Objective Sham acupuncture control is essential for evaluating the specific efficacy of acupuncture. However, the complex nature of acupuncture components presents challenges in designing an inert sham acupuncture control while maintaining blinding. Currently, no standardized guidance exists for the design of sham acupuncture controls. This study aimed to propose guidelines for optimizing the design of sham acupuncture in randomized controlled trials. Methods The initial draft of the guidelines was developed through a literature review and expert interviews. The items in the guidelines were revised and finalized through consensus meetings. Results The resulting Recommendations for the DesIgn of sham acupuncture in RandomizEd Controlled Trials (the DIRECT guidelines) include issues to consider prior to adopting a sham acupuncture control, a five-stage framework for designing sham acupuncture, which addresses feasibility, risks, and recommendations for the implementation of sham acupuncture in clinical trials. Conclusion These guidelines offer practical recommendations for establishing appropriate sham acupuncture controls and optimizing their implementation in randomized controlled trials of acupuncture.Please cite this article as: Chen Y, Liu XY, Liu ZS, Guo Y, Zhou KH, Bian ZX, Wu M, Tian RH, Yang F, Zhang LY, Lu Y, Lao LX, He LY, Liu CZ, Liu BY, Yan SY. Recommendations for the DesIgn of sham acupuncture in RandomizEd Controlled Trials (the DIRECT guidelines). J Integr Med. 2026; Epub ahead of print.

Background:Depression is a detrimental mental disorder. Self-administered acupressure (SAA), a flexible self-help intervention, may be beneficial for relieving depression. Methods:A randomized controlled trial with cost-effectiveness analysis was conducted in a community setting in Hong Kong, China, between November 20, 2022, and August 19, 2024. Adults with moderate depression were randomized into SAA or mental health education (MHE) group. Participants in the SAA group underwent an acupressure training program (two 2-h sessions); they were told to practice SAA daily for 12 weeks. Participants in the MHE group received mental health education with the same schedule and duration. The primary outcome was the Patient Health Questionnaire-9 (PHQ-9) score over 12 weeks. This study was registered in ClinicalTrials.gov (#NCT05631184). Findings:A total of 250 participants (186 female [74.4%]; mean [SD] age, 41.86 [12.85] years; mean [SD] depression duration, 5.58 [6.86] years) were recruited. The SAA group (n = 125) showed a significantly greater reduction from baseline in the PHQ-9 score than the MHE group across all assessment time points (week 4: mean difference -1.04 [95% CI: -2.02 to -0.06], d = 0.26, P = 0.04; week 8: -1.25 [-2.39 to -0.11], d = 0.27, P = 0.03; week 12: -1.46 [-2.65 to -0.27], d = 0.31, P = 0.02). No serious adverse events were reported, although the adverse events may not have been adequately collected at all time points. Interpretation:Despite the clinically small effect sizes, the SAA training program is a potentially effective intervention for moderate depression. Funding:Health Medical Research Fund.

OBJECTIVE:Patients with ankylosing spondylitis (AS), who suffer from inflammatory back pain, spend about two times more on healthcare than the general population. However, current treatments are unsatisfactory. The aim of this single-armed pilot study was to assess the feasibility of using electroacupuncture (EA) to manage AS pain that is not adequately controlled by analgesics. We hypothesized that, after 6 weeks of treatment, at least 10% of the subjects would experience a 30% reduction in their pain severity numerical rating scale (NRS) score when compared to baseline. METHODS:Twenty AS subjects who were experiencing moderate to severe pain despite usual care were recruited between March 2016 and August 2017 in Hong Kong, with two patients ultimately dropping out. Semi-standardized EA was performed on the 20 subjects twice a week for 6-10 weeks. Outcome measures were mainly examined at baseline and at weeks 6, 10 and 18. These measures included: pain severity NRS, medication use, Bath ankylosing spondylitis functional index, Bath ankylosing spondylitis disease activity index, Bath ankylosing spondylitis global index, short-form 36, Bath ankylosing spondylitis metrology index, chest expansion, swollen and painful joint count, C-reactive protein and erythrocyte sedimentation rate. RESULTS:A one-sided exact binomial test showed that at least 10% of the subjects achieved a 30% pain reduction at week 6 (p = 0.002). CONCLUSION:AS pain was decreased after 6 weeks of EA treatment. However, a randomized controlled trial with an adequate sample size is needed to confirm this finding. TRIAL REGISTRATION NUMBER:NCT02697968 (ClinicalTrials.gov).

