Impact of Investigator Initiated Trials and Industry Sponsored Trials on Medical Practice (Impact): Results of a Cohort Study

Abstract BackgroundDecisions in healthcare are ideally made on basis of the results of clinical trials, published in study registries, as primary journal articles or summarized in secondary research articles. It is still unclear, whether and to what extent public and commercial expenses invested in clinical trials pays out in a way that their findings have an impact on publication output and medical practice.MethodsThe aim of this project was to examine the lifecycle of clinical trials from their registration to their publication and citation in secondary research articles by determining the proportion of trials that were published and were included in systematic review and clinical guidelines. We set-up a cohort of randomized controlled trials (n=691). We created and compared four sub-cohorts of investigator initiated trials (IITs) and industry sponsor trials (ISTs) with and without German contribution. For each trial, we searched for corresponding publications and citing systematic reviews and clinical guidelines.Additionally, we investigated what study characteristics are associated with publication and impact by using multivariable logistic regressions. ResultsOf the 691 trials, 576 (83%) were published as method article or result article in a medical journal and/or the trial results were made available in study registries; results were available for 555 (80%) of the trials. More than half (52%) of the trials were cited by a systematic review and about a quarter (26%) reached impact in a clinical guideline. Drug trials and larger trials are associated with a higher probability to be published and to have an impact than non-drug trials and smaller trials. Results of IITs were more often published as journal article, results of ISTs more often in study registries. International ISTs gain less often impact by inclusion in systematic reviews or guidelines than publicly sponsored trials.ConclusionA considerable proportion of clinical trials investigated was published and had an impact on clinical practice, whereas the proportions depend on specific study characteristic. Study registries are an important alternative or complement to journal articles for publishing study results. There is still a need to improve the transfer of knowledge generated in clinical research into practice.

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Investigator initiated trials versus industry sponsored trials - translation of randomized controlled trials into clinical practice (IMPACT)

BMC Medical Research Methodology ◽

10.1186/s12874-021-01359-x ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Anette Blümle ◽

Katharina Wollmann ◽

Karin Bischoff ◽

Philipp Kapp ◽

Szimonetta Lohner ◽

...

Keyword(s):

Clinical Trials ◽

Clinical Practice ◽

Randomized Controlled Trials ◽

Systematic Reviews ◽

Controlled Trials ◽

Drug Trials ◽

Journal Articles ◽

Randomized Controlled ◽

Investigator Initiated Trials ◽

German Contribution

Abstract Background Healthcare decisions are ideally based on clinical trial results, published in study registries, as journal articles or summarized in secondary research articles. In this research project, we investigated the impact of academically and commercially sponsored clinical trials on medical practice by measuring the proportion of trials published and cited by systematic reviews and clinical guidelines. Methods We examined 691 multicenter, randomized controlled trials that started in 2005 or later and were completed by the end of 2016. To determine whether sponsorship/funding and place of conduct influence a trial’s impact, we created four sub-cohorts of investigator initiated trials (IITs) and industry sponsored trials (ISTs): 120 IITs and 171 ISTs with German contribution compared to 200 IITs and 200 ISTs without German contribution. We balanced the groups for study phase and place of conduct. German IITs were funded by the German Research Foundation (DFG), the Federal Ministry of Education and Research (BMBF), or by another non-commercial research organization. All other trials were drawn from the German Clinical Trials Register or ClinicalTrials.gov. We investigated, to what extent study characteristics were associated with publication and impact using multivariable logistic regressions. Results For 80% of the 691 trials, results were published as result articles in a medical journal and/or study registry, 52% were cited by a systematic review, and 26% reached impact in a clinical guideline. Drug trials and larger trials were associated with a higher probability to be published and to have an impact than non-drug trials and smaller trials. Results of IITs were more often published as a journal article while results of ISTs were more often published in study registries. International ISTs less often gained impact by inclusion in systematic reviews or guidelines than IITs. Conclusion An encouraging high proportion of the clinical trials were published, and a considerable proportion gained impact on clinical practice. However, there is still room for improvement. For publishing study results, study registries have become an alternative or complement to journal articles, especially for ISTs. IITs funded by governmental bodies in Germany reached an impact that is comparable to international IITs and ISTs.

