We sincerely thank the authors of the commentary1 for their thoughtful analysis and constructive critique of our systematic review on ischemic preconditioning(IPC)and placebo effects in exercise capacity and athletic ...We sincerely thank the authors of the commentary1 for their thoughtful analysis and constructive critique of our systematic review on ischemic preconditioning(IPC)and placebo effects in exercise capacity and athletic performance.2Their attention to methodological details,particularly concerning the inclusion and timing of warm-up protocols across studies,is commendable and contributes meaningfully to the ongoing refinement of IPC research in sports science.展开更多
Background:Acupuncture has shown potential therapeutic benefits for individuals with simple obesity.However,some researchers argue that some of the effectiveness of acupuncture may be due to the placebo response.Objec...Background:Acupuncture has shown potential therapeutic benefits for individuals with simple obesity.However,some researchers argue that some of the effectiveness of acupuncture may be due to the placebo response.Objective:To understand the placebo response of acupuncture treatment in simple obesity,a systematic review and meta-analysis was designed based on the comparison between sham acupuncture before and after treatment.Search strategy:Eight databases(Pub Med,Web of Science,Cochrane Library,Embase,China National Knowledge Infrastructure,Wanfang Database,China Biology Medicine Database,and Chinese Scientific Journals Database)were searched from inception to August 1,2023.The Me SH search terms comprised obesity and acupuncture.Inclusion criteria:Randomized controlled trials(RCTs)using sham or placebo acupuncture as a control in treating obesity were enrolled.Data extraction and analysis:Two researchers independently extracted data,and the results were crosschecked after completion.Each RCT’s detailed sham/placebo acupuncture treatment protocol was assessed according to the SHam Acupuncture REporting guidelines.The revised Cochrane risk-of-bias tool for randomized trials and the Grading of Recommendations Assessment,Development,and Evaluation(GRADE)system were used to determine the risk of bias and quality of evidence,respectively.Body mass index(BMI)was defined as the primary outcome.Anthropometric parameters and laboratory test parameters related to obesity were defined as secondary outcomes.We used standardized mean difference(SMD)with 95%confidence interval(CI)to calculate treatment effects of outcomes.Results:Fifteen RCTs with a total of 1250 patients were included.The BMI significantly decreased after treatment in the sham acupuncture group compared to baseline(SMD 0.37,95%CI 0.09–0.66;I2=81%,random model;P<0.01).Treatment duration(P=0.02)and other interventions significantly impacted the placebo response rate(P=0.00).Conclusion:The placebo response of sham acupuncture was strong in the RCTs for simple obesity,and the effect sizes differed between various outcomes.The treatment duration and other interventions emerged as potential influencing factors for the placebo response of sham acupuncture.展开更多
BACKGROUND In randomized controlled trials(RCTs),the placebo arm has often been ignored as the attention tends to be focused on the treatment arm.We undertook a meta-analysis based on the data from the placebo arm in ...BACKGROUND In randomized controlled trials(RCTs),the placebo arm has often been ignored as the attention tends to be focused on the treatment arm.We undertook a meta-analysis based on the data from the placebo arm in RCTs of hepatocellular carci-noma(HCC),the response rates and survival status,and adverse events(AEs)were summarized and evaluated.AIM To systematically evaluate the response rates,survival status and AEs in the placebo arms of RCTs for HCC.METHODS A systematic search was performed on PubMed,Ovid MEDLINE,Embase and Cochrane Library to identify relevant trials evaluating the efficacy of drugs for the treatment of HCC,published until December 31,2023.Statistical analysis was performed using R statistical software(version 4.3.2).RESULTS A total of 18 RCTs,involving 2390 patients,met the criteria for inclusion in the meta-analysis.The pooled overall disease control rate and objective response rate in the placebo group were 38%[95%confidence interval(CI):33%-42%]and 1%(95%CI:1%-2%),respectively.Overall survival and progression-free survival in the placebo group were 7.9 months(95%CI:7.6-8.31 months)and 1.9 months(95%CI:1.6-2.1 months),respectively.The incidence of grade 3 or 4 AEs was 37%(95%CI:30%-43%).Additionally,the incidence of interruptions or dose reductions due to AEs was 20%(95%CI:13%-27%),while the incidence of treatment discontinuation due to AEs was 9%(95%CI:6%-12%).CONCLUSION Over one-third of advanced HCC patients exhibit therapy-free disease control,with placebo-arm AEs observed.These findings guide single-arm trials design and enhance patient acceptance of anticancer therapies.展开更多
We highly commend Dr Souza et al.1for their systematic review research.The authors conducted a detailed investigation into the effects of ischemic preconditioning(IPC)on athletic performance,comparing it with placebo ...We highly commend Dr Souza et al.1for their systematic review research.The authors conducted a detailed investigation into the effects of ischemic preconditioning(IPC)on athletic performance,comparing it with placebo and no-intervention conditions.The study found that while IPC demonstrated superior effects over the no-intervention group in certain metrics(e.g.,time to exhaustion),its performance did not significantly surpass that of the placebo group.This suggests that the potential benefits of IPC may partially stem from participants’psychological expectations,or placebo effects.The study also highlighted the significant impact of placebo interventions on athletic performance,emphasizing the importance of distinguishing between placebo and no-intervention conditions in experimental designs.展开更多
Identifying key acupuncture elements is essential for optimizing sham acupuncture controls.Based on the characteristics and current state of acupuncture therapy,this paper categorizes key acupuncture elements into typ...Identifying key acupuncture elements is essential for optimizing sham acupuncture controls.Based on the characteristics and current state of acupuncture therapy,this paper categorizes key acupuncture elements into types and contents.Taking the former as a clue,it examines the current understanding of key acupuncture elements and underscores the need for further refinement to ensure that sham acupuncture controls more closely approximate physiological inertness.Additionally,it explores strategies and methodologies for advancing the understanding of key acupuncture elements from both the type and content perspectives.Key acupuncture elements should expand the number of included element types.Elements such as acupuncture needles,point selection,point combination,needle insertion,needle manipulation,and needle withdrawal should all be included,and they should be reported in a standardized manner in the trials.Regarding element content,improvements should be made in three key areas to enhance selection accuracy:1.Strengthening the comprehensiveness of relevant theoretical frameworks.2.Emphasizing the role of Traditional Chinese Medicine(TCM)diagnosis and acupoint palpation methods in trial application and reporting.3.Continuously investigating the mechanisms underlying both the specific efficacy and the placebo efficacy of acupuncture.展开更多
