***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: DFP [ 3-(2-propyloxy)-(4-methyl-sulfonylphenyl)-(5,5-dimethyl)-fu ranone ] is a highly specific cyclooxygenase-2 inhibitor ( > 2500-fold selective in transfected Chinese hamster ovary cell assays ) that has demonstrated efficacy in pre clinical models of pain and inflammation . The present single-dose , r and omized , double-masked , double-dummy , placebo-controlled , parallel-group study was undertaken to compare DFP 5 , 25 , and 50 mg with naproxen sodium 550 mg and with placebo in 196 patients ( mean age , 25.8 years ; 187 [ 95.4 % ] males ) who experienced moderate-to-severe pain after surgical removal of > or = 2 third molars .  Overall analgesic effect , duration of effect , time to onset of analgesic effect , peak analgesic effect , and tolerability were assessed over a 24-hour postdose period . Both DFP 25 and 50 mg , as well as the active comparator , naproxen sodium 550 mg , were significantly more effective than placebo . The onset of analgesic effect in the DFP 25-mg , DFP 50-mg , and naproxen sodium 550-mg groups did not differ significantly . DFP was generally well tolerated in single doses up to 50 mg . DFP 50 mg was efficacious in the treatment of postoperative dental pain and was indistinguishable from the active comparator , naproxen sodium 550 mg In a double-blind , parallel , placebo-controlled study , 203 patients with post-operative dental pain following the extraction of one or two bony impacted third molars were r and omized to receive a single dose of naproxen sodium 220 mg , ibuprofen 200 mg or placebo .  Pain intensity and pain relief were assessed at intervals for 12 hours postdose . Both active drugs demonstrated superior analgesic efficacy over placebo . Naproxen sodium and ibuprofen were comparable both in onset of analgesic action and in pain relief . From 1 to 12 hours postdose , naproxen sodium showed a trend for superior analgesic efficacy compared with ibuprofen ; this trend reached statistical significance at the 12-hour time point . Both drugs were well-tolerated and effective analgesics for postoperative dental pain Abstract  Variability  in patients ' response to interventions in pain and other clinical setting s is large . Many explanations such as trial methods , environment or culture have been proposed , but this paper sets out to show that the main cause of the variability may be r and om chance , and that if trials are small their estimate of magnitude of effect may be incorrect , simply because of the r and om play of chance . This is highly relevant to the questions of ‘ How large do trials have to be for statistical accuracy ? ’ and ‘ How large do trials have to be for their results to be clinical ly valid ? ’ The true underlying control event rate ( CER ) and experimental event rate ( EER ) were determined from single‐dose acute pain analgesic trials in over 5000 patients . Trial group size required to obtain statistically significant and clinical ly relevant ( 0.95 probability of number‐needed‐to‐treat within ±0.5 of its true value ) results were computed using these values . Ten thous and trials using these CER and EER values were simulated using varying group sizes to investigate the variation due to r and om chance alone . Most common analgesics have EERs in the range 0.4–0.6 and CER of about 0.19 . With such efficacy , to have a 90 % chance of obtaining a statistically significant result in the correct direction requires group sizes in the range 30–60 . For clinical relevance nearly 500 patients are required in each group . Only with an extremely effective drug ( EER>0.8 ) will we be reasonably sure of obtaining a clinical ly relevant NNT with commonly used group sizes of around 40 patients per treatment arm . The simulated trials showed substantial variation in CER and EER , with the probability of obtaining the correct values improving as group size increased . We contend that much of the variability in control and experimental event rates is due to r and om chance alone . Single small trials are unlikely to be correct . If we want to be sure of getting correct ( clinical ly relevant ) results in clinical trials we must study more patients . Credible estimates of clinical efficacy are only likely to come from large trials or from pooling multiple trials of conventional ( small ) size BACKGROUND Although aspirin has been shown to protect patients from acute myocardial infa rct ion ( AMI ) , the effect of nonaspirin nonsteroidal anti-inflammatory drugs ( NSAIDs ) is not clear . OBJECTIVE To determine whether NSAIDs have a similar effect or whether they differ in their effect on the risk of