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BACKGROUND: GI-specific psychological factors are important contributors to patients' symptom experience and quality of life across all disorders of gut-brain interaction (DGBI). Clinicians' ability to recognize the role of these psychological factors is essential for formulating a biopsychosocial case conceptualization and informing treatment decisions. PURPOSE: This article will familiarize gastroenterology providers with conceptualizing the role of GI-specific psychological factors in DGBI and provides stepwise, practical guidance for how to assess these during clinical encounters in a time-efficient manner.
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Background: Hope is an integral, multi-dimensional part of seeking medical treatment. The aim of this study was to develop a self-report scale, the Hope in Medicine (HIM) scale, to measure different modes of hoping in relation to the course of symptoms, the effects of treatment, and supporting medical research. Method: We examined the psychometric properties of the scale in a sample of 74 allergic rhinitis patients participating in a 2-week randomized-controlled trial comparing open-label placebos (OLP) with treatment as usual (TAU). Results: The HIM scale had a Cronbach's α of .78. An exploratory factor analysis revealed four factors: realistic hope (i.e., hoping for specific positive outcomes such as improvement in symptoms), transcendent hope (i.e., non-directed hoping that things will turn out positively), utopian hope (i.e., hoping to contribute to greater knowledge), and technoscience hope (i.e., hoping for scientific breakthroughs). Speaking to the convergent validity of the scale, realistic hope was moderately related to treatment expectancies (r = .54); transcendent hope was related to optimism (r = .50), treatment expectancies (r = .37), self-efficacy (r = .36), and inversely correlated with pessimism (r = -.43). Hope subscales predicted neither course of symptoms nor impairment. Conclusion: The HIM scale is a questionnaire with adequate internal consistency allowing to assess four modes of hoping. Preliminary results for its convergent validity are promising. Yet, further validation is needed.
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BACKGROUND AND AIMS: Postprandial diarrhea (PPD) is commonly seen in patients with disorders of gut-brain interaction (DGBI), but the factors associated with it have not been well studied. In this study, we aim to study the burden, impact, and predictors of PPD using a clinical cohort of DGBI patients. METHODS: This study included patients with chronic diarrhea fulfilling ROME IV criteria for irritable bowel syndrome (IBS) or functional diarrhea (FDiarr). PPD was defined as patients reporting mushy/watery stools following meals ≥30% of the time in the last 3 months using a ROME IV question on PPD. Age, sex, and BMI, the severity of diarrhea, abdominal pain, depression, anxiety, somatization, and quality of life were assessed using validated measures. Person's chi-square test and Student's t-test were used to compare variables. A multiple linear regression model with backward elimination was done to determine predictors of PPD severity. KEY RESULTS: Of 213 eligible patients, more than three-fourth of patients (75.6%) had PPD. Women (79.0%, p = 0.037), patients with ROME IV diagnosis of IBS-D (90.5%, p = 0.002), and functional dyspepsia (83.2%, p = 0.014), and those with a history of cholecystectomy (CCY) (95.5%, p = 0.022) were more likely to report PPD. PPD patients experienced more severe abdominal pain, diarrhea, and decreased quality of life (QoL) but showed no significant difference in BMI, anxiety, depression, sleep, or somatization. In our regression model, female sex and history of CCY were independent predictors of PPD. CONCLUSIONS AND INFERENCES: PPD is frequently reported among chronic diarrhea patients and is associated with more severe GI symptoms and decreased QoL. Female sex and CCY predict PPD, while psychological factors do not.