OBJECTIVE:To use functional MRI to assess the effect of acupuncture on brain resting-state functional connectivity in breast cancer patients with hot flashes. METHODS:A total of 24 breast cancer patients experiencing hot flashes (BC-HF) underwent 5 weeks of acupuncture treatment and follow-up at 4-6 months after therapy. The control groups included 35 patients with breast cancer without hot flashes (BC-NF) and 30 healthy controls respectively. Functional connectivity (FC) within the brain default mode network (DMN) was assessed using resting-state functional MRI at baseline and after treatment. The primary outcome was the change in the hot flash composite score (HFCS), and secondary outcomes included sleep quality and quality of life. RESULTS:Acupuncture significantly improved HFCS (-3.87; 95 % CI, -2.21 to -7.32; p < 0.001) and enhanced FC between the right temporal gyrus and angular area (p = 0.001) as well as the medial prefrontal cortex (p = 0.009). At 4-6 months follow-up, BC-HF group maintained 45.4 % improvement in hot flashes syndrome. No significant changes were observed in the sleep quality or quality of life. A strong correlation was found between increased FC and a reduction in HFCS only in a subgroup of patients who responded positively to acupuncture (r = 0.726, p = 0.001). CONCLUSIONS:This study provided the first evidence that acupuncture can enhance brain connectivity within the DMN and significantly alleviate the long-term clinical outcome of HF in breast cancer patients. These findings underscore the potential of acupuncture as a viable nonpharmacological option for managing vasomotor symptoms.

Acupuncture, a nonpharmacologic therapy, effectively reduced acute postconcussion symptom severity and alleviated long-term neurologic impairments in participants with mild traumatic brain injury.

Background:Acupuncture is widely practiced globally, with significant variations in the length and quality of clinical training across different countries and regions. Methods:This article examines the acupuncture program at the Virginia University of Integrative Medicine to illustrate typical training in the United States. It also compares acupuncture training in mainland China and Hong Kong. Results:By identifying the strengths and weaknesses of these programs, this study aims to propose strategies to enhance the quality of acupuncture education. Conclusion:It is essential for US acupuncture schools to collaborate closely with hospitals and medical schools to improve acupuncture education and training.

Background: Acupuncture and its related therapies, as an important part of traditional Chinese medicine, have been widely accepted by the public and healthcare professionals all over the world. According to previous reviews, the department of acupuncture is a potential place where nosocomial infection might occur. Objectives: To investigate the common pathogens and possible risk factors for nosocomial infection, figure out the measures and strategies for control and prevention, and provide general reporting guideline for future cases. Methods: A systematic literature search of 6 libraries (EMBASE, CINAHL, PubMed, VIP, CNKI, SinoMed) was carried out on nosocomial infection (NIs) after acupuncture and its related therapies (e.g., moxibustion, cupping, massage, dry needling) published from January 1, 2012 to August 31, 2023. Studies providing primary data were included; reviews, comments, and non-primary data studies were excluded to prevent duplicate case analysis. Data on bibliographic details, study characteristics, and clinical information were extracted. Results were synthesized through tabulation and categorized by therapy type, country income level, symptoms/diagnoses, pathogens, risk factors, treatments, and outcomes. Conclusion: Nosocomial infections after acupuncture and its related therapies are possible but preventable. Prevention measures can be carried out in terms of the risk factors listed above. Future case reports are suggested to provide specific details of infection, including the setting, qualification, treatment, disinfection, and causal evidence.