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Impact of investigator initiated trials and industry sponsored trials on medical practice (IMPACT): rationale and study design

BMC Medical Research Methodology ◽

10.1186/s12874-020-01125-5 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

E. Nury ◽

K. Bischoff ◽

K. Wollmann ◽

K. Nitschke ◽

S. Lohner ◽

...

Keyword(s):

Clinical Practice ◽

Systematic Reviews ◽

Medical Practice ◽

Research Impact ◽

Study Cohort ◽

Drug Trials ◽

Study Characteristics ◽

Investigator Initiated Trials ◽

Meta Analyses ◽

The Impact

Abstract Background The German Research Foundation (DFG) and the Federal Ministry of Education and Research (BMBF) initiated large research programs to foster high quality clinical research in the academic area. These investigator initiated trials (IITs) cover important areas of medical research and often go beyond the scope of industry sponsored trials (ISTs). The purpose of this project was to understand to what extent results of randomized controlled IITs and ISTs have an impact on medical practice, measured by their availability for decisions in healthcare and their implementation in clinical practice. We aimed to determine study characteristics influencing a trial’s impact such as type of sponsor and place of conduct. In this article, we describe the rationale and design of this project and present the characteristics of the trials included in our study cohort. Methods The research impact of the following sub-cohorts was compared: German IITs (funded by DFG and BMBF or by other German non-commercial organizations), international IITs (without German contribution), German ISTs, and international ISTs. Trials included were drawn from the DFG−/BMBF-Websites, the German Clinical Trials Register, and from ClinicalTrials.gov. Research impact was measured as follows: 1) proportion of published trials, 2) time to publication, 3) proportion of publications appropriately indexed in biomedical databases, 4) proportion of openly accessible publications, 5) broadness of publication’s target group, 6) citation of publications by systematic reviews or meta-analyses, and 7) appearance of publications or citing systematic reviews or meta-analyses in clinical practice guidelines. We also aimed to identify study characteristics associated with the impact of trials. Results We included 691 trials: 120 German IITs, 200 International IITs, 171 German ISTs and 200 International ISTs. The median number of participants was 150, 30% were international trials and 70% national trials, 48% drug-trials and 52% non-drug trials. Overall, 72% of the trials had one pre-defined primary endpoint, 28% two or more (max. 36). Conclusions The results of this project deepen our understanding of the impact of biomedical research on clinical practice and healthcare policy, add important insights for the efficient allocation of scarce research resources and may facilitate providing accountability to the different stakeholders involved.

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Impact of investigator initiated trials and industry sponsored trials on medical practice (IMPACT): Rationale and study design

10.21203/rs.3.rs-34368/v2 ◽

2020 ◽

Author(s):

Edris Nury ◽

Karin Bischoff ◽

Katharina Wollmann ◽

Kai Nitschke ◽

Szimonetta Lohner ◽

...

Keyword(s):

Clinical Practice ◽

Systematic Reviews ◽

Medical Practice ◽

Research Impact ◽

Study Cohort ◽

Drug Trials ◽

Study Characteristics ◽

Investigator Initiated Trials ◽

Meta Analyses ◽

The Impact

Abstract Background: The German Research Foundation (DFG) and the Federal Ministry of Education and Research (BMBF) initiated large research programs to foster high quality clinical research in the academic area. These investigator initiated trials (IITs) cover important areas of medical research and often go beyond the scope of industry sponsored trials (ISTs). The purpose of this project was to understand to what extent results of randomized controlled IITs and ISTs have an impact on medical practice, measured by their availability for decisions in healthcare and their implementation in clinical practice. We aimed to determine study characteristics influencing a trial’s impact such as type of sponsor and place of conduct. In this article, we describe the rationale and design of this project and present the characteristics of the trials included in our study cohort. Methods: The research impact of the following sub-cohorts was compared: German IITs (funded by DFG and BMBF or by other German non-commercial organizations), international IITs (without German contribution), German ISTs, and international ISTs. Trials included were drawn from the DFG-/BMBF-Websites, the German Clinical Trials Register, and from ClinicalTrials.gov. Research impact was measured as follows: 1) proportion of published trials, 2) time to publication, 3) proportion of publications appropriately indexed in biomedical databases, 4) proportion of openly accessible publications, 5) broadness of publication’s target group, 6) citation of publications by systematic reviews or meta-analyses, and 7) appearance of publications or citing systematic reviews or meta-analyses in clinical practice guidelines. We also aimed to identify study characteristics associated with the impact of trials.Results: We included 691 trials: 120 German IITs, 200 International IITs, 171 German ISTs and 200 International ISTs. The median number of participants was 150, 30% were international trials and 70% national trials, 48% drug-trials and 52% non-drug trials. Overall, 72% of the trials had one pre-defined primary endpoint, 28% two or more (max. 36).Conclusions: The results of this project deepen our understanding of the impact of biomedical research on clinical practice and healthcare policy, add important insights for the efficient allocation of scarce research resources and may facilitate providing accountability to the different stakeholders involved.

