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1.
Int J Mol Sci ; 23(8)2022 Apr 11.
Artigo em Inglês | MEDLINE | ID: mdl-35457014

RESUMO

The placebo effect can be defined as the improvement of symptoms in a patient after the administration of an innocuous substance in a context that induces expectations regarding its effects. During recent years, it has been discovered that the placebo response not only has neurobiological functions on analgesia, but that it is also capable of generating effects on the immune and endocrine systems. The possible integration of changes in different systems of the organism could favor the well-being of the individuals and go hand in hand with conventional treatment for multiple diseases. In this sense, classic conditioning and setting expectations stand out as psychological mechanisms implicated in the placebo effect. Recent advances in neuroimaging studies suggest a relationship between the placebo response and the opioid, cannabinoid, and monoaminergic systems. Likewise, a possible immune response conditioned by the placebo effect has been reported. There is evidence of immune suppression conditioned through the insular cortex and the amygdala, with noradrenalin as the responsible neurotransmitter. Finally, a conditioned response in the secretion of different hormones has been determined in different studies; however, the molecular mechanisms involved are not entirely known. Beyond studies about its mechanism of action, the placebo effect has proved to be useful in the clinical setting with promising results in the management of neurological, psychiatric, and immunologic disorders. However, more research is needed to better characterize its potential use. This review integrates current knowledge about the psycho-neuro-endocrine-immune basis of the placebo effect and its possible clinical applications.


Assuntos
Analgesia , Efeito Placebo , Sistema Endócrino , Humanos , Dor/tratamento farmacológico , Manejo da Dor
2.
Perspect Biol Med ; 65(1): 1-24, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35307698

RESUMO

Since psychoneuroimmunology's (PNI) inception four decades ago, so-called "mind-body" approaches relying on or inspired by PNI have offered the promise of healing various ailments based on the age-old but metaphysically ambiguous principle that the mind can heal the body. How this principle is operationalized not only reveals limitations of PNI-based mind-body therapies but offers a test kit of possibilities for exploring the conceptual foundations of PNI. This article presents an integrative analysis of the role of consciousness-related phenomena (such as willful intentions, thoughts, beliefs) in their causal efficacy, examining their relationships with placebo effects and the boundaries of immune homeostatic control, as well as their therapeutic prospects. Focusing on mindfulness, the article notes how understanding the mechanisms of mindfulness, specifically those mechanisms related to consciousness and placebo effects, can lend insight into how it can validly be evaluated for effectiveness. While taking care not to overstate the role of consciousness in the control of immune homeostatic functions, this article places consciousness center stage to evaluate how mindfulness might be harnessed to modulate the immune system in a clinically relevant manner.


Assuntos
Atenção Plena , Psiconeuroimunologia , Estado de Consciência , Humanos , Efeito Placebo
3.
Eur J Neurosci ; 55(7): 1840-1858, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-35266226

RESUMO

Placebo analgesia (PA) is defined as a psychobiological phenomenon triggered by the information surrounding an analgesic drug instead of its inherent pharmacological properties. PA is hypothesized to be formed through either verbal suggestions or conditioning. The present study aims at disentangling the neural correlates of expectations effects with or without conditioning through prior experience using the model of PA. We addressed this question by recruiting two groups of individuals holding comparable verbally-induced expectations regarding morphine analgesia but either (i) with or (ii) without prior experience with opioids. We then contrasted the two groups' neurocognitive response to acute heat-pain induction following the injection of sham morphine using electroencephalography (EEG). Topographic ERP analyses of the N2 and P2 pain evoked potential components allowed to test the hypothesis that PA involves distinct neural networks when induced by expectations with or without prior experience. First, we confirmed that the two groups showed corresponding expectations of morphine analgesia (Hedges' gs < .4 positive control criteria, gs = .37 observed difference), and that our intervention induced a medium-sized PA (Hedges' gav ≥ .5 positive control, gav = .6 observed PA). We then tested our hypothesis on the recruitment of different PA-associated brain networks in individuals with versus without prior experience with opioids and found no evidence for a topographic N2 and P2 ERP components difference between the two groups. Our results thus suggest that in the presence of verbally-induced expectations, modifications in the PA-associated brain activity by conditioning are either absent or very small.


