Retracted: Effect of Sham Acupuncture on Chronic Pain: A Bayesian Network Meta-Analysis.

BACKGROUND: Along with increasing research on acupuncture for chronic pain, the validity of sham acupuncture (SA) has also been argued. METHODS: Nine databases were searched for randomized controlled trials (RCTs) from the inception dates of the databases to July 5, 2022. With Markov Chain Monte Carlo methods, a Bayesian multiple-treatment network meta-analysis (NMA) with random-effects model was conducted. RESULTS: A total of 62 RCTs with 6,806 patients and four kinds of treatments (real acupuncture [RA], non-acupuncture [NA], penetrative SA [PSA], and non-penetrative SA [NPSA]) were included. The results indicated that both NPSA and PSA were not superior to NA in improving chronic pain (NPSA: mean difference [MD]= -4.77, 95% confidence interval [CI] -11.09 to 1.52; PSA: MD= -4.96, 95% CI -10.38 to 0.48). After NPSA and PSA were combined into the SA group, the weak trend of pain relief from SA was still not statistically significant (MD= -4.91, 95% CI -9.93 to 0.05). NPSA and PSA had similar effects (MD= 0.18, 95% CI -5.45 to 5.81). RA was significantly associated with pain relief, compared with NPSA and PSA (NPSA: MD= -12.03, 95% CI -16.62 to -7.41; PSA: MD= -11.85, 95% CI -15.48 to -8.23). The results were generally consistent regardless of pain phenotype, frequency, duration, acupuncture methods, analgesic intake, or detection bias. CONCLUSION: These results suggested that acupuncture was significantly associated with reduced chronic pain. The two kinds of placebo acupuncture, NPSA and PSA, have similar effects. Both NPSA and PSA, with a weak but not significant effect, are appropriate to be inert placebo controls in RCTs for chronic pain.

Effect of acupuncture and metformin on insulin sensitivity in women with polycystic ovary syndrome and insulin resistance: a three-armed randomized controlled trial.

STUDY QUESTION: Does acupuncture improve insulin sensitivity more effectively than metformin or sham acupuncture in women with polycystic ovary syndrome (PCOS) and insulin resistance (IR)? SUMMARY ANSWER: Among women with PCOS and IR, acupuncture was not more effective than metformin or sham acupuncture in improving insulin sensitivity. WHAT IS KNOWN ALREADY: Uncontrolled trials have shown that acupuncture improved insulin sensitivity with fewer side effects compared with metformin in women with PCOS and IR. However, data from randomized trials between acupuncture and metformin or sham acupuncture are lacking. STUDY DESIGN, SIZE, DURATION: This was a three-armed randomized controlled trial enrolling a total of 342 women with PCOS and IR from three hospitals between November 2015 and February 2018, with a 3-month follow-up until October 2018. PARTICIPANTS/MATERIALS, SETTING, METHODS: Women aged from 18 to 40 years with PCOS and homeostasis model assessment of insulin resistance (HOMA-IR) ≥2.14 were randomly assigned (n = 114 per group) to receive true acupuncture plus placebo (true acupuncture), metformin plus sham acupuncture (metformin, 0.5 g three times daily) or sham acupuncture plus placebo (sham acupuncture) for 4 months, with an additional 3-month follow-up. True or sham acupuncture was given three times per week, and 0.5 g metformin or placebo was given three times daily. The primary outcome was change in HOMA-IR from baseline to 4 months after baseline visit. Secondary outcomes included changes in the glucose AUC during an oral glucose tolerance test, BMI and side effects at 4 months after baseline visit. MAIN RESULTS AND THE ROLE OF CHANCE: After 4 months of treatment, the changes of HOMA-IR were -0.5 (decreased 14.7%) in the true acupuncture group, -1.0 (decreased 25.0%) in the metformin group and -0.3 (decreased 8.6%) in the sham acupuncture group, when compared with baseline. True acupuncture is not as effective as metformin in improving HOMA-IR at 4 months after baseline visit (difference, 0.6; 95% CI, 0.1-1.1). No significant difference was found in change in HOMA-IR between true and sham acupuncture groups at 4 months after baseline visit (difference, -0.2; 95% CI, -0.7 to 0.3). During the 4 months of treatment, gastrointestinal side effects were more frequent in the metformin group, including diarrhea, nausea, loss of appetite, fatigue, vomiting and stomach discomfort (31.6%, 13.2%, 11.4%, 8.8%, 14.0% and 8.8%, respectively). Bruising was more common in the true acupuncture group (14.9%). LIMITATIONS, REASONS FOR CAUTION: This study might have underestimated the sample size in the true acupuncture group with 4 months of treatment to enable detection of statistically significant changes in HOMA-IR with fixed acupuncture (i.e. a non-personalized protocol). Participants who withdrew because of pregnancy did not have further blood tests and this can introduce bias. WIDER IMPLICATIONS OF THE FINDINGS: True acupuncture did not improve insulin sensitivity as effectively as metformin in women with PCOS and IR, but it is better than metformin in improving glucose metabolism (which might reduce the risk of type 2 diabetes) and has less side effects. Metformin had a higher incidence of gastrointestinal adverse effects than acupuncture groups, and thus acupuncture might be a non-pharmacological treatment with low risk for women with PCOS. Further studies are needed to evaluate the effect of acupuncture combined with metformin on insulin sensitivity in these women. STUDY FUNDING/COMPETING INTEREST(S): This work was supported by grants 2017A020213004 and 2014A020221060 from the Science and Technology Planning Project of Guangdong Province. The authors have no conflicts of interest. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov number: NCT02491333. TRIAL REGISTRATION DATE: 8 July 2015. DATE OF FIRST PATIENT'S ENROLLMENT: 11 November 2015.

