***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: Study Design . A prospect i ve , r and omized , single ( investigator ) blind , comparative efficacy trial was conducted . Objective . To compare the efficacy of continuous low-level heat wrap therapy ( 40 C , 8 hours/day ) with that of ibuprofen ( 1200 mg/day ) and acetaminophen ( 4000 mg/day ) in subjects with acute nonspecific low back pain . Summary of Background Data . The efficacy of topical heat methods , as compared with oral analgesic treatment of low back pain , has not been established . Methods . Subjects ( n = 371 ) were r and omly assigned to heat wrap ( n = 113 ) , acetaminophen ( n = 113 ) , or ibuprofen ( n = 106 ) for efficacy evaluation , or to oral placebo ( n = 20 ) or unheated back wrap ( n = 19 ) for blinding . Outcome measures included pain relief , muscle stiffness , lateral trunk flexibility , and disability . Efficacy was measured over two treatment days and two follow-up days . Results . Day 1 pain relief for the heat wrap ( mean , 2 ) was higher than for ibuprofen ( mean , 1.51;P = 0.0007 ) or acetaminophen ( mean , 1.32;P = 0.0001 ) . Extended mean pain relief ( Days 3 to 4 ) for the heat wrap ( mean , 2.61 ) also was higher than for ibuprofen ( mean , 1.68;P = 0.0001 ) or acetaminophen ( mean , 1.95;P = 0.0009 ) . Lateral trunk flexibility was improved with the heat wrap ( mean change , 4.28 cm ) during treatment ( P ≤ 0.009 vs acetaminophen [ mean change , 2.93 cm ] , P ≤ 0.001 vs ibuprofen [ mean change , 2.51 cm ] ) . The results were similar on Day 4 . Day 1 reduction in muscle stiffness with the heat wrap ( mean , 16.3 ) was greater than with acetaminophen ( mean , 10.5;P = 0.001 ) . Disability was reduced with the heat wrap ( mean , 4.9 ) , as compared with ibuprofen ( mean , 2.7;P = 0.01 ) and acetaminophen ( mean , 2.9;P = 0.0007 ) , on Day 4 . None of the adverse events were serious . The highest rate ( 10.4 % ) was reported in the ibuprofen group . Conclusion . Continuous low-level heat wrap therapy was superior to both acetaminophen and ibuprofen for treating low back pain A double-blind , 18-center , balanced trial of diflunisal vs. cyclobenzaprine HCl vs. these two drugs combined vs. placebo produced complete results from 175 patients . They had sought treatment at the cooperating centers for acute painful spasms of the back within a day or two of trauma or strain . Global results over the 7 to 10 days of observations revealed a clinical ly and statistically significant superiority of the combined therapy by Day 4 ( P=0.006 ) and almost all patients recovered within a week to 10 days . A combination therapy with an effective safe analgesic and a true muscle relaxant for less than a week appears to be an excellent relief measure for acute back problems Study Design . Two replicate , 4-week , r and omized , double-blind , placebo-controlled , trials of rofecoxib 25 and 50 mg versus placebo for chronic low back pain . Objectives . To determine the efficacy and safety of two doses of rofecoxib compared to placebo in the treatment of chronic low back pain . Summary of Background Data . Although nonsteroidal anti-inflammatory drugs are commonly prescribed for chronic low back pain , their efficacy is unproven and toxicity can be serious . These studies evaluated the efficacy and tolerability of rofecoxib , a selective COX-2 inhibitor , in the treatment of chronic low back pain . Methods . Patients with chronic low back pain were r and omized 1:1:1 to rofecoxib 25 mg , 50 mg , or placebo once daily . Primary endpoint : Low Back Pain Intensity . Secondary endpoints : Pain Bothersomeness , Global Assessment s of Response to Therapy , Global Assessment of Disease Status , Rol and -Morris Disability Question naire , SF-12 Health Survey , Use of Rescue Acetaminophen , and Discontinuations Due to Lack of Efficacy . Results . Combining both studies , 690 patients were r and omized to placebo ( N = 228 ) ,  rofecoxib 25 mg ( N = 233 ) , or  rofecoxib 50 mg ( N = 229 ) . Mean ( ± SD ) age was 53.4 ( ± 12.9 ) years , pain duration 12.1 ( ± 11.8 ) years , 62.3 % female .  