***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: Objective : To determine the effectiveness of steroids , acyclovir , and surgical facial nerve decompression  in Bell ’s palsy . Methods : The authors identified articles by search ing MEDLINE and selected those that prospect ively compared outcomes in patients treated with steroids , acyclovir , or surgery with patients not receiving these modalities . The authors grade d the quality of each study ( class I to IV ) using a st and ard classification-of- evidence scheme . They compared the proportion of patients recovering facial function in the treated group to the proportion of patients recovering facial function in the control group . Results : The authors identified no adequately powered class I studies for any treatment modality . The pooled results of two class I and two class II studies showed significantly better facial outcomes in steroid-treated patients compared with non – steroid-treated patients ( relative rate good outcome 1.16 , 95 % CI 1.05 to 1.29 ) . One class II study demonstrated a significant benefit from acyclovir in combination with prednisone compared with prednisone alone ( relative rate good outcome 1.22 , 95 % CI 1.02 to 1.45 ) . All studies describing outcomes in patients treated with facial nerve decompression were grade d as class IV . Conclusion : For patients with Bell ’s palsy , a benefit from steroids , acyclovir , or facial nerve decompression has not been definitively established . However , available evidence suggests that steroids are probably effective and acyclovir ( combined with prednisone ) is possibly effective in improving facial functional outcomes . There is insufficient evidence to make recommendations regarding surgical facial nerve decompression for Bell ’s palsy . Well- design ed studies of the effectiveness of treatments for Bell ’s palsy are still needed BACKGROUND Corticosteroids and antiviral agents are widely used to treat the early stages of idiopathic facial paralysis ( i.e. , Bell 's palsy ) , but their effectiveness is uncertain . METHODS We conducted a double-blind , placebo-controlled , r and omized , factorial trial involving patients with Bell 's palsy who were recruited within 72 hours after the onset of symptoms . Patients were r and omly assigned to receive 10 days of treatment with prednisolone , acyclovir , both agents , or placebo . The primary outcome was recovery of facial function , as rated on the House-Brackmann scale . Secondary outcomes included quality of life , appearance , and pain . RESULTS Final outcomes were assessed for 496 of 551 patients who underwent r and omization . At 3 months , the proportions of patients who had recovered facial function were 83.0 % in the prednisolone group as compared with 63.6 % among patients who did not receive prednisolone ( P<0.001 ) and 71.2 % in the acyclovir group as compared with 75.7 % among patients who did not receive acyclovir ( adjusted P=0.50 ) . After 9 months , these proportions were 94.4 % for prednisolone and 81.6 % for no prednisolone ( P<0.001 ) and 85.4 % for acyclovir and 90.8 % for no acyclovir ( adjusted P=0.10 ) . For patients treated with both drugs , the proportions were 79.7 % at 3 months ( P<0.001 ) and 92.7 % at 9 months ( P<0.001 ) . There were no clinical ly significant differences between the treatment groups in secondary outcomes . There were no serious adverse events in any group . CONCLUSIONS In patients with Bell 's palsy , early treatment with prednisolone significantly improves the chances of complete recovery at 3 and 9 months . There is no evidence of a benefit of acyclovir given alone or an additional benefit of acyclovir in combination with prednisolone . ( Current Controlled Trials number , IS RCT N71548196 [ controlled-trials.com ] . ) The therapeutic effect of corticosteroids in acute idiopathic peripheral nerve paralysis ( Bell 's palsy ) in children is controversial . The authors evaluated the effect of steroids on the early and late outcome of children with Bell 's palsy in a prospect i ve r and omized controlled setting . Forty-two patients ( 21 females , 21 males ) with complete paralysis were enrolled in the study . Group 1 ( n = 21 ) received methylprednisolone ( 1 mg/kg daily for 10 days orally ) ; Group 2 ( n = 21 ) did not . All patients were observed in the first 3 days of the disease and at 4 , 6 , and 12 months of follow-up . The mean age of Group 1 was 52.4 + /- 4.3 months , not significantly different from that of Group 2 . In Group 1 , 86 % and 100 % exhibited normal nerve function at 4 and 6 months of follow-up , respectively ; in Group 2 , 72 % and 86 % demonstrated complete recovery at 4 and 6 months , respectively , with improvement in all patients by 12 months . The improvement rates between the treated and untreated groups did not differ significantly . No side effects necessitated steroid withdrawal . The results of this study indicate that steroid therapy initiated at an early stage of childhood Bell 's palsy does not significantly improve the outcome Abstract . The objective of this double-blind , r and omized , placebo-controlled study was to test the efficacy of high-dose prednisone , administered as early as possible , in modifying the natural progression of Bell 's palsy . Sixty-two consecutive patients , enrolled within 72 hours of facial palsy onset , were assigned to high dose intravenous prednisone in combination with intramuscular polyvitaminic therapy ( group A ) or polyvitaminic therapy alone ( group B ) . Clinical grading of facial muscle strength and length of absence from work were evaluated . An early worsening of facial muscle strength was observed in controls , leading to the divergence in the trends of the grading scores in the two groups ; this result was not confirmed in the long-term follow-up . Treated patients returned to work earlier than controls . In conclusion , early treatment based on high-dose corticosteroids slightly accelerates spontaneous improvement in Bell 's palsy AIM To present an overview of the main components of r and omised controlled trials and identify issues for consideration during their design and management . BACKGROUND R and omised controlled trials ( RCTs ) are considered to be the gold st and ard for determining causality and can provide high quality evidence to inform nursing practice . DATA SOURCES A search of online data bases and websites was undertaken to identify relevant contemporary literature to inform the discussion . DISCUSSION / CONCLUSION Conducting a robust r and omised controlled trial can present research ers with numerous challenges and practical considerations . The importance of taking account of the Consort guidelines during their design , conduct and reporting is emphasised . IMPLICATION S FOR RESEARCH / PRACTICE Evidence from well conducted RCTs contributes to the development of effective nursing interventions . To avoid bias and ensure valid results , the design , conduct and reporting of RCTs should follow the Consort guidelines . Service users should be involved in the design and management of RCTs Objective : To investigate the effects of valacyclovir and prednisolone in comparison with those of placebo and prednisolone for the treatment of Bell 's palsy , excluding zoster sine herpete . Study Design : Prospect i ve , multicenter , r and omized placebo-controlled study . Setting : Six academic tertiary referral centers . Patients : Ultimately , 221 patients with Bell 's palsy who were treated within 7 days of the onset . Serological and polymerase chain reaction examinations were performed to distinguish Bell 's palsy from zoster sine herpete . Intervention : The patients were treated with either valacyclovir ( dosage , 1,000 mg/d for 5 days ) plus prednisolone ( VP [ n = 114 ] ) or placebo plus prednisolone ( PP [ n = 107 ] ) administered orally . Main Outcome Measure : Recovery from the palsy was defined as a score higher than 36 using Yanagihara 40-point scoring system without facial contracture or synkinesis . The patients were followed up until complete recovery occurred or for more than 6 months in cases with a poor prognosis . Results : The overall rate of patient recovery among those treated with VP ( 96.5 % ) was significantly better ( p < 0.05 ) than the rate among those treated with PP ( 89.7 % ) . The rate of patient recovery was also analyzed by classifying the initial severity of facial palsy . In cases of complete or severe palsy , the rates of patients treated with VP and PP who recovered were 95.7 % ( n = 92 ) and 86.6 % ( n = 82 ) , respectively ; the recovery rate for treatment with VP was significantly better than that with PP ( p < 0.05 ) . Conclusion : The valacyclovir and prednisolone therapy was more effective in treating Bell 's palsy , excluding zoster sine herpete , than the conventional prednisolone therapy . To our knowledge , this is the first controlled study of an antiviral agent in the treatment of a sufficient number of Bell 's palsy cases based on an etiologic background Idiopathic facial nerve paralysis ( IFNP ) is a common malady . Because its etiology is unclear , there are a variety of treatment options . Studies to date have not clearly established the benefits of treatment with oral steroids ( prednisone ) . The authors performed a r and omized double-blind controlled study comparing the use of placebo versus prednisone which shows that  prednisone-treated  patients benefit from early treatment . Seventy-six patients met inclusion criteria and completed follow-up until recovery ; 35 patients received prednisone and 41 received placebo . Their mean age was 36.8 years .  