Double-blinding of an acupuncture randomized controlled trial optimized with clinical translational science award resources.

BACKGROUND: Clinical trial articles often lack detailed descriptions of the methods used to randomize participants, conceal allocation, and blind subjects and investigators to group assignment. We describe our systematic approach to implement and measure blinding success in a double-blind phase 2 randomized controlled trial testing the efficacy of acupuncture for the treatment of vulvodynia. METHODS: Randomization stratified by vulvodynia subtype is managed by Research Electronic Data Capture software's randomization module adapted to achieve complete masking of group allocation. Subject and acupuncturist blinding assessments are conducted multiple times to identify possible correlates of unblinding. RESULTS: At present, 48 subjects have been randomized and completed the protocol resulting in 87 subject and 206 acupuncturist blinding assessments. DISCUSSION: Our approach to blinding and blinding assessment has the potential to improve our understanding of unblinding over time in the presence of possible clinical improvement.

Efficacy and Safety of Acupuncture for Chronic Discogenic Sciatica, a Randomized Controlled Sham Acupuncture Trial.

OBJECTIVE: To evaluate the efficacy and safety of acupuncture for discogenic sciatica. DESIGN: Single-center, parallel, randomized controlled sham acupuncture trial. METHODS: Twelve sessions of acupuncture or sham acupuncture at the same traditional acupoints over four weeks. The primary outcome was change from baseline in weekly mean leg pain, measured by the visual analog scale (VAS) over the four-week treatment period. The secondary outcomes were determined by the change from baseline in mean VAS scores for leg pain, VAS scores for low back pain, Oswestry Disability Index (ODI) scores, and 36-Item Short Form Health Survey (SF-36) scores. Patients were followed for 28 weeks. RESULTS: Forty-six patients were enrolled in this study between June 2017 and January 2018, of which 23 were in the acupuncture group and 23 were in the sham acupuncture group. The between-group difference in weekly mean leg pain measured by the VAS over the four-week treatment period was -7.28 mm (95% confidence interval = -13.76 to -0.80, P = 0.029), which is larger than the minimum clinically important difference of 5 mm. The between-group differences in mean VAS scores for low back pain, ODI scores, and SF-36 scores were not significant in the study period (P > 0.05 for all). The proportion of acupuncture-related adverse events was 4.3%, and all adverse events were mild and transient. CONCLUSIONS: Twelve sessions of acupuncture showed short-term clinical benefits in relieving the symptoms of leg pain for patients with chronic discogenic sciatica compared with sham acupuncture. Acupuncture is safe in treating chronic discogenic sciatica. Further studies with larger sample sizes, a longer treatment period, and long-term follow-up should be conducted to verify these results.

Effectiveness and feasibility of acupuncture for knee osteoarthritis: a pilot randomized controlled trial.

