***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: A system has been constructed to evaluate the design , implementation , and analysis of  r and omized control trials ( RCT ) . The degree of quadruple blinding ( the r and omization process , the physicians and patients as to therapy , and the physicians as to ongoing results ) is considered to be the most important aspect of any trial . The analytic techniques are scored with the same emphasis as is placed on the control of bias in the planning and implementation of the studies . Description of the patient and treatment material s and the measurement of various controls of quality have less weight . An index of quality of a RCT is proposed with its pros and cons . If published papers were to approximate these principles , there would be a marked improvement in the quality of r and omized control trials . Finally , a reasonable st and ard design and conduct of trials will facilitate the interpretation of those with conflicting results and help in making valid combinations of undersized trials CONTEXT Acute diarrhea with gas-related abdominal discomfort is a common , usually self-limited disorder with substantial social and economic impact . OBJECTIVE To compare the efficacy and safety of a loperamide hydrochloride-simethicone combination product with those of loperamide alone , simethicone alone , and placebo in treating acute diarrhea with gas-related abdominal discomfort . DESIGN R and omized , placebo-controlled , double-blind trial of 48 hours ' duration . SETTING A primary care , ambulatory practice in Acapulco , Mexico . PATIENTS A total of 493 outpatient adults aged 18 to 63 years , with acute nonspecific diarrhea with at least moderately severe abdominal discomfort . INTERVENTIONS Each patient was r and omly assigned to receive 2 chewable tablets containing loperamide hydrochloride , 2 mg , and simethicone , 125 mg ( n = 124 ) ; loperamide hydrochloride , 2 mg ( n = 123 ) ; simethicone , 125 mg ( n = 123 ) ; or placebo ( n = 123 ) . This was followed by 1 tablet after each unformed stool , up to 4 tablets in any 24-hour period . MAIN OUTCOME MEASURES Time to last unformed stool and time to complete relief of gas-related abdominal discomfort were the protocol -specified primary outcomes . Secondary outcomes included time to complete relief of diarrhea , number of unformed stools , and patient-assessed variables at the end of the study ( overall illness relief , diarrhea relief , and abdominal discomfort relief ) . RESULTS Patients who received loperamide-simethicone had significantly ( P < .001 ) shorter time to last unformed stool and faster relief of gas-related abdominal discomfort than patients who received loperamide , simethicone , or placebo alone . Loperamide-simethicone was significantly ( P < or = .01 ) more effective than the other 3 treatments for all end-of- study patient-assessed outcomes and all clinical ly important secondary outcomes . No significant differences in adverse events were found among treatment groups . CONCLUSIONS The loperamide-simethicone combination chewable product provides faster and more complete relief of acute nonspecific diarrhea and associated gas-related abdominal discomfort ( gas pain , cramps , gas pressure , and bloating ) than either of its components or placebo . The combination is well tolerated BACKGROUND Traveler 's diarrhea in Thail and is frequently caused by Campylobacter jejuni . Rates of fluoroquinolone ( FQ ) resistance in Campylobacter organisms have exceeded 85 % in recent years , and reduced fluoroquinolone efficacy has been observed . METHODS Azithromycin regimens were evaluated in a r and omized , double-blind trial of azithromycin , given as a single 1-g dose or a 3-day regimen ( 500 mg daily ) , versus a 3-day regimen of levofloxacin ( 500 mg daily ) in military field clinics in Thail and . Outcomes included clinical end points ( time to the last unformed stool [ TLUS ] and cure rates ) and microbiological end points ( pathogen eradication ) . RESULTS A total of 156 patients with acute diarrhea were enrolled in the trial . Campylobacter organisms predominated ( in 64 % of patients ) , with levofloxacin resistance noted in 50 % of Campylobacter organisms and with no azithromycin resistance noted . The cure rate at 72 h after treatment initiation was highest ( 96 % ) with single-dose azithromycin , compared with the cure rates of 85 % noted with 3-day azithromycin and 71 % noted with levofloxacin ( P=.002 ) . Single-dose azithromycin was also associated with the shortest median TLUS ( 35 h ; P=.03 , by log-rank test ) .  Levofloxacin 's efficacy was inferior to azithromycin 's efficacy , except in patients with no pathogen identified during the first 24 h of treatment or in patients with levofloxacin-susceptible Campylobacter isolates , in whom it appeared to be equal to azithromycin . The rate of microbiological eradication was significantly better with azithromycin-based regimens ( 96%-100 % ) , compared with levofloxacin ( 38 % ) ( P=.001 ) ; however , this finding was poorly correlated with clinical outcome . A higher rate of posttreatment nausea in the 30 min after receipt of the first dose ( 14 % vs. < 6 % ; P=.06 ) was observed as a mild , self-limited complaint associated with single-dose azithromycin . CONCLUSIONS Single-dose azithromycin is recommended for empirical therapy of traveler 's diarrhea acquired in Thail and and is a reasonable first-line option for empirical management in general BACKGROUND The recommended treatment for traveler 's diarrhea is the combination of an appropriate antibiotic ( usually a fluoroquinolone ) and loperamide . Azithromycin compared favorably with fluoroquinolones in trials that did not include the use of loperamide , but combination therapy has not , to our knowledge , been studied to date . METHODS A r and omized , double-blind trial was conducted at Incirlik Air Base , Turkey , fromJ une 2003 through August 2004 . Adults from the United States with noninflammatory diarrhea were r and omized to receive a single dose of  azithromycin ( 1000 mg ; 106 persons ) or levofloxacin ( 500 mg ; 101 persons ) plus loperamide ( 4 mg initially and as needed thereafter ) . Volunteers maintained a