Trials Of Acupuncture Research Articles

How is the quality of randomized controlled trials (RCTs) for acupuncture treatment of post-stroke aphasia? A report quality assessment.

This study aimed to assess the quality of randomized controlled trials (RCTs) that have reported the use of acupuncture for the treatment of post-stroke aphasia (PSA). We systematically searched PubMed, Embase, Cochrane Library, Web of Science, Chinese National Knowledge Infrastructure (CNKI), Wanfang data Information Site, and China Science and Technology Journal Database from January 2013 to June 2023. RCTs utilizing acupuncture as an intervention for the treatment of post-stroke aphasia were included in this study. The overall quality score (OQS) of RCTs was independently evaluated by two researchers using the Consolidated Standards for Reporting Trials (CONSORT) and the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) guidelines, with the agreement between researchers calculated using Cohen's kappa statistics. In conclusion, we included 38 RCTs in this study. The median OQS of the 38 RCTs was 13 (minimum 8, maximum 20) based on the CONSORT statement. Out of all CONSORT items, 10 (27%) had a positive rate of greater than 80%, while 17 (46%) had a positive rate of less than 10%. The median OQS of the 38 RCTs was 12 (minimum 6, maximum 14) based on the STRICTA guideline. Within the STRICTA guideline, 6 items (35%) had a positive rate of greater than 80%, and 3 items (18%) had a positive rate of less than 10%. Most items based on the CONSORT and STRICTA guidelines were observed to have a perfect or good degree of agreement. The overall reporting quality of RCTs for acupuncture treatment of PSA was found to be suboptimal. Notably, the reporting quality of the STRICTA guideline is higher compared to the CONSORT statement. Therefore, strict adherence to both the CONSORT and STRICTA statements is recommended to enhance the quality of RCT reports on acupuncture treatment for post-stroke aphasia.

Acupuncture combined with opioid for treatment of lung cancer-related pain: A systematic review and meta-analysis.

Many individuals diagnosed with lung cancer suffer from tremendous pain, and it is crucial to implement more effective measures to assist these patients in alleviating their pain. The present study utilizes a meta-analysis to evaluate the safety and efficacy of acupuncture combined with opioids for treating lung cancer-related pain in patients. We have searched 8 electronic databases: The Cochrane Library, PubMed, Embase, Web of Science, China National Knowledge Infrastructure, China Science and Technology Journal Database, Wanfang Database, and SinoMed. We included all randomized controlled trials of acupuncture combined with opioids for lung cancer-related pain in adults. We observed the main outcome indicators, including pain relief rates, numeric rating scale scores, and adverse events. Two researchers independently conducted literature screening, literature data extraction, and assessment of bias risk in the literature quality. Any disagreements were resolved through discussions between the 2 researchers or consultations with a third researcher. The risk of bias in the included studies was assessed using the revised risk of bias assessment tool. The overall quality of evidence for each outcome was evaluated using Grading of Recommendations, Assessment, Development and Evaluations. We retrieved 812 lung cancer patients from 11 trials. The study showed that compared to opioids alone, the combination of acupuncture and opioids significantly reduced numeric rating scale scores, increased pain relief rates, and decreased the occurrence of side effects. The current evidence indicates that combining acupuncture with opioid analgesics is superior to using opioid analgesics alone for managing lung cancer-related pain. Additionally, this combination therapy has fewer adverse reactions.

Moving the Needle on Acupuncture Trials

Moving the Needle on Acupuncture Trials

Overall Reporting Quality of Randomized Controlled Trials of Acupuncture for Knee Osteoarthritis: A Systematic Review.