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Recombinant Human Adenovirus-p53 Therapy for the Treatment of Oral Leukoplakia and Oral Squamous Cell Carcinoma: A Systematic Review

Medicina ◽

10.3390/medicina57050438 ◽

2021 ◽

Vol 57 (5) ◽

pp. 438

Author(s):

Jagadish Hosmani ◽

Shazia Mushtaq ◽

Shahabe Saquib Abullais ◽

Hussain Mohammed Almubarak ◽

Khalil Assiri ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Oral Cancer ◽

Adverse Events ◽

Randomized Clinical Trials ◽

Oral Leukoplakia ◽

Research Articles ◽

Original Research ◽

Therapeutic Effects ◽

The World

Background and Objectives: Oral cancer is the 6th most common cancer in the world and oral leukoplakia is an oral potentially malignant disorder that could develop into oral cancer. This systematic review focusses on randomized clinical trials for recombinant adenovirus p-53 (rAD-p53) therapy for the treatment of oral leukoplakia and cancer. Materials and Methods: We searched for research articles on various databases such as Pubmed/Medline, Embase, CNKI (China National Knowledge Infra-structure), Springerlink, cochrane and Web of sciences from 2003 to 2020. MeSH (Medical Subject Headings) terms were used for the search. Inclusion criteria included original research, randomized clinical trials and articles only in English language. Exclusion criteria were any articles that were not research articles, not randomized trials, non-human studies, etc. The articles were further graded on the Jadad scale. Results: 578 articles were assessed from various databases; only 3 articles were found to be appropriate for this review. Thus, meta-analysis was not performed because of heterogeneity and lack of data. In the three studies, whether rAD-p53 was used as a standalone therapy or with other therapies, there was a beneficial effect of the therapy. Furthermore, there were no serious adverse events and the only adverse events reported were fever, pain at the local injection site, flu-like symptoms and lowered WBC count. Conclusions: Thus, we can conclude that this therapy has a potential for beneficial therapeutic effects and further clinical trials with more patients need to be performed to get better understanding of the effect of rAD-p53 therapy, which probably will pave the way to its approval in other parts of the world.

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Identifying patient-important outcomes for treatment of bipolar disorder: a systematic review protocol

BMJ Open ◽

10.1136/bmjopen-2021-050453 ◽

2021 ◽

Vol 11 (12) ◽

pp. e050453

Author(s):

Alessia D'Elia ◽

Olivia Orsini ◽

Stephanie Sanger ◽

Alannah Hillmer ◽

Nitika Sanger ◽

...

Keyword(s):

