Validating a New Non-Penetrating Sham Acupuncture Device: Two Randomised Controlled Trials The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials Do certain countries produce only positive results? A systematic review of controlled trials. The health-related, social, and economic consequences of parkinsonism: a controlled national study The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial. Survey of 71 "negative" trials. [Therapeutic effect of scalp electroacupuncture on Parkinson disease]. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials
For clinical trials of acupuncture , it would be desirable to have a sham procedure that is indistinguishable from the real treatment , yet inactive . A sham needle has been design ed which telescopes instead of penetrating the skin . The Park Sham Device involves an improved method of supporting the sham needle and requires validation . The objective of these studies was to test whether the sham procedure using the new device was 1 ) indistinguishable from the same procedure using real needles in acupuncture naïve subjects , and 2 ) inactive , where the specific needle sensation ( de qi ) is taken as a surrogate measure of activity . The studies were design ed as subject and assessor blind , r and omised controlled trials . Study 1 ) included 58 patients enrolled in a clinical trial of acupuncture for acute stroke . Study 2 ) included 63 healthy , acupuncture naïve , adult volunteers . The interventions used were real or sham acupuncture using the Park Sham Device . Study 1 ) was set in a district general hospital , and study 2 ) in a university laboratory . The outcome measure in study 1 ) was the form of treatment that patients believed they had received . In study 2 ) the outcome measure was experience of de qi , as judged by three acupuncture experts . No patient in either group ( study 1 ) believed he or she had been treated with the sham needle . In 40 volunteers ( study 2 ) for whom experts achieved consensus , the relative risk of experiencing de qi with real acupuncture to that with sham acupuncture was 15.38 ( 95 % CI 2.26 to 104.86 ) . The inter-rater reliability of all 13 experts ( study 2 ) , calculated from their judgements on 10 subjects selected by r and omisation , was 0.52 ( 95 % CI 0.19 to 0.61 ) . In conclusion , the results suggest that the procedure using the new device is indistinguishable from the same procedure using real needles in acupuncture naïve subjects , and is inactive , where the specific needle sensation ( de qi ) is taken as a surrogate measure of activity . It is therefore a valid control for acupuncture trials . The findings also lend support to the existence of de qi , a major concept underlying traditional Chinese acupuncture Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more OBJECTIVE To determine whether clinical trials originating in certain countries always have positive results . DATA SOURCES Abstract s of trials from Medline ( January 1966-June 1995 ) . STUDY SELECTION Two separate studies were conducted . The first included trials in which the clinical outcome of a group of subjects receiving acupuncture  was compared to that of a group receiving placebo , no treatment , or a nonacupuncture intervention . In the second study , r and omized or controlled trials of interventions other than  acupuncture  that were published in China , Japan , Russia/USSR , or Taiwan were compared to those published in Engl and . DATA EXTRACTION Blinded review ers determined inclusion and outcome and separately classified each trial by country of origin . DATA SYNTHESIS In the study of acupuncture  trials , 252 of 1085 abstract s met the inclusion criteria . Research conducted in certain countries was uniformly favorable to acupuncture ; all trials originating in China , Japan , Hong Kong , and Taiwan were positive , as were 10 out of 11 of those published in Russia/USSR . In studies that examined interventions other than acupuncture , 405 of 1100 abstract s met the inclusion criteria . Of trials published in Engl and , 75 % gave the test treatment as superior to control . The results for China , Japan , Russia/USSR , and Taiwan were 99 % , 89 % , 97 % , and 95 % , respectively . No trial published in China or Russia/USSR found a test treatment to be ineffective . CONCLUSIONS Some countries publish unusually high proportions of positive results . Publication bias is a possible explanation . Research ers undertaking systematic review s should consider carefully how to manage data from these countries Parkinson ’s disease ( PD ) and atypical parkinsonism ( AP ) cause a significant socioeconomic burden , but there is insufficient information about the total disease burden at a national level . Thus , the goal of this study was to estimate the excess direct and indirect costs of PD and AP in a national sample . Using records from the Danish National Patient Registry ( 1997–2007 ) , 13,400 PD and 647 AP patients were identified and compared with , respectively , 53,600 and 2,588 control cases r and omly selected with respect to age , gender , civil status , and geographic location .  