De Qi: Chinese Acupuncture Patients' Experiences and Beliefs regarding Acupuncture Needling Sensation – An Exploratory Survey Practice, practitioner, or placebo? A multifactorial, mixed-methods randomized controlled trial of acupuncture German Acupuncture Trials (GERAC) for chronic low back pain: randomized, multicenter, blinded, parallel-group trial with 3 groups. Biomechanical response to acupuncture needling in humans. Can individuals identify if needling was performed with an acupuncture needle or a non-penetrating sham needle? Deqi sensations without cutaneous sensory input: results of an RCT Acupuncture modulates temporal neural responses in wide brain networks: evidence from fMRI study Acupuncture in patients with chronic low back pain: a randomized controlled trial. Deqi sensation between the acupuncture-experienced and the naïve: a Korean study II. Characterization of the "deqi" response in acupuncture A Systematic Review of the Effect of Expectancy on Treatment Responses to Acupuncture Brain imaging of acupuncture: Comparing superficial with deep needling Acupuncture for patients with migraine: a randomized controlled trial. Efficacy of acupuncture for the prophylaxis of migraine: a multicentre randomised controlled clinical trial Psychophysical outcomes from a randomized pilot study of manual, electro, and sham acupuncture treatment on experimentally induced thermal pain. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome Expectancy and belief modulate the neuronal substrates of pain treated by acupuncture [Effects of reinforcing and reducing methods by twirling and rotating the needle on contents of CGRP and NO in rats with stress-induced hypertension]. Does Deqi (needle sensation) exist? The impact of patient expectations on outcomes in four randomized controlled trials of acupuncture in patients with chronic pain Acupuncture in patients with osteoarthritis of the knee or hip: a randomized, controlled trial with an additional nonrandomized arm. Acupuncture and knee osteoarthritis: a three-armed randomized trial. The placebo needle, is it a valid and convincing placebo for use in acupuncture trials? A randomised, single-blind, cross-over pilot trial The evolution of the randomized controlled trial and its role in evidence-based decision making. The significance of needle placement site in acupuncture.
Introduction While de qi , the acupuncture needling sensation , has been considered as an important component of acupuncture , little is known of the acupuncture patient 's experience and beliefs about de qi in clinical setting s. The aim of this study was to describe Chinese acupuncture patients ’ perceived sensations of , and beliefs about , acupuncture needling . Methods We developed a question naire and conducted a survey study at two time periods among 200 subjects at six outpatient acupuncture clinics in Beijing , China . Results Respondents were 55 % female and had a mean age of 41 years . The most common types of needling sensations reported by subjects were the terms ‘ distended’(94 % ) , ‘ sore’(81 % ) , ‘ electric’(81 % ) and ‘ numb ’ ( 78 % ) . Eighty-nine percent of subjects reported that the needling sensation travelled away from the puncturing points or travelled among the needling points . Eighty-two percent of subjects believed that the needling sensation was very important for acupuncture treatment , and 68 % further indicated that the stronger the needling sensation , the more effective the therapy . Eighty-one percent of subjects found the acupuncture process to be very comfortable and relaxing . Conclusion Chinese acupuncture patients described the common characteristics of de qi and its migratory nature . The sensations were believed to be important in producing clinical efficacy by most patients . Measuring the sensations described as de qi in future prospect i ve studies will help us underst and the degree to which this phenomenon has an effect on the physiological outcome and clinical response to acupuncture . There appears to be a limit to the number of sensations that can be discriminated by each individual patient , and further development of the question naire is planned Summary This multifactorial mixed‐ methods r and omized controlled trial quantified the specific and nonspecific factors of acupuncture , and found that the practitioner , not the treatment , has the strongest effect on outcome . Abstract The nonspecific effects of acupuncture are well documented ; we wished to quantify these factors in osteoarthritic ( OA ) pain , examining needling , the consultation , and the practitioner . In a prospect i ve r and omised , single‐blind , placebo‐controlled , multifactorial , mixed‐ methods trial , 221 patients with OA awaiting joint replacement surgery were recruited . Interventions were acupuncture , Streitberger placebo acupuncture , and mock electrical stimulation , each with empathic or nonempathic consultations . Interventions involved eight 30‐minute treatments over 4 weeks . The primary outcome was pain ( VAS ) at 1 week posttreatment . Face‐to‐face qualitative interviews were conducted ( purposive sample , 27 participants ) . Improvements occurred from baseline for all interventions with no significant differences between real and placebo acupuncture ( mean difference −2.7 mm , 95 % confidence intervals −9.0 to 3.6 ; P = .40 ) or mock stimulation ( −3.9 , −10.4 to 2.7 ; P = .25 ) . Empathic consultations did not affect pain ( 3.0 mm , −2.2 to 8.2 ; P = .26 ) but practitioner 3 achieved greater analgesia than practitioner 2 ( 10.9 , 3.9 to 18.0 ; P = .002 ) . Qualitative analysis indicated that patients ’ beliefs about treatment veracity and confidence in outcomes were reciprocally linked . The supportive nature of the trial attenuated differences between the different consultation styles . Improvements occurred from baseline , but acupuncture has no specific efficacy over either placebo . The individual practitioner and the patient ’s belief had a significant effect on outcome . The 2 placebos  were equally as effective and credible as acupuncture . Needle and