***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 investigate the characteristics and outcomes of patients undergoing acupuncture treatment for chronic headaches under conditions of routine care provided within the framework of statutory health insurance in Germany . Furthermore , we investigated correlations between different outcomes . PATIENTS AND METHODS Patients with migraine , episodic or chronic tension-type headache ( TTH ) , or several other forms of chronic headache ( cluster , vascular , drug-induced headache ; other specific headaches ) treated with acupuncture ( mean number of sessions 8.6 + /- 3.0 ) were included into an observational study . Detailed question naires including questions on headache days and instruments measuring disability ( Pain Disability Index ) and quality of life ( SF-36 ) were completed before treatment , after treatment , and at 6 months after inclusion . RESULTS A total of 2,022 patients ( 732 with migraine , 351 with episodic and 440 with chronic TTHs , and 499 with other diagnoses ) treated by 1,418 physicians were included in the main analysis . Sociodemographic and baseline characteristics differed considerably in the four diagnostic groups . Statistically highly significant and clinical ly relevant improvements were seen for all clinical outcome measures in all diagnostic groups . In 52.6 % of patients headache frequency decreased by at least 50 % compared to baseline . The comparison of headache frequency , pain intensity , and generic outcome measures showed that some of these outcomes correlate only weakly . CONCLUSIONS In this epidemiological study , headache patients reported clinical ly relevant improvements after receiving acupuncture . R and omized trials performed in parallel to this study confirm the relevant overall effect , however , the effect may largely be due to potent unspecific needling and placebo effects & 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 : 0.4 ) ; and by 3.9 ( SE : 0.4 ) to 50.5 ( SE : 0.4 ) , difference 12.3 ( p < 0.001 ) in the acupuncture and control group , respectively . Treatment success was essentially maintained through six months . Non‐r and omized patients had more severe symptoms at baseline and showed higher neck pain and disability improvement compared to r and omized patients . Treatment with acupuncture added to routine care in  patients with chronic neck pain  was associated with improvements in neck pain and disability compared to treatment with routine care alone BACKGROUND Baseline data collected on each patient at r and omisation in controlled clinical trials can be used to describe the population of patients , to assess comparability of treatment groups , to achieve balanced r and omisation , to adjust treatment comparisons for prognostic factors , and to undertake subgroup analyses . We assessed the extent and quality of such practice s in major clinical trial reports . METHODS A sample of 50 consecutive clinical -trial reports was obtained from four major medical journals during July to September , 1997 . We tabulated the detailed information on uses of baseline data by use of a st and ard form . FINDINGS Most trials presented baseline comparability in a table . These tables were often unduly large , and about half the trials inappropriately used significance tests for baseline comparison . Methods of r and omisation , including possible stratification , were often poorly described . There was little consistency over whether to use covariate adjustment and the criteria for selecting baseline factors for which to adjust were often unclear . Most trials emphasised the simple unadjusted results and covariate adjustment usually made negligible difference . Two-thirds of the reports presented subgroup findings , but mostly without appropriate statistical tests for interaction . Many reports put too much emphasis on subgroup analyses that commonly lacked statistical power . INTERPRETATION Clinical trials need a predefined statistical analysis plan for uses of baseline data , especially covariate-adjusted analyses and subgroup analyses . Investigators and journals need to adopt improved st and ards of statistical reporting , and exercise caution when drawing conclusions from subgroup findings In a r and omized controlled trial plus a nonr and omized cohort , the authors investigated the effectiveness and costs of acupuncture in addition to routine care in the treatment of chronic low back pain and assessed whether the effects of acupuncture differed in r and omized and nonr and omized patients . In 2001 , German patients with chronic low back pain were allocated to an acupuncture group or a no-acupuncture control group .  Persons who did not consent to r and omization were included in a nonr and omized acupuncture group . All patients were allowed to receive routine medical care in addition to study treatment .  Back function ( Hannover Functional Ability Question naire ) , pain , and quality of life were assessed at baseline and after 3 and 6 months , and cost-effectiveness was analyzed . Of 11,630 patients ( mean age=52.9 years ( st and ard deviation , 13.7 ) ; 59 % female ) , 1,549 were r and omized to the acupuncture group and 1,544 to the control group ; 8,537 were included in the nonr and omized acupuncture group . At 3 months , back function improved by 12.1 ( st and ard error ( SE ) , 0.4 ) to 74.5 ( SE , 0.4 ) points in the acupuncture group and by 2.7 ( SE , 0.4 ) to 65.1 ( SE , 0.4 ) points among controls ( difference=9.4 points ( 95 % confidence interval 8.3 , 10.5 ) ; p<0.001 ) . Nonr and omized patients had more severe symptoms at baseline and showed improvements in back function similar to those seen in r and omized patients . The incremental cost-effectiveness ratio was euro10,526 ( euros ) per quality -adjusted life year . Acupuncture plus routine care was associated with marked clinical improvements in these patients and was relatively cost-effective Abstract Objective To investigate whether a sham device ( a vali date d sham acupuncture needle ) has a greater placebo effect than an inert pill in patients with persistent arm pain . Design A single blind r and omised controlled trial created from the two week placebo run-in periods for two nested trials that compared acupuncture and amitriptyline with their respective placebo controls . Comparison of participants who remained on placebo continued beyond the run-in period to the end of the study . Setting Academic medical centre . Participants 270 adults with arm pain due to repetitive use that had lasted at least three months despite treatment and who scored ≥3 on a 10 point pain scale . Interventions Acupuncture with sham device twice a week for six weeks or placebo pill once a day for eight weeks . Main outcome measures Arm pain measured on a 10 point pain scale . Secondary outcomes were symptoms