Facial nerve function was assessed using the House-Brackmann facial nerve grading scale , as well as a variety of other measures . Patients were evaluated pretreatment , regularly post-treatment until judged recovered ( return of facial function to a grade III or better ) , and at 6 months after recovery . Difference in mean time to resolution for the prednisone ( 51.4 days ) and placebo ( 69.3 days ) groups was not statistically significant . There was a significant difference in grade at recovery , with the placebo group having a higher proportion of grade III results ( P < .03 ) . Eight of 10 patients with electroneurography ( ENOG ) evidence of denervation were in the placebo group and accounted for 6 of the 7 grade III results . However , the difference in proportion of patients with evidence of denervation for the prednisone ( 5.7 % ) and placebo ( 19.5 % ) groups did not achieve statistical significance . This study shows that patients treated with prednisone have less denervation than placebo-treated patients . They also have a significant improvement in facial grade at recovery compared to placebo-treated patients . Therefore , the authors recommend that all patients at risk for developing denervation receive prednisone treatment The etiology of Bell 's palsy is unknown and present treatment is empirical and , at best , controversial . Between 1973 and 1976 , 174 consecutive cases were seen and clinical ly divided into a group with incomplete facial palsy and a group with complete facial palsy . The incomplete group consisted of 82 patients who were matched and treated alternatively with steroids or supportive treatment only .  The return of function in each patient was tabulated and results in the two groups compared . Patients in this group have an excellent prognosis regardless of treatment . The complete facial palsy group consisted of 92 cases , who were matched according to age , sex , race and clinical picture and most importantly to the results of a series of tests design ed to test the function of the affected facial nerve and its musculature . In this group 10 patients elected to have supportive treatment only , while 41 cases received cortisone and 41 matching patients underwent well planned decompression of the facial nerve Two hundred thirty-nine patients with Bell palsy were r and omly distributed into prednisone-treated and control groups . Patients were followed until complete recovery or for 1 year . In the steroid-treated and control groups , respectively , incomplete recovery of facial strength occurred in 12 percent and 20 percent ; motor synkinesis in 9 percent and 15 percent ; autonomic synkinesis in 1 percent and 10 percent ; and electromyographic evidence of severe denervation in 9 percent and 17 percent . The differences reached statistical significance only for autonomic synkinesis . In the total series recovery of facial strength was incomplete in 16 percent . Residual weakness was mild in 14 percent and moderate in 2 percent . No patient remained with severe weakness . Age , hyperacusis , and severity of the initial palsy were associated with an increased risk of poor outcome A prospect i ve , controlled , double-blind study was design ed to evaluate the effect of steroid treatment  on the natural history of Bell 's palsy . Fifty-one patients were included in the study between 1972 and 1974 . The patients were evaluated and started on treatment within two days of onset of Bell 's palsy and followed for six months . Treatment was given in r and omized double-blind fashion and consisted of either vitamins or a total of 410 mg of prednisone plus vitamins in descending doses over 10 days . The recovery of facial motor function was determined by three physicians who had no knowledge of the treatment received by the patients . They examined photographs of the patients taken six months after onset of paralysis in eight positions of facial function and categorized them as to complete fair , or poor recovery of facial function . These results of this evaluation were su bmi tted to the biostatistician who broke the treatment code . The results of this study demonstrate no statistically significant beneficial effect of steroid therapy  upon recovery from Bell 's palsy . Factors considered 
    Output:
    
The available moderate- to high- quality evidence from r and omised controlled trials showed significant benefit from treating Bell 's palsy with corticosteroids