nonneedle placebos are equivalent . An unknown characteristic of the treating practitioner predicts outcome , as does the patient ’s belief ( independently ) . Beliefs about treatment veracity shape how patients self‐report outcome , complicating and confounding study interpretation BACKGROUND To our knowledge , verum acupuncture has never been directly compared with sham acupuncture and guideline -based conventional therapy in patients with chronic low back pain . METHODS A patient- and observer-blinded r and omized controlled trial conducted in Germany involving 340 outpatient practice s , including 1162 patients aged 18 to 86 years ( mean + /- SD age , 50 + /- 15 years ) with a history of chronic low back pain for a mean of 8 years . Patients underwent ten 30-minute sessions , generally 2 sessions per week , of verum acupuncture ( n = 387 ) according to principles of traditional Chinese medicine ; sham acupuncture ( n = 387 ) consisting of superficial needling at nonacupuncture points ; or conventional therapy , a combination of drugs , physical therapy , and exercise ( n = 388 ) . Five additional sessions were offered to patients who had a partial response to treatment ( 10%-50 % reduction in pain intensity ) . Primary outcome was response after 6 months , defined as 33 % improvement or better on 3 pain-related items on the Von Korff Chronic Pain Grade Scale question naire or 12 % improvement or better on the back-specific Hanover Functional Ability Question naire . Patients who were unblinded or had recourse to other than permitted concomitant therapies during follow-up were classified as nonresponders regardless of symptom improvement . RESULTS At 6 months , response rate was 47.6 % in the verum acupuncture group , 44.2 % in the sham acupuncture group , and 27.4 % in the conventional therapy group . Differences among groups were as follows : verum vs sham , 3.4 % ( 95 % confidence interval , -3.7 % to 10.3 % ; P = .39 ) ; verum vs conventional therapy , 20.2 % ( 95 % confidence interval , 13.4 % to 26.7 % ; P < .001 ) ; and sham vs conventional therapy , 16.8 % ( 95 % confidence interval , 10.1 % to 23.4 % ; P < .001 . CONCLUSIONS Low back pain improved after acupuncture treatment for at least 6 months . Effectiveness of acupuncture , either verum or sham , was almost twice that of conventional therapy During acupuncture treatments , acupuncture needles are manipulated to elicit the characteristic " de qi " reaction widely viewed as essential to acupuncture 's therapeutic effect . De qi has a biomechanical component , " needle grasp , " which we have quantified by measuring the force necessary to pull an acupuncture needle out of the skin ( pullout force ) in 60 human subjects . We hypothesized that pullout force is greater with both bidirectional needle rotation ( BI ) and unidirectional rotation ( UNI ) than no rotation ( NO ) . Acupuncture needles were inserted , manipulated , and pulled out by using a computer-controlled acupuncture needling instrument at eight acupuncture points and eight control points . We found 167 and 52 % increases in mean pullout force with UNI and BI , respectively , compared with NO ( repeated- measures ANOVA , P < 0.001 ) . Pullout force was on average 18 % greater at acupuncture points than at control points ( P < 0.001 ) . Needle grasp is therefore a measurable biomechanical phenomenon associated with acupuncture needle manipulation UNLABELLED A control treatment in acupuncture research must be credible , regardless if the needling is performed by one or by several therapists . OBJECTIVE To investigate if individuals could identify whether needling had been given with an acupuncture needle or a sham needle and if the therapist influenced this ability . DESIGN Eighty individuals were r and omized to one single needling given by one of four physiotherapists using either an invasive needle or a non-penetrating telescopic sham needle . RESULTS An equal proportion of individuals , 27 ( 68 % ) , in the acupuncture group and the sham group answered incorrectly or was not sure at all regarding needling type but the proportion varied between the therapists from 55 to 80 % ( ns ) . Bang 's blinding index was 0.20 ( 95 % CI 0.03 - 0.36 ) in the acupuncture group and 0.10 ( 95 % CI 0.09 - 0.29 ) in the sham group ( interpretation : 20 and 10 % identified needling type beyond statistical chance ) . Acupuncture was on a four- grade scale rated as median " mildly painful " and sham as " not painful " ( ns ) . Pain ratings varied from median " not " to " mildly painful " in the therapists ( p = 0.01 ) . CONCLUSIONS Two thirds of individuals needled by acupuncture as well as sham could not identify needling type and only 10 - 20 % of the individuals were unblinded beyond chance . The therapists , not the needling type , influenced how painful the needling was perceived . IMPLICATION S To achieve blinding success in acupuncture efficacy studies using the sham needle , the needling procedure must be strictly st and ardized in order to minimize differences between the therapists Background Deqi is defined in relation to acupuncture needling as a sensory perception of varying character . In a recently published sham laser validation study , we found that subjects in the verum and the sham laser group experienced deqi sensations . Therefore , we aim to further analyze whether the perceptions reported in the two study arms were distinguishable and whether expectancy effects exhibited considerable impact on our results . Methods A detailed re- analysis focusing on deqi sensations was performed from data collected in a previously published placebo-controlled , double-blind , clinical cross-over trial for a sham laser evaluation . Thirty-four healthy volunteers ( 28 ± 10.7 years ; 16 women , 18 men ) received two laser acupuncture treatments at three acupuncture points LI4 ( hégu ) , LU7 ( liéque ) , and LR3 ( táichong ) ; once by verum laser and once using a sham device containing an inactive laser in r and omized order . Outcome measures were frequency , intensity ( evaluated by visual analogue scale ; VAS ) , and quality of the subjects ' sensations perceived during treatments ( assessed with the " acupuncture sensation scale " ) . Results Both , verum and the sham laser acupuncture result in similar deqi sensations with regard to frequency ( p-value = 0.67 ) , intensity ( p-value = 0.71 ) and quality ( p-values between 0.15 - 0.98 ) . In both groups the most frequently used adjectives to describe these perceptions were " spreading " , " radiating " , " tingling " , " tugging " , " pulsing " , " warm " , " dull " , and " electric " . Sensations reported were consistent with the perception of deqi as previously defined in literature . Subjects ' conviction regarding the effectiveness of laser acupuncture or the history of having received acupuncture treatments before did not correlate with the frequency or intensity of sensations reported . Conclusions Since deqi sensations , described as sensory perceptions , were elicited without any cutaneous sensory input , we assume that they are a product of non-specific effects from the overall treatment procedure . Expectancy-effects due to previous acupuncture experience and belief in laser acupuncture do not seem to play a major role in elicitation of deqi sensations . Our results give hints that deqi might be a central phenomenon of awareness and consciousness , and that its relevance should be taken into account , even in clinical trials . However , further research is required to underst and mechanisms underlying deqi Background Accumulating neuroimaging studies in humans have shown that acupuncture can modulate a widely distributed brain network , large portions of which are overlapped with the pain-related areas . Recently , a striking feature of acupuncture-induced analgesia is found to be associated with its long-last effect , which has a delayed onset and gradually reaches a peak even after acupuncture needling being terminated . Identifying temporal neural responses in these areas that occur at particular time -- both acute and sustained effects during acupuncture processes -- may therefore shed lights on how such peripheral inputs are conducted and mediated through the CNS . In the present study , we adopted a non-repeated event-related ( NRER ) fMRI paradigm and control theory based approach namely change-point analysis in order to capture the detailed temporal profile of neural responses induced by acupuncture . Results Our findings demonstrated that neural activities at the different stages of acupuncture presented distinct temporal patterns , in which consistently positive neural responses were found during the period of acupuncture needling while much more complex and dynamic activities found during a post-acupuncture period . These brain responses had a significant time-dependent effect which showed different onset time and duration of neural activities . The amygdala and perigenual anterior cingulate cortex ( pACC ) , exhibited increased activities during the needling phase while decreased gradually to reach a peak below the baseline . The periaqueductal gray ( PAG ) and hypothalamus presented saliently intermittent activations across the whole fMRI session . Apart from the time-dependent responses , relatively persistent activities were also identified in the anterior insula and prefrontal cortices . The overall findings indicate that acupuncture may engage differential temporal neural responses as a function of time in a wide range of brain networks . Conclusions Our study has provided evidence supporting a view that acupuncture intervention involves complex modulations of temporal neural response , and its effect can gradually resolve as a function of time . The functional specificity of acupuncture at ST36 may involve multiple levels of differential activities of a wide range of brain networks , which are gradually enhanced even after acupuncture needle being terminated BACKGROUND Acupuncture is widely used by patients with low back pain , although its effectiveness is unclear . We investigated the efficacy of acupuncture compared with minimal acupuncture and with no acupuncture in patients with chronic low back pain .  METHODS Patients were r and omized to treatment with acupuncture , minimal acupuncture ( superficial needling at nonacupuncture points ) , or a waiting list control . Acupuncture and minimal acupuncture were administered by specialized acupuncture physicians in 30 outpatient centers , and consisted of 12 sessions per patient over 8 weeks . Patients completed st and ardized question naires at baseline and at 8 , 26 , and 52 weeks after r and omization . The primary outcome variable was the change in low back pain intensity from baseline to the end of week 8 , as determined on a visual analog scale ( range , 0 - 100 mm ) . RESULTS A total of 298 patients ( 67.8 % female ; mean + /- SD age , 59 + /- 9 years ) were included . Between baseline and week 8 , pain intensity decreased by a mean + /- SD of 28.7 + /- 30.3 mm in the acupuncture group , 23.6 + /- 31.0 mm in the minimal acupuncture group , and 6.9 + /- 22.0 mm in the waiting list group . The difference for the acupuncture vs minimal acupuncture group was 5.1 mm ( 95 % confidence interval , -3.7 to 13.9 mm ; P = .26 ) , and the difference for the acupuncture vs waiting list group was 21.7 mm ( 95 % confidence interval , 13.9 - 30.0 mm ; P<.001 ) . Also , at 26 ( P=.96 ) and 52 ( P=.61 ) weeks , pain did not differ significantly between the acupuncture and the minimal acupuncture groups . CONCLUSION Acupuncture was more effective in improving pain than no acupuncture treatment in patients with chronic low back pain , whereas there were no significant differences between acupuncture and minimal acupuncture Previous experience of acupuncture is believed to affect people 's expectation of future treatments . Therefore , subjects who have had acupuncture  are generally excluded from sham-controlled acupuncture clinical trials . However , this assumption has not been proven , but just accepted because of the lack of evidence to the contrary . To investigate the difference in frequency and