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Diarreia , Síndrome do Intestino Irritável , Período Pós-Prandial , Centros de Atenção Terciária , Humanos , Feminino , Masculino , Diarreia/epidemiologia , Pessoa de Meia-Idade , Adulto , Prevalência , Síndrome do Intestino Irritável/epidemiologia , Síndrome do Intestino Irritável/psicologia , Síndrome do Intestino Irritável/complicações , Qualidade de Vida , IdosoRESUMO
BACKGROUND: In recent years, legislation targeting the sexual and gender minority (SGM) community has been passed at an increasingly alarming rate, affecting access to safe and effective gender-affirming care and forcing many SGM patients, including those with inflammatory bowel disease (IBD), to withhold their identities and health concerns. Additionally, SGM patients with IBD may have unique health considerations that have not yet been well-studied OBJECTIVE: This article aims to explore the intersection of IBD and sexual health in patients who identify as SGM and to identify limitations for gastroenterologists in caring for SGM patients. The article also aims to provide suggestions for improvement in SGM-competent care within gastroenterology METHODS: A thorough literature review was conducted regarding sexual health and the SGM community with IBD. This included a review of surgical considerations in SGM patients, sexually transmitted infections (STIs) and prevention, and sexual dysfunction RESULTS: Overall, little is known about the impact of IBD on patients who identify as sexual and gender minorities. Surgery, medications, and STIs continue to be a concern in the SGM community with IBD and these areas represent opportunities to improve SGM-competent IBD care. Additionally, implementation of an SGM-focused curriculum is urgently needed in medical education to improve provider knowledge and care for this unique group of patients CONCLUSIONS: Patients with IBD who identify as SGM experience challenges that are not well described in prior literature. More research is needed and is actively being pursued to guide provider awareness and improve sexual health for this patient population.
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Doenças Inflamatórias Intestinais , Saúde Sexual , Minorias Sexuais e de Gênero , Infecções Sexualmente Transmissíveis , Humanos , Doenças Inflamatórias Intestinais/complicações , Doenças Inflamatórias Intestinais/epidemiologia , Doenças Inflamatórias Intestinais/terapia , Comportamento Sexual , Infecções Sexualmente Transmissíveis/epidemiologia , Infecções Sexualmente Transmissíveis/terapia , Masculino , FemininoRESUMO
BACKGROUND & AIMS: Chronic gastrointestinal (GI) symptoms are a common reason for seeking medical care. We aim to determine the rates of ambulatory care use and to characterize demographics, work-up, and treatment (pharmacologic and nonpharmacologic) for patients with chronic upper GI symptoms and conditions in the United States. METHODS: Estimates of annual visits for the most common upper GI symptoms and diagnoses including gastroesophageal reflux disease, dyspepsia, nausea and vomiting, and gastroparesis were recorded from the 2007-2015 National Ambulatory Medical Care Surveys. Only chronic conditions, defined as >3 months, were included. We calculated the weighted proportion of ambulatory visits associated with pharmacologic, nonpharmacologic treatment (eg, diet, complementary and alternative medicine), or both. RESULTS: A total of 116,184,475 weighted ambulatory visits were identified between the years of 2007 and 2015 for adults (average of 12,909,386 annual visits) with chronic upper GI symptoms and diagnoses. Gastroesophageal reflux disease was the most common reason for an ambulatory visit (n = 11,200,193), followed by dyspepsia (n = 1,232,598), nausea and vomiting (n = 714,834), and gastroparesis (n = 140,312). Pharmacologic treatment was more common than nonpharmacologic treatment (44.7% vs 28.5%). A total of 37.6% of patients were not receiving treatment at the time of the visit. These treatment patterns did not significantly change over the time of our study. Upper endoscopies were the most ordered test, representing 7.5% of all investigated upper GI symptoms. CONCLUSIONS: Chronic upper GI symptoms and diagnoses account for a high number of annual health care visits, both in primary care and specialty care. Although there are several treatments, many of these patients are not on any treatments.
