PMID 26662928 Effects and safety of periconceptional oral folate supplementation for preventing birth defects 메타분석(코크란) · Cochrane Database Syst Rev, 2015 5개 RCT·7,391명 - 임신 전후 엽산 보충이 태아 신경관결손을 약 69% 낮춤(RR 0.31, 고품질).
핵심요약
5개 RCT·7,391명 임신부(2,033명은 신경관결손 임신 이력)를 종합한 코크란치료·예방의 근거를 엄격히 검토·종합하는 국제 연구 네트워크(Cochrane). 리뷰. 매일 엽산 보충(단독 또는 다른 비타민·미네랄 병용)은 신경관결손을 위약유효 성분이 없는 가짜 약(플라시보). 효과 비교의 기준으로 쓴다.·무처치 대비 유의하게 줄였다(RR 0.31, 95% CI 0.17~0.58, 고품질 근거). 이력이 있는 여성의 재발도 유의하게 줄었다(RR 0.34). 하위분석에서 하루 400 µg(0.4 mg) 이상이면 용량에 관계없이 효과가 유지됐다. 반면 구순열·구개열·선천 심장기형 등 다른 기형에는 뚜렷한 효과가 없었다.
원문 초록 보기
BACKGROUND: It has been reported that neural tube defects (NTD) can be prevented with periconceptional folic acid supplementation. The effects of different doses, forms and schemes of folate supplementation for the prevention of other birth defects and maternal and infant outcomes are unclear. OBJECTIVES: This review aims to examine whether periconceptional folate supplementation reduces the risk of neural tube and other congenital anomalies (including cleft palate) without causing adverse outcomes in mothers or babies. MAIN RESULTS: Five trials involving 7391 women (2033 with a history of a pregnancy affected by a NTD and 5358 with no history of NTDs) were included. The results of the first comparison involving 6708 births with information on NTDs and other infant outcomes, show a protective effect of daily folic acid supplementation (alone or in combination with other vitamins and minerals) in preventing NTDs compared with no interventions/placebo or vitamins and minerals without folic acid (risk ratio (RR) 0.31, 95% confidence interval (CI) 0.17 to 0.58); five studies; 6708 births; high quality evidence). Folic acid had a significant protective effect for reoccurrence (RR 0.34, 95% CI 0.18 to 0.64); four studies; 1846 births). Subgroup analyses suggest that the positive effect of folic acid on NTD incidence and recurrence is not affected by the explored daily folic acid dosage (400 µg (0.4 mg) or higher) or whether folic acid is given alone or with other vitamins and minerals. There is no evidence of any preventive or negative effects on cleft palate, cleft lip, congenital cardiovascular defects, miscarriages or any other birth defects. AUTHORS' CONCLUSIONS: Folic acid, alone or in combination with vitamins and minerals, prevents NTDs, but does not have a clear effect on other birth defects. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.
원문 보기 ↗ PMID 1677062 Prevention of neural tube defects: results of the Medical Research Council Vitamin Study RCT · Lancet, 1991 고위험 여성 1,817명 - 임신 전후 엽산이 신경관결손 재발을 72% 줄인 획기적 시험(RR 0.28).
핵심요약
7개국 33개 센터에서 진행한 무작위 이중맹검 요인설계 시험(MRC Vitamin Study). 신경관결손 임신 이력이 있는 고위험 여성 1,817명을 엽산·기타 비타민·둘 다·둘 다 아님으로 무작위 배정했다. 임신 결과가 확인된 1,195건 중 신경관결손은 엽산군 6건 대 비엽산군 21건으로, 엽산의 72% 예방 효과가 확인됐다(상대위험 0.28, 95% CI 0.12~0.71). 다른 비타민 혼합은 유의한 효과가 없었다. 임신 전부터의 엽산 보충을 처음으로 확고히 권고한 근거 시험이다.
원문 초록 보기
A randomised double-blind prevention trial with a factorial design was conducted at 33 centres in seven countries to determine whether supplementation with folic acid (one of the vitamins in the B group) or a mixture of seven other vitamins (A,D,B1,B2,B6,C and nicotinamide) around the time of conception can prevent neural tube defects (anencephaly, spina bifida, encephalocele). A total of 1817 women at high risk of having a pregnancy with a neural tube defect, because of a previous affected pregnancy, were allocated at random to one of four groups--namely, folic acid, other vitamins, both, or neither. 1195 had a completed pregnancy in which the fetus or infant was known to have or not have a neural tube defect; 27 of these had a known neural tube defect, 6 in the folic acid groups and 21 in the two other groups, a 72% protective effect (relative risk 0.28, 95% confidence interval 0.12-0.71). The other vitamins showed no significant protective effect (relative risk 0.80, 95% Cl 0.32-1.72). There was no demonstrable harm from the folic acid supplementation, though the ability of the study to detect rare or slight adverse effects was limited. Folic acid supplementation starting before pregnancy can now be firmly recommended for all women who have had an affected pregnancy, and public health measures should be taken to ensure that the diet of all women who may bear children contains an adequate amount of folic acid. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.