intensity of acupuncture sensation between subjects who have had acupuncture and those who have not , 36 acupuncture-experienced subjects were invited to take part in the study . After informed consent was obtained , participants were asked to complete the  acupuncture sensation scale ( ASS ) according to what they expected needling to feel like . The needling was done at the left Hegu ( LI 4 ) point and consisted of insertion , stimulation for 30 seconds and removal . After needling , the subjects were asked to complete the same ASS according to what they actually experienced . Adverse events were monitored . The frequency of each sensation expected and experienced , as well as acupuncture sensation scores were compared . More than 60 % of the subjects expected to feel sensations of penetrating ( 87.6 % to 100 % ) , aching ( 71.2 % to 95.5 % ) , tingling ( 87.6 % to 100 % ) , pricking ( 79.7 % to 99.2 % ) and throbbing ( 64.2 % to 91.4 % ) . In fact , the subjects experienced sharp ( 60.9 % to 89.1 % ) , intense ( 60.9 % to 89.1 % ) , radiating ( 71.2 % to 95.5 % ) and heavy ( 74.8 % to 97.4 % ) sensations just as much . The subjects expected more hurting ( p = 0.001 ) , tingling ( p < 0.001 ) , pricking ( p = 0.010 ) , stinging ( p = 0.012 ) , burning ( p = 0.001 ) and pulsing ( p = 0.009 ) than they experienced , while more heaviness ( p = 0.011 ) was experienced than expected . The same outcome measures were also compared between experienced and naive groups . Apart from the fact that the acupuncture-experienced participants expected to feel pricking ( p = 0.030 ) and stinging ( p = 0.002 ) , and experienced hurting ( p = 0.022 ) and stinging ( p = 0.028 ) significantly less than those who had not had acupuncture before , there was no significant difference between first time and experienced subjects . The results indicate that previous experience does not affect the people 's expectation and does not hinder people from experiencing Deqi . In addition , a constellation of Deqi-related acupuncture-specific sensations is more than just a general pain intensity dimension , which requires a biochemical and physiological exploration Background Acupuncture stimulation elicits deqi , a composite of unique sensations that is essential for clinical efficacy according to traditional Chinese medicine ( TCM ) . There is lack of adequate experimental data to indicate what sensations comprise deqi , their prevalence and intensity , their relationship to acupoints , how they compare with conventional somatosensory or noxious response . The objective of this study is to provide scientific evidence on these issues and to characterize the nature of the deqi phenomenon in terms of the prevalence of sensations as well as the uniqueness of the sensations underlying the deqi experience . Methods Manual acupuncture was performed at LI4 , ST36 and LV3 on the extremities in r and omized order during fMRI in 42 acupuncture naïve healthy adult volunteers .  Non-invasive tactile stimulation was delivered to the acupoints by gentle tapping with a von Frey monofilament prior to acupuncture to serve as a sensory control . At the end of each procedure , the subject was asked if each of the sensations listed in a question naire or any other sensations occurred during stimulation , and if present to rate its intensity on a numerical scale of 1–10 . Statistical analysis including paired t-test , analysis of variance , Spearman 's correlation and Fisher 's exact test were performed to compare responses between acupuncture and sensory stimulation . Results The deqi response was elicited in 71 % of the acupuncture procedures compared with 24 % for tactile stimulation when thresholded at a minimum total score of 3 for all the sensations . The frequency and intensity of individual sensations were significantly higher in acupuncture . Among the sensations typically associated with deqi , aching , soreness and pressure were most common , followed by tingling , numbness , dull pain , heaviness , warmth , fullness and coolness . Sharp pain of brief duration that occurred in occasional subjects was regarded as inadvertent noxious stimulation . The most significant differences in the deqi sensations between acupuncture and tactile stimulation control were observed with aching , soreness , pressure and dull pain . Consistent with its prominent role in TCM , LI4 showed the most prominent response , the largest number of sensations as well as the most marked difference in the frequency and intensity of aching , soreness and dull pain between acupuncture and tactile stimulation control . Interestingly , the dull pain generally preceded or occurred in the absence of sharp pain in contrast to reports in the pain literature . An approach to summarize a sensation profile , called the deqi composite , is proposed and applied to explain differences in deqi among acupoints . Conclusion The complex pattern of sensations in the deqi response suggests involvement of a wide spectrum of myelinated and unmyelinated nerve fibers , particularly the slower conducting fibers in the tendinomuscular layers . The study provides scientific data on the characteristics of the ' deqi ' response in acupuncture and its association with distinct nerve fibers . The findings are clinical ly relevant and consistent with modern concepts in neurophysiology . They can provide a foundation for future studies on the deqi phenomenon R and omised controlled trials ( RCTs ) of acupuncture often find equivalent responses to real and placebo acupuncture despite both appearing superior to no treatment . This raises questions regarding the mechanisms of acupuncture , especially the contribution of patient expectancies . We systematic ally review ed previous research assessing the relationship between expectancy and treatment responses following acupuncture , whether real or placebo . To be included , studies needed to assess and /or manipulate expectancies about acupuncture and relate these to at least one health-relevant outcome . Nine such independent studies were identified through systematic search