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Gastroenteropatias , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Adulto , Estados Unidos/epidemiologia , Idoso , Doença Crônica , Adulto Jovem , Adolescente , Gastroenteropatias/terapia , Gastroenteropatias/diagnóstico , Gastroenteropatias/epidemiologia , Assistência Ambulatorial/estatística & dados numéricos , Idoso de 80 Anos ou maisRESUMO
BACKGROUND & AIMS: Bloating is a common symptom in the general population and among disorders of gut-brain interaction, although its prevalence has not been well characterized. The aim of this study was to report the prevalence of bloating as a symptom in the worldwide population and to identify factors associated with this symptom in the general population. METHODS: Rome Foundation Global Epidemiology Study internet survey data were analyzed. After excluding respondents with potential organic causes of bowel symptoms, the current analysis included 51,425 individuals in 26 countries. Data included diet, medical history, quality of life, and Rome IV diagnostic questions. Presence of bloating was defined as experiencing bloating at least once per week for the last 3 months. Descriptive statistics estimated prevalence by country, region, and disorder of gut-brain interaction diagnosis. Logistic regression evaluated predictors of bloating. RESULTS: Nearly 18% of the global study population reported bloating (ranging from 11% in East Asia to 20% in Latin America). Prevalence decreased with age and women were approximately twice as likely as men to report bloating. More than one-half of respondents who reported weekly epigastric pain (71.39%), nausea (59.7%), or abdominal pain (61.69%) also reported bloating at least once per week. In logistic regression, the strongest associations were with abdominal pain (odds ratio, 2.90) and epigastric pain (odds ratio, 2.07). CONCLUSIONS: Bloating is common throughout the world. Nearly 18% of the general population experience bloating at least once per week. Reported bloating prevalence is lower in older age groups, most common in women, and strongly associated with abdominal pain.
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Síndrome do Intestino Irritável , Masculino , Humanos , Feminino , Idoso , Síndrome do Intestino Irritável/complicações , Constipação Intestinal/etiologia , Prevalência , Qualidade de Vida , Cidade de Roma , Dor Abdominal/etiologia , Flatulência , Inquéritos e QuestionáriosRESUMO
INTRODUCTION: Unspecified functional bowel disorder (FBD-U) is a Rome IV diagnosis of exclusion and occurs when patients report bowel symptoms but do not meet the criteria for other functional bowel disorders (FBD; irritable bowel syndrome [IBS], functional constipation [FC], functional diarrhea [FDr], or functional bloating). Previous research suggests that FBD-U is as/more common than IBS. METHODS: One thousand five hundred one patients at a single-center tertiary care center completed an electronic survey. Study questionnaires included Rome IV Diagnostic Questionnaires, anxiety, depression, sleep, health care utilization, and bowel symptom severity measures. RESULTS: Eight hundred thirteen patients met Rome IV criteria for a FBD and 194 patients (13.1%) met criteria for FBD-U, representing the second most common FBD after IBS. Severity of abdominal pain, constipation, and diarrhea were lower in FBD-U compared with other FBD, whereas health care utilization was similar among the groups. Scores on measures of anxiety, depression, and sleep disturbances were similar in FBD-U compared with FC and FDr but were less severe than IBS. Between 25% and 50% of patients with FBD-U did not meet Rome IV criteria for other FBD due to timing of onset of the target symptom (e.g., constipation for FC, diarrhea for FDr, and abdominal pain for IBS). DISCUSSION: FBD-U, by Rome IV criteria, is highly prevalent in clinical settings. These patients are not represented in mechanistic studies or clinical trials for not having met Rome IV criteria for other FBD. Making future Rome criteria less stringent would minimize the number fulfilling criteria for FBD-U and maximize the true representation of FBD in clinical trials.
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Gastroenteropatias , Síndrome do Intestino Irritável , Humanos , Síndrome do Intestino Irritável/diagnóstico , Gastroenteropatias/diagnóstico , Diarreia/etiologia , Diarreia/diagnóstico , Constipação Intestinal/diagnóstico , Constipação Intestinal/etiologia , Dor Abdominal/diagnóstico , Dor Abdominal/etiologia , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Hyperemesis gravidarum is the most severe form of nausea and vomiting of pregnancy, potentially affecting both maternal and pregnancy health. Hyperemesis gravidarum often results in emergency department visits, although the exact frequency and costs associated with these visits have not been well studied. OBJECTIVE: This study aimed to analyze the trends in hyperemesis gravidarum emergency department visits, inpatient admissions, and the associated costs between 2006 and 2014. STUDY DESIGN: Patients were identified from the 2006 and 2014 Nationwide Emergency Department Sample database files using International Classification of Diseases, Ninth Revision diagnosis codes. Patients with a primary diagnosis of hyperemesis gravidarum, nausea and vomiting of pregnancy, and all nondelivery pregnancy-related diagnoses (all antepartum visits) were identified. All groups were analyzed; trends in demographics, number of emergency department visits, and visit costs were compared. Costs were inflation-adjusted to 2021 US dollars. RESULTS: Emergency department visits for hyperemesis gravidarum increased by 28% from 2006 to 2014; however, the proportion of those who were subsequently admitted to the hospital decreased. The average cost of an emergency department visit for hyperemesis gravidarum increased by 65% ($2156 to $3549), as opposed to an increase of 60% for all antepartum visits ($2218 to $3543). The aggregate cost for all hyperemesis gravidarum visits increased by 110% ($383,681,346 to $806,696,513) from 2006 to 2014, which was similar to the increase observed for all antepartum emergency department visits. CONCLUSION: From 2006 to 2014, emergency department visits for hyperemesis gravidarum increased by 28%, with associated costs increasing by 110%, whereas the number of admissions from the emergency department for hyperemesis gravidarum decreased by 42%.