To evaluate the reporting quality of randomized controlled trials (RCT) of acupuncture for knee osteoarthritis and explore factors associated with the reporting. Eight databases were searched from inception to August 2024 to assess the quality of acupuncture for knee osteoarthritis RCTs based on the CONSORT, the STRICTA, and the CONSORT-Outcomes. We performed regression analyses on pre-specified study characteristics to explore factors associated with reporting quality. One hundred and seventy-four RCTs were evaluated by 69 items from 3 checklists. Seventeen of 37 items on the CONSORT were under-reported (reported in less than 20% of RCTs), and the weakest reported item was why the trial ended or was stopped (0%). Four of 17 items on the STRICTA were under-reported, and the weakest reported item was the number of needle insertions per subject per session (9.2%). Eight of 17 items on the CONSORT-Outcomes were under-reported, and the weakest reported item was identifying any outcomes that were not pre-specified in a trial registry or trial protocol (0.6%). RCT locations include countries other than China, published in English, or funded were more likely to have better reporting. RCTs of acupuncture for knee osteoarthritis need to focus more on reporting details of acupuncture interventions, the reporting of protocol amendment, and the complete reporting of outcome-related content. Journals should encourage authors to adhere strictly to reporting guidelines, which is necessary to improve the quality of reporting, which is very important for Chinese journals.

Effects of Laser Acupuncture on Metabolic Functions of Sedentary People: A Double-Blind Randomized Clinical Trial.

Background: Laser acupuncture regulates energy flow and restores body fluid metabolism. Objective: To evaluate the effects of the laser acupuncture protocol (LAP) on hepatic and renal metabolism in sedentary people. Methods: Longitudinal, double-blind, and randomized clinical trial with 29 participants, adults, both sexes, sedentary, without pre-existing metabolic diseases, subdivided into control and laser groups. Based on the STandards for Reporting Interventions in Clinical Trials of Acupuncture 2010 guidelines, 10 laser applications (660 nm ±10 nm wavelength, 100 mW power. The irradiation tip has a diameter of 5 mm, which corresponds to an area of 0.19 cm2, totaling a power density of 0.52 W/cm2 and considering the irradiation time of 90 s, the energy density applied was 47.3 J/cm2) were performed on the acupoints of metabolic functions (LR3, SP6, ST36, and LI4) and blood samples were collected for fasting glycemia, lipid profile (HDL, LDL, total cholesterol, and triglycerides), liver function (AST/GOT and ALT/GPT), and renal function (serum creatinine and urea). A repeated measures analysis of variance (ANOVA) with Bonferroni corrected post hoc comparisons was applied to compare statistical differences between groups and times, adopting p < 0.05 as the null hypothesis. Results: The laser stimulated changes in serum lipid profile values and renal and hepatic functions. There was a significant (p = 0.014) reduction in LDL ("bad" cholesterol) from 105.75 ± 32.83 pre- to 84.32 ± 18.38 mg/dL postintervention, associated with cardioprotective function. Positive significant (p = 0.035) impacts were also observed in the reduction of creatinine (0.86 ± 0.12 mg/dL to 0.75 ± 0.12 mg/dL) and the enzyme AST/GOT (33.73 ± 12.95 U/L to 20.80 ± 4.99 U/L, p = 0.002). Conclusion: LAP applied to basal metabolism acupoints promoted positive metabolic changes in the lipid profile (LDL), and in main markers of the liver (AST/GOT) and kidney (creatinine) functions, contributing to risk control of cardiovascular diseases.

Analysis of status quo on the outcome indexes in randomized controlled trials of acupuncture for polycystic ovary syndrome

To analyze the application and status quo of the outcome indexes in randomized controlled trials (RCTs) of acupuncture for polycystic ovary syndrome (PCOS) so as to provide a favorable reference for the construction of the core outcome set. RCTs of acupuncture for PCOS were searched in databases, i. e. CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library and Web of Science, from January 1st, 2018 to June 28th, 2023. The relevant outcome indexes were extracted, collected and analyzed to collate the index domains of acupuncture for PCOS. A total of 60 articles were included, involving 123 outcome indexes. The outcome indexes of the physical and chemical detection were the highest in frequency (65.79%), followed by the symptoms/signs (23.37%), safety events (4.02%), TCM syndrome (3.10%), quality of life (1.86%) and the long-term prognosis (1.86%). None of the RCTs included the indexes for the economic evaluation. Regarding the status quo of outcome indexes, the primary outcome index was not distinguished from secondary one, the types of outcome indexes were various, the effect evaluation was not specified, and the assessment of quality of life and safety was ignored. The status quo of the outcome indexes in RCTs of acupuncture for PCOS is not conducive to pooling and comparing the data and the results among the different trials. It is recommended to structure the core outcome index set consistent with the therapeutic characteristics of TCM so as to improve the standardization of the clinical design of acupuncture and the quality of evidence in the trials.

