PMID 17943794 Milk thistle for alcoholic and/or hepatitis B or C virus liver diseases 체계적 문헌고찰(코크란) · Cochrane Database Syst Rev, 2007 18개 RCT·1,088명 - 밀크씨슬은 사망률(RR 0.78)·합병증(0.95)·간 조직에 유의한 효과 없음; 간질환 사망은 질 높은 시험만 보면 효과 소멸(0.57 NS). '유익함에 의문'.
핵심요약
알코올성·B/C형간염 간질환에서 밀크씨슬의 효과를 본 코크란치료·예방의 근거를 엄격히 검토·종합하는 국제 연구 네트워크(Cochrane). 체계적 문헌고찰. 무작위 시험 18건·환자 1,088명을 모았으나 방법론적 질이 낮았다(질 높은 특성을 보고한 시험은 28.6%뿐). 밀크씨슬은 위약유효 성분이 없는 가짜 약(플라시보). 효과 비교의 기준으로 쓴다. 또는 무처치 대비 사망률(상대위험 0.78, 95% CI 0.53~1.15), 간질환 합병증(0.95, 0.83~1.09), 간 조직 어디에도 유의한 효과가 없었다. 간질환 관련 사망은 전체 시험 합산 시 유의하게 감소했으나(0.50, 0.29~0.88) 질 높은 시험만 보면 유의하지 않았다(0.57, 0.28~1.19). 이상반응 위험은 위약과 다르지 않았다(0.83). 저자들은 밀크씨슬의 유익함에 의문을 제기하고 질 높은 근거의 부재를 강조했다.
원문 초록 보기
BACKGROUND: Alcohol and hepatotoxic viruses cause the majority of liver diseases. Randomised clinical trials have assessed whether extracts of milk thistle, Silybum marianum (L) Gaertneri, have any effect in patients with alcoholic and/or hepatitis B or C virus liver diseases. OBJECTIVES: To assess the beneficial and harmful effects of milk thistle or milk thistle constituents versus placebo or no intervention in patients with alcoholic liver disease and/or viral liver diseases (hepatitis B and hepatitis C). SEARCH STRATEGY: The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and full text searches were combined (July 2007). Manufacturers and researchers in the field were contacted. SELECTION CRITERIA: Only randomised clinical trials in patients with alcoholic and/or hepatitis B or C virus liver diseases (acute and chronic) were included. Interventions encompassed milk thistle at any dose or duration versus placebo or no intervention. The trials could be double blind, single blind, or unblinded. The trials could be unpublished or published and no language limitations were applied. DATA COLLECTION AND ANALYSIS: The primary outcome measure was mortality. Binary outcomes are reported as relative risks (RR) with 95% confidence interval (CI). Subgroup analyses were performed with regard to methodological quality. MAIN RESULTS: Eighteen randomised clinical trials assessed milk thistle in 1088 patients with alcoholic and/or hepatitis B or C virus liver diseases. The methodological quality was low: only 28.6% of the trials reported high methodological quality characteristics. Milk thistle versus placebo or no intervention had no significant effect on mortality (RR 0.78, 95% CI 0.53 to 1.15), complications of liver disease (RR 0.95, 95% CI 0.83 to 1.09), or liver histology. Liver-related mortality was significantly reduced by milk thistle in all trials (RR 0.50, 95% CI 0.29 to 0.88), but not in high-quality trials (RR 0.57, 95% CI 0.28 to 1.19). Milk thistle was not associated with a significantly increased risk of adverse events (RR 0.83, 95% CI 0.46 to 1.50). AUTHORS' CONCLUSIONS: Our results question the beneficial effects of milk thistle for patients with alcoholic and/or hepatitis B or C virus liver diseases and highlight the lack of high-quality evidence to support this intervention. Adequately conducted and reported randomised clinical trials on milk thistle versus placebo are needed. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.
원문 보기 ↗ PMID 22797645 Effect of silymarin (milk thistle) on liver disease in patients with chronic hepatitis C unsuccessfully treated with interferon therapy: a randomized controlled trial 무작위 대조시험(SyNCH) · JAMA, 2012 154명·이중맹검 - 실리마린밀크씨슬(엉겅퀴) 씨앗에서 추출한 성분 복합체. 실리빈(실리비닌)이 주된 활성 성분이다. 420·700 mg/일(고용량)도 24주 뒤 ALT를 위약유효 성분이 없는 가짜 약(플라시보). 효과 비교의 기준으로 쓴다.보다 못 낮춤(P=0.75), HCV RNA·삶의 질도 차이 없음.
