The placebo effect, a beneficial effect attributable to a treatment containing no specific properties for the condition being treated, has been demonstrated in a variety of medical conditions. This thesis includes four studies aimed at increasing our knowledge on the neurobiology of placebo. Study I, a review of the placebo neuroimaging literature, suggested that the anterior cingulate cortex (ACC) may be a common site of action for placebo responses. However, because placebo neuroimaging studies in clinical disorders are largely lacking, the clinical relevance of this needs further clarification. The subsequent three empirical studies were thus designed from a clinical perspective. Using positron emission tomography (PET) these studies investigated the underlying neurobiology of sustained placebo responses in patients with social anxiety disorder (SAD), a disabling psychiatric condition that nonetheless may be mitigated by placebo interventions. Study II demonstrated that serotonergic gene polymorphisms affect anxiety-induced neural activity and the resultant placebo phenotype. In particular, anxiety reduction resulting from placebo treatment was tied to the attenuating effects of the TPH2 G-703T polymorphism on amygdala activity. Study III further compared the neural response profile of placebo with selective serotonin reuptake inhibitors (SSRIs), i.e the first-line pharmacological treatment for SAD. A similar anxiety reduction was noted in responders of both treatments. PET-data further revealed that placebo and SSRI responders had similar decreases of the neural response in amygdala subregions including the left basomedial/basolateral (BM/BLA) and the right ventrolateral (VLA) sections. To clarify whether successful placebo and SSRI treatments operate via similar or distinct neuromodulatory pathways, study IV focused on the connectivity patterns between the amygdala and prefrontal cortex that may be crucial for normal emotion regulation. In responders of both treatment modalities, the left amygdala (BM/BLA) exhibited negative coupling with the dorsolateral prefrontal cortex and the rostral ACC as well as a shared positive coupling with the dorsal ACC. This may represent shared treatment mechanisms involving improved emotion regulation and decreased rumination. This thesis constitutes a first step towards better understanding of the neurobiology of placebo in the treatment of anxiety, including the neural mechanisms that unite and segregate placebo and SSRI treatment.

The effects of caffeine (250 mg) and placebo on healthy controls were studied in a double-blind, cross over study on 24 healthy subjects who performed a working memory n-back task. Reaction time and accuracy levels were tested using the n-back working memory measure in cognitive neuroscience. An experimental study tested on the 1, 2 and 3-back tasks under the placebo/coffee condition. Based on the empirical results obtained in this thesis it can be concluded that changes produced by caffeine ingestion support the hypothesis that caffeine acts as a stimulant. However, it cannot be proven that the stimulant translates into enhanced motor processes with an improvement in performance.

Thesis (M.Tech.: Homoeopathy)-Dept. of Homoeopathy, Durban University of Technology, 2006 xxxiii, 112 leaves : ill. / The purpose of this double-blind placebo-controlled study was to evaluate the relative and combined efficacy of the homoeopathic similimum, taken orally, and the topical application of a lotion made from the homoeopathic mother tinctures of Hypericum perforatum and Calendula officinalis in the treatment of venous leg ulcers. Venous hypertension in the lower limb, occurring from a variety of causes, leads to microcirculatory abnormalities which may permit the formation of a chronic ulcer (Zimmet, 1998). Venous leg ulcers are a cause of much debility, social isolation, depression, fears of loss of employment and income (Royal College of Nursing Institute, 1998). The mainstay of treatment at present is compression bandaging to reduce the venous pressure in the lower limb. Eighty percent of venous leg ulcers will heal within eight to twelve weeks with compression bandaging (Thomas, 1997). Homoeopathy is a system of medicine based on natural laws of healing, and recognizes the biophysical energy of an individual (also known as the vital force) as that which provides the normal protective defence mechanisms of the body, and is disturbed in disease, producing symptoms on the physical, mental and emotional levels (Vithoulkas, 1980). Many plants are known to have wound-healing properties (Curtis and Fraser, 2003). Calendula officinalis and Hypericum perforatum were considered the best plants in a homoeopathic lotion to be used on chronic venous leg ulcers, as they cover all the common problems associated with this type of wound, providing pain relief and anti-microbial activity (Lawless, 1995). In this study, homoeopathic mother tinctures of the herbs were used to make the lotion for topical application to the wounds.

