Статті в журналах: "Placebo interventions"

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Linde, Klaus, Margrit Fässler, and Karin Meissner. "Placebo interventions, placebo effects and clinical practice." Philosophical Transactions of the Royal Society B: Biological Sciences 366, no. 1572 (June 27, 2011): 1905–12. http://dx.doi.org/10.1098/rstb.2010.0383.

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This article reviews the role of placebo interventions and placebo effects in clinical practice. We first describe the relevance of different perspectives among scientists, physicians and patients on what is considered a placebo intervention in clinical practice. We then summarize how placebo effects have been investigated in randomized controlled trials under the questionable premise that such effects are produced by placebo interventions. We further discuss why a shift of focus from the placebo intervention to the overall therapeutic context is necessary and what research methods can be used for the clinical investigation of the relevance of context effects. In the last part of the manuscript, we discuss why placebo or context effects are seen as positive in clinical practice when they are associated with active treatments, while placebo interventions pose major ethical and professional problems and have to be avoided.

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Staudacher, Heidi M., Peter M. Irving, Miranda C. E. Lomer, and Kevin Whelan. "The challenges of control groups, placebos and blinding in clinical trials of dietary interventions." Proceedings of the Nutrition Society 76, no. 3 (June 20, 2017): 203–12. http://dx.doi.org/10.1017/s0029665117000350.

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High-quality placebo-controlled evidence for food, nutrient or dietary advice interventions is vital for verifying the role of diet in optimising health or for the management of disease. This could be argued to be especially important where the benefits of dietary intervention are coupled with potential risks such as compromising nutrient intake, particularly in the case of exclusion diets. The objective of the present paper is to explore the challenges associated with clinical trials in dietary research, review the types of controls used and present the advantages and disadvantages of each, including issues regarding placebos and blinding. Placebo-controlled trials in nutrient interventions are relatively straightforward, as in general placebos can be easily produced. However, the challenges associated with conducting placebo-controlled food interventions and dietary advice interventions are protean, and this has led to a paucity of placebo-controlled food and dietary advice trials compared with drug trials. This review appraises the types of controls used in dietary intervention trials and provides recommendations and nine essential criteria for the design and development of sham diets for use in studies evaluating the effect of dietary advice, along with practical guidance regarding their evaluation. The rationale for these criteria predominantly relate to avoiding altering the outcome of interest in those delivered the sham intervention in these types of studies, while not compromising blinding.

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Addington, Donald, Richard Williams, Yvon Lapierre, and Nady El-Guebaly. "Placebos in Clinical Trials of Psychotropic Medication." Canadian Journal of Psychiatry 42, no. 3 (April 1997): 1–6. http://dx.doi.org/10.1177/070674379704200312.

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This paper represents the position of the Canadian Psychiatric Association on the ethical and scientific issues related to the use of placebos in the evaluation of new psychotropic drugs. The position taken by the Association is that new psychotropic medications must be shown to be effective and must be weighed against the best current interventions. Placebo controls may be appropriate under certain circumstances, even when an established intervention is effective. These include situations in which placebo response rates are high, variable, or close to response rates for effective therapies. Placebo controls arc also appropriate when established interventions cany a high risk of side effects or are effective against only certain symptoms of the disorder.

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Spiegler, Ran. "Placebo Reforms." American Economic Review 103, no. 4 (June 1, 2013): 1490–506. http://dx.doi.org/10.1257/aer.103.4.1490.

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I study a dynamic model of strategic reform decisions that potentially affect the stochastic evolution of a publicly observed economic variable. Policy makers maximize their evaluation by a boundedly rational public. Specifically, the public follows a rule that attributes recent changes to the most recent intervention. I analyze subgame perfect equilibrium in this model when the economic variable follows a linear growth trend with noise. Equilibrium is essentially unique and stationary, bearing a subtle formal relation to optimal search models. Policy makers tend to act during crises, display risk aversion conditional on acting, and prefer interventions that induce permanent noise. (JEL D78, D83)

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Deer, Rachel R., Jared M. Dickinson, Jacques Baillargeon, Steven R. Fisher, Mukaila Raji, and Elena Volpi. "A Phase I Randomized Clinical Trial of Evidence-Based, Pragmatic Interventions to Improve Functional Recovery After Hospitalization in Geriatric Patients." Journals of Gerontology: Series A 74, no. 10 (March 25, 2019): 1628–36. http://dx.doi.org/10.1093/gerona/glz084.

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Abstract Background Physical function declines during hospitalization in geriatric patients, increasing the risk of loss of independence. There is a need for evidence-based, pragmatic interventions to improve functional recovery of older adults following acute hospitalization. Here, we report the results of a Phase I randomized clinical trial designed to determine safety and effect size of protein supplementation, exercise, and testosterone interventions on 30-day post-discharge functional recovery and readmissions in geriatric patients. Methods A total of 100 patients admitted to the University of Texas Medical Branch hospital for an acute medical illness were randomized to one of five intervention groups: isocaloric placebo, whey protein supplement, in-home rehabilitation + placebo, in-home rehabilitation + whey protein, or testosterone. Primary outcome measure was the change from baseline in short physical performance battery score at 1 and 4 weeks post-discharge. Secondary outcomes were changes in body composition, activities of daily living, and 30-day readmissions. Comparisons were made across study groups and between placebo and all active intervention groups. Results Four weeks post-discharge, the short physical performance battery total score and balance score increased more in active intervention groups than placebo group (p < .05). There were no significant differences in change in body composition or activities of daily living across groups or between active intervention groups and placebo group. Readmission rates were highest in placebo (28%), followed by rehabilitation + placebo (15%), whey protein (12%), rehabilitation + whey protein (11%), and testosterone (5%). There was a trend for lower readmission rates in all active intervention groups (11%) versus placebo group (28%). Conclusions Findings from this Phase I clinical trial suggest that pragmatic, evidence-based interventions may accelerate recovery from acute hospitalization in geriatric patients. These data provide essential information to design larger randomized controlled trials to test the effectiveness of these interventions.

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Addington, Donald, Richard Williams, Yvon Lapierre, and Nady el-Guebaly. "Les placebos dans les essais cliniques sur les psychotropes." Canadian Journal of Psychiatry 42, no. 5 (June 1997): i—vi. http://dx.doi.org/10.1177/070674379704200523.

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Le présent document exprime la position adoptée par l'Association des psychiatres du Canada sur les questions éthiques et scientifiques que soulève l'utilisation de placebos dans l'évaluation de nouveaux psychotropes. Selon l'Association, il faut démontrer l'efficacité des nouveaux psychotropes et les comparer aux interventions qui sont actuellement plus efficaces. Les groupes témoins placebos peuvent être indiqués dans certaines circonstances, malgré l'efficacité d'une intervention établie, c.-à-d. dans les situations où les taux de réponse au placebo sont élevés, variables, ou proches des taux de réponse aux traitements efficaces. Les groupes témoins placebos sont également indiqués quand les interventions établies comportent un risque élevé d'effets secondaires ou lorsqu'elles sont efficaces seulement contre certains symptômes d'un trouble.

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Macdonald, Clare, Anna Sternberg, and Paul Hunter. "A systematic review and meta-analysis of interventions used to reduce exposure to house dust and their effect on the development and severity of asthma." Ciência & Saúde Coletiva 13, no. 6 (December 2008): 1907–15. http://dx.doi.org/10.1590/s1413-81232008000600026.

