Illness perception and health care use in individuals with irritable bowel syndrome: results from an online survey.

BACKGROUND: Individual illness perception is known to influence a range of outcome variables. However, little is known regarding illness perception in irritable bowel syndrome (IBS) and its relation to the use of the health care system. This study hypothesised a relationship between illness perception and inappropriate health care use (under-, over- and misuse). METHODS: An internet-based, cross-sectional study in participants affected by IBS symptoms was carried out (April - October 2019) using open questions as well as validated standardized instruments, e.g. the illness perception questionnaire revised (IPQ-R) and its subscales. Sub-group comparisons were done non-parametrically and effect sizes were reported. Potential predictors of (1) conventional health care utilisation and (2) utilisation of treatment approaches with lacking or weak evidence regarding effectiveness in IBS were examined with logistic regression analyses and reported as odds ratio (OR) and 95% confidence interval. RESULTS: Data from 513 individuals were available. More than one-third (35.7%) of participants were classified as high utilisers (> 5 doctor visits during the last year). Several indicators of inappropriate health care use were detected, such as a low proportion of state-of-the-art gynaecological evaluation of symptoms (35.0% of women) and a high proportion of individuals taking ineffective and not recommended non-steroidal antirheumatic drugs for IBS (29.4%). A majority (57.7%) used treatment approaches with lacking or weak evidence regarding the effectiveness in IBS (e.g. homeopathy). Being a high utiliser as defined above was predicted by the perceived daily life consequences of IBS (IPQ-R subscale "consequences", OR = 1.189 [1.100-1.284], p ≤ 0.001) and age (OR = 0.980 [0.962-0.998], p = 0.027). The use of treatment approaches with lacking or weak evidence was forecasted by the perceived daily life consequences (OR = 1.155 [1.091-1.223], p ≤ 0.001) and gender (reference category male: OR = 0.537 [0.327-0.881], p = 0.014), however effect sizes were small. CONCLUSIONS: Daily life consequences, perceived cure and personal control as aspects of individual disease perception seem to be related to individuals' health care use. These aspects should be a standard part of the medical interview and actively explored. To face inappropriate health care use patients and professionals need to be trained. Interdisciplinary collaborative care may contribute to enhanced quality of medical supply in IBS.

Effects of a probiotic treatment (Enterococcus faecalis) and open-label placebo on symptoms of allergic rhinitis: study protocol for a randomised controlled trial.

INTRODUCTION: Several studies suggest that gut microbiota may play an important role in allergic diseases. The present trial aims to examine effects of the probiotic Enterococcus faecalis on symptoms of allergic rhinitis in patients. Effects of this probiotic on the immune system have been reported by several studies, but the majority of the previous trials were animal studies. In addition, it is well known that symptoms in allergic rhinitis are prone to exhibit high placebo responses. Moreover, recent studies report that even placebos without deception (open-label placebos) are highly effective in reducing symptoms of allergic rhinitis. Our study design combines both new approaches to assess effects on allergic symptoms in patients. The objective of this study is to compare the effects of a probiotic treatment (E. faecalis) with effects seen by open-label placebo, concealed placebo treatment and no treatment control. METHODS AND ANALYSIS: A total of 120 patients with allergic rhinitis will be randomly assigned to one of four different groups: a double-blind probiotic/placebo group (groups 1 and 2), an open-label placebo group (group 3) and a no-treatment group (group 4) to control for spontaneous variation of symptoms. The primary outcome is the evaluation of allergic symptoms using the Combined Symptoms Medication Score. Furthermore, health-related quality of life is examined (Rhinitis Quality of Life Questionnaire). Secondary outcomes include a visual analogue scale on allergic burden and a second quality of life questionnaire. This report describes the study design of the randomised controlled trial. ETHICS AND DISSEMINATION: The study design was approved by the ethical committee of the UKT Department of Psychosomatic Medicine and Psychotherapy, Tübingen, Germany. The trial is registered at the German Clinical Trials Register (www.drks.de, DRKS00015804). The trial results will be published in peer-reviewed journals and at conferences. TRIAL REGISTRATION NUMBER: German Clinical Trials Register (www.drks.de, DRKS00015804); Pre-results.