Thesis (MNutr)--Stellenbosch University, 2012. / ENGLISH ABSTRACT: It is estimated that 1.3 billion people worldwide are either overweight or obese, making this a global epidemic. An effective weight-loss method involves the lifestyle changes of increased physical activity and lowered energy intake. These changes are difficult to carry out and to maintain. As a result, there is a soaring demand for weight-loss aids, including dietary supplements, which exploit consumers’ eagerness to find an effortless weight-loss solution. These supplements are easily accessible, require no prescription and are heavily marketed to suggest that weight loss is achievable without exercise and dieting. One such dietary supplement, Bioslim, is tested in this study. The aim of this study was to investigate whether Bioslim results in greater weight loss than a placebo, and whether the marketing of the Bioslim brand has an influence on the placebo response. Overweight adults residing in Cape Town (n = 87) were recruited by advertising in community newspapers and setting up stands at shopping centres. The subjects were randomised into one of four groups: Bioslim in Bioslim packaging (n = 26), Bioslim in unbranded packaging (n = 22), placebo in Bioslim packaging (n = 17) and placebo in unbranded packaging (n = 22). At baseline, the subjects were given one of the four products and anthropometric measurements (weight, height and skinfold thickness) were taken. After four weeks, these measurements were repeated. The subjects also had to complete a questionnaire regarding their experiences. The body mass index (BMI) for the total population was 31.90 kg/m2 (SD = 3.91) at baseline and 31.89 kg/m2 (SD = 3.92) at follow-up. None of the measured anthropometric variables had changed significantly after four weeks. When the total study group sample was analysed, based on the allocated drug treatment groups (active or placebo), neither group showed significant weight loss from baseline to follow-up. Twenty-three subjects from the Bioslim group and 21 from the unbranded group reported exercising during the trial. The total group’s exercise time correlated significantly with fat-mass reduction (r = -0.31, p = 0.004). Furthermore, when data was analysed separately for the active and placebo groups, the active group showed a significant correlation (r = -0.45, p = 0.0012), while the placebo group showed an insignificant correlation (r = -0.05, p = 0.77). The same was not reflected in weight loss (r = -0.007, p = 0.95). It is concluded that Bioslim is an ineffective weight-loss supplement: subjects receiving active pills evidenced no significant beneficial changes in weight, waist circumference or body composition. More than half of the subjects attempted dieting and exercising, but these efforts were insufficient to impact on weight loss. The marketing and packaging of Bioslim did not enhance the placebo effect. One subject from the active group withdrew from the study, complaining of severe headaches and heart palpitations. There was no difference in adverse events reported by the remaining active and placebo group subjects. In conclusion, this study emphasises the need for better regulation of the efficacy and safety of dietary supplements. / AFRIKAANSE OPSOMMING: Daar word geskat dat 1.3 biljoen mense wêreldwyd oorgewig of vetsugtig is, wat dit ‘n globale problem maak. ‘n Effektiewe gewigsverlies metode inkorporeer leefstyl veranderinge soos verhoogde fisiese aktiwiteit en ‘n laer energie inname. Hierdie veranderinge is moeilik om uit te voer en vol te hou. Die gevolg is ‘n stygende aanvraag vir gewigsverliesprodukte en supplemente, wat verbruikers se gretigheid om ‘n maklike gewigsverlies oplossing te kry, uitbuit. Hierdie supplemente is maklik verkrygbaar sonder ‘n voorskrif en word aggressief bemark met bewering dat gewigsverlies moontlik is sonder oefening en dieetaanpassing. Een van die beskikbare produkte, Bioslim, is getoets in die studie. Die doel van die studie was om te ondersoek of die gewigsverlies produk, Bioslim, lei tot ‘n groter gewigsverlies as ‘n plasebo produk en of die bemarking van die Bioslim handelsmerk ‘n invloed op die plasebo-effek het. Oorgewig volwassenes woonagtig in Kaapstad (n = 87) is gewerf deur advertering in