OBJECTIVE:: To evaluate the effectiveness of acupuncture for pain relief and function improvement in patients with knee osteoarthritis and to determine the feasibility of an eight-week acupuncture intervention. DESIGN:: Pilot randomized controlled trial. SETTING:: Three teaching hospitals in China. SUBJECTS:: Patients with knee osteoarthritis (Kellgren grade II or III). INTERVENTIONS:: Patients were randomly assigned to an eight-week (three sessions per week) intervention of either traditional Chinese acupuncture or sham acupuncture. MAIN MEASURES:: The primary outcome was response rate-the proportion of patients achieving score ⩾36% decrease in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function at week 8 compared with baseline. Secondary outcomes included pain, function and quality of life. RESULTS:: Of 42 patients randomized, 36 (85.7%) completed the study. There was no significant difference in response rate between the traditional Chinese acupuncture and control groups: 61.9% (13 of 21) versus 42.9% (9 of 21) achieved score ⩾36% decrease in WOMAC pain and function at week 8 ( P = 0.217). The sum of WOMAC pain and function scores at week 8 was 11.6 (9.1) in the traditional Chinese acupuncture group compared with 16.3 (10.9) in the control group ( P = 0.183). There was no significant difference between groups. Three adverse events were recorded and were classified as mild. CONCLUSION:: It showed that three sessions per week acupuncture intervention of knee osteoarthritis was feasible and safe. No difference was observed between groups due to small sample size. Larger (sample size ⩾ 296) randomized controlled trials of this intervention appear justified.

Sinew acupuncture for knee osteoarthritis: study protocol for a randomized sham-controlled trial.

BACKGROUND: Sinew acupuncture is a new modality of acupuncture in which needles are inserted into acupoints, ashi points or spasm points of sinew and muscles along the meridian sinew pathway. A previous observational study revealed that sinew acupuncture has immediate analgesic effects on various soft tissue injuries, including knee injuries. However, no rigorous trials have been conducted. This study aims to examine whether sinew acupuncture can safely relieve pain and symptoms of knee osteoarthritis (KOA) and improve patients' functional movement and quality of life. METHODS/DESIGN: A randomized, sham-controlled, patient- and assessor-blinded trial will be conducted to compare the efficacy of sinew acupuncture and sham acupuncture. Subjects will be assessed by the physician and acupuncturists. A sample of eighty-six eligible subjects will be randomized into either the sinew acupuncture group or the sham acupuncture group. The intervention will be performed in the Hong Kong Tuberculosis Association Chinese Medicine Clinic cum Training Centre of the University of Hong Kong by acupuncturists with over 3 years of acupuncture experience. Subjects will receive 10 sessions of interventions for 4 weeks, followed by a 6-week follow-up. The visual analogue scale (VAS) score at week 4 will be the primary outcome. The Western Ontario and McMasters University Osteoarthritis Index (WOMAC), Timed Up & Go Test (TUG), 8-step Stair Climb Test (SCT) and the 36-Item Short Form Survey (SF-36) will be secondary outcomes. DISCUSSION: Sinew acupuncture is a potential alternative non-pharmacological therapy for KOA. This rigorous trial will expand our knowledge of whether sinew acupuncture reduces pain intensity and improves symptoms, functional movements, and quality of life of KOA patients. TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov (Identifier: NCT03099317) in March 2017.

Feasibility and acceptability of a proposed trial of acupuncture as an adjunct to lifestyle interventions for weight loss in Polycystic Ovary Syndrome: a qualitative study.

BACKGROUND: Polycystic Ovary Syndrome (PCOS) is a common female reproductive disorder with multiple manifestations. Weight management is a key therapeutic goal. Acupuncture is a potential adjunctive weight loss treatment in non-PCOS populations. We aimed to engage patients in co-design and assess the feasibility and acceptability of methods for a randomised controlled trial (RCT) on acupuncture and telephone-based health coaching for weight management in overweight or obese women with PCOS using qualitative methods. METHODS: We recruited women who had PCOS and were aged 18-45 years and with a body mass index of 25 kg/m2 and over, using social media. Two face-to-face focus group meetings and three semi-structured telephone interviews were conducted (n = 10). We analysed data using thematic analysis and aimed to compare and contrast motivations for joining the trial between women who were actively trying to conceive (n = 7) and not trying to conceive (n = 3). Attitudes to, knowledge and experiences of acupuncture; perceptions and attitudes towards the interventions in the RCT (real acupuncture, sham acupuncture and telephone-based health coaching); the outcomes of importance; and barriers and facilitators to successful trial recruitment and retention were collected. RESULTS: Women were both acupuncture-naive and acupuncture-experienced. Overall, attitudes towards acupuncture were positive, and the trial design was acceptable with appointment flexibility requested. Ideal enrolment time, if women were trying to conceive, was six months prior to conception. Women supported three-month intervention and the use of sham acupuncture as a control. Financial incentives were not believed to be necessary, and women spoke of altruistic intentions in enrolling for such a trial. Women who were trying to conceive voiced a need for support from their family, health coaches, and peers. The telephone-based health coaching offered welcome support and accountability, noted as possible facilitators of weight loss. CONCLUSIONS: Our findings show that acupuncture is a likely acceptable adjunct to lifestyle interventions for weight loss in PCOS, and that a sham-controlled trial is feasible and acceptable to PCOS women. Further research is required in order to evaluate the efficacy of acupuncture together with lifestyle for weight management in PCOS.