Increasing effort without noticing: A randomized controlled pilot study about the ergogenic placebo effect in endurance athletes and the role of supplement salience.

PURPOSE: Previous research shows that endurance performance can be enhanced by placebo ergogenic aids. This study investigates the ergogenic placebo response, which we define as an increase in objective and physiological effort without an increase in subjective effort, in competitive cyclists. The primary objective of this study is to explore the role of supplement salience in the ergogenic placebo response, while the secondary aim is to assess whether believing to have taken an inactive placebo supplement attenuates the desired ergogenic effect. METHODS: We employed a double-blind placebo-controlled study design and compared a high salience (pudding) to a low salience (capsules) ergogenic placebo supplement and to a no treatment control group. Thirty-four male athletes (30.0 ± 5.7 years) performed two self-regulated time trials on an isokinetic cycling ergometer, one without intervention serving as a baseline and one with intervention according to group assignment. At both time trials, power output (objective effort), blood lactate (physiological effort) and the rating of perceived exertion (subjective effort) were measured. RESULTS: Receiving a high salience supplement can increase physiological and objective effort without a proportional rise in subjective effort, suggesting a decoupling of perceived exertion and endurance performance. Low salience and control group both showed no such ergogenic placebo response. Athletes' belief concerning the true nature of the ergogenic aid (inactive placebo vs. ergogenic supplement) did not influence the ergogenic placebo response. CONCLUSION: High salience placebo ergogenic aids can elicit enhanced performance without the athlete noticing (exertion), and deception of athletes seems unnecessary as even believing to have received an inactive placebo supplement maintains the ergogenic placebo response.

How Placebo Needles Differ From Placebo Pills?

Because acupuncture treatment is defined by the process of needles penetrating the body, placebo needles were originally developed with non-penetrating mechanisms. However, whether placebo needles are valid controls in acupuncture research is subject of an ongoing debate. The present review provides an overview of the characteristics of placebo needles and how they differ from placebo pills in two aspects: (1) physiological response and (2) blinding efficacy. We argue that placebo needles elicit physiological responses similar to real acupuncture and therefore provide similar clinical efficacy. We also demonstrate that this efficacy is further supported by ineffective blinding (even in acupuncture-naïve patients) which may lead to opposite guesses that will further enhances efficacy, as compared to no-treatment, e.g., with waiting list controls. Additionally, the manner in which placebo needles can exhibit therapeutic effects relative to placebo pills include enhanced touch sensations, direct stimulation of the somatosensory system and activation of multiple brain systems. We finally discuss alternative control strategies for the placebo effects in acupuncture therapy.

The Diagnosis and Treatment of Functional Dyspepsia.

BACKGROUND: Functional dyspepsia (FD) is one of the more common functional disorders, with a prevalence of 10-20%. It affectsthe gastrointestinal tract. METHODS: This article is based on publications retrieved by a selective search of PubMed, with special attention to controlled trials, guidelines, and reviews. RESULTS: Typical dyspeptic symptoms in functional dyspepsia include epigastric pain, sensations of pressure and fullness, nausea, and early subjective satiety. The etiology of the disorder is heterogeneous and multifactorial. Contributory causes include motility disturbances, visceral hypersensitivity, elevated mucosal permeability, and disturbances of the autonomic and enteric nervous system. There is as yet no causally directed treatment for functional dyspepsia. Its treatment should begin with intensive patient education regarding the benign nature of the disorder and with the establishment of a therapeutic pact for long-term care. Given the absence of a causally directed treatment, drugs to treat functional dyspepsia should be given for no more than 8-12 weeks. Proton-pump inhibitors, phytotherapeutic drugs, and Helicobacter pylori eradication are evidence-based interventions. For intractable cases, tricyclic antidepressants and psychotherapy are further effective treatment options. CONCLUSION: The impaired quality of life of patients with functional dyspepsia implies the need for definitive establishment of the diagnosis, followed by symptom-oriented treatment for the duration of the symptomatic interval.