Assuntos
Analgesia , Analgésicos Opioides , Analgesia/psicologia , Analgésicos Opioides/farmacologia , Analgésicos Opioides/uso terapêutico , Encéfalo , Humanos , Morfina/farmacologia , Motivação , Dor/tratamento farmacológico , Dor/psicologia , Efeito Placebo
5.
J Affect Disord ; 305: 55-64, 2022 05 15.
Artigo em Inglês | MEDLINE | ID: mdl-35247482

RESUMO

BACKGROUND: There are few available antidepressants for pediatric Major Depressive Disorder (MDD). The objective of this systematic review and meta-analysis was to review industry-funded studies of antidepressants in children and adolescents with MDD, and to better understand the contribution of study design and placebo response to the findings of these studies. METHODS: Randomized, double-blind, placebo-controlled clinical trials that compared antidepressant with placebo for the acute treatment of MDD in children and/or adolescents were selected. Estimates of the standardized mean difference (SMD) in change in Children's Depression Rating Scale-Revised scores were pooled, after examining for heterogeneity. A random-effects meta-analysis was completed. RESULTS: Thirty-four antidepressant-placebo comparisons, involving 6161 subjects, were included. The SMD among all studies was 0.12 (CI 0.08, 0.17; p < 0.001), a very small effect size, lower than that seen in studies of adults with MDD. When the meta-analysis was limited to studies with a low mean placebo response, the SMD increased to 0.19 and further increased to 0.22 when studies with at least a 50% chance of receiving placebo were included. LIMITATIONS: Many studies focused on older children and younger adolescents. Our findings may not reflect antidepressant efficacy in older adolescents. CONCLUSIONS: The modest SMD identified in this analysis may reflect study design factors and the application of antidepressants developed for adults to pediatric patients. Given the urgent clinical need for more pediatric MDD treatments, the influence of placebo response and the need for drug development tailored to this population should be considered in pediatric MDD trial design.


Assuntos
Transtorno Depressivo Maior , Adolescente , Adulto , Antidepressivos/uso terapêutico , Criança , Transtorno Depressivo Maior/tratamento farmacológico , Método Duplo-Cego , Humanos , Efeito Placebo , Ensaios Clínicos Controlados Aleatórios como Assunto
6.
Sci Rep ; 12(1): 2552, 2022 02 15.
Artigo em Inglês | MEDLINE | ID: mdl-35169169

RESUMO

There is a need for effective therapy for COVID-19 pneumonia. Convalescent plasma has antiviral activity and early observational studies suggested benefit in reducing COVID-19 severity. We investigated the safety and efficacy of convalescent plasma in hospitalized patients with COVID-19 in a population with a high HIV prevalence and where few therapeutic options were available. We performed a double-blinded, multicenter, randomized controlled trial in one private and three public sector hospitals in South Africa. Adult participants with COVID-19 pneumonia requiring non-invasive oxygen were randomized 1:1 to receive a single transfusion of 200 mL of either convalescent plasma or 0.9% saline solution. The primary outcome measure was hospital discharge and/or improvement of ≥ 2 points on the World Health Organisation Blueprint Ordinal Scale for Clinical Improvement by day 28 of enrolment. The trial was stopped early for futility by the Data and Safety Monitoring Board. 103 participants, including 21 HIV positive individuals, were randomized at the time of premature trial termination: 52 in the convalescent plasma and 51 in the placebo group. The primary outcome occurred in 31 participants in the convalescent plasma group and and 32 participants in the placebo group (relative risk 1.03 (95% CI 0.77 to 1.38). Two grade 1 transfusion-related adverse events occurred. Participants who improved clinically received convalescent plasma with a higher median anti-SARS-CoV-2 neutralizing antibody titre compared with those who did not (298 versus 205 AU/mL). Our study contributes additional evidence for recommendations against the use of convalescent plasma for COVID-19 pneumonia. Safety and feasibility in this population supports future investigation for other indications.


