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Irritable bowel syndrome (IBS) is a frequent health condition which can be associated with functional disability and reduced health-related quality of life. IBS is classified as a disorder of the brain-gut axis. IBS is a very heterogenous condition with regards to the underlying pathophysiological mechanisms, the clinical picture and the amount of functional impairment. Within a biopsychosocial model of IBS psychosocial factors can play a role in the in the predisposition, triggering and development of chronicity. Somatic or psychosocial or a mixture of both factors might predominate in an individual patient. Gut-directed hypnosis is a special type of medical hypnosis combining standardised gut-directed suggestions (hypnosis) with suggestions tailored to the psychological characteristics of the patient (hypnotherapy). Of brain-gut behavioral therapies, cognitive bahvioral-based interventions and gut-directed hypnosis have the largest evidence for both short-term and long-term efficacy in controlled trials for IBS and are recommended by current European and North American gastroenterology guidelines as second line treatment options. Standardised gut-directed hypnosis is available by audiotapes and can be part of a multicomponent self-management approach by digital health applications. It can be used – based on the patient‘s preferences—as first line therapy for mild forms of IBS. Severe forms of IBS require face-to-face interdisciplinary management. Standardised gut-directed hypnosis and hypnotherapy tailored to the individual patient can be part of this approach.

Abstract The irritation scale is a widely used and reliable self-report scale for measuring cognitive and emotional strain related to the work environment. It extends existing measures by providing a sensitive assessment for pre-clinical stress at work. Existing normative data are based on convenience samples and are therefore not representative. This study provides new normative data for the irritation scale based on a representative German sample (N = 1480). The new normative data indicate that the overall level of irritation in the German workforce is significantly lower compared to previously published data. Convergent and discriminant validity is confirmed by correlations with depression and anxiety (Patient Health Questionnaire-4 for Depression and Anxiety), somatic symptom scales (Bodily Distress Syndrome 25 checklist, Somatic Symptom Scale-8, Giessen Subjective Complaints List-8, comorbidity), psychological functioning (Mini-ICF rating for activity and participation disorders in mental illness), work-related stressors (overcommitment and bullying) and individual resources (self-efficacy). The results confirm the utility of the irritation scale and provide new benchmarks that avoid an underestimation of the levels of irritation in future studies.

In this article, supplementary data analyses regarding the association between different types of child maltreatment (CM) and diabetes as well as mediation analyses examining the role of personality functioning are provided (original research article: ‘Associations of different types of child maltreatment and diabetes in adulthood – the mediating effect of personality functioning: findings from a population-based representative German sample’) (Zara et al., 2023). Analyses are based on a representative sample of the German population (N = 5,041). Data was acquired through a representative survey conducted by the independent research institute USUMA Berlin. CM, personality functioning, a diabetes diagnosis as well as symptoms of depression and anxiety were assessed using self-report questionnaires (CTQ, OPD-SQS, PHQ-4).Correlation analyses for all used variables were conducted. Independent t-tests were performed to examine whether symptoms of depression and anxiety are elevated in patients with diabetes and CM (compared to no CM). Regarding the odd ratios (ORs) calculated to examine the association between types of CM and diabetes as well as mediation analyses investigating the role of personality functioning in these associations, sensitivity analyses with persons ≥ 30 years are provided. The additional analyses are intended to add to the body of research showing that patients with diabetes experience symptoms of depression and anxiety more frequently compared to the general population (Kampling and Kruse, 2020; Chireh et al., 2019; Smith et al., 2018), examine the association between different types of CM and diabetes, and explore the role of personality functioning in the association between CM and diabetes.

Abstract. The concept that a regional musculoskeletal pain may occur in the absence of identifiable tissue abnormality may be puzzling. Previously these regional complaints were generally categorized as myofascial pain syndromes, or prior to the formalization of the nociplastic pain concept, as musculoskeletal pain with a neuropathic component, and treatments were anatomically focussed. Chronic primary musculoskeletal pain is now identified under the chronic primary pain stem category with the mechanistic descriptor of nociplastic pain. It is possible that many patients previously diagnosed with myofascial pain do in fact suffer from chronic primary musculoskeletal pain, requiring a paradigm shift in management towards more centrally directed treatment strategies. Many questions remain, including validation of the proposed examination techniques, prevalence, ideal treatment, and uptake and acceptance by the healthcare community. This new classification should be welcomed as an explanation for regional pain conditions that previously responded poorly to physically focussed treatments.