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We assessed whether any household dust reduction intervention has the effect of increasing or decreasing the development or severity of atopic disease. Electronic searches on household intervention and atopic disease were conducted in 2007 in EMBASE, MEDLINE, and the Cochrane Central Register of Controlled Trials. We included randomized controlled trials comparing asthma outcomes in a household intervention group with either placebo intervention or no intervention. Meta-analyses on the prevention studies found that the interventions made no difference to the onset of wheeze but made a significant reduction in physician-diagnosed asthma. Meta-analysis of lung function outcomes indicated no improvement due to the interventions but found a reduction in symptom days. Qualitatively, health care was used less in those receiving interventions. However, in one study that compared intervention, placebo, and control arms, the reduction in heath care use was similar in the placebo and intervention arms. This review suggests that there is not sufficient evidence to suggest implementing hygiene measures in an attempt to improve outcomes in existing atopic disease, but interventions from birth in those at high risk of atopy are useful in preventing diagnosed asthma but not parental-reported wheeze.

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Donnelly, Gloria F. "The Placebo Effect and Holistic Interventions." Holistic Nursing Practice 18, no. 5 (September 2004): 238–41. http://dx.doi.org/10.1097/00004650-200409000-00006.

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Koudstaal, Stefan, Sophie L. Niemansburg, Nabil Dib, Justin Wallet, Pieter A. Doevendans, Annelien L. Bredenoord, and Steven A. J. Chamuleau. "Placebo in Autologous Cell-Based Interventions." Journal of the American College of Cardiology 63, no. 25 (July 2014): 2877–79. http://dx.doi.org/10.1016/j.jacc.2014.03.045.

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Nouchi, Rui, Qingqiang Hu, Toshiki Saito, Natasha Yuriko dos Santos Kawata, Haruka Nouchi, and Ryuta Kawashima. "Brain Training and Sulforaphane Intake Interventions Separately Improve Cognitive Performance in Healthy Older Adults, Whereas a Combination of These Interventions Does Not Have More Beneficial Effects: Evidence from a Randomized Controlled Trial." Nutrients 13, no. 2 (January 25, 2021): 352. http://dx.doi.org/10.3390/nu13020352.

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Background: Earlier studies have demonstrated that a single-domain intervention, such as a brain-training (BT) game alone and a sulforaphane (SFN) intake, positively affects cognition. This study examined whether a combined BT and SFN intake intervention has beneficial effects on cognitive function in older adults. Methods: In a 12-week double-blinded randomized control trial, 144 older adults were randomly assigned to one of four groups: BT with SFN (BT-S), BT with placebo (BT-P), active control game (AT) with SFN (AT-S), and active control game with placebo (AT-P). We used Brain Age in BT and Tetris in AT. Participants were asked to play BT or AT for 15 min a day for 12 weeks while taking a supplement (SFN or placebo). We measured several cognitive functions before and after the intervention period. Results: The BT (BT-S and BT-P) groups showed more improvement in processing speed than the active control groups (AT-S and AT-P). The SFN intake (BT-S and AT-S) groups recorded significant improvements in processing speed and working memory performance unlike the placebo intake groups (BT-P and AT-P). However, we did not find any evidence of the combined intervention’s beneficial effects on cognition. Discussion: We discussed a mechanism to improve cognitive functions in the BT and SFN alone interventions.

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Colloca, Luana, Wayne B. Jonas, John Killen, Franklin G. Miller, and David Shurtleff. "Reevaluating the Placebo Effect in Medical Practice." Zeitschrift für Psychologie 222, no. 3 (January 2014): 124–27. http://dx.doi.org/10.1027/2151-2604/a000177.

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Recent findings from placebo research corroborate the evidence that the placebo effect represents a promising model to shed new light on brain-mind-body interactions. In particular, this research has partially elucidated the role of how patients’ expectations and the quality of physician-patient communication can influence the efficacy of interventions and overall clinical outcomes. Accordingly, the study of the placebo effect should be incorporated in the core clinical practice curriculum of all health practitioners. While the growing knowledge about the placebo effect points to it being an irreducible primary reality of medical practice, an ethical analysis aimed at avoiding the misuse of placebos and maximizing beneficial placebo effects is needed.

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Price, Donald D. "Do hypnotic analgesic interventions contain placebo effects?" Pain 124, no. 3 (October 2006): 238–39. http://dx.doi.org/10.1016/j.pain.2006.04.021.

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Szabo, Attila, and Anna Müller. "Coaches' attitudes towards placebo interventions in sport." European Journal of Sport Science 16, no. 3 (March 6, 2015): 293–300. http://dx.doi.org/10.1080/17461391.2015.1019572.

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Quinn, Veronica F., and Ben Colagiuri. "Placebo Interventions for Nausea: a Systematic Review." Annals of Behavioral Medicine 49, no. 3 (December 17, 2014): 449–62. http://dx.doi.org/10.1007/s12160-014-9670-3.

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Gould, Rebecca L., Mark C. Coulson, Natasha Patel, Elizabeth Highton-Williamson, and Robert J. Howard. "Interventions for reducing benzodiazepine use in older people: meta-analysis of randomised controlled trials." British Journal of Psychiatry 204, no. 2 (February 2014): 98–107. http://dx.doi.org/10.1192/bjp.bp.113.126003.

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BackgroundThe use of benzodiazepines has been advised against in older people, but prevalence rates remain high.AimsTo review the evidence for interventions aimed at reducing benzodiazepine use in older people.MethodWe conducted a systematic review, assessment of risk of bias and meta-analyses of randomised controlled trials of benzodiazepine withdrawal and prescribing interventions.ResultsTen withdrawal and eight prescribing studies met the inclusion criteria. At post-intervention, significantly higher odds of not using benzodiazepines were found with supervised withdrawal with psychotherapy (odds ratio (OR) = 5.06, 95% CI 2.68–9.57,P<0.00001) and withdrawal with prescribing interventions (OR = 1.43, 95% CI 1.02–2.02,P=0.04) in comparison with the control interventions treatment as usual (TAU), education placebo, withdrawal with or without drug placebo, or psychotherapy alone. Significantly higher odds of not using benzodiazepines were also found for multifaceted prescribing interventions (OR = 1.37, 95% CI 1.10–1.72,P= 0.006) in comparison with control interventions (TAU and prescribing placebo).ConclusionsSupervised benzodiazepine withdrawal augmented with psychotherapy should be considered in older people, although pragmatic reasons may necessitate consideration of other strategies such as medication review.

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Lauder, Lucas, Bruno R. da Costa, Sebastian Ewen, Sean S. Scholz, William Wijns, Thomas F. Lüscher, Patrick W. Serruys, et al. "Randomized trials of invasive cardiovascular interventions that include a placebo control: a systematic review and meta-analysis." European Heart Journal 41, no. 27 (July 14, 2020): 2556–69. http://dx.doi.org/10.1093/eurheartj/ehaa495.

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Abstract Aims The difference in the benefit of invasive cardiovascular interventions compared with placebo controls has not been analysed systematically. Methods and results MEDLINE and Web of Science were searched through 29 March 2020. Randomized, placebo-controlled trials of invasive cardiovascular interventions (including catheter-based interventions and pacemaker-like devices) investigating predefined primary outcomes were included. Standardized mean differences (SMD) and odds ratios were calculated for continuous and dichotomous outcomes, respectively. Meta-regression analyses were performed to assess whether estimates of treatment effects were associated with methodological characteristics of trials. Thirty trials, including 4102 patients, were analysed. The overall risk of bias was judged to be low in only 43% of the trials. Ten trials (33%) demonstrated statistically significant superiority of invasive interventions over placebo controls for the respective predefined primary outcomes. In almost half of the 16 trials investigating continuous predefined primary outcomes, the SMD between the active and placebo procedure indicated a small (n = 4) to moderate (n = 3) treatment effect of active treatment over placebo. In contrast, one trial indicated a small treatment effect in favour of the placebo procedure. In the remaining trials, there was no relevant treatment effect of active treatment over placebo. In trials with a protocol-mandated stable and symmetrical use of co-interventions, the superiority of active procedures vs. invasive placebo procedures was significantly larger as compared with trials with frequent or unbalanced changes in co-interventions (P for interaction 0.027). Conclusions The additional treatment effect of invasive cardiovascular interventions compared with placebo controls was small in most trials.