Assuntos
COVID-19/terapia , Adulto , COVID-19/mortalidade , COVID-19/patologia , COVID-19/virologia , Método Duplo-Cego , Feminino , Infecções por HIV/complicações , Hospitais Públicos , Humanos , Imunização Passiva , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Efeito Placebo , SARS-CoV-2/isolamento & purificação , Índice de Gravidade de Doença , África do Sul , Resultado do Tratamento
7.
Prostate ; 82(6): 633-656, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-35133667

RESUMO

BACKGROUND: It is a common practice to control efficacy of pharmacological treatment with a placebo group. However, placebo itself may affect subjective and even objective results. The purpose of this study was to evaluate the placebo effect on symptoms of CP/CPPS to improve future clinical trials. METHODS: A search at three databases (Scopus, MEDLINE, and Web of Science) was conducted to identify double-blind placebo-controlled clinical trials on the treatment of CP/CPPS published until April 2021. The primary outcome - National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score. SECONDARY OUTCOMES: Qmax, PVR, IPSS, and prostate volume. RESULTS: A total of 3502 studies were identified. Placebo arms of 42 articles (5512 patients, median 31 patients) were included in the systematic review. Systematic review identified positive changes in the primary endpoint, meta-analysis of 10 articles found that NIH-CPSI total score results were significantly influenced by placebo, mean difference -4.2 (95% confidence interval [CI]: -6.31, -2.09). Mean difference of NIH-CPSI pain domain was -2.31 (95% CI: -3.4, -1.21), urinary domain -1.12 (95% CI: -1.62, -0.62), quality of life domain -1.67 (95% CI: -2.38, -0.96); p < 0.001 for all. In case of the objective indicator - Qmax, there were three articles included in the meta-analysis. Qmax mean change from baseline was 0.68 (95% CI: -0.85, 2.22, p = 0.38). Systematic review showed no significant changes in pain, measured by VAS or other scores, IPSS and PVR. CONCLUSIONS: Placebo significantly affected the subjective parameters (NIH-CPSI) and limitedly affected various other measurements of pain (visual analog scale, McGill pain questionnaire). There was no long-term effect on IPSS and objective measurements (Qmax, PVR). This study can be used in further clinical trials to develop general rules of CPPS treatment assessment.


Assuntos
Dor Crônica , Prostatite , Doença Crônica , Dor Crônica/tratamento farmacológico , Humanos , Masculino , Dor Pélvica/tratamento farmacológico , Efeito Placebo , Prostatite/complicações , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto
8.
Eur J Pain ; 26(5): 1006-1020, 2022 May.
Artigo em Inglês | MEDLINE | ID: mdl-35129852

RESUMO

BACKGROUND: In prospective experimental studies of neck pain patients, it is difficult to determine whether responses to sham acupuncture differ from responses to real acupuncture due to the heterogeneous methodologies in control/sham interventions. Here we aim to compare the specific and nonspecific effects of electroacupuncture with four types of sham acupuncture. METHODS: In this double-blind, sham-controlled study, we randomly assigned 175 patients with neck pain to receive 10 sessions of electroacupuncture, shallow puncture, nonacupoint deep puncture, nonacupoint shallow puncture, or nonpenetration acupuncture. We used the Northwick Park Neck Pain Questionnaire (NPQ) as our primary outcome, and Short-form McGill Pain Questionnaire, visual analog scale (VAS), and Pain Threshold as secondary outcomes to measure the changes from baseline to a 3-month follow up. RESULTS: All groups, except nonacupoint shallow puncture, had significant improvement in all outcome measurements. Electroacupuncture only showed superior improvements than the shallow puncture, nonacupoint shallow puncture, and nonpenetration groups when compared using the NPQ and VAS scale (*p < 0.001). Interestingly, the nonacupoint shallow puncture produced even less placebo response than nonpenetration acupuncture. CONCLUSION: Our study demonstrates the high variability of placebo response among different types of sham controls depending on the depth of needle insertion and the puncture location. An important implication of our results is nonacupoint deep puncture produced similar analgesic effects as electroacupuncture. Our study may shed a new light on the predominant underlying mechanisms among different types of sham acupuncture controls, which can help with interpreting the effect of acupuncture in other studies. TRIAL REGISTRATION: Chinese clinical trial registry (ChiCTR-IOR-15006886). SIGNIFICANCE: This study compared the observed specific and nonspecific analgesia effect in four different types of sham acupuncture stimulation with neck pain patients, assessed by four outcomes. Although all of the sham controls produced significant reduction in neck pain, electroacupuncture had superior significant improvement. Importantly, placebo responses differed significantly between the sham controls and responses were inconsistent according to different outcome assessments. This study emphasizes the importance of taking into consideration which sham control and method of outcome measurement were used in a pain research study when evaluating its results.