Brain structural properties predict psychologically mediated hypoalgesia in an 8-week sham acupuncture treatment for migraine.

Neuroimaging studies described brain structural changes that comprise the mechanisms underlying individual differences in migraine development and maintenance. However, whether such interindividual variability in migraine was observed in a pretreatment scan is a predisposition for subsequent hypoalgesia to placebo treatment that remains largely unclear. Using T1-weighted imaging, we investigated this issue in 50 healthy controls (HC) and 196 patients with migraine without aura (MO). An 8-week double-blinded, randomized, placebo-controlled acupuncture was used, and we only focused on the data from the sham acupuncture group. Eighty patients participated in an 8-weeks sham acupuncture treatment, and were subdivided (50% change in migraine days from baseline) into recovering (MOr) and persisting (MOp) patients. Optimized voxel-based morphometry (VBM) and functional connectivity analysis were performed to evaluate brain structural and functional changes. At baseline, MOp and MOr had similar migraine activity, anxiety and depression; reduced migraine days were accompanied by decreased anxiety in MOr. In our findings, the MOr group showed a smaller volume in the left medial prefrontal cortex (mPFC), and decreased mPFC-related functional connectivity was found in the default mode network. Additionally, the reduction in migraine days after placebo treatment was significantly associated with the baseline gray matter volume of the mPFC which could also predict post-treatment groups with high accuracy. It indicated that individual differences for the brain structure in the pain modulatory system at baseline served as a substrate on how an individual facilitated or diminished hypoalgesia responses to placebo treatment in migraineurs. Hum Brain Mapp 38:4386-4397, 2017. © 2017 Wiley Periodicals, Inc.

A New Method for Sham-Controlled Acupuncture in Experimental Visceral Pain - a Randomized, Single-Blinded Study.

OBJECTIVE: Acupuncture is increasingly used as an alternative to medical therapy for various pain conditions. To study the effect of acupuncture in experimental and clinical studies, a control condition with sham acupuncture is needed. However, as such models have not been established in assessment of acupunctures effect against visceral pain, this study aimed to validate a new method for blinded sham acupuncture in experimental rectal pain. METHODS: Fifteen subjects underwent a sequence of either sham or real acupuncture in randomized order. In the sham arm, a hollow inner tube with a sharp tip was fitted into an outer tube and subjects were blinded to the stimulations. Before and after the intervention, pain was induced by rectal stimulation with an inflatable balloon distended until the subjects' pain threshold was reached. The resting electroencephalogram (EEG) was quantified by spectral power analysis to explore the central nervous system effects objectively. Additionally, after the second study day, the subject was asked to indicate the sequence of interventions. RESULTS: A significant increase in rectal balloon volume was observed after sham 12 ± 21 mL (P = 0.049) and acupuncture 17 ± 30 mL (P = 0.046). However, the change in volume was not different between groups (P = 0.6). No differences in EEG spectral power distributions between sham and acupuncture were seen (all P > 0.6). The correct sequence of sham and acupuncture was indicated by 36% of the subjects (P = 0.4). CONCLUSIONS: The presented sham procedure provides a valid method for blinding of "sham acupuncture" and may be used in future blinded controlled trials of acupuncture for visceral pain.

Placebo response to sham electroacupuncture in patients with chronic functional constipation: A secondary analysis.

