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Ultrasound in Obstetrics & Gynecology :... May 2022Fetal intracranial hemorrhage (ICH) is associated with an increased risk of perinatal mortality and morbidity. Healthcare professionals often find it challenging to... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Fetal intracranial hemorrhage (ICH) is associated with an increased risk of perinatal mortality and morbidity. Healthcare professionals often find it challenging to counsel parents due to its rarity and diverse presentation. The aim of this systematic review and meta-analysis was to investigate the perinatal outcome of fetuses with ICH.
METHODS
MEDLINE, EMBASE, ClinicalTrials.gov and The Cochrane Library databases were searched. Inclusion criteria were studies reporting the outcome of fetuses, newborns and infants diagnosed with ICH. The primary outcome was perinatal death (PND), defined as the sum of intrauterine (IUD) and neonatal death (NND). The secondary outcomes were stillbirth, NND, IUD, termination of pregnancy, need for surgery/shunting at birth, cerebral palsy (defined according to the European Cerebral Palsy Network and classified as diplegia, hemiplegia, quadriplegia, dyskinetic or mixed), neurodevelopmental delay and intact survival. All outcomes were explored in the included fetuses with ICH. A subgroup analysis according to the location of the hemorrhage (intra-axial and extra-axial) was also planned. Meta-analysis of proportions was used to combine data, and pooled proportions and their 95% CI were reported.
RESULTS
Sixteen studies (193 fetuses) were included in the meta-analysis. PND occurred in 14.6% (95% CI, 7.3-24.0%) of fetuses with ICH. Among liveborn cases, 27.6% (95% CI, 12.5-45.9%) required shunt placement or surgery after birth and 32.0% (95% CI, 22.2-42.6%) had cerebral palsy. Furthermore, 16.7% (95% CI, 8.4-27.2%) of cases had mild neurodevelopmental delay, while 31.1% (95% CI, 19.0-44.7%) experienced severe adverse neurodevelopmental outcome. Normal neurodevelopmental outcome was reported in 53.6% of fetuses. Subgroup analysis according to the location of ICH showed that PND occurred in 13.3% (95% CI, 5.7-23.4%) of fetuses with intra-axial bleeding and 26.7% (95% CI, 5.3-56.8%) of those with extra-axial bleeding. In fetuses with intra-axial hemorrhage, 25.2% (95% CI, 11.0-42.9%) required shunt placement or surgery after birth and 25.5% (95% CI, 15.3-37.2%) experienced cerebral palsy. In fetuses with intra-axial hemorrhage, mild and severe neurodevelopmental delay was observed in 14.9% (95% CI, 12.0-27.0%) and 32.8% (95% CI, 19.8-47.4%) of cases, respectively, while 53.2% (95% CI, 37.0-69.1%) experienced normal neurodevelopmental outcome. The incidence of mortality and postnatal neurodevelopmental outcome in fetuses with extra-axial hemorrhage could not be estimated reliably due to the small number of cases.
CONCLUSIONS
Fetuses with a prenatal diagnosis of ICH are at high risk of perinatal mortality and adverse neurodevelopmental outcome. Postnatal shunt placement or surgery was required in 28% of cases and cerebral palsy was diagnosed in approximately one-third of infants. Due to the rarity of ICH, multicenter prospective registries are warranted to collect high-quality data. © 2021 International Society of Ultrasound in Obstetrics and Gynecology.
Topics: Cerebral Palsy; Female; Fetal Diseases; Fetus; Hemorrhage; Humans; Infant; Infant, Newborn; Intracranial Hemorrhages; Multicenter Studies as Topic; Nervous System Malformations; Perinatal Death; Pregnancy; Prospective Studies
PubMed: 34529308
DOI: 10.1002/uog.24766 -
BMJ Open Sep 2023We conducted a systematic review to evaluate associations between influenza vaccination during pregnancy and adverse birth outcomes and maternal non-obstetric serious...
OBJECTIVE
We conducted a systematic review to evaluate associations between influenza vaccination during pregnancy and adverse birth outcomes and maternal non-obstetric serious adverse events (SAEs), taking into consideration confounding and temporal biases.
