Sustained improvements in EQ-5D utility scores and self-rated health status in patients with ankylosing spondylitis after spa treatment including low-dose radon - an analysis of prospective radon indication registry data.

BACKGROUND: Patients with ankylosing spondylitis (AS) have significantly lower quality of life (QoL) than the general population. Holistic interventions addressing QoL comprise spa- or balneotherapy including radon. These interventions have shown to be beneficial in reducing pain and improving QoL in AS-patients. We explored the association of spa-therapy including low-dose radon with QoL in AS-patients over an extended time period. METHODS: Registry data collected for the "Radon indication registry" in the Austrian Gastein valley comprising data on QoL (EuroQol EQ-5D) directly before the treatment (baseline), directly(t1), 3 (t2); 6(t3) and 9(t4) months after the treatment, age, sex and body mass index (BMI) were analysed. Linear regression models explored the association of measurement time with 1) EQ-5D-5L utilities and 2) EuroQol visual analogue scale (VAS) score. Alterations of 0.05 (utilities) and 5.00 (VAS) were considered clinically relevant. RESULTS: Two-hundred-ninety-one AS-patients were included in the analyses. Forty-four percent (n = 128) were women, the mean age was 52 (SD 10) and the average BMI was 26 (SD 4). Utilities (t1: 0.09 [0.07;0.11]; t2: 0.08 [0.06; 0.10]; t3: 0.06 [0.05;0.09]; t4: 0.04 [0.02;0.06]) and VAS (t1: 11.68 [9.38; 13.97]; t2: 12.20 [9.78; 14.61]; t3: 9.70 [7.24; 12.17]; t4: 6.11 [3.57; 8.65]) were significantly higher at all timepoints compared to baseline. Improvements were clinically relevant at all timepoints in case of the VAS and until 6 months after treatment for the utilities. CONCLUSION: AS-patients who received spa therapy including radon show significantly and clinically relevant improvements in Qol until 6-9 months after treatment.

Clinical impact of confinement due to the COVID-19 pandemic on patients with fibromyalgia: a cohort study.

OBJECTIVES: To our knowledge, the impact of the COVID-19 pandemic on fibromyalgia (FM) patients has not been studied before. FM patients often experience clinical impairment with stress. The aim of this study was to determine whether severity of FM increases because of confinement by the COVID-19 pandemic. METHODS: This prospective study includes patients from the Combined Index of Severity of Fibromyalgia (ICAF) cohort who met the 2010 ACR FM criteria. In this cohort, all patients have a periodical evaluation of their quality of life through two questionnaires, the ICAF, which assesses the ability to perform daily living activities, anxiety and depression, and through the Patient Global Impression of Change (PGIC), which assesses overall change after a therapeutical intervention. Pre- and post-confinement measurements were analysed. Inferential statistical analysis and ANOVA for repeated measurements were used. RESULTS: A total of 93 patients received a phone consultation, (95.5% females), mean (SD) age of 48.23 (8.38) years. Four patients were excluded as presenting COVID-19 and 51 (57%) completed the post-confinement ICAF. Following confinement, 25 (49%) patients got worse (group-worse) and 26 (51%) patients experienced no change or improved (group-stable). Comparisons between pre- and post-confinement ICAF did not show significant differences in both groups. Passive coping was significantly different in group-worse in pre-confinement evaluation. In the 80% of patients with passive coping predominance there were no changes in coping strategy. CONCLUSIONS: No clinical impairment due to COVID-19 confinement occurred. The perceived worsening among FM patients relies primarily on how patients cope with their disease, without a real impact on clinical manifestations.

Self-forgiveness in fibromyalgia patients and its relationship with acceptance, catastrophising and coping.

