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
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
BACKGROUND： Rheumatoid arthritis （RA）, as a common systemic inflammatory autoimmune disease, affects approximately 1 in 100 individuals. Effective treatment for RA is not yet available because current research does...BACKGROUND： Rheumatoid arthritis （RA）, as a common systemic inflammatory autoimmune disease, affects approximately 1 in 100 individuals. Effective treatment for RA is not yet available because current research does not have a clear understanding of the etiology and pathogenesis of RA. Xinfeng Capsule, a patent Chinese herbal medicine, has been used in the treatment of RA in recent years. Despite its reported clinical efficacy, there are no large-sample, multicenter, randomized trials that support the use of Xinfeng Capsule for RA. Therefore, we designed a randomized, double-blind, multicenter, placebo-controlled trial to assess the efficacy and safety of Xinfeng Capsule in the treatment of RA. METHODS AND DESIGN： This is a 12-week, randomized, placebo-controlled, double-blind, multicenter trial on the treatment of RA. The participants will be randomly assigned to the experimental group and the control group at a ratio of 1：1. Participants in the experimental group will receive Xinfeng Capsule and a pharmaceutical placebo （imitation leflunomide）. The control group will receive leflunomide and an herbal placebo （imitation Xinfeng Capsule）. The American College of Rheumatology （ACR） Criteria for RA will be used to measure the efficacy of the Xinfeng Capsule. The primary outcome measure will be the percentage of study participants who achieve an ACR 20% response rate （ACR20）, which will be measured every 4 weeks after randomization. Secondary outcomes will include the ACR50 and ACR70 responses, the side effects of the medications, the Disease Activity Score 28, RA biomarkers, quality of life, and X-rays of the hands and wrists. The first four of the secondary outcomes will be measured every 4 weeks and the others will be measured at baseline and after 12 weeks of treatment. DISCUSSION： The result of this trial will help to evaluate whether Xinfeng Capsule is effective and safe in the treatment of RA. TRIAL REGISTRATION： This trial has been registered in ClinicalTrials.gov. The identifier is N CT01774877.展开更多
BACKGROUND： When performing clinical trials involving acupuncture, it can be difficult to choose a placebo control. OBJECTIVE： To validate the Park sham needle for use as a double-blind control intervention. DESIGN,...BACKGROUND： When performing clinical trials involving acupuncture, it can be difficult to choose a placebo control. OBJECTIVE： To validate the Park sham needle for use as a double-blind control intervention. DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS： Two different methods were employed. First, a researcher blinded to needle type administered the Park sham or a real needle, chosen at random, on the arms of 16 healthy volunteers. The researcher and the volunteers independently recorded which needle type they thought had been applied at each acupuncture point. Second, 19 patients with shoulder impingement syndrome were randomly assigned to receive acupuncture applied with the real needle or the Park sham needle, once a week for 6 weeks alongside a course of physiotherapy. At the end of the 6 sessions the patients recorded which needle type they thought was being used. The results were analyzed with a Fisher＇s exact test. This study was carried out in the Outpatient Department of Physiotherapy in Chafing Cross Hospital, London, UK, on healthy volunteers and patients with shoulder impingement pain. The age range was 23 to 54 and 22 to 74 years respectively. RESULTS： Of the healthy volunteers, there was no difference （P=0.23） between the number of needles that were correctly （n=43） or incorrectly identified （n=53）. All patients thought that they had received the real needles. The researcher correctly identified all needles that were applied. CONCLUSION： The researcher delivering the acupuncture recognized the needle type. However, both healthy and patient volunteers were blind to the needle type. This demonstrates that the Park sham needle is an effective single-blind control. It should be noted that the number of patients recruited was small and the study was underpowered to detect an effect of treatment.展开更多