es of Medline , PsycInfo , PubMed , and Cochrane Clinical Trials Register . The methodology and reporting of these studies were quite heterogeneous , meaning that meta- analysis was not possible . A descriptive review revealed that five studies found statistically significant effects of expectancy on a least one outcome , with three also finding evidence suggestive of an interaction between expectancy and type of acupuncture ( real or placebo ) . While there were some trends in significant effects in terms of study characteristics , their generality is limited by the heterogeneity of study design s. The differences in design across studies highlight some important method ological considerations for future research in this area , particularly regarding whether to assess or manipulate expectancies and how best to assess expectancies The difference between superficial and deep needling at acupuncture points has yet to be mapped with functional magnetic resonance imaging ( fMRI ) . Using a 3 T MRI , echo planar imaging data were acquired for 17 right-h and ed healthy volunteer participants . Two fMRI scans of acupuncture needling were taken in r and om order in a block design , one for superficial and one for deep needling on the right h and at the acupuncture point LI-4 ( Hegu ) , with the participant blind to the order . For both scans needle stimulation was used . Brain image analysis tools were used to explore within-group and between-group differences in the blood oxygen level dependent ( BOLD ) responses . The study demonstrated marked similarities in BOLD signal responses between superficial and deep needling , with no significant differences in either activations ( increases in BOLD signal ) or deactivations ( decreases in BOLD signal ) above the voxel Z score of 2.3 with corrected cluster significance of P=0.05 . For both types of needling , deactivations predominated over activations . These fMRI data suggest that acupuncture needle stimulation at two different depths of needling , superficial and deep , do not elicit significantly different BOLD responses . This data is consistent with the equivalent therapeutic outcomes that are cl aim ed by proponents of Japanese and Chinese styles of acupuncture that utilise superficial and deep needling , respectively CONTEXT Acupuncture is widely used to prevent migraine attacks , but the available evidence of its benefit is scarce . OBJECTIVE To investigate the effectiveness of acupuncture compared with sham acupuncture and with no acupuncture in patients with migraine . DESIGN , SETTING , AND PATIENTS Three-group , r and omized , controlled trial ( April 2002-January 2003 ) involving 302 patients ( 88 % women ) , mean ( SD ) age of 43 ( 11 ) years , with migraine headaches , based on International Headache Society criteria . Patients were treated at 18 outpatient centers in Germany . INTERVENTIONS Acupuncture , sham acupuncture , or waiting list control . Acupuncture and sham acupuncture were administered by specialized physicians and consisted of 12 sessions per patient over 8 weeks . Patients completed headache diaries from 4 weeks before to 12 weeks after r and omization and from week 21 to 24 after r and omization . MAIN OUTCOME MEASURES Difference in headache days of moderate or severe intensity between the 4 weeks before and weeks 9 to 12 after r and omization . RESULTS Between baseline and weeks 9 to 12 , the mean ( SD ) number of days with headache of moderate or severe intensity decreased by 2.2 ( 2.7 ) days from a baseline of 5.2 ( 2.5 ) days in the acupuncture group compared with a decrease to 2.2 ( 2.7 ) days from a baseline of 5.0 ( 2.4 ) days in the sham acupuncture group , and by 0.8 ( 2.0 ) days from a baseline if 5.4 ( 3.0 ) days in the waiting list group . No difference was detected between the acupuncture and the sham acupuncture groups ( 0.0 days , 95 % confidence interval , -0.7 to 0.7 days ; P = .96 ) while there was a difference between the acupuncture group compared with the waiting list group ( 1.4 days ; 95 % confidence interval ; 0.8 - 2.1 days ; P<.001 ) . The proportion of responders ( reduction in headache days by at least 50 % ) was 51 % in the acupuncture group , 53 % in the sham acupuncture group , and 15 % in the waiting list group . CONCLUSION Acupuncture was no more effective than sham acupuncture in reducing migraine headaches although both interventions were more effective than a waiting list control 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 UNLABELLED In this pilot study comparing the analgesic effects of three acupuncture modes -- manual , electro , and placebo ( with Streitberger placebo needles)--in a cohort of healthy subjects , we found that verum acupuncture treatment , but not placebo , lowered pain ratings in response to calibrated noxious thermal stimuli . This finding was mainly the result of highly significant analgesia in 5 of the 11 subjects who completed the 5-session study . Of the 5 responders , 2 responded only to electroacupuncture and 3 only to manual acupuncture , suggesting that acupuncture 's analgesic effects on experimental pain may be dependent on both subject and mode . We developed a simple quantitative assessment tool , the  Subjective Acupuncture Sensation Scale ( SASS ) , comprised of 9 descriptors and an anxiety measure to study the relationship between the deqi sensation induced by acupuncture and the putative therapeutic effects of acupuncture . The SASS results confirm that the deqi sensation is complex , with all subjects rating multiple descriptors during each mode . We found significant correlations of analgesia with SASS ratings of numbness and soreness , but not with ratings of stabbing , throbbing , tingling , burning , heaviness , fullness , or aching . This suggests that attributes of the deqi sensation may be useful clinical indicators of effective treatment . PERSPECTIVE The results of this study indicate the existence of both individual subject and acupuncture mode variability in the analgesic effects of acupuncture . This suggests that switching acupuncture mode may be a