Patient-Provider Interactions Affect Symptoms in Gastroesophageal Reflux Disease: A Pilot Randomized, Double-Blind, Placebo-Controlled Trial

Dossett, Michelle L.; Lin, Min; Davis, Roger B.; Bell, Iris R.; Lembo, Anthony; Kaptchuk, Ted J.; Yeh, Gloria Y.

doi:10.1371/journal.pone.0136855

Cited by 26 publications

(11 citation statements)

References 34 publications

(37 reference statements)

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…In six studies, patients received placebo pills in open-label conditions; that is, they knew that they received placebo pills only, in combination with an explanation on how they work and improve symptoms to increase treatment expectations (8, 9, 11, 26–28). In three studies, enhanced and particularly empathic patient–physician relationships were applied to enhance expectations of patients (15, 29, 30). Two studies used psychological interventions developed to optimize expectations concerning treatment outcomes (31, 32).…”

Section: Resultsmentioning

confidence: 99%

“…Two studies used psychological interventions developed to optimize expectations concerning treatment outcomes (31, 32). Placebo interventions and mechanisms were applied to adult patients suffering from various diseases and disorders: with gastrointestinal disorders (8, 29, 30), respiratory or allergic diseases (11, 27, 31), cancer-related fatigue (26, 28), common cold (15), chronic low back pain (9), and heart surgery (32). Outcome measures eligible for HEEs were patient-reported general or disease-specific quality of life questionnaires such as different versions of the Short Form Health survey (SF-8, SF-12, and SF-36), specific questionnaires for IBS, gastroesophageal reflux disease (GERD), asthma, fatigue, and a disability questionnaire.…”

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Placebo Economics: A Systematic Review About the Economic Potential of Utilizing the Placebo Effect

et al. 2019

View full text Add to dashboard Cite

Background: Recent research shows that placebo mechanisms can be utilized in ethical and legal ways such as in open-label conditions, when patients know that they receive placebos, and through psychological interventions aiming to optimize patients’ expectations. Showing that placebo interventions are also cost-efficient could improve their acceptability. Objective: To review studies that performed health economic evaluations (HEEs) of intentional placebo interventions and to review studies that intentionally applied placebo interventions and reported outcomes eligible for HEEs. Methods: Two systematic reviews of the literature were performed. For the first review, we searched MEDLINE using “placebo” and Medical Subject Headings (MeSH) terms associated with HEEs such as “costs,” “cost–benefit analyses,” and “economics.” Studies were eligible if they employed patients, applied placebo interventions, included an appropriate control group, and reported results of cost analyses. For the second review, we searched the Journal of Interdisciplinary Placebo Studies (JIPS) database and MEDLINE using search terms for outcomes eligible for cost–utility analyses, such as “quality of life” or “quality-adjusted life years” (“QALYs”). Risk of bias of all studies found was assessed according to the Cochrane Handbook, and a narrative synthesis of the results is provided. Results: The first search resulted in 1,853 articles, which were screened for eligibility. Two studies were found only in which costs or cost-effectiveness analysis were reported, but with medium to high risks of biases. The second search yielded 164 articles particularly from the JIPS database of which 11 studies met our search criteria: in six studies, patients received placebo pills in open-label conditions; three studies investigated effects of patient–physician relationships; and two studies used psychological interventions to optimize treatment expectations, in patients with various diseases and disorders. These studies report outcomes potentially eligible for HEEs when costs of interventions were known. Risks of biases were low to medium, but patients were not blinded to the conditions in most studies. Conclusions: The state of knowledge about HEEs of placebo interventions is scarce. To gain more visibility and acceptability for placebo interventions, future studies should measure outcomes usable for HEEs and costs of interventions, and HEEs should be performed for existing studies if data are available.

show abstract

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Placebo Economics: A Systematic Review About the Economic Potential of Utilizing the Placebo Effect

et al. 2019

View full text Add to dashboard Cite

show abstract

“…In the present study, children and adolescents receive longer and more intensive medical therapy from their paediatrician compared with the real medical practice situation. However, previous studies indicate that patient-provider interactions can largely influence gastrointestinal treatment outcomes 40. Therefore, it is important to control for the time spent per patient in the SMT group.…”