METHODS
Electronic databases (Ovid MEDLINE ALL, Embase Classic+Embase and the Cochrane Central Register of Controlled Trials) were searched to June 2021 for observational studies assessing associations between influenza vaccination during pregnancy and maternal non-obstetric SAEs and adverse birth outcomes, including preterm birth, spontaneous abortion, stillbirth, small-for-gestational-age birth and congenital anomalies. Studies of live attenuated vaccines, single-arm cohort studies and abstract-only publications were excluded. Records were screened using a liberal accelerated approach initially, followed by a dual independent approach for full-text screening, data extraction and risk of bias assessment. Pairwise meta-analyses were conducted, where two or more studies met methodological criteria for inclusion. The Grading of Recommendations, Assessment, Development and Evaluation approach was used to assess evidence certainty.
RESULTS
Of 9443 records screened, 63 studies were included. Twenty-nine studies (24 cohort and 5 case-control) evaluated seasonal influenza vaccination (trivalent and/or quadrivalent) versus no vaccination and were the focus of our prioritised syntheses; 34 studies of pandemic vaccines (2009 A/H1N1 and others), combinations of pandemic and seasonal vaccines, and seasonal versus seasonal vaccines were also reviewed. Control for confounding and temporal biases was inconsistent across studies, limiting pooling of data. Meta-analyses for preterm birth, spontaneous abortion and small-for-gestational-age birth demonstrated no significant associations with seasonal influenza vaccination. Immortal time bias was observed in a sensitivity analysis of meta-analysing risk-based preterm birth data. In descriptive summaries for stillbirth, congenital anomalies and maternal non-obstetric SAEs, no significant association with increased risk was found in any studies. All evidence was of very low certainty.
CONCLUSIONS
Evidence of very low certainty suggests that seasonal influenza vaccination during pregnancy is not associated with adverse birth outcomes or maternal non-obstetric SAEs. Appropriate control of confounding and temporal biases in future studies would improve the evidence base.
Topics: Infant, Newborn; Female; Pregnancy; Humans; Abortion, Spontaneous; Stillbirth; Influenza A Virus, H1N1 Subtype; Influenza, Human; Premature Birth
PubMed: 37673449
DOI: 10.1136/bmjopen-2022-066182 -
Cureus Dec 2022Sildenafil is a medication used for the treatment of erectile dysfunction. It was approved by the U.S. Food and Drug Administration (FDA) in 1998. Several articles have... (Review)
Review
Sildenafil is a medication used for the treatment of erectile dysfunction. It was approved by the U.S. Food and Drug Administration (FDA) in 1998. Several articles have raised concerns regarding the use of sildenafil and the occurrence of serious adverse events, such as myocardial ischemia, stroke, and even death. Our aim is to systematically review the existing literature on mortality associated with sildenafil use. The method used for this systematic review was completed by searching three databases: PubMed, Scopus, and Web of Science. Articles were screened and assessed for eligibility. This review uses the articles found to address the concerns associated with sildenafil and mortality. A total of 19 reports were used in our systematic review, in which there were 10 case reports, two case series, three systematic reviews, one narrative review, one retrospective study, one article in the , and one commentary article. One FDA article in particular included case reports and reports to the FDA on the use of sildenafil eight months after its introduction to the market in 1998, with 522 deaths reported. Another retrospective study examined the use of sildenafil on infants below the age of 1 who did not have congenital heart disease but did suffer from severe pulmonary hypertension. The study found a mortality rate of 29%, which increased with sildenafil dosage. A case series examined six deaths related to non-prescription use of sildenafil. All these cases were subjected to autopsies and related to sexual activity. The study suggests that phosphodiesterase 5 inhibitors induced the deaths, and the concentration of sildenafil in the femoral blood was found to be between 0.032and0.087 μg. To conclude, the literature available on this topic is deemed insufficient to provide enough data to establish a direct link of causality between sildenafil and mortality. Although some studies paint sildenafil as the culprit behind these deaths, further studies and research are needed to explain the unexpected deaths following sildenafil use.
PubMed: 36474651
DOI: 10.7759/cureus.32179 -
Scandinavian Journal of Surgery : SJS :... Sep 2023Non-obstetric surgery is fairly common in pregnant women. We performed a systematic review to update data on non-obstetric surgery in pregnant women. The aim of this... (Review)
Review
BACKGROUND AND OBJECTIVE
Non-obstetric surgery is fairly common in pregnant women. We performed a systematic review to update data on non-obstetric surgery in pregnant women. The aim of this review was to evaluate the effects of non-obstetric surgery during pregnancy on pregnancy, fetal and maternal outcomes.