OBJECTIVE: To examine German controlled clinical trials on the therapeutic effects of acupuncture vs sham acupuncture, and to find whether there are problems with the conclusion that sham acupuncture has no significan...OBJECTIVE: To examine German controlled clinical trials on the therapeutic effects of acupuncture vs sham acupuncture, and to find whether there are problems with the conclusion that sham acupuncture has no significant deviation from acupuncture. METHODS: We focused on literature from the last ten years (2002-2011) included in PubMed about controlled clinical trials on acupuncture vs sham acupuncture carried out in Germany. The methods applied in sham acupuncture are summarized, and the difference between the acupuncture and sham groups were analyzed. We measured effects based on the following criteria: acupuncture is effective and superior to sham, acupuncture is effective but similar to sham, both of them have uncertainty regarding treatment effect, or no significant effect. Finally, we reviewed the hypotheses of different scholars on sham acupuncture and analyzed their results.RESULTS: Four types of controlled clinical trials including sham acupuncture on non-Traditional Chinese Medicine acupoints, minimal acupuncture on non-acupoints, placebo needle and sham laser acupuncture had varying results in the 57 articles analyzed. Some showed that acupuncture had a better effect than sham, while some suggest acupuncture and sham had similar effects. In all studies using sham acupuncture on non-therapeutic points, sham electrodes, and sham electro-acupuncture, the therapeutic effect was better than sham. Of the trials, 37 demonstrated that acupuncture had a better effect than sham acupuncture. Only nine trials found no significant difference between acupuncture and sham. Two controlled trials for the same condition (neck pain) conducted by two different German research institutes used the same control method, but reached contradictory conclusions. CONCLUSION: We found problems in conclusions based on results of controlled clinical trials of sham acupuncture in Germany. Therefore, there is still not enough evidence to support the statements that "acupuncture and sham acupuncture have no difference in treatment effect" and "acupuncture is just a placebo effect." The control methods of sham acupuncture used in Germany may not be standardized and may not be suitable for acupuncture clinical trial research. We suggest that research on the methodology of sham acupuncture should be given priority in the design of acupuncture trials in the future.展开更多
Aiming at the conclusion that ＂there is no difference in efficacy between acupuncture and sham-acupuncture＂ in clinical research field of migraine in foreign countries in recent years, through the discussions on the...Aiming at the conclusion that ＂there is no difference in efficacy between acupuncture and sham-acupuncture＂ in clinical research field of migraine in foreign countries in recent years, through the discussions on the definition of sham acupuncture （placebo acupuncture）, the principles required to be obey in satisfactory placebo acupuncture, the definition, location, function as well as clinical results of shallow puncture, the authors probed into whether shallow puncture could be the control method of sham acupuncture （placebo acupuncture） in clinical research of acupuncture. It was demonstrated in the results that ＂acupuncture with minimal stimulation on skin superficial layer of meridian points or non-meridian points＂, the so-called control method of ＂sham acupuncture （placebo acupuncture）＂ excited holistic regulation of human body quite probably through ＂shallow puncture on cutaneous region of meridians＂ to achieve therapeutic effects. Hence, this method is not the appropriate control method of placebo acupuncture and cannot be the control method of sham acupuncture （placebo acupuncture） in clinical research of acupuncture. Therefore, it is naturally to repudiate the conclusion that ＂there is no difference in efficacy between acupuncture and sham acupuncture＂ in the research where this method is taken as the control of placebo acupuncture.展开更多
Pain perception and its genesis in the human brain have been reviewed recently. In the current article, the reports on pain modulation in the human brain were reviewed from higher cortical regulation, i.e. top-down ef...Pain perception and its genesis in the human brain have been reviewed recently. In the current article, the reports on pain modulation in the human brain were reviewed from higher cortical regulation, i.e. top-down effect, particularly studied in psychological determinants. Pain modulation can be examined by gene therapy, physical modulation, pharmacological modulation, psychological modulation, and pathophysiological modulation. In psychological modulation, this article exam- ined （a） willed determination, （b） distraction, （c） placebo, （d） hypnosis, （e） meditation, （f） qi-gong, （g） belief, and （h） emotions, respectively, in the brain function for pain modulation. In each, the operational definition, cortical processing, neuroimaging, and pain modulation were systematically deliberated. However, not all studies had featured the brain modulation processing but rather demonstrated potential effects on human pain. In our own studies on the emotional modulation on human pain, we observed that emotions could be induced from music melodies or pictures perception for reduction of tonic human pain, mainly in potentiation of the posterior alpha EEG fields, likely resulted from underneath activities of precuneous in regulation of consciousness, including pain perception. To sum, higher brain functions become the leading edge research in all sciences. How to solve the information bit of thinking and feeling in the brain can be the greatest challenge of human intelligence. Application of higher cortical modulation of human pain and suffering can lead to the progress of social humanity and civilization.展开更多