Systematic Review ◽

Bipolar Disorder ◽

Clinical Trials ◽

Systematic Reviews ◽

Treatment Effectiveness ◽

Data Extraction ◽

Risk Of Bias ◽

Observational Research ◽

Cochrane Library ◽

Randomised Controlled

IntroductionTreatment of bipolar disorder is the focus of several clinical trials, however the understanding of the outcomes for establishing treatment effectiveness within these trials is limited. Further, there is limited literature which reports on the outcomes considered to be important to patients, indicating that patient perspectives are often not considered when selecting outcomes of effectiveness within trials. This protocol describes a systematic review which aims to describe the outcomes being used within trials to measure treatment effectiveness, commenting on the inclusion of patient-important outcomes within previous trials.Methods and analysisThis protocol is reported using the Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocols statement. OVID MEDLINE, OVID Embase, OVID APA PsycINFO, Web of Science, the Wiley Cochrane Library, ClinicalTrials.gov and the International Clinical Trials Registry Platform databases will be searched for eligible studies. Screening, full-text and data extraction stages will be completed in duplicate using the Covidence platform for systematic reviews. Eligible studies will include clinical trials of interventions in bipolar disorder, in order to identify outcomes used to assess treatment effectiveness, and qualitative studies, to determine which outcomes have been reported as important by patients. Risk of bias for included studies will be assessed using the Cochrane Risk of Bias Tool for randomised controlled trials, and the Newcastle-Ottawa Scale for observational research.Ethics and disseminationThis review will involve dissemination to key stakeholders, including primary end users such as patients, clinicians and trialists. Knowledge translation tools will be generated to share the relevant conclusions of this review. Results will be communicated to the scientific community through peer-reviewed publications, conferences and workshops. No ethics approval will be sought as this study is based on literature.PROSPERO registration numberCRD42021214435.

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Eysenbach, Tuische and Diepgen’s Evaluation of Web Searching for Identifying Unpublished Studies for Systematic Reviews: An Innovative Study Which is Still Relevant Today

Evidence Based Library and Information Practice ◽

10.18438/b8f049 ◽

2016 ◽

Vol 11 (3) ◽

pp. 108

Author(s):

Simon Briscoe

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Search Engine ◽

Systematic Reviews ◽

Search Engines ◽

Web Search ◽

Web Searching ◽

Web Searches ◽

Web Search Engine ◽

Unpublished Studies

A Review of: Eysenbach, G., Tuische, J. & Diepgen, T.L. (2001). Evaluation of the usefulness of Internet searches to identify unpublished clinical trials for systematic reviews. Medical Informatics and the Internet in Medicine, 26(3), 203-218. http://dx.doi.org/10.1080/14639230110075459 Objective – To consider whether web searching is a useful method for identifying unpublished studies for inclusion in systematic reviews. Design – Retrospective web searches using the AltaVista search engine were conducted to identify unpublished studies – specifically, clinical trials – for systematic reviews which did not use a web search engine. Setting – The Department of Clinical Social Medicine, University of Heidelberg, Germany. Subjects – n/a Methods – Pilot testing of 11 web search engines was carried out to determine which could handle complex search queries. Pre-specified search requirements included the ability to handle Boolean and proximity operators, and truncation searching. A total of seven Cochrane systematic reviews were randomly selected from the Cochrane Library Issue 2, 1998, and their bibliographic database search strategies were adapted for the web search engine, AltaVista. Each adaptation combined search terms for the intervention, problem, and study type in the systematic review. Hints to planned, ongoing, or unpublished studies retrieved by the search engine, which were not cited in the systematic reviews, were followed up by visiting websites and contacting authors for further details when required. The authors of the systematic reviews were then contacted and asked to comment on the potential relevance of the identified studies. Main Results – Hints to 14 unpublished and potentially relevant studies, corresponding to 4 of the 7 randomly selected Cochrane systematic reviews, were identified. Out of the 14 studies, 2 were considered irrelevant to the corresponding systematic review by the systematic review authors. The relevance of a further three studies could not be clearly ascertained. This left nine studies which were considered relevant to a systematic review. In addition to this main finding, the pilot study to identify suitable search engines found that AltaVista was the only search engine able to handle the complex searches required to search for unpublished studies. Conclusion –Web searches using a search engine have the potential to identify studies for systematic reviews. Web search engines have considerable limitations which impede the identification of studies.

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Vitamin D Food Fortification and Nutritional Status in Children: A Systematic Review of Randomized Controlled Trials

Nutrients ◽

10.3390/nu11112766 ◽

2019 ◽

Vol 11 (11) ◽

pp. 2766 ◽

Cited By ~ 2

Author(s):

Paula Nascimento Brandão-Lima ◽

Beatriz da Cruz Santos ◽

Concepción Maria Aguilera ◽

Analícia Rocha Santos Freire ◽

Paulo Ricardo Saquete Martins-Filho ◽

...