Mapping knowledge domain of acupuncture for Parkinson's disease: a bibliometric and visual analysis.

This study points to probing the inclination and mapping knowledge domain of acupuncture for Parkinson's disease through bibliometrics. A search was conducted on 1 February 2024 using the Web of Science to identify papers published on acupuncture for Parkinson's disease. The analysis included scientific research, countries, organizations, authors/cited authors, keywords, journals, and cited references. Bibliometric data were analyzed using VOSviewer software, CiteSpace, GraphPad Prism, and Scimago Graphica. The studies on acupuncture for Parkinson's disease were visualized as a network map according to the publication year. The cumulative publication trend on acupuncture for Parkinson's disease is increasing year by year. China is the leading contributor in this field. International collaboration is predominantly concentrated in Europe, while institutional collaboration is chiefly limited to Chinese universities specializing in traditional Chinese medicine. Park HJ is the most prolific author, with "Movement Disorders" being the journal with the most publications. "Brain Research" is identified as a key journal, reflecting a focus on neuroscience. Kim SN is the most cited author, while Eisenberg DM is a prominent author in this field. Research topics such as mouse models, systematic reviews, and non-motor symptoms are frequently explored, with messenger RNA of substantia nigra emerging as a notable keyword in this field. Choi YG's 2009 paper, published in the Neuroscience Letters journal, is a critical reference in this field. Key papers include Eisenberg DM's 1998 study on randomized trials of acupuncture for non-motor symptoms of PD, as well as research focusing on the neuroinflammatory regulatory mechanisms of acupuncture for PD. The bibliometric analysis offers an exhaustive generality of the advancement and worldwide trends in acupuncture treatments for Parkinson's disease, shedding light on potential avenues for prospective research.

Analysis of placebo effect of acupuncture.

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.

Evaluation of the reporting quality of randomized controlled trials of acupuncture for depression based on CONSORT statement, STRICTA criteria and SHARE checklist

To evaluate the reporting quality of randomized controlled trials (RCTs) of acupuncture for depression. Systematic searches were performed in PubMed, the Cochrane Library, EMbase, CNKI, Wanfang, SinoMed and VIP Database for RCTs of acupuncture in treatment of depression. The search time was from the establishment of database to December 1, 2023, and the language restriction was Chinese and English. The reporting quality of RCTs of acupuncture for depression was evaluated using the CONSORT statement, the international standardization for trial reporting, STRICTA, the international standard for clinical trial interventions of acupuncture, and SHARE, the guideline and checklist for reporting sham acupuncture controls. According to the CONSORT statement items, the items with the reporting rate less than 50% was accounted for 54.05% of all of the items for Chinese articles, and there were 8 and 1 items with a reporting rate of 0% and 100%, respectively. For the English articles, the items with the reporting rate less than 50% was accounted for 35.14% of all of the items, and there were 3 and 7 items with a reporting rate of 0% and 100%, respectively. The reporting rate of 15 items in Chinese and English articles was greater than 50%, e.g. structured abstract, background and purpose. Based on STRICTA criteria, the reporting rate of either Chinese or English articles was relatively high. The items for Chinese articles with the reporting rate less than 50% was accounted for 23.53% of all of the items, and there were 1 and 4 items with a reporting rate of 0% and 100%, respectively. For English articles, the items with the reporting rate less than 50% was accounted for 11.76% of all of the items, and there was 1 item with a reporting rate of either 0% or 100%. In compliance with SHARE checklist, the reporting rate was low for either Chinese or English articles. The items with the reporting rate less than 50% was accounted for 57.89% of all of the items for Chinese articles, and there were 2 and 0 items with a reporting rate of 0% and 100%, respectively. For English articles, the items with the reporting rate less than 50% was accounted for 52.63% of all of the items, and there was 1 item with a reporting rate of 0% and 100%, respectively. The overall reporting quality of RCTs of acupuncture for depression is low currently. It is urgent to enhance the reporting of the details on sham acupuncture control especially. It is suggested that RCTs should be reported strictly in compliance with the CONSORT statement, STRICTA criteria, and SHARE checklist in the future.

Suboptimal reporting of randomized controlled trials on non-pharmacological therapies in Chinese medicine.