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Gut-directed hypnotherapy (GDH) is a highly effective brain-gut behavioral therapy which is recommended in international guidelines for the treatment of irritable bowel syndrome (IBS). There is increasing recognition of the value of GDH as part of integrated care alongside medical and dietary approaches. This has led to recent innovations to widen access to GDH to meet the increasing demand. Recent advances include streamlined courses of individualized GDH, group therapy, and remote delivery. In this issue of Neurogastroenterology and Motility, Peters et al. retrospectively report outcomes of smartphone app-delivered GDH in a population with self-reported IBS. While adherence was low, those that completed smart phone-delivered GDH-achieved symptom benefit. This mini-review summarizes the current evidence-base for available modalities of GDH and discusses the current and future utility and development of mobile health applications in the digital therapeutics' era.
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Hipnose , Síndrome do Intestino Irritável , Aplicativos Móveis , Humanos , Síndrome do Intestino Irritável/terapia , Estudos Retrospectivos , EncéfaloRESUMO
Tricyclic antidepressants (TCAs) are frequently prescribed for chronic functional pain disorders. Although the mechanism of action targets pain perception, treating patients with TCAs for disorders conceptualized as "functional" can promote stigmatization in these patients because it hints at psychological dimensions of the disorder. The goal of this study was to understand how physicians prescribe TCAs in the face of this challenge. We interviewed eleven gastroenterologists in tertiary care clinics specializing in functional gastrointestinal disorders, such as irritable bowel syndrome. We found that the physicians interviewed (1) were aware of the stigma attached to taking antidepressants for a medical condition, (2) emphasized biological, as opposed to psychological, mechanisms of action, (3) while focusing on biological mechanisms, they nevertheless prescribed TCAs in a way that is highly attentive to the psychology of expectations, making specific efforts to adjust patients' expectations to be realistic and to reframe information that would be discouraging and (4) asked patients to persist in taking TCAs despite common and, at times, uncomfortable side effects. In this context of shared decision making, physicians described nuanced understanding and behaviours necessary for treating the complexity of functional disorders and emphasized the importance of a strong patient-provider relationship.
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Síndrome do Intestino Irritável , Médicos , Humanos , Síndrome do Intestino Irritável/tratamento farmacológico , Síndrome do Intestino Irritável/induzido quimicamente , Padrões de Prática Médica , Antidepressivos/uso terapêutico , Antidepressivos Tricíclicos/efeitos adversosRESUMO
BACKGROUND: We examined whether the difficulties of patients with somatoform disorders (SFDs) in integrating medical reassurance can be altered by preventing patients from devaluing reassuring information through defensive cognitive strategies. METHOD: Patients with SFD (n = 60), patients with major depression (n = 32), and healthy volunteers (n = 37) watched a videotaped doctor's report, which provided medical reassurance for gastroenterological complaints. Subsequently, participants were asked about their perception of the report. In the SFD sample, patients' appraisal of the reassuring was experimentally modulated: In one condition, doubts about the validity of the doctor's diagnostic assessment were triggered; in another condition, the devaluation of medical reassurance was blocked through underscoring the validity of the doctor's diagnostic assessment; and a control condition received no manipulation. RESULTS: As evident on all outcome variables, patients with SFD had more difficulty integrating medical reassurance than depressed and healthy people. Within the SFD sample, participants from the experimental condition blocking the devaluation of medical reassurance rated the likelihood of an undetected serious disease to be significantly lower than the other two conditions. They also reported less emotional concern and a lower desire to seek the opinion of another doctor. CONCLUSIONS: By comparing patients with SFD to both a healthy and a clinical control group, the current study suggests that the difficulty in processing reassuring medical information is a specific psychopathological feature of SFD. Furthermore, our results suggest that the integration of medical reassurance can be improved by preventing patients from devaluing reassuring information through dismissive cognitive strategies. (PsycInfo Database Record (c) 2023 APA, all rights reserved).