OBJECTIVES: Forgiveness influences health through numerous mechanisms, but commonly it is thought to reduce stress, increase healthy behaviour, and promote social support, thereby positively impacting health and wellbeing. Self-forgiveness has been given considerable attention in relation to health and wellbeing. Fibromyalgia (FM) patients had lower forgiveness of others and self-forgiveness as compared to controls. The aim of this study is to explore the relationship of self-forgiveness (FS) with the impact and severity of FM, acceptance, catastrophising, and coping. METHODS: We evaluated 228 FM female patients who completed the Mauger Forgiveness Scale, the Combined Index of Severity in Fibromyalgia (ICAF) survey, the Chronic Pain Acceptance Questionnaire (CPAQ), and the Pain Catastrophising Scale (PCS). RESULTS: High self-forgiveness is related to high levels of active coping (r=.41) and acceptation (r=.38), and low self-forgiveness is related to emotional negative factors and catastrophising (r=-.56). Two factors (physical and emotional) were obtained. Lower FS is an emotional factor with negative emotion, catastrophising and a deficit in active coping. A decision-tree analysis showed a first node with ICAF Emotional scores and a second level with CPAQ and PCS scores as predictors. CONCLUSIONS: A notable lack of FS indicates a problem (distress and catastrophising) with the health aspects related to this syndrome. Acceptance could require a low negative emotional status. People with high FS were likely to increase acceptation as the positive component of acceptance in FS. This finding does not indicate an interest in maintaining problematic behaviours.

Fibromyalgia impact and depressive symptoms: Can perceiving a silver lining make a difference?

Individuals with fibromyalgia are at greater risk for depressive symptoms than the general population, and this may be partially attributable to physical symptoms that impair day-to-day functioning. However, individual-level protective characteristics may buffer risk for psychopathology. For instance, the ability to perceive a "silver lining" in one's illness may be related to better mental and physical health. We examined perceived silver lining as a potential moderator of the relation between fibromyalgia impact and depressive symptoms. Our sample of persons with fibromyalgia (N = 401) completed self-report measures including the Fibromyalgia Impact Questionnaire-Revised, Depression Anxiety Stress Scales, and the Silver Lining Questionnaire. Moderation analyses covaried age, sex, and ethnicity. Supporting hypotheses, increasing impact of disease was related to greater depressive symptoms, and perceptions of a silver lining attenuated that association. Despite the linkage between impairment and depressive symptoms, identifying positive aspects or outcomes of illness may reduce risk for psychopathology. Therapeutically promoting perception of a silver lining, perhaps via signature strengths exercises or a blessings journal, and encouraging cognitive reframing of the illness experience, perhaps via Motivational Interviewing or Cognitive Behavioral Therapy, may reduce depressive symptoms in persons with fibromyalgia.

Health beliefs, attitudes, and health-related quality of life in persons with fibromyalgia: mediating role of treatment adherence.

Fibromyalgia is a chronic illness characterized by pain and fatigue. Persons with fibromyalgia experience increased the risk for poor mental and physical health-related quality of life, which may be dependent on multiple factors, including health beliefs, such as confidence in physicians and the health-care system, and health behaviors, such as treatment adherence. Respondents with fibromyalgia (n = 409) were recruited nationally, via support organizations, and completed self-report measures: Multidimensional Health Profile - Health Functioning Index (MHP-H), Short-Form-36 Health Survey (SF-36v2), and Medical Outcomes Study (MOS) Measure of Patient Adherence - General Adherence Items. In mediation models, belief in the healthcare system and health-care personnel, and health efficacy exerted an indirect effect through treatment adherence on mental and physical quality of life. Adaptive health beliefs and attitudes were related to greater treatment adherence and, in turn, to a better quality of life. Maladaptive health beliefs and mistrusting attitudes about physician-level and systemic-level healthcare provision are negatively related to both treatment adherence and consequent physical and mental health-related quality of life in persons with fibromyalgia. Future randomized controlled trials are needed to determine if therapeutic strategies to alter health values might improve adherence and self-rated health.

[Current Research Activities on Person-Centered Medicine in Academic Institutes of General Practice in Germany and Austria]. / Aktuelle Forschungsaktivitäten zur personenzentrierten Medizin in akademischen Instituten für Allgemeinmedizin in Deutschland und Österreich.