BACKGROUND: Chronic severe functional constipation is a common disease that requires novel and effective treatment strategies. Acupuncture might constitute a promising therapeutic approach for chronic constipation, but it reportedly engenders an enhanced placebo response. Herein, we aimed to determine the magnitude of the placebo responses to electroacupuncture for constipation and identify its influencing factors. METHODS: In this secondary analysis of a multicenter randomized trial, patients were randomized to a sham electroacupuncture group, which was administered for 8 weeks in 24 sessions of superficial needling at nonacupoints. The placebo response rates were assessed using three responder criteria: ≥3 complete spontaneous bowel movements per week (CSBMs/week), overall CSBM, and sustained CSBM. Logistic regression with backward selection method was employed to identify the potential factors that affected the placebo response. KEY RESULTS: Overall, 539 patients were included in the study. The placebo response rate was 10.58%, 9.46%, and 9.09% according to the three aforementioned criteria, respectively. Those who exhibited more CSBMs/week at baseline were more likely to respond to sham electroacupuncture. Among patients with more than one CSBM per week at baseline, the response rates for achieving the criteria of ≥3 CSBMs per week, overall CSBM, and sustained CSBM were 25.40%, 30.16%, and 22.22%. CONCLUSIONS AND INFERENCE: Electroacupuncture did not demonstrate a large placebo response in functional constipation treatment. The number of CSBMs at baseline may be a moderator of the placebo response to sham electroacupuncture. Thus, superficial needling sham acupuncture may be considered an ideal sham control for clinical trials of chronic constipation.

Analysis of placebo effect of acupuncture. / é’ˆåˆºå®‰æ °å‰‚æ•ˆåº”å‰–æž.

Acupuncture is a comprehensive therapy which takes the theory of traditional Chinese medicine as the core. Currently, there is much controversy surrounding the "placebo effect" of acupuncture： some people argue that acupuncture is a "super placebo", while others believe that the so-called placebo effect is just part of the therapeutic effect of acupuncture. To solve the controversy, this article clarified the definition, composition, and research purposes of "placebo acupuncture", pointed out its differences from "sham acupuncture", elucidated the relationship between the placebo effect and the intrinsic efficacy of acupuncture, distinguished the differences between the "observed placebo effect" and the "real placebo effect" in acupuncture clinical trials, and proposed the dilemmas and prospects of implementing "placebo acupuncture" and "sham acupuncture" contrasts at the current stage, in order to provide clues for optimizing randomized controlled trials of acupuncture.

Auricular Acupressure on Breast Pain Among Breastfeeding Mothers Receiving Gentle Hand Techniques: A Randomized, Single-Blind, Sham-Controlled Trial.

BACKGROUND: Auricular acupressure influences pain reduction in patients with diseases. However, study results on its influence on breast pain, common among breastfeeding mothers, are insufficient. RESEARCH AIM: This study aimed to explore the effectiveness of auricular acupressure on breast pain among breastfeeding mothers who also received a standard gentle hand technique. METHODS: This was a placebo-controlled study wherein auricular acupressure was provided for 4 weeks to 52 breastfeeding mothers consulting a local breastfeeding clinic. In the intervention group, auricular acupressure was applied to specific acupoints, including Shenmen, central rim, breast, and endocrine, which are related to breast pain and postpartum lactation. For the placebo control group, auricular acupressure was applied to acupoints not related to breast pain. The degree of breast pain was assessed using a numeric rating scale and a pressure algometer. RESULTS: After 4 weeks of auricular acupressure, numeric rating scale pain scores did not show a significant change. However, the pressure pain threshold for the upper left (Z = -2.202, p = .028) and upper right (t = 2.613, p = .012) areas of the right breast increased significantly in the intervention group. CONCLUSION: This study employed subjective and objective measurements to evaluate the efficacy of auricular acupressure in alleviating breast pain. The intervention shows potential as a nursing measure. Further research is required to determine the optimal intervention duration and frequency, particularly for breastfeeding parents with severe pain, and to evaluate long-term outcomes.

Discussion on Efficacy of intensive acupuncture versus sham acupuncture in knee osteoarthritis: a randomized controlled trial published in Arthritis & Rheumatology. / 对Arthritis & Rheumatology"å¼ºåŒ–é’ˆåˆºå¯¹æ¯”å‡é’ˆæ²»ç–—è†éª¨å ³èŠ‚ç‚Žéšæœºå¯¹ç §è¯•éªŒ"一文的讨论.