METHODS
A systematic literature search of MEDLINE and Scopus was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The search span was from January 2000 to November 2022. Thirty-six studies matched the inclusion criteria, and 24 publications were identified through reference mining; 60 studies were included in this review. Outcome measures were miscarriage, stillbirth, preterm birth, low birth weight, low Apgar score, and infant and maternal morbidity and mortality rates.
RESULTS
We obtained data for 80,205 women who underwent non-obstetric surgery and data for 16,655,486 women who did not undergo surgery during pregnancy. Prevalence of non-obstetric surgery was between 0.23% and 0.74% (median 0.37%). Appendectomy was the most common procedure with median prevalence of 0.10%. Near half (43%) of the procedures were performed during the second trimester, 32% during the first trimester, and 25% during the third trimester. Half of surgeries were scheduled, and half were emergent. Laparoscopic and open techniques were used equally for abdominal cavity. Women who underwent non-obstetric surgery during pregnancy had increased rate of stillbirth (odds ratio (OR) 2.0) and preterm birth (OR 2.1) compared to women without surgery. Surgery during pregnancy did not increase rate of miscarriage (OR 1.1), low 5 min Apgar scores (OR 1.1), the fetus being small for gestational age (OR 1.1) or congenital anomalies (OR 1.0).
CONCLUSIONS
The prevalence of non-obstetric surgery has decreased during last decades, but still two out of 1000 pregnant women have scheduled surgery during pregnancy. Surgery during pregnancy increases the risk of stillbirth, and preterm birth. For abdominal cavity surgery, both laparoscopic and open approaches are feasible.
Topics: Infant; Pregnancy; Infant, Newborn; Female; Humans; Pregnancy Outcome; Premature Birth; Stillbirth; Abortion, Spontaneous; Fetus
PubMed: 37329286
DOI: 10.1177/14574969231175569 -
The Cochrane Database of Systematic... Jul 2021Ministries of health, donors, and other decision-makers are exploring how they can use mobile technologies to acquire accurate and timely statistics on births and...
BACKGROUND
Ministries of health, donors, and other decision-makers are exploring how they can use mobile technologies to acquire accurate and timely statistics on births and deaths. These stakeholders have called for evidence-based guidance on this topic. This review was carried out to support World Health Organization (WHO) recommendations on digital interventions for health system strengthening.
OBJECTIVES
Primary objective: To assess the effects of birth notification and death notification via a mobile device, compared to standard practice. Secondary objectives: To describe the range of strategies used to implement birth and death notification via mobile devices and identify factors influencing the implementation of birth and death notification via mobile devices.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, the Global Health Library, and POPLINE (August 2, 2019). We searched two trial registries (August 2, 2019). We also searched Epistemonikos for related systematic reviews and potentially eligible primary studies (August 27, 2019). We conducted a grey literature search using mHealthevidence.org (August 15, 2017) and issued a call for papers through popular digital health communities of practice. Finally, we conducted citation searches of included studies in Web of Science and Google Scholar (May 15, 2020). We searched for studies published after 2000 in any language. SELECTION CRITERIA: For the primary objective, we included individual and cluster-randomised trials; cross-over and stepped-wedge study designs; controlled before-after studies, provided they have at least two intervention sites and two control sites; and interrupted time series studies. For the secondary objectives, we included any study design, either quantitative, qualitative, or descriptive, that aimed to describe current strategies for birth and death notification via mobile devices; or to explore factors that influence the implementation of these strategies, including studies of acceptability or feasibility. For the primary objective, we included studies that compared birth and death notification via mobile devices with standard practice. For the secondary objectives, we included studies of birth and death notification via mobile device as long as we could extract data relevant to our secondary objectives. We included studies of all cadres of healthcare providers, including lay health workers; administrative, managerial, and supervisory staff; focal individuals at the village or community level; children whose births were being notified and their parents/caregivers; and individuals whose deaths were being notified and their relatives/caregivers.
DATA COLLECTION AND ANALYSIS
For the primary objective, two authors independently screened all records, extracted data from the included studies and assessed risk of bias. For the analyses of the primary objective, we reported means and proportions, where appropriate. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess the certainty of the evidence and we prepared a 'Summary of Findings' table. For the secondary objectives, two authors screened all records, one author extracted data from the included studies and assessed methodological limitations using the WEIRD tool and a second author checked the data and assessments. We carried out a framework analysis using the Supporting the Use of Research Evidence (SURE) framework to identify themes in the data. We used the GRADE-CERQual (Confidence in the Evidence from Reviews of Qualitative research) approach to assess our confidence in the evidence and we prepared a 'Summary of Qualitative Findings' table.