AIM OF STUDY: Person-centered medicine (PCM) with its focus on humanistic-biographical-oriented medicine and integrated, positive-salutogenic health is a central aspect in the patient-physician relationship in general practice. The objective of this analysis is to assess the prevalence and type of research project in academic institutions of general practice in Germany (Ger) and Austria (At) and the thematic priorities of the projects in the areas PCM, health promotion (HP), prevention (PRE) and conventional medicine (CM). METHODS: A search was conducted (September-December 2015) on the websites of 30 institutes and divisions of general medicine for their current research projects. The retrieved projects were assigned to five categories: PCM, HP, PRE, CM and others. Subsequently, we identified the targeted patient groups of the projects as well as the thematic focus in the categories PCM, HP, PRE and CM with focus on PCM and HP. RESULTS: 541 research projects were identified, 452 in Germany and 89 in Austria. Research projects were only included if they were explicitly indicated as research-oriented. Seventy projects addressed PCM aspects, 15 projects HP aspects, 32 projects PRE aspects and 396 projects CM aspects. The most frequently target groups in the categories PCM (24 of 70) and HP (7 of 15) were chronically ill patients. The most common thematic focus in PCM was communication (13 of 70) and in HP, physical activity (6 of 15). CONCLUSION: The vast majority of research projects investigated conventional medical topics. The percentage of research activities in the field of PCM (13%) or PCM including HP (16%) in Ger and At is below the European average of 20%. From our point of view, PCM and HP need to be implemented to a greater extent in general practice.

Gratitude mediates quality of life differences between fibromyalgia patients and healthy controls.

PURPOSE: Despite a growing literature on the benefits of gratitude for adjustment to chronic illness, little is known about gratitude in medical populations compared to healthy populations, or the degree to which potential deficits in gratitude might impact quality of life. The purpose of the present study was to (1) examine levels of gratitude and quality of life in fibromyalgia patients and healthy controls and (2) consider the role of gratitude in explaining quality of life differences between fibromyalgia patients and healthy controls. METHODS: Participants were 173 fibromyalgia patients and 81 healthy controls. All participants completed measures of gratitude, quality of life, and socio-demographics. RESULTS: Although gratitude was positively associated with quality of life, levels of gratitude and quality of life were lower in the fibromyalgia sample relative to the healthy controls. This difference in gratitude partially mediated differences in quality of life between the two groups after controlling for socio-demographic variables. CONCLUSIONS: Our findings suggest that gratitude is a valuable positive psychological trait for quality of life in people with fibromyalgia. Interventions to improve gratitude in this patient population may also bring enhancement in quality of life.

Functional limitations in children and adolescents suffering from chronic pain: validation and psychometric properties of the German Functional Disability Inventory (FDI-G).

Our objective was to translate the Functional Disability Inventory (FDI) into German, to evaluate its validity and to assess functional limitation in a large cohort of children and adolescents with juvenile fibromyalgia syndrome (jFMS). We administered several questions (e.g., sociodemographics, school-related issues) and questionnaires to 329 patients and one parent. The questionnaires included, among others, a German version of the FDI, the CHAQ (parent report), KIDSCREEN, tender point score (TPS), Depression Inventory for Children and Adolescents (DIKJ) and others. Patients were asked about the severity of pain today (NRS = numerical rating scale) and other symptoms. Internal consistency was evaluated with Cronbach's alpha. Construct validity of the FDI was evaluated by correlating the FDI with the questionnaires as well as with the pain and other variables, e.g., days missed school. An exploratory factor analysis (EFA) was also performed. Mean age was 13.9 years (SD ±2.48). Means were for pain today 5.37 (±2.39) and for the TPS 39.71 (±21.56). Internal consistency was α = .90. Low-to-moderate correlations were obtained between the FDI and the CHAQ (ρ = .51**), KIDSCREEN (e.g., physical well-being ρ = -.62**; peers and social support ρ = -.28**) as well as the pain variables (NRS ρ = .24**; TPS ρ = .38**). Psychological variables were also correlated with the FDI (e.g., DIJK ρ = .28**). An EFA suggested a two-factor solution. The FDI is a valid instrument for measuring functional limitations in German children and adolescents with jFMS.