Professor LIU Cunzhi's team from Beijing University of Chinese Medicine published Efficacy of intensive acupuncture versus sham acupuncture in knee osteoarthritis: a randomized controlled trial in Arthritis & Rheumatology on November 10th, 2021, which demonstrates that three-session per week acupuncture is safe and effective for knee osteoarthritis patients. Experts from home and abroad discussed in depth the study design, acupuncture protocol, and interpretation of the results of the trial, emphasizing the importance of pretrial implementation, acupuncture dosage, reasonable setting of control group and assessing the efficacy of acupuncture, and pointed out that the mechanism of acupuncture for knee osteoarthritis still needs further study, and how to promote acupuncture for knee osteoarthritis according to the clinical practice abroad while ensuring the efficacy of acupuncture is worthwhile to explore.

Elastic acupuncture needle: a set of one-piece elastic double-blind placebo acupuncture. / Elasticé’ˆå ·ï¼šä¸€å¥—ä¸€ä½“å¼å¯å¼¹ç¼©åŒç›²å®‰æ °é’ˆ.

The Elastic acupuncture needle, a set of clinical device used in randomized controlled trials of acupuncture is developed, which may potentially obtain the double-blind placebo control. This kind of acupuncture device consists of a real needle and a sham one (placebo needle) with a identical appearance. Either of the needle is composed of an integrated cap-type handle and needle body, and a sterile double-sided adhesive pad is designed on the bottom for fixation. A spring with miniature low profile is built in sham needle. During operation, the real needle can be normally inserted, while the sham one be retracted because of the elasticity generated by the pressure on the skin, but deqi can still be felt by patients whenever the force difference between the skin and the spring reaches a certain balance. The rubber pad designed in this acupuncture needle can simulate the "resistance" felt by operators during needle insertion so that the double blinding is actualized in terms of the appearance and sensations.

The effect of sham acupuncture can differ depending on the points needled in knee osteoarthritis: A systematic review and network meta-analysis.

Objective: In sham acupuncture-controlled acupuncture clinical trials, although sham acupuncture techniques are different from those of verum acupuncture, the same acupuncture points are often used for verum and sham acupuncture, raising the question of whether sham acupuncture is an appropriate placebo. We aimed to examine the effects of sham and verum acupuncture according to the points needled (same or different between verum and sham acupuncture) in knee osteoarthritis. Methods: Ten databases were searched to find randomized controlled clinical trials (RCTs) assessing the effects of verum acupuncture with sham acupuncture or waiting lists on knee osteoarthritis. Sham acupuncture was classified as using the same acupuncture points as those in verum acupuncture (SATV) or using sham points (SATS). A frequentist network meta-analysis (NMA) was conducted, and the certainty of evidence was evaluated. Results: A total of 10 RCTs involving 1628 participants were included. Verum acupuncture was significantly superior to SATS but not different from SATV in terms of pain reduction. Additionally, SATV was significantly superior to the waiting list. For physical function, no difference were found between verum acupuncture, SATV, and SATS. The certainty of evidence was low to moderate. Conclusion: For knee osteoarthritis, the pain reduction effect of acupuncture may differ according to the needling points of sham acupuncture, and the control group should be established according to the specific aim of the study design and treatment mechanism.

Altered functional brain activity in first-episode major depressive disorder treated with electro-acupuncture: A resting-state functional magnetic resonance imaging study.

Background: Previous studies have found electroacupuncture could improve the clinical symptoms of first-episode major depressive disorder (MDD), but the exact neural mechanism of action needs to be further elucidated. Methods: Twenty-eight first-episode MDD patients were randomly divided into 14 electro-acupuncture stimulation (EAS) groups and 14 sham-acupuncture stimulation (SAS) groups, and clinical symptoms were assessed and functional magnetic resonance imaging (fMRI) scans were done in both groups. Amplitude of low-frequency fluctuations (ALFF) was used to observe the changes between the pre-treatment and post-treatment in the two groups, and the altered brain areas were selected as region of interest (ROI) to observe the FC changes. Meanwhile, the correlation between the altered clinical symptoms and the altered ALFF and FC of brain regions in the two groups was analyzed. Results: The EAS significantly decreased the HAMD-24 and HAMA-14 scores of MDD than SAS group. The imaging results revealed that both groups were able to increase the ALFF of the left middle temporal gyrus and the left cerebellar posterior lobe. When using the left middle temporal gyrus and the left posterior cerebellar lobe as ROIs, EAS group increased the FC between the left middle temporal gyrus with the left superior frontal gyrus, the left middle frontal gyrus, and the left hippocampus, and decreased the FC between the left posterior cerebellar lobe and the left calcarine gyrus, while SAS group only increased the FC between the left middle temporal gyrus with the left superior frontal gyrus. The alternations in clinical symptoms after EAS treatment were positively correlated with the altered ALFF values in the left middle temporal gyrus and the altered FC values in the left middle temporal gyrus and the left middle frontal gyrus. Conclusion: EA demonstrates modulation of functional activity in the default mode network (DMN), sensorimotor network (SMN), cognitive control network (CCN), limbic system, and visual network (VN) for the treatment of the first-episode MDD. Our findings contribute to the neuroimaging evidence for the efficacy of EAS.

