***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: BACKGROUND Amyotrophic lateral sclerosis ( ALS ) is a neurodegenerative disorder associated with respiratory muscle weakness and respiratory failure . Non-invasive ventilation alleviates respiratory symptoms and prolongs life , but is a palliative intervention . Slowing the deterioration of diaphragm function before respiratory failure would be desirable . We aim ed to assess whether early diaphragm pacing could slow down diaphragm deterioration and would therefore delay the need for non-invasive ventilation . METHODS We did a multicentre , r and omised , controlled , triple-blind trial in patients with probable or definite ALS in 12 ALS centres in France . The main inclusion criterion was moderate respiratory involvement ( forced vital capacity 60 - 80 % predicted ) . Other key eligibility criteria were age older than 18 years and bilateral responses of the diaphragm to diagnostic phrenic stimulation . All patients were operated laparoscopically and received  phrenic stimulators . Clinicians r and omly assigned patients ( 1:1 ) to receive either active or sham stimulation with a central web-based r and omisation system ( computer-generated list ) . Investigators , patients , and an external outcome allocation committee were masked to treatment . The primary outcome was non-invasive ventilation-free survival , analysed in the intention-to-treat population . Safety outcomes were also assessed in the intention-to-treat population . This trial is registered with Clinical Trials.gov , number NCT01583088 . FINDINGS Between Sept 27 , 2012 , and July 8 , 2015 , 74 participants were r and omly assigned to receive either active ( n=37 ) or sham ( n=37 ) stimulation . On July 16 , 2015 , an unplanned masked analysis was done after another trial showed excess mortality with diaphragm pacing in patients with hypoventilation ( DiPALS , IS RCT N 53817913 ) . In view of this finding , we analysed mortality in our study and found excess mortality ( death from any cause ) in our active stimulation group . We therefore terminated the study on July , 16 , 2015 . Median non-invasive ventilation-free survival was 6·0 months ( 95 % CI 3·6 - 8·7 ) in the active stimulation group versus 8·8 months ( 4·2-not reached ) in the control ( sham stimulation ) group ( hazard ratio 1·96 [ 95 % CI 1·08 - 3·56 ] , p=0·02 ) . Serious adverse events ( mainly capnothorax or pneumothorax , acute respiratory failure , venous thromboembolism , and gastrostomy ) were frequent ( 24 [ 65 % ] patients in the active stimulation group vs 22 [ 59 % ] patients in the control group ) . No treatment-related death was reported . INTERPRETATION Early diaphragm pacing in patients with ALS and incipient respiratory involvement did not delay non-invasive ventilation and was associated with decreased survival .  Diaphragm pacing is not indicated at the early stage of the ALS-related respiratory involvement . FUNDING Hospital Program for Clinical Research , French Ministry of Health ; French Patients ' Association for ALS Research ( Association pour la Recherche sur la Sclérose Latérale Amyotrophique ) ; and Thierry de Latran Foundation BACKGROUND Prior unblinded studies have suggested that catheter-based renal-artery denervation reduces blood pressure in patients with resistant hypertension . METHODS We design ed a prospect i ve , single-blind , r and omized , sham-controlled trial . Patients with severe resistant hypertension were r and omly assigned in a 2:1 ratio to undergo renal denervation or a sham procedure . Before r and omization , patients were receiving a stable antihypertensive regimen involving maximally tolerated doses of at least three drugs , including a diuretic . The primary efficacy end point was the change in office systolic blood pressure at 6 months ; a secondary efficacy end point was the change in mean 24-hour ambulatory systolic blood pressure . The primary safety end point was a composite of death , end-stage renal disease , embolic events result ing in end-organ damage , renovascular complications , or hypertensive crisis at 1 month or new renal-artery stenosis of more than 70 % at 6 months . RESULTS A total of 535 patients underwent r and omization . The mean ( ±SD ) change in systolic blood pressure at 6 months was -14.13±23.93 mm Hg