Patients' experiences treated with open-label placebo versus double-blind placebo: a mixed methods qualitative study.

BACKGROUND: There is increasing evidence suggesting that open-label placebo (OLP) is an effective treatment for several medical conditions defined by self-report. However, little is known about patients' experiences with OLP, and no studies have directly compared patients' experiences in double-blind placebo (DBP) conditions. METHODS: This study was nested in a large randomized-controlled trial comparing the effects of OLP and DBP treatments in individuals with irritable bowel syndrome (IBS). We randomly selected 33 participants for interviews concerning their experiences in the parent trial. The data were qualitatively analyzed using an iterative immersion/crystallization approach. We then compared the qualitative interview data to the quantitative IBS severity data assessed during the parent trial, using a mixed methods approach. RESULTS: Two prominent interview themes were identified: (1) the participants' feelings about their treatment allocation and (2) their reflections about the treatment. Both OLP and DBP participants mentioned hope and curiosity as major feelings driving them to engage with their treatment. However, while DBP participants tended to be more enthusiastic about their allocation, OLP participants were more ambivalent. Furthermore, OLP participants reflected more on their treatment, often involving noticeable cognitive and emotional processes of self-reflection. They offered a variety of explanations for their symptom improvement and were significantly less likely to attribute it to the treatment itself than DBP participants (Χ2 [3] = 8.28; p = .041). Similarly, the participants' retrospective narratives of symptom improvement were significantly correlated with their corresponding quantitative IBS severity scores only in DBP (p's ≤ .006) but not in OLP (p's ≥ .637). CONCLUSION: OLP and DBP participants share feelings of hope, uncertainty and curiosity but differ in the extent of conscious reflection. The counter-intuitive OLP prompts more self-examination, ambivalent feelings and active engagement compared to DBP. At the same time, OLP participants are more reluctant to attribute symptom improvement to their treatment. Our findings substantially add to the emerging picture of factors that distinguish OLP and DBP and their potential mechanisms.

Intuitive eating buffers the link between internalized weight stigma and body mass index in stressed adults.

Internalized weight stigma (IWS) is independently associated with less intuitive eating (i.e., eating based on endogenous hunger/satiety cues) and higher Body Mass Index (BMI), and intuitive eating training is commonly conceptualized as protective against the effects of IWS on poor behavioral health. The 3-way relationship between IWS, intuitive eating, and BMI has yet to be examined, and it is unclear whether the link between IWS and BMI is buffered by high intuitive eating. This secondary preliminary analysis examined baseline data of stressed adults with poor diet (N = 75, 70% female, 64.1% White, 42.7% with overweight/obesity) in a parent clinical trial that tested the effects of yoga on diet and stress. Validated self-report surveys of IWS and intuitive eating were analyzed with objectively-assessed BMI. Moderated regression analyses using the SPSS PROCESS macro tested whether intuitive eating moderated the IWS-BMI link. The analysis revealed IWS was positively associated with BMI except among people with high intuitive eating. Results extend observational findings linking intuitive eating to lower BMI, and offer preliminary support for the hypothesis that this link may hold even among those with greater IWS. It's possible that individuals with lower BMI and greater IWS may gravitate more towards intuitive eating than those with greater BMI, and/or intuitive eating may be an important target for ameliorating the adverse association of IWS with behavioral and physical health indicators linked to BMI. Continued work is warranted in larger, more generalizable samples using causal and prospective designs.

Internalized weight stigma and intuitive eating among stressed adults during a mindful yoga intervention: associations with changes in mindfulness and self-compassion.

