PMID 20427778 Pioglitazone, vitamin E, or placebo for nonalcoholic steatohepatitis 무작위 대조시험(PIVENS) · N Engl J Med, 2010 247명·96주 - 비타민E 800 IU/일이 위약유효 성분이 없는 가짜 약(플라시보). 효과 비교의 기준으로 쓴다.보다 NASH 조직 개선(43% 대 19%)·간효소·지방·염증↓, 단 섬유화는 개선 안 됨. 당뇨 없는 성인 한정.
핵심요약
당뇨가 없는 비알코올성 지방간음주와 무관하게 간에 지방이 쌓이는 흔한 만성 간질환(NAFLD).염(NASH) 성인 247명을 피오글리타존(30 mg/일), 비타민E(800 IU/일), 위약유효 성분이 없는 가짜 약(플라시보). 효과 비교의 기준으로 쓴다.으로 나눠 96주간 본 무작위 시험(PIVENS). 주요 지표는 간 조직(조직학) 소견의 개선이었다. 비타민E군은 위약보다 조직 개선율이 유의하게 높았고(43% 대 19%, P=0.001), 간효소(ALT·AST)와 지방 침착·소엽 염증도 줄었으나 섬유화 점수는 유의하게 나아지지 않았다. 피오글리타존은 1차 지표에서 위약 대비 유의하지 않았고 체중이 더 늘었다. 저자들은 당뇨가 없는 성인 NASH에서 비타민E가 위약보다 우수했다고 결론지었다. 사용 용량 800 IU는 고용량으로, 다른 맥락의 안전성 우려와 함께 해석해야 한다.
원문 초록 보기
BACKGROUND: Nonalcoholic steatohepatitis is a common liver disease that can progress to cirrhosis. Currently, there is no established treatment for this disease. METHODS: We randomly assigned 247 adults with nonalcoholic steatohepatitis and without diabetes to receive pioglitazone at a dose of 30 mg daily (80 subjects), vitamin E at a dose of 800 IU daily (84 subjects), or placebo (83 subjects), for 96 weeks. The primary outcome was an improvement in histologic features of nonalcoholic steatohepatitis, as assessed with the use of a composite of standardized scores for steatosis, lobular inflammation, hepatocellular ballooning, and fibrosis. Given the two planned primary comparisons, P values of less than 0.025 were considered to indicate statistical significance. RESULTS: Vitamin E therapy, as compared with placebo, was associated with a significantly higher rate of improvement in nonalcoholic steatohepatitis (43% vs. 19%, P=0.001), but the difference in the rate of improvement with pioglitazone as compared with placebo was not significant (34% and 19%, respectively; P=0.04). Serum alanine and aspartate aminotransferase levels were reduced with vitamin E and with pioglitazone, as compared with placebo (P<0.001 for both comparisons), and both agents were associated with reductions in hepatic steatosis (P=0.005 for vitamin E and P<0.001 for pioglitazone) and lobular inflammation (P=0.02 for vitamin E and P=0.004 for pioglitazone) but not with improvement in fibrosis scores (P=0.24 for vitamin E and P=0.12 for pioglitazone). Subjects who received pioglitazone gained more weight than did those who received vitamin E or placebo; the rates of other side effects were similar among the three groups. CONCLUSIONS: Vitamin E was superior to placebo for the treatment of nonalcoholic steatohepatitis in adults without diabetes. There was no benefit of pioglitazone over placebo for the primary outcome; however, significant benefits of pioglitazone were observed for some of the secondary outcomes. (ClinicalTrials.gov number, NCT00063622.) ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.
원문 보기 ↗ PMID 15769967 Effects of long-term vitamin E supplementation on cardiovascular events and cancer: a randomized controlled trial 무작위 대조시험(HOPE-TOO) · JAMA, 2005 혈관질환·당뇨 9,500여명·7년 - 비타민E 400 IU/일이 암·심혈관 사건 못 줄임(RR 1.04), 오히려 심부전심장이 몸에 필요한 만큼 혈액을 충분히 내보내지 못하는 상태.↑(RR 1.13)·심부전 입원↑(1.21).
핵심요약
혈관질환이나 당뇨가 있는 55세 이상 환자를 대상으로 장기 비타민E 보충의 암·심혈관 효과를 본 대형 무작위 시험(HOPE 및 연장 HOPE-TOO). 천연 비타민E 400 IU 또는 위약유효 성분이 없는 가짜 약(플라시보). 효과 비교의 기준으로 쓴다.을 매일 투여했고 추적 중앙값은 7년이었다. 비타민E군은 암 발생(상대위험 0.94), 암 사망(0.88), 주요 심혈관 사건(1.04)에서 위약과 유의한 차이가 없었다. 그러나 심부전심장이 몸에 필요한 만큼 혈액을 충분히 내보내지 못하는 상태. 위험이 더 높았고(1.13), 심부전으로 인한 입원도 더 많았다(1.21). 연장 코호트에서도 같은 양상이었다. 저자들은 혈관질환·당뇨 환자에서 장기 비타민E 보충이 암·심혈관 사건을 예방하지 못하며 심부전 위험을 높일 수 있다고 결론지었다.