Abstract Background Hitherto only studies with selected populations have found an increased all-cause mortality of some selected opioids compared to selected non-opioids for chronic non-cancer pain (CNCP). We have examined the all-cause mortality for CNCP associated with all established opioids compared to non-opioid analgesic therapy (anticonvulsants, antidepressants, dipyrone, non-steroidal agents). Methods The study used the InGef (Institute for Applied Health Research Berlin) database which is an anonymized healthcare claims database including 4,711,668 insured persons who were covered by 61 German statutory health insurances between 2013 and 2017.The health insurance companies are the owners of the database. All-cause mortality was determined from death certificates. Adjusted hazard ratios (HRs) including age, gender, comorbidity index, and propensity score as covariates and risk differences (RD) in incidence of death between patients with long-term opioid therapy (LTOT) and control-drug therapy were calculated. Results The mean age of participants was 66 years; 55% were women. There were 554 deaths during 10,435 person-years for the LTOT patients, whereas there were 340 deaths during 11,342 person-years in the control group. The HR for all-cause mortality was 1.59 (95% CI, 1.38–1.82) with a risk difference of 148 excess deaths (95% CI 99–198) per 10,000 person-years. The elevated risk of death for LTOT was confined to the out-of-hospital deaths: LTOT patients had 288 out-of-hospital deaths during 10,435 person-years (276 per 10,000 person-years) whereas there were 110 deaths during 11,342 person-years (97 per 10,000 person-years) in the control group. HR was 2.29 (95% CI 1.86, 2.83). Although our propensity score matching model indicated a good classification, residual confounding cannot be fully excluded. The opioid group had a higher prevalence of heart failure and a higher use of anti-thrombotic and antiplatelet agents and of psycholeptics. Conclusions LTOT for CNCP compared to non-opioid analgesics was associated with an increased risk for all-cause mortality. When considering treatment options for patients with CNCP, the relevant risk of increased all-cause mortality with opioids should be discussed. Trial registration ClinicalTrials.gov , NCT03778450, Registered on 7 December 2018

Objective Recreational legalization of cannabis may influence the medical use by patients. When only medical access was legally available in Canada, 4.3% of rheumatology patients reported use. With the current recreational legalization, we have reexamined the prevalence and characteristics of medical cannabis use in this same rheumatology setting. Methods Consecutively attending rheumatology patients participated in an onsite survey comprising the following two questionnaires: 1) demographic and disease information completed by the rheumatologist and 2) patient anonymous questionnaire of health status, cannabis use (recreational and/or medicinal), and characteristics of cannabis use. Results Of 1047 attendees from June to August 2019, with 1000 participating, medical cannabis had been used by 12.6% of patients (95% confidence interval 10.7%‐14.8%), with half continuing use for mostly pain relief. Discontinuation was due to lack of effect in 57% of patients and side effects in 28% of patients. Ever medical users were younger (61.2 vs. 64.9 years; P = 0.006), more likely unemployed/disabled (16.7% vs. 5.9%; P < 0.001), and had more previous (47.6% vs. 25.5%; P < 0.001) and current recreational cannabis use (17.5% vs. 3.1%; P < 0.001) than nonusers. Most patients used multiple methods of administration, including smoking, vaporizing, and using oral oil preparations, but were poorly knowledgeable of product content, which was bought solely via the legal medical route by only 20%, and only one‐third disclosed their use to the rheumatologist. Conclusion Medical cannabis use has tripled for rheumatology patients since recreational legalization, with users being younger, not working, and having recreational cannabis experience. Concerning issues are the poor knowledge of the product being used, access via the nonmedical route, and nondisclosure to the physician.