Profiles of well-being and their associations with self-forgiveness, forgiveness of others, and gratitude among patients with rheumatic and musculoskeletal diseases.

OBJECTIVES: Patients with rheumatic and musculoskeletal diseases (RMDs) often experience poor well-being. Common limitations of the studies on this topic involve using variable-centred and deficit-based approaches. In this study, we used the person-centred approach to identify profiles of positive (life satisfaction and health status) and negative (depression, anxiety, fatigue, and stress) indicators of well-being among patients with RMDs. Moreover, we tested self-forgiveness, forgiveness of others, gratitude, and sociodemographics as contributors to latent profile membership. DESIGN: A cross-sectional questionnaire survey. METHODS: Using a latent profile analysis, we investigated well-being profiles among 892 patients with RMDs (759 patients with arthritis and 133 with fibromyalgia [FM]) and examined the correlates of latent profile membership. RESULTS: We identified four profiles of well-being: (1) 'life dissatisfaction' (9.2%), (2) 'high well-being' (43.4%), (3) 'suboptimal well-being' (35.2%), and (4) 'very poor well-being' (12.2%). Members of Profile 2 had higher levels of self-forgiveness and gratitude than members of the remaining profiles, had higher levels of forgiveness of others than Profile 3, and were older than members of Profile 4. Moreover, members of Profile 2 had a higher proportion of patients with arthritis relative to those with FM than all other profiles and men to women than Profile 4. CONCLUSIONS: Patients with RMDs are heterogeneous in terms of well-being. Self-forgiveness, gratitude, and forgiveness of others may serve as psychological capital that enhances patients' well-being. Special attention should be paid to patients with FM, women, and younger patients since they can be especially susceptible to poor well-being.

Quality of life in patients with fibromyalgia: validation and psychometric properties of the German Quality of Life Scale (QOLS-G).

Our objectives were to translate the Quality of Life Scale (QOLS) into German and to evaluate its reliability and validity for the use in patients with fibromyalgia (FMS). Together with German versions of the Fibromyalgia Impact Questionnaire (FIQ), the SF-36, a tender point count (TPC) and other questionnaires, we administered the QOLS to 146 patients with FMS. Patients were asked about the severity of pain today (VAS) and the duration of symptoms. Test-retest reliability was assessed using Spearman's correlations. Internal consistency was evaluated with Cronbach's alpha. Construct validity of the QOLS was evaluated by correlating the QOLS with the FIQ, the SF-36, the Beck Depression Inventory (BDI), and the Symptom Checklist (SCL-90-R) as well as with the pain variables. An exploratory factor analysis (EFA) was also conducted. Mean age was 53.1 years. Means were for pain today 6.8 and for duration of symptoms 11.8 years. Test-retest reliability for the total QOLS was rho = .91. Internal consistency was α = .90. Low-to-moderate correlations were obtained between the QOLS and the total FIQ (rho = -.42), the SF-36 (e.g. physical functioning rho = .37; mental health rho = .56) as well as the pain variables (VAS rho = -.11 ns; TPC rho = -.20). Psychological variables were moderately to substantially correlated with the QOLS (e.g. BDI rho = -.61). An EFA suggested a three-factor solution. The QOLS-G is a reliable and valid instrument for measuring quality of life in German patients with FMS.

Is sham laser a valid control for acupuncture trials?