Background:The outbreak of coronavirus disease 2019(COVID-19)infection posed a huge threat and bur-den to public healthcare in late 2022.Non-drug measures of traditional Chinese medicine(TCM),such as acupuncture,cupping and moxibustion,are commonly used as adjuncts in China to help in severe cases,but their effects remain unclear. Objectives:To observe the clinical effect of TCM non-drug measures in improving respiratory function and symptoms among patients with severe COVID-19. Design,setting,participants and interventions:This study was designed as a multicenter,assessor-blind,randomized controlled trial.Hospitalized patients with COVID-19 were randomly assigned to the treat-ment or control group.The treatment group received individualized TCM non-drug measures in combi-nation with prone position ventilation,while the control group received prone position ventilation only for 5 consecutive days. Main outcome measures:The primary outcome measures were the percentage of patients with improved oxygen saturation(SpO2)at the end of the 5-day intervention,as well as changes of patients'respiratory rates.The secondary outcome measures included changes in SpO2 and total score on the self-made res-piratory symptom scale.The improvement rate,defined as a 3-day consecutive increase in SpO2,the duration of prone positioning,and adverse events were recorded as well. Results:Among the 198 patients included in the intention-to-treat analysis,159(80.3％)completed all assessments on day 5,and 39(19.7％)patients withdrew from the study.At the end of the intervention,71(91％)patients in the treatment group had SpO2 above 93％,while 61(75.3％)in the control group reached this level.The proportion of participant with improved SpO2 was significantly greater in the intervention group(mean difference[MD]=15.7;95％confidence interval[CI]:4.4,27.1;P=0.008). Compared to the baseline,with daily treatment there were significant daily decreases in respiratory rates in both groups,but no statistical differences between groups were found(all P ≥ 0.05).Compared to the control group,the respiratory-related symptoms score was lower among patients in the treatment group(MD=-1.7;95％CI:-2.8,-0.5;P=0.008)after day 3 of treatment.A gradual decrease in the total scores of both groups was also observed.Thirty-one adverse events occurred during the intervention,and 2 patients were transferred to the intensive care unit due to deterioration of their illness. Conclusion:TCM non-drug measures combined with prone positioning can effectively treat patients with severe COVID-19.The combined therapy significantly increased SpO2 and improved symptom scores compared to prone positioning alone,thus improving the patients'respiratory function to help them recover.However,the improvement rate did not differ between the two groups.

BACKGROUND:Diabetes leads to chronic kidney disease (CKD) and kidney failure, requiring dialysis or transplantation. Astragalus, a common herbal medicine and US pharmacopeia-registered food ingredient, is shown kidney protective by retrospective and preclinical data but with limited long-term prospective clinical evidence. This trial aimed to assess the effectiveness of astragalus on kidney function decline in macroalbuminuric diabetic CKD patients.METHODS:This randomized, assessor-blind, standard care-controlled, multi-center clinical trial randomly assigned 118 patients with estimated glomerular filtration rate (eGFR) of 30-90 ml/min/1.73m2 and urinary albumin-to-creatinine ratio (UACR) of 300-5000 mg/g from 7 public outpatient clinics and the community in Hong Kong between July 2018 and April 2022 to add-on oral astragalus granules (15 gs of raw herbs daily equivalent) or to continue standard care alone as control for 48 weeks. Primary outcomes were the slope of change of eGFR (used for sample size calculation) and UACR of the intention-to-treat population. Secondary outcomes included endpoint blood pressures, biochemistry, biomarkers, concomitant drug change and adverse events. (ClinicalTrials.gov: NCT03535935) RESULTS: During the 48-week period, the estimated difference in the slope of eGFR decline was 4.6 ml/min/1.73m2 per year (95 %CI: 1.5 to 7.6, p = 0.003) slower with astragalus. For UACR, the estimated inter-group proportional difference in the slope of change was insignificant (1.14, 95 %CI: 0.85 to 1.52, p = 0.392). 117 adverse events from 31 astragalus-treated patients and 41 standard care-controlled patients were documented. The 48-week endpoint systolic blood pressure was 7.9 mmHg lower (95 %CI: -12.9 to -2.8, p = 0.003) in the astragalus-treated patients. 113 (96 %) and 107 (91 %) patients had post-randomization and endpoint primary outcome measures, respectively.CONCLUSION:In patients with type 2 diabetes, stage 2 to 3 CKD and macroalbuminuria, add-on astragalus for 48 weeks further stabilized kidney function on top of standard care.