Introduction:. The opioid epidemic in North America challenges national guidelines worldwide to define the importance of opioids for the management of chronic noncancer pain (CNCP). Methods:. The second update of the German guidelines on long-term opioid therapy for CNCP was developed by 26 scientific associations and 2 patient self-help organizations. A systematic literature search in CENTRAL, Medline, and Scopus (to May 2019) was performed. Meta-analyses of randomized controlled trials and open-label extension studies with opioids for CNCP were conducted. Levels of evidence were assigned according to the Oxford Centre for Evidence-Based Medicine classification system. The formulation and strength of recommendations were established by multistep formalized procedures to reach a consensus according to German Association of the Medical Scientific Societies regulations. The guidelines underwent external review by 4 experts and public commentary. Results:. Opioids are one drug-based treatment option for short- (4–12 weeks), intermediate- (13–26 weeks), and long-term (>26 weeks) therapy of chronic pain in osteoarthritis, diabetic polyneuropathy, postherpetic neuralgia, and low back pain. Contraindications are primary headaches, functional somatic syndromes, and mental disorders with the (cardinal) symptom of pain. For specified other clinical pain conditions, short- and long-term therapy with opioids should be evaluated on an individual basis. Long-term therapy with opioids is associated with relevant risks. Conclusion:. Responsible application of opioids requires consideration of possible indications and contraindications, as well as regular assessment of clinical response and adverse effects. Neither uncritical opioid prescription nor general rejection of opioids is justified in patients with CNCP.

Abstract Non‐opioid analgesics are widely used for pain relief in palliative medicine. However, there is a lack of evidence‐based recommendations addressing the efficacy, tolerability, and safety of non‐opioids in this field. A comprehensive systematic review and meta‐analysis on current evidence can provide a basis for sound recommendations in clinical practice. A database search for controlled trials on the use of non‐opioids in adult palliative patients was performed in Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PsycINFO, and EMBASE from inception to 18 February 2018. Endpoints were pain intensity, opioid‐sparing effects, safety, and quality of life. Studies with similar patients, interventions, and outcomes were included in the meta‐analyses. Our systematic search was able to only identify studies dealing with cancer pain. Of 5991 retrieved studies, 43 could be included (n = 2925 patients). There was no convincing evidence for satisfactory pain relief by acetaminophen alone or in combination with strong opioids. We found substantial evidence of moderate quality for a satisfactory pain relief in cancer by non‐steroidal anti‐inflammatory drugs (NSAIDs), flupirtine, and dipyrone compared with placebo or other analgesics. There was no evidence for a superiority of one specific non‐opioid. There was moderate quality of evidence for a similar pain reduction by NSAIDs in the usual dosage range compared with up to 15 mg of morphine or opioids of equianalgesic potency. The combination of NSAID and step III opioids showed a beneficial effect, without a decreased tolerability. There is scarce evidence concerning the combination of NSAIDs with weak opioids. There are no randomized‐controlled studies on the use of non‐opioids in a wide range of end‐stage diseases except for cancer. Non‐steroidal anti‐inflammatory drugs, flupirtine, and dipyrone can be recommended for the treatment of cancer pain either alone or in combination with strong opioids. The use of acetaminophen in the palliative setting cannot be recommended. Studies are not available for long‐term use. There is a lack of evidence regarding pain treatment by non‐opioids in specific cancer entities.

