Abstract:
Background:Probiotics, prebiotics, and synbiotics are used increasingly, although the safety and potential harms of these interventions are poorly understood. Purpose:To examine how harms-related information is reported in publications of randomized controlled trials (RCTs) of probiotics, prebiotics, and synbiotics. Data Sources:Cochrane Central Register of Controlled Trials, PubMed, EMBASE, and Web of Science (without language restrictions) from 1 January 2015 to 20 March 2018. Study Selection:RCTs assessing the safety or efficacy of at least 1 intervention involving probiotics, prebiotics, or synbiotics alone or in combination with another intervention compared with any control (such as a placebo or an antibiotic) for any clinical condition. Data Extraction:4 reviewers independently assessed study characteristics, the reporting of harms, and the presentation of safety results. Data Synthesis:Of 384 trials conducted in healthy volunteers (n = 136) or patients with any of several medical conditions (n = 248), 339 (88%) were published in specialty journals. Trials most often evaluated probiotics (n = 265 [69%]). Studies in persons with medical conditions enrolled outpatients (n = 195) and high-risk patients (n = 53). No harms-related data were reported for 106 trials (28%), safety results were not reported for 142 (37%), and the number of serious adverse events (SAEs) per study group was not given for 309 (80%). Of 242 studies mentioning harms-related results, 37% (n = 89) used only generic statements to describe AEs and 16% (n = 38) used inadequate metrics. Overall, 375 trials (98%) did not give a definition for AEs or SAEs, the number of participant withdrawals due to harms, or the number of AEs and SAEs per study group with denominators. Limitation:Journal publication processes may have affected the completeness of reporting; only English-language publications were examined. Conclusion:Harms reporting in published reports of RCTs assessing probiotics, prebiotics, and synbiotics often is lacking or inadequate. We cannot broadly conclude that these interventions are safe without reporting safety data. Primary Funding Source:No specific funding.
journal_name
Ann Intern Medjournal_title
Annals of internal medicineauthors
Bafeta A,Koh M,Riveros C,Ravaud Pdoi
10.7326/M18-0343subject
Has Abstractpub_date
2018-08-21 00:00:00pages
240-247issue
4eissn
0003-4819issn
1539-3704pii
2687953journal_volume
169pub_type
杂志文章abstract::The term "medical necessity" is used ubiquitously in health care, but its meaning and implementation vary substantially among providers, payers, and patients. This ambiguity has led some to suggest that cost-effectiveness be used as a basis for decision rules. This paper presents an analytical framework that is famili...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:10.7326/0003-4819-126-2-199701150-00011
更新日期:1997-01-15 00:00:00
abstract::Subjects (109) with symptomatic Paget's disease of bone were treated with 5, 10, or 20 mg of sodium etidronate (EHDP)/kg body weight - day for 6 to 24 months. Significant decreases in serum alkaline phosphatase and urinary hydroxyproline were noted after 6 months of therapy; no significant further improvement resulted...
journal_title:Annals of internal medicine
pub_type: 临床试验,杂志文章
doi:10.7326/0003-4819-87-6-656
更新日期:1977-12-01 00:00:00
abstract:OBJECTIVE:To determine if polyvalent IgG is promising therapy for severe IgG nephropathy. DESIGN:Open prospective cohort study. SETTING:Referral nephrology unit. PATIENTS:11 adult patients with severe IgA nephropathy (9 who had idiopathic disease and 2 who had Henoch-Schönlein purpura) and indicators of poor prognos...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-120-6-199403150-00005
更新日期:1994-03-15 00:00:00
abstract:BACKGROUND:Longer-term mortality benefit and cost-effectiveness for abdominal aortic aneurysm (AAA) screening are uncertain. OBJECTIVE:To estimate the benefits, in terms of AAA-related and all-cause mortality, and cost-effectiveness of ultrasonography screening for AAA in a group that was invited to screening compared...
journal_title:Annals of internal medicine
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.7326/0003-4819-146-10-200705150-00003
更新日期:2007-05-15 00:00:00
abstract:BACKGROUND:Little evidence exists to support the theory that small-bore nasogastric tubes prevent gastroesophageal reflux and microaspiration in intubated patients. OBJECTIVE:To determine whether gastroesophageal reflux and microaspiration in intubated patients can be reduced by the use of a small-bore nasogastric tub...
journal_title:Annals of internal medicine
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.7326/0003-4819-130-12-199906150-00007
更新日期:1999-06-15 00:00:00
abstract:OBJECTIVE:To determine whether antimicrobial therapy for Helicobacter pylori infection accelerates the healing of duodenal ulcers. DESIGN:Single-blind, randomized, controlled trial. SETTING:Veterans Affairs hospital. PARTICIPANTS:One hundred and five patients with endoscopically verified duodenal ulcers. INTERVENTI...