With the successive release of the CONSORT extensions for acupuncture, moxibustion, cupping, and Tuina/massage, this review aims to assess the reporting characteristics and quality of randomized controlled trials (RCTs) based on these specific guidelines. A comprehensive review was conducted by searching multiple databases, including Embase, Ovid MEDLINE(R), All EBM Reviews, AMED, CNKI, VIP Chinese Medical Journal Database, and Wanfang Data, for publications from January 1 to December 31, 2022. Two reviewers independently evaluated the eligibility of the records, extracted predetermined information, and assessed the reporting based on the STRICTA, STRICTOM, STRICTOC, and STRICTOTM checklists. Among the included 387 studies (acupuncture, 213; Tuina/massage, 85; moxibustion, 73; cupping, 16), the overall reporting compliance averaged 56.0%, with acupuncture leading at 62.6%, followed by cupping (60.2%), moxibustion (53.1%), and Tuina/massage (47.9%). About half of the evaluated items showed poor reporting (compliance rate < 65%). Notably, international journals demonstrated significantly higher reporting quality than Chinese journals (P < 0.05). Although acupuncture trials had relatively higher compliance rates, deficiencies persist in reporting non-pharmacological therapies of Chinese medicine, particularly in areas like treatment environment details and provider background information.

A randomized controlled trial of acupuncture and receptive music therapy for sleep disorders in the elderly—ELAMUS: study protocol

BackgroundGlobally, the demographic shift towards an aging population leads to significant challenges in healthcare systems, specifically due to an increasing incidence of multimorbidity resulting in polypharmacy among the elderly. Simultaneously, sleep disorders are a common complaint for elderly people. A treatment with pharmacological therapies often leads to side effects causing a high potential for dependency. Within this context, there is a high need to explore non-pharmacological therapeutic approaches. The purpose of this study is to evaluate the effectiveness of acupuncture and music therapy, both individually and combined as a multimodal therapy, in the treatment of sleep disorders in individuals aged 70 years and older.MethodsWe conduct a confirmatory randomized controlled trial using a two-factorial study design. A total of n = 100 elderly people receive evidence-based standard care information for age-related sleep disorders. Beyond that, patients are randomly assigned into four groups of n = 25 each to receive acupuncture, receptive music therapy with a monochord, multimodal therapy with both acupuncture and music therapy, or no further therapy. The study’s primary outcome measurement is the improvement in sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) (global score), at the end of intervention. Additionally, depression scores (Geriatric Depression Scale), health-related quality of life (Short-Form-Health Survey-12), neurovegetative activity measured via heart rate variability, and safety data are collected as secondary outcomes. Using a mixed-methods approach, a qualitative process evaluation will be conducted to complement the quantitative data.DiscussionThe study is ongoing and the last patient in is expected to be enrolled in April 2024. The results can provide valuable insights into the effectiveness of non-pharmacological interventions for sleep disorders among the elderly, contributing to a more personalized and holistic approach in geriatric healthcare.Trial registrationGerman Clinical Trials Register (DRKS00031886).

Acupuncture for the treatment of painful diabetic peripheral neuropathy: A systematic review and meta-analysis

Background and purposeA growing number of studies have investigated the efficacy of acupuncture in the treatment of painful diabetic peripheral neuropathy (PDPN), but the findings of these studies have generated conflicting results. This study therefore aimed to assess the efficacy of acupuncture for treating PDPN so as to offer more conclusive results. MethodsSeven databases were systematically searched for studies published up until December 1, 2023. All randomized controlled trials (RCTs) of acupuncture for PDPN with visual analog scale (VAS) for pain score were included. Study selection, data extraction, and evaluation were conducted independently by researchers. The Risk of Bias 2 (RoB2) tool was employed to assess the risk of bias. From this sample, the mean difference (MD), 95 % confidence intervals (CI), publication bias, and heterogeneity were then computed. ResultsThe manual acupuncture group exhibited a significant decrease in the VAS for pain score compared with the routine care group (p < 0.0001; MD = −1.45 [95 % CI, −1.97 to −0.93], I2 = 84 %). The real acupuncture group demonstrated a greater reduction in VAS scores than the sham acupuncture group (p = 0.004; MD = −0.97 [95 % CI, −1.63 to −0.31], I2 = 65 %). Additionally, the acupuncture group showed improvements in sensory nerve conduction velocity (SNCV, p < 0.0001; MD = 2.29 [95 % CI, 1.79 to 2.78], I2 = 14 %) as well as motor nerve conduction velocity (MNCV, p < 0.0001; MD = 2.87 [95 % CI, 2.46 to 3.27], I2 = 0). Different durations of acupuncture treatment, including 6–10 weeks and 3–4 weeks, demonstrated a significant reduction in VAS scores compared with the routine care group. ConclusionThis meta-analysis provides preliminary evidence for the claim that acupuncture has the potential to alleviate PDPN symptoms and improve SNCV and MNCV. However, high-quality RCTs are needed to offer further evidence and thus better substantiate such a contention.