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Esser, Diederik, Juri Matualatupauw, Ric C. H. de Vos, Ron Wehrens, Jos van der Stappen, Ingrid van der Meer, and Lydia A. Afman. "Ayurvedic Herbal Preparation Supplementation Does Not Improve Metabolic Health in Impaired Glucose Tolerance Subjects; Observations from a Randomised Placebo Controlled Trial." Nutrients 13, no. 1 (January 18, 2021): 260. http://dx.doi.org/10.3390/nu13010260.

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The increased usage of alternative Ayurvedic treatments as potential health-beneficial therapies emphasizes the importance of studying its efficacy in sound placebo-controlled intervention trials. An example of such a traditional Ayurvedic herbal preparation is Mohana Choorna, a mixture composed of 20 different herbs and used to prevent and treat type 2-diabetes (T2D). We studied the efficacy of “Mohana Choorna” on T2D-related parameters in subjects with impaired glucose tolerance. In a double blind, placebo-controlled cross-over trial, 19 overweight (BMI > 27 kg/m2) subjects aged 50–70 years with an impaired glucose tolerance received two four-week interventions, i.e., herbal or placebo with a four-week wash-out between interventions. HbA1c, glucose, insulin, triglycerides, cholesterol, blood pressure and augmentation index were measured before and after both interventions at fasting and during a glucose tolerance test. After both interventions, urine was collected to measure treatment exposure using LCMS-based metabolomics and whole genome gene-expression in adipose tissue of 13 subjects. The herbal intervention did not affect plasma glucose triglycerides, cholesterol, blood pressure or the augmentation index but showed a trend towards an increased insulin, HOMA-IR and postprandial insulin levels (p = 0.054, p = 0.056 and p = 0.095 respectively). An increase in expression of inflammation-related gene sets in adipose tissue was observed after the herbal intervention compared to placebo. Urine metabolomic analysis did not reveal a correlation of the presence of specific plant metabolites with “health markers”. Our findings suggest that there is no substantiating evidence to claim that four weeks’ use of the Ayurvedic herbal supplement Mohana Choorna beneficially affects glucose homeostasis.

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Kenny, Dianna T., and Naomi Halls. "Development and evaluation of two brief group interventions for music performance anxiety in community musicians." Psychology of Music 46, no. 1 (May 17, 2017): 66–83. http://dx.doi.org/10.1177/0305735617702536.

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This study presents the development, administration and evaluation of two brief group interventions for music performance anxiety (MPA) aimed at reducing anxiety and improving performance quality. A cognitive behavioural therapy intervention was developed based on an existing empirically-supported treatment Chilled (Rapee et al., 2006), focusing on cognitive, physiological and behavioural symptoms. The second treatment, anxiety sensitivity reduction, targeted primarily physiological symptoms and included relaxation strategies. Interventions were administered in a workshop format over one day with four intervention sessions, preceded by a pedagogic practice skills session that functioned as a control/placebo intervention. A quasi-experimental group randomization design compared the interventions in a heterogeneous sample of community musicians. Sixty-eight participants completed measures of trait anxiety, anxiety sensitivity, depression, and MPA. Participants performed four times (pre- and post-placebo, post-treatment and follow-up) and were assessed for state anxiety and performance quality at each performance. Results indicated that both interventions offered moderately significant gains for the musicians: anxiety was reduced and performance quality improved after each intervention and changes were maintained at follow-up. Anxiety sensitivity reduction showed a trend to exceed the CBT-based interventions, but a larger, higher-powered study is needed to confirm this advantage.

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Beissner, Florian, Franziska Brünner, Maria Fink, Karin Meissner, Ted J. Kaptchuk, and Vitaly Napadow. "Placebo-Induced Somatic Sensations: A Multi-Modal Study of Three Different Placebo Interventions." PLOS ONE 10, no. 4 (April 22, 2015): e0124808. http://dx.doi.org/10.1371/journal.pone.0124808.

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Folli, Anna, Filippo Ghirlanda, Corrado Cescon, Alessandro Schneebeli, Céline Weber, Patrick Vetterli, and Marco Barbero. "A single session with a roller massager improves hamstring flexibility in healthy athletes: a randomized placebo-controlled crossover study." Sport Sciences for Health 17, no. 3 (February 15, 2021): 717–24. http://dx.doi.org/10.1007/s11332-021-00737-8.

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Abstract Purpose The aim of this randomized placebo-controlled crossover study was to compare the acute effect on young athletes of a single session of roller massager (RM) with that obtained from passive static stretching (PSS) and a placebo intervention (PL) on hamstring flexibility and on strength. Methods Twenty-nine (23 male, 6 female) young athletes completed the study. Maximal voluntary contraction (MVC) and two-leg sit-and-reach test were performed before and immediately after PL, PSS and RM on three different days. Results Results showed that all three interventions increased the flexibility of the hamstring muscles compared to the pre-test measurements (Wilcoxon signed-rank test, p < 0.05). Only the RM intervention was significantly higher than the PL intervention (sham ultrasound). Stretching intervention was not significantly different from either of the other two interventions. None of the three interventions significantly changed the muscle strength in the short term. Conclusions RM can be considered as an effective alternative to stretching to increase the flexibility of the hamstring. This could be meaningful when stretching is contraindicated or evokes pain.

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Hasan, Mohammed Imrul, Sheikh Jamal Hossain, Sabine Braat, Michael John Dibley, Jane Fisher, Sally Grantham-McGregor, Fahmida Tofail, et al. "Benefits and risks of Iron interventions in children (BRISC): protocol for a three-arm parallel-group randomised controlled field trial in Bangladesh." BMJ Open 7, no. 11 (November 2017): e018325. http://dx.doi.org/10.1136/bmjopen-2017-018325.

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IntroductionAnaemia is a major global health problem affecting about 43% of preschool children globally and 60% of 6–24-month-old children in rural Bangladesh, half of which is attributed to iron deficiency (ID). Although WHO recommends universal supplementation with iron or home fortification with iron-containing multiple micronutrient powders (MMPs) to children under 2 years, evidence for benefits of these interventions on childhood development (a key rationale for these interventions) and harms (especially infection) remains limited. This study aims to evaluate the impact of iron or MMPs supplementation compared with placebo on (a) children’s development, (b) growth, (c) morbidity from infections and (d) haematological and iron indices.Methods and analysisThis study is a three-arm, blinded, double-dummy, parallel-group, placebo-controlled superiority trial using stratified individual block randomisation. The trial will randomise 3300 children aged 8–9 months equally to arm 1: iron syrup (12.5 mg elemental iron), placebo MMPs; arm 2: MMPs (including 12.5 mg elemental iron), placebo syrup; and arm 3: placebo syrup, placebo MNPs. Children will receive interventions for 3 months based on WHO recommendations and then be followed up for 9 months post intervention. The primary outcome is cognitive composite score measured by Bayley III. Secondary outcomes include motor and language composite score by Bayley III, behaviour rating using selected items from Wolke’s rating scales and BSID-II behaviour ratings, temperament, growth, haemoglobin, anaemia and iron status, and infectious morbidity. Outcomes will be measured at baseline, at the end of 3-month intervention and after 9 months postintervention follow-up.Ethics and disseminationThe trial has been approved by the Ethical Review Committee of icddr,b (Dhaka, Bangladesh) and the Melbourne Health Human Research Ethics Committee (Melbourne, Australia). Results of the study will be disseminated through scientific publications, presentations at international meetings and policy briefs to key stakeholders.Trial registration numberACTRN12617000660381;Pre-results.WHO Universal Trial NumberU1111-1196-1125.

