***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: We did a prospect i ve study of women with singleton viable pregnancies at 10 - 13 weeks ' gestation who requested first-trimester fetal karyotyping because of advanced maternal age , parental anxiety , or family history of chromosomal abnormality . Women were counselled as to the available options of non-invasive screening or invasive testing by mid-trimester amniocentesis , early amniocentesis ( EA ) , or chorionic villus sampling ( CVS ) , or r and omisation to EA or CVS at 10 - 13 weeks . EA was done in 731 patients ( 493 by choice and 238 by r and omisation ) and CVS in 570 ( 320 by choice and 250 by r and omisation ) . Both procedures were done by transabdominal ultrasound-guided insertion of a 20-gauge needle . The rate of successful sampling was the same for both procedures ( 97.5 % ) . Spontaneous loss ( intrauterine or neonatal death ) was significantly higher after EA ( total group mean = 5.3 % , 95 % CI 3.8 - 7.2 ; r and omised subgroup mean = 5.9 % , 3.3 - 9.7 ) than after CVS ( total group : mean = 2.3 % , 1.2 - 3.9 ; r and omised subgroup : mean = 1.2 % , 0.3 - 3.5 ) . The gestation at delivery and birthweight of the infants after EA and CVS were similar . In the EA group the incidence of talipes equinovarus ( 1.63 % ) , was higher than in the CVS group ( 0.56 % ) , but this difference was not significant BACKGROUND There is a mismatch between the wish of a patient with depression to have counselling and the prescription of antidepressants by the doctor . AIMS To determine whether counselling is as effective as antidepressants for depression in primary care and whether allowing patients to choose their treatment affects their response . METHOD A partially r and omised preference trial , with patients r and omised to either antidepressants or counselling or given their choice of either treatment . The treatment and follow-up were identical in the r and omised and patient preference arms . RESULTS There were 103 r and omised and 220 preference patients in the trial . We found : no differences in the baseline characteristics of the r and omised and preference groups ; that the two treatments were equally effective at 8 weeks , both for the r and omised group and when the r and omised and patient preference groups for a particular treatment were combined ; and that expressing a preference for either treatment conferred no additional benefit on outcome . CONCLUSIONS These data challenge several assumptions about the most appropriate treatment for depression in a primary care setting BACKGROUND Plantar fasciitis is a common foot disorder that may be resistant to nonoperative treatment . This study evaluated the use of electrohydraulic high-energy shock waves in patients who failed to respond to a minimum of six months of antecedent nonoperative treatment . METHODS A r and omized , placebo-controlled , multiply blinded , crossover study was conducted . Phase 1 consisted of twenty patients who were nonr and omized to treatment with extracorporeal shock waves  to assess the phase-2 study protocol . In phase 2 , 293 patients were r and omized and an additional seventy-one patients were nonr and omized . Following ankle-block anesthesia , each patient received 100 grade d shocks starting at 0.12 to 0.22 mJ/mm(2 ) , followed by 1400 shocks at 0.22 mJ/mm(2 ) with use of a high-energy electrohydraulic shock-wave device . Patients in the placebo group received minimal subcutaneous anesthetic injections and nontransmitted shock waves by the same protocol . Three months later , patients were given the opportunity to continue without further treatment or have an additional treatment . This allowed a patient in the active treatment arm to receive a second treatment and a patient who received the placebo to cross over to the active treatment arm . Patients were followed at least one year after the final treatment . RESULTS Treatment was successful in seventeen of the twenty phase-1 patients at three months . This improved to nineteen ( 95 % ) of twenty patients at one year and was maintained at five years . In phase 2 , three months after treatment , sixty-seven ( 47 % ) of the 144 actively treated patients had a completely successful result compared with forty-two ( 30 % ) of the 141 placebo-treated patients ( p = 0.008 ) . At one year , sixty-five of the sixty-seven actively treated , r and omized patients maintained a successful result . Thirty-six ( 71 % ) of the remaining fifty-one nonr and omized patients had a successful result at three