Keyword(s):

Systematic Review ◽

Vitamin D ◽

Clinical Trials ◽

Nutritional Status ◽

Systematic Reviews ◽

Randomized Clinical Trials ◽

Hypovitaminosis D ◽

Food Fortification ◽

Fortified Foods ◽

Eligibility Criteria

Children are in the risk group for developing hypovitaminosis D. Several strategies are used to reduce this risk. Among these, fortification of foods with vitamin D (25(OH)D) has contributed to the achievement of nutritional needs. This systematic review aims to discuss food fortification as a strategy for maintenance or recovery of nutritional status related to vitamin D in children. The work was developed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and registered in the International prospective register of systematic reviews (PROSPERO) database (CRD42018052974). Randomized clinical trials with children up to 11 years old, who were offered vitamin D-fortified foods, and who presented 25(OH)D concentrations were used as eligibility criteria. After the selection stages, five studies were included, totaling 792 children of both sexes and aged between two and 11 years. Interventions offered 300–880 IU of vitamin D per day, for a period of 1.6–9 months, using fortified dairy products. In four of the five studies, there was an increase in the serum concentrations of 25(OH)D with the consumption of these foods; additionally, most children reached or maintained sufficiency status. Moreover, the consumption of vitamin D-fortified foods proved to be safe, with no concentrations of 25(OH)D > 250 nmol/L. Based on the above, the fortification of foods with vitamin D can help maintain or recover the nutritional status of this vitamin in children aged 2–11 years. However, it is necessary to perform additional randomized clinical trials in order to establish optimal doses of fortification, according to the peculiarities of each region.

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Smartphone Apps for the Treatment of Mental Disorders: Systematic Review (Preprint)

10.2196/preprints.14897 ◽

2019 ◽

Cited By ~ 1

Author(s):

Ignacio Miralles ◽

Carlos Granell ◽

Laura Díaz-Sanahuja ◽

William Van Woensel ◽

Juana Bretón-López ◽

...

Keyword(s):

Systematic Review ◽

Mental Disorders ◽

Mental Disorder ◽

Systematic Reviews ◽

Research Articles ◽

Multidisciplinary Teams ◽

Psychological Interventions ◽

Clinical Effects ◽

Smartphone Apps ◽

Technical Features

BACKGROUND Smartphone apps are an increasingly popular means for delivering psychological interventions to patients suffering from a mental disorder. In line with this popularity, there is a need to analyze and summarize the state of the art, both from a psychological and technical perspective. OBJECTIVE This study aimed to systematically review the literature on the use of smartphones for psychological interventions. Our systematic review has the following objectives: (1) analyze the coverage of mental disorders in research articles per year; (2) study the types of assessment in research articles per mental disorder per year; (3) map the use of advanced technical features, such as sensors, and novel software features, such as personalization and social media, per mental disorder; (4) provide an overview of smartphone apps per mental disorder; and (5) provide an overview of the key characteristics of empirical assessments with rigorous designs (ie, randomized controlled trials [RCTs]). METHODS The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines for systematic reviews were followed. We performed searches in Scopus, Web of Science, American Psychological Association PsycNET, and Medical Literature Analysis and Retrieval System Online, covering a period of 6 years (2013-2018). We included papers that described the use of smartphone apps to deliver psychological interventions for known mental disorders. We formed multidisciplinary teams, comprising experts in psychology and computer science, to select and classify articles based on psychological and technical features. RESULTS We found 158 articles that met the inclusion criteria. We observed an increasing interest in smartphone-based interventions over time. Most research targeted disorders with high prevalence, that is, depressive (31/158,19.6%) and anxiety disorders (18/158, 11.4%). Of the total, 72.7% (115/158) of the papers focused on six mental disorders: depression, anxiety, trauma and stressor-related, substance-related and addiction, schizophrenia spectrum, and other psychotic disorders, or a combination of disorders. More than half of known mental disorders were not or very scarcely (<3%) represented. An increasing number of studies were dedicated to assessing clinical effects, but RCTs were still a minority (25/158, 15.8%). From a technical viewpoint, interventions were leveraging the improved modalities (screen and sound) and interactivity of smartphones but only sparingly leveraged their truly novel capabilities, such as sensors, alternative delivery paradigms, and analytical methods. CONCLUSIONS There is a need for designing interventions for the full breadth of mental disorders, rather than primarily focusing on most prevalent disorders. We further contend that an increasingly systematic focus, that is, involving RCTs, is needed to improve the robustness and trustworthiness of assessments. Regarding technical aspects, we argue that further exploration and innovative use of the novel capabilities of smartphones are needed to fully realize their potential for the treatment of mental health disorders. CLINICALTRIAL