in the denervation group as compared with -11.74±25.94 mm Hg in the sham-procedure group ( P<0.001 for both comparisons of the change from baseline ) , for a difference of -2.39 mm Hg ( 95 % confidence interval [ CI ] , -6.89 to 2.12 ; P=0.26 for superiority with a margin of 5 mm Hg ) . The change in 24-hour ambulatory systolic blood pressure was -6.75±15.11 mm Hg in the denervation group and -4.79±17.25 mm Hg in the sham-procedure group , for a difference of -1.96 mm Hg ( 95 % CI , -4.97 to 1.06 ; P=0.98 for superiority with a margin of 2 mm Hg ) . There were no significant differences in safety between the two groups . CONCLUSIONS This blinded trial did not show a significant reduction of systolic blood pressure in patients with resistant hypertension 6 months after renal-artery denervation as compared with a sham control . ( Funded by Medtronic ; SYMPLICITY HTN-3 Clinical Trials.gov number , NCT01418261 . ) BACKGROUND Vertebroplasty has become a common treatment for painful osteoporotic vertebral fractures , but there is limited evidence to support its use . METHODS We performed a multicenter , r and omized , double-blind , placebo-controlled trial in which participants with one or two painful osteoporotic vertebral fractures that were of less than 12 months ' duration and unhealed , as confirmed by magnetic resonance imaging , were r and omly assigned to undergo vertebroplasty or a sham procedure . Participants were stratified according to treatment center , sex , and duration of symptoms ( < 6 weeks or > or = 6 weeks ) . Outcomes were assessed at 1 week and at 1 , 3 , and 6 months . The primary outcome was overall pain ( on a scale of 0 to 10 , with 10 being the maximum imaginable pain ) at 3 months . RESULTS A total of 78 participants were enrolled , and 71 ( 35 of 38 in the vertebroplasty group and 36 of 40 in the placebo group ) completed the 6-month follow-up ( 91 % ) . Vertebroplasty did not result in a significant advantage in any measured outcome at any time point . There were significant reductions in overall pain in both study groups at each follow-up assessment . At 3 months , the mean ( + /-SD ) reductions in the score for pain in the vertebroplasty and control groups were 2.6+/-2.9 and 1.9+/-3.3 , respectively ( adjusted between-group difference , 0.6 ; 95 % confidence interval , -0.7 to 1.8 ) . Similar improvements were seen in both groups with respect to pain at night and at rest , physical functioning , quality of life , and perceived improvement . Seven incident vertebral fractures ( three in the vertebroplasty group and four in the placebo group ) occurred during the 6-month follow-up period . CONCLUSIONS We found no beneficial effect of vertebroplasty as compared with a sham procedure in patients with painful osteoporotic vertebral fractures , at 1 week or at 1 , 3 , or 6 months after treatment . ( Australian New Zeal and Clinical Trials Registry number , ACTRN012605000079640 . BACKGROUND Arthroscopic partial meniscectomy is one of the most common orthopedic procedures , yet rigorous evidence of its efficacy is lacking . METHODS We conducted a multicenter , r and omized , double-blind , sham-controlled trial in 146 patients 35 to 65 years of age who had knee symptoms consistent with a degenerative medial meniscus tear and no knee osteoarthritis . Patients were r and omly assigned to arthroscopic partial meniscectomy or sham surgery . The primary outcomes were changes in the Lysholm and Western Ontario Meniscal Evaluation Tool ( WOMET ) scores ( each ranging from 0 to 100 , with lower scores indicating more severe symptoms ) and in knee pain after exercise ( rated on a scale from 0 to 10 , with 0 denoting no pain ) at 12 months after the procedure . RESULTS In the intention-to-treat analysis , there were no significant between-group differences in the change from baseline to 12 months in any primary outcome . The mean changes ( improvements ) in the primary outcome measures were as follows : Lysholm score , 21.7 points in the partial-meniscectomy group as compared with 23.3 points in the sham-surgery group ( between-group difference , -1.6 points ; 95 % confidence interval [ CI ] , -7.2 to 4.0 ) ; WOMET score , 24.6 and 27.1 points , respectively ( between-group difference , -2.5 points ; 95 % CI , -9.2 to 4.1 ) ; and score for knee pain after