PURPOSE: Internalized weight stigma (IWS) is common in the United States of America across body weight categories, and is implicated in the development of distress and unhealthy eating behaviors (e.g. overeating, disordered eating) that can foster poor cardiometabolic health. While emerging intervention research shows early promise in reducing IWS, long-term efficacy is unclear and novel strategies remain needed. This analysis examined whether participation in a mindful yoga intervention was associated with reduced IWS and increased intuitive eating, an adaptive eating behavior, and whether these changes correlated with each other or with changes in mindfulness and self-compassion. METHODS: Participants were stressed adults with low fruit and vegetable intake (N = 78, 64.1% White, M. Body Mass Index 25.59 ± 4.45) enrolled in a parent clinical trial of a 12-week mindful yoga intervention. Validated self-report measures of IWS, intuitive eating, mindfulness, and self-compassion were administered at pre-treatment, mid-treatment (8 weeks), post-treatment (12 weeks), and 4-month follow-up (24 weeks). RESULTS: Linear mixed modeling revealed significant improvements in IWS and intuitive eating across the four timepoints (p < .001). Reduced IWS correlated with increased intuitive eating pre- to post-treatment (p = .01). Improved self-compassion and mindfulness correlated with intuitive eating (both p = . 04), but not IWS (p = .74 and p = .56, respectively). CONCLUSION: This study offers preliminary support for the hypothesis that mindful yoga may promote intuitive eating and reduce IWS among stressed adults with poor diet, and suggests that changes in these factors may co-occur over time. Further investigation with controlled designs is necessary to better understand the temporality and causality of these relationships.Trial registration: ClinicalTrials.gov identifier: NCT02098018.

Latent Factor Decomposition Model: Applications for Questionnaire Data.

The analysis of clinical questionnaire data comes with many inherent challenges. These challenges include the handling of data with missing fields, as well as the overall interpretation of a dataset with many fields of different scales and forms. While numerous methods have been developed to address these challenges, they are often not robust, statistically sound, or easily interpretable. Here, we propose a latent factor modeling framework that extends the principal component analysis for both categorical and quantitative data with missing elements. The model simultaneously provides the principal components (basis) and each patients' projections on these bases in a latent space. We show an application of our modeling framework through Irritable Bowel Syndrome (IBS) symptoms, where we find correlations between these projections and other standardized patient symptom scales. This latent factor model can be easily applied to different clinical questionnaire datasets for clustering analysis and interpretable inference.

Yoga participation associated with changes in dietary patterns and stress: A pilot study in stressed adults with poor diet.

BACKGROUND AND PURPOSE: Stress contributes to dietary patterns that impede health. Yoga is an integrative stress management approach associated with improved dietary patterns in burgeoning research. Yet, no research has examined change in dietary patterns, body mass index (BMI), and stress during a yoga intervention among stressed adults with poor diet. MATERIALS AND METHODS: Objectively-measured BMI and a battery of self-report questionnaires were collected at four time points during and following a 12-week yoga intervention (N = 78, 71% women, mean BMI = 25.69 kg/m2±4.59) - pre-treatment (T1), mid-treatment (6 weeks; T2), post-treatment (12 weeks; T3), and at 3-month follow-up (24 weeks; T4). RESULTS: T1 to T3 fruit and vegetable intake, BMI, and stress significantly declined in the overall sample. Reduction in vegetable intake was no longer significant after accounting for reductions in caloric intake, and reduction in caloric intake remained significant after accounting for reductions in stress. CONCLUSION: Findings may be interpreted as yoga either encouraging or adversely impacting healthy dietary patterns (i.e., minimizing likelihood of future weight gain vs. decreasing vegetable intake and overall caloric intake among individuals who may not need to lose weight, respectively). Continued research is warranted, utilizing causal designs.

Sex-Based Differences in Plasma Autoantibodies to Central Nervous System Proteins in Gulf War Veterans versus Healthy and Symptomatic Controls.

Veterans from the 1991 Gulf War (GW) have suffered from Gulf War illness (GWI) for nearly 30 years. This illness encompasses multiple body systems, including the central nervous system (CNS). Diagnosis and treatment of GWI is difficult because there has not been an objective diagnostic biomarker. Recently, we reported on a newly developed blood biomarker that discriminates GWI from GW healthy controls, and symptomatic controls with irritable bowel syndrome (IBS) and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The present study was designed to compare levels of these biomarkers between men and women with GWI, as well as sex-specific effects in comparison to healthy GW veterans and symptomatic controls (IBS, ME/CFS). The results showed that men and women with GWI differ in 2 of 10 plasma autoantibodies, with men showing significantly elevated levels. Men and women with GWI showed significantly different levels of autoantibodies in 8 of 10 biomarkers to neuronal and glial proteins in plasma relative to controls. In summary, the present study addressed the utility of the use of plasma autoantibodies for CNS proteins to distinguish among both men and women veterans with GWI and other healthy and symptomatic control groups.