Direct costs including frequencies of primary and sector contacts and procedures , and medication from primary and secondary sectors were obtained from the Danish Ministry of Health , the Danish Medicines Agency , and the National Health Security . Indirect costs , which included labor supply and social transfer payments , were based on income data derived from the Coherent Social Statistics . Patients with PD and AP had significantly higher rates of health-related contact and medication use and a higher socioeconomic cost . Furthermore , they had very low employment rates , and those in employment had a lower income level than employed control subjects . The annual mean excess health-related cost was € 6,500 ( $ 8,975/£5,543 ) and € 9,771 ( $ 13,491/£8,332 ) for each patient with PD and AP , respectively . In addition , the patients with PD and AP received an annual mean excess social transfer income of € 324 ( £ 276/$447 ) and € 844 ( £ 719/$1,165 ) , respectively . The employment- and health-related consequences could be identified up to 8 years before the first diagnosis and increased with disease advancement . PD and AP have major socioeconomic consequences for patients and society . The health effects are present for up to more than 8 years before a diagnosis of PD/AP Seventy-one " negative " r and omized control trials were re-examined to determine if the investigators had studied large enough sample s to give a high probability ( greater than 0.90 ) of detecting a 25 per cent and 50 per cent therapeutic improvement in the response . Sixty-seven of the trials had a greater than 10 per cent risk of missing a true 25 per cent therapeutic improvement , and with the same risk , 50 of the trials could have missed a 50 per cent improvement . Estimates of 90 per cent confidence intervals for the true improvement in each trial showed that in 57 of these " negative " trials , a potential 25 per cent improvement was possible , and 34 of the trials showed a potential 50 per cent improvement . Many of the therapies labeled as " no different from control " in trials using inadequate sample s have not received a fair test . Concern for the probability of missing an important therapeutic improvement because of small sample sizes deserves more attention in the planning of clinical trials OBJECTIVE To observe the therapeutic effect of scalp electroacupuncture on Parkinson disease ( PD ) of grade 1.5 - 3.0 on Hoehn-Yahr scale . METHODS Thirty patients with Parkinson disease were r and omized equally into the treatment group and control group . Patients in the treatment group were treated by scalp eletroacupuncture at the contralateral points of MS6 , MS4 , MS8 , MS9 and MS14 in cases of unilateral lesions or at the bilateral points for bilateral lesions , with also medication with Madopar . The patients in the control group were given Madopar only . The scores of Webster scale and the motor function of United Parkinson 's Disease Rating Scale ( UPDRS ) were used to for assessment before and after the therapeutic course ( 6 weeks ) . RESULTS Tremor , rigidity and bradykinesia were obviously improved in both the groups ( P<0.05 ) . The difference in the score of Webster scale was not significant between the two groups ( P>0.05 ) , but the treatment group showed greater improvement in motor functions than the control group ( P<0.05 ) . CONCLUSION Scalp electroacupuncture is effective and safe for therapy of Parkinson disease Overwhelming evidence shows the quality of reporting of r and omised controlled trials ( RCTs ) is not optimal . Without transparent reporting , readers can not judge the reliability and validity of trial findings nor extract information for systematic review s. Recent method ological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects . Such systematic error is seriously damaging to RCTs , which are considered the gold st and ard for evaluating interventions because of their ability to minimise or avoid bias . A group of scientists and editors developed the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to improve the quality of reporting of RCTs . It was first published in 1996 and up date d in 2001 . The statement consists of a checklist and flow diagram that authors can use for reporting an RCT . Many leading medical journals and major international editorial groups have endorsed the CONSORT statement . The statement facilitates critical appraisal and interpretation of RCTs . During the 2001 CONSORT revision , it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports . A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement . After an expert meeting in January 2007 , the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement . This up date improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition , such as selective outcome reporting bias . This explanatory and elaboration document-intended to enhance the use , underst and ing , and dissemination of the CONSORT statement-has also been extensively revised . It presents the meaning and rationale for each new and up date d checklist item providing examples of good reporting and , where possible , references to relevant empirical studies . Several examples of flow diagrams are included . The CONSORT 2010 Statement , this revised explanatory and elaboration document , and the associated website ( www.consort-statement.org ) should be helpful re sources to improve reporting of r and omised trials
Objective To evaluate the effectiveness of  scalp acupuncture ( SA ) , a modern acupuncture technique specialized to neurological disorders , in managing motor function and symptoms for Parkinson ’s disease ( PD ) patients .