Mirror Therapy in Patients with Somatoform Pain Disorders-A Pilot Study.

Patients with chronic pain report reduced quality of life and high symptom burden while often responding insufficiently to treatment options. Mirror therapy has been proven to be effective in treating phantom limb pain and other conditions such as CRPS. This study was designed to investigate the efficacy of mirror therapy in patients with somatoform pain disorders on symptom severity and associated physiological parameters. Fifteen patients with persistent somatoform pain disorder (F45.40) or chronic pain disorder with somatic and psychological factors (F45.41) participated and received four weeks of tablet-based mirror therapy. Symptom severity was measured with established questionnaires, and their thermal detection, pain thresholds, and heart rate variability (HRV) were also assessed. After mirror therapy, pain intensity was reduced (z = -2.878, p = 0.004), and pain thresholds for cold stimuli were also diminished, i.e., the subjects became more sensitive to cold stimuli (z = -2.040, p = 0.041). In addition, a reduction of absolute power in the low-frequency band of HRV (t(13) = 2.536, p = 0.025) was detected. These findings indicate that this intervention may reduce pain intensity and modulate associated physiological parameters. As these results are limited by several factors, e.g., a small sample size and no control group, they should be validated in further studies investigating this novel intervention in these patients.

The role of face masks within in-patient psychotherapy: Results of a survey among inpatients and healthcare professionals.

Introduction: Face-to-face medical and psychotherapeutic treatments during the Corona pandemic often involve patients and health care providers wearing face masks. We performed a pilot survey assessing the subjective experience of wearing face masks during psychotherapy sessions regarding (i) feasibility, (ii) psychotherapeutic treatment and (iii) communication, emotion and working alliance in patients and healthcare professionals. Methods: A total of n = 62 inpatients (RR = 95.4%) and n = 33 healthcare professionals (RR = 86.8%) at an academic department of Psychosomatic Medicine and Psychotherapy participated in this survey anonymously. The items of the questionnaire were created by the interprofessional expert team and were based on existing instruments: (i) the Therapeutic Relationship Questionnaire and (ii) the German translation of Yalom's Questionnaire on Experiencing in Group Psychotherapy. Results: The majority of patients rate their psychotherapy as highly profitable despite the mask. In individual therapy, face masks seem to have a rather low impact on subjective experience of psychotherapy and the relationship to the psychotherapist. Most patients reported using alternative facial expressions and expressions. In the interactional group therapy, masks were rather hindering. On the healthcare professional side, there were more frequent negative associations of face masks in relation to (i) experiencing connectedness with colleagues, (ii) forming relationships, and (iii) therapeutic treatment. Discussion: Information should be given to patients about the possible effects of face masks on the recognition of emotions, possible misinterpretations and compensation possibilities through alternative stimuli (e.g., eye area) and they should be encouraged to ask for further information. Especially in group therapy, with patients from other cultural backgrounds and in cases of need for help (e.g., hearing impairment) or complex disorders, appropriate non-verbal gestures and body language should be used to match the intended emotional expression.

Gastrointestinal complaints in patients with anorexia nervosa in the timecourse of inpatient treatment.

Background: In patients with anorexia nervosa (AN), gastrointestinal (GI) symptoms are common and usually improve during or after nutritional rehabilitation. It is unclear when exactly GI symptoms change in the timecourse of treatment and to which extent. In this study, we analyzed the timecourse of GI symptoms and their relation to disease-specific, demographic, anthropometric, and psychological factors in inpatients with AN. Methods: In weekly intervals, the Gastrointestinal Symptom Rating Scale (GSRS) was completed, and body weight was measured over a mean of 9.5 weeks in inpatients with AN. A total of four self-report questionnaires assessing psychological factors were completed before and after inpatient treatment. Data from 38 inpatients with AN were analyzed using mixed linear models. Results: Abdominal pain and constipation improved significantly in the timecourse with 0.085 (p = 0.002) and 0.101 (p = 0.004) points per week on the GSRS and were predicted to normalize after 13 (p = 0.002) and 17 (p = 0.004) weeks, respectively. Total GI symptoms tended to normalize after 25 weeks (p = 0.079). Indigestion (borborygmus, abdominal distension, eructation, flatulence) was the most severely pathological symptom at admission and did not improve significantly (p = 0.197). Diarrhea and reflux were, on average, not pathological at admission and remained stable during treatment. In addition to treatment time, the strongest predictors were ED pathology at admission for the development of abdominal pain, constipation, reflux, and total GI symptoms; stress for the development of constipation and total GI symptoms; and depression for constipation. Conclusions: Informing patients with AN about the course of GI symptoms and their improvement during weight rehabilitation may help support compliance during treatment.