目的:评估针对膝骨性关节炎治疗中安慰针刺的随机对照试验(RCT)文献的质量,探讨安慰针刺临床试验设计的思路。方法:计算机检索中国期刊全文数据库(CNKI)、维普中文期刊全文数据数据库(VIP)、万方数据知识服务平台(WF)、中国生物医学文...目的:评估针对膝骨性关节炎治疗中安慰针刺的随机对照试验(RCT)文献的质量,探讨安慰针刺临床试验设计的思路。方法:计算机检索中国期刊全文数据库(CNKI)、维普中文期刊全文数据数据库(VIP)、万方数据知识服务平台(WF)、中国生物医学文献数据库(SinoMed)、PubMed、Web of Science(WOS)及Embase数据库,收集使用单纯针刺与安慰针刺进行对比的针灸治疗膝骨性关节炎RCT研究,检索时限从建库至2022年12月31日。使用CONSORT与TIDieR-Placebo标准评估文献报告质量,并对结果进行分析讨论。结果:共纳入20篇文献。CONSORT评价结果显示报告率不高于10%的条目为条目3b、6b、11b、12b、14b、17b、18。TIDieR-Placebo评价结果显示报告率不高于10%的条目为条目6、9、10、11、13。安慰针刺的方式主要为“假穴假刺”“假穴真刺”“假穴浅刺”“非治疗穴真刺”“治疗穴假刺”5种。结论:有关安慰针刺的临床试验尚不严谨,质量有待提高。为推动针灸领域临床研究的标准化,建议未来的研究应更加重视依据这些标准来规范化研究报告。展开更多
Objective The placebo response in depression studies is the change in symptoms amongst those who receive an inactive treatment.Many well-designed randomized controlled trials(RCTs)of depression have a high proportion ...Objective The placebo response in depression studies is the change in symptoms amongst those who receive an inactive treatment.Many well-designed randomized controlled trials(RCTs)of depression have a high proportion of placebo responders,with little understanding as to why.The present study assesses characteristics associated with the placebo response in a nutraceutical trial with a large proportion of placebo responders.Methods This is a secondary analysis of a nutraceutical depression RCT which identified no overall treatment benefit relative to placebo(n=69 in placebo group).We investigated participant characteristics such as socio-demographics,clinical features,and recruitment methods,and their association with the placebo response.Monoaminergic genetic polymorphisms were also assessed.Placebo response was measured based on change in Montgomery-Asberg Depression Rating Scale score.The association of these hypothesis-driven variables of interest and the placebo response was examined using linear mixed effects models.Results Greater levels of education,particularly pursuing post-high school education,better self-reported general health,marriage/de facto,greater improvement in the first trial week,and more failed antidepressant therapies in the current depressive episode were associated with greater placebo response.An increased placebo response was not found in those recruited via social media nor in those with concomitant antidepressant therapy.Single nucleotide polymorphisms from the tryptophan hydroxylase 1(TPH1)gene(A779C and A218C)were weakly associated with greater placebo response,although the evidence was attenuated after accounting for multiple comparisons.Conclusion This is,to our knowledge,the first study within nutraceutical research for depression to assess the association between participant characteristics and variation in the placebo response.Several variables appeared to predict the placebo response.Such findings may encourage future trial designs which could dampen placebo response,improve assay sensitivity,and allow for treatment effects to be potentially more detectable.展开更多
Placebo has been reported to exert beneficial effects in patients regarding the treatment of pain. Human functional neuroimaging technology can study the intact human brain to elucidate its functional neuroanatomy and...Placebo has been reported to exert beneficial effects in patients regarding the treatment of pain. Human functional neuroimaging technology can study the intact human brain to elucidate its functional neuroanatomy and the neurobiological mechanism of the placebo effect. Blood flow measurement using functional magnetic resonance imaging and positron emission tomography （PET） has revealed that analgesia is related to decreased neural activities in pain-modulatory brain regions, such as the rostral anterior cingulate cortex （rACC）, insula, thalamus, and brainstem including periaqueductal gray （PAG） and ventromedial medulla. The endogenous opioid system and its activation of g-opioid receptors are thought to mediate the observed effects of placebo. The μ-opioid receptor-selective radiotracer-labeled PET studies show that the placebo effects are accompanied by reduction in activation of opioid neural transmission in pain-sensitive brain regions, including rACC, prefrontal cortex, insula, thalamus, amygdala, nucleus accumbens （NAC） and PAG. Further PET studies with dopamine D2/D3 receptor-labeling radiotracer demonstrate that basal ganglia including NAC are related to placebo analgesic responses. NAC dopamine release induced by placebo analgesia is related to expectation of analgesia. These data indicate that the aforementioned brain regions and neurotransmitters such as endogenous opioid and dopamine systems contribute to placebo analgesia.展开更多
目的应用试验报告统一标准(Consolidated Standards for Reporting of Trials,CONSORT)与安慰措施描述规范清单(Template for Intervention Description and Replication-Placebo,TIDieR-Placebo)评价安慰针刺治疗偏头痛随机对照试验(Ra...目的应用试验报告统一标准(Consolidated Standards for Reporting of Trials,CONSORT)与安慰措施描述规范清单(Template for Intervention Description and Replication-Placebo,TIDieR-Placebo)评价安慰针刺治疗偏头痛随机对照试验(Randomized controlled trials,RCT)的文献报告质量。通过评价结果讨论目前安慰针刺的运用现状,并为今后安慰针刺的试验设计提供参考。方法计算机检索中国期刊全文数据库(CNKI)、维普数据库(VIP)、万方数据资源系统(WF)、中国生物医学文献数据库(SinoMed)、PubMed、Embase、Web of Science(WOS),收集近10年使用单纯针刺与安慰针刺进行对比的针灸治疗偏头痛RCT研究,检索时限为2011年7月20日-2021年7月20日。应用CONSORT与TIDieR-Placebo评价文献报告的规范性,并对结果进行分析讨论。结果共纳入59篇文献。CONSORT评价结果显示报告率低于10%的条目为条目3b、6b、11b、12b、14b、16、17b、18、24。TIDieR-Placebo评价结果显示报告率低于10%的条目为条目6、7、9、10、13。安慰针刺的方式主要为“假穴假刺”、“假穴真刺”、“假穴浅刺”及“非治疗穴真刺”4种。结论目前安慰针刺治疗偏头痛RCT的文献报告质量总体不高,研究者未来应重视使用此两项清单对自身研究进行规范报告。大部分研究的安慰针刺设计方式尚缺合理性,亟需国内外在安慰针刺的设计和选择方面形成共识,以推动针灸临床研究的规范化。展开更多
BACKGROUND Acute pancreatitis is the leading cause of hospitalization for acute gastrointestinal disease worldwide.The effects of probiotics in mild acute pancreatitis have not been studied.We hypothesized that the ad...BACKGROUND Acute pancreatitis is the leading cause of hospitalization for acute gastrointestinal disease worldwide.The effects of probiotics in mild acute pancreatitis have not been studied.We hypothesized that the administration of probiotics may accelerate the recovery of intestinal function and shorten the length of hospital stay(LOS)in patients with mild pancreatitis.AIM To investigate the value of probiotics in reducing the LOS in patients with mild acute pancreatitis.METHODS We conducted a double-blind randomized clinical trial to evaluate the effects of probiotics administered to patients with mild acute pancreatitis at a tertiary medical center.The patients were given probiotics capsules(a mixed preparation of Bacillus subtilis and Enterococcus faecium)or placebo.The primary study endpoint was the LOS.The secondary endpoints included time to abdominal pain relief,recurrent abdominal pain,and time to successful oral feeding.RESULTS A total of 128 patients were included,with 64 patients in each arm.The severity of illness and the etiological distribution of disease were similar in the two groups.There was a significant reduction in the LOS in the probiotics treatment group vs the placebo group(5.36±0.15 vs 6.02±0.17 d,P<0.05).The probiotics group was associated with a shorter time to abdominal pain relief and time to successful oral feeding(P<0.01 for both)than the placebo group.No statistical difference was found in recurrent abdominal pain between the two groups.CONCLUSION The study results showed that the administration of probiotics capsules is associated with a shorter duration of hospitalization in patients with mild acute pancreatitis.展开更多
