Analysis Of Clinical Evidence For Acupuncture Efficacy

Background:Acupuncture,with highly changing times and internationalization,is facing the challenge to provide evidence for its efficacy.Under the background of evidence-based medicine,more and more in-depth and extensive scientific research,that is,randomized controlled trial(RCT),have made conclusion that acupuncture can not be used to guide medical practice only by intuition and inaccurate and rough clinical experiences.The conclusion is mostly based on the "clinical observation and study of a lack of standardized large samples".The most controversial issue abroad is whether acupuncture has specific effect for lumbago.Almost all the ERCTs abroad made conclusions that the effect of acupuncture is equivalent to placebo.In particular,the NICE institution in Britain revoked the recommendation of acupuncture for low back pain at the beginning of 2016 and that is the most popular concern.The scientists are against the efficacy of acupuncture for low back pain according to "the difference between the acupuncture group and the sham acupuncture group did not reach the clinical value of more than 0.5 of the effect".Thus they denied the biological effect of the acupuncture non-specific low back pain.Is the RCT,the "gold standard more reliable than any other evidence",however consistent with acupuncture?To answer this question,we need to obtain the information of the current process of the production of acupuncture clinical evidence and to analyze the influence factors of the effect of acupuncture.These are particularly important for objectively evaluating the current acupuncture research.Therefore,two major studies have been carried out with acupuncture in the treatment of non-specific low back pain(NSLBP):1.the literature analysis of clinical evidence for acupuncture's efficacy;2.the appropriateness of sham or placebo acupuncture for randomized controlled trials of acupuncture for nonspecific low back pain:a systematic review and meta-analysis.Part 1 Literature analysis of clinical evidence for acupuncture's efficacy:based on randomized controlled trials of acupuncture for nonspecific low back pain(Prospero registration number:CRD42017059438)Objectives:To assess the evidence of efficacy of acupuncture for non-specific low back pain(LBP),compared to sham or placebo therapies.To dig out the acupuncture information and research design in the "randomised sham acupuncture/placebo acupuncture controlled trials" of acupuncture for non-specific low back pain(NSLBP),in order to judge the level of evidence of the conclusion of "acupuncture as a placebo".Methods:We searched Cochrane CENTRAL,PubMed,MEDLINE and EMBASE.There were no regions restrictions used.We included only randomized controlled trials of adults with non-specific LBP.Placebo/sham procedure was one of the control interventions.The trials were combined using meta-analysis methods when the data reported allowed statistical pooling.The key words that mainly used for searching included acupuncture,acupuncture therapy,points,low back pain,backache and lumbago.The data were extracted from included RCTs according to Consort and Stricta Statement.The data extracted were classified into 6 items which were acupuncture rationale,details of needling,treatment regimen,other components of treatment,practitioner background and control or comparator interventions.And the Risk of Bias was used to evaluate the methodological quality of each RCT.Finally,all the above data were analysed.Results:We included 14 trials(2110 participants)in this review.A total of 9 were included in the meta-analysis.For acupuncture rationale,only 1 trial had the syndrome differentiation and treatment.4 took Chinese acupuncture and the remaining took Japanese,wenstern,and Korea acupuncture.For details of needling,depth of insertion was 0.3?10cm.The needling stimulation was manual except one.The retention time was 20?30min.Number of treatment sessions was from 20min to 12weeks.Frequency of treatment sessions was 1?3 times a week.For sham/placebo acupuncture rationale,7 trials used non-points and 5 trials used traditional points.3 trials took the trigger points,only 1 trial had the syndrome differentiation and treatment.For details of sham/placebo needling,non-points were located 1cm apart form the real points.The sham needling stimulation contained non-insertion and shallow penetration.The sensation of deqi was described in 1 trial.The Number and frequency of treatment sessions were the same as acupuncture group.For methodological quality,2 trials did not take blind method between patients and prationers.However,evaluators were blinded in all the 14 trials.For immediately after treatments we found statistically differences in pain reduction between acupuncture and sham or placebo therapy(SMD of-0.40[95%CI-0.54 to-0.25];I2 statistic = 7%;participants = 753;studies = 9).For follow-up,there were significant differences in pain reduction(SMD of-0.46;95%CI-0.82 to-0.09;I2 statistic = 67%).But there were no differences in function whether at post-treatment or follow-up.We conducted subgroups analyses both immediately after treatments and follow-up.Conclusion:There is moderate evidence of efficay of acupuncture in pain reduction immediately after treatments for non-specific LBP((sub)acute and chronic)when compared to sham or placebo acupuncture.Whether from the point of view of methodological quality,needling quality,the outcome evaluation,or discuss if the"specific and non-specific effect" is in accordance with the origin and nature of acupuncture,it is believed that the conclusion that acupuncture is a placebo is lack of evidence.The randomized sham/placebo acupuncture controlled trial commonly used in the current phase does not reflect the characteristics and advantages of acupuncture.Part 2 appropriateness of sham or placebo acupuncture for randomized controlled trials of acupuncture for nonspecific low back pain:a systematic review and meta-analysis(Prospero registration number:CRD42017070122)Objectives:To establish whether sham acupuncture(SA)or placebo acupuncture treatments and to discuss whether SA or PA is appropriate for randomized controlled trials of acupuncture for LBP.Methods:Six databases were searched on 31 May 2017.We included only randomized controlled trials of adults with LBP and lower back myofascial pain syndrome.The studies had at least two control arms:a sham-controlled acupuncture arm and a routine care or waiting list arm(people who did not receive acupuncture until the end of treatment).Trials were combined using meta-analysis methods when the data allowed statistical pooling.Pooled effect sizes were calculated by random effects models.Results:This review identified 7 trials(1768 participants);all were included in the meta-analysis.We found statistically significant differences in pain reduction post-intervention between SA or PA and routine care or a waiting list,with a standardized mean difference of-0.36(95%CI-0.54 to-0.18;I2 statistic=16%;participants=624;studies=6)for the Visual Analog Scale and-0.35(95%CI-0.49 to-0.20;I2 statistic=0%;participants=736;studies=1)for the Chronic Pain Grade Scale;however,no significant difference was observed between SA or PA and routine care or no treatment for post-intervention function.Conclusion:Compared with routine care or a waiting list,SA or PA was more efficacious for pain relief post-intervention.Concluding that SA or PA is appropriate for acupuncture research would be premature,because its physical inert can not be exclude.