Efficacy and safety of acupuncture for cognitive impairment in Alzheimer's disease: a systematic review and meta-analysis.

To systematically evaluate the efficacy of acupuncture in the treatment of cognitive impairment in Alzheimer's disease (AD) by meta-analysis, in order to provide evidence-based evidence for the application of acupuncture therapy in the clinical process of AD. From the establishment of the database to December 31, 2022, China Biomedical Literature Database (CBM), China National Knowledge Network (CNKI), VIP database, WanFang Database, Pubmed, Embase and Cochrane Library Database were systematically searched. To collect published randomized controlled clinical trials (RCTS) of acupuncture in the treatment of cognitive impairment in AD. The subjects in the intervention group were given acupuncture alone or combined with other treatments the same as the control group; the control group received conventional Western medicine treatment. The main outcome indicators of the study were cognitive function assessment of subjects, including: Simple Mental State Examination Scale (MMSE), Assessment of daily Living Ability Scale (ADL), Alzheimer's Disease Cognitive Function Assessment Scale (ADAS-Cog), TCM syndrome score (SDSD), Montreal Cognitive Test (MoCA), Secondary outcome indicators were the occurrence of adverse reactions. Literature screening, data extraction, and quality evaluation of the included literature were performed independently by two researchers, according to bias risk assessment tools recommended in the Cochrane manual. Data were analyzed by RevMan5.3 software. Dichotomous variables were represented by risk ratio (OR) and 95% CI, and continuity variables were represented by mean difference (MD) and 95% CI. For heterogeneity analysis, when P > 0.1 and I 2 ≤ 50%, fixed effect model was applied. When P ≤ 0.1 and I 2 > 50%, the random effects model is applied. A total of 1,172 eligible subjects were included in 18 RCTS, including 595 in the intervention group and 577 in the control group. The results of meta-analysis are as follows: acupuncture intervention group improved MMSE [MD = 1.67, 95% CI (0.94, 2.41), P < 0.00001], ADL [MD = -1.18, 95% CI (-3.09, 0.72), P = 0.22], ADAS-Cog [MD = 3.31, 95% CI (5.84, 0.78), P = 0.01], SDSD [MD = 2.40, 95% CI (3.53, 1.26), P < 0.0001], MoCA [MD = 4.80, 95% CI (3.74, 5.86), P = 0.04] were better than the control group. No serious adverse reactions related to acupuncture were observed in the intervention group, and the incidence and severity of adverse reactions were lower than those in the control group, with statistical significance [OR = 0.17, 95% CI (0.04, 0.67), P = 0.01]. Existing data show that acupuncture therapy has certain advantages in improving cognitive dysfunction and improving self-care ability of patients with Alzheimer's disease. However, due to the small number of RCTS and cases evaluating the efficacy of acupuncture, and the possibility of measurement bias and selectivity bias in included studies, it is still unable to conduct high-intensity demonstration on its effectiveness. Further large-scale, high-quality randomized, double-blind controlled trials are needed to evaluate its efficacy. https://inplasy.com/inplasy-2021-12-0125/, identifier: INPLASY2021120125.

