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Predictors of the placebo response in a nutraceutical randomized controlled trial for depression

Journal of Integrative Medicine 2024年第1期22卷 46-53页

作者： Rosemary Arnold Jenifer Murphy-Smith Chee H.Ng David Mischoulon Gerard J.Byrne Chad A.Bousman Con Stough Michael Berk Jerome Sarris Professorial Unit the Melbourne ClinicDepartment of PsychiatryUniversity of MelbourneRichmond 3121Australia Depression Clinical and Research Program Department of PsychiatryMassachusetts General HospitalHarvard Medical SchoolBostonMA 02115USA Faculty of Medicine Discipline of PsychiatryCentre for Clinical ResearchRoyal Brisbane&Women’s HospitalHerstonthe University of QueenslandBrisbane 4006Australia Departments of Medical Genetics PsychiatryPhysiology&Pharmacology and Community Health SciencesUniversity of CalgaryCalgaryAB T2N 1N4Canada Department of Psychiatry the University of MelbourneMelbourne 3052Australia Centre for Human Psychopharmacology Swinburne UniversityMelbourne 3122Australia The Institute for Mental and Physical Health and Clinical Translation School of MedicineBarwon HealthDeakin UniversityGeelong 3220Australia The Centre of Excellence in Youth Mental Health the University of MelbourneParkville 3052Australia Florey Institute of Neuroscience and Mental Health the University of MelbourneParkville 3052Australia NICM Health Research Institute Western Sydney UniversityWestmeadNSW 2145Australia

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 as

关键词： Randomized controlled trial placebo Depression Nutraceutical Psychiatry

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Adjuvant Rectal Diclofenac for Post Operative Analgesia after Caesarean Section—A Randomized Controlled Study

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Open Journal of Obstetrics and Gynecology 2024年第4期14卷 591-609页

作者： Eziaha Eric S. Ede Ayodele A. Olaleye John C. Irechukwu Uchenna Nelson Nwaedu Borniface N. Ejikeme Vincent Chidiebere Ali Bartholomew I. Olinya Department of Obstetrics and Gynaecology Alex Ekwueme Federal University Teaching Hospital Abakaliki Nigeria

BACKGROUND: Pain management following caesarean section still remains a challenge in our environment. Most potent analgesics are either not readily available or expensive. Diclofenac suppository is an NSAID that can be used for postoperative analgesia. It is available and affordable. OBJECTIVE: To compare the efficacy and safety of combined rectal diclofenac and intramuscular pentazocine with intramuscular pentazocine alone for post operative pain control following lower segment caesarean section. METHODOLOGY: A total of 120 women who met the selection criteria scheduled for caesarean section under spinal anaesthesia with bupivacaine were randomized into two equal groups to receive either 75 mg diclofenac suppository 12 hourly for 24 hours or one anusol suppository (the placebo) 12 hourly for 24 hours. Both groups received pentazocine as primary analgesia. RESULT: The primary outcome measure is the proportion of patients with severe pain at 24 hours using the visual analogue rating scale. Secondary outcome measures are the time from surgery to ambulation, Passage of flatus, maternal satisfaction and presence of complications. Statistical analysis was done using spss version 22 and graph pad statistical package. Student T-test was used for continuous variables whereas chi square was used for categorical variables P CONCLUSION: Adjuvant rectal diclofenac is superior to pentazocine alone in the management of pain after caesarean section. Less number of patients had moderate to severe pain at 24 hours post operation. Maternal satisfaction in relation to pain management is better with diclofenac suppository. The levels of complications were comparable in both groups.

关键词： Pain Caesarean Section Diclofenac placebo Suppository

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Efficacy and safety of low-dose interleukin-2 in combination with methotrexate in patients with active rheumatoid arthritis:a randomized,double-blind,placebo-controlled phase 2 trial

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Signal Transduction and Targeted Therapy 2022年第4期7卷 1194-1201页