Autonomic changes as reaction to experimental social stress in an inpatient psychosomatic cohort.

Objectives: Patients with psychosomatic disorders suffer from social isolation that might further lead to destabilization and exacerbation of bodily symptoms via autonomic pathways. We aimed to investigate the influence of controlled social stress (model of social ostracism) on the autonomic nerve system (ANS) in an inpatient cohort with psychosomatic disorders. Methods: We examined heart rate variability (HRV), skin conductance (SC) and skin temperature (ST) as well as ECG-derived respiration rate (EDR) and subjective reports on stress during exposure to experimental social stress (cyberball game). Data were collected from 123 participants (f:m = 88:35, 42.01 ± 13.54 years) on admission and upon discharge from the university psychosomatic clinic. All data were recorded during baseline, inclusion and exclusion phases of the cyberball game as well as during the recovery phase. Results: We found significant changes between admission and discharge with a decline in parasympathetic-related HRV parameters (SDRR -3.20 ± 1.30 ms, p = 0.026; RMSSD: -3.77 ± 1.28 ms, p = 0.007) as well as a decrease in SC (-0.04 ± 0.17 µS, p = 0.019) and EDR (-0.01 ± 0.01 Hz, p = 0.007), suggesting a drop in sympathetic tonus, with no changes in ST (p = 0.089) and subjective stress levels (p = 0.322). HRV parameters decreased during the cyberball game (SDRR p = 0.026; RMSSD p = 0.002; lnHF p < 0.001). In contrast, both SC (p < 0.001) and EDR (p < 0.001) increased during the game with SC being slightly lower during the exclusion phase. This can point toward a stimulation of sympathetic nervous system during game participation, which was concordant with the rise in subjective stress values (p < 0.001). ST showed a continuous, unspecific rise over time (p < 0.001). Conclusion: Our data demonstrate the decrease of ANS parameters during experimental social stress when data upon discharge were compared to those upon admission. These results are partially contradictory to previous studies that showed a rise in HRV in a psychiatric cohort over the course of (outpatient) treatment. Further research is required to help attributing these differences to effects of treatment or acute states relating to admission to or discharge from a psychosomatic department.

A Nonviable Probiotic in Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study.

BACKGROUND & AIMS: The aim of this study was to investigate the effectiveness of oral treatment with a nonviable probiotic lysate (BL) of Escherichia coli (DSM 17252) and Enterococcus faecalis (DSM 16440) in patients with irritable bowel syndrome (IBS). METHODS: A phase IV, randomized, double-blind, placebo-controlled, multicenter (30 study sites), parallel group study was conducted in 389 patients of both sexes with IBS according to Rome III criteria. The treatment period was 26 weeks. The participants were allocated to either placebo or BL after a 2-week baseline period. The primary outcome was based on the European Medicines Agency IBS guideline: improvement in global assessment (GAI) and improvement in abdominal pain. RESULTS: Patients (BL, n = 191; placebo, n = 198) had similar baseline values and dropout rates. Overall, the response was similar between BL and placebo for IBS-GAI (17.4% and 14.4%, respectively; P = ·4787) and abdominal pain (42.0% and 35.4%, respectively; P = ·1419). Some secondary outcome measures and sensitivity analyses pointed toward potentially higher sensitivity of the abdominal pain measures in diarrhea-predominant IBS (IBS-D) but not the other subtypes. For the GAI, no subgroup differences were detected. For IBS-D, post hoc analyses for abdominal pain response over time and stool consistency showed potentially promising effects of BL. Finally, the treatment with BL was well-tolerated. CONCLUSIONS: BL is not effective across all IBS subtypes. However, BL may offer a treatment option for IBS-D that needs verification by an adequately powered drug trial; EudraCT-No.: 2012-002741-38.

Decreased Autonomic Reactivity and Psychiatric Comorbidities in Neurological Patients With Medically Unexplained Sensory Symptoms: A Case-Control Study.