AMI . METHODS We performed a case-control study of AMI in a large health care data base containing information on all filled prescriptions , hospitalizations , diagnoses , and procedures for all patients covered by the New Jersey Medicaid or Medicare and Pharmaceutical Assistance for the Aged and Disabled programs . We identified 4425 patients hospitalized for AMI between January 1 , 1991 , and December 31 , 1995 , and 17 700 control subjects . Multivariate models were constructed to control for potential confounders . RESULTS A quarter of the cases and controls had filled a prescription for an NSAID in the 6 months before theirAMI ( cases ) or a r and omly assigned index date ( controls ) ; 9 % had filled a prescription for an NSAID that overlapped with their date of AMI or index date . Overall , NSAID users had the same risk of AMI as nonusers , whether such use was measured on the index date ( adjusted odds ratio , 1.04 ; 95 % confidence interval , 0.92 - 1.18 ; P = .55 ) or at any time in the prior 6 months ( adjusted odds ratio , 1.00 ; 95 % confidence interval , 0.92 - 1.08 ; P = .92 ) . However , use of naproxen was associated with a significant reduction in the risk of AMI ( adjusted odds ratio , 0.84 ; 95 % confidence interval , 0.72 - 0.98 ; P = .03 ) . CONCLUSIONS Although NSAIDs have anti-inflammatory and antiplatelet effects similar to those of aspirin , we did not find that these drugs confer a protective effect against AMI . However , use of one specific NSAID , naproxen , appeared to be associated with a reduced rate of AMI , an effect recently suggested by a large r and omized controlled trial as well In a double-blind study , 198 out patients with pain after oral surgery were r and omly assigned to treatment with a single oral dose of naproxen sodium 550 mg , codeine sulfate 60 mg , a combination of naproxen sodium 550 mg with codeine sulfate 60 mg , aspirin 650 mg or placebo . Using a self-rating record , subjects rated their pain and its relief hourly for 12 hours after medication . Orthogonal contrasts for the four treatments making up the factorial component showed that the naproxen effect was significant for every measurement of total and peak analgesia ; the codeine effect was significant for total and peak pain relief and patients ' overall evaluation . The naproxen-codeine interaction was not statistically significant for any measure , which suggests that the analgesic effect of the combination represents the additive effect of its constituents . Based on pairwise comparisons , aspirin was significantly superior to placebo for most measures of effect , naproxen was significantly superior to both aspirin and codeine for all measures and the combination was significantly superior to naproxen for patients ' overall evaluation . No more patients experienced adverse effects with aspirin or naproxen than with placebo , but significantly more patients receiving the codeine-containing treatments experienced adverse effects than those receiving aspirin and naproxen Abstract A previously established relationship for deriving dichotomous from continuous information in r and omised controlled trials ( RCTs ) of analgesics has been tested using an independent data set . Individual patient information from 18 RCTs of parallel‐group design in acute postoperative pain ( after abdominal , gynaecological and oral surgery ) was used to calculate the percentage of the maximum possible pain relief score  ( % maxTOTPAR ) and the proportion of patients with > 50%maxTOTPAR for the different treatments . The relationship between the measures was investigated in 85 treatments with over 3400 patients . In 80 of 85 treatments ( 94 % ) agreement between calculated and actual number of patients with > 50%maxTOTPAR was within four patients per treatment and in 72 ( 85 % ) was within three ( average of 40 patients per treatment , range 21–58 patients ) . Summing the positive and negative differences between actual and calculated numbers of patients with > 50%maxTOTPAR gave an average difference of 0.30 patients per treatment arm . Reports of RCTs of analgesics frequently describe results of studies in the form of mean derived indices , rather than using discontinuous events , such as number or proportion of patients with 50 % pain relief . Because mean data inadequately describe information with a non‐normal distribution , combining mean data in systematic review s may compromise the results . Showing that dichotomous data can reliably be derived from mean data in acute pain studies enables data published as means to be used for quantitative systematic review s which require data in dichotomous form We