作者： Xiaoying Zhang Miao Miao Ruijun Zhang Xu Liu Xiaozhen Zhao Miao Shao Tian Liu Yuebo Jin Jiali Chen Huixin Liu Xia Zhang Yun Li Yunshan Zhou Yue Yang Ru Li Haihong Yao Yanying Liu Chun Li Yuhui Li Limin Ren Yin Su Xiaolin Sun Jing He Zhanguo Li Department of Rheumatology and Immunology Peking University People’s Hospital100044 BeijingChina Department of Rheumatology and Immunology The First Affiliated Hospital of Wannan Medical College241000 WuhuAnhuiChina Department of Clinical Epidemiology and Biostatistics Peking University People’s Hospital100044 BeijingChina Beijing Key Laboratory for Rheumatism Mechanism and Immune Diagnosis(BZ0135) BeijingChina Peking-Tsinghua Center for Life Sciences BeijingChina State Key Laboratory of Natural and Biomimetic Drugs School of Pharmaceutical SciencesPeking UniversityBeijingChina

Rheumatoid arthritis(RA)is an aggressive autoimmune arthritis,and current therapies remain unsatisfactory due to low remission rate and substantially adverse effects.Low-dose interleukin-2(Ld-IL2)is potentially a therapeutic approach to further improve the disease.This randomized,double-blind,placebo-controlled trial was undertaken to evaluate the efficacy and safety of Ld-IL2 in patients with active RA.Patients were randomly assigned(1:1)to receive Ld-IL2,defined as a dose of 1 million IU,or placebo in a 12-week trial with a 12-week follow-up.Three cycles of Ld-IL2 or placebo were administered subcutaneously every other day for 2 weeks(a total of 7 doses),followed by a 2-week break.All patients received a stable dose of methotrexate(MTX).The primary outcomes were the proportion of patients achieving the ACR20,DAS28-ESRplacebo+MTX group(n=23)(P=0.018 and P=0.015,respectively).More patients achieved ACR20 response in the Ld-IL2+MTX group than those in the placebo+MTX group at week 12(70.6%vs 43.5%)and at week 24(76.5%vs 56.5%)(P=0.014).In addition,low Treg and high IL-21 were associated with good responses to Ld-IL2.Ld-IL-2 treatment was well-tolerated in this study.These results suggested that Ld-IL2 was effective and safe in RA.ClinicalTrials.gov number:NCT 02467504.

关键词： patients placebo methotrexate

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Efficacy and Safety of Mulberry Twig Alkaloids Tablet for Treatment of Type 2 Diabetes:A Randomized,Double-Blind,placebo-Controlled Multicenter Clinical Study

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Chinese Journal of Integrative Medicine 2022年第4期28卷 304-311页

作者： QU Ling LIANG Xiao-chun TIAN Guo-qing ZHANG Gai-li WU Qun-li HUANG Xiu-mei CUI Ya-zhong LIU Yu-ling SHEN Zhu-fang MA Guo-qing LU Hao LI Yi JIANG Hong YANG Xi-yan ZHANG Guang-de YANG Chen-hua Department of Traditional Chinese Medicine Peking Union Medical College HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing100730China Institute of Materia Medica Chinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing100050China Department of Endocrinology the Second Affiliated Hospital of Heilongjiang University of Chinese MedicineHaerbin150001China Department of Endocrinology Shuguang HospitalShanghai University of Traditional Chinese MedicineShanghai201203China Department of Traditional Chinese Medicine Beijing HospitalBeijing10005China Department of Endocrinology the Second Affiliated Hospital of Liaoning University of Traditional Chinese MedicineShenyang110034China Department of Geriatrics the First Affiliated Hospital of Tianjin University of Chinese MedicineTianjin300073China Department of Endocrinology Xiyuan HospitalChina Academy of Chinese Medical SciencesBeijing100091China Department of Endocrinology Affiliated Hospital of Henan Academy of Traditional Chinese MedicineZhengzhou450003China

Objective:To assess the efficacy and safety of mulberry twig alkaloids(Sangzhi alkaloids,SZ-A)for treatment of type 2 diabetes in a randomized,double-blind,placebo-controlled multicenter clinical trial.Methods:A total of 200 patients were randomized to receive SZ-A(n=100)or placebo(n=100)for 16 weeks.The data analysis system for electronic data capture clinical trial central randomization system was used for randomization and dispensing of drugs.The primary outcome was the change in glycosylated hemoglobin(Hb A1c)level.The secondary outcome included the proportions of cases with Hb A1cplacebo group,respectively.The proportion of patients with Hb A1cplacebo group(46.8%vs.21.6%and 29.9%vs.10.8%).The observed values and changes in FBG,1 h-PBG,2 h-PBG,and AUC_(0-2h) differed significantly between groups(P0.05).The incidence rates of AEs,TAEs,and GDs differed significantly between groups(P=0.010,P=0.005,and P=0.006,respectively),whereas the incidence rates of SAEs showed no significant differences between groups(P=1.000).Conclusion:SZ-A are effective and safe for treatment of type 2 diabetes.