Up to 48% of patients with medically unexplained symptoms seen in neurological practice suffer from sensory symptoms, which could be of functional nature or secondary to psychiatric disorders. These patients show high medical care utilization causing elevated healthcare costs. Despite the high prevalence, little is known about clinical characteristics and pathophysiological mechanisms. For functional disorders such as irritable bowel syndrome, a reduction of heart rate variability (HRV) has been shown, suggesting a dysfunction of the autonomic nervous system (ANS). The aim of this study was to investigate psychological data and functional changes of the ANS in patients with medically unexplained sensory symptoms (MUSS). In this exploratory pilot study, 16 patients (11 females, 31.6 ± 11.9 years) with MUSS, who were recruited at a single tertiary neurological center, underwent a structured clinical interview (SCID) to evaluate psychiatric comorbidities. Patients and age- and sex-matched healthy volunteers filled in questionnaires, and individual sensory thresholds (perception, pain) were detected by quantitative sensory testing (QST). HRV was assessed at baseline and under three different experimental conditions (tonic pain stimulus, placebo application, cold-face test). All tests were repeated after 6-8 weeks. SCID interviews revealed clinical or subclinical diagnoses of psychiatric comorbidities for 12 patients. Questionnaires assessing somatization, depression, anxiety, and perceived stress significantly discriminated between patients with MUSS and healthy controls. While there was no difference in QST, reduced ANS reactivity was found in patients during experimental conditions, particularly with regard to vagally mediated HRV. Our pilot study of neurological patients with MUSS reveals a high prevalence of psychiatric comorbidities and provides evidence for altered ANS function. Our data thus give insight in possible underlying mechanisms for these symptoms and may open the door for a better diagnostic and therapeutic approach for these patients in the future.

Impact of Childhood Obesity and Psychological Factors on Sleep.

The aim of the study was to analyze sleep duration and behaviors in relation to psychological parameters in children and adolescents with obesity seeking inpatient weight-loss treatment in comparison to normal-weight children, and whether or not these variables would improve during the time course of treatment. Sixty children or adolescents with overweight and obesity (OBE) and 27 normal-weight (NW) peers (age: 9-17) were assessed for subjective sleep measures through self-reported and parent-reported questionnaires, as well as body weight, body composition, and psychological questionnaires. The OBE participants were assessed upon admission and before discharge of an inpatient multidisciplinary weight-loss program. NW participants' data were collected for cross-sectional comparison. In comparison to NW, children and adolescents with OBE had a shorter self-reported sleep duration and had poorer sleep behaviors and more sleep-disordered breathing as reported by their parents. No change in sleep measures occurred during the inpatient treatment. Psychological factors including higher anxiety, depression, and destructive-anger-related emotion regulation were moderate predictors for unfavorable sleep outcomes, independent of weight status. Children with obesity had less favorable sleep patterns, and psychological factors influenced sleep in children, independent of weight. More research is needed on the relationship and direction of influence between sleep, psychological factors, and obesity, and whether they can be integrated in the prevention and management of childhood obesity and possibly also other pediatric diseases.

Quality of life in inflammatory bowel diseases: it is not all about the bowel.

BACKGROUND/AIMS: The inflammatory bowel diseases (IBD), ulcerative colitis (UC), and Crohn's disease (CD) are chronic diseases mostly affecting young patients. As they are diseases accompanying patients for their entire life, and the quality of life (QUOL) interacts with disease activity, improving QUOL should be one of the main goals of therapy. This study aims to identify factors contributing to good or impaired QUOL. METHODS: Questionnaires addressing health-related QUOL and other psychological and social features were positioned on our institutions' webpage and on the webpage of the largest self-help group for IBD in Germany. Patients were subdivided according to their QUOL score with a cutoff of <60. We used the Short Inflammatory Bowel Disease Questionnaire, the Assessment of the Demand for Additional Psychological Treatment, and the Fear of Progression Questionnaire Short Form. RESULTS: High numbers of patients in both subgroups showed an impaired QUOL (87.34% in UC, 91.08% in CD). Active extraintestinal manifestations, smoking, high fear of progression and high demand for psychotherapy were associated with reduced QUOL. In addition, polypharmacological interventions did not result in a good QUOL, but ostomies are linked to improved QUOL especially in CD patients. CONCLUSIONS: Scores used in clinical day-to-day-practice mainly focusing on somatic factors do not sufficiently address important aspects concerning QUOL. Most importantly, extraintestinal manifestations show a hitherto underestimated impact on QUOL.