treatment option for unresponsive patients Objective To investigate whether placebo effects can experimentally be separated into the response to three components— assessment and observation , a therapeutic ritual ( placebo treatment ) , and a supportive patient-practitioner relationship— and then progressively combined to produce incremental clinical improvement in patients with irritable bowel syndrome . To assess the relative magnitude of these components . Design A six week single blind three arm r and omised controlled trial . Setting Academic medical centre . Participants 262 adults ( 76 % women ) , mean ( SD ) age 39 ( 14 ) , diagnosed by Rome II criteria for and with a score of ≥150 on the symptom severity scale . Interventions For three weeks either waiting list ( observation ) , placebo acupuncture alone ( “ limited ” ) , or placebo acupuncture with a patient-practitioner relationship augmented by warmth , attention , and confidence ( “ augmented ” ) . At three weeks , half of the patients were r and omly assigned to continue in their originally assigned group for an additional three weeks . Main outcome measures Global improvement scale ( range 1 - 7 ) , adequate relief of symptoms , symptom severity score , and quality of life . Results At three weeks , scores on the global improvement scale were 3.8 ( SD 1.0 ) v 4.3 ( SD 1.4 ) v 5.0 ( SD 1.3 ) for waiting list versus “ limited ” versus “ augmented , ” respectively ( P<0.001 for trend ) . The proportion of patients reporting adequate relief showed a similar pattern : 28 % on waiting list , 44 % in limited group , and 62 % in augmented group ( P<0.001 for trend ) . The same trend in response existed in symptom severity score ( 30 ( 63 ) v 42 ( 67 ) v 82 ( 89 ) , P<0.001 ) and quality of life ( 3.6 ( 8.1 ) v 4.1 ( 9.4 ) v 9.3 ( 14.0 ) , P<0.001 ) . All pairwise comparisons between augmented and limited patient-practitioner relationship were significant : global improvement scale ( P<0.001 ) , adequate relief of symptoms ( P<0.001 ) , symptom severity score ( P=0.007 ) , quality of life ( P=0.01 ) . Results were similar at six week follow-up . Conclusion Factors contributing to the placebo effect can be progressively combined in a manner resembling a grade d dose escalation of component parts . Non-specific effects can produce statistically and clinical ly significant outcomes and the patient-practitioner relationship is the most robust component . Trial registration Clinical Trials NCT00065403 Both specific and non-specific factors may play a role in acupuncture therapy for pain . We explored the cerebral consequences of needling and expectation with real acupuncture , placebo acupuncture and skin-prick , using a single-blind , r and omized crossover design with 14 patients suffering from painful osteoarthritis , who were scanned with positron emission tomography ( PET ) .  The three interventions , all of which were sub-optimal acupuncture treatment , did not modify the patient 's pain . The insula ipsilateral to the site of needling was activated to a greater extent during real acupuncture than during the placebo intervention . Real acupuncture and placebo ( with the same expectation of effect as real acupuncture ) caused greater activation than skin prick ( no expectation of a therapeutic effect ) in the right dorsolateral prefrontal cortex , anterior cingulate cortex , and midbrain . These results suggest that real acupuncture has a specific physiological effect and that patients ' expectation and belief regarding a potentially beneficial treatment modulate activity in component areas of the reward system OBJECTIVE To explore the different effects of reinforcing and reducing methods by twirling and rotating the needle on stress-induced hypertension and its mechanism . METHODS Sixty male Wistar rats were r and omly divided into a nomal group ( group A ) , a model group ( group B ) , an acupuncture control group ( group C ) , an acupuncture with reinforcing method group ( group D ) and an acupuncture with reducing method group ( group E ) , 12 rats in each group . The model of stress-induced hypertension was established by foot-shock and noise stimulation in the other groups except group A. Group C was treated by acupuncture at left " Taichong " ( LR 3 ) with no manipulation , group D with twirling reinforcement method and group E with twirling reducing method at the same acupoint , respectively , and group A and B with no acupuncture treatment . The contents of calcitonin gene-related peptide ( CGRP ) and nitrogen monoxidum ( NO ) in blood plasma and hypothalamus after 7 days were observed . RESULTS After acupuncture treatment , the contents of CGRP in blood plasma and hypothalamus were ( 375.9 + /- 36.5 ) pg/mL and ( 213.6 + /- 50.1 ) pg/mg in group A , which were higher than ( 261.0 + /- 20.1 ) pg/mL and ( 156.0 + /- 21.8 ) pg/mg in group B , and ( 255.3 + /- 33.6 ) pg/mL and ( 154.3 + /- 47.3 ) pg/mg in group C ( all P < 0.05 ) , and ( 465.9 + /- 53.2 ) pg/mL and ( 250.74 + /- 47.7 ) pg/mg in group E higher than those in group C and ( 283.3 + /- 29.8 ) pg/mL and ( 164.6 + /- 47.4 ) pg/mg in group D ( all P < 0.05 ) , and there was no significant difference among group B , C and D ( all P > 0.05 ) . After acupuncture treatment , the contents of NO in blood plasma and hypothalamus were ( 43.7 + /- 5.5 ) micromol/L and ( 23.3 + /- 2.9 ) micromol/g in group B , ( 46.5 + /- 6.4 ) micromol/L and ( 23.1 + /- 3.3 ) micromol/g in group C , ( 45.8 + /- 6.7 ) micromol/L and ( 25.0 + /- 2.7 ) micromol/g in group D , which were all lower than ( 64.5 + /- 9.9 ) micromol/L and ( 30.7 + /- 1.6 ) micromol/g in group A ( all P < 0.05 ) , ( 55.9 + /- 4.6 ) micromol/L and ( 30.4 + /- 2.1 ) micromol/g in group E higher than those in group C and group D ( all P < 0.05 ) , and there was no significant difference among group B , C and D either ( all P > 0.05 ) . CONCLUSION Acupuncture with twirling reducing method can increase the contents of CGRP and NO in rats with stress-induced hypertension , thereby causing a fall in blood pressure , however , no significant influence