exercise , 3.1 and 3.3 points , respectively ( between-group difference , -0.1 ; 95 % CI , -0.9 to 0.7 ) . There were no significant differences between groups in the number of patients who required subsequent knee surgery ( two in the partial-meniscectomy group and five in the sham-surgery group ) or serious adverse events ( one and zero , respectively ) . CONCLUSIONS In this trial involving patients without knee osteoarthritis but with symptoms of a degenerative medial meniscus tear , the outcomes after arthroscopic partial meniscectomy were no better than those after a sham surgical procedure . ( Funded by the Sigrid Juselius Foundation and others ; Clinical Trials.gov number , NCT00549172 . ) Objective To test the equivalence for clinical effectiveness between microdecompression and laminectomy in patients with central lumbar spinal stenosis . Design Multicentre observational study . Setting Prospect i ve data from the Norwegian Registry for Spine Surgery . Participants 885 patients with central stenosis of the lumbar spine who underwent surgery at 34 Norwegian orthopaedic or neurosurgical departments . Patients were treated from October 2006 to December 2011 . Interventions Laminectomy and microdecompression . Main outcome measures The primary outcome was change in Oswestry disability index score one year after surgery . Secondary endpoints were quality of life ( EuroQol EQ-5D ) , perioperative complications , and duration of surgical procedures and hospital stays . A blinded biostatistician performed predefined statistical analyses in unmatched and propensity matched cohorts . Results The study was powered to detect a difference between the groups of eight points on the Oswestry disability index at one year . 721 patients ( 81 % ) completed the one year follow-up . Equivalence between microdecompression and laminectomy was shown for the Oswestry disability index ( difference 1.3 points , 95 % confidence interval −1.36 to 3.92 , P<0.001 for equivalence ) . Equivalence was confirmed in the propensity matched cohort and full information regression analyses . No difference was found between groups in quality of life ( EQ-5D ) one year after surgery . The number of patients with complications was higher in the laminectomy group ( 15.0 % v 9.8 % , P=0.018 ) , but after propensity matching for complications the groups did not differ ( P=0.23 ) . The duration of surgery for single level decompression was shorter in the microdecompression group ( difference 11.2 minutes , 95 % confidence interval 4.9 to 17.5 , P<0.001 ) , but after propensity matching the groups did not differ ( P=0.15 ) . Patients in the microdecompression group had shorter hospital stays , both for single level decompression ( difference 1.5 days , 95 % confidence interval 1.7 to 2.6 , P<0.001 ) and two level decompression ( 0.8 days , 1.0 to 2.2 , P=0.003 ) . Conclusion At one year the effectiveness of microdecompression is equivalent to laminectomy in the surgical treatment of central stenosis of the lumbar spine . Favourable outcomes were observed at one year in both treatment groups . Trial registration Clinical Trials.gov NCT02006901 BACKGROUND Multiple open-label trials of deep brain stimulation ( DBS ) for treatment-resistant depression ( TRD ) , including those targeting the ventral capsule/ventral striatum target , have shown encouraging response rates . However , no r and omized controlled trials of DBS for TRD have been published . METHODS Thirty patients with TRD participated in a sham-controlled trial of DBS  at the ventral capsule/ventral striatum target for TRD . Patients were r and omized to active versus sham DBS treatment in a blinded fashion for 16 weeks , followed by an open-label continuation phase . 
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In fact , an overwhelming majority of sham-controlled trials in surgery fail to demonstrate an effect of the intervention [ 18 ] .
Does this mean that surgery often is less effective than we like to believe ?
Or does it merely reflect the fact that few surgical interventions can be placebo controlled and that such trials are more often done when the likelihood of surgery being an effective treatment is low in the first place ?
However , can we trust the surgical RCTs — and is RCT design really the best study design in surgery ?