Effects of Expectancy on Cognitive Performance, Mood, and Psychophysiology in Healthy Adolescents and Their Parents in an Experimental Study.

OBJECTIVE: Placebo effects on cognitive performance and mood and their underlying mechanisms have rarely been investigated in adolescents. Therefore, the following hypotheses were investigated with an experimental paradigm: (1) placebo effects could be larger in adolescents than in adults, (2) parents' expectations influence their adolescents' expectations and placebo effects, and (3) a decrease in stress levels could be an underlying mechanism of placebo effects. METHODS: Twenty-six healthy adolescents (13.8 ± 1.6 years, 14 girls) each with a parent (45.5 ± 4.2 years, 17 mothers) took part in an experimental within-subjects study. On two occasions, a transdermal patch was applied to their hips and they received an envelope containing either the information that it is a Ginkgo patch to improve cognitive performance and mood, or it is an inactive placebo patch, in counterbalanced order. Cognitive performance and mood were assessed with a parametric Go/No-Go task (PGNG), a modification of California Verbal Learning Test, and Profile of Mood Scales (POMS). Subjects rated their expectations about Ginkgo's effects before patch application as well as their subjective assessment of its effects after the tests. An electrocardiogram and skin conductance levels (SCLs) were recorded and root mean square of successive differences (RMSSD), high-frequency power (HF), and the area under the curve of the SCL (AUC) were analyzed as psychophysiological stress markers. RESULTS: Expectations did not differ between adolescents and parents and were correlated concerning reaction times only. Overall, expectations did not influence placebo effects. There was only one significant placebo effect on the percentage of correct inhibited trials in one level of the PGNG in adolescents, but not in parents. RMSSD and HF significantly increased, and AUC decreased from pre- to post-patch application in adolescents, but not in parents. CONCLUSION: With this experimental paradigm, we could not induce relevant placebo effects in adolescents and parents. This could be due to aspects of the study design such as application form and substance, and that healthy subjects were employed. Nevertheless, we could show that adolescents are more sensitive to psychophysiological reactions related with interventions which could be part of the underlying mechanisms of placebo effects in adolescents.

[Microbiota and irritable bowel syndrome: A critical inventory]. / Mikrobiota und Reizdarmsyndrom ­ eine kritische Bestandsaufnahme.

This narrative review critically explores the role of the gut microbiota in functional bowel disorders of IBS-type. Starting with changes in the microbiota composition and diversity, as they have been often found in correlative IBS studies, it raises the question of cause and consequence, of sensitivity and specificity of findings in comparison to other diseases, and of the scientific and clinical options to manipulate the microbiota. This includes a discussion of pre- and probiotics and antibiotics as well as the role of nutrition and the microbiota exchange with fecal microbiota transfer (FMT). For IBS, most of these strategies have not been found to be successful therapies. This may be due to the heterogeneity of the disease itself, but eventually also due to the concepts of microbiological research, e. g., the term dysbiosis, or in methodological differences of the molecular-genetic research that are not visible in the published papers. Future studies should aim to identify those factors that may explain and predict the response to such therapies.

Impaired Gastric Myoelectrical Reactivity in Children and Adolescents with Obesity Compared to Normal-Weight Controls.

Obesity often has its onset in childhood and can be accompanied by various comorbidities such as functional gastrointestinal disorders and altered gastric myoelectrical activity (GMA). This study investigates whether obesity in childhood and adolescence is already associated with altered GMA, and whether an inpatient weight loss program affects GMA. Sixty children with obesity (OBE) and 27 normal-weight children (NW) (12.9 ± 1.7 years; 51% female) were compared for their GMA at rest, after a stress test, and after a drink-to-full water load test. A continuous electrogastrogram (EGG) was recorded and analyzed with respect to gastric slow waves and tachygastric activity. OBE were examined upon admission (T1) and before discharge (T2) following an inpatient weight loss program; NW served as control group. Compared to NW, children with obesity showed flattened GMA as indicated by lower tachygastric reactivity after stress and water load test at T1. Data of OBE did not differ between T1 and T2. EGG parameters were associated neither with sex, age, and BMI nor with subjective stress and food intake. Children with obesity show impaired gastric myoelectrical reactivity in response to a stress and water load test compared to normal-weight controls, which does not change during an inpatient weight loss program.