Objective： To investigate the influence of the depth of skin press in blunt tip placebo acupuncture needles on patient blinding and its relationship to needle diameter.Methods： Forty healthy volunteers were enrolled...Objective： To investigate the influence of the depth of skin press in blunt tip placebo acupuncture needles on patient blinding and its relationship to needle diameter.Methods： Forty healthy volunteers were enrolled as subjects for patient blinding. Four acupuncturists applied the following needles randomly at three points in each forearm： 0.18 mm and 0.25 mm diameter penetrating needles inserted to a depth of 5 mm, and 0.18 mm and 0.25 mm diameter skin-touch needles depressing the skin at the acupoint to a depth of 1 mm and 2 mm from the skin surface. The subjects reported their guesses at the nature of needles they received, and rated needle pain and de qi. A blinding index was calculated to define the success of blinding for subjects.Results： The blinding status of subjects for 1 mm press needles of 0.18 mm diameter was ＂random guess＂,but ＂unblinded＂ for 1 mm press needles of 0.25 mm diameter. For 2 mm press needles of both diameters,the blinding status was ＂opposite guess＂ and the blinding status for penetrating needles of both diameters was ＂unblinded.＂ The percentages of ＂felt pain＂ with 2 mm press needles of both diameters were similar to that with penetrating needles, but those were not similar for 1 mm press needles. The frequency of de qi occurrence with 2 mm press needles of 0.18 mm diameter was similar to that of penetrating needles of both diameters.Conclusion： Placebo needles of 2 mm press made more subjects guess that the needles penetrated the skin than 1 mm press needles. The use of small diameter needles increased patient blinding.展开更多
Over the last several years there has been a growing interest in placebo, not only as an inert control in clinical trials, but also in the placebo effect as a group effect as well as a reaction in individual subjects....Over the last several years there has been a growing interest in placebo, not only as an inert control in clinical trials, but also in the placebo effect as a group effect as well as a reaction in individual subjects. Methodological factors such as regression to the mean and natural history of the disease play a role in the evaluation of a possible placebo effect. In this report, we discuss several factors including PavIovian conditioning, beliefs outcome, expectations, and other factors as potential mediators of the placebo response. Placebo effects are common in gastrointestinal diseases and there seems to be no clear difference between placebo effects in functional gastrointestinal diseases （functional dyspepsia and irritable bowel syndrome） and organic gastrointestinal disease （duodenal ulcer and inflammatory bowel disease）.展开更多
AIM: To investigate the early mortality of placebo-treated alcoholic hepatitis patients. METHODS: Mortality data about alcoholic hepatitis patients who participated in randomized placebo-controlled trials were searche...AIM: To investigate the early mortality of placebo-treated alcoholic hepatitis patients. METHODS: Mortality data about alcoholic hepatitis patients who participated in randomized placebo-controlled trials were searched from PubMed, EMBASE, and Cochrane Library, extracted and analyzed. RESULTS: A total of 661 placebo-treated patients in 19 trials were included. The overall mortality rate was 34.19% with a median observation time of 160 d (range 21-720 d). Hepatic failure, gastrointestinal bleeding and infection were the three main causes of death, accounting for 55.47%, 21.17% and 7.30% of all deaths, respectively. One-month mortality data about 324 placebo-treated alcoholic hepatitis patients in 10 trials were reported with a pooled mortality rate of 20.37%. The one-month mortality rate of patients with moderate to severe alcoholic hepatitis tended to be higherthan that of general patients (22.69% vs 10.93%, P < 0.05), whereas no signifi cant difference was observed between the patients from North America or Europe (22.43% vs 18.45%, P > 0.05), neither any difference was found between the studies published before and after 1990 (18.18% vs 21.88%, P > 0.05). CONCLUSION: Alcoholic hepatitis is a severe liver disease with a high mortality rate, and hepatic failure, gastrointestinal bleeding and infection are the three main causes of death.展开更多
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 comparin...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 interventions.CONCLUSION The PRR is probably determined to a larger extent by patient-related factors,such as expectations and desire for the treatment to be effective,than the content of the placebo intervention.展开更多
In recent years,new preparations of traditional Chinese medicines(TCMs)have been developed,increasing the need for their clinical trials.Using placeboes rather than control drugs is increasingly popular in clinical tr...In recent years,new preparations of traditional Chinese medicines(TCMs)have been developed,increasing the need for their clinical trials.Using placeboes rather than control drugs is increasingly popular in clinical trials of TCMs,as the therapeutic effects of the tested TCMs can be more properly judged.The basic attributes of TCM placeboes include similarity,safety,applicability and controllability.In particular,it is necessary to have similarities in appearance,color,smell and taste between the tested TCMs and placeboes.This is quite difficult for some TCMs due to their distinctive smell and taste.On the other hand,according to the TCM theory on homology of medicine and food,many foods also have certain bioactivities,potentially further complicating the selection of materials for TCM placeboes.In this review,firstly,studies on the special smell and taste of TCMs were introduced.Then,the preparation quality evaluation processes for TCM placeboes were summarized and discussed,based on the relevant literature published in recent years and the research results from our own lab.This review will facilitate the further research and development of TCM placeboes.展开更多
Objective:To evaluate the efficacy and safety of Chinese herbal medicine(CHM)for the treatment of functional dyspepsia(FD).Methods:Web of Science,PubMed,EMBASE,Cochrane Library,and four other Chinese electronic databa...Objective:To evaluate the efficacy and safety of Chinese herbal medicine(CHM)for the treatment of functional dyspepsia(FD).Methods:Web of Science,PubMed,EMBASE,Cochrane Library,and four other Chinese electronic databases,including China National Knowledge Infrastructure(CNKI),Chinese Biological Medical Database(CBM),Chinese Scientific Journals Database(VIP),and WanFang Database were used to search(up to Feb,2016)for randomized,double-blind,placebocontrolled trials recruiting adults with FD treated with CHM.Study selection,data extraction,quality assessment,and data analyses were conducted based on Cochrane standards using Review Manager software.Results:Fourteen publications(1424 patients)were included.Evidence revealed that CHM was more efficacious than the placebo in improving global dyspepsia symptoms(RR,1.45;95%CI,1.31e1.60),Chinese medicine syndrome(CMS)(RR,1.36;95%CI,1.23e1.50),and quality of life(SMD,0.30;95%CI,0.15e0.45)in FD patients.Furthermore,the difference in the incidence of adverse events between CHM and placebo groups had no statistical significance(RR,1.06;95%CI,0.66e1.70).Conclusion:This meta-analysis demonstrates that CHM has a therapeutic potential in treating FD with a certain safety.However,due to the restricted number of trials included,wellplanned,long-term studies are necessary to provide credible evidence.展开更多