핵심요약
인터페론 치료에 실패한 만성 C형간염 환자 154명을 대상으로 미국 4개 기관에서 진행한 이중맹검 위약유효 성분이 없는 가짜 약(플라시보). 효과 비교의 기준으로 쓴다.대조 시험. 실리마린밀크씨슬(엉겅퀴) 씨앗에서 추출한 성분 복합체. 실리빈(실리비닌)이 주된 활성 성분이다. 420 mg, 700 mg, 또는 위약을 하루 3회 24주간 투여했다(통상보다 높은 용량). 주요 지표인 ALT 정상화 달성자는 각 군 2명씩뿐이었고(위약 3.8%·420 mg 4.0%·700 mg 3.8%, P≥0.99), 평균 ALT 감소도 세 군 간 유의한 차이가 없었다(P=0.75). C형간염 바이러스(HCV RNA) 수치(P=0.54)와 삶의 질에서도 차이가 없었고, 이상반응은 위약과 비슷했다. 저자들은 통상보다 높은 용량의 실리마린도 위약보다 ALT를 유의하게 낮추지 못했다고 결론지었다.
원문 초록 보기
CONTEXT: The botanical product silymarin, an extract of milk thistle, is commonly used by patients to treat chronic liver disease, despite scant and conflicting evidence of its efficacy. OBJECTIVE: To determine the effect of silymarin on liver disease activity in patients with chronic hepatitis C virus (HCV) infection unsuccessfully treated with interferon-based therapy. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, double-blind, placebo-controlled trial conducted at 4 medical centers in the United States. Participants included 154 persons with chronic HCV infection and serum alanine aminotransferase (ALT) levels of 65 U/L or greater who were previously unsuccessfully treated with interferon-based therapy. Enrollment began in May 2008 and was completed in May 2010, with the last follow-up visit completed in March 2011. INTERVENTION: Participants were randomly assigned to receive 420-mg silymarin, 700-mg silymarin, or matching placebo administered 3 times per day for 24 weeks. MAIN OUTCOME MEASURES: The primary outcome measure was serum ALT level of 45 U/L or less (considered within the normal range) or less than 65 U/L, provided this was at least a 50% decline from baseline values. Secondary outcomes included changes in ALT levels, HCV RNA levels, and quality-of-life measures. RESULTS: After 24 weeks of treatment, only 2 participants in each treatment group (P >/= .99) met the primary outcome measure (3.8% [95% CI, 0.5% to 13.2%] for placebo, 4.0% [95% CI, 0.5% to 13.7%] for 420-mg silymarin, and 3.8% [95% CI, 0.5% to 13.2%] for 700-mg silymarin). The mean decline in serum ALT activity at the end of treatment did not differ significantly (P = .75) across the 3 treatment groups (mean decline, -4.3 [95% CI, -17.3 to 8.7] U/L for placebo, -14.4 [95% CI, -41.6 to 12.7] U/L for 420-mg silymarin, -11.3 [95% CI, -27.9 to 5.4] U/L for 700-mg silymarin); there likewise were no significant differences in HCV RNA levels (mean change, 0.07 [95% CI, -0.05 to 0.18] log10 IU/mL for placebo, -0.03 [95% CI, -0.18 to 0.12] log10 IU/mL for 420-mg silymarin, 0.04 [95% CI, -0.08 to 0.16] log10 IU/mL for 700-mg silymarin; P = .54) or quality-of-life measures. The adverse event profile of silymarin was comparable with that of placebo. CONCLUSION: Higher than customary doses of silymarin did not significantly reduce serum ALT levels more than placebo in participants with chronic HCV infection unsuccessfully treated with interferon-based therapy. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00680342. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.
원문 보기 ↗ PMID 33418491 Impact of Silymarin in individuals with nonalcoholic fatty liver disease: A systematic review and meta-analysis 체계적 문헌고찰·메타분석 · Nutrition, 2021 RCT 8건 - 실리마린밀크씨슬(엉겅퀴) 씨앗에서 추출한 성분 복합체. 실리빈(실리비닌)이 주된 활성 성분이다.이 NAFLD 간효소(ALT·AST)를 위약유효 성분이 없는 가짜 약(플라시보). 효과 비교의 기준으로 쓴다.보다 유의하게 낮춤(체중과 무관). 단 저자가 '연구 질 결함' 경고+'간 조직 개선 여부는 미확인'.