Efficacy of the spirit-regulation method of Jin's three-needle therapy for post-stroke anxiety and its effect on the hypothalamus-pituitary-adrenal axis. / 靳三针调神针法治疗卒中后焦虑的疗效观察及对下丘脑-垂体-è‚¾ä¸Šè ºè½´çš„å½±å“.

OBJECTIVES: To observe the clinical efficacy of the spirit-regulation method of Jin's three-needle therapy on post-stroke anxiety and its effects on the hypothalamus-pituitary-adrenal (HPA) axis. METHODS: Fifty-four patients with post-stroke anxiety were divided into spirit regulation (Jin's three needle therapy) group and sham-acupuncture group according to the random number table method, 28 cases in the spirit regulation and 26 cases in the sham-acupuncture group. The patients of the two groups received the same regimen of basic medication and rehabilitation, and the same acupoint prescription was adopted, including Sishenzhen (extra points, 1.5 cun to Baihui ［GV20］ at 3, 6, 9 and 12 o'clock positions), Shenting (GV24), Yintang (EX-HN3), and bilateral Shenmen (HT7), Sanyinjiao (SP6), Hegu (LI4) and Taichong (LR3). The true acupuncture was delivered in the spirit regulation group and the sham acupuncture operated in the sham-acupuncture group. One treatment lasted for 30 min, once daily, 5 times a week. The duration of treatment was 3 weeks in the trial. Before treatment and on day 10 and day 21 of treatment, the changes in the score of Hamilton anxiety scale (HAMA) and that of National Institutes of Health Stroke Scale (NIHSS) were compared between the two groups separately. Using ELISA, the contents of adrenocorticotropin (ACTH) and cortisol (CORT) in the serum were detected, and the adverse reactions were recorded. RESULTS: In the within-group comparison before and after treatment, HAMA score and NIHSS score dropped on day 10 and day 21 after treatment in the spirit regulation group (P<0.05)；HAMA score and NIHSS score in the sham-acupuncture group were decreased on day 21 of treatment (P<0.05). After 21 days of treatment, HAMA score and NIHSS score in the spirit-regulation group were decreased significantly than those in the sham-acupuncture group (P<0.05) and the contents of ACTH and CORT in the serum decreased when compared with those before treatment and those of the sham-operation group (P<0.05). No obvious adverse events occurred in the spirit-regulation group and the sham-acupuncture group. CONCLUSIONS: Using sham acupuncture as a control, it is preliminarily confirmed that the spirit regulation method of Jin's three-needle therapy is effective on post-stroke anxiety. In association of the downtrend of serological indicators, it is speculated that the underlying mechanism of this therapy is related to HPA axis.

The effect and safety of acupuncture as adjunctive therapy for STEMI patients after PCI: study protocol of a randomized controlled trial.

BACKGROUND: ST-elevation myocardial infarction (STEMI) is a common acute ischemia heart disease that causes serious damage to human health worldwide. Even though morbidity and mortality have significantly decreased by percutaneous coronary intervention (PCI), an additional cardiac protection strategy is still required. Acupuncture therapy has presented a dominant cardiac protection in many studies lately. Thus, we aim to evaluate the effect and safety of acupuncture as an adjunctive therapy in STEMI patients after PCI through a randomized controlled trial. METHODS/DESIGN: This study describes a protocol of multicenter, double-blinded, parallel-controlled, randomized controlled trial. Ninety-six patients with STEMI aged 18-85 years who undergoing PCI will be recruited from the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, The Affiliated Third Hospital of Chengdu Traditional Chinese Medicine University/Chengdu Pidu District Hospital of Traditional Chinese Medicine, and Zhaotong Municipal Hospital of Traditional Chinese Medicine. Participants will be randomly assigned (1:1 ratio) to the verum acupuncture plus basic therapy (i.e., treatment) group or the sham acupuncture plus basic therapy (i.e., control) group. These participants will be treated for 5 days and then will be followed up for 24 weeks. Any adverse events will be recorded throughout the study to evaluate safety. DISCUSSION: The present study aims to investigate the effect and safety of acupuncture for patients with STEMI after PCI and set up standardized treatment programs for acupuncture of these patients. TRIAL REGISTRATION: This study was registered in the Chinese Clinical Trial Registry (Registration ID: [ChiCTR2400081117]), on February 22, 2024.