ImportanceThe effects of self-administered acupressure (SAA) on knee osteoarthritis (OA) pain remain unclear.ObjectiveTo evaluate the effectiveness of SAA taught via a short training course on reducing knee OA pain in middle-aged and older adults.Design, Setting, and ParticipantsThis randomized clinical trial was conducted among community-dwelling individuals in Hong Kong who were aged 50 years or older with probable knee OA from September 2019 to May 2022.InterventionsThe intervention included 2 training sessions for SAA with a brief knee health education (KHE) session, in which participants practiced acupressure twice daily for 12 weeks. The control group (KHE only) received only education about maintaining knee health on the same schedule and duration.Main Outcomes and MeasuresThe primary outcome was the numerical rating scale (NRS) pain score at 12 weeks. Other outcomes included Western Ontario and McMaster University Osteoarthritis Index, Short Form 6 Dimensions (SF-6D), Timed Up and Go, and Fast Gait Speed tests.ResultsA total of 314 participants (mean [SD] age, 62.7 [4.5] years; 246 [78.3%] female; mean [SD] knee pain duration, 7.3 [7.6] years) were randomized into intervention and KHE-only groups (each 157). At week 12, compared with the KHE-only group, the intervention group had a significantly greater reduction in NRS pain score (mean difference [MD], −0.54 points; 95% CI, −0.97 to −0.10 points; P = .02) and higher enhancement in SF-6D utility score (MD, 0.03 points; 95% CI, 0.003 to 0.01 points; P = .03) but did not have significant differences in other outcome measures. The cost-effectiveness acceptability curve demonstrated a greater than 90% probability that the intervention is cost-effective at a willingness to pay threshold of 1 GDP per capita.Conclusions and RelevanceIn this randomized clinical trial, SAA with a brief KHE program was efficacious and cost-effective in relieving knee pain and improving mobility in middle-aged and older adults with probable knee OA.Trial RegistrationClinicalTrials.gov Identifier: NCT04191837

The term "acupuncture" commonly refers to a non-pharmacologic therapy that is increasingly employed by diverse segments of the population for a wide variety of complaints including pain, insomnia, anxiety, depression, frozen shoulder, and other issues. The term is also used as a short-hand for the wider medical system from which the placement of needles into the skin for therapeutic benefit and related techniques evolved. Thus "acupuncture" refers both to the therapeutic technique and the therapeutic system of Acupuncture and Herbal Medicine (AHM). The other modalities included within AHM include a wide variety of physical and mechanical manipulations, herbal medicines, dietary recommendations, and lifestyle modifications. Clinically, acupuncture is increasingly offered in a variety of conventional medical settings such as hospitals, medical school clinics, veterans' healthcare centers, oncology facilities, and rehabilitation centers, and its safety profile is excellent overall. Barriers to further incorporation of acupuncture into biomedical sites include insurance coverage of acupuncture, education of conventional medical practitioners and other stakeholders about the utility, efficacy, and evidence base of acupuncture. Acupuncturists in the United States are skilled practitioners who are highly educated in the complex therapeutic system from which acupuncture arose and in the technical aspects of its utility as a treatment modality. The training, certification, licensure, and regulation of acupuncturists is similar to that of conventional providers such has physician's assistants, advanced practice nurses, and medical and osteopathic doctors. While clinical use and acceptance of acupuncture continues to grow, there is to date no definitive composite document explaining the utility of acupuncture in various healthcare settings, the current understanding of how acupuncture works, and the training, professional regulation, and certification of acupuncture practitioners. This article will address these topics and strive to create a reference for practitioners, administrators, legislators, insurance providers, patients and their families, and other stakeholders.