Dysbiosis in Functional Bowel Disorders.

Functional bowel disorders (FBD) resemble a group of diseases of the gastrointestinal (GI) tract that are without a clear pathogenesis; the best known is probably the "irritable bowel syndrome" (IBS). Only recently we have been able to explore the role of the gut microbiota in FBD due to progress in microbiological analytic techniques. There are different ways to explore the role of the gut microbiota and its dysbiosis in FBD. Comparison of the microbial composition in a group of patients with FBD, for example, with IBS to a group of healthy volunteers is one way. Studies have shown that the microbiota in FBD is different from that of healthy controls, but the recorded differences are not necessarily specific for FBD, they may also occur in other diseases. Another approach to explore the role of the gut microbiota in FBD is to challenge the existing "flora" with novel bacteria (probiotics) or with nutritional substrates that stimulate bacterial growth (prebiotics). More than 60 such trials including several thousand patients have been performed in IBS. These studies have produced mixed outcome: some probiotics appear to be better than others, and some appear to work only for a part of the IBS symptoms and not for all. An extreme form of this approach is the transfer of an entire microbiota from 1 healthy person to another, called fecal microbiota transplantation. This has rarely been tested in FBD but is not without risk in benign disorders.

Is the Impact of Starvation on the Gut Microbiota Specific or Unspecific to Anorexia Nervosa? A Narrative Review Based on a Systematic Literature Search.

BACKGROUND: The role of the gut microbiota in Anorexia Nervosa (AN) has long been neglected by researchers, although the fact that the former is known to play an important role in health, disease and weight regulation. Cycles of overweight and underweight due to natural states of starvation and refeeding are normal in many vertebrates in their ecological niches. OBJECTIVE: The aim of this review was to compare the similarities and differences of the gut microbiota in eating disorders with conditions of fasting and refeeding in other vertebrates. METHOD: A systematic literature search was conducted in Pubmed and Web of Science to find all relevant studies examining the gut microbiota in eating disorders and different states of fasting in vertebrates for this narrative review. RESULTS: Gut microbiota appears to differ in AN versus normal-weight individuals. Induced fasting conditions in other vertebrates resulted in heterogeneous effects on gut microbiota with respect to their richness, diversity and community structures. The findings for hibernating animals were generally consistent. A decrease in microbial richness and diversity was observed in the hibernating animal compared to the active animal, and the community structures were linked to these conditions. Some similarities and differences between AN and different states of fasting in other vertebrates were found. CONCLUSION: The complexity of the relationship between fasting and gut microbiota is difficult to interprete. A deeper biological understanding is necessary to identify promising approaches for the modulation of the AN gut microbiota to support established psychotherapies.

High Demand for Psychotherapy in Patients with Inflammatory Bowel Disease.

BACKGROUND: The relative contribution of psychological factors to the onset and course of inflammatory bowel diseases (IBD) is a matter of constant debate since its beginning, as is the clinical need and the efficacy of psychotherapeutic interventions. However, the perspective of patients with IBD has largely been ignored in this debate. METHODS: Psychometric tests including the Short-Form IBD Questionnaire (SIBDQ), the ADAP test measuring demand for psychotherapy, and the Fear-of-Progression Questionnaire Short Form as well as disease-related questions were positioned on the internet between December 2014 and January 2016. The study was advertised through DCCV (German branch of the European Federation of Crohn's and Ulcerative Colitis Associations). RESULTS: n = 631 patients responded, and complete data from n = 578 (356 Crohn's disease, 219 ulcerative colitis, 3 unclear) were available for analysis. n = 296 had previous experiences with psychotherapy, whereas n = 282 had not. This distribution clearly determined the factor "demand for psychotherapy" (chi-square = 23.7, P < 0.001). When all available data were entered into a (stepwise-forward) regression model, psychotherapy demand was dependent on previous experience (P < 0.001), fear of progression (P < 0.001), quality of life (P = 0.001), smoking (P = 0.003), and previous surgery (P = 0.005) with the total model explaining 29.7% of the variance. The total explained variance of this model was higher in ulcerative colitis (37.6%) than in Crohn's disease alone (25.4%). CONCLUSIONS: The demand for psychotherapy as additional therapy in IBD depends on previous experience with psychotherapy, fear for disease progression but also other disease or social characteristics and quality of life.