assessed the quality of assessment and reporting of adverse effects in r and omized , double-blind clinical trials of single-dose acetaminophen or ibuprofen compared with placebo in moderate to severe postoperative pain . Reports were identified by systematic search ing of a number of bibliographic data bases ( e.g. , MEDLINE ) . Information on adverse effect assessment , severity and reporting , patient withdrawals , and anesthetic used was extracted . Compliance with former guidelines for adverse effect reporting was noted . Fifty-two studies were included ; two made no mention of adverse effects . No method of assessment was given in 19 studies . Twenty trials failed to report the type of anesthetic used , eight made no mention of patient withdrawals , and nine did not state the severity of reported adverse effects . Only two studies described the method of assessment of adverse effect severity . When all adverse effect data were pooled , significantly more adverse effects were reported with active treatment than with placebo . For individual adverse effects , there was no difference between active ( acetaminophen 1000 mg or ibuprofen 400 mg ) and placebo ; the exception was significantly more somnolence/drowsiness with ibuprofen 400 mg . Ninety percent of trials reporting somnolence/drowsiness with ibuprofen 400 mg were in dental pain . All studies published after 1994 complied with former guidelines for adverse effect reporting . Different methods of assessing adverse effects produce different reported incidence : patient diaries yielded significantly more adverse effects than other forms of assessment . We recommend guidelines for reporting adverse effect information in clinical trials & NA ; Reports of RCTs of analgesics frequently describe results of studies in the form of mean derived indices , rather than using discontinuous events — such as number or proportion of patients with 50 % pain relief . Because mean data inadequately describe information with a non‐normal distribution , combining mean data in systematic review s may compromise the results . Showing that dichotomous data can reliably be derived from mean data , at least in acute pain models , indicates that more meaningful overviews or meta‐ analysis may be possible . This study investigated the relationship between continuous and dichotomous analgesic measures in a set of individual patient data , and then used that relationship to derive dichotomous from continuous information in r and omised controlled trials ( RCTs ) of analgesics .  Individual patient information from 13 RCTs of parallel‐group and crossover design in acute postoperative pain was used to calculate the percentage of the maximum possible pain relief score ( % maxTOTPAR ) and the proportion of patients with greater than 50 % pain relief ( > 50%maxTOTPAR ) for the different treatments . The relationship between the measures was investigated in 45 actual treatments and 10 000 treatments simulated using the underlying actual distribution ; 1283 patients had 45 separate treatments . Mean % maxTOTPAR correlated with the proportion of patients with > 50%maxTOTPAR ( r2 = 0.90 ) . The relationship calculated from all the 45 treatments predicted to within three patients the number of patients with more than 50 % pain relief in 42 of 45 treatments , and 98.8 % of 10 000 simulated treatments . For seven effective treatments , actual numbers‐needed‐to‐treat ( NNT ) to achieve > 50%maxTOTPAR compared with placebo were very similar to those derived from calculated data The aim of this study was to examine the clinical effect of naproxen sodium  after knee arthroscopy . The design was r and omized , prospect i ve , and double-blind , with a placebo control group . Patients with preoperative synovial reaction were excluded . One hundred twenty consecutive arthroscopies were performed in 77 men and 43 women , median age 34 ( range 18 - 65 ) years .  General anesthesia was used . Ninety-one arthroscopies were operative , whereas 29 were diagnostic . Postoperatively the patients received either 550 mg naproxen sodium twice daily or placebo for 10 days . Patients were given 500 mg acetaminophen to use if needed . Clinical examinations were performed 10 and 20 days postoperation . The results were analyzed using the Mann-Whitney test and chi 2 test . No operative complications were registered . All but two patients completed the study . Six patients had 
    Output:
    
Conclusion A single oral dose of naproxen sodium 550 mg is an effective analgesic in the treatment of acute postoperative pain .
A low incidence of adverse events was found , although these were not reported consistently