Section: Discussionmentioning

confidence: 99%

Gut-directed hypnotherapy versus standard medical treatment for nausea in children with functional nausea or functional dyspepsia: protocol of a multicentre randomised trial

et al. 2019

View full text Add to dashboard Cite

IntroductionThe treatment of chronic functional nausea or nausea due to functional dyspepsia in children is generally symptomatic. Moreover, these disorders pose a risk for worse psychosocial and health outcomes in children. Hypnotherapy (HT), by its ability to positively influence gastrointestinal and psychosocial functioning, may be an effective treatment for chronic nausea.Methods and analysisTo test efficacy, this multicentre, parallel, randomised controlled, open label trial evaluates whether gut-directed HT is superior to standard medical treatment (SMT) for reducing nausea. The study will be conducted at eleven academic and non-academic hospitals across the Netherlands. A total of 100 children (8–18 years), fulfilling the Rome IV criteria for chronic idiopathic nausea or functional dyspepsia with prominent nausea, will be randomly allocated (1:1) to receive HT or SMT. Children allocated to the HT group will receive six sessions of HT during 3 months, while children allocated to the SMT group will receive six sessions of SMT+supportive therapy during the same period. The primary outcome will be the difference in the proportion of children with at least 50% reduction of nausea, compared with baseline at 12 months’ follow-up. Secondary outcomes include the changes in abdominal pain, dyspeptic symptoms, quality of life, anxiety, depression, school absences, parental absence of work, healthcare costs and adequate relief of symptoms, measured directly after treatment, 6 and 12 months’ follow-up. If HT proves effective for reducing nausea, it may become a new treatment strategy to treat children with chronic functional nausea or functional dyspepsia with prominent nausea.Ethics and disseminationResults of the study will be publicly disclosed to the public, without any restrictions, in peer-reviewed journal and international conferences. The study is approved by the Medical Research Ethics Committees United (MEC-U) in the Netherlands.Trial registration numberNTR5814.

show abstract

“…In patients with irritable bowel syndrome, for example, statistically and clinically significant effects on symptoms and quality of life were observed by augmenting the therapeutic encounter with warmth, attention and confidence . In patients with gastroesophageal reflux disease, expanded patient‐provider visits—with added consultations in a style of complementary and integrative medicine—provided significant improvements in symptom severity compared to standard empathic visits . In both health and disease, experimental studies strongly suggest the possibility of manipulating therapeutic encounters for the benefit of the patient .…”

Section: Psychosocial Determinants Of Placebo Effectsmentioning

confidence: 99%

“…11 In patients with gastroesophageal reflux disease, expanded patient-provider visits-with added consultations in a style of complementary and integrative medicine-provided significant improvements in symptom severity compared to standard empathic visits. 12 In both health and disease, experimental studies strongly suggest the possibility of manipulating therapeutic encounters for the benefit of the patient. 13,14 These findings together suggest that the nonspecific benefits traditionally ascribed to the placebo effect can be augmented intentionally by careful attention to therapeutic contexts.…”

Section: The Therapeutic Encountermentioning

confidence: 99%

Placebos in the era of open‐label trials: An update for clinicians

Sagy

Abres

Winnick

et al. 2018

Eur J Clin Investigation

View full text Add to dashboard Cite

Placebos have been used extensively by vast numbers of physicians, in a majority of clinical trials. Placebo effects involve behavioural, psychological and genetic factors and have been subject to ethical controversies stemming from the use of deception in treating patients. The patient‐physician encounter, endogenous pharmacological pathways, personality traits and genetic diversity have all been reported to be key players in placebo responses. In the last decade, a new methodological paradigm of placebo research has emerged, using open‐label placebos to investigate their effects which showed promising results for various common medical conditions. In this review, we will summarize the current body of evidence on placebos in clinical practice, with a view to open‐label placebo trials in particular. It is our view that future larger‐scale randomized blinded open placebo trials will benefit physicians and improve patient outcomes.

show abstract

Patient-Provider Interactions Affect Symptoms in Gastroesophageal Reflux Disease: A Pilot Randomized, Double-Blind, Placebo-Controlled Trial

Cited by 26 publications

References 34 publications

Placebo Economics: A Systematic Review About the Economic Potential of Utilizing the Placebo Effect

Placebo Economics: A Systematic Review About the Economic Potential of Utilizing the Placebo Effect

Gut-directed hypnotherapy versus standard medical treatment for nausea in children with functional nausea or functional dyspepsia: protocol of a multicentre randomised trial

Placebos in the era of open‐label trials: An update for clinicians

Contact Info

Product

Resources

About