Using Plasma Autoantibodies of Central Nervous System Proteins to Distinguish Veterans with Gulf War Illness from Healthy and Symptomatic Controls.

For the past 30 years, there has been a lack of objective tools for diagnosing Gulf War Illness (GWI), which is largely characterized by central nervous system (CNS) symptoms emerging from 1991 Gulf War (GW) veterans. In a recent preliminary study, we reported the presence of autoantibodies against CNS proteins in the blood of veterans with GWI, suggesting a potential objective biomarker for the disorder. Now, we report the results of a larger, confirmatory study of these objective biomarkers in 171 veterans with GWI compared to 60 healthy GW veteran controls and 85 symptomatic civilian controls (n = 50 myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and n = 35 irritable bowel syndrome (IBS)). Specifically, we compared plasma markers of CNS autoantibodies for diagnostic characteristics of the four groups (GWI, GW controls, ME/CFS, IBS). For veterans with GWI, the results showed statistically increased levels of nine of the ten autoantibodies against neuronal "tubulin, neurofilament protein (NFP), Microtubule Associated Protein-2 (MAP-2), Microtubule Associated Protein-Tau (Tau), alpha synuclein (α-syn), calcium calmodulin kinase II (CaMKII)" and glial proteins "Glial Fibrillary Acidic Protein (GFAP), Myelin Associated Glycoprotein (MAG), Myelin Basic Protein (MBP), S100B" compared to healthy GW controls as well as civilians with ME/CFS and IBS. Next, we summed all of the means of the CNS autoantibodies for each group into a new index score called the Neurodegeneration Index (NDI). The NDI was calculated for each tested group and showed veterans with GWI had statistically significantly higher NDI values than all three control groups. The present study confirmed the utility of the use of plasma autoantibodies for CNS proteins to distinguish among veterans with GWI and other healthy and symptomatic control groups.

In the Eyes of Those Who Were Randomized: Perceptions of Disadvantaged Older Adults in a Tai Chi Trial.

BACKGROUND AND OBJECTIVES: Older adults living in subsidized housing have typically been excluded from exercise intervention studies. We conducted a qualitative study to explore the perceived physical, psychological, social, and economic factors that influenced participation in and adherence to a year-long Tai Chi intervention within an ongoing cluster-randomized controlled trial (RCT) for older adults living within subsidized housing facilities. RESEARCH DESIGN AND METHODS: Focus groups were held with participants of the RCT who were allocated to the trial's Tai Chi intervention. Individual phone interviews were conducted with those allocated to Tai Chi who had low adherence or who had withdrawn their participation from the study. Emergent themes were extracted using grounded-theory methods. RESULTS: In this qualitative study, we enrolled 41 participants who were allocated to the RCT's Tai Chi intervention: 38 completed and 3 withdrew from the study. Average Tai Chi class attendance was 64.3%. Pragmatic factors that led to higher adherence and retention included: locating classes within each facility; providing programs at no cost; and deployment of a skilled research support team. In addition, the use of an accessible, simplified Tai Chi program improved confidence, social support, self-efficacy, and self-reported improvements in physical and psychological well-being. DISCUSSION AND IMPLICATIONS: Perceived physical, psychological, social benefits, and self-efficacy likely enhance adherence and retention to research-based Tai Chi interventions for older adults. Delivering an on-site, no cost, and supportive program appears critical to overcoming financial and environmental barriers to participation for those living within subsidized housing.

Can Reliability of the Chinese Medicine Diagnostic Process Be Improved? Results of a Prospective Randomized Controlled Trial.

