***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Interest in the chemopreventive effects of the trace element selenium has spanned the past three decades . Of > 100 studies that have investigated the effects of selenium in carcinogen-exposed animals , two-thirds have observed a reduction in tumor incidence and /or preneoplastic endpoints ( G. F. Combs and S. B. Combs , The Role of Selenium in Nutrition Chapter 10 , pp . 413 - 462 . San Diego , CA : Academic Press , 1986 , and B. H. Patterson and O. A. Lev and er , Cancer Epidemiol . Biomark . Prev . , 6 : 63 - 69 , 1997 ) . The Nutritional Prevention of Cancer Trial , a r and omized clinical trial reported by Clark et al. ( L. C. Clark et al. , JAMA , 276 : 1957 - 1963 , 1996 ) , showed as a secondary end point , a statistically significant decrease in lung cancer incidence with selenium supplementation . The adjusted hazard ratio ( HR ) was 0.56 [ 95 % confidence interval ( CI ) , 0.31 - 1.01 ; P = 0.05 ] . These results were based on active follow-up of 1312 participants . This re analysis used an extended Nutritional Prevention of Cancer Trial participant follow-up through the end of the blinded clinical trial on February 1 , 1996 . The additional 3 years added 8 cases to the selenium-treated group and 4 cases to the placebo group , and increased follow-up to 7.9 years . The relative risk of 0.70 ( 95 % CI , 0.40 - 1.21 ; P = 0.18 ) is not statistically significant . Whereas the overall adjusted HR is not significant ( HR = 0.74 ; 95 % CI , 0.44 - 1.24 ; P = 0.26 ) , and the HR for current and former smokers was not significant , the trend is toward a reduction in risk of incident lung cancer with selenium supplementation . In a subgroup analysis there was a nominally significant HR among subjects with baseline plasma selenium in the lowest tertile ( HR = 0.42 ; 95 % CI , 0.18 - 0.96 ; P = 0.04 ) . The analysis for the middle and highest tertiles of baseline showed HRs of 0.91 and 1.25 . The current re analysis indicates that selenium supplementation did not significantly decrease lung cancer incidence in the full population , but a significant decrease among individuals with low baseline selenium concentrations was observed Controlled trials that use r and omized allocation are the best tool to control for bias and confounding in trials testing clinical interventions . Investigators must be sure to include information that is required by the reader to judge the validity and implication s of the findings in the reports of these trials . In part , complete reporting of trials will allow clinicians to modify their clinical practice to reflect current evidence toward the improvement of clinical outcomes . The consoli date d st and ards of reporting trials ( CONSORT ) statement was developed to assist investigators , authors , review ers , and editors on the necessary information to be included in reports of controlled clinical trials . The CONSORT statement is applicable to any intervention , including herbal medicinal products . Controlled trials of herbal interventions do not adequately report the information suggested in CONSORT . Recently , reporting recommendations were developed in which several CONSORT items were elaborated to become relevant and complete for r and omized controlled trials of herbal medicines . We expect that these recommendations will lead to more complete and accurate reporting of herbal trials . We wrote this explanatory document to outline the rationale for each recommendation and to assist authors in using them by providing the CONSORT items and the associated elaboration , together with examples of good reporting and empirical evidence , where available , for each . These recommendations for the reporting of herbal medicinal products presented here are open to revision as more evidence accumulates and critical comments are collected BACKGROUND Brazil nuts provide a rich natural source of selenium , yet no studies have investigated the bioavailability of selenium in humans . OBJECTIVE We investigated the efficacy of Brazil nuts in increasing selenium status in comparison with selenomethionine . DESIGN A r and omized controlled trial was conducted with 59 New Zeal and adults . Participants consumed 2 Brazil nuts thought to provide approximately 100 mug Se , 100 mug Se as