Abstract We provide a systematic review and meta‐analysis on the efficacy, tolerability, and safety of cannabinoids in palliative medicine. The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PsycINFO, PubMed, Scopus, and http://clinicaltrials.gov, and a selection of cancer journals were searched up until 15th of March 2017. Of the 108 screened studies, nine studies with a total of 1561 participants were included. Overall, the nine studies were at moderate risk of bias. The quality of evidence comparing cannabinoids with placebo was rated according to Grading of Recommendations Assessment, Development, and Evaluation as low or very low because of indirectness, imprecision, and potential reporting bias. In cancer patients, there were no significant differences between cannabinoids and placebo for improving caloric intake (standardized mean differences [SMD]: 0.2 95% confidence interval [CI]: [−0.66, 1.06] P = 0.65), appetite (SMD: 0.81 95% CI: [−1.14, 2.75]; P = 0.42), nausea/vomiting (SMD: 0.21 [−0.10, 0.52] P = 0.19), >30% decrease in pain (risk differences [RD]: 0.07 95% CI: [−0.01, 0.16]; P = 0.07), or sleep problems (SMD: −0.09 95% CI: [−0.62, 0.43] P = 0.72). In human immunodeficiency virus (HIV) patients, cannabinoids were superior to placebo for weight gain (SMD: 0.57 [0.22; 0.92]; P = 0.001) and appetite (SMD: 0.57 [0.11; 1.03]; P = 0.02) but not for nausea/vomiting (SMD: 0.20 [−0.15, 0.54]; P = 0.26). Regarding side effects in cancer patients, there were no differences between cannabinoids and placebo in symptoms of dizziness (RD: 0.03 [−0.02; 0.08]; P = 0.23) or poor mental health (RD: −0.01 [−0.04; 0.03]; P = 0.69), whereas in HIV patients, there was a significant increase in mental health symptoms (RD: 0.05 [0.00; 0.11]; P = 0.05). Tolerability (measured by the number of withdrawals because of adverse events) did not differ significantly in cancer (RD: 1.15 [0.80; 1.66]; P = 0.46) and HIV patients (RD: 1.87 [0.60; 5.84]; P = 0.28). Safety did not differ in cancer (RD: 1.12 [0.86; 1.46]; P = 0.39) or HIV patients (4.51 [0.54; 37.45]; P = 0.32) although there was large uncertainty about the latter reflected in the width of the CI. In one moderate quality study of 469 cancer patients with cancer‐associated anorexia, megestrol was superior to cannabinoids in improving appetite, producing >10% weight gain and tolerability. In another study comparing megestrol to dronabinol in HIV patients, megestrol treatment led to higher weight gain without any differences in tolerability and safety. We found no convincing, unbiased, high quality evidence suggesting that cannabinoids are of value for anorexia or cachexia in cancer or HIV patients.

Antecedentes/Objetivo: El autoinforme acerca de la salud depende del marco de referencia interno y de los estilos de respuesta. Una manera de estudiar esta dependencia es usando vinetas ˜ de anclaje. Método: Se seleccionó una muestra representativa de la población alemana (N = 2.409). Se pidió a los participantes que evaluasen (en una escala de 0 a 100) su propia salud y la de los estados de salud de dos vinetas ˜ relativamente complejas, las cuales representaban pacientes con distintos problemas de salud. Resultados: La puntuación promedio en evaluación autoinformada fue de M = 76,20 (DT = 20,60). Se encontró una pequena˜ correlación positiva entre la evaluación de la salud propia y la evaluación de las vinetas ˜ (r = 0,12). Después de controlar por un proxy de salud objetiva, medido en términos de condiciones crónicas, la relación continuó siendo ligeramente positiva. Las condiciones crónicas solo se relacionaron marginalmente con la evaluación de las vinetas ˜ (0 condiciones: M = 44,80; ≥ 2 condiciones: M = 42,20). Conclusiones: La ausencia de la relación propuesta entre el autoinforme de la salud propia y la evaluación de las vinetas ˜ significa que no podemos derivar herramientas para la corrección de las puntuaciones subjetivas del uso diferencial de marcos de referencia.