Assuntos
Terapia por Acupuntura , Eletroacupuntura , Terapia por Acupuntura/métodos , Método Duplo-Cego , Eletroacupuntura/métodos , Humanos , Cervicalgia/terapia , Efeito Placebo , Estudos Prospectivos , Resultado do Tratamento
9.
J Affect Disord ; 304: 159-166, 2022 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-35181385

RESUMO

BACKGROUND: Recent studies demonstrate substantial effects of deceptive placebo on experimentally induced sadness, even on autonomic activity. Whether deception is necessary, remains to be elucidated. We investigated the effect of an open-label placebo (OLP) treatment, i.e. an openly administered placebo delivered with a convincing rationale for its sadness-protecting effect. METHODS: Eighty-four healthy females were randomized to an OLP group or a no-treatment control group. All participants received the same detailed information about the OLP effect, only the OLP group received an OLP nasal spray. Before and after the OLP intervention, participants underwent a sad mood induction procedure combining self-deprecating statements (Velten's method) and sad music. Sadness was assessed by the Positive and Negative Affect Schedule (PANAS-X). Autonomic activity was measured continuously. RESULTS: Participants in the OLP group reported a significantly attenuated increase in sadness upon mood induction and less sadness after induction compared to the control group (d = 0.79). Regardless of intervention, heart rate decreased during mood inductions with a more pronounced deceleration in the second mood induction. LIMITATIONS: Generalizability is limited due to the selective sample and the reliance on an experimentally controlled mood induction. CONCLUSION: OLP treatment had a beneficial effect on perceived sadness, at least at the subjective level. Hence, deception may not necessarily be required for placebos to modulate experienced sad mood. Investigating the beneficial effects of OLP in (sub-)clinical samples would seem a promising and required next step towards a clinical use of placebo-associated positive treatment expectations.


Assuntos
Efeito Placebo , Tristeza , Afeto , Sistema Nervoso Autônomo , Feminino , Humanos , Projetos de Pesquisa
10.
Transfus Med ; 32(2): 115-119, 2022 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-35193168

RESUMO

BACKGROUND: Our own observations suggested that placebo and nocebo effects may occur with transfusions. However these effects seem to have been poorly studied. OBJECTIVES: To examine published information on, and draw attention to the possibility of, placebo and nocebo effects with transfusion. METHODS: Focused literature review. RESULTS: There is some information on placebo effects with clotting factors and this effect appears modest at best. There is very little published information on this regarding other fresh blood components. Although unknown biologic effects cannot be ruled out, there are hints that placebo effects might operate - especially with red blood cell transfusions. There is practically no information on nocebo effects with transfusions. CONCLUSIONS: There are ways of surmounting the practical and ethical difficulties involved, and obtaining better information on both types of effects. Individualised, contextualised, informed consenting of transfusion recipients may help to enhance placebo, and reduce nocebo, effects. This may be supportable ethically, and desirable clinically, and financially.