关键词： type 2 diabetes mellitus mulberry twig alkaloids tablets(Sangzhi alkaloids) efficacy safety placebo

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Tranexamic acid for intracerebral haemorrhage within 2 hours of onset: protocol of a phase Ⅱ randomised placebo-controlled double-blind multicentre trial

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Stroke & Vascular Neurology 2022年第2期7卷 158-165页

作者： Nawaf Yassi Henry Zhao Leonid Churilov Bruce C V Campbell Teddy Wu Henry Ma Andrew Cheung Timothy Kleinig Helen Brown Philip Choi Jiann-Shing Jeng Annemarei Ranta Hao-Kuang Wang Geoffrey C Cloud Rohan Grimley Darshan Shah Neil Spratt Der-Yang Cho Karim Mahawish Lauren Sanders John Worthington Ben Clissold Atte Meretoja Vignan Yogendrakumar Mai Duy Ton Duc Phuc Dang Nguyen Thai My Phuong Huy-Thang Nguyen Chung Y Hsu Gagan Sharma Peter J Mitchell Bernard Yan Mark W Parsons Christopher Levi Geoffrey A Donnan Stephen M Davis Department of Medicine and Neurology Melbourne Brain Centre at The Royal Melbourne HospitalThe University of MelbourneParkvilleVictoriaAustralia Population Health and Immunity Division Walter and Eliza Hall Institute of Medical ResearchParkvilleVictoriaAustralia Ambulance Victoria MelbourneVictoriaAustralia Melbourne Medical School The University of MelbourneMelbourneVictoriaAustralia Stroke Division The Florey Institute of Neuroscience and Mental HealthParkvilleVictoriaAustralia Department of Neurology Christchurch HospitalChristchurchNew Zealand Department of Neurology Monash Medical CentreMonash UniversityClaytonVictoriaAustralia Department of Interventional Neuroradiology Liverpool HospitalLiverpoolNew South WalesAustralia Department of Neurology Royal Adelaide HospitalAdelaideSouth AustraliaAustralia Department of Neurology Princess Alexandra HospitalWoolloongabbaQueenslandAustralia Department of Neurology Box Hill HospitalEastern HealthBox HillVictoriaAustralia Stroke Centre and Department of Neurology National Taiwan University HospitalTaipeiTaiwan Department of Medicine Dunedin School of MedicineUniversity of OtagoWellingtonNew Zealand Department of Neurosurgery E-Da HospitalYanchaoKaohsiungTaiwan Department of Neurology Alfred HospitalMelbourneVictoriaAustralia Department of Clinical Neuroscience Monash University Central Clinical SchoolMelbourneVictoriaAustralia Department of Medicine Sunshine Coast University HospitalNambourQueenslandAustralia Department of Neurology Gold Coast University HospitalSouthportQueenslandAustralia Department of Neurology John Hunter HospitalThe University of NewcastleNewcastleNew South WalesAustralia Department of Neurosurgery China Medical University HospitalTaichungTaiwan Department of Internal Medicine Palmerston North HospitalPalmerston NorthNew Zealand Department of Neurology St Vincent's HospitalFitzroyVictoriaAustralia Department of Neurology Royal Prince Alfred HospitalCamperdownNew South WalesAustra