Functional dyspepsia.

Functional dyspepsia is one of the most prevalent functional gastrointestinal disorders. Functional dyspepsia comprises three subtypes with presumed different pathophysiology and aetiology: postprandial distress syndrome (PDS), epigastric pain syndrome (EPS) and a subtype with overlapping PDS and EPS features. Functional dyspepsia symptoms can be caused by disturbed gastric motility (for example, inadequate fundic accommodation or delayed gastric emptying), gastric sensation (for example, sensations associated with hypersensitivity to gas and bloating) or gastric and duodenal inflammation. A genetic predisposition is probable but less evident than in other functional gastrointestinal disorders, such as irritable bowel syndrome (IBS). Psychiatric comorbidity and psychopathological state and trait characteristics could also play a part, although they are not specific to functional dyspepsia and are less pronounced than in IBS. Possible differential diagnoses include Helicobacter pylori infection and peptic ulceration. Pharmacological therapy is mostly based on the subtype of functional dyspepsia, such as prokinetic and fundus-relaxing drugs for PDS and acid-suppressive drugs for EPS, whereas centrally active neuromodulators and herbal drugs play a minor part. Psychotherapy is effective only in a small subset of patients, whereas quality of life can be severely affected in nearly all patients. Future therapies might include novel compounds that attempt to treat the underlying gastric and duodenal inflammation.

The potential effects of chlorogenic acid, the main phenolic components in coffee, on health: a comprehensive review of the literature.

Chlorogenic acid (CGA), an important biologically active dietary polyphenol, is produced by certain plant species and is a major component of coffee. Reduction in the risk of a variety of diseases following CGA consumption has been mentioned in recent basic and clinical research studies. This systematic review discusses in vivo animal and human studies of the physiological and biochemical effects of chlorogenic acids (CGAs) on biomarkers of chronic disease. We searched PubMed, Embase, Amed and Scopus using the following search terms: ("chlorogenic acid" OR "green coffee bean extract") AND (human OR animal) (last performed on April 1st, 2015) for relevant literature on the in vivo effects of CGAs in animal and human models, including clinical trials on cardiovascular, metabolic, cancerogenic, neurological and other functions. After exclusion of editorials and letters, uncontrolled observations, duplicate and not relevant publications the remaining 94 studies have been reviewed. The biological properties of CGA in addition to its antioxidant and anti-inflammatory effects have recently been reported. It is postulated that CGA is able to exert pivotal roles on glucose and lipid metabolism regulation and on the related disorders, e.g. diabetes, cardiovascular disease (CVD), obesity, cancer, and hepatic steatosis. The wide range of potential health benefits of CGA, including its anti-diabetic, anti-carcinogenic, anti-inflammatory and anti-obesity impacts, may provide a non-pharmacological and non-invasive approach for treatment or prevention of some chronic diseases. In this study, the effects of CGAs on different aspects of health by reviewing the related literatures have been discussed.

Abdominal pain, cramping or discomfort impairs quality of life in women: An internet-based observational pilot study focussing on impact of treatment.

