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Systematic review: The placebo effect of psychological interventions in the treatment of irritable bowel syndrome

World Journal of Gastroenterology 2017年第12期23卷 2223-2233页

作者： Carla E Flik Laura Bakker Wijnand Laan Yanda R van Rood André JPM Smout Niek J de Wit Department of General Practice Julius Centre for Health Sciences and Primary CareUniversity Medical Centre Utrecht Department of Psychiatry and Psychology St Antonius Hospital Department of Psychiatry University Medical Centre Department of Gastroenterology and Hepatology Academic Medical Centre

AIM To determine the placebo response rate associated with different types of placebo interventions used in psychological intervention studies for irritable bowel syndrome. METHODS Randomized controlled trials comparing psychological interventions(stress management/relaxation therapy(cognitive) behavioral therapy, short-term psychodynamic therapy, and hypnotherapy) for the treatment of adult patients with irritable bowel syndrome(IBS) diagnosed with the Manning or Rome criteria with an adequate placebo control treatment and reporting data on IBS symptom severity were identified by searching Pub Med, Embase, the Cochrane Library, CINAHL and Psyc INFO databases. Full-text articles that were written in English and published between 1966 and February 2016 in peer-reviewed journals were selected for the present review. placebo interventions were considered to be adequate if the number of sessions and the amount of time spent with the therapist were the same as in the active treatment. The placebo response rate(PRR) was computed for IBS symptom severity(primary outcome measure) as well as for anxiety, depression and quality of life(secondary outcome measures). RESULTS Six studies, with a total of 555 patients met the inclusion criteria. Four studies used an educational intervention, whereas two studies used a form of supportive therapy as the placebo intervention. The PRR for IBS symptom severity ranged from 25% to 59%, with a pooled mean of 41.4%. The relative PRR for the secondary outcome measures ranged from 0% to 267% for anxiety, 6% to 52% for depression 20% to 125% for quality of life. The PRR associated with pharmacological treatments, treatment with dietary bran and complementary medicine ranged from 37.5% to 47%. Contrary to our expectations, the PRR in studies on psychological interventions was comparable to that in studies on pharmacological, dietary and alternative medical *** The PRR is probably determined to a larger extent by patient-re

关键词： placebo effect Psychological interventions Irritable bowel syndrome Systematic review

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placebo effect in the treatment of non-small cell lung cancer:a meta-analysis

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Journal of Bio-X Research 2022年第3期5卷 132-140页

作者： Siyuan Ren Mengyao Ma Chuan He Yuhui Deng Xiaoyun Chen Yonglin Liu Yangyang Jin Yansong Liu Lei Cai Lin He Bio-X Institutes Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders(Ministry of Education)Collaborative Innovation Center for Genetics and DevelopmentShanghai Mental Health CenterShanghai Jiao Tong University Shanghai Center for Women and Children’s Health Department of Rheumatology Longhua HospitalShanghai University of Traditional Chinese MedicineShanghai Sanya Maternal and Child Health Hospital SanyaHainan Province Faculty of Medical Laboratory Science Ruijin HospitalShanghai Jiao Tong University School of MedicineShanghai Department of Clinical Psychology Suzhou Guangji HospitalThe Affiliated Guangji Hospital of Soochow UniversitySuzhouJiangsu ProvinceChina