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Emoções , Transtornos Somatoformes , Humanos , Transtornos Somatoformes/diagnóstico , Transtornos Somatoformes/psicologiaRESUMO
INTRODUCTION: Nocebo effects are believed to influence the rate of reported adverse events (AE) and subject withdrawal in both the treatment and placebo groups of randomized clinical trials (RCT). Neuromodulators are commonly prescribed to treat disorders of gut-brain interaction (DGBI), but adherence to these medications is often limited by side effects such as headache, dry mouth, fatigue, and altered bowel habits. We performed a systematic review and meta-analysis to assess the proportion and risk difference of patients who experienced side effects leading to withdrawal in the placebo arm vs the treatment arm of RCT of neuromodulators for DGBI. We also sought to estimate the risk of developing any AE in the placebo arm of these studies and the rate of specific individual AEs. METHODS: We searched MEDLINE, Embase, Web of Science Core Collection, and the Cochrane Central Register of Controlled Trials Searches to identify RCT that included terms for DGBI and for commonly prescribed neuromodulators. We calculated pooled proportions of patients experiencing an AE leading to withdrawal in the active treatment group vs the placebo group with 95% confidence intervals (CI), the pooled proportions of patients experiencing any AE, the pooled proportions of patients experiencing specific AE such as dizziness and headache, the pooled proportions of patients experiencing severe AE, and corresponding pooled risk differences with 95% CI. RESULTS: There were 30 RCT included representing 2,284 patients with DGBI. Twenty-seven RCT reported data on AE leading to withdrawal. The pooled proportion of total patients with AE leading to withdrawal in the placebo group was 4% (95% CI 0.02-0.04). The pooled proportion of patients with AE leading to withdrawal who received neuromodulators was 9% (95% CI 0.06-0.13). In the 12 studies reporting data on patients experiencing at least 1 AE, the pooled proportion of patients experiencing any AE in the placebo group was 18% (95% CI 0.08-0.30), compared with 43% (95% CI 0.24-0.63) in the neuromodulator group. Thus, approximately 44% of the rate of withdrawal (0.04/0.09) and 42% of the rate reporting any side effects (0.18/0.43) in the neuromodulator group may be attributed to nocebo effects in the right context. Subgroup analysis by sex, medication class, risk of bias, and specific DGBI revealed differing withdrawal rates. There was no statistically significant difference in patients experiencing individual AE of dizziness, headache, or diarrhea. Rates of dry mouth, fatigue, and constipation were higher in treatment groups compared with those in placebo groups. DISCUSSION: Patients with DGBI in RCT randomized to placebo groups frequently experience AE and AE that lead to withdrawal consistent with a strong nocebo effect. Nonspecific AE such as dizziness, headaches, and diarrhea occurred similarly in patients receiving placebo compared with those receiving neuromodulators.