gemeenskapskoerante en deur stalletjies by inkopiesentrums. Die proefpersone is ewekansig in vier groepe ingedeel: Bioslim in Bioslim verpakking (n = 26); Bioslim in verpakking sonder ‘n handelsmerk (n = 22); ‘n plasebo produk in Bioslim verpakking (n = 17) en ‘n plasebo produk in verpakking sonder ‘n handelsmerk (n = 17). Met aanvang van die studie is een van die vier produkte aan die proefpersone gegee en antropometriese metings (gewig, lengte en velvoudikte) is gemeet. Metings is na vier weke herhaal. Die proefpersone moes ook ‘n vraelys oor hul ervarings voltooi. Die liggaamsmassa indeks (LMI) van die totale populasie was 31,90 kg/m2 (SD = 3.91) by basislyn en 31.89 kg/m2 (SD = 3.92) met opvolg. Geen van die antropometriese veranderlikes het betekenisvol verander na vier weke nie. Met ontleding van die totale studie polulasie, gebasseer op die toegekende behandeling (aktiewe of plasebo bestanddele), is gevind dat geen groep ‘n betekenisvolle gewigsverlies getoon het van basislyn tot opvolg nie. Drie-en-twintig proefpersone uit die Bioslim groep en 21 uit die geen-handelsmerk-groep het gerapporteer dat hul geoefen het gedurende die studie. Die totale groep se oefenings tydsduur het betekenisvol gekorreleer met ‘n verlaging in vetmassa (r = -0.31, p = 0.004). Met verdere analiese van die data in die aktiewe en plasebo groepe, is gevind dat die aktiewe groep ‘n betekenisvolle korrelasie getoon het (r = -0.45, p = 0.0012), maar die plasebo groep nie (r = -0.05, p = 0.77). Hierdie bevinding is nie gevind in die gewigsverlies nie (r = -0.007, p = 0.95). Die gevolgtrekking word gemaak dat Bioslim ‘n oneffektiewe gewigsverlies supplement is, aangesien proefpersone wat die aktiewe pille geneem het, geen betekenisvolle voordelige veranderinge in hul gewig, middelomtrek of liggaamsamestelling getoon het nie. Alhoewel ‘n betekenisvolle korrelasie gevind is tussen oefeningsduur en verlies aan vetmassa in meer as die helfte van die proefpersone, was die omvang daarvan onvoldoende om ‘n impak op hul gewigsverlies te hê. Die bemarking en Bioslim handelsmerk het nie die placebo-effek versterk nie. Een persoon uit die aktiewe groep het van die studie onttrek as gevolg van erge hoofpyn en hartkloppings. Daar was geen verskil in die nadelige effekte gerapporteer deur die oorblywende proefpersone in die aktiewe en plasebo groepe nie. Ten slotte beklemtoon die studie die behoefte aan beter regulering van die effektiwiteit en veiligheid van dieetsupplemente.

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Made available in DSpace on 2014-06-12T23:01:36Z (GMT). No. of bitstreams: 2 arquivo3943_1.pdf: 1196752 bytes, checksum: aa74d03d61ae3ff87aef11fb6f56ef46 (MD5) license.txt: 1748 bytes, checksum: 8a4605be74aa9ea9d79846c1fba20a33 (MD5) Previous issue date: 2008 / O sulfato ferroso (SF) representa o tratamento de eleição para um dos problemas de maior magnitude e importância em saúde pública do mundo, a deficiência de ferro e a anemia ferropriva. No entanto, a baixa adesão ao tratamento devido aos efeitos colaterais deste mineral limitando sua efetividade, representa um grande desafio ainda a ser superado no controle desta doença carencial. Objetivou-se conhecer o grau de adesão e associações ao uso do SF, efeitos colaterais, perfil e motivos do abandono ao seu tratamento aplicado em diferentes posologias entre mulheres. Realizou-se um ensaio populacional, randomizado, duplo cego e controlado por placebo em 727 mulheres nãográvidas de 20 a 49 anos, durante oito semanas, em ambulatório de ginecologia da UPE entre outubro/05 a outubro/06, recrutadas por amostra probabilística sistemática e alocadas aleatoriamente em oito grupos com tomadas diárias de 300mg de SF ou duas vezes por semana e durante (DR) ou no intervalo das refeições (IR). O uso dos comprimidos foi registrado mediante questionário aplicado semanalmente por telefone. Encontrou-se regular adesão (74,2%) ao uso do SF e não houve associações significativas entre adesão ao SF e as variáveis estudadas. O uso diário de comprimidos (SF/placebo) comparado com o semanal, independentemente do horário, diminuiu significativamente a adesão (p<0,001). A presença do SF nos comprimidos reduziu significativamente a adesão quando comparado com placebo, independentemente da