with twirling reinforcing method . Reinforcing or reducing method by twirling and rotating the needle has different efficacy The mechanism , by which acupuncture works is not yet clear , therefore there is no unequivocal consensus about styles and sensations of needling . To enhance the scientific base of acupuncture , needling somehow should be objectified . The term Deqi is understood to represent all or at least the main form of phenomena to acupuncture stimulation . The characteristics of Deqi , however , have always been based on a translation of original Chinese description . Hoping to find a clue to develop sham ( placebo ) method for subject blinding , we investigated which sensations are frequently expected and experienced , and whether or not these expectations and experiences of sensations are similar in naive subjects . The  acupuncture sensation scale developed by Vincent et al. ( 1989 ) was translated into Korean . Thirty-eight healthy acupuncture naïve female volunteers ( mean age 29.1 , range 25 - 39 ) were asked to complete the  sensation scale of acupuncture according to what they expected needling to feel like before needling . Needling was done on left Hegu ( LI4 ) point in the h and and consisted of insertion , stimulation for 30 seconds , and removal . Directly after needling , the subjects were asked to complete the same sensation scale according to what they experienced . The subjects expected to feel hurting , penetrating , sharp , tingling , pricking and stinging , and actually experienced aching , spreading , radiating , pricking and stinging more than 60 % of the time . Comparison between expectation and experience , the subjects expected more penetrating , tingling , pricking and burning than they experienced , and on the contrary experienced more aching , pulling , heavy , dull , electric and throbbing than they expected . Traditionally described sensations of Deqi are something beyond just a general pain dimension in the Korean population . Further study involving acupuncture experienced subjects or subjects from other cultures need to confirm this finding . Moreover , sham acupuncture should be studied Abstract In a pooled analysis of four r and omized controlled trials of acupuncture in patients with migraine , tension‐type headache , chronic low back pain , and osteoarthritis of the knee we investigated the influence of expectations on clinical outcome . The 864 patients included in the analysis received either 12 sessions of  acupuncture or minimal ( i.e. sham ) acupuncture ( superficial needling of non‐acupuncture points ) over an 8 week period . Patients were asked at baseline whether they considered acupuncture to be an effective therapy in general and what they personally expected from the treatment . After three acupuncture sessions patients were asked how confident they were that they would benefit from the treatment strategy they were receiving . Patients were classified as responders if the respective main outcome measure improved by at least fifty percent . Both univariate and multivariate analyses adjusted for potential confounders ( such as condition , intervention group , age , sex , duration of complaints , etc . ) consistently showed a significant influence of attitudes and expectations on outcome . After completion of treatment , the odds ratio for response between patients considering acupuncture an effective or highly effective therapy and patients who were more sceptical was 1.67 ( 95 % confidence interval 1.20–2.32 ) . For personal expectations and confidence after the third session , odds ratios were 2.03 ( 1.26–3.26 ) and 2.35 ( 1.68–3.30 ) , respectively . Results from the 6‐month follow‐up were similar . In conclusion , in our trials a significant association was shown between better improvement and higher outcome expectations OBJECTIVE To investigate the effectiveness of acupuncture in addition to routine care , compared with routine care alone , in the treatment of patients with chronic pain due to osteoarthritis ( OA ) of the knee or hip . METHODS In a r and omized , controlled trial , patients with chronic pain due to OA of the knee or hip were r and omly allocated to undergo up to 15 sessions of acupuncture in a 3-month period or to a control group receiving no acupuncture . Another group of patients who did not consent to r and omization underwent acupuncture treatment . All patients were allowed to receive usual medical care in addition to the study treatment . Clinical OA severity ( Western Ontario and McMaster Universities Osteoarthritis Index [ WOMAC ] ) and health-related quality of life ( Short Form 36 ) were assessed at baseline and after 3 months and 6 months . RESULTS Of 3,633 patients ( mean + /- SD age 61.8 + /- 10.8 years ; 61 % female ) , 357 were r and omized to the acupuncture group and 355 to the control group , and 2,921 were included in the nonr and omized acupuncture group . At 3 months , the WOMAC had improved by a mean + /- SEM of 17.6 + /- 1.0 in the acupuncture group and 0.9 + /- 1.0 in the control group ( 3-month scores 30.5 + /- 1.0 and 47.3 + /- 1.0 , respectively [ difference in improvement 16.7 + /- 1.4 ; P < 0.001 ] ) . Similarly , quality of life improvements were more pronounced in the acupuncture group versus the control group ( P < 0.001 ) . Treatment success was maintained through 6 months . The changes in outcome in nonr and omized patients were comparable with those in r and omized patients who received acupuncture . CONCLUSION These results indicate that acupuncture plus routine care is associated with marked clinical improvement in patients with chronic OA-associated pain of the knee or hip BACKGROUND Despite the popularity of acupuncture , evidence of its efficacy for reducing pain remains equivocal . OBJECTIVE To assess the efficacy and safety of traditional Chinese acupuncture ( TCA ) compared with sham acupuncture ( needling at defined nonacupuncture points ) and conservative therapy in patients with chronic pain due to osteoarthritis of the knee . DESIGN R and omized , controlled trial . SETTING 315 primary care