Delivery of acupuncture in the setting of a clinical trial is a unique practice that diverges significantly from the delivery of acupuncture in a real-world clinical setting. Research acupuncturists, particularly thos...Delivery of acupuncture in the setting of a clinical trial is a unique practice that diverges significantly from the delivery of acupuncture in a real-world clinical setting. Research acupuncturists, particularly those trained in traditional Chinese medicine(TCM), are often required to set aside valued precepts of traditional care, including diagnosing imbalances, individualizing treatment, and forging a therapeutic relationship with patients. TCM-trained acupuncturists express mixed feelings about participating in clinical trials. Many are eager to play a vital role in the advancement of acupuncture science and appreciate the need for strict protocol adherence to minimize bias. However, the acupuncturist(s) may also have concerns about clinical trial methodology, including but not limited to the delivery of a control condition, e.g., sham acupuncture. Investigators should anticipate certain questions and even a level of resistance to the requirements of research among acupuncturists and be prepared to address them. This manuscript presents a brief review of the subjective experience of the research acupuncturist within the available scientific literature as it pertains to the delivery of active and sham clinical research protocols. Our goals are to better understand the perspectives of acupuncturists who may participate in clinical research, so that their concerns may be addressed in study design and methodology. To that end, we suggest the creation of a novel training program specifically for clinical trial acupuncturists, intended for qualified TCM-and Western-trained practitioners, that would help to standardize the research acupuncturist’s role and help to strengthen the design and execution of acupuncture studies.展开更多
Placebo control is designed to evaluate the specific effect of one intervention.Relevant studies showed that acupuncture has a considerable placebo effect affected by many factors.In this paper,the relevant articles o...Placebo control is designed to evaluate the specific effect of one intervention.Relevant studies showed that acupuncture has a considerable placebo effect affected by many factors.In this paper,the relevant articles of acupuncture placebo studies all around the world were reviewed comprehensively to clarify the definition of acupuncture placebo effect and its psychological mechanism.The factors of acupuncture placebo effect were discussed in view of three aspects,i.e.types of sham acupuncture as control,patient-doctor interaction and outcome types.Eventually,the issues encountered in current studies of acupuncture placebo effect were described,e.g.lack of relevant studies especially with systematic and in-depth approaches in this field,inappropriate classification of specific non-needling effect relevant with acupuncture theory,and inaccurate assessment of acupuncture placebo effect due to the dificulty of sham-acupuncture design.In order to drive the future research direction of acupuncture placebo effect,it is suggested that more attention should be paid on the topic,including but not limited to correct recognition of the holistic effect of acupuncture,the appropriate design of sham acupuncture and in-depth research of mechanism of acupuncture placebo effect and its contributing factors.展开更多
We evaluated the eff icacy and tolerability of mebeverine, a musculotropic antispasmodic agent, in irritable bowel syndrome (IBS) and compared its usual dosages by meta-analysis. Medical databases and all relevant lit...We evaluated the eff icacy and tolerability of mebeverine, a musculotropic antispasmodic agent, in irritable bowel syndrome (IBS) and compared its usual dosages by meta-analysis. Medical databases and all relevant literature were searched from 1965 to June 2009 for any placebo-controlled clinical trials of mebeverine, using search terms such as mebeverine, clinical trials, and IBS. Eight randomized trials met our criteria, including six trials that compared mebeverine with placebo and two that compared mebeverine tablets with capsules. These eight trials included 555 patients randomized to receive either mebeverine or placebo with 352 (63%)women and 203 (37%) men in all subtypes of IBS. The pooled relative risk (RR) for clinical improvement of mebeverine was 1.13 (95% CI: 0.59-2.16, P = 0.7056) and 1.33 (95% CI: 0.92-1.93, P = 0.129) for relief of abdominal pain. The efficacy of mebeverine 200 mg compared to mebeverine 135 mg indicated RRs of 1.12 (95% CI: 0.96-1.3, P = 0.168) for clinical or global improvement and 1.08 (95% CI: 0.87-1.34, P = 0.463) for relief of abdominal pain. Thus, mebeverine is mostly well tolerated with no signif icant adverse effects; however, its eff icacy in global improvement of IBS is not statistically signif icant.展开更多