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Tontura , Efeito Nocebo , Humanos , Encéfalo , Diarreia , Cefaleia/induzido quimicamente , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: The estimated prevalence of bloating is 15 to 30% in the adult US population and is even higher in patients with disorders of gut-brain interaction (DGBIs). Despite this frequency, there is little research into patients who endorse bloating as a predominant symptom. The aim of this study was to better characterize these patients. MATERIALS AND METHODS: New patients with DGBIs were asked to identify their 3 most predominant symptoms over the preceding 3 months; those who reported bloating were classified as "bloating predominant." Rome IV and symptom-specific questionnaires were administered to assess for the frequency of DGBIs and other predominant symptoms in this patient population. Using univariable and multivariable modeling, we analyzed the associations between bloating predominance, DGBI subtype, and clinical characteristics. RESULTS: Of the 586 patients surveyed, 242 (41%) reported predominant bloating. Bloating-predominant patients were more likely to be female, younger, and meet the criteria for IBS-mixed (IBS-M), functional constipation, and functional dyspepsia compared with nonbloating-predominant patients. Bloating-predominant patients were also more likely to endorse concurrently predominant constipation, incomplete evacuation, abdominal pain, belching, and/or nausea. On multivariable logistic regression, constipation and abdominal pain severity were positively associated, although depression was negatively associated with predominant bloating. CONCLUSIONS: Patients with predominant bloating are more likely to have constipation-related symptoms than diarrhea-related symptoms. They are also more likely to have more severe abdominal pain than patients without predominant bloating. These findings help characterize patients with bloating as a predominant symptom and suggest that diagnosing and treating constipation should be considered as first-line treatment.
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Dispepsia , Síndrome do Intestino Irritável , Adulto , Humanos , Feminino , Masculino , Síndrome do Intestino Irritável/diagnóstico , Constipação Intestinal/diagnóstico , Constipação Intestinal/epidemiologia , Constipação Intestinal/etiologia , Diarreia/epidemiologia , Diarreia/etiologia , Dor Abdominal/epidemiologia , Dor Abdominal/etiologia , Flatulência/epidemiologia , Flatulência/etiologia , Inquéritos e QuestionáriosRESUMO
In this review article, we show that stress and resilience play an integral role in the brain-gut axis and are critical to symptom expression across all digestive disorders. The relationship between stress, coping, and resilience provides a mechanistic basis for brain-gut behavior therapies. Psychogastroenterology is the field best equipped to translate and mitigate these constructs as part of patient care across all digestive disorders.
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Eixo Encéfalo-Intestino , Doenças do Sistema Digestório , Humanos , Terapia Comportamental , EncéfaloRESUMO
OBJECTIVE: There is growing evidence that open-label placebo (OLP) may be an efficacious treatment of chronic and functional conditions. However, patient-level predictors of response to OLP have not been clearly identified. The aim of this study is to evaluate the psychological predictors of response to OLP and to compare this to double-blind placebo (DBP) and no-pill control (NPC). METHODS: This study is a secondary analysis of data collected in a 6-week randomized controlled trial evaluating placebo effects in irritable bowel syndrome (IBS). The primary outcome was change in IBS severity. Hierarchical linear regression identified predictors of placebo response in general and compared them between those randomized to OLP, DBP, and NPC. Predictor variables included personality traits, generalized anxiety, depression, visceral sensitivity (a measure of symptom-specific anxiety), and pain catastrophizing. RESULTS: A total of 210 participants (mean age = 42.3 years, 73.3% female) were included. Regression models revealed that visceral sensitivity was a predictor of response to OLP and NPC but not DBP. Interestingly, the effects were opposite, with high visceral sensitivity predicting less improvement in NPC and more improvement in OLP. Pain catastrophizing was a negative predictor of response to OLP (i.e., high pain catastrophizing was associated with less improvement in OLP). Neither visceral sensitivity nor pain catastrophizing played a significant role for response to DBP. CONCLUSIONS: IBS participants who score low on the Pain Catastrophizing Scale but high on the Visceral Sensitivity Index seem to benefit particularly from OLP. Our study suggests that different psychological mechanisms may be involved in DBP and OLP interventions.