Insomnia is a highly prevalent symptom occurred during and post-chemotherapy. Acupuncture may have beneficial effects in the management of chemotherapy-associated insomnia. This study was conducted to determine the efficacy and safety of acupuncture in improving chemotherapy-associated insomnia in breast cancer patients. This assessor-participant blinded, randomized, sham-controlled trial was conducted from November 2019 to January 2022 (follow-up completed July 2022). Participants were referred by oncologists from two Hong Kong hospitals. Assessments and interventions were conducted at the outpatient clinic of School of Chinese Medicine, the University of Hong Kong. The 138 breast cancer patients with chemotherapy-associated insomnia were randomly assigned to receive either 15 sessions of active acupuncture regimen by combining needling into body acupoints and acupressure on auricular acupoints or sham acupuncture control (69 each) for 18 weeks, followed by 24 weeks of follow-up. The primary outcome was measured using Insomnia Severity Index (ISI). Secondary outcomes included the Pittsburgh Sleep Quality Index, Actiwatch and sleep diary for sleep parameters, depression and anxiety, fatigue and pain, and quality of life. There were 87.7 Clinicaltrials.gov : NCT04144309. Registered 30 October 2019.

BACKGROUND:Diabetes is the leading cause of CKD and kidney failure. We assessed the real-world effectiveness of Rehmannia-6-based Chinese medicine treatment, the most used Chinese medicine formulation, on the change in eGFR and albuminuria in patients with diabetes and CKD with severely increased albuminuria. METHODS:In this randomized, assessor-blind, standard care-controlled, parallel, multicenter trial, 148 adult patients from outpatient clinics with type 2 diabetes, an eGFR of 30-90 ml/min per 1.73 m 2 , and a urine albumin-to-creatinine ratio (UACR) of 300-5000 mg/g were randomized 1:1 to a 48-week add-on protocolized Chinese medicine treatment program (using Rehmannia-6-based formulations in the granule form taken orally) or standard care alone. Primary outcomes were the slope of change in eGFR and UACR between baseline and end point (48 weeks after randomization) in the intention-to-treat population. Secondary outcomes included safety and the change in biochemistry, biomarkers, and concomitant drug use. RESULTS:The mean age, eGFR, and UACR were 65 years, 56.7 ml/min per 1.73 m 2 , and 753 mg/g, respectively. Ninety-five percent ( n =141) of end point primary outcome measures were retrievable. For eGFR, the estimated slope of change was -2.0 (95% confidence interval [CI], -0.1 to -3.9) and -4.7 (95% CI, -2.9 to -6.5) ml/min per 1.73 m 2 in participants treated with add-on Chinese medicine or standard care alone, resulting in a 2.7 ml/min per 1.73 m 2 per year (95% CI, 0.1 to 5.3; P = 0.04) less decline with Chinese medicine. For UACR, the estimated proportion in the slope of change was 0.88 (95% CI, 0.75 to 1.02) and 0.99 (95% CI, 0.85 to 1.14) in participants treated with add-on Chinese medicine or standard care alone, respectively. The intergroup proportional difference (0.89, 11% slower increment in add-on Chinese medicine, 95% CI, 0.72 to 1.10; P = 0.28) did not reach statistical significance. Eighty-five adverse events were recorded from 50 participants (add-on Chinese medicine versus control: 22 [31%] versus 28 [36%]). CONCLUSIONS:Rehmannia-6-based Chinese medicine treatment stabilized eGFR on top of standard care alone after 48 weeks in patients with type 2 diabetes, stage 2-3 CKD, and severely increased albuminuria. CLINICAL TRIAL REGISTRY:Semi-individualized Chinese Medicine Treatment as an Adjuvant Management for Diabetic Nephropathy (SCHEMATIC), NCT02488252 .