The purpose of this work was to assess the evidence for effectiveness of acupuncture （AC） treatment in gastrointestinal diseases. A systematic review of the Medline-cited literature for clinical trials was performed...The purpose of this work was to assess the evidence for effectiveness of acupuncture （AC） treatment in gastrointestinal diseases. A systematic review of the Medline-cited literature for clinical trials was performed up to May 2006. Controlled trials assessing acupuncture point stimulation for patients with gastrointestinal diseases were considered for inclusion. The search identified 18 relevant trials meeting the inclusion criteria. Two irritable bowel syndrome （IBS） trials, 1 Crohn＇s disease and 1 colitis ulcerosa trial had a robust random controlled trial （RCT） design. In regard to other gastrointestinal disorders, study quality was poor. In all trials, quality of life （QoL） improved significantly independently from the kind of acupuncture, real or sham. Real AC was significantly superior to sham acupuncture with regard to disease activity scores in the Crohn and Colitis trials. Efficacy of acupuncture related to QoL in IBS may be explained by unspecific effects. This is the same for QoL in inflammatory bowel diseases （IBD）, whereas specific acupuncture effects may be found in clinical scores. Further trials for IBDs and in particular for all other gastrointestinal disorders would be necessary to evaluate the efficacy of acupuncture treatment. However, it must be discussed on what terms patients benefit when this harmless and obviously powerful therapy with regard to QoL is demystified by further placebo controlled trials.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
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 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 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
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.
基金supported by the Twelfth Five-Year Support Project of the Ministry of Science and Technology for clinical studies investigating Xin'an medicine in the treatment of complicated ascites diseases(No.2012BAI26B02)
文摘BACKGROUND： Rheumatoid arthritis （RA）, as a common systemic inflammatory autoimmune disease, affects approximately 1 in 100 individuals. Effective treatment for RA is not yet available because current research does not have a clear understanding of the etiology and pathogenesis of RA. Xinfeng Capsule, a patent Chinese herbal medicine, has been used in the treatment of RA in recent years. Despite its reported clinical efficacy, there are no large-sample, multicenter, randomized trials that support the use of Xinfeng Capsule for RA. Therefore, we designed a randomized, double-blind, multicenter, placebo-controlled trial to assess the efficacy and safety of Xinfeng Capsule in the treatment of RA. METHODS AND DESIGN： This is a 12-week, randomized, placebo-controlled, double-blind, multicenter trial on the treatment of RA. The participants will be randomly assigned to the experimental group and the control group at a ratio of 1：1. Participants in the experimental group will receive Xinfeng Capsule and a pharmaceutical placebo （imitation leflunomide）. The control group will receive leflunomide and an herbal placebo （imitation Xinfeng Capsule）. The American College of Rheumatology （ACR） Criteria for RA will be used to measure the efficacy of the Xinfeng Capsule. The primary outcome measure will be the percentage of study participants who achieve an ACR 20% response rate （ACR20）, which will be measured every 4 weeks after randomization. Secondary outcomes will include the ACR50 and ACR70 responses, the side effects of the medications, the Disease Activity Score 28, RA biomarkers, quality of life, and X-rays of the hands and wrists. The first four of the secondary outcomes will be measured every 4 weeks and the others will be measured at baseline and after 12 weeks of treatment. DISCUSSION： The result of this trial will help to evaluate whether Xinfeng Capsule is effective and safe in the treatment of RA. TRIAL REGISTRATION： This trial has been registered in ClinicalTrials.gov. The identifier is N CT01774877.