Current Status of Research on the Treatment of Insomnia with Acupuncture

Insomnia is a non-organic sleep disorder that currently affects the quality of life of people around the globe, and has received widespread attention at home and abroad. Current treatments such as psychotherapy, medication, and physical therapy can improve patients' sleep quality, but they have drawbacks such as high price, drug resistance, and easy to damage the skin, whereas acupuncture has significant efficacy, few side effects, low price, and ease of use in the treatment of insomnia. Acupuncture is widely recognised in the treatment of insomnia, and research on different acupuncture therapies is increasing year by year. By searching the Chinese Journal Full Text Database (CNKI), Wanfang Database and PubMed Database, relevant clinical randomised controlled trials of acupuncture for insomnia in the past 6 years were included for generalisation and summary, aiming to provide clinicians with new ideas and methods for the treatment of insomnia.

Key issues in the STRICTA checklist.

The STRICTA checklist is the guideline for reporting clinical trials undertaken using acupuncture intervention. As an extension of the CONSORT checklist, the STRICTA checklist facilitates the reporting quality of acupuncture clinical trials. The clinical research paradigm changes along with the development of science and technology. It is crucial to ensure whether or not the existing STRICTA checklist guides the reporting clinical trials of acupuncture now and in the future as well. This paper introduces the development and the updating procedure of the STRICTA checklist, analyzes the characteristics of utility and the limitation, and proposes several suggestions on the difficulties and challenges encountered in the implementation of the STRICTA checklist of current version so as to advance the further update and improvement.

A randomized phase III clinical trial of acupuncture for chemotherapy-induced peripheral neuropathy treatment (ACT).

TPS12151 Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common and potentially dose-limiting side effect of neurotoxic chemotherapy among people who experience cancer, presenting pain, numbness, tingling, and motor weakness. CIPN worsens quality of life and disrupts active treatment regimens. Currently, duloxetine is the only ASCO-recommended painful CIPN treatment after chemotherapy completion. Still, it has undesirable side effects, i.e., fatigue, sleep disturbance, and digestive symptoms, posing a pressing need for well-tolerated, evidence-based interventions. Our pilot study demonstrated the feasibility and preliminary efficacy of acupuncture in relieving CIPN pain. Based on that, we developed the ACT trial to evaluate the effect of acupuncture on improving pain and other related symptoms among cancer survivors with CIPN pain. Methods: ACT is a prospective phase III multicenter, parallel two-arm randomized clinical trial at Dana-Farber Cancer Institute (DFCI) and Memorial Sloan Kettering Cancer Center (MSK) (ClinicalTrials.gov Identifier: NCT04917796). ACT aims to determine the efficacy of an eight-week electroacupuncture (EA) treatment vs. sham acupuncture (SA) on improving CIPN symptoms severity in cancer survivors. We plan to enroll 250 participants to detect an effect size of at least 0.45 for the primary pain outcome at 12 weeks post-randomization between EA vs. SA, with 80% power and a 1% Type I error rate, assuming a 10% loss to follow-up. Major eligibility criteria include 1) adults who have no evidence of disease or stable diseases, 2) who have completed neurotoxic chemotherapy such as platinum agents, taxanes, vinca alkaloids, and bortezomib at least three months before enrollment, and 3) who have a clinical diagnosis of CIPN with moderate to severe pain, defined as a score of at least four on the Brief Pain Inventory (BPI) average pain item. We randomly allocate participants to receive ten real or sham acupuncture treatments over eight weeks at two centers and their regional clinics. Aside from patient-reported outcome measures (i.e., BPI, Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity, EORTC Quality of Life Questionnaire-CIPN 20), we conduct quantitative sensory testing to assess changes in sensory function. The primary study endpoint is week 12, and the secondary study endpoint is week 24. Progress: 1) We are currently transitioning this trial to a multicenter trial, with DFCI being the coordinating center and MSK a subsite; 2) As of January 18, 2024, a total of 133 of the planned 250 participants have been enrolled; 3) The DSMB last reviewed the trial in December 2023, and suggested that the trial continue as planned at MSK. We anticipate initiating participant enrollment at DFCI in February 2024. Accrual completion is expected by December 2024. Clinical trial information: NCT04917796 .