Background: The diagnostic framework and clinical reasoning process of Chinese medicine are central to the practice of acupuncture and other related disciplines. There is growing interest in integrating it into clinical trials of acupuncture and Chinese herbal medicine to guide individualized treatment protocols and evaluate outcomes. Strategies that enhance diagnostic reliability may contribute to this integration. Objectives: (1) To evaluate inter-rater reliability among practitioners of Traditional Chinese Medicine (TCM) when assessing women with dysmenorrhea using a structured assessment questionnaire (Traditional East Asian Medicine Structure Interview [TEAMSI]-TCM) compared to using a TCM questionnaire from routine clinical practice, not developed for research purposes (CONTROL); and (2) To evaluate the impact of training in the use of each approach on reliability. Design: Thirty-eight acupuncturists were asked to complete assessments of 10 subjects based on the viewing of a videotape of the initial assessment interview, a picture of the tongue, and a description of the pulse. Acupuncturists were randomized into one of four groups comparing the use of two questionnaires, TEAMSI-TCM versus CONTROL, and comparing training in the use of each versus no training. Analysis: The authors used Cohen's kappa to estimate agreement on TCM diagnostic categories relevant to dysmenorrhea between 2 practitioners with respect to questionnaires and training over all 10 patients and all 10 TCM diagnostic categories. For all analyses, the authors estimated kappa values for questionnaire, training, and experience level. Analysis of variance was used to test agreement among various groupings. Results: Regardless of the questionnaire used or training, analysis of inter-rater reliability indicated overall agreement to be low among practitioners (median 0.26). Kappa varied slightly by questionnaire and training, among 38 practitioners, but the difference was not statistically significant (p = 0.227 and p = 0.126, respectively). Conclusions: A structured assessment interview instrument designed for research purposes with or without training did not significantly improve reliability of TCM diagnosis of dysmenorrhea compared to a commonly used instrument. Challenges in assessing reliability in TCM remain.

Matrix Analysis of Traditional Chinese Medicine Differential Diagnoses in Gulf War Illness.

Objective: To qualitatively categorize Traditional Chinese Medicine (TCM) differential diagnoses in a sample of veterans with Gulf War Illness (GWI) pre- and postacupuncture treatment. Subjects and methods: The authors randomized 104 veterans diagnosed with GWI to a 6-month acupuncture intervention that consisted of either weekly or biweekly individualized acupuncture treatments. TCM differential diagnoses were recorded at baseline and at 6 months. These TCM diagnoses were evaluated using Matrix Analysis to determine co-occurring patterns of excess, deficiency, and channel imbalances. These diagnoses were examined within and between participants to determine patterns of change and to assess stability of TCM diagnoses over time. Results: Frequencies of diagnoses of excess, deficiency, and channel patterns were tabulated. Diagnoses of excess combined with deficiency decreased from 43% at baseline to 39% of the sample at 6 months. Excess+deficiency+channel imbalances decreased from 26% to 17%, while deficiency+channel imbalances decreased from 11% to 4% over the study duration. The authors observed a trend over time of decreased numbers of individuals presenting with all three types of differential diagnosis combinations. This may suggest that fewer people were diagnosed with concurrent excess, deficiency, and channel imbalances and perhaps a lessening in the complexity of their presentation. Conclusion: This is the first published article that organizes and defines TCM differential diagnoses using Matrix Analysis; currently, there are no TCM frameworks for GWI. These findings are preliminary given the sample size and the amount of missing data at 6 months. Characterization of the TCM clinical presentation of veterans suffering from GWI may help us better understand the potential role that East Asian medicine may play in managing veterans with GWI and the design of effective acupuncture treatments based on TCM. The development of a TCM manual for treating GWI is merited.

Is less more? A randomized comparison of home practice time in a mind-body program.

Home practice is a major component of mind-body programs, yet little is known about how to optimize the amount of prescribed home practice in order to achieve an effective "dose" of practice while minimizing participant burden. This study tested how varying the amount of home practice in a mind-body program impacts compliance and stress reduction, and whether prescribing a flexible home practice schedule increases compliance. Eighty-four stressed participants undergoing a 12-week yoga program were randomized to low, medium, and high home practice conditions. The medium condition allowed participants the flexibility to choose one of two amounts of practice each day. The low practice group exhibited the highest compliance (91%) compared to the medium and low practice groups (∼60%), but exhibited the lowest total practice time, and did not significantly reduce stress. The high practice group was the only group to achieve significant stress-reduction, which was maintained 12 weeks post program. Prescribing a flexible home practice schedule did not increase compliance. Results suggest that prescribing higher practice doses may maximize practice time and symptom reduction despite lower compliance.