journal_title:Annals of internal medicine
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.7326/0003-4819-115-4-266
更新日期:1991-08-15 00:00:00
abstract:BACKGROUND:The risk for and determinants of transmission of tuberculosis in hospitals caring for moderate numbers of patients with tuberculosis remain uncertain. OBJECTIVE:To study the association of tuberculin conversion among health care workers with ventilation of patient care areas. DESIGN:Cross-sectional observa...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-133-10-200011210-00010
更新日期:2000-11-21 00:00:00
abstract::Medical professional codes have long prohibited physician involvement in assisting a patient's suicide. However, despite ethical and legal prohibitions, calls for the liberalization of this ban have grown in recent years. The medical profession should articulate its views on the arguments for and against changes in pu...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-135-3-200108070-00015
更新日期:2001-08-07 00:00:00
abstract::The clinical significance of anatomic substage was assessed in 130 patients with Hodgkin's disease in pathologic stage III-A: stage III1-A includes involvement of spleen, or splenic, celiac, or portal nodes, or any combination of these; stage III2-A includes involvement of para-aortic, iliac, or mesenteric nodes, with...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-92-2-159
更新日期:1980-02-01 00:00:00
abstract:BACKGROUND:The National Kidney Foundation has advocated the use of the abbreviated Modification of Diet in Renal Disease (MDRD) equation to estimate glomerular filtration rate (GFR) from serum creatinine measurements in clinical laboratories. However, healthy persons were not included in the development of the MDRD equ...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-141-12-200412210-00009
更新日期:2004-12-21 00:00:00
abstract:BACKGROUND:Reviews have compared the efficacy and tolerability of newer second-generation antidepressants with those of placebo or older treatments, but comparative evidence for use of second-generation antidepressants to treat major depressive disorder has not been evaluated. PURPOSE:To systematically evaluate compar...
journal_title:Annals of internal medicine
pub_type: 杂志文章,meta分析,评审
doi:10.7326/0003-4819-143-6-200509200-00006
更新日期:2005-09-20 00:00:00
abstract::Because the cholesterol-rich very low density (VLD) lipoproteins of subjects with type III hyperlipoproteinemia are distinctively enriched in apolipoprotein E, a radial immunodiffusion assay for apolipoprotein E in whole plasma was developed. Its diagnostic usefulness was tested in randomly selected (n = 174) and hype...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-87-5-509
更新日期:1977-11-01 00:00:00
abstract::In addition to gonorrhea and syphilis, both of which may develop primarily at anorectal or pharyngeal sites, a number of conditions, including Neisseria meningitidis urethritis, nonspecific urethritis, anorectal herpes, condyloma acuminatum, amebiasis, giardiasis, shigellosis, typhoid fever, enterobiasis, and hepatiti...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:10.7326/0003-4819-92-6-805
更新日期:1980-06-01 00:00:00
abstract:BACKGROUND:Hospice providers contend that enrollment reduces the cost of the Medicare programs, but estimates of effects are dated, methodologically limited, and focused on persons with cancer. OBJECTIVE:To estimate the effects of hospice care on Medicare program payments during the last year of life from 1996 to 1999...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-140-4-200402170-00009
更新日期:2004-02-17 00:00:00
abstract::We observed the course of cytomegalovirus (CMV) retinitis in 21 eyes of 14 immunosuppressed patients. In two patients, other organisms, specifically Toxoplasma and Candida, also appeared to be causing retinal disease simultaneously. Post-mortem examination was done on 10 eyes from seven patients. At initial presentati...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-93-5-664
更新日期:1980-11-01 00:00:00
abstract:BACKGROUND:The risk for hypertension after kidney donation remains uncertain. PURPOSE:To see whether normotensive adults who donate a kidney develop higher blood pressure and risk for hypertension compared with nondonor adults acting as control participants. DATA SOURCES:MEDLINE, EMBASE, and Science Citation Index we...