원문 초록 보기
CONTEXT: Experimental and epidemiological data suggest that vitamin E supplementation may prevent cancer and cardiovascular events. Clinical trials have generally failed to confirm benefits, possibly due to their relatively short duration. OBJECTIVE: To evaluate whether long-term supplementation with vitamin E decreases the risk of cancer, cancer death, and major cardiovascular events. DESIGN, SETTING, AND PATIENTS: A randomized, double-blind, placebo-controlled international trial (the initial Heart Outcomes Prevention Evaluation [HOPE] trial conducted between December 21, 1993, and April 15, 1999) of patients at least 55 years old with vascular disease or diabetes mellitus was extended (HOPE-The Ongoing Outcomes [HOPE-TOO]) between April 16, 1999, and May 26, 2003. Of the initial 267 HOPE centers that had enrolled 9541 patients, 174 centers participated in the HOPE-TOO trial. Of 7030 patients enrolled at these centers, 916 were deceased at the beginning of the extension, 1382 refused participation, 3994 continued to take the study intervention, and 738 agreed to passive follow-up. Median duration of follow-up was 7.0 years. INTERVENTION: Daily dose of natural source vitamin E (400 IU) or matching placebo. MAIN OUTCOME MEASURES: Primary outcomes included cancer incidence, cancer deaths, and major cardiovascular events (myocardial infarction, stroke, and cardiovascular death). Secondary outcomes included heart failure, unstable angina, and revascularizations. RESULTS: Among all HOPE patients, there were no significant differences in the primary analysis: for cancer incidence, there were 552 patients (11.6%) in the vitamin E group vs 586 (12.3%) in the placebo group (relative risk [RR], 0.94; 95% confidence interval [CI], 0.84-1.06; P = .30); for cancer deaths, 156 (3.3%) vs 178 (3.7%), respectively (RR, 0.88; 95% CI, 0.71-1.09; P = .24); and for major cardiovascular events, 1022 (21.5%) vs 985 (20.6%), respectively (RR, 1.04; 95% CI, 0.96-1.14; P = .34). Patients in the vitamin E group had a higher risk of heart failure (RR, 1.13; 95% CI, 1.01-1.26; P = .03) and hospitalization for heart failure (RR, 1.21; 95% CI, 1.00-1.47; P = .045). Similarly, among patients enrolled at the centers participating in the HOPE-TOO trial, there were no differences in cancer incidence, cancer deaths, and major cardiovascular events, but higher rates of heart failure and hospitalizations for heart failure. CONCLUSION: In patients with vascular disease or diabetes mellitus, long-term vitamin E supplementation does not prevent cancer or major cardiovascular events and may increase the risk for heart failure. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.
원문 보기 ↗ PMID 21990298 Vitamin E and the risk of prostate cancer: the Selenium and Vitamin E Cancer Prevention Trial (SELECT) 무작위 대조시험(SELECT) · JAMA, 2011 건강한 남성 3만5천여명 - 비타민E 400 IU/일이 전립선암 위험을 유의하게↑(HR 1.17, P=0.008). 1,000인년당 1.6건 초과.
핵심요약
비교적 건강한 남성 3만5천여 명을 대상으로 셀레늄·비타민E의 전립선암 예방 효과를 본 대형 무작위 시험(SELECT). 참가자를 셀레늄(200 µg/일), 비타민E(400 IU/일, all rac-α-토코페릴 아세테이트), 병용, 위약유효 성분이 없는 가짜 약(플라시보). 효과 비교의 기준으로 쓴다. 4군으로 나눴다. 장기 추적 결과, 위약군에서 529명이 전립선암에 걸린 데 비해 비타민E군은 620명으로 유의하게 많았다(위험비 1.17, 99% CI 1.004~1.36, P=0.008). 셀레늄 단독·병용군은 유의하지 않았다. 절대 위험 증가는 비타민E에서 1,000인년당 1.6건이었다. 저자들은 비타민E 보충이 건강한 남성의 전립선암 위험을 유의하게 높였다고 결론지었다.