months . For all 289 patients who had one or more actual treatments , 222 ( 76.8 % ) had a good or excellent result . No patient was made worse by the procedure . CONCLUSIONS The application of electrohydraulic high-energy shock waves to the heel is a safe and effective noninvasive method to treat chronic plantar fasciitis , lasting up to and beyond one year Cocaine-abusing patients r and omly assigned to day-hospital or inpatient rehabilitation were compared with patients who self-selected these treatment setting s  to examine differences in substance use and psychosocial outcomes under experimental and nonexperimental design s. There was little evidence of setting or assignment effects or Setting x Assignment interactions over the 12-month follow-up period . However , Assignment x Time interactions were obtained with 2 measures of cocaine use and measures of family-social and psychiatric problem severity . These interactions indicated greater problem severity at intake among the r and omized patients coupled with greater improvements by the 3-month follow-up relative to the nonr and omized patients . Findings suggest that r and omized studies of treatment for cocaine abuse may produce somewhat larger estimates of improvement than what is observed in more typical treatment situations OBJECTIVE To determine whether IVF or a st and ard infertility treatment algorithm results in better outcome and /or lower cost when used as first-line therapy for couples with infertility . DESIGN Prospect i ve , r and omized clinical study . SETTING University-affiliated infertility clinic . PATIENT(S ) Couples with newly diagnosed infertility and no prior treatment . INTERVENTION(S ) Couples were r and omized to undergo either IVF ( group 1 , n = 46 ) or a st and ard infertility treatment algorithm ( group 2 , n = 50 ) as initial therapy for infertility . MAIN OUTCOME MEASURE(S ) Pregnancy rates and costs per couple , per month of treatment , and per pregnancy . RESULT ( S ) Pregnancy rates were higher in group 2 than in group 1 . Costs per couple were not statistically different , although a trend toward higher costs was apparent in group 1 , reflected by a higher median cost per clinical pregnancy established and a higher cost per month of treatment . Whereas cost differences between the groups diminished over time , pregnancy rates remained the same . CONCLUSION ( S ) In vitro fertilization currently does not represent an appropriate first-line treatment option for couples with infertility . The use of a st and ard infertility treatment algorithm results in a higher pregnancy rate and lower cost and therefore should be the preferred treatment approach OBJECTIVE We attempted to compare the use of low-dose heparin with a st and ard dose of 40 mg prednisone daily ( both plus low-dose aspirin ) for treatment of pregnant women with antiphospholipid antibody-associated recurrent fetal loss with respect to maternal and perinatal morbidity and efficacy in prevention of fetal death . STUDY DESIGN A multicenter r and omized trial included 20 patients . Generalizability of results from r and omized patients was evaluated by means of additional data from 13 women refusing and 12 women ineligible for r and omization . Data from study groups were compared with Fisher 's exact test , and generalizability was evaluated with a chi 2 test for trend . RESULTS Live birth rates were the same ( 75 % ) with either treatment , but " serious " maternal morbidity and the frequency of preterm delivery were significantly higher among women r and omly assigned to prednisone ( p = 0.02 vs p = 0.006 ) . Preterm delivery among prednisone-treated women was usually associated with premature rupture of the membranes or preeclampsia . These results could be generalized to the other groups of women ascertained during the course of the study . CONCLUSIONS Low-dose heparin should be preferred to prednisone when treatment is indicated for high-risk pregnant women with antiphospholipid antibodies Dietary DHA enhances infant  attention and visual development . Because the DHA content of red blood cells and plasma lipids varies approximately threefold in pregnancy , maternal DHA status may influence subsequent infant function . It would be feasible to study the effects of higher maternal  DHA intake on infant development if dietary intake of DHA could be increased by a reliable means . This study was design ed to determine whether women provided with one dozen high-DHA hen eggs ( 135 mg DHA/egg ) would consume the eggs and have higher blood DHA