To explore the application status and prospect of sham acupuncture in clinical trials of acupuncture based on 5G+VR technology / 国际中医中药杂志

Acupuncture has been proved to be safe and effective by large-scale and authoritative clinical observation at home and abroad. However, in recent years, the results of some randomized controlled trials of acupuncture in JAMA showed no significant difference between acupuncture effect and sham acupuncture effect. Acupuncture and moxibustion in clinical practice is a summary of academic and clinical rules. Different from chemical drugs, the amount of stimulation, methods of operation and techniques vary. At present, sham acupuncture in clinical trials at home and abroad has been questioned by many scholars, who believe that sham acupuncture is not fake, and call for "fake targeted research" to be stopped. In order to improve the sham acupuncture control design, 5G + VR technology and the principle elements of sham acupuncture should be combined. We also discussed and analyzed advantages and prospects of modern intelligent medical technology of 5G + VR technology in the sham acupuncture RCT. We hope to promote standardization of acupuncture clinical trials, and the development, innovation and application of acupuncture research at home and abroad.

Sham acupuncture and placebo acupuncture in clinical trials / 中国针灸

The commonly used terms "sham acupuncture" and "placebo acupuncture" in clinical acupuncture research is compared and analyzed in this article. In terms of their respective characteristics, sham acupuncture has a wider scope, including various types of acupoints, needle insertion at non-acupoint or non-insertion at acupoints, while placebo acupuncture mainly focuses on non-insertion at acupoints. Sham acupuncture mainly emphasizes the appearance similarity to real acupuncture, while placebo acupuncture emphasizes both similarity in appearance and the absence of therapeutic effects. Properly distinguishing and applying sham acupuncture and placebo acupuncture can help standardize their usage in terminology. Considering the difficulty in setting up qualified placebo acupuncture, it is suggested that researchers use the term "sham acupuncture" to describe the acupuncture control methods used in clinical research.

Placebo control and its methodological issues on clinical trials of acupuncture therapy / 中国针灸

The paper introduces the placebo acupuncture simulation devices commonly used in clinical trial of acupuncture therapy. These devices are composed of Streitberger, Park, Takakura, Foam and Phantom acupuncture. Because acupuncture therapy is a kind of complex intervention, there are the controversies in methodology for the acupuncture placebo control of clinical trial. Placebo acupuncture may be an effective control, with a certain of specific therapeutic effect. The blinding effect of placebo acupuncture is highly questioned, specially, the sensation of deqi is hardly imitated during acupuncture. On these grounds, in this research, the suggestions has been proposed on the selection and the setting of placebo control in clinical trial of acupuncture therapy.

Effect of acupuncture on knee injury and osteoarthritis outcome score in patients with knee osteoarthritis / 中国针灸

OBJECTIVE@#To verify the clinical effect of acupuncture on knee osteoarthritis (KOA).@*METHODS@#Forty-two patients with KOA were randomly divided into an acupuncture group (21 cases, 1 case dropped off) and a sham acupuncture group (21 cases, 1 case dropped off). The patients in the acupuncture group were treated with routine acupuncture at 5-6 local acupoints [Dubi (ST 35), Neixiyan (EX-LE 4), Heding (EX-LE 2), Yinlingquan (SP 9), Xuehai (SP 10), Zusanli (ST 36), etc.] and 3-4 distal acupoints [Fengshi (GB 31), Waiqiu (GB 36), Xuanzhong (GB 39), Zulinqi (GB 41), etc.]. The patients in the sham acupuncture group were treated with shallow needling technique at non-acupoint. The needles were retained for 30 min in both groups. All the treatment was given three times a week for 8 weeks. Knee injury and osteoarthritis outcome score (KOOS) were recorded before and after treatment and 18-week follow-up.@*RESULTS@#Compared before treatment, the scores of 5 dimensions of KOOS [pain, symptoms (except pain), daily activities, sports and entertainment, and quality of life] were increased after treatment and during follow-up in the two groups (@*CONCLUSION@#Acupuncture can reduce the pain symptoms and improve daily activities in patients with KOA.

Acupuncture is ineffective for chronic low back pain? A critical analysis and rethinking / 医学前沿

Acupuncture is a promising treatment for relieving pain and improving lower back function in clinical practice. However, evidence from randomized clinical trials (RCTs) remains controversial. Most RCTs conclude that acupuncture procedures for chronic low back pain (CLBP) had no significant difference in efficacy and belonged to placebo. We carefully reviewed and analyzed the methodology and implementation of sham acupuncture in RCTs. Controversial evidence of acupuncture for CLBP is only a microcosm of the evaluation methodological limitation of acupuncture. Inappropriate selection of sham acupuncture controls, rigorous RCT research models, and incorrect interpretation of results may contribute to negative evidence. Evaluating and disregarding the holistic efficacy of acupuncture with an explanatory RCT model based on evaluation drugs may be unwise. Moreover, sham acupuncture is often proven to be non-inert, unreasonable, and with low fidelity. Pitfalls of the explanatory RCT model and sham acupuncture design should be avoided. Establishing a new evaluation system that is in line with the clinical characteristics of acupuncture and obtaining high-quality evidence are difficult but promising tasks.