symptom diary and were evaluated on days 1 , 3 , and 7 after treatment . RESULTS No differences were noted with respect to pretreatment symptoms or pathogen distribution . Enterotoxigenic Escherichia coli was the most common pathogen isolated ( from 45 % of patients in the azithromycin group and 42 % of patients in the levofloxacin group ) , and Campylobacter species was the second most common pathogen isolated ( from 6 % of patients in the azithromycin group and 9 % of patients in the levofloxacin group ) . Median time to last diarrheal stool  ( azithromycin group , 13 h ; levofloxacin group , 3 h ) , median time to resolution of associated symptoms ( 2 days ) , and additional loperamide usage ( azithromycin group , 39 % of patients ; levofloxacin group , 34 % of patients ) were similar between groups . Azithromycin use was associated with more nausea in the 30 min after dosing ( azithromycin group , 8 % of patients ; levofloxacin group , 1 % of patients ; Pp.004 ) , but no vomiting or other adverse events were noted in either group . CONCLUSIONS Single-dose treatment with azithromycin ( 1000 mg ) and loperamide is as effective as single-dose treatment with levofloxacin ( 500 mg ) and loperamide for noninflammatory diarrhea . Although nausea after dosing is uncommon , it is more frequently associated with azithromycin than with levofloxacin . Future studies should focus on determining whether lower doses of azithromycin would decrease the frequency of nausea and decrease treatment costs without affecting efficacy Background : Although the use of the antimicrobial , trimethoprim-sulfamethoxazole , in combination with the antisecretory and antimotility agent , loperamide , has been shown to be efficacious in the treatment of traveler 's diarrhea , the use of fluoroquinolone antimicrobials in combination with loperamide has less support in the literature . The present study was design ed to compare the efficacy of ofloxacin versus ofloxacin plus loperamide in the treatment of acute traveler 's diarrhea . Method : This prospect i ve , r and omized , evaluator-blinded treatment trial was conducted in Guadalajara , Mexico , during the summers of 1992 - 1994 . Adults newly arrived in Mexico from the United States who developed acute diarrhea of less than 2 weeks ' duration were r and omized to receive orally either : A ) ofloxacin , 400 mg once ; B ) ofloxacin , 200 mg twice a day for six doses ; or C ) ofloxacin , 400 mg once , plus loperamide , 4 mg once followed by 2 mg after each loose stool , not to exceed 16 mg per day , for 3 days . The duration of illness was the number of hours elapsed from the beginning of therapy to the passage of the last unformed stool . Results : Ofloxacin and loperamide were well tolerated . Combination therapy with single dose ofloxacin plus loperamide was significantly more efficacious in reducing the duration of diarrhea than single dose ofloxacin or ofloxacin given for 3 days ( p < .00001 ) . Furthermore , combination therapy was more efficacious when enterotoxigenic Escherichia coli ( ETEC ) was the pathogen ( p < .01 ) or when no pathogen was isolated ( p < .001 ) . Sixty-three percent of subjects passed no further unformed stools after the initial doses of combination therapy , and 91 % were well by the end of the first 24 hours . Conclusions : The combined use of a single dose of ofloxacin with loperamide is safe and more efficacious in the treatment of traveler 's diarrhea than use of ofloxacin alone We evaluated the use of azithromycin ( 500 mg ) or ciprofloxacin ( 500 mg ) daily for 3 days for the treatment of acute diarrhea among United States military personnel in Thail and . Stool cultures were obtained and symptoms were recorded on study days 0 , 1 , 2 , 3 , and 10 . Campylobacter species were the most common pathogen isolated ( 44 isolates from 42 patients ) . All Campylobacter isolates were susceptible to azithromycin ; 22 were resistant to ciprofloxacin . Among the 42 patients with campylobacter infection , there were 2 clinical and 6 bacteriologic treatment failures in the ciprofloxacin group and no treatment failures in the azithromycin group ( P = .021 for bacteriologic failures ) . Overall , azithromycin was as effective as ciprofloxacin in decreasing the duration of illness ( 36.9 hours vs. 38.2 hours , respectively ) and the number of stools ( 6.4 vs. 7.8 , respectively ) . Among those not infected with Campylobacter species ( n = 30 ) , the duration of illness was 32.9 hours vs. 20.7 hours ( P = .03 ) for the azithromycin and ciprofloxacin groups , respectively . Azithromycin is superior to ciprofloxacin in decreasing the excretion of Campylobacter species and as effective as ciprofloxacin in shortening the duration of illness .  Azithromycin therapy may be an effective alternative to ciprofloxacin therapy in areas where ciprofloxacin-resistant Campylobacter species are prevalent BACKGROUND Because the combination of loperamide and some antimicrobials has proven to be more efficacious than the antimicrobial agent alone in the treatment of travelers ' diarrhea , we set out to prove loperamide plus azithromycin was more efficacious than azithromycin alone . METHODS During the summers of 2002 to 2003 , 176 US adults recently arrived in Guadalajara , Mexico were enrolled in a prospect i ve , double-blinded , r and omized trial of the treatment of acute diarrhea . Subjects received single doses ( 1,000 or 500 mg ) of azithromycin or a single 500 mg dose of azithromycin plus loperamide . Subjects gave a pre- and post-treatment stool sample for analysis and maintained daily diaries of symptoms and passage of stools . RESULTS The duration of diarrhea was significantly ( p=0.0002 ) shorter following treatment with azithromycin plus loperamide ( 11 h ) than with either dose of azithromycin alone ( 34 h ) . In the first 24 hours , 
    Output:
    
Factors that possibly affect advantage of combination therapy over solo therapy included increased frequency of pretreatment diarrhea and higher prevalence of noninvasive pathogens .
CONCLUSION Antibiotic therapy with adjunctive loperamide offers an advantage over antibiotics alone by decreasing the illness duration and increasing the probability of early clinical cure