***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 group of 200 patients who presented in general practice with symptoms but no abnormal physical signs and in whom no definite diagnosis was made were r and omly selected for one of four consultations : a consultation conducted in a " positive manner , " with and without treatment , and a consultation conducted in a " non-positive manner , " called a negative consultation , with and without treatment . Two weeks after consultation there was a significant difference in patient satisfaction between the positive and negative groups but not between the treated and untreated groups . Similarly , 64 % of those receiving a positive consultation  got better , compared with 39 % of those who received a negative consultation ( p = 0.001 ) and 53 % of those treated got better compared with 50 % of those not treated ( p = 0.5 ) Summary The efficacy of naproxen and paracetamol in relieving  uterine cramps  has been compared in a sequential trial . The treatments did not differ significantly in a two-sided test in 56 patients . A corresponding fixed sample test would have required 140 patients to obtain the same significance level and power . In addition to uterine pain , the effect on episiotomy pain was also estimated at the termination of the trial . Again , there seemed to be no difference between naproxen and paracetamol BACKGROUND For many years it has been cl aim ed that observational studies find stronger treatment effects than r and omized , controlled trials . We compared the results of observational studies with those of r and omized , controlled trials . METHODS We search ed the Abridged Index Medicus and Cochrane data bases to identify observational studies reported between 1985 and 1998 that compared two or more treatments or interventions for the same condition . We then search ed the Medline and Cochrane data bases to identify all the r and omized , controlled trials and observational studies comparing the same treatments for these conditions . For each treatment , the magnitudes of the effects in the various observational studies were combined by the Mantel-Haenszel or weighted analysis -of-variance procedure and then compared with the combined magnitude of the effects in the r and omized , controlled trials that evaluated the same treatment . RESULTS There were 136 reports about 19 diverse treatments , such as calcium-channel-blocker therapy for coronary artery disease , appendectomy , and interventions for subfertility .  In most cases , the estimates of the treatment effects from observational studies and r and omized , controlled trials were similar . In only 2 of the 19 analyses of treatment effects did the combined magnitude of the effect in observational studies lie outside the 95 percent confidence interval for the combined magnitude in the r and omized , controlled trials . CONCLUSIONS We found little evidence that estimates of treatment effects in observational studies reported after 1984 are either consistently larger than or qualitatively different from those obtained in r and omized , controlled trials Patients who agree and those who refuse clinical trial entry may differ in attitudes towards decision control and the benefits associated with the trial arms . These differences , if they exist , have implication s for the process of obtaining informed consent and for the generalization of the results of a clinical trial . This paper describes the development and initial application of methods design ed to detect such differences . Developmental work involved creating an inventory of instruments design ed to determine patients ' attitudes towards participating in treatment decision making , permitting r and om selection of treatment , and undertaking the risks and benefits associated with the various treatments in a trial . Initial application involved modifying these instruments in terms of an actual chemotherapeutic trial for colonic adenocarcinoma , seeking responses to these measures from 60 non-eligible colorectal cancer patients , then determining whether those who would agree to trial entry differed systematic ally on these measures from those who indicated that they would refuse such a trial . Twenty-five of the respondents reported that , if faced with the actual decision , they would agree to trial entry : 35 would refuse . Refusers dem and ed more participation in decision making ( Chi-square ; P = 0.01 ) and a greater increment in treatment benefit ( t-test ; P = 0.0001 ) . Twenty-two of the 35 refusers reported aversion to r and omization as their primary reason for trial refusal . Since their particular content can be modified , these measures may be applicable to all clinical trials . They could be used to study the reasons patients accept or refuse trial entry and to determine if agreer-refuser attitude differences undermine the generalizability of a trials results To examine whether written informed consent might influence the results of clinical trials the effect of placebo when given with or without informed consent to patients suffering from insomnia was studied . The study was a single blind observer blinded trial , and patients