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Acetaminophen, Asthma Link 'Overstated'http://www.medscape.com/viewarticle/835494Laurie Barclay, MD | DisclosuresThere is insufficient evidence of a link between early life exposure to acetaminophen (paracetamol) and asthma to warrant changing guidelines on early life paracetamol exposure, according to a systematic review and meta-analysis published online November 25 in the Archives of Diseases of Childhood.The included studies showed a highly variable association between asthma and exposure to acetaminophen in early pregnancy, as well as moderate confounding by respiratory tract infections for exposure during infancy."Paracetamol, a widely used analgesic and antipyretic, has historically been considered to be safe in both pregnancy and young children," write Mweene Cheelo, MSc, from the Allergy and Lung Health Unit, Centre for Epidemiology and Biostatistics at the Melbourne School of Population and Global Health, University of Melbourne, Australia, and colleagues. "However, paracetamol has recently been identified as a possible cause for the current asthma epidemic. Paracetamol replaced aspirin as analgesic of choice in the 1990s when aspirin was found to be associated with Reyes syndrome."To better understand the possible risk, Cheelo and colleagues reviewed longitudinal studies of the association between paracetamol exposure in utero or during pregnancy and the development of childhood asthma at age 5 years or older.Among 11 observational cohort studies meeting inclusion criteria (of 1192 potentially relevant studies), any use of acetaminophen during the first trimester was associated with increased risk for childhood asthma (five studies, pooled odds ratio [OR], 1.39; 95% confidence interval [CI], 1.01 - 1.91). However, only one of these studies adjusted for maternal respiratory tract infections, and between-study heterogeneity was considerable (I 2, 63%).Of six studies looking at infancy to age 2 years, three studies showed that increasing frequency of acetaminophen use during infancy was linked to greater odds of childhood asthma (pooled OR, 1.15 per doubling of days of exposure; 95% CI, 1.00 - 1.31). However, adjustment for respiratory tract infections in these studies attenuated the association (OR, 1.06, 95% CI, 0.92 - 1.22)."The evidence of an association between early life paracetamol and asthma is often overstated, and there is currently insufficient evidence to support changing guidelines in the use of this medicine," the review authors write.The authors note several limitations of the study include only a small number of studies for each exposure period, limited statistical power, inability to quantitate publication bias, and marked heterogeneity among studies looking at prenatal exposure."Further well designed clinical trials and/or cohort studies are required to definitely answer this question," the review authors write. "Respiratory tract infections appear to confound this association and it is essential that this be accounted for in future observational studies. Future studies should also assess the effect of paracetamol exposure on lung function outcomes given that paracetamol is proposed to induce oxidative stress on the airway."The authors have disclosed no relevant financial relationships. Arch Dis Child. Published online November 25, 2014.
Hyperbaric Oxygen No Better Than Sham After Concussionhttp://www.medscape.com/viewarticle/835490Pauline Anderson | DisclosuresAlthough hyperbaric oxygen (HBO) treatment is well tolerated by patients with postconcussion syndrome, and improves their symptoms and quality of life, it does not work any better than a sham air compression treatment, results of a new pilot study suggest.The improvements are likely attributable to a placebo effect or to the benefits of intensive daily routine involving social interactions.The study was among a series of trials funded by the Department of Defense (DOD) that tested different doses of HBO to try to determine the validity of anecdotal reports of improvements resulting from this treatment approach.The results are "definitely disappointing," R. Scott Miller, MD, assistant professor, medicine and preventive medicine, Uniformed Services University of the Health Sciences, Bethesda, Maryland, told Medscape Medical News. "We were all hopeful that it would be proven to be effective."Still, a larger confirmatory trial funded by DOD will proceed, he said."Trying to find interventions to help our veterans who are struggling with symptoms is a high priority," he said. "Given the fact that there was improvement in the study, although it doesn't appear to be specifically to HBO, and because the confirmatory study has slightly larger sample sizes and is attempting to look at some of the underlying pathophysiologic changes that might be the mechanism of action, we felt it was important to continue that trial."Dr Miller reported that that trial is fully enrolled and is following individuals for a year after the