***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 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 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 .  Adverse reactions were reported in only 7 patients ( 3 % ) , 4 ( 5 % ) in the dipyrone , 1 ( 1 % ) in the diclofenac , and 2 ( 2 % ) in the placebo group A double-blind trial of azapropazone ( 300 mg . 4-times daily ) and ketoprofen ( 50 mg . 4-times daily ) was carried out in 50 patients with acute backache sufficiently severe to necessitate hospital admission . Of 39 patients who completed the full 3-weeks ' study period , 18 preferred azapropazone therapy , 10 preferred ketoprofen , and 11 showed either preference for the intermediate placebo period or no preference at all . Ten patients suffered from sufficiently severe side-effects with  ketoprofen  to necessitate their withdrawal from the trial . There were no similar episodes of withdrawal occurring during the azapropazone period The roles of bedrest , antiinflammatory medication , and analgesic medication in the treatment of acute back strain were objective ly analyzed to determine whether they have a measurable effect on the return of  patients  to full daily activities as well as on the relief of pain . Two hundred patients were studied prospect ively . Each patient had the diagnosis of acute back strain , which was defined as nonradiating low-back pain . The results of the patient 's neurologic examination , straight leg raising test , and lumbosacral spine roentgenograms had to be within normal limits for the patient to be included in the study . The results showed that bedrest , as compared with ambulation , will decrease the amount of time lost from work by 50 % . Bedrest will also decrease the amount of discomfort by 60 % . Analgesic medication , when combined with bedrest , will further decrease the amount of pain incurred , particularly when used in the first three days of the healing process . However , analgesic medication will not allow a more prompt return to work .  Antiinflammatory medication , when added to bedrest in the treatment of lumbago , does not provide an advantage over bedrest alone Pain syndromes of the lumbar spine are one of the main problems in orthopedic practice . The therapeutic effect of NSAIDs is not subject to doubt in this connection . But considering that the application of NSAIDs is frequently associated with side effects , a reduction of dosage would be to the patient 's benefit . Clinical studies have shown that concomitant treatment with vitamins B1 , B6 , B12 and diclofenac leads to a more efficient pain relief than treatment using diclofenac alone and thus provides the possibility of saving NSAIDs . This clinical trial was carried out in order to determine whether these results can also be achieved when a reduced dosage of diclofenac ( 75 mg daily ) is used . 123 patients with acute pain syndromes of the lumbar spine were treated with either B-vitamins and diclofenac or diclofenac alone for a maximum of 7 days . There was the option to terminate therapy in the trial after 3 - 4 days in the case of total pain relief .  45 patients could stop the treatment due to remission of symptoms . 30 patients belonged to the combination therapy group , the other 15 took diclofenac alone ; this difference is statistically significant ( p less than 0.05 ) . All parameters concerning pain relief and movement of the vertebral column showed statistically significant differences in favour of the B-vitamin-diclofenac-combination , too . The results document the positive influence of B-vitamins on painful vertebral syndromes and indicate that B-vitamins contribute to saving of NSAIDs by shortening the treatment time and reducing daily NSAID-dosage A short-term double-blind sequential trial of indomethacin against placebo in the treatment of low back pain , with and without nerve root pain such as sciatica , showed that indomethacin was significantly more effective than placebo in the group with nerve root pain . On the other h and , no difference was found between the treatments in the patients with uncomplicated low back pain . This difference may result from an effect of indomethacin on the inflammatory process around the nerve root which has been shown to be present when this is compressed Thirty patients suffering from painful syndromes of the spine were admitted to a r and omized controlled clinical trial . They were divided into two groups and treated either with transcutaneous electrical nerve stimulation ( TENS ) , one application every other day , for 20 days or with TENS and an ointment containing etofenamate 10 % gel , 3 - 5 cm daily on the day of TENS therapy , and the same dose twice daily on the other days . The associated therapy achieved , when compared with TENS alone , a statistically significant better outcome . Furthermore a marked improvement of symptoms was observed in a shorter period of time . Therapy was well tolerated and in only four cases mild , self-limiting , skin reactions were observed . On the basis of these results the use of etofenamate and TENS could represent a viable alternative to systemic nonsteroidal antiinflammatory drug therapy Several clinical trials have shown that the duration of treatment of painful vertebral syndromes can be shortened by using a combination of vitamins B1 , B6 , B12 and diclofenac instead of diclofenac . In addition , a more efficient pain relief could be achieved by the combination therapy . In order to confirm these results , we compared the clinical efficacy of diclofenac ( 25 mg ) and a combination preparation with diclofenac ( 25 mg ) plus vitamins B1 ( thiamine nitrate 50 mg ) , B6 ( pyridoxine hydrochloride 50 mg ) and B12 ( cyanocobalamin 0.25 mg ) in a multicentric r and omized double-blind study including 418 patients . All patients received 3 x 2 capsules daily for a maximum of 2 weeks . In case of total pain relief , therapy should be discontinued after one week . Data of 376 patients could be evaluated . 