원문 보기 ↗ PMID 25771069 Efficacy of folic acid therapy in primary prevention of stroke among adults with hypertension in China: the CSPPT randomized clinical trial RCT · JAMA, 2015 저엽산 중국 고혈압 환자 20,702명 - 엽산 병용이 첫 뇌졸중을 21% 줄임(HR 0.79), 심근경색은 무변화.
핵심요약
엽산 강화 정책이 없는 중국에서 뇌졸중·심근경색 이력이 없는 고혈압 환자 20,702명을 대상으로 한 무작위 이중맹검 시험(CSPPT). 에날라프릴+엽산 0.8 mg 복합제는 에날라프릴 단독 대비 중앙 4.5년 추적에서 첫 뇌졸중을 유의하게 줄였다(2.7% 대 3.4%, HR 0.79, 95% CI 0.68~0.93). 반면 심근경색(HR 1.04)과 전체 사망(HR 0.94)에는 차이가 없었다. 저자들은 기저 엽산이 낮은 인구에서의 이득과 일치한다고 결론지었다.
원문 초록 보기
IMPORTANCE: Uncertainty remains about the efficacy of folic acid therapy for the primary prevention of stroke because of limited and inconsistent data. OBJECTIVE: To test the primary hypothesis that therapy with enalapril and folic acid is more effective in reducing first stroke than enalapril alone among Chinese adults with hypertension. DESIGN, SETTING, AND PARTICIPANTS: The China Stroke Primary Prevention Trial, a randomized, double-blind clinical trial conducted from May 19, 2008, to August 24, 2013, in 32 communities in Jiangsu and Anhui provinces in China. A total of 20,702 adults with hypertension without history of stroke or myocardial infarction (MI) participated in the study. INTERVENTIONS: Eligible participants, stratified by MTHFR C677T genotypes (CC, CT, and TT), were randomly assigned to receive double-blind daily treatment with a single-pill combination containing enalapril, 10 mg, and folic acid, 0.8 mg (n = 10,348) or a tablet containing enalapril, 10 mg, alone (n = 10,354). RESULTS: During a median treatment duration of 4.5 years, compared with the enalapril alone group, the enalapril-folic acid group had a significant risk reduction in first stroke (2.7% of participants in the enalapril-folic acid group vs 3.4% in the enalapril alone group; hazard ratio [HR], 0.79; 95% CI, 0.68-0.93). The risks of myocardial infarction (HR, 1.04; 95% CI, 0.60-1.82) and all-cause deaths (HR, 0.94; 95% CI, 0.81-1.10) did not differ significantly between the 2 treatment groups. CONCLUSIONS AND RELEVANCE: Among adults with hypertension in China without a history of stroke or MI, the combined use of enalapril and folic acid, compared with enalapril alone, significantly reduced the risk of first stroke. These findings are consistent with benefits from folate use among adults with hypertension and low baseline folate levels. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.
원문 보기 ↗ PMID 28816346 Homocysteine-lowering interventions for preventing cardiovascular events 메타분석(코크란) · Cochrane Database Syst Rev, 2017 15개 RCT·71,422명 - 엽산 등 호모시스테인엽산·B6·B12가 부족하면 오르는 혈중 아미노산. 높으면 심혈관 위험과 연관되나, 낮춰도 심장사건은 줄지 않았다. 저하는 심근경색·사망을 못 줄이고(고품질), 뇌졸중만 소폭 감소.
핵심요약
15개 RCT·71,422명을 종합한 코크란치료·예방의 근거를 엄격히 검토·종합하는 국제 연구 네트워크(Cochrane). 리뷰. 비타민 B6·B9(엽산)·B12로 호모시스테인엽산·B6·B12가 부족하면 오르는 혈중 아미노산. 높으면 심혈관 위험과 연관되나, 낮춰도 심장사건은 줄지 않았다.을 낮추는 개입은 위약유효 성분이 없는 가짜 약(플라시보). 효과 비교의 기준으로 쓴다. 대비 심근경색(RR 1.02), 전체 사망(RR 1.01), 중대 이상반응을 전혀 줄이지 못했다(모두 고품질 근거). 뇌졸중만 소폭 줄었다(RR 0.90, 95% CI 0.82~0.99, 고품질). 호모시스테인 저하가 심장병 예방으로 이어진다는 가설을 뒷받침하지 못한 결과다.