Assuntos
Efeito Nocebo , Medicina Transfusional , Humanos , Consentimento Livre e Esclarecido , Efeito Placebo , Inquéritos e Questionários
11.
Stat Med ; 41(12): 2166-2190, 2022 May 30.
Artigo em Inglês | MEDLINE | ID: mdl-35184326

RESUMO

In clinical trials, placebo response is considered a beneficial effect arising from multiple factors, including the patient's expectations for the treatment. Its presence makes the classical parallel study design suboptimal and can bias the inference. The sequential parallel comparison design (SPCD), a two-stage design where the first stage is a classical parallel study design, followed by another parallel design among placebo subjects from the first stage, was proposed to address the shortcomings of the classical design. In SPCD, in lieu of treatment effect, a weighted average of the mean treatment difference in Stage I among all randomized subjects and the mean treatment difference in Stage II among placebo non-responders was proposed as the efficacy measure. However, by linking two possibly different populations, this weighted average lacks interpretability, and the choice of weight remains controversial. In this work, under the principal stratification framework, we propose a causal estimand for the treatment effect under each of three clinically important principal strata: Always Responders, Never Responders, and Drug-only Responders. To make the stratum treatment effect identifiable, we introduce a set of assumptions and two sensitivity parameters. By further considering the strata as latent characteristics, the sensitivity parameters can be estimated. An extensive simulation study is conducted to evaluate the operating characteristics of the proposed method. Finally, we apply our method on the ADAPT-A study data to assess the benefit of low-dose aripiprazole adjunctive to antidepressant therapy treatment.


Assuntos
Efeito Placebo , Projetos de Pesquisa , Viés , Simulação por Computador , Humanos
12.
PLoS One ; 17(2): e0261980, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35139097

RESUMO

INTRODUCTION: Health care workers are at high risk of being infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Our aim is to evaluate the efficacy and safety of hydroxychloroquine (HCQ) for prophylaxis of coronavirus disease 19 (COVID-19) in health personnel exposed to patients infected by SARS-CoV-2. METHODS: Double-blind randomized, placebo-controlled single center clinical trial. Included subjects were health care workers caring for severe COVID-19 patients. Main outcome was time to symptomatic SARS-CoV-2 infection. RESULTS: 127 subjects with a confirmed baseline negative RT-PCR SARS-CoV2 test were included in the trial. 62 assigned to HCQ and 65 to placebo. One subject (1.6%) in the HCQ group and 6 (9.2%) subjects in the placebo group developed COVID-19 (Log-Rank test p = 0.07). No severe COVID-19 cases were observed. The study was suspended because of a refusal to participate and losses to follow up after several trials reported lack of effectiveness of hydroxychloroquine in hospitalized patients with COVID-19. CONCLUSION: The effect size of hydroxychloroquine was higher than placebo for COVID-19 symptomatic infection in health personnel, although this was not statistically significant. The trial is underpowered due to the failure to complete the estimated sample size.


Assuntos
Antimaláricos/uso terapêutico , Antivirais/uso terapêutico , COVID-19/prevenção & controle , Hidroxicloroquina/uso terapêutico , Adulto , COVID-19/diagnóstico , Método Duplo-Cego , Feminino , Pessoal de Saúde , Humanos , Masculino , Efeito Placebo , SARS-CoV-2/efeitos dos fármacos , SARS-CoV-2/isolamento & purificação , Resultado do Tratamento
13.
J Integr Complement Med ; 28(2): 136-145, 2022 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-35167363

RESUMO

Objective: An open-label placebo (OLP) is a placebo treatment in which the patient is aware that the treatment is a placebo. OLPs are considered effective for reducing pain, and previous studies have shown a stronger placebo effect for placebo acupuncture than for placebo pills. In this study, the authors compared the analgesic effects of OLP pills, OLP acupuncture, and a no treatment condition in healthy participants, and then examined the factors contributing to the OLP effect. Design: Randomized controlled crossover trial. Settings/Location: College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea. Subjects: 34 healthy participants. Intervention: Participants received three different treatments ("OLP-pill," "OLP-acupuncture," and "no treatment") on three separate days in random order. Outcome Measurements: Before and after the treatment, heat pain stimuli were applied to the participants' hands, and pain tolerance, intensity, and unpleasantness were measured using a visual analog scale (range, 0-10). Results: Data of 31 participants were included in the analysis. The authors found significant analgesic effects of the placebo pill and placebo acupuncture in the OLP condition. Regression analyses revealed that expectations regarding treatment and practitioner identity influenced the analgesic effects of OLP acupuncture. There was no adverse event. Conclusions: Expectations regarding treatment and practitioner identity influenced the analgesic effect of placebo acupuncture without deception. These findings provide new information regarding the cognitive factors underlying pharmacologic and nonpharmacologic treatments. Clinical Trial Registration Number: KCT0004928.