Placebo response of sham acupuncture in patients with primary dysmenorrhea: A meta-analysis.

BACKGROUND: The placebo response of sham acupuncture in patients with primary dysmenorrhea is a substantial factor associated with analgesia. However, the magnitude of the placebo response is unclear. OBJECTIVE: This meta-analysis assessed the effects of sham acupuncture in patients with primary dysmenorrhea and the factors contributing to these effects. SEARCH STRATEGY: PubMed, Embase, Web of Science, and Cochrane CENTRAL databases were searched from inception up to August 20, 2022. INCLUSION CRITERIA: Randomized controlled trials (RCTs) using sham acupuncture as a control for female patients of reproductive age with primary dysmenorrhea were included. DATA EXTRACTION AND ANALYSIS: Pain intensity, retrospective symptom scale, and health-related quality of life were outcome measures used in these trials. Placebo response was defined as the change in the outcome of interest from baseline to endpoint. We used standardized mean difference (SMD) to estimate the effect size of the placebo response. RESULTS: Thirteen RCTs were included. The pooled placebo response size for pain intensity was the largest (SMD = -0.99; 95% confidence interval [CI], -1.31 to -0.68), followed by the retrospective symptom scale (Total frequency rating score: SMD = -0.20; 95% CI, -0.80 to -0.39. Average severity score: SMD = -0.35; 95% CI, -0.90 to -0.20) and physical component of SF-36 (SMD = 0.27; 95% CI, -0.17 to 0.72). Studies using blunt-tip needles, single-center trials, studies with a low risk of bias, studies in which patients had a longer disease course, studies in which clinicians had < 5 years of experience, and trials conducted outside Asia were more likely to have a lower placebo response. CONCLUSION: Strong placebo response and some relative factors were found in patients with primary dysmenorrhea. PROSPERO registration number: CRD42022304215. Please cite this article as: Sun CY, Xiong ZY, Sun CY, Ma PH, Liu XY, Sun CY, Xin ZY, Liu BY, Liu CZ, Yan SY. Placebo response of sham acupuncture in patients with primary dysmenorrhea: A meta-analysis. J Integr Med. 2023; 21(5): 455-463.

Efficacy and safety of acupuncture treatment for fatigue after COVID-19 infection: study protocol for a pilot randomized sham-controlled trial.

Background: As the coronavirus disease 2019 (COVID-19) pandemic has spread globally, its sequelae, called Long COVID, have persisted, troubling patients worldwide. Although fatigue is known to be the most frequent among Long COVID symptoms, its mechanism and treatment have not been clearly demonstrated. In 2022, we conducted a preliminary prospective case series and found that acupuncture and moxibustion were feasible interventions for fatigue. This study is a pilot patient-assessor-blinded randomized sham-controlled trial to evaluate the efficacy and safety of acupuncture treatment for patients with fatigue that has persisted for at least 4 weeks after recovery from COVID-19. Methods: Thirty patients will be recruited and randomly assigned to either the acupuncture or sham acupuncture treatment groups. Treatment will be conducted thrice a week for both groups during 4 weeks. The primary outcome will be the efficacy and safety of acupuncture, including numeric rating scale (NRS), brief fatigue inventory (BFI), fatigue severity scale (FSS), and adverse event evaluation. Secondary outcomes will be evaluation of improvement in the comorbid symptoms of fatigue and feasibility variables. Outcome variables will be assessed before treatment, 4 weeks after treatment, and 8 weeks after treatment completion. Discussion: The results of this study will be used to clarify the efficacy and safety of acupuncture treatment for persistent fatigue in patients with Long COVID. Additionally, the feasibility of the study design was validated to provide evidence for future full-scale randomized controlled trials.Clinical trial registration: identifier: KCT0008656 https://cris.nih.go.kr/cris/search/detailSearch.do?seq=24785&search_page=L.