Background Abdominal pain, cramping, and discomfort (APCD) are experienced by up to 30 % of adults in Europe. Objective To assess the impact of APCD on quality of life (QoL) and to investigate the effectiveness, tolerability, and impact on QoL of hyoscine butylbromide (HBB, Buscopan®) compared with STW 5 (Iberogast®) or analgesics in women with APCD. Methods An internet-based observational pilot study was conducted in Germany in women who had predominantly used HBB, STW 5, or analgesics (n = 240 per treatment) to treat APCD. This online survey included questions on QoL, effectiveness, and tolerability. Results A total of 720 completed questionnaires was evaluated. APCD had a major impact on QoL, with 96 % of women reporting that daily activities were disrupted at least sometimes, and 44 % at least often. Other aspects of QoL, such as quality of work, eating habits, and social activities, were also affected in most women. After taking their medication of choice, 91 % of women in the HBB group reported they could "very often" or "often" continue with their daily activities, compared with 84 % and 85 % in the STW 5 and analgesic groups, respectively (p < 0.05 for both comparisons). HBB was perceived to be the "best solution" to overcome APCD symptoms "very often" or "often" by more women (86 %) than STW 5 (75 %) and analgesics (74 %) (p < 0.05 for both comparisons). Conclusion Women with APCD have impaired QoL. All treatments were considered effective by the majority of participants. Compared with STW 5 or analgesics, HBB was reported to facilitate return to daily activities more frequently.

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.

Autonomic Function in Seasonal Allergic Rhinitis and Acupuncture - an Experimental Pilot Study within a Randomized Trial.

BACKGROUND: Acupuncture was shown to reduce symptoms of seasonal allergic rhinitis (SAR). The present study investigated (a) whether autonomic function would differ in SAR patients and healthy controls, and (b) whether acupuncture treatment would evoke changes in autonomic function compared to sham acupuncture. PATIENTS AND METHODS: SAR patients (n = 30) were recruited from a larger randomized controlled trial investigating the efficacy of acupuncture in SAR. 21 patients received acupuncture, and 9 patients received sham acupuncture. Among other we measured resting heart rate variability and cardiovascular reactivity to a cold pressure test prior to and after 12 sessions of acupuncture or sham acupuncture. In addition, 30 age- and sex-matched healthy controls were tested once. RESULTS: SAR patients showed higher resting heart rate and lower heart rate variability as well as blunted cardiovascular responses compared to controls. After treatment, resting heart rate had decreased, and systolic blood pressure response to the cold pressure test had increased in SAR patients. We found no significant differences in autonomic function changes between patients receiving acupuncture or sham acupuncture. CONCLUSION: SAR patients showed alterations in autonomic function, which had partially normalized after treatment. However, in this sample we found no specific effect of acupuncture compared to sham acupuncture.

How to study placebo responses in motion sickness with a rotation chair paradigm in healthy participants.

Placebo responses occur in every medical intervention when patients or participants expect to receive an effective treatment to relieve symptoms. However, underlying mechanisms of placebo responses are not fully understood. It has repeatedly been shown that placebo responses are associated with changes in neural activity but for many conditions it is unclear whether they also affect the target organ, such as the stomach in motion sickness. Therefore, we present a methodology for the multivariate assessment of placebo responses by subjective, behavioral and objective measures in motion sickness with a rotation chair paradigm. The physiological correlate of motion sickness is a shift in gastric myoelectrical activity towards tachygastria that can be recorded with electrogastrography. The presented study applied the so-called balanced placebo design (BPD) to investigate the effects of ginger compared to placebo and the effects of expectations by verbal information. However, the study revealed no significant main or interactional effects of ginger (as a drug) or information on outcome measures but showed interactions when sex of participants and experimenters are taken into considerations. We discuss limitations of the presented study and report modifications that were used in subsequent studies demonstrating placebo responses when rotation speed was lowered. In general, future placebo studies have to identify the appropriate target organ for the studied placebo responses and to apply the specific methods to assess the physiological correlates.

[Dropout behavior during inpatient psychotherapy ]. / Behandlungsabbrüche während einer stationären Psychotherapie.