MAIN RESULTS
For the primary objective, we included one study, which used a controlled before-after study design. The study was conducted in Lao People's Democratic Republic and assessed the effect of using mobile devices for birth notification on outcomes related to coverage and timeliness of Hepatitis B vaccination. However, we are uncertain of the effect of this approach on these outcomes because the certainty of this evidence was assessed as very low. The included study did not assess resource use or unintended consequences. For the primary objective, we did not identify any studies using mobile devices for death notification. For the secondary objective, we included 21 studies. All studies were conducted in low- or middle-income settings. They focussed on identification of births and deaths in rural, remote, or marginalised populations who are typically under-represented in civil registration processes or traditionally seen as having poor access to health services. The review identified several factors that could influence the implementation of birth-death notification via mobile device. These factors were tied to the health system, the person responsible for notifying, the community and families; and include: - Geographic barriers that could prevent people's access to birth-death notification and post-notification services - Access to health workers and other notifiers with enough training, supervision, support, and incentives - Monitoring systems that ensure the quality and timeliness of the birth and death data - Legal frameworks that allow births and deaths to be notified by mobile device and by different types of notifiers - Community awareness of the need to register births and deaths - Socio-cultural norms around birth and death - Government commitment - Cost to the system, to health workers and to families - Access to electricity and network connectivity, and compatibility with existing systems - Systems that protect data confidentiality We have low to moderate confidence in these findings. This was mainly because of concerns about methodological limitations and data adequacy.
AUTHORS' CONCLUSIONS
We need more, well-designed studies of the effect of birth and death notification via mobile devices and on factors that may influence its implementation.
Topics: Bias; Birth Certificates; Computers, Handheld; Controlled Before-After Studies; Death Certificates; Health Services Accessibility; Humans; Rural Population; Time Factors
PubMed: 34271590
DOI: 10.1002/14651858.CD012909.pub2 -
American Journal of Obstetrics &... Jan 2023The World Health Organization has recently declared a monkeypox outbreak as a public health emergency of global concern. The main aim of this systematic review was to... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
The World Health Organization has recently declared a monkeypox outbreak as a public health emergency of global concern. The main aim of this systematic review was to ascertain the maternal and perinatal outcomes of pregnancies complicated by monkeypox infection.
DATA SOURCES
The Medline, Embase, and Cochrane databases were searched on June 25, 2022 utilizing combinations of the relevant medical subject heading terms, key words, and word variants for "monkeypox" and "pregnancy."
STUDY ELIGIBILITY CRITERIA
The search and selection criteria were restricted to the English language.
METHODS
The outcomes observed were miscarriage; intrauterine, neonatal, and perinatal death; preterm birth, vertical transmission, and maternal symptoms. A metaanalysis of proportions was used to analyze the data.
RESULTS
Four studies were included. All the cases in the present systematic review presented with symptoms and signs of monkeypox infection. There was no case of maternal death. Miscarriage occurred in 39% of cases (95% confidence interval, 0-89.0), whereas intrauterine fetal death occurred in 23.0% (95% confidence interval, 0-74.0) of cases. The overall incidence of late fetal and perinatal loss was 77.0% (95% confidence interval, 26.0-100), whereas only 23% (95% confidence interval, 0-74.0) of the included fetuses survived to birth. The incidence of preterm birth before 37 weeks of gestation was 8.0% (95% confidence interval, 0-62.0). Vertical transmission occurred in 62.0% (95% confidence interval, 3.0-100) of cases. When stratifying the analysis according to gestational age at infection, fetal loss was found to occur in 67.0% (95% confidence interval, 9.0-99.0) of cases with first-trimester infection and in 82.0% (95% confidence interval, 17.0-100) of those with second-trimester infection.
CONCLUSION
Monkeypox infection in pregnancy is associated with a high risk of perinatal loss and vertical transmission. The preliminary results from this systematic review affected by a very small number of included cases highlight the need for thorough maternal and fetal surveillance in pregnancies complicated by monkeypox infection.
Topics: Pregnancy; Female; Infant, Newborn; Humans; Premature Birth; Abortion, Spontaneous; Gestational Age; Stillbirth; Fetal Death
PubMed: 36096413
DOI: 10.1016/j.ajogmf.2022.100747 -
International Archives of Occupational... Jan 2023Ionizing radiation is a human carcinogen, and there is evidence that exposure to low-dose ionizing radiation increases the risk of adverse birth outcomes. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Ionizing radiation is a human carcinogen, and there is evidence that exposure to low-dose ionizing radiation increases the risk of adverse birth outcomes.