intervention. The results are expected to be released in early 2016.The current study results were published online November 17 in JAMA Internal Medicine.HOPPS Study The Hyperbaric Oxygen Therapy for Persistent Post-concussive Symptoms After Mild Traumatic Brain Injury (HOPPS) was a pilot study designed to define significant postconcussion symptom change scores and to determine an effect size of symptomatic improvements by HBO compared with a sham procedure when supplementing routine care. It was hoped that the results would inform sample sizes for potential pivotal trials.For the study, researchers enrolled 72 participants, median age 31 years, 96% of whom men, and 94% of whom were enlisted in the military service, mostly the Army and Navy. All were experiencing persistent postconcussion symptoms. Two thirds (66%) met criteria for posttraumatic stress disorder (PTSD), 48% were taking daily pain medication, and 60% were receiving an antidepressant.These patients were randomly assigned to one of three study groups: treatments with HBO (100% oxygen delivered at 1.5 atmospheres absolute [ATA]), a sham procedure (slightly pressurized room air at 1.2 ATA), or routine postconcussion care only. The other DOD studies tested 2.4 and 2.0 ATAs, said Dr Miller.The length and amount of the HBO intervention (40 hour-long sessions within a 10-week period) was determined through expert consensus, said Dr Miller.Although it is difficult to mask HBO, the researchers chose a sham that is indistinguishable from HBO pressurization. "It has been shown in a previous clinical trial to cause popping in the ears and a pressure sensation within the face and sinus area, and people could not tell the difference with that level of pressurization," said Dr Miller.There have been anecdotal reports that HBO improves cognitive function, but the exact mechanism by which HBO might affect postconcussion symptoms is unknown. However, possibilities could include "spawning of angiogenesis" that may change blood supply or blood flow within the brain, said Dr Miller.The primary outcome of the study was change in scores of the 16-item Rivermead Post-Concussion Symptoms Questionnaire (RPQ). Researchers deemed a 15% improvement as clinically relevant, which translates to a change in score of at least 2 points on the RPQ-3 subscale, which measures dizziness, headache, and nausea.The study found that routine care showed no improvement during the 3-month observational period, with a mean RPQ-3 subscale change of 0.0 (95% confidence interval [CI], −1.0 to 1.0; P = .97) and mean total RPQ change score of 0.5 (95% CI, −4.8 to 5.8; P = .91).The HBO group had a mean change score of 1.2 (95% CI, 0.0 - 2.4; P = .04) on the RPQ-3 subscale and 5.4 (95% CI, −0.5 to 11.3; P = .008) on the total RPQ.However. the group receiving sham treatment also improved: mean change in RPQ-3 subscale score, 1.5 (95% CI, 0.1 to 2.9; P = .03), and on the total RPQ, mean change 7.0 (95% CI, 1.0 - 12.9; P = .02).Although greater, there were no meaningful differences between the HBO and sham groups in the percentage who met the prespecified change of at least 2 points on the RPQ-3.The sham group tended to do better in terms of improvements in PTSD symptoms and in outcomes of depression, generalized anxiety, pain, and sleep. Measures of quality of life, such as physical functioning, bodily pain, and social functioning, also favored the sham group.Both the HBO and hyperbaric air sham sessions were well tolerated. There were no serious adverse events, although two participants withdrew from chamber sessions because of claustrophobia in one case and worsening of headaches in the other.Because this and the other two dose-ranging studies "could not reproduce the benefit independent of the changes seen in the sham," researchers believe the findings are a result of a marked placebo response, said Dr Miller. The HBO procedure, note the authors, involved "an intense ritual experience consisting of 2 hours of daily social interactions with a dedicated team of nurses and hyperbaric technicians as well as other participants."The researchers acknowledge that the sham was not completely inert and that there are some increases in nitrogen or oxygen in the blood from pressurized room air, "but not at a level that any of our experts felt would be physiologically important," said Dr Miller.Broad Implications Writing in an accompanying editorial, Charles W. Hoge, MD, senior scientist, Walter Reed Army Institute of Research, Silver Spring, Maryland, and Wayne B. Jonas, MD, from the Samueli Institute, Alexandria, Virginia, describe the study as exemplary, unique, and well-designed, and said it provides "compelling results with broad implications."The editorialists argue that the persistent postconcussion condition is such an elusive target for treatment that effective interventions will likely not be identified until the condition is "reconceptualized."In an interview with Medscape Medical News, Dr Hoge said he has long argued that a more holistic approach