Rationale Haematoma growth is common early after intracerebral haemorrhage(ICH),and is a key determinant of outcome.Tranexamic acid,a widely available antifibrinolytic agent with an excellent safety profile,may reduce haematoma growth.Methods and design Stopping intracerebral haemorrhage with tranexamic acid for hyperacute onset presentation including mobile stroke units(STOP-MSU)is a phase Ⅱ double-blind,randomised,placebo-controlled,multicentre,international investigator-led clinical trial,conducted within the estimand statistical framework.Hypothesis In patients with spontaneous ICH,treatment with tranexamic acid within 2 hours of onset will reduce haematoma expansion compared with placebo.Sample size estimates A sample size of 180 patients(90 in each arm)would be required to detect an absolute difference in the primary outcome of 20%(placebo 39%vs treatment 19%)under a two-tailed significance level of 0.05.An adaptive sample size re-estimation based on the outcomes of 144 patients will allow a possible increase to a prespecified maximum of 326 patients.Intervention Participants will receive 1 g intravenous tranexamic acid over 10 min,followed by 1 g intravenous tranexamic acid over 8 hours;or matching placebo.Primary efficacy measure The primary efficacy measure is the proportion of patients with haematoma growth by 24±6 hours,defined as either≥33%relative increase or≥6 mL absolute increase in haematoma volume between baseline and follow-up CT scan.Discussion We describe the rationale and protocol of STOP-MSU,a phase Ⅱ trial of tranexamic acid in patients with ICH within 2 hours from onset,based in participating mobile stroke units and emergency departments.

关键词： placebo centre absolute

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Progress in the design and quality control of placeboes for clinical trials of traditional Chinese medicine

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Journal of Integrative Medicine 2022年第3期20卷 204-212页

作者： Ning Guo Fei Wu Mei Wu Yuan Wang Qing Lang Xiao Lin Yi Feng College of Chinese Materia Medica Shanghai University of Traditional Chinese MedicineShanghai 201203China Engineering Research Center of Modern Preparation Technology of TCM of Ministry of Education Shanghai University of Traditional Chinese MedicineShanghai 201203China Department of Traditional Chinese Medicine Beicai Community Health Service Center of Pudong New DistrictShanghai 201204China

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.

关键词： Traditional Chinese medicines placebo Critical quality attributes Clinical trial Similarity

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Patient blinding with blunt tip placebo acupuncture needles:comparison between 1 mm and 2 mm skin press

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Journal of Integrative Medicine 2018年第3期16卷 164-171页

作者： Nobuari Takakura Miho Takayama Morihiro Nasu Masako Nishiwaki Akiko Kawase Hiroyoshi Yajima Department of Acupuncture and Moxibustion Faculty of Health Sciences Tokyo Ariake University of Medical and Health Sciences Department of Physiology Showa University School of Medicine Japan School of Acupuncture Moxibustion and Physiotherapy

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.

关键词： Double-blind method Acupuncture placebo Sham De qi

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Tranexamic acid for acute intracerebral haemorrhage growth based on imaging assessment (TRAIGE): a multicentre, randomised, placebo- controlled trial

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Stroke & Vascular Neurology 2021年第2期6卷 160-169页

作者： Jingyi Liu Ximing Nie Hongqiu Gu Qi Zhou Haixin Sun Ying Tan Dacheng Liu Lina Zheng Jiahui Zhao Yan Wang Yibin Cao Haomeng Zhu Yunpeng Zhang Lijin Yi Yuehua Pu Miao Wen Zhonghua Yang Shengjun Sun Wenzhi Wang Xingquan Zhao Liping Liu Yongjun Wang Department of Neurology Beijing Tiantan HospitalCapital Medical UniversityBeijingChina China National Clinical Research Center for Neurological Diseases BeijingChina Beijing Neurosurgical Institute Beijing Tiantan HospitalCapital Medical UniversityBeijingChina Department of Neurology The First Affiliated Hospital of Xi'an Jiaotong UniversityBeijingChina Department of Medicine and Therapeutics Prince of Wales HospitalShatinHong Kong Department of Neurology Tangshan People’s HospitalTangshanChina Department of Neurology Tangshan Gongren HospitalTangshanChina Department of Neurology Beijing Luhe HospitalCapital Medical UniversityBeijingChina Department of Neurology Beijing Pinggu HospitalBeijingChina Department of Neurology Liangxiang Hospital of Beijing Fangshan DistrictBeijingChina Department of Neuroradiology Beijing Tiantan HospitalCapital Medical UniversityBeijingChina