Acupuncture for the Treatment of Diabetes Related Distal Sensory Neuropathy: A Review of Study Designs and Quality of Randomized Controlled Trials

Diabetes affects nearly every organ system in the body, including the peripheral nervous system, and leads to the development of distal sensory peripheral neuropathy (DSP) in roughly 50% of patients. Between 30% to 50% of patients with DSP experience pain and impaired quality of life. Dissatisfaction with currently available pharmacological treatments for neuropathic pain is common, primarily due to limited effectiveness and potential for adverse side effects. Acupuncture, a non-pharmacologic intervention, is often used in the management of chronic pain and is widely available and acceptable to many patients. In this narrative review, we describe clinical research related to acupuncture and diabetes related DSP management including meta-analyses, systematic reviews, and randomized controlled clinical trials (RCTs). Data from the few clinical trials available support the use of acupuncture to reduce neuropathic pain including DSP pain; however, available studies suffer from methodological weaknesses including inadequate blinding, sample size justification, lack of well-designed controls, and gaps in reporting. These limitations highlight a critical gap and an unmet need for more rigorous and robust clinical research requiring the use of Standards for Reporting Clinical Trials of Acupuncture (STRICTA) guidelines as a design, implementation, and reporting template.

Exploring the rules of related parameters in acupuncture for post-stroke dysphagia based on data mining

BackgroundPost-stroke dysphagia (PSD) affects the efficacy and safety of swallowing, causing serious complications. Acupuncture is a promising and cost-effective treatment for PSD; however, as the number of randomized controlled trials increases, scientific analysis of the parameters and acupoint prescription is required. Therefore, this study aimed to explore the effects of acupuncture on parameters related to post-stroke dysphagia (PSD).MethodsWe searched the Cochrane Library, PubMed, Embase, Web of Science, China National Knowledge Infrastructure, Wanfang Database, Chinese Biomedical Literature, and Chongqing VIP Database for randomized controlled trials of acupuncture for PSD in the last 15 years and relevant parameters were analyzed using data mining techniques.ResultsIn total, 3,205 records were identified, of which 3,507 patients with PSD were included in 39 studies. The comprehensive analysis demonstrated that the closest parameter combinations of acupuncture on PSD were 0.25 mm × 40 mm needle size, 30 min retention time, five treatments per week, and a 4-week total course of treatment. Additionally, the gallbladder and nontraditional meridians, crossing points, and head and neck sites are the most commonly used acupoint parameters. The core acupoints identified were GB20, RN23, EX-HN14, Gongxue, MS6, SJ17, EX-HN12, EX-HN13, and the commonly used combination of EX-HN12, EX-HN13, GB20, and RN23.ConclusionThis study analyzed the patterns of PSD-related needling and acupoint parameters to provide evidence-based guidelines for clinical acupuncturists in treating PSD, potentially benefitting affected patients.

Exploration of quantitative-effectiveness association between acupuncture temporal parameters and stable chronic obstructive pulmonary disease: A systematic review and dose-response meta-analysis of randomized controlled trials