posologia (p<0,001). Encontrou-se menor adesão no uso diário do SF, comparado com o semanal, independentemente do horário das tomadas (p<0,001), contudo tomar SF no intervalo ou durante a refeição não interferiu com a adesão da mulher no estudo (p=0,930). O abandono do experimento ocorreu em 102 mulheres (15,9%) principalmente por efeitos colaterais e quase 84,0%, pertenciam aos grupos de SF (p<0,001). Diarréia (55,5%), náusea (22,5%) e constipação (19,6%) motivaram os abandonos em todos os grupos. O uso do SF diariamente no IR foi quem provocou maisabandono no experimento (40,0%). Diarréia foi mais freqüente com o uso do SF na refeição e a constipação, no intervalo desta (p<0,001). Registraram-se 8,2% relatos de queixas nos telefonemas (principalmente mal estar e diarréia) sendo 85,7% para o grupo de SF. O uso do SF interferiu positivamente na presença de queixas quando comparado com placebo, p<0,05. Nos grupos de uso apenas de SF, 72,6% das queixas pertenciam ao uso diário quando comparadas com o semanal, com diferenças estatisticamente significantes (p<0,001). Náusea e diarréia foram as únicas queixas que apresentaram diferenças estatisticamente significantes quando comparadas com o horário da tomada, sendo náusea no intervalo e diarréia durante a refeição. Conclui-se que o uso diário do SF apresentou mais relatos de queixas, efeitos colaterais e abandono ao tratamento do que o semanal e que diarréia foi uma variável que esteve presente em todas as formas de uso do SF. Recomenda-se, como uma possibilidade posológica, o uso semanal do SF independentemente do horário da aplicação, como modalidade de melhor adesão

This thesis examines patient recruitment in clinical trials. It is a current and pressing issue, which is not sufficiently embedded in the thinking of doctors and patients, their patterns of communication, and more broadly in the traditional doctor-patient relationship, which continues to be burdened by post-socialist paternalism. The formal framework and ethics have been developed relatively recently, and their application causes confusion to all participants regarding how to proceed in specific situations. In addition, the choice of topic, and especially the form of dealing with the topic, was motivated by the relative lack of academic resources and publications in the field. The theoretical section of the thesis defines clinical research and its phases, and introduces basic terminology and documents closely linked to clinical research. In addition, it focuses on research ethics, thoroughly examining the issue of informed consent - a fundamental document necessary for recruiting a patient in a clinical trial. Finally, one chapter of the thesis focuses on the issue of medical literacy, the level of which is integral to the participants' understanding of the importance of clinical research, and directly affects participants' decision-making. The empirical section is divided into two parts. The...

Several trials have reported rapid antidepressant response from the anesthetic drug ketamine although the mechanism behind this effect is not fully understood. Research has focused mainly on ketamine’s action in the brain, including its effects on chemical balance, connections between brain cells and networks, and cognition. Trials with psychedelic drugs have had similar antidepressant results as ketamine, and the quality of the subjective psychedelic experience seems to mediate antidepressant action. Ketamine causes similar alterations of consciousness, which have been viewed as side effects. This thesis examines whether ketamine works in a similar way as psychedelics, where the ketamine-induced dissociative-like experience has a relationship to antidepressant response. Leading theories of depression and ketamine’s action in the brain are presented, and eight studies examining the relationship between ketamine-induced subjective experience and antidepressant response are reviewed. Three included studies found a relationship between psychedelic- and dissociative-like symptoms and reduction in depression, while five did not. The supposed relationship between psychedelic- and dissociative-like symptoms and antidepressant action has not been adequately explored and needs further examination in clinical trials.