Background Studies show tranexamic acid can reduce the risk of death and early neurological deterioration after intracranial haemorrhage.We aimed to assess whether tranexamic acid reduces haematoma expansion and improves outcome in intracerebral haemorrhage patients susceptible to haemorrhage expansion.Methods We did a prospective,double-blind,randomised,placebo-controlled trial at 10 stroke centres in China.Acute supratentorial intracerebral haemorrhage patients were eligible if they had indication of haemorrhage expansion on admission imaging(eg,spot sign,black hole sign or blend sign),and were treatable within 8 hours of symptom onset.Patients were randomly assigned(1:1)to receive either tranexamic acid or a matching placebo.The primary outcome was intracerebral haematoma growth(>33% relative or>6 mL absolute)at 24 hours.Clinical outcomes were assessed at 90 days.Results Of the 171 included patients,124(72.5%)were male,and the mean age was 55.9±11.6 years.89 patients received tranexamic acid and 82 received placebo.The primary outcome did not differ significantly between the groups:36(40.4%)patients in the tranexamic acid group and 34(41.5%)patients in the placebo group had intracranial haemorrhage growth(OR 0.96,95% CI 0.52 to 1.77,p=0.89).The proportion of death was lower in the tranexamic acid treatment group than placebo group(8.1%vs 10.0%),but there were no significant differences in secondary outcomes including absolute intracranial haemorrhage growth,death and dependency.Conclusions Among patients susceptible to haemorrhage expansion treated within 8 hours of stroke onset,tranexamic acid did not significantly prevent intracerebral haemorrhage growth.Larger studies are needed to assess safety and efficacy of tranexamic acid in intracerebral haemorrhage patients.

关键词： placebo centre absolute

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Efficacy and safety of intravenous tranexamic acid in total shoulder arthroplasty:A meta-analysis

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World Journal of Clinical Cases 2023年第13期11卷 2992-3001页

作者： Hua-Mei Deng The Second Affiliated Hospital Guangzhou University of Chinese MedicineGuangzhou 510120Guangdong ProvinceChina

BACKGROUND Total shoulder arthroplasty(TSA)results in a large amount of perioperative blood loss due to severe trauma.AIM To investigate the safety and efficacy of intravenous tranexamic acid(TXA)in TSA.METHODS We searched the PubMed,Cochrane Library,Embase and Web of Science databases for randomized controlled trials(RCTs)on the use of TXA in TSA.And all the results were checked and assessed by Reference Citation Analysis(https://***/).A meta-analysis was performed with Review Manager 5.3 to calculate the odds ratio(OR)or weighted mean difference(WMD)of related outcome indicators.RESULTS A total of 5 RCTs with level 1 evidence were included.There were 369 cases,with 186 in the TXA group and 183 in the placebo group.The meta-analysis showed that TXA can significantly reduce total blood loss during the perioperative period[WMD=-249.56,95%confidence interval(CI):-347.6 to-151.52,Pplacebo group,the TXA group had significantly less total haemoglobin loss(WMD=-34.39,95%CI:-50.56 to-18.22),less haemoglobin fluctuation before and after the operation(WMD=-0.6,95%CI:-0.93 to-0.27)and less 24-h drain output(WMD=-136.87,95%CI:-165.87 to-106.49).There were no significant differences in the operation time(P=0.11)or hospital length of stay(P=0.30)between the two groups.CONCLUSION The application of intravenous TXA in the perioperative period of TSA can significantly reduce the total volume of perioperative blood loss and reduce the incidence of adverse reactions,so TXA is worthy of widespread clinical use.

关键词： Intravenous Tranexamic acid Total shoulder arthroplasty placebo Meta-analysis

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A Preparation Model of Chinese Medicine Decoction placebo

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Chinese Journal of Integrative Medicine 2017年第8期23卷 631-634页

作者： BIAN Li-qun LI Bao-shuang LI Zhen-hua WANG Feng-yun WEN Yan-dong TANG Xu-dong Department of Gastroenterology Xiyuan Hospital China Academy of Chinese Medical Sciences Beijing 100091 China

Chinese medicine（CM）decoction placebo is one of the key factors restricting the placebo-controlled clinical trial of CM.In this article,based on the analysis of the difficulties in preparing CM placebo,the production requirements for placebo were put forward.Moreover,in accordance with clinical practices,a production method and evaluation process of CM decoction placebo was proposed,to provide a reference for clinical research.

关键词： placebo decoction Chinese medicine preparation model

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