practice s staffed by 320 practitioners with at least 2 years ' experience in acupuncture . PATIENTS 1007 patients who had had chronic pain for at least 6 months due to osteoarthritis of the knee ( American College of Rheumatology [ ACR ] criteria and Kellgren-Lawrence score of 2 or 3 ) . INTERVENTIONS Up to 6 physiotherapy sessions and as-needed anti-inflammatory drugs plus 10 sessions of TCA , 10 sessions of sham acupuncture , or 10 physician visits within 6 weeks . Patients could request up to 5 additional sessions or visits if the initial treatment was viewed as being partially successful . MEASUREMENTS Success rate , as defined by at least 36 % improvement in Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) score at 26 weeks . Additional end points were WOMAC score and global patient assessment . RESULTS Success rates were 53.1 % for TCA , 51.0 % for sham acupuncture , and 29.1 % for conservative therapy . Acupuncture groups had higher success rates than conservative therapy groups ( relative risk for TCA compared with conservative therapy , 1.75 [ 95 % CI , 1.43 to 2.13 ] ; relative risk for sham acupuncture compared with conservative therapy , 1.73 [ CI , 1.42 to 2.11 ] ) . There was no difference between TCA and sham acupuncture ( relative risk , 1.01 [ CI , 0.87 to 1.17 ] ) . LIMITATIONS There was no blinding between acupuncture and traditional therapy and no monitoring of acupuncture compliance with study protocol . In general , practitioner-patient contacts were less intense in the conservative therapy group than in the TCA and sham acupuncture groups . CONCLUSIONS Compared with physiotherapy and as-needed anti-inflammatory drugs , addition of either TCA or sham acupuncture led to greater improvement in WOMAC score at 26 weeks . No statistically significant difference was observed between TCA and sham acupuncture , suggesting that the observed differences could be due to placebo effects , differences in intensity of provider contact , or a physiologic effect of needling regardless of whether it is done according to TCA principles & NA ; The issue of what constitutes an effective and realistic acupuncture placebo control has been a continuing problem for acupuncture research . In order to provide an effective placebo , the control procedure must be convincing , visible and should mimic , in all respects , apart from a physiological effect , the real active treatment . The ‘ Streitberger ’ needle might fulfil these criteria and this paper reports on a validation study . This was a single‐blind , r and omised , cross‐over pilot study . Patients were drawn from the orthopaedic hip and knee , joint replacement waiting list . Intervention consisted of either 2 weeks of treatment with real acupuncture followed by 2 weeks on placebo , or vice versa . The prime outcome was a needle sensation question naire and there was a range of secondary outcomes . Thirty‐seven patients were r and omised and completed treatment . Groups were well balanced at baseline . No significant differences between groups or needle types were found for any of the sensations measured . Most patients were unable to discriminate between the needles by penetration ; however , nearly 40 % were able to detect a difference in treatment type between needles . No major differences in outcome between real and placebo needling could be found . The fact that nearly 40 % of subjects did not find that the two interventions were similar , however , raises some concerns with regard to the wholesale adoption of this instrument as a st and ard acupuncture placebo . Further work on inter‐tester reliability and st and ardisation of technique is highly recommended before we can be confident about using this needle in further studies The r and omized controlled trial has been used in medical research for a little over half a century . This manuscript provides an overview of some of the history and evolution of the r and omized controlled trial during this period . There exists hierarchies of evidence for therapeutic , diagnostic and prognostic questions , and the r and omized controlled trial is at the top of the therapeutic hierarchy . Despite being at the top of the therapeutic hierarchy r and omization in itself does not guarantee the trial results approximate the true effect . Issues that result in systematic and non systematic deviations from the truth in r and omized controlled trials must also be considered . We present a model for evidence -based decision making that includes the following components : the clinical state , patient preferences , research evidence from a range of studies and clinical expertise . We discuss the role of the r and omized controlled trial within evidence -based decision making Traditional acupuncturists cl aim that correct needling of classical acupuncture loci is associated with a characteristic set of sensations usually referred to as ' Teh Chi ' . The studies reported here examine this cl aim . In the first a multiple adjective sensation rating scale was developed and administered to 125 patients receiving acupuncture treatment .  The results were subjected to principal components analysis and the first factor to emerge provided some support for the constellation of sensations corresponding to Teh Chi . In the second study the scale was used in a r and omised controlled mixed single/double blind experiment in which 65 volunteers were stimulated at three classical and three non-classical ( sham ) needling sites by either a trained acupuncturist ( single blind ) or an anaesthetist ( double blind ) . The results of the second study did not support the contention that the sensations of Teh Chi occur more frequently at classical acupuncture needling sites . The implication s of the results for the practice of acupuncture are discussed
Acupuncture treatment has been widely used for many conditions , while results of the increasing numbers of r and omized trials and systematic review s remain controversial .
Acupuncture is a complex intervention of both specific and non-specific factors associated with therapeutic benefit .