基金supported by the Imperial College London, Acupuncture Association of Chartered Physiotherapists and the Therapy Department at Imperial College NHS Trust
文摘BACKGROUND： When performing clinical trials involving acupuncture, it can be difficult to choose a placebo control. OBJECTIVE： To validate the Park sham needle for use as a double-blind control intervention. DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS： Two different methods were employed. First, a researcher blinded to needle type administered the Park sham or a real needle, chosen at random, on the arms of 16 healthy volunteers. The researcher and the volunteers independently recorded which needle type they thought had been applied at each acupuncture point. Second, 19 patients with shoulder impingement syndrome were randomly assigned to receive acupuncture applied with the real needle or the Park sham needle, once a week for 6 weeks alongside a course of physiotherapy. At the end of the 6 sessions the patients recorded which needle type they thought was being used. The results were analyzed with a Fisher＇s exact test. This study was carried out in the Outpatient Department of Physiotherapy in Chafing Cross Hospital, London, UK, on healthy volunteers and patients with shoulder impingement pain. The age range was 23 to 54 and 22 to 74 years respectively. RESULTS： Of the healthy volunteers, there was no difference （P=0.23） between the number of needles that were correctly （n=43） or incorrectly identified （n=53）. All patients thought that they had received the real needles. The researcher correctly identified all needles that were applied. CONCLUSION： The researcher delivering the acupuncture recognized the needle type. However, both healthy and patient volunteers were blind to the needle type. This demonstrates that the Park sham needle is an effective single-blind control. It should be noted that the number of patients recruited was small and the study was underpowered to detect an effect of treatment.
基金Supported by the Program of China Academy of Chinese Medical Sciences for Young Researchers in Medical Science(No.ZZ040305)
文摘OBJECTIVE: To examine German controlled clinical trials on the therapeutic effects of acupuncture vs sham acupuncture, and to find whether there are problems with the conclusion that sham acupuncture has no significant deviation from acupuncture. METHODS: We focused on literature from the last ten years (2002-2011) included in PubMed about controlled clinical trials on acupuncture vs sham acupuncture carried out in Germany. The methods applied in sham acupuncture are summarized, and the difference between the acupuncture and sham groups were analyzed. We measured effects based on the following criteria: acupuncture is effective and superior to sham, acupuncture is effective but similar to sham, both of them have uncertainty regarding treatment effect, or no significant effect. Finally, we reviewed the hypotheses of different scholars on sham acupuncture and analyzed their results.RESULTS: Four types of controlled clinical trials including sham acupuncture on non-Traditional Chinese Medicine acupoints, minimal acupuncture on non-acupoints, placebo needle and sham laser acupuncture had varying results in the 57 articles analyzed. Some showed that acupuncture had a better effect than sham, while some suggest acupuncture and sham had similar effects. In all studies using sham acupuncture on non-therapeutic points, sham electrodes, and sham electro-acupuncture, the therapeutic effect was better than sham. Of the trials, 37 demonstrated that acupuncture had a better effect than sham acupuncture. Only nine trials found no significant difference between acupuncture and sham. Two controlled trials for the same condition (neck pain) conducted by two different German research institutes used the same control method, but reached contradictory conclusions. CONCLUSION: We found problems in conclusions based on results of controlled clinical trials of sham acupuncture in Germany. Therefore, there is still not enough evidence to support the statements that "acupuncture and sham acupuncture have no difference in treatment effect" and "acupuncture is just a placebo effect." The control methods of sham acupuncture used in Germany may not be standardized and may not be suitable for acupuncture clinical trial research. We suggest that research on the methodology of sham acupuncture should be given priority in the design of acupuncture trials in the future.