were paired according to sex , age , and hospital environment . R and omisation assigned the first patient of each pair to the control group ( without informed consent ) or the group to give informed consent . Of the 56 patients , 26 refused to give informed consent , and the age and sex distribution of these differed significantly ( p less than 0.02 ) from the 30 pairs of patients ultimately enrolled into the study . In this " biased " sample , the hypnotic activity of placebo was significantly higher in the control group ( p less than 0.05 ) . It is concluded that the informed consent procedure biases the results of clinical trials and might affect their general applicability Background Despite the increasing dem and for acupuncture and homoeopathy in Germany , little is known about the effects of these treatments in routine care . We set up a pragmatic documentation study in general practice funded within the scope of project launched by a German health insurer . Patients were followed-up for up to four years . Methods The aim of the project was to study the effects and benefits of acupuncture and /or homoeopathy , and to assess patient satisfaction within a prospect i ve documentation of over 5000 acupuncture and over 900 homoeopathy patients . As data sources , we used the documentation made available by therapists on every individual visit and a st and ardised quality -of-life question naire ( MOS SF-36 ) ; these were complemented by questions concerning the patient 's medical history and by questions on patient satisfaction . The health insurer provided us with data on work absenteeism . Results Descriptive analyses of the main outcomes showed benefit of treatment with middle to large-sized effects for the quality of life question naire SF-36 and about 1 point improvement on a rating scale of effects , given by doctors . Data on the treatment and the patients ' and physicians ' background suggests chronically ill patients treated by fairly regular schemes . ConclusionS ince the results showed evidence of a subjective benefit for patients from  acupuncture and homoeopathy  , this may account for the increase in dem and for these treatments especially when patients are chronically ill and unsatisfied with the conventional treatment given previously QUESTIONS UNDER STUDY To date most of the published studies on the effectiveness of  complementary therapies in cancer patients have yielded controversial results because of question able methodology . Research strategies and method ologies acceptable to both conventional and unconventional medicine are difficult to find due to different belief systems . In this publication we describe the development and implementation of a project conducted as part of National Research Programme 34 ( NFP 34 ) . Detailed analysis of our experiences might provide some information on how to deal with practical difficulties in the planning and conduct of further research projects in this field . The project involved the anthroposophical Lukas Clinic in Arlesheim and the Institute of Medical Oncology of the University Hospital , Berne . This interdisciplinary research project was devised to study the relative merits of these two schools of medicine in the care of advanced cancer patients . The project was made up of three components : ( 1 ) a registration study aim ed at comparing the case mix at the two institutions ; ( 2 ) a three armed r and omised study on the effectiveness of supportive therapy , comparing anthroposophy to psychosocial group therapy , and ( 3 ) a longitudinal study to monitor the evaluation of quality of life of patients at the anthroposophical clinic .  METHODS After a brief review of the study protocol , which presents the theoretical framework of the project , problems of its implementation are described . Aspects of accrual , acceptance of r and omisation and data availability are presented using simple descriptive statistics and logistic regression . RESULTS The registration study was duly completed with a total of 567 patients . For several reasons ( not meeting inclusion requirements , high refusal rate ) the accrual into the r and omised study was slower than expected and required modification of the original design specifications with regard to inclusion criteria and data collection schedule . Additionally , a high dropout rate contributed to premature closure of this part of the project . The longitudinal study also suffered from low data availability at follow up . CONCLUSIONS The study protocol constituted a major effort at compromise without loss of scientific rigour , and this effort demonstrates that it is possible to allow for different views on patients , on clinical interventions and on research strategies when establishing collaboration between different schools of medicine . Despite a theoretically sound framework , the r and omised part of the project proved difficult in its practical execution . Some unexpected logistical constraints and some unmet expectations influenced the feasibility of this part of the project . Therefore , careful planning of research projects in this field of medicine should always include an extended analysis of