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Linde, K. "The use of placebo interventions in clinical practice." Complementary Therapies in Medicine 21, no. 2 (April 2013): 109–11. http://dx.doi.org/10.1016/j.ctim.2012.11.010.

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Bishop, Felicity, Maddy Greville-Harris, George Lewith, Lucy Yardley, Christina Liossi, Cynthia Graham, Peter White, et al. "Improving informed choice about acupuncture and placebo interventions." European Journal of Integrative Medicine 7, no. 6 (December 2015): 682. http://dx.doi.org/10.1016/j.eujim.2015.07.012.

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Molin, Christine Zomer Zomer Dal, Thiago Mamoru Sakae, Fabiana Schuelter-Trevisol, and Daisson Jose Trevisol. "Effects of sertraline in the prevention of low blood pressure in patients undergoing hemodialysis." Brazilian Journal of Nephrology 41, no. 4 (December 2019): 492–500. http://dx.doi.org/10.1590/2175-8239-jbn-2018-0189.

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Abstract Introduction: Intradialytic hypotension (IDH) is a major complication of hemodialysis, with a prevalence of about 25% during hemodialysis sessions, causing increased morbidity and mortality. Objective: To study the effects of sertraline to prevent IDH in hemodialysis patients. Methods: This was a double-blind, crossover clinical trial comparing the use of sertraline versus placebo to reduce intradialytic hypotension. Results: Sixteen patients completed the two phases of the study during a 12-week period. The IDH prevalence was 32%. A comparison between intradialytic interventions, intradialytic symptoms, and IDH episodes revealed no statistical difference in the reduction of IDH episodes (p = 0.207) between the two intervention groups. However, the risk of IDH interventions was 60% higher in the placebo group compared to the sertraline group, and the risk of IDH symptoms was 40% higher in the placebo group compared to the sertraline group. Survival analysis using Kaplan-Meier estimator supported the results of this study. Sertraline presented a number needed to treat (NNT) of 16.3 patients to prevent an episode from IDH intervention and 14.2 patients to prevent an episode from intradialytic symptoms. Conclusion: This study suggests that the use of sertraline may be beneficial to reduce the number of symptoms and ID interventions, although there was no statistically significant difference in the blood pressure levels.

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Keijsers, Merel, Maria Cecilia Vega-Corredor, Melanie Tomintz, and Simon Hoermann. "Virtual Reality Technology Use in Cigarette Craving and Smoking Interventions (I “Virtually” Quit): Systematic Review." Journal of Medical Internet Research 23, no. 9 (September 17, 2021): e24307. http://dx.doi.org/10.2196/24307.

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Background Over the last 2 decades, virtual reality technologies (VRTs) have been proposed as a way to enhance and improve smoking cessation therapy. Objective This systematic review aims to evaluate and summarize the current knowledge on the application of VRT in various smoking cessation therapies, as well as to explore potential directions for future research and intervention development. Methods A literature review of smoking interventions using VRT was conducted. Results Not all intervention studies included an alternative therapy or a placebo condition against which the effectiveness of the intervention could be benchmarked, or a follow-up measure to ensure that the effects were lasting. Virtual reality (VR) cue exposure therapy was the most extensively studied intervention, but its effect on long-term smoking behavior was inconsistent. Behavioral therapies such as a VR approach-avoidance task or gamified interventions were less common but reported positive results. Notably, only 1 study combined Electronic Nicotine Delivery Devices with VRT. Conclusions The inclusion of a behavioral component, as is done in the VR approach-avoidance task and gamified interventions, may be an interesting avenue for future research on smoking interventions. As Electronic Nicotine Delivery Devices are still the subject of much controversy, their potential to support smoking cessation remains unclear. For future research, behavioral or multicomponent interventions are promising avenues of exploration. Future studies should improve their validity by comparing their intervention group with at least 1 alternative or placebo control group, as well as incorporating follow-up measures.

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Mackinnon, Andrew, Kathleen M. Griffiths, and Helen Christensen. "Comparative randomised trial of online cognitive–behavioural therapy and an information website for depression: 12-month outcomes." British Journal of Psychiatry 192, no. 2 (February 2008): 130–34. http://dx.doi.org/10.1192/bjp.bp.106.032078.

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BackgroundAn earlier paper reported positive outcomes immediately following access to a cognitive–behavioural therapy (CBT) internet intervention and a depression information website.AimsTo determine 6-month and 12-month outcomes of the interventions relative to a placebo control condition.MethodParticipants allocated to the depression information website condition, the CBT internet intervention and the placebo control condition were followed up at 6 and 12 months by survey. The primary outcome measure was the Center for Epidemiologic Studies – Depression (CES–D) scale. Of 525 participants recruited, 79% completed their assigned intervention and 60% were retained at 12-month follow-up. Attrition was handled using mixed-model repeated-measures ANOVA.ResultsBoth the CBT site and depression information sites were associated with statistically significant benefits in CES–D score reduction compared with controls at post-test. At 6-months follow-up, the reduction seen for the people allocated to the CBT arm remained significant, whereas that for the depression information website arm was not. At 12 months, both active interventions were statistically significantly superior to the control condition.ConclusionsThere is some evidence that benefits of these brief internet interventions are retained beyond their endpoint. The impact of human support provided by interviewers in the trial must be considered when comparing these outcomes to routine use of both internet interventions.

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Wei, Hua, Lili Zhou, Huijuan Zhang, Jie Chen, Xuejing Lu, and Li Hu. "The Influence of Expectation on Nondeceptive Placebo and Nocebo Effects." Pain Research and Management 2018 (2018): 1–8. http://dx.doi.org/10.1155/2018/8459429.

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Nondeceptive placebo has demonstrated its efficiency in clinical practice. Although the underlying mechanisms are still unclear, nondeceptive placebo effect and nondeceptive nocebo effect may be mediated by expectation. To examine the extent to which expectation influences these effects, the present study compared nondeceptive placebo and nocebo effects with different expectation levels. Seventy-two healthy female participants underwent a standard conditioning procedure to establish placebo and nocebo effects. Sequentially, participants were randomized to one of the four experimental groups—baseline (BL), no expectation intervention (NoEI), expectation increasing (EI), and expectation decreasing (ED) groups, to receive either no intervention or interventions through different verbal suggestions that modulated their expectation. Placebo and nocebo effects were established in all four groups after the conditioning phase. However, after disclosing the placebo and nocebo, the analgesic and the hyperalgesic effects only persisted in the EI group, when compared with the BL group. Our results provide evidence highlighting the critical role of increased expectation in nondeceptive placebo and nocebo effects. The finding suggests that open-label placebo or nocebo per se might be insufficient to induce strong analgesic or hyperalgesic response and sheds insights into administrating open-label placebo and avoiding open-label nocebo in clinical practice.

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Beard, David J., Marion K. Campbell, Jane M. Blazeby, Andrew J. Carr, Charles Weijer, Brian H. Cuthbertson, Rachelle Buchbinder, et al. "Placebo comparator group selection and use in surgical trials: the ASPIRE project including expert workshop." Health Technology Assessment 25, no. 53 (September 2021): 1–52. http://dx.doi.org/10.3310/hta25530.