Screening for novel central nervous system biomarkers in veterans with Gulf War Illness.

Gulf War illness (GWI) is primarily diagnosed by symptom report; objective biomarkers are needed that distinguish those with GWI. Prior chemical exposures during deployment have been associated in epidemiologic studies with altered central nervous system functioning in veterans with GWI. Previous studies from our group have demonstrated the presence of autoantibodies to essential neuronal and glial proteins in patients with brain injury and autoantibodies have been identified as candidate objective markers that may distinguish GWI. Here, we screened the serum of 20 veterans with GWI and 10 non-veteran symptomatic (low back pain) controls for the presence of such autoantibodies using Western blot analysis against the following proteins: neurofilament triplet proteins (NFP), tubulin, microtubule associated tau proteins (Tau), microtubule associated protein-2 (MAP-2), myelin basic protein (MBP), myelin associated glycoprotein (MAG), glial fibrillary acidic protein (GFAP), calcium-calmodulin kinase II (CaMKII) and glial S-100B protein. Serum reactivity was measured as arbitrary chemiluminescence units. As a group, veterans with GWI had statistically significantly higher levels of autoantibody reactivity in all proteins examined except S-100B. Fold increase of the cases relative to controls in descending order were: CaMKII 9.27, GFAP 6.60, Tau 4.83, Tubulin 4.41, MAG 3.60, MBP 2.50, NFP 2.45, MAP-2 2.30, S-100B 1.03. These results confirm the continuing presence of neuronal injury/gliosis in these veterans and are in agreement with the recent reports indicating that 25years after the war, the health of veterans with GWI is not improving and may be getting worse. Such serum autoantibodies may prove useful as biomarkers of GWI, upon validation of the findings using larger cohorts.

Group-Based Yogic Weight Loss with Ayurveda-Inspired Components: A Pilot Investigation of Female Yoga Practitioners and Novices.

INTRODUCTION: Overweight/obesity is a pressing international health concern and conventional treatments demonstrate poor long-term efficacy. Preliminary evidence suggests yoga and Ayurveda may be promising approaches, although recent NHIS estimates indicate rare utilization of Ayurveda in the US. Group-based curricula that integrate yoga and Ayurveda-inspired principles to attenuate overweight and obesity across individuals may prove a feasible, disseminable clinical adjunct to facilitate psychosocial health and weight loss and/or maintenance. AIMS: Determine feasibility and preliminary effectiveness of a ten-week yoga - based, Ayurveda-inspired weight management curriculum (YWL) piloted in female yoga practitioners (Study 1) then refined and tailored for yoga naïves (Study 2), on self-reported psychosocial process variables and % of self-reported total body weight loss (%TBWL). METHODOLOGY: Study 1 enrolled 22 yoga-experienced women (48.2 ± 14.3 years, BMI 30.8 ± 4.2 kg/m2) in a 10-week yoga-based program (YWL-YE). Study 2 enrolled 21 yoga- naïve women (49.4 ± 10.7 years, BMI 35.5 ± 6.8 kg/m2) in a revised 10-week program (YWL-YN). Self-reported weight and self-ratings of mindful eating behavior, body image disturbance, weight loss self-efficacy, body awareness, and self-compassion were collected at baseline, post-treatment (T2), and 3-month follow- up (T3). RESULTS: YWL curricula was feasible in both studies. While attrition rates for both studies favorably compared to other weight management studies, attrition was higher for YWL-YN (28.6%) than YWL-YE (18.2%). In both studies, self-reported process variables and self-reported % TBWL changed in hypothesized directions at T2 and evidenced greater improvement at T3; effect sizes across all process variables were medium (-0.4) to large (-1.8). % TBWL reached clinical significance (>5%) only at T3 for the YWL-YE group. CONCLUSIONS: The YWL curricula employed here appear to improve psychosocial health among both overweight/obese yoga-experienced and yoga- naïve women. Results must be interpreted with caution due to study design, self-report assessments, and other limitations. Nonetheless, hypotheses are generated for future investigation.

Conscientiousness is modified by genetic variation in catechol-O-methyltransferase to reduce symptom complaints in IBS patients.