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Síndrome do Intestino Irritável , Adulto , Ansiedade/tratamento farmacológico , Ansiedade/psicologia , Catastrofização , Método Duplo-Cego , Feminino , Humanos , Síndrome do Intestino Irritável/tratamento farmacológico , Masculino , Resultado do TratamentoRESUMO
BACKGROUND & AIMS: Many of the reported adverse events in clinical trials of irritable bowel syndrome are extraintestinal symptoms, which typically are assessed by open-ended questions during the trial and not at baseline. This may lead to misattribution of some pre-existing symptoms as side effects to the treatment. METHODS: The current study analyzed data from a 6-week clinical trial of irritable bowel syndrome. Participants were randomized to receive double-blind peppermint oil, double-blind placebo, or treatment as usual. Extraintestinal symptoms were assessed at baseline and at the end of the study. RESULTS: This analysis included 173 participants (30 received double-blind peppermint oil, 72 received treatment as usual, and 71 received double-blind placebo). At baseline, each group reported approximately 5 extraintestinal symptoms per participant. The number of symptoms per participant decreased to an average of 3 by the end-of-study visit, and this change was statistically significant in all groups (P < .001 for each group). When evaluating individual extraintestinal symptoms, the majority of participants did not report new/worse symptoms. In fact, between the baseline assessment and the final assessment, the average symptom severity decreased significantly in all 3 groups (P < .001). CONCLUSIONS: Our study suggests that participants with irritable bowel syndrome often experience extraintestinal symptoms at baseline and that these symptoms generally improve in severity over the course of a clinical trial, regardless of the treatment arm. Systematic assessment of extraintestinal symptoms at the beginning of a clinical trial is necessary to determine more definitively whether these symptoms may be considered an adverse event attributable to a study medication.
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Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Síndrome do Intestino Irritável , Humanos , Síndrome do Intestino Irritável/terapia , Método Duplo-Cego , Doença Iatrogênica , Resultado do TratamentoRESUMO
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.
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Síndrome do Intestino Irritável , Método Duplo-Cego , Humanos , Síndrome do Intestino Irritável/tratamento farmacológico , Estudos Retrospectivos , Resultado do TratamentoRESUMO
Importance: Adverse events (AEs) after placebo treatment are common in randomized clinical drug trials. Systematic evidence regarding these nocebo responses in vaccine trials is important for COVID-19 vaccination worldwide especially because concern about AEs is reported to be a reason for vaccination hesitancy. Objective: To compare the frequencies of AEs reported in the placebo groups of COVID-19 vaccine trials with those reported in the vaccine groups. Data Sources: For this systematic review and meta-analysis, the Medline (PubMed) and Cochrane Central Register of Controlled Trials (CENTRAL) databases were searched systematically using medical subheading terms and free-text keywords for trials of COVID-19 vaccines published up to July 14, 2021. Study Selection: Randomized clinical trials of COVID-19 vaccines that investigated adults aged 16 years or older were selected if they assessed solicited AEs within 7 days of injection, included an inert placebo arm, and provided AE reports for both the vaccine and placebo groups separately. Full texts were reviewed for eligibility by 2 independent reviewers. Data Extraction and Synthesis: Data extraction and quality assessment were performed independently by 2 reviewers, adhering to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guideline and using the Cochrane risk-of-bias tool. Meta-analyses were based on random-effects models. Main Outcomes and Measures: The primary outcomes were the proportions of placebo recipients reporting overall, systemic, and local (injection-site) AEs as well as logarithmic odds ratios (ORs) to evaluate group differences. Outcomes were tested for significance using z tests with 95% CIs. Results: Twelve articles with AE reports for 45â¯380 participants (22â¯578 placebo recipients and 22â¯802 vaccine recipients) were analyzed. After the first dose, 35.2% (95% CI, 26.7%-43.7%) of placebo recipients experienced systemic AEs, with headache (19.3%; 95% CI, 13.6%-25.1%) and fatigue (16.7%; 95% CI, 9.8%-23.6%) being most common. After the second dose, 31.8% (95% CI, 28.7%-35.0%) of placebo recipients reported systemic AEs. The ratio between placebo and vaccine arms showed that nocebo responses accounted for 76.0% of systemic AEs after the first COVID-19 vaccine dose and for 51.8% after the second dose. Significantly more vaccine recipients reported AEs, but the group difference for systemic AEs was small after the first dose (OR, -0.47; 95% CI, -0.54 to -0.40; P < .001; standardized mean difference, -0.26; 95% CI, -0.30 to -0.22) and large after the second dose (OR, -1.36; 95% CI, -1.86 to -0.86; P < .001; standardized mean difference, -0.75; 95% CI, -1.03 to -0.47). Conclusions and Relevance: In this systematic review and meta-analysis, significantly more AEs were reported in vaccine groups compared with placebo groups, but the rates of reported AEs in the placebo arms were still substantial. Public vaccination programs should consider these high rates of AEs in placebo arms.