PURPOSE:Multiple clinical and epidemiological studies have provided estimates of fibromyalgia prevalence and sex ratio, but different criteria sets and methodology, as well as bias, have led to widely varying (0.4%->11%) estimates of prevalence and female predominance (>90% to

Objective: Self-stigma in overweight and obese individuals has strong associations with impairment in mental and global health. This study sought to explore self-compassion as a psychological resource in the self-stigma process. Methods: In a 2012 representative German population survey of N = 1,158 overweight and obese individuals, self-compassion was examined as a mediator between self-stigma and mental and physical health outcomes, including BMI (kg/m2), using structural equation modeling and controlling for sociodemographic factors. Results: Psychological variables were assessed using validated self-report questionnaires. Self-compassion partially mediated the relationships between self-stigma and depression, somatic symptoms, and health status / quality of life, lowering the predictive effect of self-stigma on the outcomes by approximately one-third. In contrast, self-compassion, because it was unrelated to BMI, did not mediate the association between self-stigma and BMI. Conclusion: Self-compassion has the potential to act as a buffer against the mental and global health detriments of self-stigma in overweight and obesity and could thus represent a target for interventions to reduce self-stigma and prevent these health impairments. In order to influence the association between self-stigma and BMI, self-compassion should conceptually be linked to weight management.

Abstract. Introduction:. A marked rise in opioid prescriptions for patients with chronic noncancer pain (CNCP) with a parallel increase in opioid abuse/misuse, and resulting deaths was noted in the Unites states in the past decade (opioid epidemic). In response, the US Center of Diseases Control (CDC) developed a guideline for prescribing of opioids for patients with CNCP. Objectives:. To assess (1) if there is an opioid epidemic in Australia, Canada, and Germany (2) to compare Australian, Canadian, German, and Center of Diseases Control guidelines recommendations for long-term opioid therapy for CNCP. Methods:. National evidence-based guidelines and PubMed were searched for recommendations for opioid prescriptions for CNCP. Results:. There are signs of an opioid epidemic in Australia and Canada, but not in Germany. Guidelines in all 4 countries provide similar recommendations: opioids are not the first-line therapy for patients with CNCP; regular clinical assessments of benefits and harms are necessary; excessive doses should be avoided (recommended morphine equivalent daily doses range from 50 to 200 mg/d); stopping rules should be followed. All guidelines do not recommend the use of opioids in chronic pain conditions without an established nociceptive or neuropathic cause such as fibromyalgia and primary headache. Conclusion:. Implementation of opioid prescribing guidelines should ensure that physicians prescribe opioids only for appropriate indications in limited doses for selected patients and advice patients on their safe use. These measures could contribute to reduce prescription opioid misuse/abuse and deaths.

Abstract. Introduction:. Chronic widespread pain (CWP) is the defining feature of fibromyalgia (FM), a worldwide prevalent condition. Chronic widespread pain is, however, not pathognomonic of FM, and other conditions may present similarly with CWP, requiring consideration of a differential diagnosis. Objectives:. To conduct a literature search to identify medical conditions that may mimic FM and have highlighted features that may differentiate these various conditions from FM. Methods:. A comprehensive literature search from 1990 through September 2016 was conducted to identify conditions characterized by CWP. Results:. Conditions that may mimic FM may be categorized as musculoskeletal, neurological, endocrine/metabolic, psychiatric/psychological, and medication related. Characteristics pertaining to the most commonly identified confounding diagnoses within each category are discussed; clues to enable clinical differentiation from FM are presented; and steps towards a diagnostic algorithm for mimicking conditions are presented. Conclusion:. Although the most likely reason for a complaint of CWP is FM, this pain complaint can be a harbinger of illness other than FM, prompting consideration of a differential diagnosis. This review should sensitize physicians to a broad spectrum of conditions that can mimic FM.

Objective. The association between Fibromyalgia Syndrome (FMS) and childhood maltreatment and adversity has frequently been proposed but limited data exists regarding the transcultural nature of this association. Methods. 75 Israeli FMS patients and 23 Rheumatoid Arthritis (RA) patients were compared. Childhood maltreatment was assessed by the Childhood Trauma Questionnaire (CTQ) and potential depressive and anxiety disorders were assessed by the Patient Health Questionnaire-4. FMS severity was assessed by the Widespread Pain Index (WPI), the Symptom Severity Score (SSS), and the FIQ. PTSD was diagnosed according to the DSM IV. RA severity was assessed by the RA Disease Activity Index. Health status was assessed by the SF-36. Results. Similar to reports in other countries, high levels of self-reported childhood adversity were reported by Israeli FMS patients. PTSD was significantly more common among FMS patients compared with RA patients, as well as childhood emotional abuse and physical and emotional neglect. Levels of depression and anxiety were significantly higher among FMS patients. Conclusion. The study demonstrated the cross cultural association between FMS and childhood maltreatment, including neglect, emotional abuse, and PTSD. Significant differences were demonstrated between FMS patients and patients suffering from RA, a model of an inflammatory chronic rheumatic disease.