BACKGROUND: Attention to and perception of physical sensations and somatic states can significantly influence reporting of complaints and symptoms in the context of clinical care and randomized trials. Although anxiety and high neuroticism are known to increase the frequency and severity of complaints, it is not known if other personality dimensions or genes associated with cognitive function or sympathetic tone can influence complaints. Genetic variation in catechol-O-methyltransferase (COMT) is associated with anxiety, personality, pain, and response to placebo treatment. We hypothesized that the association of complaint reporting with personality might be modified by variation in the COMT val158met genotype. METHODS: We administered a standard 25-item complaint survey weekly over 3-weeks to a convenience sample of 187 irritable bowel syndrome patients enrolled in a placebo intervention trial and conducted a repeated measures analysis. RESULTS: We found that complaint severity rating, our primary outcome, was negatively associated with the personality measures of conscientiousness (ß = -0.31 SE 0.11, P = 0.003) and agreeableness (ß = -0.38 SE 0.12, P = 0.002) and was positively associated with neuroticism (ß = 0.24 SE 0.09, P = 0.005) and anxiety (ß = 0.48 SE 0.09, P < 0.0001). We also found a significant interaction effect of COMT met alleles (ß = -32.5 SE 14.1, P = 0.021). in patients genotyped for COMT val158met (N  = 87) specifically COMT × conscientiousness (ß = 0.73 SE 0.26, P = 0.0042) and COMT × anxiety (ß = -0.42 SE 0.16, P = 0.0078) interaction effects. CONCLUSION: These findings potentially broaden our understanding of the factors underlying clinical complaints to include the personality dimension of conscientiousness and its modification by COMT.

Qualitative evaluation of a high school yoga program: feasibility and perceived benefits.

This is the first published qualitative assessment of a yoga program applied in a high school setting. This qualitative interview study was nested in a randomized, controlled trial studying the effects of a yoga program offered in place of a semester of physical education classes at a rural public high school. Student interviews were conducted after taking part in a semester of the yoga program. A formal passive consent with information about the qualitative study was sent home to parents/guardians of all students in the parent study before the interviews. Most students enjoyed the yoga classes and felt benefits. Negative reports of yoga practice were associated with gender as most males sensed peer pressure against practicing yoga. Despite this finding, most students wanted to continue yoga and would continue if it were offered in school. Positive reports include a greater kinesthetic awareness, which some students associated with a greater respect for the body and improved self-image. Among students reporting psychological benefits, many cited stress reduction; many used yoga to manage negative emotions; and some propagated more optimism. Most thought yoga could reduce interest in the use of drugs and alcohol and increase social cohesion with family and peers. We found that a yoga program is feasible in this sample of 9th and 10th graders, especially after benefits are perceived. We also found evidence that yoga may lead to emergent positive benefits in health behaviors not directly prescribed by the program. These results suggest that school-based yoga programs may be appropriate for promoting healthy behaviors at a societal level by focusing on the prevention of negative patterns during the adolescent transition.

Catechol-O-methyltransferase val158met polymorphism predicts placebo effect in irritable bowel syndrome.

Identifying patients who are potential placebo responders has major implications for clinical practice and trial design. Catechol-O-methyltransferase (COMT), an important enzyme in dopamine catabolism plays a key role in processes associated with the placebo effect such as reward, pain, memory and learning. We hypothesized that the COMT functional val158met polymorphism, was a predictor of placebo effects and tested our hypothesis in a subset of 104 patients from a previously reported randomized controlled trial in irritable bowel syndrome (IBS). The three treatment arms from this study were: no-treatment ("waitlist"), placebo treatment alone ("limited") and, placebo treatment "augmented" with a supportive patient-health care provider interaction. The primary outcome measure was change from baseline in IBS-Symptom Severity Scale (IBS-SSS) after three weeks of treatment. In a regression model, the number of methionine alleles in COMT val158met was linearly related to placebo response as measured by changes in IBS-SSS (p = .035). The strongest placebo response occurred in met/met homozygotes treated in the augmented placebo arm. A smaller met/met associated effect was observed with limited placebo treatment and there was no effect in the waitlist control. These data support our hypothesis that the COMT val158met polymorphism is a potential biomarker of placebo response.

Placebo acupuncture as a form of ritual touch healing: a neurophenomenological model.