Both rofecoxib groups improved significantly . Mean differences from placebo in pain intensity were −13.50 mm , −13.81 mm ( 25 , 50 mg doses ) respectively ( P < 0.001 ) . Both regimens were superior to placebo in eight of nine secondary endpoints . Fifty mg provided no advantage over 25 mg . Both rofecoxib regimens were well tolerated , although 25 mg had a slightly better safety profile . Conclusions . Rofecoxib significantly  reduced chronic low back pain in adults and was well tolerated The study objective was to assess the efficacy and patient acceptance of ketorolac as an alternative to meperidine for the treatment of severe musculoskeletal low back pain ( LBP ) . A double blinded prospect i ve trial in a convenience sample of patients > 18 years of age presenting to an urban university hospital emergency department ( ED ) was conducted over a 19-month period . Patients were included if the pain was musculoskeletal in origin and was severe enough to warrant parenteral analgesics . Patients were r and omized to receive 1 mg/kg meperidine intramuscularly ( IM ) or 60 mg ketorolac IM . Pain intensity was measured preadministration and at 60 minutes via a 100 mm Visual Analog Scale ( VAS ) . Outcomes measured at 60 minutes were pain intensity decrease ( PID ) , patient satisfaction , rescue analgesia requirement , sedation level , and adverse effects . Clinical ly significant pain reduction was defined as a PID of at least 13 mm or a reduction in pain of least 30 % . One hundred fifty-five patients were enrolled ( meperidine = 75 , ketorolac = 80 ) and 153 patients completed the study . At 60 minutes the mean PID was 7 mm less in the ketorolac group ( 95 % confidence interval [ CI ] - 15 mm to 2.6 mm ) . Pain reduction of at least 30 % occurred in 63 % of the ketorolac group versus 67 % of the meperidine group ( 95 % CI , odds ratio [ OR ] .43 to 1.61 ) . Rescue analgesia was required in 35 % of the ketorolac group versus 37 % of the meperidine group ( 95 % CI , OR .47 to 1.74 ) . Patient satisfaction was less in the ketorolac group ( ketorolac 68 % satisfied versus meperidine 74 % satisfied ) however this was not significant ( 95 % CI , OR .66 to 2.72 ) . Sedation level and adverse effects were significantly greater in the meperidine group . Ketorolac shows comparable single dose analgesic efficacy to a single moderate dose of meperidine with less sedation and adverse effects in an ED population with severe musculoskeletal LBP . The trend for greater pain reduction and patient satisfaction with meperidine needs further investigation Abstract The efficacy and tolerability of aceclofenac was compared with diclofenac resinate in a double-blind , multicentre r and omised study in patients with acute low back pain suffering from degenerative spinal disorders . The study included 227 patients r and omised to receive either aceclofenac 2 × 100 mg daily or diclofenac resinate 2 × 75 mg daily for up to 10 days . The primary objective was to demonstrate the clinical non-inferiority of the analgesic efficacy of aceclofenac compared with diclofenac resinate , as assessed by changes from baseline in the visual analogue scale ( 0–100 mm ) pain score , at rest and at visit 3 ( final visit on day 's 8–10 ) . Secondary objectives included the time to early cure ( resolution of pain ) and global assessment of tolerability . Mean change in pain score at rest , and as visit 3 , compared with baseline , was 61.6 mm ( SD 24.5 ) for the aceclofenac group ( n = 100 ) and 57.3 mm ( SD 22.8 ) for the diclofenac resinate group ( n = 105 ) in the per- protocol population . Similar changes were observed in the intention-to-treat population . Between-group differences of 4.5 mm and 5.5 mm for the per- protocol and intention-to-treat population s , respectively , demonstrated clinical non-inferiority of aceclofenac compared with diclofenac resinate . Furthermore , there was evidence for superiority of aceclofenac over diclofenac resinate in terms of statistical significance , as the one-sided 97.5 % confidence interval was above −10 mm and 0 mm . In the intention-to treat population , a total of six aceclofenac-treated patients discontinued their medication owing to early cure , compared with only one patient receiving diclofenac resinate . Seventeen aceclofenac- ( 14.9 % ) , and 18 diclofenac resinate-treated patients ( 15.9 % ) reported at least one adverse event . However , the total number of adverse events reported was lower in patients receiving aceclofenac ( 22 versus 31 in the diclofenac resinate group ) . In conclusion , non-inferiority of the analgesic efficacy of aceclofenac compared with diclofenac resinate was demonstrated in patients with localised , uncomplicated acute lumbosacral pain . For the reduction in pain levels from baseline there was also evidence for superiority of aceclofenac compared with diclofenac resinate in terms of statistical significance , although this difference was not considered clinical ly relevant . The results also showed a trend towards a better safety and tolerability profile of aceclofenac over diclofenac resinate from a clinical point of view This study reports on 105 patients with acute low-back pain given tizanidine  ( 4 mg three times daily ) plus ibuprofen ( 400 mg three times daily ) or placebo plus ibuprofen ( 400 mg three times daily ) . Patients assessed their pain using visual analogue scales in a daily diary and the doctor assessed their condition at baseline and on days 3 and 7 . Both groups were treated effectively , but earlier improvement occurred in patients given tizanidine/ibuprofen , particularly regarding pain at night and at rest . Doctors assessed the helpfulness of treatment : tizanidine/ibuprofen was significantly better than placebo/ibuprofen at day 3 ( P = 0.05 ) . Significant differences between treatments in favour of tizanidine/ibuprofen occurred in patients with moderate and severe pain at night ( P<0.05 ) , at rest ( P<0.05 ) and those with moderate or severe sciatica ( P<0.05 ) . Significantly more patients given placebo/ibuprofen had gastro-intestinal side-effects compared with tizanidine/ibuprofen ( P = 0.002 ) . This supports previous work in animals showing that tizanidine mediates gastric mucosal protection against anti-inflammatory drugs . More patients given tizanidine/ibuprofen suffered drowsiness and other central nervous system effects ( P = 0.025 ) . In patients with severe acute low-back pain , however , some sedation and bed rest is advantageous . This study shows that tizanidine/ibuprofen is more effective in the treatment of moderate or severe acute low-back pain than placebo and ibuprofen alone Two hundred and sixty patients with lumbago or sciatic pain participated in a multicenter observer-blind r and omized trial to compare the efficacy and tolerability of dipyrone 2.5 g , diclofenac 75 mg , and placebo administered as an intramuscular injection once daily for the duration of one to two days . The effectiveness of the test treatments in relieving sciatic pain was measured by a visual analog scale ( VAS ) before and 30 minutes , 1 , 2 , 3 , 6 and 24 hours after each injection . In addition , the patient 's general well-being was measured on a 5-point rating scale on day 0 , 1 and 2 . At the end of the trial , the patients evaluated the overall efficacy of the study drugs on a 5-point rating scale . Minimal finger-toe distance was measured every day of the trial . Pain intensity on VAS ( primary endpoint ) showed a significantly greater reduction with dipyrone than with diclofenac or placebo between 1 and 6 hours after application ( p < 0.01 ) and at the end of the trial ( after 48 hours ) . Improvement in general well-being and minimal finger-toe distance was greatest in the dipyrone group . 59 % of the patients with dipyrone assessed the overall efficacy as " excellent " or " very good " , compared with 30 % with diclofenac , and 18 % with placebo . 
    Output:
    
Statistically significant effects were found in favor of NSAIDs compared with placebo , but at the cost of statistically significant more side effects .
There is moderate evidence that NSAIDs are not more effective than paracetamol for acute low back pain , but paracetamol had fewer side effects .
There is moderate evidence that NSAIDs are not more effective than other drugs for acute low back pain .
There is strong evidence that various types of NSAIDs , including COX-2 NSAIDs , are equally effective for acute low back pain .
COX-2 NSAIDs had statistically significantly fewer side effects than traditional NSAIDs .
The evidence from the 65 trials included in this review suggests that NSAIDs are effective for short-term symptomatic relief in patients with acute and chronic low back pain without sciatica .
Furthermore , there does not seem to be a specific type of NSAID , which is clearly more effective than others .
The selective COX-2 inhibitors showed fewer side effects compared with traditional NSAIDs in the r and omized controlled trials included in this review .
However , recent studies have shown that COX-2 inhibitors are associated with increased cardiovascular risks in specific patient population