selenomethionine , or placebo daily for 12 wk . Actual intake from nuts averaged 53 mug Se/d ( possible range : 20 - 84 mug Se ) . Plasma selenium and plasma and whole blood glutathione peroxidase ( GPx ) activities were measured at baseline and at 2 , 4 , 8 , and 12 wk , and effects of treatments were compared . RESULTS Plasma selenium increased by 64.2 % , 61.0 % , and 7.6 % ; plasma GPx by 8.3 % , 3.4 % , and -1.2 % ; and whole blood GPx by 13.2 % , 5.3 % , and 1.9 % in the Brazil nut , selenomethionine , and placebo groups , respectively . Change over time at 12 wk in plasma selenium ( P < 0.0001 for both groups ) and plasma GPx activity in the Brazil nut ( P < 0.001 ) and selenomethionine ( P = 0.014 ) groups differed significantly from the placebo group but not from each other . The change in whole blood GPx activity was greater in the Brazil nut group than in the placebo ( P = 0.002 ) and selenomethionine ( P = 0.032 ) groups . CONCLUSION Consumption of 2 Brazil nuts daily is as effective for increasing selenium status and enhancing GPx activity as 100 mug Se as selenomethionine . Inclusion of this high-selenium food in the diet could avoid the need for fortification or supplements to improve the selenium status of New Zeal and ers This pilot study evaluated the feasibility and effectiveness of conducting a double-blind clinical trial for the prevention of  lung cancer  with  selenium ( Se ) in Yunnan Tin Corporation , the People 's Republic of China , where the incidence rates of lung cancer are extraordinarily high among the miners . Forty healthy miners were r and omized to either 300 μg of Se in high Se malt cakes or an identical placebo of malt cakes daily for one year . Subjects consumed their usual daily diet . The low Se concentrations in plasma ( 0.05±0.008 μg/mL ) and hair ( 0.442±0.085 μg/g ) reflected their low dietary Se intake in the control subjects . In Se-supplemented group , the Se status was increased by 178 % for serum and 194.8 % for hair . The serum GSHpx activity was increased by 155.7 % , whereas the lipid peroxide level was reduced by 74.5 % compared to the placebo . The results of UDS assay indicated that the lymphocyte DNA damage induced by ultraviolet irradiation and carcinogen 3,4-benzpyrene could be protected by Se supplementation . Se-supplementation did not affect the liver function test ( SGPT ) , as well as the concentrations of hemoglobin , albumin , and cholesterol . Thus , daily intake of 300 μg Se in form of Se-malt as a chemopreventive measure is safe and effective to humans with low Se status The Nutritional Prevention of Cancer Trial was a r and omized , clinical trial design ed to evaluate the efficacy of selenium as selenized yeast ( 200 microg daily ) in preventing the recurrence of nonmelanoma skin cancer among 1312 residents of the Eastern United States . Original secondary analyses through December 31 , 1993 showed striking inverse associations between treatment and the incidence of total [ hazard ratio ( HR ) = 0.61 , 95 % confidence interval ( CI ) = 0.46 - 0.82 ] , lung , prostate , and colorectal cancer and total cancer mortality . This report presents results through February 1 , 1996 , the end of blinded treatment . Effect modification by baseline characteristics is also evaluated . The effects of treatment overall and within subgroups of baseline age , gender , smoking status , and plasma selenium were examined using incidence rate ratios and Cox proportional hazards models . Selenium supplementation reduced total ( HR = 0.75 , 95 % CI = 0.58 - 0.97 ) and prostate ( HR = 0.48 , 95 % CI = 0.28 - 0.80 ) cancer incidence but was not significantly associated with lung ( HR = 0.74 , 95 % CI = 0.44 - 1.24 ) and colorectal ( HR = 0.46 , 95 % CI = 0.21 - 1.02 ) cancer incidence . The effects of treatment on other site-specific cancers are also described . The protective effect of selenium was confined to males ( HR = 0.67 , 95 % CI = 0.50 - 0.89 ) and was most pronounced in former smokers . Participants with baseline plasma selenium concentrations in the lowest two tertiles ( < 121.6 ng/ml ) experienced reductions in total cancer incidence , whereas those in the highest tertile showed an elevated incidence ( HR = 1.20 , 95 % CI = 0.77 - 1.86 ) . The Nutritional Prevention of Cancer trial continues to