Methodological problems of acupuncture trials focus on adequate placebo controls. In this trial we evaluated the use of sham laser acupuncture as a control procedure. Thirty-four healthy volunteers received verum laser (invisible infrared laser emission and red light, 45 s and 1 J per point) and sham laser (red light) treatment at three acupuncture points (LI4, LU7 and LR3) in a randomized, double-blinded, cross-over design. The main outcome measure was the ratio of correct to incorrect ratings of treatment immediately after each session. The secondary outcome measure was the occurrence of deqi-like sensations at the acupuncture points and their intensity on a 10-fold visual analog scale (VAS; 10 being the strongest sensible sensation). We pooled the results of three former trials to evaluate the credibility of sham laser acupuncture when compared to needle acupuncture. Fifteen out of 34 (44%) healthy volunteers (age: 28 ± 10.7 years) identified the used laser device after the first session and 14 (41%) after the second session. Hence, both treatments were undistinguishable (P = .26). Deqi-like sensations occurred in 46% of active laser (2.34 VAS) and in 49.0% of sham laser beams (2.49 VAS). The credibility of sham laser was not different from needle acupuncture. Sham laser acupuncture can serve as a valid placebo control in laser acupuncture studies. Due to similar credibility and the lack of sensory input on the peripheral nervous system, sham laser acupuncture can also serve as a sham control for acupuncture trials, in order to evaluate needling effects per se.

Positive Psychological Factors and Impairment in Rheumatic and Musculoskeletal Disease: Do Psychopathology and Sleep Quality Explain the Linkage?

OBJECTIVE: Little is known about potential mechanisms of action linking protective positive psychological variables and functional disability in patients with rheumatic and musculoskeletal disease. The present study was undertaken to examine symptoms of psychopathology, including stress, depression, anxiety, and sleep quality, as serial mediators of the association between gratitude, self-compassion, self-forgiveness, and functional impairment. METHODS: We assessed risk and protective factors for functional disability in patients with fibromyalgia (FM), osteoarthritis (OA), rheumatoid arthritis (RA), and ankylosing spondylitis (AS) who were recruited from an Austrian health care facility. Respondents completed online surveys, including the Gratitude Questionnaire 6-item form, the Self-Compassion Scale short form, the Self-Forgiveness and Forgiveness of Others Index, the Perceived Stress Scale 4, the Patient Health Questionnaire 2, the 2-item Generalized Anxiety Disorder Scale, the Sleep Condition Indicator, and the Health Assessment Questionnaire. Bivariate and serial mediation analyses were conducted. RESULTS: For our sample of 1,218 patients (52% female, n = 632; AS [37%], OA [34%], RA [14%], and FM [24%]), stress, depression, and anxiety, in parallel as first-order mediators, and sleep quality as a second-order mediator, explained the association between positive psychological variables and functional disability. CONCLUSION: Positive psychological factors exert a beneficial downstream effect on mental well-being, sleep health, and health-related functional impairment. Therapeutic promotion of gratitude, self-compassion, and self-forgiveness may improve mental and physical health in patients with rheumatic and musculoskeletal disease.

Effectiveness of Progressive Muscle Relaxation, Deep Breathing, and Guided Imagery in Promoting Psychological and Physiological States of Relaxation.

Research suggests that multiple forms of relaxation training (e.g., progressive muscle relaxation, meditation, breathing exercises, visualization, and autogenics) can help individuals reduce stress, enhance relaxation states, and improve overall well-being. We examined three different, commonly used approaches to stress relaxation-progressive muscle relaxation, deep breathing, and guided imagery-and evaluated them in a head-to-head comparison against each other and a control condition. Sixty healthy undergraduate participants were randomized to one of the four conditions and completed 20 minutes of progressive muscle relaxation, deep breathing, or guided imagery training that was delivered by recorded audio instruction. Baseline and follow-up assessment of psychological relaxation states were completed. Physiological relaxation was also assessed continuously using measures of electrodermal activity and heart rate. Results showed that progressive muscle relaxation, deep breathing, and guided imagery all increased the state of relaxation for participants in those groups, compared to participants in the control group. In each case, the increase was statistically significant and although the groups did not differ on relaxation before training, all groups were significantly higher on relaxation after training, as compared to the control group. Progressive muscle relaxation and guided imagery showed an immediate linear trend toward physiological relaxation, compared to the control group, and the deep breathing group showed an immediate increase in physiological arousal followed quickly by a return to initial levels. Our results lend support to the body of research showing that stress relaxation training can be effective in improving relaxation states at both the psychological and physiological level. Future research could examine stress relaxation techniques in a similar manner using designs where multiple techniques can be compared in the same samples.

