***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: OBJECTIVE We examined the effects of megestrol acetate versus placebo and progressive resistance physical exercise on weight , lean muscle mass , quality of life , ability to exercise , proinflammatory cytokines , and anti-inflammatory cytokines , and their correlations with one another . DESIGN We organized a prospect i ve 20-week , r and omized , double-blind , placebo-controlled pilot trial of hemodialysis patients . SETTING This study took place at the Outpatient Unit of the Northport Veteran Affairs Medical Center . SUBJECTS We studied nine male hemodialysis patients who had two or more of the following : albumin level < 4.0 g/dL , total cholesterol < 150 mg/dL , protein catabolic rate < 0.8 g/kg/day , and predialysis serum urea nitrogen < 60 mg/dL. Their ages were 50 to 83 years . Two were diabetic , and seven were nondiabetic . INTERVENTIONS Interventions included megestrol acetate ( MA ) or placebo 800 mg oral daily for 20 weeks , along with weight resistance physical therapy with weights twice a week before dialysis . Patients were followed prospect ively for an additional 4 weeks . MAIN OUTCOME MEASUREMENTS Weight , body composition , activities of daily living , ability to exercise , and plasma cytokine levels were measured . RESULTS At 24 weeks , the MA group had a statistically significant weight gain ( 11.1-pound increase vs. 1.5-pound decrease for the placebo group , P = .018 ) , body fat gain ( 6.2-pound increase vs. a 0.4-pound decrease for the placebo group , P = .044 ) and fat-free mass gain ( 5-pound increase vs. a 1.2-pound decrease in the placebo group ) . The MA group also had a greater tendency toward increased appetite and sense of well-being . The MA group showed a greater improvement in ability to exercise ( mean change in rate of perceived exertion ( RPE ) , 4.7 ) vs. the placebo group ( mean change in RPE vs. 0.5 , P = .02 ) . Elevated cytokine levels were evident at baseline in both groups . In all patients , increases in weight , fat-free mass , sense of well-being , appetite , and ability to exercise were negatively correlated with tumor necrosis factor receptor subunit p75 ( P < .05 ) . There was a trend toward all of these parameters to be negatively correlated with tumor necrosis factor receptor subunit p55 , although only sense of well-being was statistically significant ( P < .05 ) . CONCLUSION In a pilot trial in dialysis patients , MA showed significant benefits in improving weight and ability to exercise . Cytokine changes were correlated with weight gains and increases in fat-free mass BACKGROUND Malnutrition-inflammation complex syndrome and anorexia , common conditions in maintenance dialysis patients , are strongly associated with higher mortality and hospitalization and lower quality of life ( QoL ) in this population . Megestrol acetate , 800 mg/day , has been shown to increase appetite and food intake and to mitigate inflammation in cachectic AIDS and cancer patients , leading to weight gain , but it is also associated with side effects at this dose . METHODS We evaluated the efficacy of the oral solution of megestrol acetate in half of its conventional dose in improving the nutritional state and inflammation in 10 hypoalbuminemic dialysis patients ( albumin < 3.7 g/dL ) . Six women and 4 men , ages 60.2 years , took 400 mg of megestrol acetate solution daily for 16 weeks . Anthropometry , dual energy x-ray absorptiometry , 24-hour diet recalls , and biochemical measurements of nutrition and inflammation , including serum C-reactive protein and leptin , were performed . RESULTS At the end of the 16 weeks of intervention , weight and body mass index increased by 9 % , body fat proportion by 31 % , and triceps skinfold by 40 % ( P < .01 ) . Serum albumin increased from 3.0 to 3.3 g/dL and continued to increase significantly to 3.6 g/dL after 3 months postintervention ( P = .03 ) . Serum leptin increased from 5.2 to 10.7 ng/mL ( P = .09 ) . Daily protein and energy intake increased progressively up to 27 % to 42 % by the end of the trial ( P < or = .01 ) . In 8 patients without acute infection , serum C-reactive protein declined from 1.24 to 0.78 mg/L ( P = .06 ) . QoL and appetite were reported to be improved . No major side effects were observed , and all 10 patients completed the 16 weeks of daily intake of megestrol acetate without interruption . CONCLUSIONS Megestrol acetate oral solution in half of its conventional dose is safe and improves the nutritional state , inflammation , and anorexia in maintenance dialysis patients . Larger-scale placebo-controlled r and omized studies are needed to confirm the beneficial effects of 400 mg/day of megestrol acetate in dialysis patients OBJECTIVE To examine the effect of megestrol acetate on nutritional parameters in a hemodialysis population . DESIGN Prospect i ve case studies of hemodialysis patients . SETTING A freest and ing , nonprofit , hemodialysis unit . SUBJECTS Seventeen patients were studied . They were included regardless of gender , age , or cause of renal disease . They had to be on dialysis for at least 2 months , had a serum albumin < 3.5 g/dL for these 2 months , and had to be at high nutritional risk . There were 8 