Assuntos
Terapia por Acupuntura , Dor , Humanos , Dor/etiologia , Manejo da Dor , Medição da Dor , Efeito Placebo
15.
J Clin Gastroenterol ; 56(4): 299-310, 2022 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-35180148

RESUMO

BACKGROUND: Functional dyspepsia (FD) is a functional digestive disease with limited management selection. Previous studies revealed that acupuncture therapy is effective for FD. However, because sham controls were not implemented in most clinical trials following acupuncture therapy, it is difficult to differentiate overall treatment responses from placebo. This study aims to quantify placebo responses in clinical trials in which FD patients received sham manual acupuncture (MA) and sham electroacupuncture (EA). MATERIALS AND METHODS: Randomized controlled trials of MA and EA for FD patients were searched in PubMed, Web of Science, Cochrane Library, and Embase databases, as well as 4 Chinese language databases from inception to January 2021. RevMan 5.20 software was used for pooled analysis of symptom scores and quality of life. The symptom scores were combined using standard mean difference (SMD) or weighted mean difference (WMD) with a 95% confidence interval (CI). The quality of included studies was tested using modified Jadad scale and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) checklist. Egger's test, Begg's test, and sensitivity analyses were conducted using Stata 11.0 statistical software. The protocol of this study is registered in PROSPERO as CRD42021233858. RESULTS: After screening, the current systematic review included 13 randomized controlled trials, of which 8 studies were used in the meta-analysis. Regarding subjective outcomes, the combined effect of sham MA on FD symptoms was [SMD=-0.42, 95% CI (-0.72, -0.12); P=0.005], whereas sham EA treatment was [SMD=-0.54, 95% CI (-0.81, -0.27); P<0.001]. The combined effect on FD quality of life of post-sham MA group was [SMD=-0.32, 95% CI (-0.52, -0.12); P=0.002]. With regard to objective outcomes, the combined effect of sham EA on dominant frequency was [WMD=-0.11, 95% CI (-0.30, -0.08); P=0.24], while the combined effect of sham EA on dominant power was [WMD=-3.35, 95% CI (-8.04, 1.35); P=0.16]. CONCLUSIONS: Sham MA and sham EA remarkably improve symptoms and quality of life scores of FD without influencing objective outcomes, highlighting the significance of sham controls in acupuncture therapy clinical trials.


Assuntos
Terapia por Acupuntura , Dispepsia , Eletroacupuntura , Terapia por Acupuntura/métodos , Dispepsia/terapia , Eletroacupuntura/métodos , Humanos , Efeito Placebo , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto
18.
J Parkinsons Dis ; 12(3): 759-771, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35034910

RESUMO

In the field of stem cell technologies, exciting advances are taking place leading to translational research to develop cell-based therapies which may replace dopamine releasing neurons lost in patients with Parkinson's disease (PD). A major influence on trial design has been the assumption that the use of sham operated comparator groups is required in the implementation of randomised double-blind trials to evaluate the placebo response and effects associated with the surgical implantation of cells. The aim of the present review is to identify the improvements in motor functioning and striatal dopamine release in patients with PD who have undergone sham surgery. Of the nine published trials, there was at the designated endpoints, a pooled average improvement of 4.3 units, with 95% confidence interval of 3.1 to 5.6 on the motor subscale of the Unified Parkinson's Disease Scale in the 'OFF' state. This effect size indicates a moderate degree of improvement in the motor functioning of the patients in the sham surgical arms of the trials. Four of the nine trials reported the results of 18F-Fluorodopa PET scans, indicating no improvements of dopaminergic nigrostriatal neurones following sham surgery. Therefore, while the initial randomised trials relying on the use of sham operated controls were justified on methodological grounds, we suggest that the analysis of the evidence generated by the completed and published trials indicates that placebo controlled trials are not necessary to advance and evaluate the safety and efficacy of emerging regenerative therapies for PD.