Different types of childhood maltreatment, like emotional abuse, emotional neglect, physical abuse, physical neglect and sexual abuse are interrelated because of their co-occurrence. Different patterns of childhood abuse and neglect are associated with the degree of severity of mental disorders in adulthood. The purpose of this study was (a) to identify different patterns of childhood maltreatment in a representative German community sample, (b) to replicate the patterns of childhood neglect and abuse recently found in a clinical German sample, (c) to examine whether participants reporting exposure to specific patterns of child maltreatment would report different levels of psychological distress, and (d) to compare the results of the typological approach and the results of a cumulative risk model based on our data set.In a cross-sectional survey conducted in 2010, a representative random sample of 2504 German participants aged between 14 and 92 years completed the Childhood Trauma Questionnaire (CTQ). General anxiety and depression were assessed by standardized questionnaires (GAD-2, PHQ-2). Cluster analysis was conducted with the CTQ-subscales to identify different patterns of childhood maltreatment.Three different patterns of childhood abuse and neglect could be identified by cluster analysis. Cluster one showed low values on all CTQ-scales. Cluster two showed high values in emotional and physical neglect. Only cluster three showed high values in physical and sexual abuse. The three patterns of childhood maltreatment showed different degrees of depression (PHQ-2) and anxiety (GAD-2). Cluster one showed lowest levels of psychological distress, cluster three showed highest levels of mental distress.The results show that different types of childhood maltreatment are interrelated and can be grouped into specific patterns of childhood abuse and neglect, which are associated with differing severity of psychological distress in adulthood. The results correspond to those recently found in a German clinical sample and support a typological approach in the research of maltreatment. While cumulative risk models focus on the number of maltreatment types, the typological approach takes the number as well as the severity of the maltreatment types into account. Thus, specific patterns of maltreatment can be examined with regard to specific long-term psychological consequences.

Nurcan Üçeyler1, Martin Offenbächer2, Frank Petzke3, Winfried Häuser4, Claudia Sommer11Department of Neurology, University of Würzburg, Germany; 2GRP – Generation Research Program, Human Science Center, University of Munich, Germany; 3Department of Anesthesiology, University of Cologne, Germany; 4Center of Pain Therapy, Klinikum Saarbrücken gGmbH, Winterberg 1, Saarbrücken, GermanyAbstract: Fibromyalgia syndrome (FMS) is a chronic condition characterized by widespread pain, tender points, fatigue, and sleep disturbance. FMS leads to high disability levels, poor quality of life, and extensive use of medical care. Effective pharmacological treatment options are rare, and treatment effects are often of limited duration. Duloxetine is a new selective serotonin and norepinephrine reuptake inhibitor that is licensed for the treatment of pain in diabetic neuropathy. So far two randomized, placebo-controlled trials have investigated the short-term safety and efficacy of duloxetine 60 mg/day and 120 mg/day in patients suffering from FMS over a period of 12 weeks. Both dosages were superior to placebo in pain relief, and improvement in quality of life and depressive symptoms. The analgesic effect was largely independent of the antidepressant action of duloxetine. The higher dose of 120 mg/day further reduced the tender point count and elevated the tender point pain thresholds. Only mild to moderate adverse effects were reported. Duloxetine 60 mg/day and 120 mg/day has proven to be beneficial in the treatment of FMS symptoms. As true for other antidepressants further studies are needed to assess the long-term efficacy and safety of duloxetine as an additional pharmacological treatment option in FMS.Keywords: fibromyalgia syndrome, duloxetine, antidepressant, review, SNRI