基金Academy-rank research project of China Academy of Chinese Medical Sciences:ZZ 2006084
文摘Aiming at the conclusion that ＂there is no difference in efficacy between acupuncture and sham-acupuncture＂ in clinical research field of migraine in foreign countries in recent years, through the discussions on the definition of sham acupuncture （placebo acupuncture）, the principles required to be obey in satisfactory placebo acupuncture, the definition, location, function as well as clinical results of shallow puncture, the authors probed into whether shallow puncture could be the control method of sham acupuncture （placebo acupuncture） in clinical research of acupuncture. It was demonstrated in the results that ＂acupuncture with minimal stimulation on skin superficial layer of meridian points or non-meridian points＂, the so-called control method of ＂sham acupuncture （placebo acupuncture）＂ excited holistic regulation of human body quite probably through ＂shallow puncture on cutaneous region of meridians＂ to achieve therapeutic effects. Hence, this method is not the appropriate control method of placebo acupuncture and cannot be the control method of sham acupuncture （placebo acupuncture） in clinical research of acupuncture. Therefore, it is naturally to repudiate the conclusion that ＂there is no difference in efficacy between acupuncture and sham acupuncture＂ in the research where this method is taken as the control of placebo acupuncture.
基金supported by the National Natural Science Foundation of China (No.30770691),Beijing Municipal Government for Advancement of Sciences,and Capital Medical University for Innovation Awards
文摘Pain perception and its genesis in the human brain have been reviewed recently. In the current article, the reports on pain modulation in the human brain were reviewed from higher cortical regulation, i.e. top-down effect, particularly studied in psychological determinants. Pain modulation can be examined by gene therapy, physical modulation, pharmacological modulation, psychological modulation, and pathophysiological modulation. In psychological modulation, this article exam- ined （a） willed determination, （b） distraction, （c） placebo, （d） hypnosis, （e） meditation, （f） qi-gong, （g） belief, and （h） emotions, respectively, in the brain function for pain modulation. In each, the operational definition, cortical processing, neuroimaging, and pain modulation were systematically deliberated. However, not all studies had featured the brain modulation processing but rather demonstrated potential effects on human pain. In our own studies on the emotional modulation on human pain, we observed that emotions could be induced from music melodies or pictures perception for reduction of tonic human pain, mainly in potentiation of the posterior alpha EEG fields, likely resulted from underneath activities of precuneous in regulation of consciousness, including pain perception. To sum, higher brain functions become the leading edge research in all sciences. How to solve the information bit of thinking and feeling in the brain can be the greatest challenge of human intelligence. Application of higher cortical modulation of human pain and suffering can lead to the progress of social humanity and civilization.
基金the National Institute of Nursing Research of the National Institutes of Health(No.R01-NR017917)。
文摘Delivery of acupuncture in the setting of a clinical trial is a unique practice that diverges significantly from the delivery of acupuncture in a real-world clinical setting. Research acupuncturists, particularly those trained in traditional Chinese medicine(TCM), are often required to set aside valued precepts of traditional care, including diagnosing imbalances, individualizing treatment, and forging a therapeutic relationship with patients. TCM-trained acupuncturists express mixed feelings about participating in clinical trials. Many are eager to play a vital role in the advancement of acupuncture science and appreciate the need for strict protocol adherence to minimize bias. However, the acupuncturist(s) may also have concerns about clinical trial methodology, including but not limited to the delivery of a control condition, e.g., sham acupuncture. Investigators should anticipate certain questions and even a level of resistance to the requirements of research among acupuncturists and be prepared to address them. This manuscript presents a brief review of the subjective experience of the research acupuncturist within the available scientific literature as it pertains to the delivery of active and sham clinical research protocols. Our goals are to better understand the perspectives of acupuncturists who may participate in clinical research, so that their concerns may be addressed in study design and methodology. To that end, we suggest the creation of a novel training program specifically for clinical trial acupuncturists, intended for qualified TCM-and Western-trained practitioners, that would help to standardize the research acupuncturist’s role and help to strengthen the design and execution of acupuncture studies.