Impact of Low Frequency Electro-acupuncture on Glucose and Lipid Metabolism in Unmarried PCOS Women: A Randomized Controlled Trial / 中国结合医学杂志

OBJECTIVE@#To explore the effect of electro-acupuncture (EA) on glucose and lipid metabolism in unmarried patients with polycystic ovary syndrome (PCOS).@*METHODS@#Fifty-four PCOS patients were equally randomized into true acupuncture group and sham acupuncture group (control) for totally 16 weeks of treatment by random method with a computerized randomization program. Patients in true acupuncture group accepted traditional acupuncture methods with EA and two sets of acupoint groups were used alternatively. The first set consisted of Zhongji (CV 3), Qihai (CV 6), Guilai (ST 29), Sanyinjiao (SP 6), Yinlingquan (SP 9), Hegu (LI4) and Baihui (GV 20), and the second set consisted of Tianshu (ST 25), ST 29, CV 3, CV 6, SP 6, Taichong (LR 3), Neiguan (PC) 6 and GV 20. Patients in the sham acupuncture group accepted shallow acupuncture methods through EA without electricity at 4 non-meridian points in each shoulder and upper arm. Outcome measures included body mass index (BMI), waist-hip-ratio (WHR), oral glucose tolerance test (OGTT), insulin release test, glucose and lipid metabolism indicators such as total cholesterol (TC), triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol, adiponectin, leptin, visfatin, resistin, and interleukin (IL-6).@*RESULTS@#Twenty-six subjects in the true acupuncture group and 20 subjects in the sham group completed the clinical trial. After 16 weeks of treatment, no significant difference in the outcome measures were observed between the two groups (P>0.05). However, as compared with baseline data, a reduction in weight, BMI, hipline, WHR, fasting glucose, homeostatic model assessment of insulin sensitivity, visfatin and HDL-C, and an increase in resistin and IL-6 were observed in the true acupuncture group (P<0.05). In addition, a reduction in visfatin and an increase in TC were also observed in the sham group (P<0.05).@*CONCLUSIONS@#Acupuncture may have a beneficial effect in the treatment of PCOS by improving glucose and lipid metabolism. Moreover, the sham acupuncture may be not completely ineffective. Sham acupuncture may improve some of the aspects of the glucose and lipid metabolism of PCOS patients through a placebo effect. (Registration Nos. ChiCTR-TRC-12002529 and NCT01812161).

Effect of acupuncture on emotional disorder in patients with chronic pain: a Meta-analysis / 中国针灸

OBJECTIVE@#To systematically review the effect of acupuncture on emotional disorder in the patients with migraine and knee osteoarthritis and its effect time limit.@*METHODS@#The randomized controlled trials of acupuncture for migraine or knee osteoarthritis were retrieved from the databases, starting from the time of establishment through to December, 2018, i.e. the Cochrane Library, PubMed, EMbase, CNKI, SinoMed, VIP and Wanfang. The bias risk assessment tool of Cochrane Review Manual 5.1.0 was adopted to evaluate the quality of trials in methodology. RevMan 5.3 software was used for the Meta-analysis.@*RESULTS@#A total of 12 articles were included, with 2450 cases. Regarding the immediate effect, the score of the emotional function subscale of migraine-specific quality-of-life questionnaire (MSQ) in the acupuncture group was higher than the control group (6.38[2.78,9.98], =25%). In view of the emotional function subscale of the short-form of health survey (SF-36/SF-12), and the scores of the mental function and negative mode scale in Spain's index of quality of life (PQLC), there were no significant differences in the scores between the acupuncture group and the control group. In 3 months of treatment, the score of the emotional function subscale of MSQ in the acupuncture group was higher than the control group (9.66 [3.06,16.25], =44%). The difference in the score of the mental health subscale of SF-36 and SF-12 was not significant between the acupuncture group and the control group. In 3 to 6 months of treatment, as well as in over 6 months of treatment, the score of every scale was not different statistically between the acupuncture group and the control group.@*CONCLUSION@#Acupuncture effectively maintains the healthy emotion in the patients with migraine and the effect is sustainable for 3 months after treatment. But the improvement of acupuncture is not remarkable in emotional disorder induced by knee osteoarthritis.