levels than women consuming ordinary eggs  ( 18 mg DHA/egg ) . The study was a r and omized , double-masked comparison of the effect of eggs with different concentrations of DHA on intake and blood lipid DHA content of women and their infants . A third nonr and omized group ate few eggs . In this study , DHA intake reported from eggs was eightfold higher in the high-DHA egg group compared to the ordinary egg group . Including all groups , DHA intake ranged from 0 to 284 mg/d . In this intake range , maternal blood lipid DHA content at enrollment best predicted DHA content at delivery , accounting for 36.5 and 51.7 % of the variance in ordinary and high-DHA egg intake groups , respectively . The high-DHA vs. ordinary egg groups had similar maternal and cord blood lipid DHA , but there was a positive relationship between maternal plasma phospholipid DHA and daily DHA intake from eggs controlled for study duration ( r=0.278 , P=0.048 ) . DHA intake and birth weight were also correlated ( r=0.299 , P=0.041 ) . High-DHA eggs were well accepted and increased DHA intake . Other benefits of DHA intake during pregnancy were also suggested We studied the effects of enteral supplements on protein and energy intakes , body composition , energy expenditure , and gastrointestinal histology in 49 subjects with human immunodeficiency virus-associated weight loss ( 12.7 + /- 0.9 % of body wt ) . We also determined whether a stable-isotope mass spectrometric measurement at baseline might predict the short-term response of fat-free mass ( FFM ) measured by bioelectrical impedance analysis .  Thirty-nine subjects completed the study after being r and omly assigned to receive either a whole-protein-based ( n = 22 ) or a peptide-based ( n = 17 ) formula . A nonsupplemented , nonr and omly assigned group ( n = 13 ) was followed concurrently . Both formulas were well tolerated . Voluntary intakes of energy and protein from nonsupplement sources decreased significantly during supplementation [ by 819 - 1638 kJ ( 196 - 382 kcal)/d and 5.6 - 14.4 g protein/d , respectively ; P < 0.01 ] but to a lesser extent than the intake from the supplement [ 2300 - 2510 kJ(550 - 600 kcal)/d and 19 - 28 g protein/d , respectively ] , so that net increases in intakes of protein and energy ( P < 0.03 ) , as well as of several vitamins and trace elements were increased . Nevertheless , the mean FFM did not increase for the group as a whole , although there was considerable interindividual heterogeneity . Changes in FFM at 6 wk were significantly inversely correlated ( r = 0.65 , P < 0.01 ) with baseline synthesis of fat ( de novo hepatic lipogenesis ) , but not with other potential measures of energy intake ( insulin-like growth factor 1 or its binding protein ) or inflammation ( soluble tumor necrosis factor receptors I or II ) . The prospect i ve identification of FFM response by measurement of de novo hepatic lipogenesis supported the hypothesis that the subset of wasting patients whose FFM is unresponsive to nutrient supplementation have altered nutrient metabolism & NA ; Acupuncture is widely used by patients with neck pain , but there is a lack of information about its effectiveness in routine medical care . The aim was to investigate the effectiveness of acupuncture in addition to routine care in patients with chronic neck pain compared to treatment with routine care alone . We performed a r and omized controlled multicentre trial plus non‐r and omized cohort in general practice s in Germany . 14,161 patients with chronic neck pain ( duration > 6 months ) . Patients were r and omly allocated to an acupuncture group or a control group receiving no acupuncture . Patients in the acupuncture group received up to 15 acupuncture sessions over three months . Patients who did not consent to r and omization received acupuncture treatment . All subjects were allowed to receive usual medical care in addition to study treatment . Neck pain and disability ( NPAD Scale by Wheeler ) after three months . Of 14,161 patients ( mean age 50.9 ± 13.1 years , 68 % female ) 1880 were r and omized to acupuncture and 1886 to control , and 10,395 included into the non‐r and omized acupuncture group . At three months , neck pain and disability improved by 16.2 ( SE : 0.4 ) to 38.3 ( SE 
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INTERPRETATION We found no evidence to support clinical ly important overall harm or benefit arising from participation in RCTs .
This conclusion refutes earlier cl aims that trial participants are at increased risk of harm