基金Supported by The National Natural Science Foundation of China:82174234.
文摘Placebo control is designed to evaluate the specific effect of one intervention.Relevant studies showed that acupuncture has a considerable placebo effect affected by many factors.In this paper,the relevant articles of acupuncture placebo studies all around the world were reviewed comprehensively to clarify the definition of acupuncture placebo effect and its psychological mechanism.The factors of acupuncture placebo effect were discussed in view of three aspects,i.e.types of sham acupuncture as control,patient-doctor interaction and outcome types.Eventually,the issues encountered in current studies of acupuncture placebo effect were described,e.g.lack of relevant studies especially with systematic and in-depth approaches in this field,inappropriate classification of specific non-needling effect relevant with acupuncture theory,and inaccurate assessment of acupuncture placebo effect due to the dificulty of sham-acupuncture design.In order to drive the future research direction of acupuncture placebo effect,it is suggested that more attention should be paid on the topic,including but not limited to correct recognition of the holistic effect of acupuncture,the appropriate design of sham acupuncture and in-depth research of mechanism of acupuncture placebo effect and its contributing factors.
文摘We evaluated the eff icacy and tolerability of mebeverine, a musculotropic antispasmodic agent, in irritable bowel syndrome (IBS) and compared its usual dosages by meta-analysis. Medical databases and all relevant literature were searched from 1965 to June 2009 for any placebo-controlled clinical trials of mebeverine, using search terms such as mebeverine, clinical trials, and IBS. Eight randomized trials met our criteria, including six trials that compared mebeverine with placebo and two that compared mebeverine tablets with capsules. These eight trials included 555 patients randomized to receive either mebeverine or placebo with 352 (63%)women and 203 (37%) men in all subtypes of IBS. The pooled relative risk (RR) for clinical improvement of mebeverine was 1.13 (95% CI: 0.59-2.16, P = 0.7056) and 1.33 (95% CI: 0.92-1.93, P = 0.129) for relief of abdominal pain. The efficacy of mebeverine 200 mg compared to mebeverine 135 mg indicated RRs of 1.12 (95% CI: 0.96-1.3, P = 0.168) for clinical or global improvement and 1.08 (95% CI: 0.87-1.34, P = 0.463) for relief of abdominal pain. Thus, mebeverine is mostly well tolerated with no signif icant adverse effects; however, its eff icacy in global improvement of IBS is not statistically signif icant.
文摘The purpose of this work was to assess the evidence for effectiveness of acupuncture （AC） treatment in gastrointestinal diseases. A systematic review of the Medline-cited literature for clinical trials was performed up to May 2006. Controlled trials assessing acupuncture point stimulation for patients with gastrointestinal diseases were considered for inclusion. The search identified 18 relevant trials meeting the inclusion criteria. Two irritable bowel syndrome （IBS） trials, 1 Crohn＇s disease and 1 colitis ulcerosa trial had a robust random controlled trial （RCT） design. In regard to other gastrointestinal disorders, study quality was poor. In all trials, quality of life （QoL） improved significantly independently from the kind of acupuncture, real or sham. Real AC was significantly superior to sham acupuncture with regard to disease activity scores in the Crohn and Colitis trials. Efficacy of acupuncture related to QoL in IBS may be explained by unspecific effects. This is the same for QoL in inflammatory bowel diseases （IBD）, whereas specific acupuncture effects may be found in clinical scores. Further trials for IBDs and in particular for all other gastrointestinal disorders would be necessary to evaluate the efficacy of acupuncture treatment. However, it must be discussed on what terms patients benefit when this harmless and obviously powerful therapy with regard to QoL is demystified by further placebo controlled trials.
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.
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）.
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.