Is sham acupuncture as effective as traditional Chinese acupuncture? It's too early to say / 中国结合医学杂志

Many clinical trials and experimental studies claim that sham acupuncture is as effective as traditional Chinese acupuncture. However, these studies have no standard sham acupuncture control and many other factors can affect the clinical effect. These factors include needle retention time, treatment frequency, and the total number of treatments needed for satisfactory results, and all can change the clinical effect. The majority of existing acupuncture treatment studies do not consider these factors and lack standard dosage criteria. Therefore, it is still too early to conclude that sham acupuncture is as effective as traditional Chinese acupuncture. This article investigates the factors that influence the curative effect of acupuncture as to help set a standard for acupuncture studies in the future.

Research of Acupuncture Manipulations and Needling Sensation / 上海针灸杂志

Several experiments were conducted to explore the relation between acupuncture manipulations and needling sensations based on M-QNS by describing needling intensity at quantification. The results indicated that the relation between acupuncture manipulations and peak value of needling sensation could not be confirmed when needling intensity and electric intensity were variables, and the peak value of needling sensation produced by manipulations should be a random variable under a certain circumstance. Sham acupuncture didn’t necessarily mean absence of stimulating intensity. Therefore, the subjects of acupuncture-moxibustion and medication are kind of heterogeneous, while acupuncture research should adopt observation of needling sensation and the peak value of needling sensation as the major research method as the basic action mechanism of acupuncture mainly involves neuroscience.

SL2 Introduction of the Japanese acupuncture and possible role of the polymodal receptor in its action mechanisms / 日本温泉気候物理医学会雑誌

  Acupuncture and moxibustion therapy in Japan has a long history, and it has developed differently from the Chinese or Korean procedures. The use of a guide tube for the insertion of a fine acupuncture needle without pain, shallow needling and use of intradermal needle without “de-qi” are known as Japanese acupuncture techniques. Our previous study clearly demonstrated variations of the point selection and methods of procedures among the Japan, Korea and Chinese traditional acupuncture therapy on the same subjects. The results obtained by three kinds of traditional acupuncture therapies were also different.   The majority of basic research and clinical trials of acupuncture have used Chinese acupuncture procedure using thick needles with “de-qi” sensation. Participation of the endogenous opioids in relatively intense electro-acupuncture induced analgesia has been well established, but similar analgesia is also induced by stressful stimuli such as electrical foot shock, so opioid-mediated analgesia is not the specific phenomena induced by acupuncture therapy.   Recent literature survey of the Ma Wang Dui（馬王堆）tomb clearly demonstrated the moxibustion (cauterization) was the primitive therapeutic procedure and the meridian concept was established by moxibustion not by acupuncture therapy. On the peripheral mechanisms, various sensory receptors could be activated by acupuncture but receptors responsive to moxibustion are limited. The polymodal receptors (PMRs), which responsive to mechanical, thermal and chemical stimuli, are activated by both acupuncture and moxibustion. They are also responsive to gentle skin scratching and pressure application with blunt acupuncture needle which used as sham acupuncture in recent clinical trials. Sensitization of the PMRs might be a possible cause of acupuncture point formation. These several lines of evidence suggest the PMRs are the key candidates of the action mechanisms of acupuncture and moxibustion. Figure 1 shows schematic illustration of the polymodal receptor hypothesis of action mechanisms of acupuncture and moxibustion.

SL2Introduction of the Japanese acupuncture and possible role of the polymodal receptor in its action mechanisms / 日本温泉気候物理医学会雑誌

  Acupuncture and moxibustion therapy in Japan has a long history, and it has developed differently from the Chinese or Korean procedures. The use of a guide tube for the insertion of a fine acupuncture needle without pain, shallow needling and use of intradermal needle without “de-qi” are known as Japanese acupuncture techniques. Our previous study clearly demonstrated variations of the point selection and methods of procedures among the Japan, Korea and Chinese traditional acupuncture therapy on the same subjects. The results obtained by three kinds of traditional acupuncture therapies were also different.<BR>  The majority of basic research and clinical trials of acupuncture have used Chinese acupuncture procedure using thick needles with “de-qi” sensation. Participation of the endogenous opioids in relatively intense electro-acupuncture induced analgesia has been well established, but similar analgesia is also induced by stressful stimuli such as electrical foot shock, so opioid-mediated analgesia is not the specific phenomena induced by acupuncture therapy. <BR>  Recent literature survey of the Ma Wang Dui（馬王堆）tomb clearly demonstrated the moxibustion (cauterization) was the primitive therapeutic procedure and the meridian concept was established by moxibustion not by acupuncture therapy. On the peripheral mechanisms, various sensory receptors could be activated by acupuncture but receptors responsive to moxibustion are limited. The polymodal receptors (PMRs), which responsive to mechanical, thermal and chemical stimuli, are activated by both acupuncture and moxibustion. They are also responsive to gentle skin scratching and pressure application with blunt acupuncture needle which used as sham acupuncture in recent clinical trials. Sensitization of the PMRs might be a possible cause of acupuncture point formation. These several lines of evidence suggest the PMRs are the key candidates of the action mechanisms of acupuncture and moxibustion. Figure 1 shows schematic illustration of the polymodal receptor hypothesis of action mechanisms of acupuncture and moxibustion.