원문 초록 보기
CONTEXT: The initial report of the Selenium and Vitamin E Cancer Prevention Trial (SELECT) found no reduction in risk of prostate cancer with either selenium or vitamin E supplements but a statistically nonsignificant increase in prostate cancer risk with vitamin E. Longer follow-up and more prostate cancer events provide further insight into the relationship of vitamin E and prostate cancer. OBJECTIVE: To determine the long-term effect of vitamin E and selenium on risk of prostate cancer in relatively healthy men. DESIGN, SETTING, AND PARTICIPANTS: A total of 35,533 men from 427 study sites in the United States, Canada, and Puerto Rico were randomized between August 22, 2001, and June 24, 2004. Eligibility criteria included a prostate-specific antigen (PSA) of 4.0 ng/mL or less, a digital rectal examination not suspicious for prostate cancer, and age 50 years or older for black men and 55 years or older for all others. The primary analysis included 34,887 men who were randomly assigned to 1 of 4 treatment groups: 8752 to receive selenium; 8737, vitamin E; 8702, both agents, and 8696, placebo. Analysis reflect the final data collected by the study sites on their participants through July 5, 2011. INTERVENTIONS: Oral selenium (200 μg/d from L-selenomethionine) with matched vitamin E placebo, vitamin E (400 IU/d of all rac-α-tocopheryl acetate) with matched selenium placebo, both agents, or both matched placebos for a planned follow-up of a minimum of 7 and maximum of 12 years. MAIN OUTCOME MEASURES: Prostate cancer incidence. RESULTS: This report includes 54,464 additional person-years of follow-up and 521 additional cases of prostate cancer since the primary report. Compared with the placebo (referent group) in which 529 men developed prostate cancer, 620 men in the vitamin E group developed prostate cancer (hazard ratio [HR], 1.17; 99% CI, 1.004-1.36, P = .008); as did 575 in the selenium group (HR, 1.09; 99% CI, 0.93-1.27; P = .18), and 555 in the selenium plus vitamin E group (HR, 1.05; 99% CI, 0.89-1.22, P = .46). Compared with placebo, the absolute increase in risk of prostate cancer per 1000 person-years was 1.6 for vitamin E, 0.8 for selenium, and 0.4 for the combination. CONCLUSION: Dietary supplementation with vitamin E significantly increased the risk of prostate cancer among healthy men. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.
원문 보기 ↗ PMID 15537682 Meta-analysis: high-dosage vitamin E supplementation may increase all-cause mortality 메타분석 · Ann Intern Med, 2005 19개 시험·13.6만명 - 고용량(≥400 IU/일) 비타민E가 전체 사망↑(1만명당 +39, P=0.035), 150 IU/일 초과부터 용량-반응. '피해야 한다'.
핵심요약
비타민E 보충과 전체 사망의 용량-반응 관계를 본 메타분석여러 개별 연구의 결과를 통계적으로 합쳐 하나의 종합 결론을 내는 분석.(무작위 시험 19건·13만5,967명, 용량 16.5~2000 IU/일, 중앙값 400). 고용량(하루 400 IU 이상) 비타민E를 시험한 11건 중 9건에서 전체 사망 위험이 높아지는 쪽이었고, 종합하면 1만 명당 39명의 초과 사망에 해당했다(P=0.035). 저용량 시험에서는 그런 신호가 없었다. 용량-반응 분석에서 하루 150 IU를 넘으면 사망 위험이 커지는 관계가 나타났다. 저자들은 고용량 비타민E 보충제가 전체 사망을 높일 수 있어 피해야 한다고 결론지었다. 다만 고용량 시험 상당수가 만성질환자 대상 소규모라 건강한 성인으로의 일반화는 불확실하다는 한계를 함께 밝혔다.
원문 초록 보기
BACKGROUND: Experimental models and observational studies suggest that vitamin E supplementation may prevent cardiovascular disease and cancer. However, several trials of high-dosage vitamin E supplementation showed non-statistically significant increases in total mortality. PURPOSE: To perform a meta-analysis of the dose-response relationship between vitamin E supplementation and total mortality by using data from randomized, controlled trials. PATIENTS: 135,967 participants in 19 clinical trials. Of these trials, 9 tested vitamin E alone and 10 tested vitamin E combined with other vitamins or minerals. The dosages of vitamin E ranged from 16.5 to 2000 IU/d (median, 400 IU/d). DATA SOURCES: PubMed search from 1966 through August 2004, complemented by a search of the Cochrane Clinical Trials Database and review of citations of published reviews and meta-analyses. No language restrictions were applied. DATA EXTRACTION: 3 investigators independently abstracted study reports. The investigators of the original publications were contacted if required information was not available. DATA SYNTHESIS: 9 of 11 trials testing high-dosage vitamin E (> or =400 IU/d) showed increased risk (risk difference > 0) for all-cause mortality in comparisons of vitamin E versus control. The pooled all-cause mortality risk difference in high-dosage vitamin E trials was 39 per 10,000 persons (95% CI, 3 to 74 per 10,000 persons; P = 0.035). For low-dosage vitamin E trials, the risk difference was -16 per 10,000 persons (CI, -41 to 10 per 10,000 persons; P > 0.2). A dose-response analysis showed a statistically significant relationship between vitamin E dosage and all-cause mortality, with increased risk of dosages greater than 150 IU/d. LIMITATIONS: High-dosage (> or =400 IU/d) trials were often small and were performed in patients with chronic diseases. The generalizability of the findings to healthy adults is uncertain. Precise estimation of the threshold at which risk increases is difficult. CONCLUSION: High-dosage (> or =400 IU/d) vitamin E supplements may increase all-cause mortality and should be avoided. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.
원문 보기 ↗ USDA FoodData Central Oil, sunflower, linoleic (approx. 65%) (FDC 171025)
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