BACKGROUND: Sleep deprivation resulting from night shifts, is a major cause of burnout among physicians. Exogenous melatonin may improve sleep quality in night-shift workers. The study aims to compare the effectivenes...BACKGROUND: Sleep deprivation resulting from night shifts, is a major cause of burnout among physicians. Exogenous melatonin may improve sleep quality in night-shift workers. The study aims to compare the effectiveness of melatonin versus placebo on sleep effi ciency in emergency medicine(EM) residents. METHODS: A randomized, double-blind, replicated crossover trial was performed on EM residents. This study consisted of 4 phases within a month with intervention periods of 2 nights and washouts of 6 days. In our study, EM residents had nine-hour shifts on 6 consecutive days, 2 mornings, 2 evenings and 2 nights and then 2 days off. At the end of shifts' cycle, 24 EM residents were given 3 mg melatonin or placebo(12 in each arm of the study) for 2 consecutive nights after the second night shift with crossover to the other arm after a six-day off drug. This crossover intervention was repeated for two more another time. Finally, we created 48 cases and comparisons in each arm. Different items related to sleep quality were assessed and compared both within the same group and between the two groups. RESULTS: In the melatonin group, daytime sleepiness(calculated by Karolinska Sleep Scale) had a signifi cant reduction after taking the second dose of drug(P=0.003) but the same result was not observed when comparing the 2 groups. Mood status(calculated by Profile of Mood States) showed no remarkable difference between the 2 groups. CONCLUSION: Melatonin might have a limited benefi t on sleep quality in EM residents working night shifts.展开更多
Purpose: In a placebo-controlled, double-blind, randomized clinical trial, the effect of an insoluble yeast beta-glucan preparation on the incidences of common colds and its effect on common cold symptoms were compare...Purpose: In a placebo-controlled, double-blind, randomized clinical trial, the effect of an insoluble yeast beta-glucan preparation on the incidences of common colds and its effect on common cold symptoms were compared to placebo. Methods: 100 healthy participants with recurring infections were randomly assigned to receive either placebo or yeast beta-glucan (Yestimun?;n = 50 each group) over a period of 26 weeks. The subjects had to document each common cold episode in a diary, and rate 6 predefined infections symptoms on a 3-point rating scale during an infection period, resulting in an infection score. The common cold episodes were confirmed by the investigators. Results: A total of 171 common cold episodes were documented. Of these, 76 were experienced by 38 subjects in the beta-glucan group and 96 were experienced by 48 subjects in the placebo group (p = 0.406). The beta-glucan group had significantly more subjects without incidences of common cold than the placebo group (15.6% vs 2.0%;p = 0.019). During the most intense infection season (first 13 weeks of the study), the beta-glucan group had significantly less infections compared to placebo (p = 0.02). Beta-glucan significantly reduced the typical cold symptoms (“sore throat and/or difficulty swallowing”, “hoarseness and/or cough” and “runny nose”) as opposed to placebo. Conclusion: The present study demonstrates a prophylactic effect of yeast beta-glucan on the occurrence of common colds as opposed to placebo. In addition, when these episodes occurred, they were from the beginning less pronounced and subsided faster.展开更多
Objective To evaluate the efficacy and safety of traditional Chinese medicine(TCM)compounds for the treatment of functional dyspepsia(FD).Methods The Pub Med,Embase,Cochrane Library,Web of Science,Chinese Biomedical D...Objective To evaluate the efficacy and safety of traditional Chinese medicine(TCM)compounds for the treatment of functional dyspepsia(FD).Methods The Pub Med,Embase,Cochrane Library,Web of Science,Chinese Biomedical Database(CBM),Wanfang Data,China National Knowledge Infrastructure(CNKI),and China Science and Technology Journal Database(VIP)were searched to collect randomized,double-blind,and placebo-controlled trials of FD treated with TCM compounds.The search duration was from the establishment of the database to March 2,2021.After two researchers independently screened the literature,extracted the data,and evaluated the bias risk included in the study,they used Rev Man 5.4 software for meta-analysis.Results A total of 23 clinical trials were included,including 2898 patients.Meta-analysis showed that the overall remission rate of FD treated with TCM compounds was significantly higher than that of placebo(73.8%vs.46.2%)[RR=1.50,95%CI(1.29,1.76),P<0.00001].Among the single symptoms,TCM compounds were superior to the placebo in improving epigastric pain[MD=﹣0.99,95%CI(﹣1.37,﹣0.61),P<0.00001],epigastric burning sensation[MD=﹣0.32,95%CI(﹣0.59,﹣0.05),P=0.02],postprandial fullness discomfort[MD=﹣1.59,95%CI(﹣1.96,﹣1.21),P<0.00001],and early satiety symptoms[MD=﹣0.93,95%CI(﹣1.32,﹣0.54),P<0.00001].Compared with the placebo,TCM compounds treatment can obviously improve TCM syndrome in patients with FD[MD=﹣5.58,95%CI(﹣7.55,﹣3.61),P<0.00001],gastric emptying rate[MD=12.22,95%CI(8.90,15.55),P<0.00001],and helped to improve patients’quality of life[MD=11.27,95%CI(0.10,22.43),P=0.05].No severe adverse events were reported between the two groups[RR=1.34,95%CI(0.91,1.96),P=0.14].Conclusion Our results showed that TCM compounds treatment could significantly alleviate FD symptoms,improve gastric emptying in FD patients,and help to improve their quality of life.No severe adverse reactions have been reported in clinical applications.Due to the limitation of the quantity and quality of the included studies,the above conclusions need to be verified by more high-quality studies.展开更多
Background The placebo response of sham acupuncture in patients with primary dysmenorrhea is a substantial factor associated with analgesia.However,the magnitude of the placebo response is unclear.Objective This meta-...Background The placebo response of sham acupuncture in patients with primary dysmenorrhea is a substantial factor associated with analgesia.However,the magnitude of the placebo response is unclear.Objective This meta-analysis assessed the effects of sham acupuncture in patients with primary dysmenorrhea and the factors contributing to these effects.Search strategy PubMed,Embase,Web of Science,and Cochrane CENTRAL databases were searched from inception up to August 20,2022.Inclusion criteria Randomized controlled trials(RCTs)using sham acupuncture as a control for female patients of reproductive age with primary dysmenorrhea were included.Data extraction and analysis Pain intensity,retrospective symptom scale,and health-related quality of life were outcome measures used in these trials.Placebo response was defined as the change in the outcome of interest from baseline to endpoint.We used standardized mean difference(SMD)to estimate the effect size of the placebo response.Results Thirteen RCTs were included.The pooled placebo response size for pain intensity was the largest(SMD=−0.99;95%confidence interval[CI],−1.31 to−0.68),followed by the retrospective symptom scale(Total frequency rating score:SMD=−0.20;95%CI,−0.80 to−0.39.Average severity score:SMD=−0.35;95%CI,−0.90 to−0.20)and physical component of SF-36(SMD=0.27;95%CI,−0.17 to 0.72).Studies using blunt-tip needles,single-center trials,studies with a low risk of bias,studies in which patients had a longer disease course,studies in which clinicians had<5 years of experience,and trials conducted outside Asia were more likely to have a lower placebo response.Conclusion Strong placebo response and some relative factors were found in patients with primary dysmenorrhea.PROSPERO registration number:CRD42022304215.展开更多
文摘We sincerely thank the authors of the commentary1 for their thoughtful analysis and constructive critique of our systematic review on ischemic preconditioning(IPC)and placebo effects in exercise capacity and athletic performance.2Their attention to methodological details,particularly concerning the inclusion and timing of warm-up protocols across studies,is commendable and contributes meaningfully to the ongoing refinement of IPC research in sports science.