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Known unknowns and unknown unknowns – An introduction to research on harms

10.31219/osf.io/gukd4 ◽

2021 ◽

Author(s):

Riaz Qureshi ◽

Evan Mayo-Wilson ◽

Tianjing Li

Keyword(s):

Clinical Trials ◽

Systematic Reviews ◽

Health Problem ◽

Randomized Trials ◽

Classification Systems ◽

Limited Information ◽

Journal Articles ◽

Multiple Dimensions ◽

Potential Benefits ◽

Known Unknowns

ObjectiveMost systematic reviews of interventions focus on potential benefits. Common methods and assumptions that are appropriate for assessing benefits can be inappropriate for harms. This paper provides a primer on researching harms, particularly in systematic reviews. Study Design and SettingNarrative review to describe challenges with assessing harm.ResultsSystematic reviewers and investigators for primary studies should be familiar with various terminologies used to describe and classify harms across settings and study reports. Some classification systems facilitate grouping harms for analysis, which has both advantages and limitations for causal inference. Published reports of clinical trials include limited information about harms, so systematic reviewers should not depend on these studies and journal articles to reach conclusions about harms. Visualizations might improve communication of multiple dimensions of harms such as severity, relatedness, and timing.ConclusionThe terminology, classification, detection, collection, and reporting of harms create unique challenges that take time, expertise, and resources to navigate in both primary studies and evidence syntheses. Systematic reviewers might reach incorrect conclusions if they focus on evidence about harms found in published reports of randomized trials of a particular health problem. Systematic reviews could be improved through better identification and reporting of harms in primary studies and through better training and uptake of appropriate methods for synthesizing evidence about harms.

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A Systematic Review and Network Meta-Analysis on the Efficacy of Medications in the Treatment of Chronic Idiopathic Constipation in Japan

Gastroenterology Research and Practice ◽

10.1155/2021/5534687 ◽

2021 ◽

Vol 2021 ◽

pp. 1-13

Author(s):

Atsushi Nakajima ◽

Ayako Shoji ◽

Kinya Kokubo ◽

Ataru Igarashi

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Bayesian Network ◽

Systematic Reviews ◽

Randomized Clinical Trials ◽

Meta Analysis ◽

Relative Efficacy ◽

Idiopathic Constipation ◽

Chronic Idiopathic Constipation ◽

Meta Analyses

Background. In the 2010s, medications with new mechanisms were introduced in Japan for the treatment of chronic idiopathic constipation (CIC). A few systematic reviews have compared medications’ relative efficacy, but the reviews included studies on patients from various races, even though the mechanism of CIC is considered to differ between races. The aim of this study was to use a systematic review and network meta-analysis to compare the relative efficacy of these medications in Japanese patients. Methods. We conducted a meta-analysis and report it here according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). We identified studies by searching MEDLINE (via the PubMed interface) and the Cochrane Library and ICHUSHI databases and included randomized clinical trials that compared medications for CIC with placebo in Japanese adults. Two reviewers independently screened and assessed articles, abstracted data, and assessed the risk of bias. We pooled data by random-effects meta-analyses and also performed a Bayesian network meta-analysis to indirectly compare data. Results. The present systematic review and meta-analyses included 1460 patients in 6 randomized clinical trials: 2 on linaclotide, 3 on elobixibat, 2 on lubiprostone, and 1 on lactulose. The results of direct comparisons showed that linaclotide, elobixibat, and lubiprostone were superior to placebo in the change of spontaneous bowel movements (SBMs) within 1 week: linaclotide, 1.95 (95% CI, 1.51-2.39); elobixibat, 5.69 (95% CI, 3.31-8.07); and lubiprostone, 2.41 (95% CI, 0.82-4.01). The Bayesian network meta-analysis showed consistent results. Elobixibat 10 mg was ranked first for the increase in SBMs and complete SBMs within 1 week and the time to first SBM. Lubiprostone 48 μg was ranked first for the proportion of patients with SBM within 24 hours. Conclusion. Our direct and indirect meta-analyses revealed that the new CIC medications available in Japan have equal efficacy but that elobixibat and lubiprostone are highly likely to be more efficacious.

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