The Importance of Daily Activity for Reducing Fibromyalgia Symptoms: A Retrospective "Real World" Data Comparison of two Multimodal Treatment Programs.

OBJECTIVES: This study aims to evaluate the effectiveness of two multidisciplinary fibromyalgia programs with different intensities. MATERIALS AND METHODS: In this retrospective real-world comparison of patient data, pre- and post-program datasets of Short Form 36 (SF36) and Fibromyalgia Impact Questionnaire (FIQ) were obtained from a total of 210 female patients in two fibromyalgia multidisciplinary day hospital programs including one intensive program with daily treatments summing up to 20 treatment days during four weeks (P20, n=70) versus a less intensive program with 12 treatment days during four weeks (P12, n=140). RESULTS: Multiple subscales of SF36 and FIQ were improved in the pre-post comparison in both groups. In the comparison between the two groups, a statistically significantly higher improvement was found in the P20 group compared to the P12 group for the FIQ subscales of stiffness (p=0.001) and the number of days during which the patient felt "good" (p=0.007). CONCLUSION: An intensive program of daily treatments and activity seems to be more effective in reducing fibromyalgia-associated stiffness and improving the number of days during which patients feel good than a less intensive program.

[Effects of lifestyle interventions for arterial hypertension in primary care: A systematic review]. / Effekte von Lebensstiländerungen bei arterieller Hypertonie in der Primärversorgung - ein systematisches Review.

BACKGROUND: The proportion of adults suffering from hypertension worldwide was estimated at 31.1 % in 2010. The aim of this study was to evaluate the effects of lifestyle changes in patients with arterial hypertension (AH) in primary care. MATERIAL AND METHODS: Systematic literature search in the online databases PubMed, Embase, Cochrane and Opengrey. Only randomized controlled trials of the years 2005 to 2017 in German or English were considered. RESULTS: 11 studies out of 458 identified references were evaluated. The patient groups investigated were very heterogeneous and underwent different types of intervention. Educating patients about the clinical picture, regular self-measurements of blood pressure, or patient memories of maintaining a healthy lifestyle have been used most frequently. CONCLUSION: There is a need for further studies focusing on primary care. However, many lifestyle interventions seem to show very good effects in patients with pre-existing AH (secondary prophylaxis), so these measures should form the basis of antihypertensive therapy in all patients with AH. In addition, it is important to maintain advice on a healthy lifestyle during drug therapy.

Educational needs of patients with rheumatic and musculoskeletal diseases attending a large health facility in Austria.

INTRODUCTION: Patient education is an important part of the management of rheumatic and musculoskeletal diseases. Given that patients with diverse diseases do not have the same needs, it is crucial to assess the educational requirements of targeted groups to provide tailored educational interventions. The aim of our study was to assess educational needs of a large cohort of patients with different rheumatic and musculoskeletal diseases attending a health facility in Austria. METHODS: We assessed educational needs, via an online survey of patients with fibromyalgia (FMS), rheumatoid arthritis (RA), and ankylosing spondylitis (AS) recruited from an Austrian health-care facility, using the Austrian version of the Educational Needs Assessment Tool (OENAT). RESULTS: For our sample of 603 patients, AS (62%), RA (15%), and FMS (24%), there were no educational need differences for the domains of movements, disease process, and self-help measures. Patients with FMS had less need for pain management education and greater need for education about feelings, than other disease groups. Patients with RA had a greater need for education related to treatments than other groups, and patients with AS had a greater need for treatment education than patients with FMS. Patients with AS reported greater need for support system education than other patient groups. CONCLUSION: Educational needs vary by disease groups, suggesting that health-care professionals should assess disease-specific needs for education to provide optimal assistance in disease management for patients.