Objective:The majority of non-small cell lung cancer(NSCLC)cases remain undiagnosed until advanced stages of the *** studies have highlighted the utility of palliative care as an effective treatment option,which relieves patients’suffering by activating placebo effect in the *** evaluate the clinical significance of palliative care,data from NSCLC drug-randomized controlled trials(RCTs)were collected and the effects of placebo treatment ***:PubMed(MEDLINE),Scopus,Web of Science,and China National Knowledge Infrastructure databases were searched from January 1,1978 to September 1,***-controlled phase II/III pharmaceutical RCTs enrolling patients with solely stage III/IV NSCLC were *** quality of included studies was assessed using the Jadad ***-arm and two-arm meta-analyses of the therapeutic and adverse effects of placebo,that is,the primary and secondary outcome measures,were subsequently performed using either Bayesian or conventional ***:Five RCTs including 2245 drug-treated and 1510 placebo-treated patients at NSCLC stage III or IV were included for the *** risk of bias was observed for all five included studies using the Cochrane *** placebo treatment,controlled disease rate of 24.1%(95%credible interval[CrI],-0.126-0.609)and dropout rate of 2.1%(95%CrI,0.007-0.039)were calculated,with a dose reduction rate of 3.0%(95%CrI,0.017-0.045).Compared with active drug treatment,the placebo treatment group had a risk ratio of 0.81(95%confidence interval,0.68-0.97)and 0.85(95%confidence interval,0.76-0.96)for the achievement of progression-free survival and overall survival,***:In NSCLC drug RCTs,placebo treatment is indicated to generally induce low toxicity in patients by dropout and dose reduction rates and adverse events,although the therapeutic responses could not be precisely *** results suggest that under specific circumstances,palliative care

关键词： lung cancer meta-analysis NSCLC palliative care placebo effect

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Regression Model to Analyze Differential Response to Treatment in Randomized Controlled Clinical Trial

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Journal of Mathematics and System Science 2013年第9期3卷 419-425页

作者： A.K. Mathai B.N. Murthy Manager - Biostatistics Early Phase PAREXEL International (lndia) Pvt. Ltd. Hyderabad 500 081 India Scientist F Head Department of Biostatistics National Institute of Epidemiology Chennai 600 077 India

The primary aim of clinical trials is to investigate whether a treatment is effective for a particular disease or condition. Randomized controlled clinical trials are considered to be the gold standard for evaluating the effect of a certain intervention. However, in clinical trials, even after randomization, there are situations where the patients differ substantially with respect to the baseline value of the outcome variable. Many a times the response to interventions depends on the baseline values of the outcome variable. When there are baseline-dependent treatment effects, differences among treatments vary as a function of baseline level. Although variation in outcome associated with baseline value is accounted for in ANCOVA, analysis of individual differences in treatment effect is precluded by the homogeneity of regression assumption. This assumption requires that expected differences in outcome among treatments be constant across all baseline levels. To overcome this difficulty, Weigel and Narvaez [7] proposed a regression model for two treatment groups to analyze individual response to treatments in randomized controlled clinical trials. The authors reviewed the model suggested by Weigel and Narvaez and extended further for three or more treatment groups. The utility of the model was demonstrated with real life data from a randomized controlled clinical trial of bronchial asthma.

关键词： Regression model differential response placebo effect clinical trial.

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Design flaws in randomized, placebo controlled, double blind clinical trials

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World Journal of Pharmacology 2012年第1期1卷 4-9页

作者： James David Adams Jr Department of Pharmacology and Phar-maceutical Sciences University of Southern California School of Pharmacy Los Angeles CA 90089 United States

The hypothesis in drug clinical trials is that the drug is better than a placebo in patients suffering from a disease. The unstated assumption is that the drug cures the disease or is a powerful treatment for the disease. This is an incorrect assumption. Drugs do not cure or treat diseases. The body heals itself; drugs promote this ability of the body to heal itself. placebos are assumed to be inactive; however, placebos can also promote the ability of the body to heal itself. placebos are actually treatments that can stimulate endogenous healing mechanisms. The possible place of placebos in health management is controversial. Clinical trial design should be altered. The hypothesis of clinical trials should be that the drug speeds up or improves the healing of the patient, putting patient healing as the first objective. placebos should not be used as controls but could be tested as drugs in their own right. The control in clinical trials should be no treatment. Alternatively, new drugs could be compared to existing drugs in clinical trials.