Preliminary evidence for increased parasympathetic activity during social inclusion and exclusion in adolescents with functional abdominal pain.

OBJECTIVE: Peer victimization (e.g. social exclusion) has been shown to be associated with physical health problems such as functional somatic complaints and especially symptoms of pain. To date, no study has investigated the mechanisms underlying this association in clinical pediatric samples. The aim of this study was to evaluate the parasympathetic activity during a social exclusion experience in adolescents with functional abdominal pain (FAP). METHODS: Twenty adolecents with FAP and 21 matched healthy participants were compared regarding parameters of parasympathetic activation before, during, and after participating in the Cyberball-game, a well-established paradigm to induce social exclusion. RESULTS: Adolescents with FAP showed an increase in parasympathetic activation during both consecutive phases of the Cyberball game (inclusion as well as exclusion condition) whereas the healthy control group remained stable. There were no differences in subjective experience of in- and exclusion between the groups. CONCLUSION: The parasympathetic activation pattern may indicate altered processing of social stimuli in adolescents with FAP.

Heart rate variability biofeedback therapy and graded exercise training in management of chronic fatigue syndrome: An exploratory pilot study.

OBJECTIVE: Chronic fatigue syndrome (CFS) is characterised by persistent fatigue, exhaustion, and several physical complaints. Research has shown cognitive behavioural therapy (CBT) and graded exercise training (GET) to be the most effective treatments. In a first step we aimed to assess the efficacy of heart rate variability biofeedback therapy (HRV-BF) as a treatment method comprising cognitive and behavioural strategies and GET in the pilot trial. In a second step we aimed to compare both interventions with regard to specific parameters. METHODS: The study was conducted in an outpatient treatment setting. A total of 28 women with CFS (50.3±9.3years) were randomly assigned to receive either eight sessions of HRV-BF or GET. The primary outcome was fatigue severity. Secondary outcomes were mental and physical quality of life and depression. Data were collected before and after the intervention as well as at a 5-month follow-up. RESULTS: General fatigue improved significantly after both HRV-BF and GET. Specific cognitive components of fatigue, mental quality of life, and depression improved significantly after HRV-BF only. Physical quality of life improved significantly after GET. There were significant differences between groups regarding mental quality of life and depression favouring HRV-BF. CONCLUSION: Both interventions reduce fatigue. HRV-BF seems to have additional effects on components of mental health, including depression, whereas GET seems to emphasise components of physical health. These data offer implications for further research on combining HRV-BF and GET in patients with CFS. TRIAL REGISTRATION: The described trial has been registered at the International Clinical Trials Registry Platform following the number DRKS00005445.

Effect of a weight reduction program on baseline and stress-induced heart rate variability in children with obesity.

OBJECTIVE: Autonomic dysregulation is a well-established feature in adults with obesity but not in children. Since this dysregulation could contribute to weight dynamics, this study aimed to compare autonomic regulation in children with obesity and normal-weight peers and to track autonomic status during weight reduction. METHODS: Sixty children with obesity and 27 age- and sex-matched normal-weight healthy participants were included. Heart rate variability (HRV) was assessed at baseline and during a mental stress test and a subsequent recovery period. Children with obesity were investigated both upon admission and discharge. RESULTS: Upon admission, no significant differences in HRV parameters were found for normal-weight participants and those with obesity. Inpatient treatment led to significant changes in HRV with increase in general variability (standard deviation of the normal-to-normal interval (SDNN), P < 0.001) as well as of parasympathetic regulation (root mean square successive difference (RMSSD) and high frequency power (logHF), P < 0.01). Children with obesity had sympathetic activation similar to normal-weight controls during mental stress with subsequent return to baseline values, and weight loss did not affect this profile. CONCLUSIONS: A weight reduction program induced a change in autonomic activity in children with obesity toward parasympathetic dominance but had no influence on autonomic nervous system reactivity during stress conditions.

Probiotic Therapy of the Irritable Bowel Syndrome: Why Is the Evidence Still Poor and What Can Be Done About It?