Are the contents of treatment outcomes in fibromyalgia trials represented in the International Classification Of Functioning, Disability, and Health?

OBJECTIVES: To identify the concepts contained in treatment outcomes of randomized controlled trials (RCTs) for interventions in patients with fibromyalgia (FM) using the International Classification of Functioning, Disability, and Health (ICF) as external reference. METHODS: RCTs between 1992 and 2001 were located in MEDLINE and selected according to predefined eligibility criteria. The outcome measures were extracted and the concepts within the outcome measures were identified and linked to the ICF using a content-analytical approach. RESULTS: Forty-two trials on FM were included. Twenty-seven different questionnaires were extracted. Of all, 79.2% (N=236) of the clinical and physiologic outcomes could be linked to 31 different ICF categories and 84.7% (N=964) of the concepts contained in the health-status questionnaire to 113 ICF categories. CONCLUSIONS: The ICF provides a useful external reference to identify the concepts contained in outcome measures used in RCTs in FM.

A randomized controlled trial on the effectiveness of mild water-filtered near infrared whole-body hyperthermia as an adjunct to a standard multimodal rehabilitation in the treatment of fibromyalgia.

OBJECTIVES: To evaluate whether mild water-filtered near infrared whole-body hyperthermia (NI-WBH) produces an additional benefit when applied as an adjunct to a standard multimodal rehabilitation (MR) compared with MR only in patients with fibromyalgia (FM). METHODS: One hundred thirty-nine patients of a German inpatient rehabilitation hospital meeting the ACR 1990 criteria for FM were randomly allocated to NI-WBH (heating-up to 38.1 degrees C body core temperature followed by a 15 min heat retention period) and MR or MR only, twice a week over 3 weeks. Main outcome measures were affective and sensory pain assessed by a German version of the McGill Pain Questionnaire, measured at baseline, postintervention, 3 and 6 months postintervention and analyzed by intention to treat. RESULTS: Repeated measures analysis of covariance showed significant differences between groups for both primary outcome measures in favor of NI-WBH and MR compared with MR only (P<0.001 for affective pain, P=0.001 for sensory pain). Secondary analyses on pain intensity, FM-related quality of life and tender point assessment yielded similar results. Moderate effect sizes were observed for all outcome measures considered (range, 0.41 to 0.75). NI-WBH related side effects were observed in 14 of 69 participants (20%) but all disappeared in less than 30 minutes. DISCUSSION: The study indicates that NI-WBH is a worthwhile adjunct to MR in the treatment of FM.

Spirituality: an overlooked predictor of placebo effects?

Empirical findings have identified spirituality as a potential health resource. Whereas older research has associated such effects with the social component of religion, newer conceptualizations propose that spiritual experiences and the intrapersonal effects that are facilitated by regular spiritual practice might be pivotal to understanding potential salutogenesis. Ongoing studies suggest that spiritual experiences and practices involve a variety of neural systems that may facilitate neural 'top-down' effects that are comparable if not identical to those engaged in placebo responses. As meaningfulness seems to be both a hallmark of spirituality and placebo reactions, it may be regarded as an overarching psychological concept that is important to engaging and facilitating psychophysiological mechanisms that are involved in health-related effects. Empirical evidence suggests that spirituality may under certain conditions be a predictor of placebo response and effects. Assessment of patients' spirituality and making use of various resources to accommodate patients' spiritual needs reflect our most current understanding of the physiological, psychological and socio-cultural aspects of spirituality, and may also increase the likelihood of eliciting self-healing processes. We advocate the position that a research agenda addressing responses and effects of both placebo and spirituality could therefore be (i) synergistic, (ii) valuable to each phenomenon on its own, and (iii) contributory to an extended placebo paradigm that is centred around the concept of meaningfulness.