IntroductionChronic Obstructive Pulmonary Disease (COPD) is a globally common chronic respiratory disease with a high morbidity and mortality rate. Acupuncture has been proven effective for COPD. A dose-response meta-analysis was conducted to assess the correlation between the acupuncture temporal parameters(session, frequency, and duration) and its effectiveness in patients with stable COPD. MethodsAcupuncture randomized controlled trials on COPD were searched in eight databases from their inception to June 2023. The "doses" were defined as the acupuncture session, frequency, and duration. The outcomes mainly included Forced Expiratory Volume in one-second rate (FEV1%) and Six-minute Walking Distance (6MWD). The assessment of bias risk and literature quality were conducted independently using the Cochrane risk of bias tool and the Standards for reporting interventions in clinical trials of acupuncture. The dose-response relationship was modeled using robust error element regression, and meta-analysis was operated by R 4.3.1 and Stata 15.0. The protocol was registered in PROSPERO with the registration number CRD42023401406. ResultOut of 1669 records, 17 RCTs with 1165 participants were finally included in the meta-analysis. There was notable heterogeneity among the studies, but sensitivity analysis demonstrated good robustness. The findings revealed a significant improvement in the following outcomes for stable COPD patients in the acupuncture group: FEV1% (MD=3.50, 95%CI: 2.05–4.95), 6MWD (MD=47.39, 95%CI: 29.29–65.50), St. George's respiratory questionnaire (SGRQ; MD=−8.25, 95%CI: −11.38 to −5.12); COPD assessment test (CAT; MD=−2.91, 95%CI: −3.99 to −1.83). The relationship between the acupuncture session, duration, and FEV1%, 6MWD followed a "Λ" curve pattern, while the relationship between acupuncture frequency and FEV1%, 6MWD exhibited logarithmic growth. Firstly, After 12 acupuncture sessions, FEV1% and 6MWD increased by 7.06% (95%CI: 4.56–9.55) and 36.28 m (95%CI: 20.37–52.20), respectively. The peak improvement in FEV1% and 6MWD was observed after 18 acupuncture sessions (MD=7.89, 95% CI: 5.33–10.45) and 45 sessions (MD=125.43, 95% CI: 72.80–178.07) each. Additionally, weekly acupuncture resulted in a 4.14% improvement in FEV1% (95% CI: 2.55–5.72) and a 42.49 m increase in 6MWD (95%CI: 17.16–67.81). Notably, the maximum effects on FEV1% and 6MWD improvement were achieved with different acupuncture frequencies, specifically three times a week (MD=6.00, 95% CI: 5.34–6.66) and once a day(MD=112.41, 95% CI: 77.27–147.56), respectively. Furthermore, after a 28-day duration of acupuncture treatment, FEV1% increased by 4.74% (95% CI: 3.73–5.75) and 6MWD increased by 47.34 m (95%CI: 22.01–72.67). During 60 days of acupuncture treatment, the FEV1% and 6MWD improvement reached their highest levels at 8.76% (95% CI: 7.05–10.47) and 88.06 m (95% CI: 45.96–130.16), respectively. ConclusionAcupuncture was effective in improving FEV1%, 6MWD, SGRQ, and CAT in patients with stable COPD. There was a dose-response relationship between the time parameters of acupuncture (session, frequency, and duration) and the efficacy of COPD treatment (FEV1% and 6MWD). The minimal clinically important difference could be achieved after 12 acupuncture sessions. Acupuncture with a medium-frequency (2–3 times per week) over 60 days may result in the greatest improvement in FEV1%, while higher-frequency acupuncture (5–7 times per week) for 2 months may lead to the maximum improvements in 6MWD. It indicated that the optimal acupuncture duration for different indicators remains consistent, while the optimal frequencies may differ. To confirm these results, it is necessary to conduct multicenter, large-scale randomized controlled trials. Ethics and disseminationEthical approval is not required for literature-based studies. The results will be published in peer-reviewed journals or conferences.

PRECIS-2 analysis of pragmatic acupuncture trials: a systematic review

BackgroundPragmatic acupuncture trials (PATs) are a research tool for assessing the effectiveness of acupuncture treatments in a real-world setting. This study aimed to provide a comprehensive methodological analysis of PATs using the PRECIS-2(PRagmatic Explanatory Continuum Indicator Summary-2) tool to determine their pragmatism.MethodsThe MEDLINE, EMBASE, Cochrane Central Register for Controlled Trials, CINAHL, Allied and Complementary Medicine Database, China National Knowledge Infrastructure, VIP, WANFANG, Taiwan Periodical Literature Database, KoreaMed, KMbase, Research Information Service System, Oriental Medicine Advanced Searching Integrated System, CiNii and ClinicalTrials.gov were searched. The search included randomised controlled trials (RCTs) and protocols of RCTs that investigated all types of acupuncture and used self-declared pragmatic design. Two authors independently collected the basic information and characteristics of the studies and assessed their pragmatism using the nine PRECIS-2 domains and the additional domain of control.ResultsA total of 93 studies were included. The means of eligibility, recruitment, organisation, primary outcome, primary analysis, and control domains were statistically larger than three and were shown to be pragmatic. The means of setting, flexibility:delivery, and follow-up domains were not greater than three and were shown to be non-pragmatic. For flexibility:adherence domain was inappropriate for assessment owing to insufficient information in the studies.ConclusionsPATs were pragmatic in the domain of eligibility, recruitment, organisation, primary outcome, primary analysis, and control and were not pragmatic in the domain of setting, flexibility:delivery, and follow-up. Future PATs need to strengthen the pragmatism in the setting, flexibility:delivery, and follow-up domains and to describe the flexibility:adherence domain in more detail.Trial registrationCRD42021236975.