is needed to treat the "chronic multisystem concerns," including headache and cognitive and memory problems, as well as physical complaints such as gastrointestinal and cardiovascular symptoms, that plague a large percentage of veterans returning from war.Such holistic models of care involve multidisciplinary teams that are centered on primary care but also involve specialists in, for instance, neuropsychology, neurology, and mental health.Although veterans' symptoms are often labeled as postconcussion, there is probably "underlying dysregulation" in the endocrine and autonomic nervous systems that occur when someone is exposed to a trauma such as a blast-related event, said Dr Hoge.This is the latest in several trials that have looked at whether hyperbaric oxygen is effective in veterans suffering postconcussion symptoms. "I think there's enough evidence to say that we need to consider other options," said Dr Hoge. "There is pretty adequate evidence now to suggest that we should be looking at other types of treatments."The HOPPS trial was funded by the Defense Health Program and was managed by the US Army Medical Materiel Development Activity. The Naval Health Research Center and Army Contracting Command contracted support throughout this trial. Dr Miller, Dr Hoge, and Dr Jonas have disclosed no relevant financial relationships. JAMA Intern Med. Published online November 17, 2014. Article abstract, Editorial extract
Folate Before Conception Lowers SGA Riskhttp://www.medscape.com/viewarticle/835492Laurie Barclay, MD | DisclosuresPreconceptual folic acid supplementation significantly reduces the risk for small for gestational age (SGA) at birth, according to a population database study and systematic review published online November 26 in BJOG."It is currently a standard recommendation in the [National Institute for Health and Care Excellence] antenatal care guidelines for women to take folic acid supplements before conception and for the first 12 weeks of pregnancy and the [Royal College of Obstetricians and Gynaecologists (RCOG)] supports this, recommending folic acid to women," RCOG Vice President of Clinical Quality Professor Alan Cameron, MD, said in an RCOG news release."There is a good scientific evidence base to suggest folic acid reduces the number of pregnancies affected by neural tube defects...such as spina bifida. This study provides further evidence of the positive health benefits of folic acid with regards to reducing the number of SGA babies born in the UK," he continued.V.A. Hodgetts, from the Sandwell and West Birmingham Hospitals National Health Service Trust, Birmingham, United Kingdom, and colleagues used a UK regional database for the population study and an electronic literature search through August 2013 for the systematic review. The researchers aimed to determine the effect of folic acid supplementation timing during pregnancy on the risk for SGA in the neonate.The population study included 111,736 singleton live births without known congenital anomalies, and the systematic review included 188,796 such births. Among 108,525 pregnancies with information about folic acid in the population study, 84.9% of mothers had taken folic acid during pregnancy, but only 25.5% began folic acid before conception.Overall, 13.4% of babies had a birth weight under the 10th centile and 7% under the 5th centile. For pregnancies in which mothers took no folate, these percentages were 16.3% and 8.9%, respectively.After adjusting for maternal and pregnancy-related characteristics, women who started folic acid supplementation before conception had a 20% lower risk for SGA lower than the 10th centile (adjusted odds ratio [aOR], 0.80; 95% confidence interval [CI], 0.71 - 0.90; P < .01) and 22% lower risk for SGA lower than the 5th centile (aOR, 0.78; 95% CI, 0.66 - 0.91; P < .01) compared with those who did not.Pooling these data with data from other studies in the systematic review yielded a similar result: Women who started folic acid supplementation before conception had a 25% lower risk for SGA lower than the 5th centile (aOR, 0.75; 95% CI, 0.61 - 0.92; P < .006). Beginning folate during pregnancy did not significantly affect SGA rates.Study limitations include the inability to determine a dose-response relationship between folic acid supplementation and SGA."Previous research has suggested that only around one-third of women take folic acid supplements pre-conceptually," Dr. Cameron said. "Therefore, strategies to increase uptake must be evaluated as some women may not plan their pregnancy."He concluded, "The RCOG supports a food fortification policy with mandatory fortification of bread or flour with folic acid as a public health measure to improve the lives of both mothers and babies, [which] will reach women most at risk due to poor dietary habits or socioeconomic status."The authors have disclosed no relevant financial relationships. BJOG. Published online November 26, 2014. Abstract
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