BACKGROUND/AIMS: Despite numerous randomized clinical trials and meta-analyses, there is no increased evidence for the efficacy of probiotics in the treatment of irritable bowel syndrome (IBS). We review this evidence, identify and analyse the reasons for this lack of evidence and propose methodological improvements for future studies. METHODS: Based on a literature search, we identified 56 papers that matched the purpose of our analyses. Twenty-seven studies used multi-species bacterial preparations and 29 used single-strain probiotics. They were analysed regarding patients included, treatment duration, probiotic dosage, and outcome measures. RESULTS: Trials in both groups suffered from heterogeneity with respect to probiotic concentration, duration of treatment, and other methodological issues (crossover design and underpowered studies). This heterogeneity did not allow the application of a meta-analytic approach and a systematic review was therefore performed instead. Multi-strain preparations combined 2 to 8 different bacterial subspecies, mostly lactobacilli or bifidobacteria, and used variable lengths of treatments. Overall, more than 50% of trials presented negative outcomes. The majority of the single-strain probiotic trials employing lactobacilli or Saccharomyces were negative, whereas trials employing bifidobacteria showed positive results. CONCLUSIONS: The heterogeneity of the studies of probiotics in IBS questions the value of meta-analyses. The use of different bacterial strains and different mixtures of these strains, as well as different dosages, are the main contributors to this heterogeneity. Current data provides limited evidence for the efficacy of a small number of single-strain probiotics in IBS (mostly bifidobacteria) and sound studies following strict trial guidelines (Food and Drug Administration and European Medicines Agency guidelines for clinical trials) are needed. We summarised and proposed some methodological issues for future studies in the field.

PreDictor Research in Obesity during Medical care - weight Loss in children and adolescents during an INpatient rehabilitation: rationale and design of the DROMLIN study.

BACKGROUND: Obesity in adults and children is increasing worldwide at alarming rates. Obese children and adolescents are likely to become obese adults with increased risk of a number of comorbidities. In addition to preventing the development of obesity at young age, it is necessary to individualize the therapy of already obese children and adolescents in order to increase the likelihood of weight loss and maintenance. Therefore, the aim of this study is to identify predictors which play a significant role in successful weight loss and weight loss maintenance in children and adolescents. METHODS/DESIGN: Over a one year period, 60 obese children and adolescents between 9 to 17 years of age shall be recruited at an inpatient children rehabilitation facility in Germany. They will be investigated twice within a few days following admission and prior to discharge. The study will be an integrated component of an established inpatient weight-loss and in part psychosomatic therapy. The collected data can be grouped into four clusters: 1) demographic, sociometric and psychometric data, 2) objective and subjective parameters of body condition, 3) autonomic nervous system regulated functions and 4) objective and subjective parameters for eating behavior. Primary outcome is the change of the body mass index standard deviation score (BMI-SDS). In order to evaluate the data appropriately, all examinations will be also conducted in a normal-weight reference group, matched for age and gender. DISCUSSION: For some of the collected parameters the time span between measures may be too short. Therefore, a 6 months, 1 year and 2 year follow-up will be performed for evaluating the different predictors and their influence in regard to a successful intervention. Further middle- and long-term follow-up studies are planned. TRIAL REGISTRATION: The study protocol was approved by the Ethics Committee of the University Hospital Tübingen, Germany. This study is registered at the German Clinical Trials Register (DRKS) with the clinical trial number DRKS00005122.

Sensitivity and specificity of hypnosis effects on gastric myoelectrical activity.

OBJECTIVES: The effects of hypnosis on physiological (gastrointestinal) functions are incompletely understood, and it is unknown whether they are hypnosis-specific and gut-specific, or simply unspecific effects of relaxation. DESIGN: Sixty-two healthy female volunteers were randomly assigned to either a single session of hypnotic suggestion of ingesting an appetizing meal and an unappetizing meal, or to relax and concentrate on having an appetizing or unappetizing meal, while the electrogastrogram (EGG) was recorded. At the end of the session, participants drank water until they felt full, in order to detect EGG-signal changes after ingestion of a true gastric load. During both conditions participants reported their subjective well-being, hunger and disgust at several time points. RESULTS: Imagining eating food induced subjective feelings of hunger and disgust as well as changes in the EGG similar to, but more pronounced than those seen with a real gastric water load during both hypnosis and relaxation conditions. These effects were more pronounced when imagining an appetizing meal than with an unappetizing meal. There was no significant difference between the hypnosis and relaxation conditions. CONCLUSION: Imagination with and without hypnosis exhibits similar changes in subjective and objective measures in response to imagining an appetizing and an unappetizing food, indicating high sensitivity but low specificity.