OBJECTIVES: Dropouts result in far-reaching consequences for the individual patient, fellow patients, therapists, and the clinic. This study was aimed at early identification of patients with a dropout risk. METHODS: Data from patients of the Department of Psychosomatic Medicine and Psychotherapy of the Medical University Clinic of Tübingen (Germany) were analyzed retrospectively in a case-control study (matched). Differences in the results of various questionnaires (SCL-90-R, IIP-D, SF-36) regarding reasons for dropout and sociodemographic data were analyzed. A total of 59 dropouts, 50 females and 9 males, were included. They were split into 28 early dropouts and 31 late dropouts. The data were compared between early and late dropouts and control group. RESULTS: Early dropouts were significantly younger than late dropouts; they tended to live with their parents or on their own, and suffered more frequently from eating disorders. Late dropouts lived together with partners and suffered from somatoform disorders more frequently than early dropouts. The reasons given for dropout did not differ between the groups. No differences between dropouts and the controls were found with respect to psychopathology (SCL- 90-R) and quality of life (SF-36). Late dropouts did show significantly lower scores on the scale "autocracy/dominance" than the controls (IIP). CONCLUSIONS: Therapy dropout is a multifactorial occurrence. It is generally not predictable, though it may be predicted with different instruments on the basis of a diagnosis, especially with respect to interpersonal behavior patterns. In further studies, targeted interventions should be developed and tested which enable procedures to minimize the risk of dropout and to achieve complete treatment according to patients' intentions.

The effects of 5-hydroxytryptophan in combination with different Fatty acids on gastrointestinal functions: a pilot experiment.

Background. Fat affects gastric emptying (GE). 5-Hydroxythryptophan (5-HTP) is involved in central and peripheral satiety mechanisms. Influence of 5-HTP in addition to saturated or monounsaturated fatty acids (FA) on GE and hormone release was investigated. Subjects/Methods. 24 healthy individuals (12f : 12m, 22-29 years, BMI 19-25.7 kg/m²) were tested on 4 days with either 5-HTP + short-chain saturated FA (butter), placebo + butter, 5-HTP + monounsaturated FA (olive oil), or placebo + olive oil in double-blinded randomized order. Two hours after FA/5-HTP or placebo intake, a (13)C octanoid acid test was conducted. Cortisol, serotonin, cholecystokinin (CCK), and ghrelin were measured, as were mood and GE. Results. GE was delayed with butter and was normal with olive (P < 0.05) but not affected by 5-HTP. 5-HTP supplementation did not affect serotonin levels. Food intake increased plasma CCK (F = 6.136; P < 0.05) irrespective of the FA. Ghrelin levels significantly decreased with oil/5-HTP (F = 9.166; P < 0.001). The diurnal cortisol profile was unaffected by FA or 5-HTP, as were ratings of mood, hunger, and stool urgency. Conclusion. Diverse FAs have different effects on GE and secretion of orexigenic and anorexigenic hormones. Supplementation of 5-HTP had no effect on plasma serotonin and central functions. Further studies are needed to explain the complex interplay.

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.

Role of serotonin in fatty acid-induced non-alcoholic fatty liver disease in mice.

BACKGROUND: Saturated fatty acids are thought to be of relevance for the development of non-alcoholic fatty liver disease and obesity. However, the underlying mechanisms are poorly understood. In previous studies we found that food-derived carbohydrates such as fructose alter the intestinal serotonergic system while inducing fatty liver disease in mice. Here, we examined the effect of fatty acid quantity (11% versus 15%) and quality (saturated, monounsaturated, or polyunsaturated fatty acids) on hepatic fat accumulation, intestinal barrier and the intestinal serotonergic system. METHODS: C57BL/6 mice had free access to diets enriched with one of the three fatty acids or standard diet, for 8 weeks. In an additional experiment mice were fed diets enriched with saturated, monounsaturated fatty acids or standard diet supplemented with tryptophan (0.4 g/(kg.d), 8 weeks) or not. Hepatic fat accumulation, small intestinal barrier impairment and components of the serotonergic system were measured with RT-PCR, western blot or immunoassays. For statistical analysis t-test and one-way ANOVA with Tukey's post hoc test and Bartlett's test for equal variances was used. RESULTS: Hepatic triglycerides, liver weight and liver to body weight ratio were significantly changed depending on the fat quality but not fat quantity. In contrast, fat quantity but not quality decreased the expression of the tight junction proteins occludin and claudin-1 in the small intestine. These changes seemed to result in enhanced portal vein endotoxin concentrations and fatty liver disease after feeding diet enriched with saturated and monounsaturated fatty acids but not polyunsaturated fatty acids. Neither fatty acid quantity nor quality significantly influenced the intestinal serotonergic system. Similarly, tryptophan supplementation had no impact on small intestinal barrier or fatty liver disease. CONCLUSION: In conclusion, diets rich in saturated or monounsaturated fatty acids promote the development of fatty liver disease in mice, likely by a dysfunction of the small intestinal mucosal barrier.