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Background The use of placebo comparisons for randomised trials assessing the efficacy of surgical interventions is increasingly being considered. However, a placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. Objectives To provide a summary of knowledge on placebo controls in surgical trials and to summarise any recommendations for designers, evaluators and funders of placebo-controlled surgical trials. Design To carry out a state-of-the-art workshop and produce a corresponding report involving key stakeholders throughout. Setting A workshop to discuss and summarise the existing knowledge and to develop the new guidelines. Results To assess what a placebo control entails and to assess the understanding of this tool in the context of surgery is considered, along with when placebo controls in surgery are acceptable (and when they are desirable). We have considered ethics arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be carried out and interpreted. The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with a high risk of bias, particularly because of the placebo effect. Conclusions The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. An outline for best practice was produced in the form of the Applying Surgical Placebo in Randomised Evaluations (ASPIRE) guidelines for those considering the use of a placebo control in a surgical randomised controlled trial. Limitations Although the workshop participants involved international members, the majority of participants were from the UK. Therefore, although every attempt was made to make the recommendations applicable to all health systems, the guidelines may, unconsciously, be particularly applicable to clinical practice in the UK NHS. Future work Future work should evaluate the use of the ASPIRE guidelines in making decisions about the use of a placebo-controlled surgical trial. In addition, further work is required on the appropriate nomenclature to adopt in this space. Funding Funded by the Medical Research Council UK and the National Institute for Health Research as part of the Medical Research Council–National Institute for Health Research Methodology Research programme.

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Someili, A., K. Alshammari, Y. Yuan, and W. Alhazzani. "A197 MEDICAL INTERVENTIONS IN EOSINOPHILIC ESOPHAGITIS (EOE): A SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS (RCTS)." Journal of the Canadian Association of Gastroenterology 3, Supplement_1 (February 2020): 70–71. http://dx.doi.org/10.1093/jcag/gwz047.196.

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Abstract Background Eosinophilic esophagitis (EoE) is a chronic, allergic/immune condition of esophagus characterized clinically by symptoms related to esophageal dysfunction and histologically by eosinophil-predominant inflammation. Aims Despite different drugs were studied for the treatment of EoE, there is no consensus on what the most effective medical interventions. We performed a systematic review and meta-analysis of RCTs to compare the efficacy of medical interventions in patients with EoE. Methods We searched MEDLINE, EMBASE and the Cochrane CENTRAL (via OvidSP) published from inception to November 01, 2018, to identify RCTs assessing the efficacy of medications (PPIs, steroids, anti-IL5 agents, anti-IL13 agents, anti-IL-4Rα agents and mast cell stabilizers) in patients with EoE. Outcomes were symptoms improvement and histology improvement. Studies that only reported continuous scores were excluded. Pooled risk ratios (RR) with 95% confidence intervals (CI), using a random effects model, were calculated. Results Among 1311 citations, 19 RCTs (n=1239 EoE cases) were included. 11 RCTs compared steroids vs placebo, two compared PPIs vs steroids, two compared anti- IL-13 vs placebo, two compared anti-IL-5 vs placebo, one compared anti-IL-4Rα vs placebo, and one compared mast cell stabilizer vs placebo. Steroids demonstrated significant improved in histology (63.3% vs 2.9%; RR 10.12, 95% CI 4.56–22.46) and improved EOE symptoms (39.6% vs 20.0%; RR =1.91, 1.16,3.14) compared to placebo. No difference was seen between oral and inhale steroids. No significant difference was seen between PPI vs prednisone either in symptom (RR 1.33, 0.36, 4.97) or in histology improvement (RR 1.83,0.76,4.40). Limited data suggest there is no significant difference between anti-IL-13 vs placebo; and anti-IL5 vs placebo; anti-IL-4Rα dupilumab but not mast cell stabilizer cromolyn may significantly improve histology compared to placebo. No substantial heterogeneity was seen in all analyses. Conclusions Current evidence suggests steroids significantly improve histology as well as symptoms in patients with EoE in compared to placebo. There is no significant difference between steroids and PPI. Data relate to other newer agents are limited. This meta-analysis highlights the variability in the interventions of EoE and the need for further studies to determine the optimal intervention. Funding Agencies None

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Taylor, Philip R., and Peter Greenwald. "Nutritional Interventions in Cancer Prevention." Journal of Clinical Oncology 23, no. 2 (January 10, 2005): 333–45. http://dx.doi.org/10.1200/jco.2005.06.190.

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The first generation of phase III nutritional intervention studies to prevent cancer has been completed. Nearly 150,000 total participants were studied in nine different interventions using randomized, double-blind, placebo-controlled designs that tested whether vitamins and/or minerals, given singly or in combination, could prevent total or site-specific cancer. The primary agents tested include beta-carotene, alpha-tocopherol, selenium, and retinol. This review summarizes the findings from the first generation of human experimental studies that tested micronutrients in the prevention of cancer, discusses lessons learned from these studies, identifies the most promising leads, and describes future prospects in nutritional intervention research.

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Walach, Harald. "Placebo controls: historical, methodological and general aspects." Philosophical Transactions of the Royal Society B: Biological Sciences 366, no. 1572 (June 27, 2011): 1870–78. http://dx.doi.org/10.1098/rstb.2010.0401.

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Control conditions were introduced through the trial of Mesmerism in Paris. Placebo controls became codified standard in 1946. Although seemingly unchallenged, there are various problems with this received view. The notion of a placebo is only defined from the negative. A positive notion proposed that placebo effects are effects owing to the meaning an intervention has for an individual. Thus, placebo effects are individualized, whereas standard research paradigms reveal only grossly averaged behaviour. Also, placebo effects are context sensitive, dependent on psychological factors such as expectancy, relief of stress and anxiety, and hence can generate strong and long-lasting treatment effects. These, however, are not predictable. Such a situation can lead to the efficacy paradox: sometimes, sham interventions can be more powerful than proved, evidence-based treatments. This situation has methodological consequences. Placebo-controlled randomized trials reveal only part of the answer, whether an intervention is effective. This is valuable information for regulators, but not necessarily also for patients and of limited value for providers. Hence, I have argued that we need to complement the hierarchical model of evidence by a circular one, in which various methods are employed on equal footing to answer different questions.

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Hempel, Susanne, Glenn D. Graham, Ning Fu, Elena Estrada, Annie Y. Chen, Isomi Miake-Lye, Jeremy N. V. Miles, et al. "A systematic review of the effects of modifiable risk factor interventions on the progression of multiple sclerosis." Multiple Sclerosis Journal 23, no. 4 (February 2, 2017): 513–24. http://dx.doi.org/10.1177/1352458517690271.

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Background: Several risk factors are associated with multiple sclerosis (MS) progression and may be amenable to intervention. Objective: To systematically review the evidence for interventions targeting risk factors for MS progression. Methods: We searched six databases and existing reviews till March 2015 and consulted with experts to identify randomized controlled trials (RCTs) of interventions targeting MS risk factors (PROSPERO 2015:CRD42015016461). Results: In total, 37 RCTs met inclusion criteria. Expanded Disability Status Scale (EDSS) scores after exercise interventions did not differ compared with untreated controls (standardized mean differences (SMDs): 0.02; confidence interval (CI): −0.40, 0.44; I2: 0%; seven RCTs; very low quality of evidence (QoE)). Dietary interventions did not show a statistically significant effect on the relative risk (RR) of progression (RR: 0.86; CI: 0.67, 1.05; I2: 0%; four RCTs; moderate QoE) compared to placebo. EDSS scores after vitamin D supplementation were not significantly different from placebo (SMD: −0.15; CI: −0.33, 0.02; I2: 0%; five RCTs; very low QoE). Conclusion: We did not identify any risk factor interventions with significant effects on MS progression, but the overall QoE was limited. More adequately powered trials are needed on vitamin D supplementation, long-term exercise, and smoking cessation.

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Gilbert, Gregory E., and Amy H. Wahlquist. "Placebo or Sham Interventions Strongly Affect Subjective Outcome Measures." Journal of the National Medical Association 103, no. 9-10 (September 2011): 1004–5. http://dx.doi.org/10.1016/s0027-9684(15)30461-2.

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Babel, Przemyslaw. "Use of Placebo Interventions in Primary Care in Poland." Medical Principles and Practice 22, no. 5 (2013): 484–88. http://dx.doi.org/10.1159/000351563.