The patient-doctor relationship (PDR) as perceived by the patient is an important concept in primary care and psychotherapy. The PDR Questionnaire (PDRQ-9) provides a brief measure of the therapeutic aspects of the PDR in primary care. We assessed the internal and external validity of the German version of the PDRQ-9 in a representative cross-sectional German population survey that included 2,275 persons aged ≥14 years who reported consulting with a primary care physician (PCP). The acceptance of the German version of this questionnaire was good. Confirmatory factor analysis demonstrated that the PRDQ-9 was unidimensional. The internal reliability (Cronbach's α) of the total score was .95. The corrected item-total correlations were ≥.94. The mean satisfaction index of persons with a probable depressive disorder was lower than that of persons without a probable depressive disorder, indicating good discriminative concurrent criterion validity. The correlation coefficient between satisfaction with PDR and satisfaction with pain therapy was r = .51 in 489 persons who reported chronic pain, indicating good convergent validity. Despite the limitation of low variance in the PDRQ-9 total scores, the results indicate that the German version of the PDRQ-9 is a brief questionnaire with good psychometric properties to assess German patients' perceived therapeutic alliance with PCPs in public health research.

PURPOSE: To describe and evaluate somatic symptoms in patients with rheumatoid arthritis (RA) and fibromyalgia, determine the relation between somatization syndromes and fibromyalgia, and evaluate symptom data in light of the Diagnostic and Statistical Manual-5 (DSM-5) criteria for somatic symptom disorder. METHODS: We administered the Patient Health Questionnaire-15 (PHQ-15), a measure of somatic symptom severity to 6,233 persons with fibromyalgia, RA, and osteoarthritis. PHQ-15 scores of 5, 10, and 15 represent low, medium, and high somatic symptom severity cut-points. A likely somatization syndrome was diagnosed when PHQ-15 score was ≥10. The intensity of fibromyalgia diagnostic symptoms was measured by the polysymptomatic distress (PSD) scale. RESULTS: 26.4% of RA patients and 88.9% with fibromyalgia had PHQ-15 scores ≥10 compared with 9.3% in the general population. With each step-wise increase in PHQ-15 category, more abnormal mental and physical health status scores were observed. RA patients satisfying fibromyalgia criteria increased from 1.2% in the PHQ-15 low category to 88.9% in the high category. The sensitivity and specificity of PHQ-15≥10 for fibromyalgia diagnosis was 80.9% and 80.0% (correctly classified = 80.3%) compared with 84.3% and 93.7% (correctly classified = 91.7%) for the PSD scale. 51.4% of fibromyalgia patients and 14.8% with RA had fatigue, sleep or cognitive problems that were severe, continuous, and life-disturbing; and almost all fibromyalgia patients had severe impairments of function and quality of life. CONCLUSIONS: All patients with fibromyalgia will satisfy the DSM-5 "A" criterion for distressing somatic symptoms, and most would seem to satisfy DSM-5 "B" criterion because symptom impact is life-disturbing or associated with substantial impairment of function and quality of life. But the "B" designation requires special knowledge that symptoms are "disproportionate" or "excessive," something that is uncertain and controversial. The reliability and validity of DSM-5 criteria in this population is likely to be low.

The Fibromyalgia Survey Questionnaire (FSQ) assesses the key symptoms of fibromyalgia syndrome. The FSQ can be administrated in survey research and settings where the use of interviews to evaluate the number of pain sites and extent of somatic symptom intensity and tender point examination would be difficult. We validated the FSQ in a cross-sectional survey with FMS patients. In a cross-sectional survey, participants with physician diagnosis of FMS were recruited by FMS-self help organisations and nine clinical institutions of different levels of care. Participants answered the FSQ (composed by the Widespread Pain Index [WPI] and the Somatic Severity Score [SSS]) assessing the Fibromyalgia Survey Diagnostic Criteria (FSDC) and the Patient Health Questionnaire PHQ 4. American College of Rheumatology 1990 classification criteria were assessed in a subgroup of participants. 1,651 persons diagnosed with FMS were included into analysis. The acceptance of the FSQ-items ranged between 78.9 to 98.1% completed items. The internal consistency of the items of the SSS ranged between 0.75-0.82. 85.5% of the study participants met the FSDC. The concordance rate of the FSDC and ACR 1990 criteria was 72.7% in a subsample of 128 patients. The Pearson correlation of the SSS with the PHQ 4 depression score was 0.52 (p

