***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: 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 Forty-five healthy men aged 21 - 34 years took part in a double-blind , parallel-group , placebo-controlled study of the effects of 28 days ' treatment with lornoxicam 4 mg twice daily or indomethacin 50 mg twice daily on faecal blood loss and the endoscopic appearances of gastric and duodenal mucosa . After an initial endoscopic examination , subjects received , intravenously , on day 0 , autologous erythrocytes labelled with 51Cr . Complete daily faecal collection s were then made from days 6 - 12 , 20 - 26 and 34 - 40 . The drug treatments or placebo were given from days 13 - 41 . Faecal blood loss was calculated from 51Cr-specific activity of blood and faeces . Endoscopy was repeated 4 - 8 hours after the last dose of medication ; mucosal appearance was grade d on a 5-point scale . Lornoxicam caused no more adverse events than placebo ; indomethacin caused more indigestion and central nervous system effects , and one subject in this group was withdrawn from the study . Median total blood losses during the pre-treatment and the second and fourth weeks of treatment were respectively 3.33 , 3.95 and 5.71 ml for lornoxicam , 2.87 , 7.04 and 7.75 ml for indomethacin , and 4.55 , 3.64 and 4.13 ml for placebo . Differences between treatments were not statistically significant ( P = 0.081 for second week of treatment , P = 0.383 for fourth week of treatment ; Kruskal-Wallis test ) . The effect of chlortenoxicam on faecal blood loss in this study was thus intermediate between placebo and indomethacin , but within- and between-subject variability was such that the differences were not statistically significant . Endoscopic findings were normal in most subjects before and after all treatments , but indomethacin was associated with a slightly greater deterioration in endoscopic score and was the only treatment associated with Grade 3 appearance ( in a single patient ) in post-treatment endoscopy 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 The aim of the present study was to investigate the dose-effect relationship of single doses of 4 to 32 mg of lornoxicam ( LNX ) , a new nonsteroidal antiinflammatory drug belonging to the oxicam group , compared with placebo and 10 mg ketorolac ( KET ) in the treatment of pain after oral surgery . Also , it was the aim of the study to evaluate the relationship between adverse events and different doses of LNX . After the surgical removal of a m and ibular third molar , test medication was taken when the patients experienced at least moderate pain . After medication , pain relief , pain intensity , and any discomfort from the medication were noted in a question naire . Paracetamol was used as rescue medication . A total of 278 patients completed the study according to the protocol . The primary efficacy parameter was total pain relief after 6 hours , and all active treatments showed significantly better effect than placebo , with LNX 16 and 32 mg being significantly superior to LNX 4 mg . All other efficacy parameters showed the same dose-effect relationship . A total of 37 adverse events were reported evenly distributed in the 6 treatment groups ; only 3 of these were considered severe , and all disappeared without treatment . In conclusion , the study showed a dose-effect relationship of LNX without a rise in adverse events . The effect of 10 mg KET seemed to be at the level of 8 to 16 mg LNX & 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 Lornoxicam is a new non-steroidal anti-inflammatory agent ( NSAID ) with a similar pharmacological profile to other oxicams and a potency 10 times greater than piroxicam . A multicentre , r and omised , double blind , parallel group study was undertaken to compare the efficacy and tolerance of four weeks ' treatment with lornoxicam ( 6 mg once daily , 4 mg twice daily , and 6 mg twice daily ) and placebo in patients with osteoarthritis of the hip or knee . A dose related efficacy of lornoxicam was shown by the numbers of patients in each treatment group who withdrew from the trial owing to inadequate symptom relief ( 12/40 ( 30 % ) receiving placebo , 6/40 ( 15 ) receiving lornoxicam 6 mg daily , 4/40 ( 10 % ) receiving lornoxicam 8 mg daily , and none receiving lornoxicam 12 mg daily ) . This effect was confirmed by pain relief scores , which were significantly better than placebo during treatment with lornoxicam 8 mg and 12 mg daily , the effect of 12 mg daily being significantly superior to that of 8 mg daily . Similar results were obtained from functional status scores . Mean functional index ( Lequesne ) scores were significantly greater than placebo only at a daily dose of 12 mg lornoxicam . Lornoxicam was generally well tolerated , though some gastrointestinal side effects were seen as has been reported with other NSAIDs . Laboratory investigations showed no evidence of drug toxicity The pain experienced after third molar surgery was used as a model to evaluate the analgesic efficacy of a new non-steroidal anti-inflammatory drug , lornoxicam , in a Phase II study . One hundred and fifty fit , young adults participated in this r and omised , single dose , double-blind , parallel group clinical study . Three doses of lornoxicam ( 2 mg , 4 mg , and 8 mg ) were compared with aspirin 650 mg and placebo .  Patients suffering from moderate to severe pain following surgery were monitored for up to 8 hours . All indices of efficacy showed similar results , all active treatments being associated with highly significant ( P less than 0.0001 ) reductions in pain during the study period . Lornoxicam 8 mg demonstrated significant analgesic efficacy as compared with placebo . The two lower doses of lornoxicam and aspirin all showed apparent degrees of efficacy intermediate between that of placebo and lornoxicam 8 mg , although the trial proved to have inadequate power to show significant differences between these three treatments . Lornoxicam was very well tolerated at all three doses studied , with no adverse events definitely attributable to its Antacids are used in the treatment of upper gastrointestinal side-effects during therapy with nonsteroidal anti-inflammatory drugs ( NSAIDs ) . Since pharmacokinetic interactions between antacids and NSAIDs have been reported , it was investigated whether aluminium and magnesium hydroxide ( Maalox as oral suspension ) or aluminium hydroxide and calcium carbonate ( Solugastril as oral gel ) influenced the bioavailability of Lornoxicam ( rINN ) , a new potent NSAID from the chemical group of the oxicams . Eighteen male volunteers were given 4 mg of Lornoxicam as a film-coated tablet either alone or together with 10 ml of Maalox or 10 g of Solugastril in an open , r and omized , three-way cross-over study . The levels of Lornoxicam in plasma were determined by HPLC following solid-phase extraction . It was found that none of the antacids changed significantly any of the following pharmacokinetic parameters : elimination half-life ( t1/2 beta ) , concentration at peak time ( Cmax ) , time to reach the peak ( tmax ) and area under the curve to infinity ( AUCo-infinity ) . The results indicate that the concomitant administration of antacids did not influence the pharmacokinetic profile of Lornoxicam .  Furthermore they confirm the short elimination half-life of Lornoxicam in man , which is markedly shorter than that of other oxicam-type compounds Abstract Objective : The aim of this study was to evaluate the analgesic efficacy and time to onset of effect of the lornoxicam quick-release ( LNX-QR ) tablet compared with the st and ard-release tablet ( LNX-ST ) . Methods : In this r and omized , double-blind , single-dose trial , 200 patients with moderate pain after surgical removal of an impacted third molar were r and omized to treatment with an LNX-QR 8 mg tablet ( 80 patients ) , an LNX-ST 8 mg tablet ( 80 patients ) or placebo ( 40 patients ) . Pain intensity ( PI ) and pain relief ( PAR ) were assessed ( numerical and verbal rating scales ) for 6 hours , and time to onset of PAR was recorded . The cumulated sum of PI differences ( SPID 
    Output:
    
Oral lornoxicam is effective at treating moderate to severe acute postoperative pain , based on limited data .
Adverse events did not differ significantly from placebo