METHODS
We undertook a systematic review and meta-analysis to synthesize the research of maternal and paternal exposure to low-dose radiation on low birth weight, miscarriage, pre-term delivery, and stillbirth. Our literature search used four databases (PubMed, Environmental Index, GeoBASE, and the Cumulative Index to Nursing and Allied Health Literature). We included study populations exposed to occupational and medical sources of radiation, nuclear disasters, and those living near nuclear power plants. We considered papers published between January 1st, 1990, and June 30th, 2021. The quality of the studies was assessed, and we performed meta-analysis using random effects models to generate summary measures of association. Forest plots were created to assess the heterogeneity in these measures, and funnel plots were used to assess publication bias.
RESULTS
Overall, 26 studies were identified, and these yielded measures of association from 10, 11, and 8 studies for low birth weight, miscarriage, and stillbirth outcomes, respectively. It was not possible to perform meta-analyses for pre-term delivery due to a small number of studies. The meta-analysis summary relative risk (RR) of having a low-birth-weight infant among those ever exposed to radiation relative to those unexposed, after adjusting for publication bias, was 1.29 (95% CI 0.97-1.73). The corresponding risk estimates for miscarriage and stillbirth were 1.15 (95% CI 1.02-1.30), and 1.19 (95% CI 0.98-1.45), respectively.
CONCLUSIONS
Our findings suggest that ionizing radiation increases the risk of adverse birth outcomes. Future work should strive to provide data needed to better understand the shape of the exposure-response curve.
Topics: Pregnancy; Infant, Newborn; Male; Female; Humans; Stillbirth; Abortion, Spontaneous; Infant, Low Birth Weight; Pregnancy Complications; Premature Birth
PubMed: 35913560
DOI: 10.1007/s00420-022-01911-2 -
BMJ (Clinical Research Ed.) Nov 2023To assess the absolute treatment effects of intravascular imaging guided versus angiography guided percutaneous coronary intervention in patients with coronary artery... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To assess the absolute treatment effects of intravascular imaging guided versus angiography guided percutaneous coronary intervention in patients with coronary artery disease, considering their baseline risk.
DESIGN
Systematic review and meta-analysis.
DATA SOURCES
PubMed/Medline, Embase, and Cochrane Library databases up to 31 August 2023.
STUDY SELECTION
Randomized controlled trials comparing intravascular imaging (intravascular ultrasonography or optical coherence tomography) guided versus coronary angiography guided percutaneous coronary intervention in adults with coronary artery disease.
MAIN OUTCOME MEASURES
Random effect meta-analysis and GRADE (grading of recommendations, assessment, development, and evaluation) were used to assess certainty of evidence. Data included rate ratios and absolute risks per 1000 people for cardiac death, myocardial infarction, stent thrombosis, target vessel revascularization, and target lesion revascularization. Absolute risk differences were estimated using SYNTAX risk categories for baseline risks at five years, assuming constant rate ratios across different cardiovascular risk thresholds.
RESULTS
In 20 randomized controlled trials (n=11 698), intravascular imaging guided percutaneous coronary intervention was associated with a reduced risk of cardiac death (rate ratio 0.53, 95% confidence interval 0.39 to 0.72), myocardial infarction (0.81, 0.68 to 0.97), stent thrombosis (0.44, 0.27 to 0.72), target vessel revascularization (0.74, 0.61 to 0.89), and target lesion revascularization (0.71, 0.59 to 0.86) but not all cause death (0.81, 0.64 to 1.02). Using SYNTAX risk categories, high certainty evidence showed that from low risk to high risk, intravascular imaging was likely associated with 23 to 64 fewer cardiac deaths, 15 to 19 fewer myocardial infarctions, 9 to 13 fewer stent thrombosis events, 28 to 38 fewer target vessel revascularization events, and 35 to 48 fewer target lesion revascularization events per 1000 people.
CONCLUSIONS
Compared with coronary angiography guided percutaneous coronary intervention, intravascular imaging guided percutaneous coronary intervention was associated with significantly reduced cardiac death and cardiovascular outcomes in patients with coronary artery disease. The estimated absolute effects of intravascular imaging guided percutaneous coronary intervention showed a proportional relation with baseline risk, driven by the severity and complexity of coronary artery disease.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO CRD42023433568.