various practical aspects of study implementation BACKGROUND Our aim was to assess the efficacy of a part-st and ardised verum acupuncture procedure , in accordance with the rules of traditional Chinese medicine , compared with that of part-st and ardised sham acupuncture and st and ard migraine prophylaxis with beta blockers , calcium-channel blockers , or antiepileptic drugs in the reduction of migraine days 26 weeks after the start of treatment . METHODS This study was a prospect i ve , r and omised , multicentre , double-blind , parallel-group , controlled , clinical trial , undertaken between April 2002 and July 2005 . Patients who had two to six migraine attacks per month were r and omly assigned  verum acupuncture ( n=313 ) , sham acupuncture ( n=339 ) , or st and ard therapy ( n=308 ) . Patients received ten sessions of acupuncture treatment in 6 weeks or continuous prophylaxis with drugs . Primary outcome was the difference in migraine days between 4 weeks before r and omisation and weeks 23 - 26 after r and omisation . This study is registered as an International St and ard R and omised Controlled Trial , number IS RCT N52683557 . FINDINGS Of 1295 patients screened , 960 were r and omly assigned to a treatment group . Immediately after r and omisation , 125 patients ( 106 from the st and ard group ) withdrew their consent to study participation . 794 patients were analysed in the intention-to-treat popoulation and 443 in the per- protocol population . The primary outcome showed a mean reduction of 2 .3 days ( 95 % CI 1.9 - 2.7 ) in the verum acupuncture group , 1.5 days ( 1.1 - 2.0 ) in the sham acupuncture group , and 2.1 days ( 1.5 - 2.7 ) in the st and ard therapy group . These differences were statistically significant compared with baseline ( p<0.0001 ) , but not across the treatment groups ( p=0.09 ) . The proportion of responders , defined as patients with a reduction of migraine days by at least 50 % , 26 weeks after r and omisation , was 47 % in the verum group , 39 % in the sham acupuncture group , and 40 % in the st and ard group ( p=0.133 ) . INTERPRETATION Treatment outcomes for migraine do not differ between patients treated with sham acupuncture , verum acupuncture , or st and ard therapy BACKGROUND Because the value of popular forms of alternative care for chronic back pain remains uncertain , we compared the effectiveness of acupuncture , therapeutic massage , and self-care education for persistent back pain . METHODS We r and omized 262 patients aged 20 to 70 years who had persistent back pain to receive Traditional Chinese Medical acupuncture ( n = 94 ) , therapeutic massage  ( n = 78 ) , or self-care educational material s  ( n = 90 ) . Up to 10 massage or acupuncture visits were permitted over 10 weeks . Symptoms ( 0 - 10 scale ) and dysfunction ( 0 - 23 scale ) were assessed by telephone interviewers masked to treatment group . Follow-up was available for 95 % of patients after 4 , 10 , and 52 weeks , and none withdrew for adverse effects . RESULTS Treatment groups were compared after adjustment for prer and omization covariates using an intent-to-treat analysis . At 10 weeks , massage was superior to self-care on the symptom scale ( 3.41 vs 4.71 , respectively ; P = .01 ) and the disability scale ( 5.88 vs 8.92 , respectively ; P<.001 ) . Massage was also superior to acupuncture on the disability scale ( 5.89 vs 8.25 , respectively ; P = .01 ) . After 1 year , massage was not better than self-care but was better than acupuncture ( symptom scale : 3.08 vs 4.74 , respectively ; P = .002 ; dysfunction scale : 6.29 vs 8.21 , respectively ; P = .05 ) . The massage group used the least medications ( P<.05 ) and had the lowest costs of subsequent care . CONCLUSIONS Therapeutic massage was effective for persistent low back pain , apparently providing long-lasting benefits . Traditional Chinese Medical acupuncture was relatively ineffective . Massage might be an effective alternative to conventional medical care for persistent back pain Background : Distant healing as a treatment modality is frequently used by patients and healers . Some preliminary evidence suggests possible effects . Since patients suffering from multiple chemical sensitivity and chronic fatigue syndrome have only few effective treatment options , distant healing will be offered as a treatment within a formal trial of distant healing . Design and Method : A four-armed r and omized trial will include 400 patients with self-attributed , environmental problems who fulfil the diagnostic criteria of severe idiopathic chronic fatigue , 
    Output:
    
Evidence from RCTs forms the basis of meta-analyses and systematic review s. This hierarchy , founded on a pharmacological model of therapy , is generalized to other interventions which may be complex and non-pharmacological ( healing , acupuncture and surgery ) .
Discussion The hierarchical model is valid for limited questions of efficacy , for instance for regulatory purpose s and newly devised products and pharmacological preparations .
It is inadequate for the evaluation of complex interventions such as physiotherapy , surgery and complementary and alternative medicine ( CAM ) .