Bakgrund: Kommunikationen mellan sjuksköterska och patient är betydande för den mellanmänskliga relationen som i sin tur är grunden för omvårdnad. Forskning visar att kommunikationen mellan sjuksköterska och patient kan främja hälsa och lindra lidande. Evidens om hur kommunikation påverkar hälsan genom placebo- eller noceboeffekt är relativt outforskat eftersom resultat är svåra att mäta. Placebo rör inte enbart “sockerpiller” utan omfattar olika former av psykologisk stimulans som aktiverar fysiologiska processer. Syfte: Syftet var att sammanställa evidens för vilka kommunikativa åtgärder sjuksköterskan kan tillämpa för att öka placeboeffekt samt minska noceboeffekt. Metod: Litteraturöversikt baserad på elva kvantitativa artiklar. Resultat: Hälsofrämjande kommunikativa åtgärder kan sammanfattas med ett positivt ordval, en varm kommunikationsstil och fysisk beröring. Kommunikation som främjar placeboeffekt minskar patientens puls, blodtryck, ångest och smärta samt ökar själveffektivitet, belåtenhet, tro på sin egen prestationsförmåga samt förväntan på behandlingsresultat. Fysisk beröring som separat åtgärd håller även patientens oxytocin-nivå stabil och ger ett ökat fysiskt och psykiskt välbefinnande samt fysisk och psykisk komfort. Konklusion: När sjuksköterskan är medveten om sitt sätt att kommunicera med patienten kan det öka placeboeffekten och främja hälsa genom att välja en varm kommunikationsstil, ge fysisk beröring samt att välja positiva ord. / Background: The communication between nurse and patient is significant for the interpersonal relationship, which is the basis for nursing. Research shows that communication can promote health and relieve suffering. Evidence on how communication affects health through a placebo or nocebo effect is relatively unexplored because results are difficult to measure. Placebo is not just about "sugarpills" but includes various forms of psychological stimuli that activate physiological processes. Aim: The purpose was to compile evidence about communicative measures nurses can utilize to increase the placebo effect and reduce the nocebo effect. Method: A literature review based on eleven quantitative articles. Findings: Health-promoting communicative measures can be summed up with a choice of positive words, a warm communication style and physical touch. Communication that promotes the placebo effect reduces patients' heart rate, bloodpressure, anxiety and pain and even increases self-efficacy, satisfaction and belief in their own performance ability and expectations of treatment results. Physical touch as a separate measure also keeps the patient's oxytocin level stable and provides increased physical and mental well-being and comfort. Conclusion: When nurses are aware of their way of communicating with patients, they can increase the placebo effect and promote health by choosing a warm communication style, providing physical touch and choosing positive words

The placebo response can affect inference in analysis of data from clinical trials. It can bias the estimate of the treatment effect, jeopardize the effort of all involved in a clinical trial and ultimately deprive patients of potentially efficacious treatment. The Sequential Parallel Comparison Design (SPCD) is one of the novel approaches addressing placebo response in clinical trials. The analysis of SPCD clinical trial data typically involves classification of subjects as ‘placebo responders’ or ‘placebo non-responders’. This classification is done using a specific criterion and placebo response is treated as a measurable characteristic. However, the use of criterion may lead to subject misclassification due to measurement error or incorrect criterion selection. Subsequently, misclassification can directly affect SPCD treatment effect estimate. We propose to view placebo response as an unknown random characteristic that can be estimated based on information collected during the trial. Two strategies are presented here. First strategy is to model placebo response using criterion classification as a starting point or the observed data, and to include the placebo response estimate into the treatment effect estimation. Second strategy is to jointly model latent placebo response and the observed data, and estimate treatment effect from the joint model. We evaluate both strategies on a wide range of simulated data scenarios in terms of type I error control, mean squared error and power. We then evaluate the strategies in presence of missing data and propose a method for missing data imputation under the non-informative missingness assumption. The data from a recent SPCD clinical trial is used to compare results of the proposed methods with reported results of the trial. / 2018-01-01T00:00:00Z