Topics: Humans; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Risk Factors; Myocardial Infarction; Thrombosis; Percutaneous Coronary Intervention; Death; Treatment Outcome
PubMed: 37973170
DOI: 10.1136/bmj-2023-077848 -
BMC Pregnancy and Childbirth Sep 2023There is a dearth of robust evidence regarding the correlation between psoriasis with maternal and neonatal outcomes, making it challenging to establish definitive... (Meta-Analysis)
Meta-Analysis
BACKGROUND
There is a dearth of robust evidence regarding the correlation between psoriasis with maternal and neonatal outcomes, making it challenging to establish definitive recommendations for the management of these patients. This systematic review and meta-analysis aimed to review the evidence with regard to the impact of maternal psoriasis on maternal and neonatal outcomes.
METHODS
Following the PRISMA guideline, a systematic search of English articles using PubMed, Embase, Scopus, ScienceDirect, Web of Science, Google Scholar, and the Cochrane Library was conducted. The search was performed from inception to 22 of May 2022.
RESULT
A significant association was observed between psoriasis and maternal outcomes, including cesarean delivery [OR = 1.25 (95% CI: 1.13-1.30, p-value = 0.001)], (pre)eclampsia [OR = 1.29 (95% CI: 1.15-1.44, p-value = 0.0001)], gestational diabetes [Odds Ratio (OR) = 1.23 (95% Confidence Intervals (CI): 1.15-1.30, p-value = 0.001)], gestational hypertension [OR = 1.31 (95% CI: 1.18-1.45, p-value = 0.001)] and preterm birth [OR = 1.22 (95% CI: 1.10-1.35, p-value = 0.001)]. Also, there was a significant association between psoriasis and neonatal outcomes, including small for gestational age [OR = 1.07 (95% CI: 1.02-1.11, p-value = 0.053)], low birth weight [OR = 1.19 (95% CI: 1.02-1.38, p-value = 0.001)] and stillbirth [OR = 1.27 (95% CI: 1.04-1.55, p-value = 0.023)].
CONCLUSION
Maternal psoriasis could negatively impact maternal and neonatal outcomes. Our results strengthen the importance of close monitoring of the mothers' psoriasis status before and during pregnancy.
Topics: Pregnancy; Female; Infant, Newborn; Humans; Pregnancy Outcome; Premature Birth; Stillbirth; Diabetes, Gestational; Pre-Eclampsia
PubMed: 37777747
DOI: 10.1186/s12884-023-06006-5 -
CJC Open Jan 2021Observational studies have identified inconsistent associations between chronic use of amiodarone and cancer-related outcomes. We performed a systematic review and... (Review)
Review
BACKGROUND
Observational studies have identified inconsistent associations between chronic use of amiodarone and cancer-related outcomes. We performed a systematic review and meta-analysis to evaluate cancer risk among patients receiving amiodarone.
METHODS
We searched MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) to May 1, 2020. We included randomized controlled trials (RCTs) with follow-up ≥2 years that compared amiodarone (any dose) to any comparator (placebo, active pharmacologic or interventional comparator, or usual care), and reported ≥1 outcome of interest. We contacted authors of published chronic amiodarone trials for potentially unreported cancer outcomes. The primary outcome was cancer incidence. Secondary outcomes were cancer-related death and site-specific cancers. We determined risk ratios and 95% confidence intervals using a fixed-effect model, and statistical heterogeneity using . We conducted prespecified subgroup and sensitivity analyses for amiodarone indication, amiodarone dose, duration of therapy, and trial-level risk of bias.
RESULTS
From 1439 articles, we included 5 RCTs (n = 4357). Mean follow-up duration ranged from 21 to 37 months. We included previously unpublished cancer outcome data from 1 RCT. Our primary outcome was not reported in any RCT. There was no significant difference in cancer-related death between amiodarone (1.69%) and the comparator (1.75%) (risk ratio 0.96, 95% confidence interval 0.57-1.63; = 0%). There were no significant interactions from our subgroup or sensitivity analyses.
CONCLUSIONS
Chronic amiodarone use did not increase cancer-related deaths. Data from RCTs do not support an increased risk of cancer-related harms with amiodarone use, and these concerns should not deter use of amiodarone when indicated.
PubMed: 33458637
DOI: 10.1016/j.cjco.2020.09.013