women and 9 men . Ages were 44 to 87 years . Eight were diabetics , and 9 were nondiabetics . INTERVENTIONS Megestrol acetate 400 mg orally twice daily was prescribed , and patients were studied for 6 months . OUTCOME MEASURES Pre-evaluation and postevaluation were performed by patient question naire , Subjective Global Assessment ( SGA ) , dry weight , and anthropometric measurements . Monthly laboratory monitoring included albumin , prealbumin , blood urea nitrogen ( BUN ) , cholesterol , triglycerides , carbon dioxide , platelets , hematocrit , alanine aminotransferase ( ALT ) , aspartate aminotransferase ( AST ) , gammaglutamyl transpeptidase ( GGT ) , lactate dehydrogenase ( LDH ) , alkaline phosphatase , and glucose . Glycohemoglobin and hemoglobin A1c were monitored in diabetic patients . RESULTS Three patients were able to take megestrol acetate for 5 to 6 months . They reported improved appetite and showed an increase in dry weight . The annualized mortality rate was about 59 % . Side effects included diarrhea , confusion , hyperglycemia , headaches , dizziness , and elevated LDH . CONCLUSION Megestrol acetate may help stimulate appetite in the hemodialysis patient , but it is risky and must be monitored closely . Eight hundred milligrams per day is probably too large a dose for the end-stage renal disease ( ESRD ) patient Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Anorexia and malnutrition are common complications and powerful predictors of morbidity and mortality in peritoneal dialysis ( PD ) patients .  Megestrol acetate ( MA ) is a progestogen that has been demonstrated to increase appetite and weight in patients with cancer or acquired immunodeficiency syndrome . To determine whether MA might benefit PD patients , we treated 32 patients with 160 mg MA daily . Treatment lasted a mean of 5.93 + /- 5.12 months ( range : 1 - 23 months ) . In 68.8 % of the patients , appetite improved . Weight gain was statistically significant starting in the third month ( initial weight : 66.5 + /- 11.4 kg ; weight at third month : 68 + /- 10.4 kg ; p < 0.05 ) . We observed a nonsignificant increase in serum albumin at the third treatment month ( initial serum albumin : 3.44 + /- 0.27 g/L ; serum albumin at third month : 3.54 + /- 0.27 g/L ; p = 0.45 ) . No side effects were observed . Our experience suggests that treatment with 160 mg MA daily in PD patients leads to an increase in appetite , serum albumin , and weight gain in most patients , with no negative side effects Malnutrition is a common clinical problem in dialysis patients . So far the management of malnutrition in this population has not been fully successful . The aim of the study was to evaluate the efficacy and safety of use of megestrol acetate suspension in malnourished dialysis patients . Twenty-six hypoalbuminemic ( albumin < or = 3.8 g/dl ) dialysis patients took 160 mg of megestrol acetate daily for a period of two months . Anthropometry ( dry weight , body mass index ) and biochemical measurements of nutrition ( serum albumin , triglycerides , total cholesterol ) and inflammation ( hsCRP , IL-1beta , IL-6 ) were performed on a monthly basis . The treatment led to a statistically significant increase ( P < 0.05 ) in anthropometry and albumin concentration , with no statistically significant changes in total cholesterol , triglycerides and indices of inflammation . Side effects included overhydration , diarrhoea and hyperglycaemia . Thus , megestrol acetate may be an effective therapeutic agent in improving the nutritional status of carefully selected dialysis patients , while it might not mitigate inflammation . Because of the prevalent side effects it must be monitored closely OBJECTIVE Malnutrition is a common problem in dialysis patients , and may affect up to one third of patients . It is associated with high mortality and morbidity . Although a number of studies were performed to determine effective treatment , there is no proven medication for this condition . This study aim ed to evaluate the effect of megestrol acetate ( MA ) on serum albumin levels in malnourished dialysis patients . DESIGN This was a r and omized , controlled clinical trial . SETTING The setting , a dialysis center at Razi Hospital , Rasht , Iran , provides services to dialysis patients . PATIENTS Twenty-two malnourished dialysis patients with persistent hypoalbuminemia ( albumin , < 3.5 g/dL for 2 months ) participated , and were r and omly assigned to either an experimental group or a control group . INTERVENTION The experimental group was treated with MA , 40 mg twice daily , over 2 months , and was compared with the control group . The collected data were analyzed using SPSS ( version 10 ; Chicago , IL ) . RESULTS After 2 months , the mean ( + /-SD ) serum albumin level in the experimental group rose from 3.31 + /- 0.31 g/dL to 4.41 + /- 0.31 g/dL , but in the control group , it declined , from 3.35 + /- 0.21 to 3.02 + /- 0.48 g/dL. The difference between the two groups was significant ( P = .002 ) . CONCLUSION At a dose of 40 mg twice a day , MA safely increased serum albumin in malnourished dialysis patients 
    Output:
    
The safety of using MA beyond 24 weeks is unknown , and use of MA is associated with significant AEs .