journal_title:Annals of internal medicine
pub_type: 杂志文章,meta分析,评审
doi:10.7326/0003-4819-145-3-200608010-00006
更新日期:2006-08-01 00:00:00
abstract:BACKGROUND:Testing has been advocated for all persons with newly diagnosed colorectal cancer to identify families with the Lynch syndrome, an autosomal dominant cancer-predisposition syndrome that is a paradigm for personalized medicine. OBJECTIVE:To estimate the effectiveness and cost-effectiveness of strategies to i...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-155-2-201107190-00002
更新日期:2011-07-19 00:00:00
abstract:BACKGROUND:Staphylococcus aureus is a common cause of serious infection in patients infected with HIV. OBJECTIVES:To evaluate risk factors for and quantitative effect of S. aureus infection in HIV-infected patients, with special attention to nasal carriage. DESIGN:Prospective, multihospital cohort study. SETTING:Thr...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-130-3-199902020-00026
更新日期:1999-02-02 00:00:00
abstract::A patient with a retained bullet developed lead poisoning in association with thyrotoxicosis. The clinical and laboratory data suggest that lead was mobilized from an increased mobile bone pool during the hypermetabolic period with resultant poisoning. The findings give factual support to earlier concepts that lead po...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-89-4-509
更新日期:1978-10-01 00:00:00
abstract:BACKGROUND:Recent guidelines for adult prevention do not recommend a comprehensive annual physical examination, but current public expectations in light of this change are unknown. OBJECTIVE:To determine public belief in the need for and content of an annual physical examination and to examine the effect of financial ...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-136-9-200205070-00007
更新日期:2002-05-07 00:00:00
abstract::A severe shortage of organs greatly limits the ability to deliver the miracle of transplantation to people suffering from end-stage organ disease. Contributing to this shortage is a high rate of refusal among families who are asked for permission to remove organs from a recently deceased relative. Mandated choice offe...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:10.7326/0003-4819-125-1-199607010-00010
更新日期:1996-07-01 00:00:00
abstract::The observations that have provided the foundation of the sodium hypothesis of human hypertension are reviewed. Clinical observations made over 125 years ago initiated an investigative effort that has encompassed epidemiologic data, development of salt-related experimental models, and elucidation of theoretical mechan...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-98-5-720
更新日期:1983-05-01 00:00:00
abstract::We treated 289 men with nongonococcal urethritis in a randomized, double-blind study with minocycline, 100 mg once or twice daily for 7 or 21 days. Ureaplasma urealyticum was isolated before treatment from 167 (58%). The pretherapy isolates from 82 men re-examined 6 to 8 days after initiation of treatment were viable....
journal_title:Annals of internal medicine
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.7326/0003-4819-94-2-192
更新日期:1981-02-01 00:00:00
abstract:BACKGROUND:The appropriate roles for several diagnostic tests for coronary disease are uncertain. OBJECTIVE:To evaluate the cost-effectiveness of alternative approaches to diagnosis of coronary disease. DESIGN:Meta-analysis of the accuracy of alternative diagnostic tests plus decision analysis to assess the health ou...
journal_title:Annals of internal medicine
pub_type: 杂志文章,meta分析
doi:10.7326/0003-4819-130-9-199905040-00003
更新日期:1999-05-04 00:00:00
abstract:OBJECTIVE:To provide a rational strategy for the evaluation and long-term management of epilepsy. DATA SOURCES:Articles written between 1964 and 1993, obtained from a MEDLINE search on epilepsy-related topics as well as from the author's personal files, major reference books on antiepileptic drugs, and references iden...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:10.7326/0003-4819-120-5-199403010-00010
更新日期:1994-03-01 00:00:00
abstract::A cohort of both active and retired older cotton textile workers was examined prospectively over a 6-year period to establish the nature and extent of chronic lung disease. Respiratory symptoms and lung function were studied in these workers and in a group of similarly aged controls. The cotton textile workers had hig...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-97-5-645
更新日期:1982-11-01 00:00:00
abstract:BACKGROUND:Early prenatal care is vital for improving maternal health outcomes and health behaviors, but medically vulnerable and underserved populations are less likely to begin prenatal care in the first trimester. In 2017, the Health Center Program provided safety-net care to more than 27 million persons, including ...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/M19-3248
更新日期:2020-12-01 00:00:00
abstract:SOURCE CITATION:Baldetti L, Melillo F, Moroni F, et al. Meta-analysis comparing P2Y12 inhibitors in acute coronary syndrome. Am J Cardiol. 2020;125;1815-22. 32305225. ...
journal_title:Annals of internal medicine
pub_type: 评论,杂志文章
doi:10.7326/ACPJ202009150-027
更新日期:2020-09-15 00:00:00
abstract:BACKGROUND:Some physicians seem to be willing to sanction deception of insurance companies. Little is known about public attitudes regarding this practice. OBJECTIVE:To assess public attitudes regarding physician deception of insurance companies. DESIGN:Cross-sectional survey using clinical vignettes. SETTING:Philad...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-138-6-200303180-00011
更新日期:2003-03-18 00:00:00
abstract:BACKGROUND:The effect of physician diagnostic variability on accuracy at a population level depends on the prevalence of diagnoses. OBJECTIVE:To estimate how diagnostic variability affects accuracy from the perspective of a U.S. woman aged 50 to 59 years having a breast biopsy. DESIGN:Applied probability using Bayes'...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/M15-0964
更新日期:2016-05-17 00:00:00