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Borges, Maraísa Rodrigues, Nuno Miguel Lopes de Oliveira, Izabella Barberato Silva Antonelli, Maristella Borges Silva, Eduardo Crema, and Luciane Fernanda Rodrigues Martinho Fernandes. "Transcutaneous electrical nerve stimulation is superior than placebo and control for postoperative pain relief." Pain Management 10, no. 4 (July 2020): 235–46. http://dx.doi.org/10.2217/pmt-2019-0063.

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Aim: To determine whether transcutaneous electrical nerve stimulation (TENS) is more efficient than placebo TENS and control groups for pain relief. Design: Randomized, single-blinded, placebo-controlled trial. Setting & participants: A total of 78 adults with postoperative pain, after cholecystectomy, at the University Hospital. They were randomized into active TENS, placebo TENS and control. Intervention: A total of 30-min interventions applied in the first 24 h after the surgery. Outcome: Pain intensity. Results: Pain significantly decreased for both TENS; however, the active TENS was better. A decrease of 2 points or more on the visual analog scale for 53.8% active TENS and 11.5% placebo. Conclusion: There was a greater reduction in pain of important clinical relevance in the active TENS group. Clinical Trial registration: Brazilian Clinical Trial (REBEC): RBR-6cgx2k.

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Yamaoka, Kazue, Asuka Nemoto, and Toshiro Tango. "Comparison of the Effectiveness of Lifestyle Modification with Other Treatments on the Incidence of Type 2 Diabetes in People at High Risk: A Network Meta-Analysis." Nutrients 11, no. 6 (June 19, 2019): 1373. http://dx.doi.org/10.3390/nu11061373.

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Background: Many clinical trials have been conducted to verify the effects of interventions for prevention of type 2 diabetes (T2D) using different treatments and outcomes. The aim of this study was to compare the effectiveness of lifestyle modifications (LM) with other treatments in persons at high risk of T2D by a network meta-analysis (NMA). Methods: Searches were performed of PUBMED up to January 2018 to identify randomized controlled trials. The odds ratio (OR) with onset of T2D at 1 year in the intervention group (LM, dietary, exercise, or medication) versus a control group (standard treatments or placebo) were the effect sizes. Frequentist and Bayesian NMAs were conducted. Results: Forty-seven interventions and 12 treatments (20,113 participants) were used for the analyses. The OR in the LM was approximately 0.46 (95% CI: 0.33 to 0.61) times lower compared to the standard intervention by the Bayesian approach. The effects of LM compared to other treatments by indirect comparisons were not significant. Conclusions: This meta-analysis further strengthened the evidence that LM reduces the onset of T2D compared to standard and placebo interventions and appears to be at least as effective as nine other treatments in preventing T2D.

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Lee, Myeong Soo, Hwa Jeong Huh, Seong Min Jeong, Hye-Sook Jang, Hoon Ryu, Jae-Hwang Park, Hun-Taeg Chung, and Won-Hong Woo. "Effects of Qigong on Immune Cells." American Journal of Chinese Medicine 31, no. 02 (January 2003): 327–35. http://dx.doi.org/10.1142/s0192415x03001016.

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The aim of this study was to investigate the influence of two acute Qigong interventions (Qi-training and Qi-therapy) on immune cells. The Qigong interventions were compared with placebo training and placebo therapy in which no attempt was made to gather or move Qi. Immune cell numbers were measured pre-intervention, immediately post-intervention and 1 or 2 hours post-intervention. White blood cells increased significantly 2 hours after actual Qi-training (p < 0.05) but not sham training compared with pre-intervention. There were significant increases in lymphocytes 2 hours after actual but not sham Qi-training (p < 0.05) and monocyte numbers were significantly increased immediately after both actual Qi-training (p < 0.01) and sham training (p < 0.05). NK cell numbers decreased significantly both immediately after Qi-training and after sham movements done without concomitant Qi-training (p < 0.01). There were no significant effects on neutrophils. Actual Qi-therapy but not sham therapy increased monocyte numbers immediately after Qi-therapy, and lymphocytes increased more after real than after sham therapy. Neutrophils were again little changed. The data indicate that a single Qigong intervention can increase the monocyte and lymphocyte numbers.

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Whyte, Adrian R., Nancy Cheng, Laurie T. Butler, Daniel J. Lamport, and Claire M. Williams. "Flavonoid-Rich Mixed Berries Maintain and Improve Cognitive Function Over a 6 h Period in Young Healthy Adults." Nutrients 11, no. 11 (November 6, 2019): 2685. http://dx.doi.org/10.3390/nu11112685.

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Research with young adults has previously indicated flavonoid-rich berry interventions facilitate improved executive function (EF) and positive affect 20 min–2 h post-dosing. There has been little consideration of the impact of a berry intervention over a working day and interventions have also tended to consider only a single berry type. This study investigated the temporal profile of EF and mood changes over a 6 h period following a mixed-berry intervention. We hypothesized berry-related benefits would be most evident when participants were cognitively compromised on demanding elements of the task or during periods of fatigue. The study employed a single-blind, randomized, placebo controlled, between-subjects design. Forty participants aged 20–30 years consumed a 400 mL smoothie containing equal blueberry, strawberry, raspberry, and blackberry (n = 20) or matched placebo (n = 20). Mood was assessed using the Positive and Negative Affect Schedule; EF was tested using the Modified Attention Network (MANT) and Task Switching (TST) Tasks. Testing commenced at baseline then 2, 4 and 6 h post-dosing. As expected, following placebo intervention, performance decreased across the day as participants became cognitively fatigued. However, following berry intervention, participants maintained accuracy on both cognitive tasks up to and including 6 h, and demonstrated quicker response times on the MANT at 2 and 4 h, and TST at 6 h. This study demonstrates the efficacy of flavonoid rich berries in maintaining or improving cognitive performance across the 6 h day.

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Meissner, Karin. "The placebo effect and the autonomic nervous system: evidence for an intimate relationship." Philosophical Transactions of the Royal Society B: Biological Sciences 366, no. 1572 (June 27, 2011): 1808–17. http://dx.doi.org/10.1098/rstb.2010.0403.

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For many subjectively experienced outcomes, such as pain and depression, rather large placebo effects have been reported. However, there is increasing evidence that placebo interventions also affect end-organ functions regulated by the autonomic nervous system (ANS). After discussing three psychological models for autonomic placebo effects, this article provides an anatomical framework of the autonomic system and then critically reviews the relevant placebo studies in the field, thereby focusing on gastrointestinal, cardiovascular and pulmonary functions. The findings indicate that several autonomic organ functions can indeed be altered by verbal suggestions delivered during placebo and nocebo interventions. In addition, three experimental studies provide evidence for organ-specific effects, in agreement with the current knowledge on the central control of the ANS. It is suggested that the placebo effects on autonomic organ functions are best explained by the model of ‘implicit affordance’, which assumes that placebo effects are dependent on ‘lived experience’ rather than on the conscious representation of expected outcomes. Nevertheless, more studies will be needed to further elucidate psychological and neurobiological pathways involved in autonomic placebo effects.

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Liu, Tao, and Cui-ping Yu. "Placebo Analgesia, Acupuncture and Sham Surgery." Evidence-Based Complementary and Alternative Medicine 2011 (2011): 1–6. http://dx.doi.org/10.1093/ecam/neq030.

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Invasive procedures, such as surgery and acupuncture, are likely better than the others in terms of eliciting placebo analgesia. Understanding how invasive procedures can elicit enhanced placebo responses may provide new insights into mechanisms underlying placebo analgesia. In this essay, it is argued that sensory, cognitive and emotional factors are major determinants of the magnitude of placebo analgesia. Sham surgery and acupuncture are good examples of placebo interventions, which generate robust placebo responses through simultaneously manipulating such three factors.