基金supported by grants from the National Natural Science Foundation of China(82405192)the Capital’s Funds for Health Improvement and Research(CFH 2022-2-20213,CFH 2022-1-2021)+1 种基金the project of"Friendship Seed Plan"Talent Project of Beijing Friendship Hospital,Capital Medical University(YYZZ202333)Beijing key project of major disease by Chinese medicine and Western medicine(Fatty liver,No.2023BJSZDYNJBXTGG-017)。
文摘Background:Acupuncture has shown potential therapeutic benefits for individuals with simple obesity.However,some researchers argue that some of the effectiveness of acupuncture may be due to the placebo response.Objective:To understand the placebo response of acupuncture treatment in simple obesity,a systematic review and meta-analysis was designed based on the comparison between sham acupuncture before and after treatment.Search strategy:Eight databases(Pub Med,Web of Science,Cochrane Library,Embase,China National Knowledge Infrastructure,Wanfang Database,China Biology Medicine Database,and Chinese Scientific Journals Database)were searched from inception to August 1,2023.The Me SH search terms comprised obesity and acupuncture.Inclusion criteria:Randomized controlled trials(RCTs)using sham or placebo acupuncture as a control in treating obesity were enrolled.Data extraction and analysis:Two researchers independently extracted data,and the results were crosschecked after completion.Each RCT’s detailed sham/placebo acupuncture treatment protocol was assessed according to the SHam Acupuncture REporting guidelines.The revised Cochrane risk-of-bias tool for randomized trials and the Grading of Recommendations Assessment,Development,and Evaluation(GRADE)system were used to determine the risk of bias and quality of evidence,respectively.Body mass index(BMI)was defined as the primary outcome.Anthropometric parameters and laboratory test parameters related to obesity were defined as secondary outcomes.We used standardized mean difference(SMD)with 95%confidence interval(CI)to calculate treatment effects of outcomes.Results:Fifteen RCTs with a total of 1250 patients were included.The BMI significantly decreased after treatment in the sham acupuncture group compared to baseline(SMD 0.37,95%CI 0.09–0.66;I2=81%,random model;P<0.01).Treatment duration(P=0.02)and other interventions significantly impacted the placebo response rate(P=0.00).Conclusion:The placebo response of sham acupuncture was strong in the RCTs for simple obesity,and the effect sizes differed between various outcomes.The treatment duration and other interventions emerged as potential influencing factors for the placebo response of sham acupuncture.
文摘BACKGROUND In randomized controlled trials(RCTs),the placebo arm has often been ignored as the attention tends to be focused on the treatment arm.We undertook a meta-analysis based on the data from the placebo arm in RCTs of hepatocellular carci-noma(HCC),the response rates and survival status,and adverse events(AEs)were summarized and evaluated.AIM To systematically evaluate the response rates,survival status and AEs in the placebo arms of RCTs for HCC.METHODS A systematic search was performed on PubMed,Ovid MEDLINE,Embase and Cochrane Library to identify relevant trials evaluating the efficacy of drugs for the treatment of HCC,published until December 31,2023.Statistical analysis was performed using R statistical software(version 4.3.2).RESULTS A total of 18 RCTs,involving 2390 patients,met the criteria for inclusion in the meta-analysis.The pooled overall disease control rate and objective response rate in the placebo group were 38%[95%confidence interval(CI):33%-42%]and 1%(95%CI:1%-2%),respectively.Overall survival and progression-free survival in the placebo group were 7.9 months(95%CI:7.6-8.31 months)and 1.9 months(95%CI:1.6-2.1 months),respectively.The incidence of grade 3 or 4 AEs was 37%(95%CI:30%-43%).Additionally,the incidence of interruptions or dose reductions due to AEs was 20%(95%CI:13%-27%),while the incidence of treatment discontinuation due to AEs was 9%(95%CI:6%-12%).CONCLUSION Over one-third of advanced HCC patients exhibit therapy-free disease control,with placebo-arm AEs observed.These findings guide single-arm trials design and enhance patient acceptance of anticancer therapies.
文摘We highly commend Dr Souza et al.1for their systematic review research.The authors conducted a detailed investigation into the effects of ischemic preconditioning(IPC)on athletic performance,comparing it with placebo and no-intervention conditions.The study found that while IPC demonstrated superior effects over the no-intervention group in certain metrics(e.g.,time to exhaustion),its performance did not significantly surpass that of the placebo group.This suggests that the potential benefits of IPC may partially stem from participants’psychological expectations,or placebo effects.The study also highlighted the significant impact of placebo interventions on athletic performance,emphasizing the importance of distinguishing between placebo and no-intervention conditions in experimental designs.
文摘Identifying key acupuncture elements is essential for optimizing sham acupuncture controls.Based on the characteristics and current state of acupuncture therapy,this paper categorizes key acupuncture elements into types and contents.Taking the former as a clue,it examines the current understanding of key acupuncture elements and underscores the need for further refinement to ensure that sham acupuncture controls more closely approximate physiological inertness.Additionally,it explores strategies and methodologies for advancing the understanding of key acupuncture elements from both the type and content perspectives.Key acupuncture elements should expand the number of included element types.Elements such as acupuncture needles,point selection,point combination,needle insertion,needle manipulation,and needle withdrawal should all be included,and they should be reported in a standardized manner in the trials.Regarding element content,improvements should be made in three key areas to enhance selection accuracy:1.Strengthening the comprehensiveness of relevant theoretical frameworks.2.Emphasizing the role of Traditional Chinese Medicine(TCM)diagnosis and acupoint palpation methods in trial application and reporting.3.Continuously investigating the mechanisms underlying both the specific efficacy and the placebo efficacy of acupuncture.