Assuntos
Doença de Parkinson , Antiparkinsonianos/uso terapêutico , Dopamina , Método Duplo-Cego , Humanos , Doença de Parkinson/complicações , Efeito Placebo , Ensaios Clínicos Controlados Aleatórios como Assunto
19.
J Oral Rehabil ; 49(5): 586-591, 2022 May.
Artigo em Inglês | MEDLINE | ID: mdl-35043415

RESUMO

BACKGROUND: Evidence for the nocebo effect, a phenomenon characterised by suboptimal treatment efficacy, worsening of symptoms, or the occurrence of adverse events caused by an individual's negative treatment expectations, is growing across a multitude of medical fields. However, little attention has been paid to patients' negative expectations and the nocebo effect within dentistry. AIM: This review summarises essential evidence of the nocebo phenomenon especially in relation to pain and drug administration. Subsequently, an overview of the current evidence of the nocebo phenomenon in the dental field is presented. METHODS: A PubMed search was performed using keywords related to "nocebo," "placebo," "expectations," and "dentistry." In addition to the articles selected from the search, placebo/nocebo researchers and dental researchers added important references from their respective fields. RESULTS: Although research on the nocebo effect in dentistry is limited, available current evidence suggests that the factors, which is related to the nocebo effect are likely to play a role in dental practice. CONCLUSION: Preliminary evidence from the review warrants further investigation into the nocebo effect in dentistry. Finally, based on the general knowledge of the nocebo effect, the review indicates fruitful arrays of research into the nocebo effect in dentistry.


Assuntos
Efeito Nocebo , Efeito Placebo , Odontologia , Humanos , Resultado do Tratamento
20.
PLoS One ; 17(1): e0247637, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35100251

RESUMO

BACKGROUND: Insufficient milk production is a common problem affecting breastfeeding women, in particular following Cesarean delivery. Wang Nam Yen herbal tea is a promising traditional Thai medicine used by postpartum women to stimulate milk production, as an alternative to pharmaceutical galactagogues. We aimed to compare the efficacy of Wang Nam Yen herbal tea, domperidone, and placebo, in increasing milk production in mothers who underwent Cesarean delivery. METHODS: Women who underwent uncomplicated cesarean delivery at Sunpasitthiprasong Hospital were randomized into three groups. The participants received the treatments daily for three consecutive days. The primary outcome was breast milk volume at 72 hours after delivery. Secondary outcomes were pregnancy and neonatal outcomes, adverse events, and participant satisfaction. RESULTS: Of the 1,450 pregnant women that underwent cesarean delivery, 120 women were enrolled. Their mean age and gestational ages were 28.7 years and 38.4 weeks, respectively. Breast milk volume at 72 hours postpartum was significantly different among the three groups (p = 0.030). The post hoc Bonferroni correction indicated a significant difference in breast milk volume between Wang Nam Yen herbal tea group and placebo control group (p = 0.007) while there was no difference between Wang Nam Yen herbal tea group and domperidone group (p = 0.806) and between domperidone group and placebo control group (p = 0.018). There was no difference in pregnancy and neonatal outcomes, adverse events, and participant satisfaction among the three groups. CONCLUSION: Wang Nam Yen herbal tea was effective in augmenting breast milk production at 72 hours postpartum in mothers following cesarean delivery, and there was no evidence that herbal tea and domperidone differed in terms of augmenting breast milk production. TRIAL REGISTRATION: The study was approved by the institutional review board of Sunpasitthiprasong Hospital (No.061/2559) and was registered TCTR20170811003 with the Thai Clinical Trial Registry.


Assuntos
Galactagogos/administração & dosagem , Lactação/fisiologia , Leite Humano/metabolismo , Chás de Ervas/análise , Adolescente , Adulto , Cesárea , Domperidona/administração & dosagem , Feminino , Humanos , Efeito Placebo , Período Pós-Parto , Gravidez , Resultado do Tratamento , Adulto Jovem
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