53 out of 184 patients receiving the combination and 48 out of 192 patients treated with diclofenac alone could stop therapy due to sufficient pain relief after one week . The evaluation of the " Hoppe Pain Question naire " and the data concerning pain intensity also revealed better results for the combination preparation . The differences in favour of the  B-vitamin-diclofenac-combination  were statistically significant in patients with severe pain  at the beginning of therapy . Considering undesirable side-effects ( symptoms in 70 out of 418 patients ) there were no significant differences between the two medications . This clinical trial provides further evidence that the combination therapy with diclofenac plus B-vitamins is more effective than diclofenac alone for the treatment of painful vertebral syndromes General Practitioners from the United Kingdom produced data on 1,282 patients with acute soft tissue injury treated with either piroxicam ( Feldene ) or matching placebo for a period of up to two weeks . The dosage of piroxicam was 40 mg for the first 2 days and 20 mg daily thereafter . Clinical assessment included pain , swelling , limitation of active and passive movement and overall assessment of efficacy and toleration .  Piroxicam was significantly better than placebo in improving patient signs and symptoms , and in its overall efficacy ( P less than 0.001 ) ; 87 % of piroxicam treated patients had excellent or good responses , compared to 53 % of placebo treated patients . On analysis of four of the most commonly occurring diagnoses ( injuries of ankle , knee , shoulder , back ) patients with moderate or severe pain showed a significant improvement on treatment with piroxicam .  Physicians ' overall assessment of toleration showed no evidence of differences between treatments . Over 90 % of patients in both treatment groups had good or excellent toleration . Withdrawals due to side effects were 3 % and 2.5 % respectively for piroxicam and placebo treated patients Twenty-eight out patients with chronic severe lumbar pain participated in a double-blind comparative trial on the clinical efficacy of orally administered piroxicam and indomethacin . Half of the patients received indomethacin , 25 mg t.i.d . ; the other half received piroxicam 20 mg in the morning and a placebo at lunchtime and before dinner for six weeks . The patients were examined four times at two-week intervals for their capability to do daily tasks and for total lumbar mobility , forward bending , raising of both legs straight and the subjective assessment of pain . Side effects were recorded on a question naire and with laboratory tests . The overall results of both groups were similar . Thus , piroxicam , 20 mg daily , matches indomethacin , 25 mg t.i.d . , in the treatment of low back pain . The side effects were slight . Treatment with  indomethacin  was stopped in one case ( erythema and conjunctivitis ) . In the piroxicam group diarrhea , constipation , and pain in the tongue were reported , whereas in the indomethacin group gastrointestinal irritation and tiredness were typical symptoms Patients ( 112 ) with acute low-back pain of recent onset were recruited to this double-blind , r and omized , placebo-controlled parallel group study in general practice to evaluate the efficacy and tolerability of the muscle relaxant , tizanidine . They were treated for 7 days with tizanidine ( 4 mg three times daily ) or matching placebo . Aspirin tablets ( 300 mg ) were taken as required as ‘ rescue ’ medication . Symptoms were assessed by the patient and doctor before treatment , and after 3 and 7 days . Patients recorded pain and aspirin consumption in a daily diary . Both treatments were effective . In patients who had taken no medication prior to entry ,  aspirin consumption was almost halved in the first 3 days of taking tizanidine compared with placebo ( P = 0.037 ) . Results for pain at rest , pain at night , restriction of movement and pain on movement suggest that tizanidine may give greater improvement , earlier . No serious drug-related adverse events or abnormal biochemistry or haematology were observed in either group . Drowsiness occurred in 22 % of patients taking tizanidine although , in patients with severe acute low-back pain , 
    Output:
    
The pooled relative risk for global improvement after 1 week was 1.24 ( 95 % confidence interval [ CI ] = 1.10 - 1.41 ) , and for additional analgesic use was 1.29 ( 95 % CI = 1.05 - 1.57 ) , indicating a statistically significant but small effect in favor of nonsteroidal anti-inflammatory drugs as compared with a placebo .
The results of the qualitative analysis showed that there is conflicting evidence ( Level 3 ) that nonsteroidal anti-inflammatory drugs are more effective than paracetamol for acute low back pain , and that there is moderate evidence ( Level 2 ) that nonsteroidal anti-inflammatory drugs are not more effective than other drugs for acute low back pain .
There is strong evidence ( Level 1 ) that various types of nonsteroidal anti-inflammatory drugs are equally effective for acute low back pain .
CONCLUSIONS The evidence from the 51 trials included in this review suggests that nonsteroidal anti-inflammatory drugs are effective for short-term symptomatic relief in patients with acute low back pain .
Furthermore , there does not seem to be a specific type of nonsteroidal anti-inflammatory drug that is clearly more effective than others .