Evidence that placebo acupuncture is an effective treatment for chronic pain presents a puzzle: how do placebo needles appearing to patients to penetrate the body, but instead sitting on the skin's surface in the manner of a tactile stimulus, evoke a healing response? Previous accounts of ritual touch healing in which patients often described enhanced touch sensations (including warmth, tingling or flowing sensations) suggest an embodied healing mechanism. In this qualitative study, we asked a subset of patients in a singleblind randomized trial in irritable bowel syndrome to describe their treatment experiences while undergoing placebo treament. Analysis focused on patients' unprompted descriptions of any enhanced touch sensations (e.g., warmth, tingling) and any significance patients assigned to the sensations. We found in 5/6 cases, patients associated sensations including "warmth" and "tingling" with treatment efficacy. The conclusion offers a "neurophenomenological" account of the placebo effect by considering dynamic effects of attentional filtering on early sensory cortices, possibly underlying the phenomenology of placebo acupuncture.

Patient and practitioner influences on the placebo effect in irritable bowel syndrome.

OBJECTIVE: To determine whether placebo responses can be explained by characteristics of the patient, the practitioner, or their interpersonal interaction. METHODS: We performed an analysis of videotape and psychometric data from a clinical trial of patients with irritable bowel syndrome who were treated with placebo acupuncture in either a warm empathic interaction (Augmented, n = 96), a neutral interaction (Limited, n = 97), or a waitlist control (Waitlist, n = 96). We examined the relationships between the placebo response and a) patient personality and demographics; b) treating practitioner; and c) the patient-practitioner interaction as captured on videotape and rated by the Psychotherapy Process Q-Set. RESULTS: Patient extraversion, agreeableness, openness to experience, and female gender were associated with placebo response, but these effects held only in the augmented group. Regression analyses controlling for all other independent variables suggest that only extraversion is an independent predictor of placebo response. There were significant differences between practitioners in outcomes; this effect was twice as large as the effect attributable to treatment group assignment. Videotape analysis indicated that the augmented group fostered a treatment relationship similar to a prototype of an ideal healthcare interaction. CONCLUSIONS: Personality and gender influenced the placebo response, but only in the warm, empathic, augmented group. This suggests that, to the degree a placebo effect is evoked by the patient-practitioner relationship, personality characteristics of the patient will be associated with the placebo response. In addition, practitioners differed markedly in effectiveness, despite standardized interactions. We propose that the quality of the patient-practitioner interaction accounts for the significant difference between the groups in placebo response.

"Maybe I made up the whole thing": placebos and patients' experiences in a randomized controlled trial.

Patients in the placebo arms of randomized controlled trials (RCT) often experience positive changes from baseline. While multiple theories concerning such "placebo effects" exist, peculiarly, none has been informed by actual interviews of patients undergoing placebo treatment. Here, we report on a qualitative study (n = 27) embedded within a RCT (n = 262) in patients with irritable bowel syndrome. Besides identical placebo acupuncture treatment in the RCT, the qualitative study patients also received an additional set of interviews at the beginning, midpoint, and end of the trial. Interviews of the 12 qualitative subjects who underwent and completed placebo treatment were transcribed. We found that patients (1) were persistently concerned with whether they were receiving placebo or genuine treatment; (2) almost never endorsed "expectation" of improvement but spoke of "hope" instead and frequently reported despair; (3) almost all reported improvement ranging from dramatic psychosocial changes to unambiguous, progressive symptom improvement to tentative impressions of benefit; and (4) often worried whether their improvement was due to normal fluctuations or placebo effects. The placebo treatment was a problematic perturbation that provided an opportunity to reconstruct the experiences of the fluctuations of their illness and how it disrupted their everyday life. Immersion in this RCT was a co-mingling of enactment, embodiment and interpretation involving ritual performance and evocative symbols, shifts in bodily sensations, symptoms, mood, daily life behaviors, and social interactions, all accompanied by self-scrutiny and re-appraisal. The placebo effect involved a spectrum of factors and any single theory of placebo--e.g. expectancy, hope, conditioning, anxiety reduction, report bias, symbolic work, narrative and embodiment--provides an inadequate model to explain its salubrious benefits.