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Hartogsohn, Ido. "Set and setting, psychedelics and the placebo response: An extra-pharmacological perspective on psychopharmacology." Journal of Psychopharmacology 30, no. 12 (November 18, 2016): 1259–67. http://dx.doi.org/10.1177/0269881116677852.

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Placebo response theory and set and setting theory are two fields which examine how non-biological factors shape the response to therapy. Both consider factors such as expectancy, preparation and beliefs to be crucial for understanding the extra-pharmacological processes which shape the response to drugs. Yet there are also fundamental differences between the two theories. Set and setting concerns itself with response to psychoactive drugs only; placebo theory relates to all therapeutic interventions. Placebo theory is aimed at medical professionals; set and setting theory is aimed at professionals and drug users alike. Placebo theory is primarily descriptive, describing how placebo acts; set and setting theory is primarily prescriptive, educating therapists and users on how to control and optimize the effects of drugs. This paper examines how placebo theory and set and setting theory can complement and benefit each other, broadening our understanding of how non-biological factors shape response to drugs and other treatment interventions.

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Lucas, V., and S. Booth. "The importance of placebo effects in enhancing palliative care interventions." BMJ Supportive & Palliative Care 4, no. 2 (January 21, 2014): 212–16. http://dx.doi.org/10.1136/bmjspcare-2013-000571.

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Barreto, Carmelia Maria Noia, Pedro Nazareth Aguiar, Daniel de Iracema Gomes Cubero, and Auro Del Giglio. "The efficacy of placebo for the treatment of cancer-related fatigue: A systematic review and meta-analysis." Journal of Clinical Oncology 37, no. 15_suppl (May 20, 2019): e23157-e23157. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.e23157.

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e23157 Background: Cancer-related fatigue (CRF) is a common symptom among patients with cancer. The efficacy of placebo, however, was never the main objective of any meta-analysis. Predicting the efficacy of placebo may facilitate researchers in designing future clinical trials for the treatment of CRF. Methods: We performed a systematic review searching for prospective clinical trials comparing any treatment versus placebo for the treatment of CRF. We included studies that enrolled patients with any primary site of neoplasia and any stage of cancer. We excluded all studies that assessed fatigue related to any treatment. The primary endpoint of this study is the mean effect of placebo on fatigue according to the Functional Assessment of Chronic Illness (FACIT-F) and Brief Fatigue Inventory (BFI) scales. The secondary endpoint was the proportion of patients who reported improvement in fatigue (response rate). Results: We found 520 studies, and 29 studies with 3,758 participants were included in the meta-analysis. Placebo had a mean effect of +4.88 (95%CI +2.45 to +7.29) using the FACIT-F scale, although it was statistically worse than the interventions studied (p = 0.005). Using the BFI scale, placebo had an average effect of +0.64 (95%CI +0.02 to +1.30), although it was also worse than the other interventions studied (p = 0.002). In terms of the response rate, 29% (95%CI 25%–32%) of patients taking a placebo reported a significant improvement in CRF compared to 36% of patients treated with other interventions (p = 0.030). Conclusions: Placebo treatments had a significant effect on CRF, and predicting these effects may help design future studies for CRF.

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Klasson, Caritha, Maria Helde Frankling, Carina Lundh Hagelin, and Linda Björkhem-Bergman. "Fatigue in Cancer Patients in Palliative Care—A Review on Pharmacological Interventions." Cancers 13, no. 5 (February 26, 2021): 985. http://dx.doi.org/10.3390/cancers13050985.

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Fatigue is one of the most distressing symptoms experienced by cancer patients. The suggested biological mechanism for cancer related fatigue (CRF) includes immune activation triggered by tumor tissue or by anticancer treatment but other mechanisms have also been proposed. Previous large meta-analysis of interventions on fatigue focuses mostly on patients early in the disease trajectory, with only one tenth of included studies performed in palliative cohorts. The aim of this narrative review is therefore to present a background on CRF with focus on the palliative setting. A summary of recent randomized, controlled trials on pharmacological interventions on CRF in palliative care is presented, including studies on psychostimulants, corticosteroids, testosterone and melatonin. Interestingly, in several of these studies there was a positive and similar effect on fatigue in both the intervention and the placebo arm—indicating an important placebo effect for any pharmacological treatment. In addition, studies on dietary supplements and on pharmacological complementary medicines are discussed. To conclude, the evidence is still weak for using pharmacological treatments on CRF in palliative care patients—although methylphenidate and corticosteroids might be considered.

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Rahmani, Zohre, Nahid Rejeh, Majideh Heravi-Karimooi, Seyed Davood Tadrisi, and Mojtaba Vaismoradi. "Effect of hand reflexology on anxiety and physiological variables among patients hospitalized in the cardiac care unit: A randomized placebo controlled clinical trial." Journal of Nursing Education and Practice 8, no. 4 (November 27, 2017): 35. http://dx.doi.org/10.5430/jnep.v8n4p35.

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Background and objective: Admission to the cardiac care unit may cause physiological and psychological problems in patients. This study aimed to investigate the effect of hand reflexology on anxiety and physiological variables among female patients with acute coronary syndrome hospitalized in the cardiac care unit.Methods: This randomized placebo controlled clinical trial was conducted on 90 female patients hospitalized in the cardiac care unit in an urban area of Iran. The patients were chosen using a convenient sampling method and then were randomly assigned into intervention (n = 45) and placebo (n = 45) groups. While the intervention group received hand reflexology for 20 minutes, the placebo group received a simple touch of hand without the stimulation of reflexology points. Demographic data was collected at the beginning of the study using face-to-face interviews with the patients. The anxiety level was assessed using the Spielberger’s State-Trait Anxiety Inventory (STAI) immediately after the intervention and 30 min after the intervention. Also, physiological variables including respiratory rate, heart rate, blood pressure and oxygen saturation were measured before, immediately after the intervention and 30 minutes after the intervention. Descriptive and inferential statistics were used for data analysis.Results: There was no statistically significant difference between the intervention and placebo groups before the intervention (p > .05). The anxiety level in the intervention group was significantly lower than that of the placebo group immediately after the intervention and 30 minutes after the intervention (p < .05, η = 0.090). However, no statistically significant differences in physiological variables between the groups were observed (p > .05).Conclusions: Hand reflexology influenced the level of anxiety. Therefore, nurses can use hand reflexology as a method for reducing patients’ anxiety along with other nursing interventions.

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Larson, Leila M., Kamija S. Phiri, and Sant-Rayn Pasricha. "Iron and Cognitive Development: What Is the Evidence?" Annals of Nutrition and Metabolism 71, Suppl. 3 (2017): 25–38. http://dx.doi.org/10.1159/000480742.

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The theoretical irreversible damage that iron deficiency and iron deficiency anemia can exert on child development makes a compelling argument for action to alleviate the burden. However, a critical analysis of evidence from iron interventions in early life is necessary to determine whether and how iron interventions improve cognitive outcomes. Key iron interventions used in clinical and public health practice include oral iron supplementation and, in young children, iron-containing multiple micronutrient powders. This article examines the evidence to answer 4 main questions. (1) Does antenatal iron supplementation influence long-term child cognitive development? (2) Does oral iron supplementation in preschool children improve short-term cognitive development? (3) Does oral iron supplementation in older children improve cognitive development? And (4), can provision of iron harm cognitive development? Early trials indicated benefit from parenteral iron in young children regardless of anemia status. There also appears to be evidence for benefit using oral iron treatment on cognitive performance in anemic primary school children. However, antenatal and early childhood oral iron intervention studies show inconsistent effects on early and long-term childhood cognitive outcomes. These data suggest either that (a) effects from oral iron on cognitive development in young children are small or nonexistent or that (b) heterogeneity between trials and the low quality of many studies make assessment of effect difficult. Importantly, few large, placebo-controlled trials in under-2-year-old children in low-income settings assessing effects of iron interventions on cognition have been performed; high-quality, placebo-controlled, adequately powered trials of universal iron interventions on cognitive performance in young children are urgently needed to justify policies of universal iron intervention in this group.