ABSTRACT BACKGROUND: Fibromyalgia is a clinically well-defined chronic condition with a biopsychosocial aetiology. Fibromyalgia is characterized by chronic widespread musculoskeletal pain, sleep problems, cognitive dysfunction, and fatigue. Patients often report high disability levels and poor quality of life. Since there is no specific treatment that alters the pathogenesis of fibromyalgia, drug therapy focuses on pain reduction and improvement of other aversive symptoms. OBJECTIVES: To assess the benefits and harms of selective serotonin reuptake inhibitors (SSRIs) in the treatment of fibromyalgia. METHODS: Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 5), MEDLINE (1966 to June 2014), EMBASE (1946 to June 2014), and the reference lists of reviewed articles. Selection criteria: We selected all randomized, double-blind trials of SSRIs used for the treatment of fibromyalgia symptoms in adult participants. We considered the following SSRIs in this review: citalopram, fluoxetine, escitalopram, fluvoxamine, paroxetine, and sertraline. Data collection and analysis: Three authors extracted the data of all included studies and assessed the risks of bias of the studies. We resolved discrepancies by discussion. MAIN RESULTS: The quality of evidence was very low for each outcome. We downgraded the quality of evidence to very low due to concerns about risk of bias and studies with few participants. We included seven placebo-controlled studies, two with citalopram, three with fluoxetine and two with paroxetine, with a median study duration of eight weeks (4 to 16 weeks) and 383 participants, who were pooled together. All studies had one or more sources of potential major bias. There was a small (10%) difference in patients who reported a 30% pain reduction between SSRIs (56/172 (32.6%)) and placebo (39/171 (22.8%)) risk difference (RD) 0.10, 95% confidence interval (CI) 0.01 to 0.20; number needed to treat for an additional beneficial outcome (NNTB) 10, 95% CI 5 to 100; and in global improvement (proportion of patients who reported to be much or very much improved: 50/168 (29.8%) of patients with SSRIs and 26/162 (16.0%) of patients with placebo) RD 0.14, 95% CI 0.06 to 0.23; NNTB 7, 95% CI 4 to 17. SSRIs did not statistically, or clinically, significantly reduce fatigue: standard mean difference (SMD) -0.26, 95% CI -0.55 to 0.03; 7.0% absolute improvement on a 0 to 10 scale, 95% CI 14.6% relative improvement to 0.8% relative deterioration; nor sleep problems: SMD 0.03, 95 % CI -0.26 to 0.31; 0.8 % absolute deterioration on a 0 to 100 scale, 95% CI 8.3% relative deterioration to 6.9% relative improvement. SSRIs were superior to placebo in the reduction of depression: SMD -0.39, 95% CI -0.65 to -0.14; 7.6% absolute improvement on a 0 to 10 scale, 95% CI 2.7% to 13.8% relative improvement; NNTB 13, 95% CI 7 to 37. The dropout rate due to adverse events was not higher with SSRI use than with placebo use (23/146 (15.8%) of patients with SSRIs and 14/138 (10.1%) of patients with placebo) RD 0.04, 95% CI -0.06 to 0.14. There was no statistically or clinically significant difference in serious adverse events with SSRI use and placebo use (3/84 (3.6%) in patients with SSRIs and 4/84 (4.8%) and patients with placebo) RD -0.01, 95% CI -0.07 to 0.05. AUTHORS' CONCLUSIONS: There is no unbiased evidence that SSRIs are superior to placebo in treating the key symptoms of fibromyalgia, namely pain, fatigue and sleep problems. SSRIs might be considered for treating depression in people with fibromyalgia. The black box warning for increased suicidal tendency in young adults aged 18 to 24, with major depressive disorder, who have taken SSRIs, should be considered when appropriate.