文摘目的:评估针对膝骨性关节炎治疗中安慰针刺的随机对照试验(RCT)文献的质量,探讨安慰针刺临床试验设计的思路。方法:计算机检索中国期刊全文数据库(CNKI)、维普中文期刊全文数据数据库(VIP)、万方数据知识服务平台(WF)、中国生物医学文献数据库(SinoMed)、PubMed、Web of Science(WOS)及Embase数据库,收集使用单纯针刺与安慰针刺进行对比的针灸治疗膝骨性关节炎RCT研究,检索时限从建库至2022年12月31日。使用CONSORT与TIDieR-Placebo标准评估文献报告质量,并对结果进行分析讨论。结果:共纳入20篇文献。CONSORT评价结果显示报告率不高于10%的条目为条目3b、6b、11b、12b、14b、17b、18。TIDieR-Placebo评价结果显示报告率不高于10%的条目为条目6、9、10、11、13。安慰针刺的方式主要为“假穴假刺”“假穴真刺”“假穴浅刺”“非治疗穴真刺”“治疗穴假刺”5种。结论:有关安慰针刺的临床试验尚不严谨,质量有待提高。为推动针灸领域临床研究的标准化,建议未来的研究应更加重视依据这些标准来规范化研究报告。
基金funded by an Australian National Health and Medical Research Council project grant (No. APP1048222) and was co-sponsored by FITBio Ceuticals (who provided the trial product and placebo)supported by an NHMRC Fellowship (No. APP1125000)supported by a NHMRC Senior Principal Research Fellowship (No. 1059660 and 1156072)
文摘Objective The placebo response in depression studies is the change in symptoms amongst those who receive an inactive treatment.Many well-designed randomized controlled trials(RCTs)of depression have a high proportion of placebo responders,with little understanding as to why.The present study assesses characteristics associated with the placebo response in a nutraceutical trial with a large proportion of placebo responders.Methods This is a secondary analysis of a nutraceutical depression RCT which identified no overall treatment benefit relative to placebo(n=69 in placebo group).We investigated participant characteristics such as socio-demographics,clinical features,and recruitment methods,and their association with the placebo response.Monoaminergic genetic polymorphisms were also assessed.Placebo response was measured based on change in Montgomery-Asberg Depression Rating Scale score.The association of these hypothesis-driven variables of interest and the placebo response was examined using linear mixed effects models.Results Greater levels of education,particularly pursuing post-high school education,better self-reported general health,marriage/de facto,greater improvement in the first trial week,and more failed antidepressant therapies in the current depressive episode were associated with greater placebo response.An increased placebo response was not found in those recruited via social media nor in those with concomitant antidepressant therapy.Single nucleotide polymorphisms from the tryptophan hydroxylase 1(TPH1)gene(A779C and A218C)were weakly associated with greater placebo response,although the evidence was attenuated after accounting for multiple comparisons.Conclusion This is,to our knowledge,the first study within nutraceutical research for depression to assess the association between participant characteristics and variation in the placebo response.Several variables appeared to predict the placebo response.Such findings may encourage future trial designs which could dampen placebo response,improve assay sensitivity,and allow for treatment effects to be potentially more detectable.
文摘Placebo has been reported to exert beneficial effects in patients regarding the treatment of pain. Human functional neuroimaging technology can study the intact human brain to elucidate its functional neuroanatomy and the neurobiological mechanism of the placebo effect. Blood flow measurement using functional magnetic resonance imaging and positron emission tomography （PET） has revealed that analgesia is related to decreased neural activities in pain-modulatory brain regions, such as the rostral anterior cingulate cortex （rACC）, insula, thalamus, and brainstem including periaqueductal gray （PAG） and ventromedial medulla. The endogenous opioid system and its activation of g-opioid receptors are thought to mediate the observed effects of placebo. The μ-opioid receptor-selective radiotracer-labeled PET studies show that the placebo effects are accompanied by reduction in activation of opioid neural transmission in pain-sensitive brain regions, including rACC, prefrontal cortex, insula, thalamus, amygdala, nucleus accumbens （NAC） and PAG. Further PET studies with dopamine D2/D3 receptor-labeling radiotracer demonstrate that basal ganglia including NAC are related to placebo analgesic responses. NAC dopamine release induced by placebo analgesia is related to expectation of analgesia. These data indicate that the aforementioned brain regions and neurotransmitters such as endogenous opioid and dopamine systems contribute to placebo analgesia.
文摘目的应用试验报告统一标准(Consolidated Standards for Reporting of Trials,CONSORT)与安慰措施描述规范清单(Template for Intervention Description and Replication-Placebo,TIDieR-Placebo)评价安慰针刺治疗偏头痛随机对照试验(Randomized controlled trials,RCT)的文献报告质量。通过评价结果讨论目前安慰针刺的运用现状,并为今后安慰针刺的试验设计提供参考。方法计算机检索中国期刊全文数据库(CNKI)、维普数据库(VIP)、万方数据资源系统(WF)、中国生物医学文献数据库(SinoMed)、PubMed、Embase、Web of Science(WOS),收集近10年使用单纯针刺与安慰针刺进行对比的针灸治疗偏头痛RCT研究,检索时限为2011年7月20日-2021年7月20日。应用CONSORT与TIDieR-Placebo评价文献报告的规范性,并对结果进行分析讨论。结果共纳入59篇文献。CONSORT评价结果显示报告率低于10%的条目为条目3b、6b、11b、12b、14b、16、17b、18、24。TIDieR-Placebo评价结果显示报告率低于10%的条目为条目6、7、9、10、13。安慰针刺的方式主要为“假穴假刺”、“假穴真刺”、“假穴浅刺”及“非治疗穴真刺”4种。结论目前安慰针刺治疗偏头痛RCT的文献报告质量总体不高,研究者未来应重视使用此两项清单对自身研究进行规范报告。大部分研究的安慰针刺设计方式尚缺合理性,亟需国内外在安慰针刺的设计和选择方面形成共识,以推动针灸临床研究的规范化。
基金National Natural Science Foundation of China,No.81370364.
文摘BACKGROUND Acute pancreatitis is the leading cause of hospitalization for acute gastrointestinal disease worldwide.The effects of probiotics in mild acute pancreatitis have not been studied.We hypothesized that the administration of probiotics may accelerate the recovery of intestinal function and shorten the length of hospital stay(LOS)in patients with mild pancreatitis.AIM To investigate the value of probiotics in reducing the LOS in patients with mild acute pancreatitis.METHODS We conducted a double-blind randomized clinical trial to evaluate the effects of probiotics administered to patients with mild acute pancreatitis at a tertiary medical center.The patients were given probiotics capsules(a mixed preparation of Bacillus subtilis and Enterococcus faecium)or placebo.The primary study endpoint was the LOS.The secondary endpoints included time to abdominal pain relief,recurrent abdominal pain,and time to successful oral feeding.RESULTS A total of 128 patients were included,with 64 patients in each arm.The severity of illness and the etiological distribution of disease were similar in the two groups.There was a significant reduction in the LOS in the probiotics treatment group vs the placebo group(5.36±0.15 vs 6.02±0.17 d,P<0.05).The probiotics group was associated with a shorter time to abdominal pain relief and time to successful oral feeding(P<0.01 for both)than the placebo group.No statistical difference was found in recurrent abdominal pain between the two groups.CONCLUSION The study results showed that the administration of probiotics capsules is associated with a shorter duration of hospitalization in patients with mild acute pancreatitis.