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Klaassen, Tim, Daniel Keszthelyi, Annick M. E. Alleleyn, Ellen Wilms, Aalt Bast, Adrian A. M. Masclee, and Freddy J. Troost. "Effect of oral or intragastric delivery of the bitter tastant quinine on food intake and appetite sensations: a randomised crossover trial." British Journal of Nutrition 125, no. 1 (July 14, 2020): 92–100. http://dx.doi.org/10.1017/s0007114520002536.

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AbstractStimulation of gastrointestinal taste receptors affects eating behaviour. Intraduodenal infusion of tastants leads to increased satiation and reduced food intake, whereas intraileal infusion of tastants does not affect eating behaviour. Currently, it is unknown whether oral- or intragastric administration of tastants induces a larger effect on eating behaviour. This study investigated the effects of oral- and/or intragastric administration of quinine on food intake, appetite sensations and heart rate variability (HRV). In a blinded randomised crossover trial, thirty-two healthy volunteers participated in four interventions with a 1-week washout: oral placebo and intragastric placebo (OPGP), oral quinine and intragastric placebo (OQGP), oral placebo and intragastric quinine (OPGQ) and oral quinine and intragastric quinine (OQGQ). On test days, 150 min after a standardised breakfast, subjects ingested a capsule containing quinine or placebo and were sham-fed a mixture of quinine or placebo orally. At 50 min after intervention, subjects received an ad libitum meal to measure food intake. Visual analogue scales for appetite sensations were collected, and HRV measurements were performed at regular intervals. Oral and/or intragastric delivery of the bitter tastant quinine did not affect food intake (OPGP: 3273·6 (sem 131·8) kJ, OQGP: 3072·7 (sem 132·2) kJ, OPGQ: 3289·0 (sem 132·6) kJ and OQGQ: 3204·1 (sem 133·1) kJ, P = 0·069). Desire to eat and hunger decreased after OQGP and OPGQ compared with OPGP (P < 0·001 and P < 0·05, respectively), whereas satiation, fullness and HRV did not differ between interventions. In conclusion, sole oral sham feeding with and sole intragastric delivery of quinine decreased desire to eat and hunger, without affecting food intake, satiation, fullness or HRV.

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Borne, Rachel, Christophe Hausswirth, and François Bieuzen. "Relationship Between Blood Flow and Performance Recovery: A Randomized, Placebo-Controlled Study." International Journal of Sports Physiology and Performance 12, no. 2 (February 2017): 152–60. http://dx.doi.org/10.1123/ijspp.2015-0779.

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Purpose:To investigate the effect of different limb blood-flow levels on cycling-performance recovery, blood lactate concentration, and heart rate.Methods:Thirty-three high-intensity intermittent-trained athletes completed two 30-s Wingate anaerobic test sessions, 3 × 30-s (WAnT 1–3) and 1 × 30-s (WAnT 4), on a cycling ergometer. WAnT 1–3 and WAnT 4 were separated by a randomly assigned 24-min recovery intervention selected from among blood-flow restriction, passive rest, placebo stimulation, or neuromuscular electrical-stimulation-induced blood flow. Calf arterial inflow was measured by venous occlusion plethysmography at regular intervals throughout the recovery period. Performance was measured in terms of peak and mean power output during WAnT 1 and WAnT 4.Results:After the recovery interventions, a large (r = .68 [90% CL .42; .83]) and very large (r = .72 (90% CL .49; .86]) positive correlation were observed between the change in calf arterial inflow and the change in mean and peak power output, respectively. Calf arterial inflow was significantly higher during the neuromuscular-electrical-stimulation recovery intervention than with the blood-flow-restriction, passive-rest, and placebo-stimulation interventions (P < .001). This corresponds to the only intervention that allowed performance recovery (P > .05). No recovery effect was linked to heart rate or blood lactate concentration levels.Conclusions:For the first time, these data support the existence of a positive correlation between an increase in blood flow and performance recovery between bouts of high-intensity exercise. As a practical consideration, this effect can be obtained by using neuromuscular electrical stimulation-induced blood flow since this passive, simple strategy could be easily applied during short-term recovery.

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Hazuda, Helen P., Qing Pan, Hermes Florez, José A. Luchsinger, Jill P. Crandall, Elizabeth M. Venditti, Sherita H. Golden, Andrea M. Kriska, and George A. Bray. "Association of Intensive Lifestyle and Metformin Interventions With Frailty in the Diabetes Prevention Program Outcomes Study." Journals of Gerontology: Series A 76, no. 5 (January 11, 2021): 929–36. http://dx.doi.org/10.1093/gerona/glaa295.

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Abstract Background Frailty is a geriatric syndrome of decreased physiologic reserve and resistance to stressors that results in increased vulnerability to adverse health outcomes with aging. Diabetes and hyperglycemia are established risk factors for frailty. We sought to examine whether the odds of frailty among individuals at high risk of diabetes randomized to treatment with intensive lifestyle (ILS), metformin, or placebo differed after long-term follow-up. Method The sample comprised participants in the Diabetes Prevention Program (DPP) clinical trial, who continued follow-up in the DPP Outcomes Study (DPPOS) and completed frailty assessments in DPPOS Years 8 (n = 2385) and 10 (n = 2289), approximately 12 and 14 years after DPP randomization. Frailty was classified using Fried Frailty Phenotype criteria. GEE models adjusting for visit year with repeated measures pooled for Years 8 and 10 were used to estimate pairwise odds ratios (ORs) between ILS, metformin, and placebo for the outcomes of frail and prefrail versus nonfrail. Results Frailty prevalence by treatment group was ILS = 3.0%, metformin = 5.4%, placebo = 5.7% at Year 8, and ILS = 3.6%, metformin = 5.3%, placebo = 5.4% at Year 10. Odds ratios (95% CI) estimated with GEE models were ILS versus placebo, 0.62 (0.42–0.93), p = .022; metformin versus placebo, 0.99 (0.69–1.42), p = .976; and ILS versus metformin, 0.63 (0.42–0.94), p = .022. Odds of being frail versus nonfrail were 37% lower for ILS compared to metformin and placebo. Conclusions Early ILS intervention, at an average age of about 50 years, in persons at high risk of diabetes may reduce frailty prevalence in later life. Metformin may be ineffective in reducing frailty prevalence. Clinical Trials Registration Numbers NCT00004992 (DPP) and NCT00038727 (DPPOS).

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Lecrubier, Y. "Pharmacological interventions in dysthymia." European Psychiatry 11, S3 (1996): 129s—133s. http://dx.doi.org/10.1016/0924-9338(96)85187-x.

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SummaryThe results of early therapeutic trials (1960s and 70s) in mild chronic depression (neurotic patients) are difficult to extrapolate to dysthymia. Most studies conducted in the early 1980s showed reference drugs (TCAs and MAOIs) to be poorly effective in chronic mild depression usually defined with RDC. The most recent trials using DSM-III-R criteria for dysthymic recruitment showed TCAs, new MAOIs (RIMA) and SSRI to be effective. AU these compounds have a rather similar pharmacological mechanism of action. It is therefore of both practical and theoretical interest that amisulpride, a benzamide derivative blocking D2 and D3 pre-synaptic receptors, has been found effective in the treatment of dysthymia in different placebo and reference controlled trials. This result is in line with the pharmacological data on animal ‘anhedonic models’.

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