원문 초록 보기
BACKGROUND: Cardiovascular disease, which includes coronary artery disease, stroke and peripheral vascular disease, is a leading cause of death worldwide. Homocysteine is an amino acid with biological functions in methionine metabolism. A postulated risk factor for cardiovascular disease is an elevated circulating total homocysteine level. The impact of homocysteine-lowering interventions, given to patients in the form of vitamins B6, B9 or B12 supplements, on cardiovascular events has been investigated. OBJECTIVES: To determine whether homocysteine-lowering interventions, provided to patients with and without pre-existing cardiovascular disease are effective in preventing cardiovascular events, as well as reducing all-cause mortality, and to evaluate their safety. MAIN RESULTS: In this third update, we identified three new randomised controlled trials, for a total of 15 randomised controlled trials involving 71,422 participants. Compared with placebo, there were no differences in effects of homocysteine-lowering interventions on myocardial infarction (homocysteine-lowering = 7.1% versus placebo = 6.0%; RR 1.02, 95% confidence interval (CI) 0.95 to 1.10, I2 = 0%, 12 trials; N = 46,699; high-quality evidence), death from any cause (homocysteine-lowering = 11.7% versus placebo = 12.3%, RR 1.01, 95% CI 0.96 to 1.06, I2 = 0%, 11 trials, N = 44,817; high-quality evidence), or serious adverse events (homocysteine-lowering = 8.3% versus comparator = 8.5%, RR 1.07, 95% CI 1.00 to 1.14, I2 = 0%, eight trials, N = 35,788; high-quality evidence). Compared with placebo, homocysteine-lowering interventions were associated with reduced stroke outcome (homocysteine-lowering = 4.3% versus comparator = 5.1%, RR 0.90, 95% CI 0.82 to 0.99, I2 = 8%, 10 trials, N = 44,224; high-quality evidence). AUTHORS' CONCLUSIONS: In this third update of the Cochrane review, there were no differences in effects of homocysteine-lowering interventions in the form of supplements of vitamins B6, B9 or B12 given alone or in combination comparing with placebo on myocardial infarction, death from any cause or adverse events. In terms of stroke, this review found a small difference in effect favouring to homocysteine-lowering interventions in the form of supplements of vitamins B6, B9 or B12 given alone or in combination comparing with placebo. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.
원문 보기 ↗ PMID 23352552 Effects of folic acid supplementation on overall and site-specific cancer incidence during the randomised trials: meta-analyses of data on 50,000 individuals 메타분석 · Lancet, 2013 13개 RCT·49,621명 - 고용량 엽산을 5년 써도 전체·부위별 암 발생에 유의한 변화 없음(RR 1.06).
핵심요약
13개 RCT·49,621명의 개별참가자 자료를 종합한 메타분석여러 개별 연구의 결과를 통계적으로 합쳐 하나의 종합 결론을 내는 분석.. 강화 수준보다 훨씬 높은 용량의 엽산 보충을 평균 5.2년 사용해 혈중 엽산이 4배로 올랐음에도, 전체 암 발생에 유의한 변화가 없었다(RR 1.06, 95% CI 0.99~1.13). 대장·전립선·폐·유방 등 특정 부위 암도 유의하게 늘거나 줄지 않았다. 밀가루 강화는 이보다 약 10배 낮은 용량이라, 엽산 강화의 암 우려를 완화하는 근거로 인용된다.
원문 초록 보기
BACKGROUND: Some countries fortify flour with folic acid to prevent neural tube defects but others do not, partly because of concerns about possible cancer risks. We aimed to assess any effects on site-specific cancer rates in the randomised trials of folic acid supplementation, at doses higher than those from fortification. METHODS: In these meta-analyses, we sought all trials completed before 2011 that compared folic acid versus placebo, had scheduled treatment duration at least 1 year, included at least 500 participants, and recorded data on cancer incidence. We obtained individual participant datasets that included 49,621 participants in all 13 such trials (ten trials of folic acid for prevention of cardiovascular disease [n=46,969] and three trials in patients with colorectal adenoma [n=2652]). FINDINGS: During a weighted average scheduled treatment duration of 5·2 years, allocation to folic acid quadrupled plasma concentrations of folic acid (57·3 nmol/L for the folic acid groups vs 13·5 nmol/L for the placebo groups), but had no significant effect on overall cancer incidence (1904 cancers in the folic acid groups vs 1809 cancers in the placebo groups, RR 1·06, 95% CI 0·99-1·13, p=0·10). There was no trend towards greater effect with longer treatment. Moreover, there was no significant effect of folic acid supplementation on the incidence of cancer of the large intestine, prostate, lung, breast, or any other specific site. INTERPRETATION: Folic acid supplementation does not substantially increase or decrease incidence of site-specific cancer during the first 5 years of treatment. Fortification of flour and other cereal products involves doses of folic acid that are, on average, an order of magnitude smaller than the doses used in these trials. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.
원문 보기 ↗ FDA (openFDA) Folic acid (엽산) - 의약품 라벨(경고·주의·상호작용)
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원문 보기 ↗ USDA FoodData Central Edamame, frozen, prepared (FDC 168411)
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원문 보기 ↗ USDA FoodData Central Beef, variety meats and by-products, liver, cooked, braised (FDC 168626)
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원문 보기 ↗ USDA FoodData Central Lentils, mature seeds, cooked, boiled, with salt (FDC 175254)
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원문 보기 ↗ USDA FoodData Central Chickpeas (garbanzo beans, bengal gram), mature seeds, cooked, boiled, with salt (FDC 173799)
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원문 보기 ↗ USDA FoodData Central Asparagus, cooked, boiled, drained (FDC 168390)
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원문 보기 ↗ USDA FoodData Central Spinach, cooked, boiled, drained, with salt (FDC 170531)
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