关键词： Randomized clinical trials placebo effect Drug effcacy Healing

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A Rumsfeld Matrix test for acupuncture clinical trials

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Digital Chinese Medicine 2024年第3期7卷 209-223页

作者： GONG Changzhen American Academy of Traditional Chinese Medicine RosevilleMN 55113USA

This study examined the application of the Rumsfeld Matrix to acupuncture clinical trials,particularly those published in leading medical journals such as The Journal of the American Medical Association(JAMA),British Medical Journal(BMJ),The Lancet,and The New Eng-land Journal of Medicine(NEJM).The integration of randomized clinical trials(RCTs)has in-troduced a level of academic rigor to acupuncture research,challenging the classical deter-ministic model and revealing a complex landscape of known knowns,known unknowns,un-known knowns,and unknown *** RCTs have validated acupuncture’s efficacy in certain conditions,they have also highlighted considerable challenges,including the limi-tations of control group designs and the potential influence of placebo *** recurring issue of no significant differences between real and sham acupuncture in many studies un-derscores the need for refined control strategies and a more nuanced understanding of acupuncture’s *** investigation calls for continued rigorous research to fully explore acupuncture’s therapeutic potential and its integration into evidence-based medicine,ultimately contributing to improved patient care and broader acceptance within the medical community.

关键词： Acupuncture Randomized clinical trials(RCTs) Rumsfeld Matrix placebo effect Control group design Therapeutic potential

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Assessments of Different Kinds of Sham Acupuncture Applied in Randomized Controlled Trials

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Journal of Acupuncture and Tuina Science 2011年第4期9卷 199-203页

作者：蒋永亮尹磊淼王宇单纯筱刘艳艳徐玉东魏颖冉君刘晓燕杨永清 Shanghai Research Institute of Acupuncture and Meridian

Objective： Different kinds of sham acupuncture are widely applied in randomized controlled trials （RCTs） to explore whether acupuncture has intrinsic therapeutic effects beyond the placebo effects for certain indication. To make conclusions of trials more comparable and convincing, it is of great necessity to unify the sham acupuncture procedure. Methods： RCTs of acupuncture with high quality in the recent 14 years were reviewed, and the appropriateness of the sham acupuncture procedures was assessed. Results： The sham acupuncture procedures were mainly classified into five kinds according to their administered sites, penetrating, and intervention apparatus. Conclusion： Among the sham acupuncture procedures, needling near the selected acupoints, needling at a distant non-acupoints, and non-penetrating sham acupuncture are most commonly used. Sham acupuncture performed at distant site belongs to non-meridian and non-acupoint may be an ideal control for the study of the intrinsic therapeutic effects of acupuncture. Besides, the selection of controls must focus on the design and aim of RCTs, such as non-inferiority, equivalence and superiority trials.

关键词： Acupuncture Therapy placebo effect Randomized Controlled Trial

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安慰剂和认知重评调节负性情绪的认知神经科学基础

安慰剂和认知重评调节负性情绪的认知神经科学基础

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第十五届全国心理学学术会议

作者：张文彩罗劲中科院心理研究所首都师范大学教育学院心理系

目的:认知或行为治疗在情感性心理障碍中应用非常广泛,但人们对认知治疗和行为治疗的神经基础及二者的异同仍了解甚少。因此,本研究比较了基于条件反射学习的安慰剂情绪调节和基于高级认知的认知重评情绪调节,以揭示二者之间相同或不同... 详细信息