Impact of biofeedback on self-efficacy and stress reduction in obesity: a randomized controlled pilot study.

Biofeedback application is an evidence-based technique to induce relaxation. A primary mechanism of action is the improvement of self-efficacy, which is needed to facilitate the translation of health behavioral intentions into action. Obesity is often associated with low self-efficacy and dysfunctional eating patterns, including comfort eating as an inexpedient relaxation technique. This is the first study investigating the effects of biofeedback on self-efficacy and relaxation in obesity. In the present experiment, 31 women, mean body mass index 35.5 kg/m², were randomized to a food-specific biofeedback paradigm, a non-specific relaxation biofeedback paradigm, or a waiting list control. Eight sessions of biofeedback of the electrodermal activity were performed while presenting either a challenging food stimulus or a non-specific landscape stimulus. Self-efficacy, stress, ability to relax, eating behavior, and electrodermal activity were assessed before, directly after, and 3 months after the intervention. The food-specific biofeedback predominantly showed effects on food-related self-efficacy and perceived stress. The non-specific relaxation biofeedback showed effects on the ability to relax. Self-reported improvements were confirmed by corresponding decrease in the electrodermal reaction to food stimuli. Biofeedback treatment is effective in improving self-efficacy in individuals with obesity and might therefore be a valuable additional intervention in obesity treatment.

The placebo response in clinical trials-the current state of play.

While randomized, placebo-controlled double-blinded trials have become the pharmacological standard over the last 60 years, the gain in knowledge of the mechanisms behind the placebo response in recent years has raised substantial concerns about the appropriateness of some of its underlying assumptions. The following questions will be addressed: Is the assumed model of drug and placebo being additive (still) valid? Does the likelihood of receiving active treatment affect the placebo response? What is the size of the placebo response in "active comparator studies"? Minimizing the placebo response/maximizing the drug-placebo difference? How to maximize the placebo response in daily medicine? What is the placebo response with personalized medicines in the future? This and other questions require answers that can only be generated with more experimental studies on the placebo response and with thorough meta- and re-analyses of placebo responses in clinical trials.

Effects of ginger and expectations on symptoms of nausea in a balanced placebo design.

OBJECTIVE: Ginger effects on (experimental) nausea have been described, but also strong placebo effects and sex differences when nausea is involved. The "balanced placebo design" has been proposed to allow better separation of drug and placebo effects. METHODS: Sixty-four healthy participants (32 women) were randomly assigned to receive an antiemetic ginger preparation or placebo, and half of each group was told to have received drug or placebo. They were exposed to 5×2 min body rotations to induce nausea. Subjective symptoms and behavioral (rotation tolerance, head movements) and physiological measures (electrogastrogram, cortisol) were recorded. Groups were balanced for sex of participants and experimenters. RESULTS: Ginger and the information given did not affect any outcome measure, and previous sex differences could not be confirmed. Adding the experimenters revealed a significant four-factorial interaction on behavioral but not on subjective or physiological measures Men who received placebo responded to placebo information when provided by the male experimenter, and to ginger information when provided by the female experimenter. This effect was not significant in women. CONCLUSION: The effects of an antiemetic drug and provided information interact with psychosocial variables of participants and experimenters in reports of nausea.