Effect of acupuncture treatment on temporomandibular disorders-Questionnaire and acupuncture treatment for university students- / 全日本鍼灸学会雑誌

[Purpose]The reason is uncertain though it is assumed that to young people that there are a lot of Temporomandibular disorders (TMD). Then, the questionnaire survey concerning the mandible function was administered for university students, and the clinical trial of the acupuncture treatment that used sham acupuncture for the one where the problem was seen in the mandible function was tried.<BR>[Method]We questioned students at Meiji University of Integrative Medicine by answer selection type concerning the mandible function. The acupuncture treatment was done on 16 students (21.5 ± 1.7 years old;mean ±S.D.) who had problems in the mandible function. The group was divided into two groups (the acupuncture group and the sham acupuncture group) at random. Each group received five acupuncture treatment sessions several times week in total. Outcome measures were pain intensity (visual analogue scale) and function of jaw (mouth opening and muscle power). Each evaluation was assumed to be done before beginning the treatment, and the effect of treatment was assumed to be the one evaluated as a therapeutic gain after one week.<BR>[Result]University students who had some problem in the mandible function were 50%or more of the whole, and a lot of problems were joint noises. On the other hand, the acupuncture group was 67.1 ± 19.1 mm and the sham group was 65.6 ± 15.2 mm. Both groups showed reduction tendencies as the acupuncture group was 9.3± 7.8 mm and the sham group was 40.5 ± 16.7 mm. The acupuncture group reported less pain intensity than the sham acupuncture group (p = 0.0152, Mann-Whitney). However, the true and sham acupuncture groups did not change the function of the jaw. <BR>[Conclusion]A lot of university students who had mandible function problems were unexpectedly regarded as necessary to treat at the early stage. On the other hand, these results suggest that true acupuncture procedures may be more effective on TMD in young patients than sham acupuncture procedures.

Acupuncture Teratment for Lower Back Pain-Multi-center Randomized Controlled Trial using Spam Acupuncture as a Control / 全日本鍼灸学会雑誌

[Objective] We performed a multi-center randomized controlled trial using sham acupuncture as a control in the 11 institutions of Aichi and Shizuoka prefecture at which we practice our original acupuncture method. <BR>[Design · Methods] Patients were randomly allocated to four groups : A group, “Taikyoku-Ryoho” (whole body acupuncture method) pole treatment combined with low frequency electroacupuncture; B group, “TaikyokuRyoho” pole treatment; C group, low frequency electroacupuncture; D group, sham acupuncture. Therapeutic effectiveness was evaluated using a visual analogue scale (VAS) and criteria of the Japanese Orthopedic Association for low back pain (JOA score). After these evaluations, patients in B group received low frequency electroacupuncture and patients in C group received “Taikyoku-Ryoho” pole treatment. Patients in D group received both therapies. Thus, all patients eventually received the entire series of therapies. [Results] Significant improvement (P<0.05) in VAS and JOA scores was recognized after one acupuncture treatment in A, B and C groups, but not in D group. There were no differences in terms of the effectiveness among A, B and C groups.<BR>[Conclusion] Our original acupuncture method of “Taikyoku-Ryoho” combined with low frequency electroacupuncture was superior to sham acupuncture. However, the definition of sham acupuncture needs to be more clearly defined in future research.

Report on the 1st Japan-Korea Workshop on Acupuncture and EBM-Proposal of Clinical Trials for the Future Japan-Korea Collaboration- / 全日本鍼灸学会雑誌

The first Japan-Korea workshop on acupuncture and EBM was held on June 4, 2004 at Chiba in the 53rd annual scientific meeting of the JSAM. The purpose of this workshop was to exchange the experiences of clinical researches on acupuncture and moxibustion therapies, and to find out the issues and their solutions for developing the excellent clinical research to establish strong evidence. The final purpose was to develop aprotocol for the collaborative work between both countries.<BR>Drs. Kawakita (JSAM) and Jang (KAMS) chaired the workshop. Three speakers from Japan (Drs Takahashi, Nabeta, and Tsukayama) and three Korean speakers (Drs Seo, Lee and Moon) presented their data on the clinical researches of acupuncture, moxibustion and bee-venom injection. After their paper presentations, various issues were discussed on their research methodology for establishing more strong evidence of acupuncture.We got interesting new findings and understood various issues for conducting clinical researches especially RCT.<BR>Although we could not develop a protocol for the collaborative research in this workshop, it was very fruitful workshop as the first step for the future Japan-Korea collaborative clinical study. The most important product of this workshop was we could understand each other and we confirmed the necessity of the future collaborative clinical research on acupuncture.