gegrundet werden kann. FMS-Patienten aus 4 verschiedenen klinischen Settings (464 Teilnehmer einer Selbsthilfeorganisation, 162 Gutachtenpatienten, 33 aus einer rheumatologischen Praxis, 36 aus einer Schmerzambulanz), 691 Patienten mit Ruckenschmerzen eines ambulanten Therapiezentrums, Patienten mit depressiven Storungen aus 2 klinischen Settings (24 aus einer psychiatrisch-psychotherapeutischen Klinik, 311 einer psychosomatisch-psychotherapeutische Ambulanz) und 1977 Personen einer allgemeinen Bevolkerungsstichprobe wurden hinsichtlich der Skalenmittelwerte des Giesener Beschwerdebogens GBB-24 verglichen. In den Skalen „Gliederschmerzen“ und „Erschopfung“ fanden sich die grosten Mittelwertdifferenzen zwischen FMS-Patienten und den ubrigen Stichproben. Auch in den Skalen „Herzbeschwerden“ und „Magenbeschwerden“ hatten die FMS-Patienten erhohte Werte, diese beiden Skalen erbrachten jedoch keinen zusatzlichen Beitrag (zusatzlich zu Gliederschmerzen und Erschopfung) zur Gruppentrennung. Die Reklassifikationsraten anhand des GBB-24-Kriteriums nach logistischer Regression lagen zwischen 80 und 93%. Eine hohe Intensitat chronischer Schmerzen in mehreren Korperregionen und chronische Erschopfung/Mudigkeit konnen die Grundlage fur eine symptombasierte Diagnose des FMS bilden.

Intensität von Gliederschmerzen und Erschöpfung bei Fibromyalgiesyndrom, depressiven Störungen und chronischen Rückenschmerzen

In Germany no data are available on the prevalence and predictors of urogenital pain in men from representative population samples.Persons older than 14 years of age from a representative sample of the German population were examined by standardized questionnaires within a cross-sectional survey. Urogenital pain was assessed by the German version of the National Institutes of Health Chronic Prostatitis Symptoms Index (NIH-CPSI), depression by the patient health questionnaire PHQ-9 and health-related quality of life by the short form health survey SF-36.A total of 2,043 persons (66.5%s) took part in the study and 960 men with a mean age of 47.2 years were analyzed. The 1-week prevalence of urogenital pain was 9.6% whereby 2.4% met the criteria of mild and 1.9% the criteria of severe prostatitis-like symptoms. The total pain score of the NIH-CPSI was predicted by old age, high income and high depression scores. Men with mild and severe prostatitis-like symptoms reported higher depression and lower health-related quality of life than men without prostatitis-like symptomsProstatitis-like symptoms are associated with depression and reduced health-related quality of life in the general population.

Prevalence and predictors of urogenital pain in men. Results from a survey of a representative German population sample

Hintergrund
Die Uberlegenheit der Verum- gegenuber der Scheinmedikation beim Fibromyalgiesyndrom (FMS) ist minimal Eine Placebotherapie von funktionellen somatischen Syndromen (FSS) wie dem FMS wird diskutiert Wir bestimmten die Hohe der Placeboresponseraten in FMS-Medikamentenstudien, um zu uberprufen, ob weitere Forschung uber die Placebobehandlung von FSS gerechtfertigt ist

Winfried Häuser

Papers

Mental Disorder and Psychologic Distress in Patients With Ulcerative Colitis After Ileal Pouch-Anal Anastomosis

[The Quality of the Family Physician-Patient Relationship. Patient-Related Predictors in a Sample Representative for the German Population].

Intensität von Gliederschmerzen und Erschöpfung bei Fibromyalgiesyndrom, depressiven Störungen und chronischen Rückenschmerzen

Prevalence and predictors of urogenital pain in men. Results from a survey of a representative German population sample

Placeboresponder in randomisierten, kontrollierten Medikamentenstudien des Fibromyalgiesyndroms