基金supported by Grant-in-Aid for Scientific Research(JP15K08938 and JP16K09266)
文摘Objective： To investigate the influence of the depth of skin press in blunt tip placebo acupuncture needles on patient blinding and its relationship to needle diameter.Methods： Forty healthy volunteers were enrolled as subjects for patient blinding. Four acupuncturists applied the following needles randomly at three points in each forearm： 0.18 mm and 0.25 mm diameter penetrating needles inserted to a depth of 5 mm, and 0.18 mm and 0.25 mm diameter skin-touch needles depressing the skin at the acupoint to a depth of 1 mm and 2 mm from the skin surface. The subjects reported their guesses at the nature of needles they received, and rated needle pain and de qi. A blinding index was calculated to define the success of blinding for subjects.Results： The blinding status of subjects for 1 mm press needles of 0.18 mm diameter was ＂random guess＂,but ＂unblinded＂ for 1 mm press needles of 0.25 mm diameter. For 2 mm press needles of both diameters,the blinding status was ＂opposite guess＂ and the blinding status for penetrating needles of both diameters was ＂unblinded.＂ The percentages of ＂felt pain＂ with 2 mm press needles of both diameters were similar to that with penetrating needles, but those were not similar for 1 mm press needles. The frequency of de qi occurrence with 2 mm press needles of 0.18 mm diameter was similar to that of penetrating needles of both diameters.Conclusion： Placebo needles of 2 mm press made more subjects guess that the needles penetrated the skin than 1 mm press needles. The use of small diameter needles increased patient blinding.
文摘Over the last several years there has been a growing interest in placebo, not only as an inert control in clinical trials, but also in the placebo effect as a group effect as well as a reaction in individual subjects. Methodological factors such as regression to the mean and natural history of the disease play a role in the evaluation of a possible placebo effect. In this report, we discuss several factors including PavIovian conditioning, beliefs outcome, expectations, and other factors as potential mediators of the placebo response. Placebo effects are common in gastrointestinal diseases and there seems to be no clear difference between placebo effects in functional gastrointestinal diseases （functional dyspepsia and irritable bowel syndrome） and organic gastrointestinal disease （duodenal ulcer and inflammatory bowel disease）.
基金Supported by Chinese State Key Project for High Technology, No. 2006AA02A308National Key Technology R&D Program, No. 2008BAI52B03Science and Technology Foundation of Zhejiang Province, No. 2008C13027-1
文摘AIM: To investigate the early mortality of placebo-treated alcoholic hepatitis patients. METHODS: Mortality data about alcoholic hepatitis patients who participated in randomized placebo-controlled trials were searched from PubMed, EMBASE, and Cochrane Library, extracted and analyzed. RESULTS: A total of 661 placebo-treated patients in 19 trials were included. The overall mortality rate was 34.19% with a median observation time of 160 d (range 21-720 d). Hepatic failure, gastrointestinal bleeding and infection were the three main causes of death, accounting for 55.47%, 21.17% and 7.30% of all deaths, respectively. One-month mortality data about 324 placebo-treated alcoholic hepatitis patients in 10 trials were reported with a pooled mortality rate of 20.37%. The one-month mortality rate of patients with moderate to severe alcoholic hepatitis tended to be higherthan that of general patients (22.69% vs 10.93%, P < 0.05), whereas no signifi cant difference was observed between the patients from North America or Europe (22.43% vs 18.45%, P > 0.05), neither any difference was found between the studies published before and after 1990 (18.18% vs 21.88%, P > 0.05). CONCLUSION: Alcoholic hepatitis is a severe liver disease with a high mortality rate, and hepatic failure, gastrointestinal bleeding and infection are the three main causes of death.
文摘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 interventions.CONCLUSION The PRR is probably determined to a larger extent by patient-related factors,such as expectations and desire for the treatment to be effective,than the content of the placebo intervention.
基金sponsored by Natural Science Foundation of Shanghai(18ZR1439800,18ZR1436600)Three-year Action Plan for the Development of Traditional Chinese Medicine of Shanghai Municipal Health Planning Commission(ZY(2018-2020)-CCCX2001-03)+2 种基金Xinglin Young Scholar Program of Shanghai University of Traditional Chinese Medicine(A1-U17205010416)the Clinical Research Fund of Shanghai Municipal Health Commission(201940296)Science and Technology Innovation Project in Traditional Chinese Medicine of Pudong New District(PDZY2021-0813)。
文摘In recent years,new preparations of traditional Chinese medicines(TCMs)have been developed,increasing the need for their clinical trials.Using placeboes rather than control drugs is increasingly popular in clinical trials of TCMs,as the therapeutic effects of the tested TCMs can be more properly judged.The basic attributes of TCM placeboes include similarity,safety,applicability and controllability.In particular,it is necessary to have similarities in appearance,color,smell and taste between the tested TCMs and placeboes.This is quite difficult for some TCMs due to their distinctive smell and taste.On the other hand,according to the TCM theory on homology of medicine and food,many foods also have certain bioactivities,potentially further complicating the selection of materials for TCM placeboes.In this review,firstly,studies on the special smell and taste of TCMs were introduced.Then,the preparation quality evaluation processes for TCM placeboes were summarized and discussed,based on the relevant literature published in recent years and the research results from our own lab.This review will facilitate the further research and development of TCM placeboes.
基金the National Natural Science Foundation of China(Grant No.81273746,and 81573806)Foundation on Beijing Key Laboratory of Functional Gastrointestinal Disorders Diagnosis and Treatment of Traditional Chinese Medicine(Grant No.BZ0374).
文摘Objective:To evaluate the efficacy and safety of Chinese herbal medicine(CHM)for the treatment of functional dyspepsia(FD).Methods:Web of Science,PubMed,EMBASE,Cochrane Library,and four other Chinese electronic databases,including China National Knowledge Infrastructure(CNKI),Chinese Biological Medical Database(CBM),Chinese Scientific Journals Database(VIP),and WanFang Database were used to search(up to Feb,2016)for randomized,double-blind,placebocontrolled trials recruiting adults with FD treated with CHM.Study selection,data extraction,quality assessment,and data analyses were conducted based on Cochrane standards using Review Manager software.Results:Fourteen publications(1424 patients)were included.Evidence revealed that CHM was more efficacious than the placebo in improving global dyspepsia symptoms(RR,1.45;95%CI,1.31e1.60),Chinese medicine syndrome(CMS)(RR,1.36;95%CI,1.23e1.50),and quality of life(SMD,0.30;95%CI,0.15e0.45)in FD patients.Furthermore,the difference in the incidence of adverse events between CHM and placebo groups had no statistical significance(RR,1.06;95%CI,0.66e1.70).Conclusion:This meta-analysis demonstrates that CHM has a therapeutic potential in treating FD with a certain safety.However,due to the restricted number of trials included,wellplanned,long-term studies are necessary to provide credible evidence.