目的:认知或行为治疗在情感性心理障碍中应用非常广泛,但人们对认知治疗和行为治疗的神经基础及二者的异同仍了解甚少。因此,本研究比较了基于条件反射学习的安慰剂情绪调节和基于高级认知的认知重评情绪调节,以揭示二者之间相同或不同的神经机制。研究方法:54名被试(安慰剂组和重评组各27人)参与行为实验,通过情绪的评分检验他们的安慰剂效应或重评效应。从行为实验中选出那些表现出更高安慰剂或重评效应的被试进入核磁实验,最终26名被试(每组13名)进入核磁数据统计。结果:对于情绪反应区,安慰剂组和重评组均使负性情绪评价显著下降,杏仁核和脑岛的激活显著下降,但安慰剂组比重评组表现出更大面积的下降,包括双侧旁海马、双侧额下叶、双侧颞上(中)回和右侧背部扣带等区域。对于情绪调控区,安慰剂组和重评组在左侧膝下扣带和双侧额下回表现出共同的激活增强,但安慰剂组在膝下扣带25区表现出特异性的激活增强,重评组在膝下扣带34区、右侧背部额叶和左侧额下叶表现出特异性的激活增强。结果:基于学习的安慰剂效应和基于认知的重评都有显著的缓解负性情绪反应的效应,但安慰剂条组对情绪刺激的认知加工显著低于重评组;基于学习的安慰剂效应可能主要依靠膝下扣带-杏仁核这一直接的通路来实现情绪调节,而基于认知的重评可能既依靠腹外侧前额叶-杏仁核和膝下扣带-杏仁核这样的直接通路,也依靠背侧前额叶-膝下扣带-杏仁核这样的非直接通路,来实现负性情绪调节。

关键词： placebo effect reappraisal emotion regulation subgenual cingulate

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抽奖促销未中奖始终是不好的？

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市场营销（理论版） 2022年第12期

作者：申汝敏孟陆焦腾啸

抽奖促销作为有效和实用的促销手段，已被企业广泛应用。已有多数研究聚焦于单次促销以及消费者幸运中奖对后续购买决策的影响，本研究则基于营销安慰剂理论和反应预期理论，重点探讨消费者抽奖促销时未中奖次数对创新产品购买意愿的影... 详细信息

抽奖促销作为有效和实用的促销手段，已被企业广泛应用。已有多数研究聚焦于单次促销以及消费者幸运中奖对后续购买决策的影响，本研究则基于营销安慰剂理论和反应预期理论，重点探讨消费者抽奖促销时未中奖次数对创新产品购买意愿的影响。实验1验证了抽奖促销时未中奖次数对激发运气安慰剂效应的影响；实验2探究了抽奖促销时未中奖次数对创新产品购买意愿的影响，并揭示了消极情绪和感知风险的链式中介解释机制；实验3揭示了消费者感知运气的不同归因在抽奖未中奖次数对创新产品购买意愿的影响中起调节作用。本研究拓展了安慰剂效应相关理论，也为企业应用抽奖促销以提升企业绩效提供了实践指导。

关键词：抽奖促销次数运气安慰剂效应感知风险创新产品购买意愿 lottery promotion times placebo effect perceived risk willingness to purchase innovative products

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奥运会运动员竞技表现提升的非训练类策略

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体育 2021年第1期

作者：黎涌明邱俊强徐飞杨贤罡廖开放李博路明月陈小平

伴随东京奥运会和北京冬奥会的临近，寻求训练策略以外的方法，实现精英运动员竞技表现的进一步提升，是科技助力在奥运备战冲刺阶段的重要内容。针对膳食营养优化、物理性恢复、安慰剂效应、热习服和睡眠改善5个领域近10年来的最新研... 详细信息

伴随东京奥运会和北京冬奥会的临近，寻求训练策略以外的方法，实现精英运动员竞技表现的进一步提升，是科技助力在奥运备战冲刺阶段的重要内容。针对膳食营养优化、物理性恢复、安慰剂效应、热习服和睡眠改善5个领域近10年来的最新研究成果进行梳理，从定义、解决问题的迫切性和可行性、作用机制、操作建议等方面对这五种非训练类策略进行了综述。科学应用这些策略能够实现竞技表现不同程度的提升，建议我国奥运备战过程中加大推进这些策略的科学应用。

关键词：奥运备战膳食营养物理性恢复安慰剂效应热习服睡眠 Olympic preparation dietary nutrition physical recovery placebo effect heat acclimation sleep

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