핵심요약
비알코올성 지방간음주와 무관하게 간에 지방이 쌓이는 흔한 만성 간질환(NAFLD).(NAFLD)에서 실리마린밀크씨슬(엉겅퀴) 씨앗에서 추출한 성분 복합체. 실리빈(실리비닌)이 주된 활성 성분이다. 효과를 본 무작위 시험 8건의 체계적 문헌고찰·메타분석여러 개별 연구의 결과를 통계적으로 합쳐 하나의 종합 결론을 내는 분석.. 주요 지표는 간효소(ALT·AST) 평균값 변화, 이차 지표는 체질량지수·간 조직이었다. 실리마린은 위약유효 성분이 없는 가짜 약(플라시보). 효과 비교의 기준으로 쓴다.보다 간효소를 통계적으로 유의하게 더 낮췄고, 이는 체중 감소와 무관했다. 그러나 저자들은 포함된 연구의 질에 잠재적 결함이 있음을 경고하며, 이 간효소 감소가 실제 간 조직(조직학적) 개선으로 이어지는지는 잘 설계된 추가 연구가 필요하다고 결론지었다. 즉 대리지표최종 결과(골절 감소·주름이 삶에 준 변화 등) 대신 재는 중간 측정치(예: 피부 탄력 수치·골밀도). 실제 임상 이득과 항상 일치하진 않는다.(혈액 수치)의 변화는 있으나 임상적 의미는 미확정이다.
원문 초록 보기
OBJECTIVES: Nonalcoholic fatty liver disease (NAFLD) is a chronic liver disease affecting a significant proportion of the general population. Recently, randomized clinical trials have been conducted examining the efficacy of silymarin in individuals with NAFLD, with conflicting results. The aim of this meta-analysis was to evaluate the efficacy of silymarin in the treatment of NAFLD by examining changes in liver biochemistry, body mass index, and liver histology. METHODS: We searched major electronic databases PubMed/MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials, as well as gray-literature sources, up to June 2020 for randomized clinical trials examining the efficacy of treatment with silymarin in individuals with NAFLD compared to placebo. The primary outcomes were changes in the mean values of transaminases (alanine aminotransferase and aspartate aminotransferase). Secondary outcomes included changes in body mass index and liver histology. Quality analysis was performed with the risk-of-bias tool 2.0. We synthesized results using weighted mean differences for continuous outcomes, along with 95% confidence intervals. RESULTS: In the meta-analysis, eight randomized clinical trials were included. A cutoff level of 0.05 was considered to provide statistically significant results. Silymarin treatment led to a statistically significant greater reduction in the levels of transaminases compared to placebo, irrespective of weight loss. CONCLUSIONS: Silymarin seems to be effective in reducing transaminase levels in individuals with NAFLD. Despite the statistical benefits, we call attention to potential flaws related to the quality of the included studies. Further well-designed studies should be carried out to examine whether this reduction in transaminase levels corresponds to histologic improvement. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.
원문 보기 ↗ PMID 33761646 The efficacy of novel metabolic targeted agents and natural plant drugs for nonalcoholic fatty liver disease treatment: A PRISMA-compliant network meta-analysis of randomized controlled trials 네트워크 메타분석 · Medicine (Baltimore), 2021 35개 RCT - NAFLD에서 오베티콜산 등 대사표적 약물이 간 조직·간효소 개선에 앞섰고, 실리마린밀크씨슬(엉겅퀴) 씨앗에서 추출한 성분 복합체. 실리빈(실리비닌)이 주된 활성 성분이다. 등 천연물은 대체로 그보다 효과가 떨어짐.
핵심요약
비알코올성 지방간음주와 무관하게 간에 지방이 쌓이는 흔한 만성 간질환(NAFLD).(NAFLD) 치료제로 대사표적 약물과 천연물을 함께 순위 매긴 네트워크 메타분석여러 치료법을 간접 비교까지 포함해 한꺼번에 순위 매기는 메타분석.(무작위 시험 35건). 오베티콜산·엘라피브라노르가 간 조직 개선과 간효소(ALT·AST) 감소에서 상위를 차지했고, 실리마린밀크씨슬(엉겅퀴) 씨앗에서 추출한 성분 복합체. 실리빈(실리비닌)이 주된 활성 성분이다.·커큐민·레스베라트롤 같은 천연물은 상대적으로 하위였다. 저자들은 '새로운 대사표적 약물이 천연물보다 대체로 효과가 낫다'고 정리했다(단 오베티콜산은 LDL저밀도 지단백 콜레스테롤 - 이른바 ‘나쁜 콜레스테롤’. 상승 등 부작용). 실리마린이 지방간에 다소 신호를 보이더라도, 검증된 약물 대비 우위에 있지는 않다는 맥락을 준다.