show a protective effect of selenium  on cancer incidence , although not all site-specific cancers exhibited a reduction in incidence . This treatment effect was restricted to males and to those with lower baseline plasma selenium concentrations Nonexperimental studies suggest that individuals with higher selenium ( Se ) status are at decreased risk of cancer . The Nutritional Prevention of Cancer ( NPC ) study r and omized 1,312 high-risk dermatology patients to 200-mcg/day of Se in selenized yeast or a matched placebo ; selenium supplementation decreased the risk of lung , colon , prostate , and total cancers but increased the risk of nonmelanoma skin cancer . In this article , we report on a small sub study in Macon , GA , which began in 1989 and r and omized 424 patients to 400-mcg/day of Se or to matched placebo .  The subjects from both arms had similar baseline Se levels to those treated by 200 mcg , and those treated with 400-mcg attained plasma Se levels much higher than subjects treated with 200 mcg . The 200-mcg/day Se treatment decreased total cancer incidence by a statistically significant 25 % ; however , 400-mcg/day of Se had no effect on total cancer incidence Summary □ Patients and Method : In order to test the hypothesis that a dietary supplement of selenium ( Se ) may reduce cancer risk , 1312 patients with histories of basa/squamous cell carcinomas of the skin were assigned in r and om , double-blind fashion to daily oral supplements of either Se-enriched yeast ( 200 µg Se/day ) , or a low-Se yeast placebo .  Patients were recruited in 1983 to 1990 and were followed with regular dermatologic examinations through , 1993 for a total of 8269 person-years of observation . Skin cancer diagnoses were confirmed histologically and plasma Se concentration was determined at 6 to 12 months intervals . All deaths and patient-reported illnesses were confirmed and documented by consultation with the patient medical care providers . □ Results : Results showed that Se-supplementation did not significantly affect the incidences of recurrent basal/squamous cell carcinomas of the skin .  However , Se-treatment was associated with reductions in total cancer mortality and in the incidences of lung , colorectal , prostate and total cancers . These effects were consistent over time and between study clinics . □ Conclusion : The results strongly suggest benefits of Se-supplementation for this cohort of patients and support the hypothesis that supplemental Se can reduce risks to at least some types of cancer Purpose We conducted a phase I study to determine the recommended dose of selenomethionine ( SLM ) in combination with irinotecan that consistently results in a protective plasma selenium ( Se ) concentrations > 15 μM after 1 week of SLM loading . Experimental Design A 3 - 3 st and ard escalation design was followed . SLM was given orally twice daily ( BID ) for one week ( loading ) followed by continuous once daily ( QD ) dosing ( maintenance ) . Seven dose levels of selenomethionine were investigated . Irinotecan was given intravenously at a fixed st and ard weekly dose , starting on the first day of maintenance SLM . Results Thirty-one patients were treated on study . Dose limiting diarrhea complicated by sepsis was noted in one of six patients at each of the dose-levels 1 and 7 . Dose-levels ≥ 5 ( 4,800 mcg/dose loading maintenance ) result ed in day 8 Se concentrations > 15 μM while dose-level 7 ( 7,200 mcg/dose loading and maintenance ) result ed in day 8 Se concentrations > 20 μM. No significant variations in SN-38 or biliary index were noted between weeks 1 and 4 of treatment . Despite achieving target Se concentrations , gastrointestinal and bone marrow toxicities were common and irinotecan dose modification was prevalent . Objective responses were seen in two patients and nine patients had disease control for 6 months or longer . Conclusions Selenomethionine can be escalated safely to 7,200 mcg BID 
    Output:
    
In the treatment of lung cancers , selenium may reduce cisplatin-induced nephrotoxicity and side effects associated with radiation therapy .
CONCLUSIONS Selenium may be effective for lung cancer prevention among individuals with lower selenium status , but at present should not be used as a general strategy for lung cancer prevention .