measured by the Levine symptom severity scale , function measured by Pransky 's upper extremity function scale , and grip strength . Results Pain decreased during the two week placebo run-in period in both the sham device and placebo pill groups , but changes were not different between the groups ( −0.14 , 95 % confidence interval −0.52 to 0.25 , P = 0.49 ) . Changes in severity scores for arm symptoms and grip strength were similar between groups , but arm function improved more in the placebo pill group ( 2.0 , 0.06 to 3.92 , P = 0.04 ) . Longitudinal regression analyses that followed participants throughout the treatment period showed significantly greater downward slopes per week on the 10 point arm pain scale in the sham device group than in the placebo pill group ( −0.33 ( −0.40 to −0.26 ) v −0.15 ( −0.21 to −0.09 ) , P = 0.0001 ) and on the symptom severity scale ( −0.07 ( −0.09 to −0.05 ) v −0.05 ( −0.06 to −0.03 ) , P = 0.02 ) . Differences were not significant , however , on the function scale or for grip strength . Reported adverse effects were different in the two groups . Conclusions The sham device had greater effects than the placebo pill on self reported pain and severity of symptoms over the entire course of treatment but not during the two week placebo run in . Placebo effects seem to be malleable and depend on the behaviours embedded in medical rituals R and omised controlled trials ( RCTs ) play a central role in modern medical advance , and they require participants who underst and and accept the procedures involved . Published evidence suggests that RCT participants often fail to underst and that treatments are allocated at r and om and that clinicians are in equipoise about which treatment is best . We examine background assumptions that members of the public might draw upon if invited to take part in a RCT .  Four studies ( N=82 ; 67 ; 67 ; 128 ) , in the UK , identified whether members of the public ( i ) . accept that an individual clinician might be genuinely unsure which of two treatments was better ; ( ii ) . judge that when there is uncertainty it is acceptable to suggest deciding at r and om ; ( iii ) . recognise scientific benefits of r and om allocation to treatment conditions in a trial . Around half the participants were loathe to accept that a clinician could be completely uncertain , and this was no different whether the context was one of individual treatment or research . Most participants found it unacceptable to suggest allocating treatment at r and om , though there was weak evidence that a research context may reduce the unacceptability . Participants did not judge that more certain knowledge would be gained about which treatment was best when treatments were allocated at r and om rather than by patient/doctor choice : scientific benefits of r and omisation were apparently not recognised . Judgements were no different in non-medical context s. Results suggest a large mismatch between the assumptions underlying the trial design , and the assumptions that lay participants can bring to bear when they try to make sense of descriptive information about r and omisation and equipoise . Previous attempts to improve underst and ing by improving the clarity or salience of trial information , or of making explicit the research context , while helpful , may need to be supplemented with accessible explanations for r and om allocation OBJECTIVE The capacities of depressed patients to consent to research have been question ed by commentators who fear that the cognitive effects of a disorder may impair subjects ' abilities to protect their interests . This study used a new instrument for assessing depressed patients ' capacities to consent to research  and examined their performance , including the relation between severity of depression and extent of impairment . METHOD Twenty-six female out patients with major depression ( assessed with the Schedule of Affective Disorders and Schizophrenia-Lifetime Version ) enrolled in a study of maintenance psychotherapy were recruited for this project . Consent-related abilities were measured with the MacArthur Competence Assessment Tool- Clinical Research ( MacCAT-CR )  1 week after intake and again 8 - 10 weeks later . Depressive symptoms were measured by the Hamilton Depression Rating Scale . RESULTS Almost all subjects performed quite well on the capacity measures and maintained that level of performance over time . There was no correlation between performance and degree of depressive symptoms and little relation to prior research experience . Some subjects appeared confused about the extent to which decisions about assignment to treatment groups would be made on the basis of their clinical condition rather than r and omly . CONCLUSIONS This outpatient group with major depression showed few impairments in their decision-making capacities related to research . As in other studies , some concerns were raised about subjects ' appreciation that treatment assignments would not be individualized for their needs . Examination of hospitalized patients and those with psychotic depression would help to determine whether they show greater degrees of impairment . The MacCAT-CR was easily adapted for use with this depressed group We aim ed to investigate the effectiveness of acupuncture in addition to routine care in patients with primary headache ( > 12 months , two or more headaches/month ) compared with treatment with routine care alone and whether the effects of acupuncture differ in r and omized and non-r and omized patients . In a r and omized controlled trial plus non-r and omized cohort , patients with headache were allocated to receive up to 15 acupuncture sessions over 3 months or to a control group receiving no acupuncture during the first 3 months . Patients who did not consent to r and omization received acupuncture treatment immediately . All subjects were allowed usual medical care in addition to study treatment . Number of days with headache , intensity of pain and health-related quality of life ( SF-36 ) were assessed at baseline , and after 3 and 6 months using st and ardized question naires . Of 15 056 headache patients ( mean age 44.1 ± 12.8 years , 77 % female ) , 1613 were r and omized to acupuncture and 1569 to control , and 11 874 included in the non-r and omized acupuncture group . At 3 months , the number of days with headache decreased from 8.4 ± 7.2 ( estimated mean ± S.E. 
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The proportion of patients who dropped out of or withdrew from the study was also different between the groups , with significantly more dropping out from the observational group than the r and omized group .
We found that patients who were r and omly assigned to treatment groups in acupuncture trials had fewer health benefits than those who were nonr and omly assigned