원문 초록 보기
BACKGROUND: Nonalcoholic fatty liver disease (NAFLD) is a highly prevalent chronic liver disease characterized by excess accumulation of fat in hepatocytes. Because no drug has been approved for NAFLD treatment, this work analyzed the effects of agents resulting from 2 research hotspots, metabolic target agents, and natural plant drugs, on NAFLD with network meta-analysis. METHODS: Public databases were searched through August 14, 2020. Randomized controlled trials that compared obeticholic acid, elafibranor, cenicriviroc, selonsertib, curcumin, silymarin, and resveratrol to placebo were included. Liver pathology improvement, hepatic biochemical indicators, and lipid metabolism indicators were analyzed. RESULTS: Thirty-five studies were included in the meta-analysis. Obeticholic acid was found to significantly increase the frequency of liver biopsy improvement compared to placebo (OR: 2.10; 95% CI: 1.60, 2.77). The ranking results among the hepatic biochemical indicators showed that obeticholic acid (94.9%) and elafibranor (86.3%) have a relative advantage in reducing alanine aminotransferase (ALT) levels, and obeticholic acid also had an advantage (95.4%) in reducing aspartate aminotransferase (AST) levels. Considering lipid metabolic indicators, elafibranor (expSMD: 0.01; 95% CI: 0.00, 0.05; SUCRA: 100%), and obeticholic acid (expSMD: 0.48; 95% CI: 0.28,0.84; SUCRA: 75.6%) significantly reduced triglyceride (TG) levels compared with placebo; moreover, obeticholic acid, but not elafibranor, caused a serious increase in total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) levels and a decrease in high-density lipoprotein cholesterol (HDL-C) levels. CONCLUSIONS: Novel metabolic targeted agents generally have better effects than natural plant drugs, especially obeticholic acid, and elafibranor. However, obeticholic acid showed serious adverse effects such as increasing LDL-C levels and decreasing HDL-C levels. Curcumin showed potential advantages for NAFLD but lacked statistical significance. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.
원문 보기 ↗ PMID 37949692 Amatoxin-containing mushroom poisoning: An update 전문가 리뷰 · Rev Med Interne, 2024 아마톡신알광대버섯 등 독버섯에 든 맹독. 간을 집중 공격해 간부전을 일으킬 수 있다. 버섯 중독 리뷰 - '해독제가 없는 상황'에서 실리빈실리마린의 주된 활성 성분(실리비닌). 정맥주사 형태는 버섯 중독 치료에 쓰인다.+N-아세틸시스테인 병용이 권고 요법; 정맥주사 보조 치료지 경구 보충제가 아님.
핵심요약
아마톡신알광대버섯 등 독버섯에 든 맹독. 간을 집중 공격해 간부전을 일으킬 수 있다. 함유 버섯(알광대버섯 등) 중독을 정리한 전문가 리뷰. 알광대버섯이 버섯 관련 사망의 90% 이상을 차지하고, 알파-아마니틴이 간을 주 표적으로 공격해 심한 간염·간부전으로 이어져 간이식이 필요할 수 있다. 특이 해독제가 없어 조기 병원 치료가 핵심이며, 수액·위장관 제염·배출 촉진·아마톡신 흡수 억제제·항산화 요법으로 구성된다. 저자들은 실리빈실리마린의 주된 활성 성분(실리비닌). 정맥주사 형태는 버섯 중독 치료에 쓰인다.과 N-아세틸시스테인 병용을 권고 요법으로 소개하며, 소생술 발전으로 현재 사망률이 10% 미만으로 낮아졌다고 정리한다. 실리빈이 이 맥락에서 쓰이지만 이는 병원 정맥 요법이며, 근거 수준은 무작위 시험이 아니다.
원문 초록 보기
Amatoxin-containing mushroom poisoning occurs after consumption of certain mushroom species, of the genera Amanita, Lepiota and Galerina. Amanita phalloides is the most implicated species, responsible for over more than 90% of mushroom-related deaths. The alpha-amanitin is responsible for most of the observed effects. Symptoms are characterized by severe delayed gastrointestinal disorders (more than six hours after ingestion). The liver being the main target organ, outcome is marked by an often severe hepatitis which can evolve towards terminal liver failure, justifying orthotopic liver transplantation. Acute renal failure is common. Diagnosis of amatoxin-containing mushroom poisoning is based primarily on clinical data; it can be biologically confirmed using detection of amatoxins, especially from urine samples. In the absence of an antidote, early hospital management is essential. It is based on supportive care (early compensation of hydroelectrolytic losses), gastrointestinal digestive decontamination, elimination enhancement, amatoxin uptake inhibitors and antioxidant therapy. Combined therapy associating silibinin and N-acetylcysteine is recommended. Prognosis of this severe poisoning has greatly benefited from improved resuscitation techniques. Mortality is currently less than 10%. In the event of a suspected or confirmed case, referral to a Poison Control Center is warranted in order to establish the diagnosis and guide the medical management of patients in an early and appropriate way. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.
원문 보기 ↗ 