文摘BACKGROUND: Sleep deprivation resulting from night shifts, is a major cause of burnout among physicians. Exogenous melatonin may improve sleep quality in night-shift workers. The study aims to compare the effectiveness of melatonin versus placebo on sleep effi ciency in emergency medicine(EM) residents. METHODS: A randomized, double-blind, replicated crossover trial was performed on EM residents. This study consisted of 4 phases within a month with intervention periods of 2 nights and washouts of 6 days. In our study, EM residents had nine-hour shifts on 6 consecutive days, 2 mornings, 2 evenings and 2 nights and then 2 days off. At the end of shifts' cycle, 24 EM residents were given 3 mg melatonin or placebo(12 in each arm of the study) for 2 consecutive nights after the second night shift with crossover to the other arm after a six-day off drug. This crossover intervention was repeated for two more another time. Finally, we created 48 cases and comparisons in each arm. Different items related to sleep quality were assessed and compared both within the same group and between the two groups. RESULTS: In the melatonin group, daytime sleepiness(calculated by Karolinska Sleep Scale) had a signifi cant reduction after taking the second dose of drug(P=0.003) but the same result was not observed when comparing the 2 groups. Mood status(calculated by Profile of Mood States) showed no remarkable difference between the 2 groups. CONCLUSION: Melatonin might have a limited benefi t on sleep quality in EM residents working night shifts.
文摘Purpose: In a placebo-controlled, double-blind, randomized clinical trial, the effect of an insoluble yeast beta-glucan preparation on the incidences of common colds and its effect on common cold symptoms were compared to placebo. Methods: 100 healthy participants with recurring infections were randomly assigned to receive either placebo or yeast beta-glucan (Yestimun?;n = 50 each group) over a period of 26 weeks. The subjects had to document each common cold episode in a diary, and rate 6 predefined infections symptoms on a 3-point rating scale during an infection period, resulting in an infection score. The common cold episodes were confirmed by the investigators. Results: A total of 171 common cold episodes were documented. Of these, 76 were experienced by 38 subjects in the beta-glucan group and 96 were experienced by 48 subjects in the placebo group (p = 0.406). The beta-glucan group had significantly more subjects without incidences of common cold than the placebo group (15.6% vs 2.0%;p = 0.019). During the most intense infection season (first 13 weeks of the study), the beta-glucan group had significantly less infections compared to placebo (p = 0.02). Beta-glucan significantly reduced the typical cold symptoms (“sore throat and/or difficulty swallowing”, “hoarseness and/or cough” and “runny nose”) as opposed to placebo. Conclusion: The present study demonstrates a prophylactic effect of yeast beta-glucan on the occurrence of common colds as opposed to placebo. In addition, when these episodes occurred, they were from the beginning less pronounced and subsided faster.
基金funding support from the National Natural Science Foundation of China Project(No.81820108033)the Project of Wangjing Hospital,China Academy of Chinese Medical Sciences(No.WJYY2020-18)。
文摘Objective To evaluate the efficacy and safety of traditional Chinese medicine(TCM)compounds for the treatment of functional dyspepsia(FD).Methods The Pub Med,Embase,Cochrane Library,Web of Science,Chinese Biomedical Database(CBM),Wanfang Data,China National Knowledge Infrastructure(CNKI),and China Science and Technology Journal Database(VIP)were searched to collect randomized,double-blind,and placebo-controlled trials of FD treated with TCM compounds.The search duration was from the establishment of the database to March 2,2021.After two researchers independently screened the literature,extracted the data,and evaluated the bias risk included in the study,they used Rev Man 5.4 software for meta-analysis.Results A total of 23 clinical trials were included,including 2898 patients.Meta-analysis showed that the overall remission rate of FD treated with TCM compounds was significantly higher than that of placebo(73.8%vs.46.2%)[RR=1.50,95%CI(1.29,1.76),P<0.00001].Among the single symptoms,TCM compounds were superior to the placebo in improving epigastric pain[MD=﹣0.99,95%CI(﹣1.37,﹣0.61),P<0.00001],epigastric burning sensation[MD=﹣0.32,95%CI(﹣0.59,﹣0.05),P=0.02],postprandial fullness discomfort[MD=﹣1.59,95%CI(﹣1.96,﹣1.21),P<0.00001],and early satiety symptoms[MD=﹣0.93,95%CI(﹣1.32,﹣0.54),P<0.00001].Compared with the placebo,TCM compounds treatment can obviously improve TCM syndrome in patients with FD[MD=﹣5.58,95%CI(﹣7.55,﹣3.61),P<0.00001],gastric emptying rate[MD=12.22,95%CI(8.90,15.55),P<0.00001],and helped to improve patients’quality of life[MD=11.27,95%CI(0.10,22.43),P=0.05].No severe adverse events were reported between the two groups[RR=1.34,95%CI(0.91,1.96),P=0.14].Conclusion Our results showed that TCM compounds treatment could significantly alleviate FD symptoms,improve gastric emptying in FD patients,and help to improve their quality of life.No severe adverse reactions have been reported in clinical applications.Due to the limitation of the quantity and quality of the included studies,the above conclusions need to be verified by more high-quality studies.
基金This work was supported by the National Natural Science Foundation of China(No.82174234)the National Science Fund for Distinguished Young Scholars(No.81825024)。
文摘Background The placebo response of sham acupuncture in patients with primary dysmenorrhea is a substantial factor associated with analgesia.However,the magnitude of the placebo response is unclear.Objective This meta-analysis assessed the effects of sham acupuncture in patients with primary dysmenorrhea and the factors contributing to these effects.Search strategy PubMed,Embase,Web of Science,and Cochrane CENTRAL databases were searched from inception up to August 20,2022.Inclusion criteria Randomized controlled trials(RCTs)using sham acupuncture as a control for female patients of reproductive age with primary dysmenorrhea were included.Data extraction and analysis Pain intensity,retrospective symptom scale,and health-related quality of life were outcome measures used in these trials.Placebo response was defined as the change in the outcome of interest from baseline to endpoint.We used standardized mean difference(SMD)to estimate the effect size of the placebo response.Results Thirteen RCTs were included.The pooled placebo response size for pain intensity was the largest(SMD=−0.99;95%confidence interval[CI],−1.31 to−0.68),followed by the retrospective symptom scale(Total frequency rating score:SMD=−0.20;95%CI,−0.80 to−0.39.Average severity score:SMD=−0.35;95%CI,−0.90 to−0.20)and physical component of SF-36(SMD=0.27;95%CI,−0.17 to 0.72).Studies using blunt-tip needles,single-center trials,studies with a low risk of bias,studies in which patients had a longer disease course,studies in which clinicians had<5 years of experience,and trials conducted outside Asia were more likely to have a lower placebo response.Conclusion Strong placebo response and some relative factors were found in patients with primary dysmenorrhea.PROSPERO registration number:CRD42022304215.
