Using the right design controls for acupuncture trials: Methodological rigor and validity in research.

Acupuncture treatment can be defined as a medical procedure with an acupuncture needle at acupoints. Establishing suitable control settings is essential, based on the target elements of the acupuncture therapy. In order to properly design a clinical trial or an experiment, a control group must be established. Here, we overview the significance of the control group and its limitations in acupuncture research. Clinical trials have employed a variety of study designs and controls for acupuncture treatment in order to compare the effects of actual treatments with control groups that include no treatment or treatment as usual, sham acupuncture at true acupoints, real acupuncture at non-acupoints, and sham acupuncture at non-acupoints. In order to determine the point-specificity of acupuncture, real acupuncture at non-acupoints should be taken into consideration, whereas sham acupuncture at the same true acupoints should be used to determine the needling-specific effect of acupuncture. It is crucial to choose the optimum control for acupuncture treatments depending on the study's main goal and to interpret the results in accordance with the research design.

Graded brain fMRI response to somatic and visual acupuncture stimulation.

Increased stimulation can enhance acupuncture clinical response; however, the impact of acupuncture stimulation as "dosage" has rarely been studied. Furthermore, acupuncture can include both somatic and visual components. We assessed both somatic and visual acupuncture dosage effects on sensory ratings and brain response. Twenty-four healthy participants received somatic (needle inserted, manually stimulated) and visual (needle video, no manual stimulation) acupuncture over the leg at three different dosage levels (control, low-dose, and high-dose) during functional magnetic resonance imaging (fMRI). Participants reported the perceived deqi sensation for each acupuncture dose level. Blood-oxygen-level dependent imaging data were analyzed by general linear model and multivariate pattern analysis. For both somatic and visual acupuncture, reported deqi sensation increased with increased dosage of acupuncture stimulation. Brain fMRI analysis demonstrated that higher dosage of somatic acupuncture produced greater brain responses in sensorimotor processing areas, including anterior and posterior insula and secondary somatosensory cortex. For visual acupuncture, higher dosage of stimulation produced greater brain responses in visual-processing areas, including the middle temporal visual areas (V5/MT+) and occipital cortex. Psychophysical and psychophysiological responses to both somatic and visual acupuncture were graded in response to higher doses. Our findings suggest that acupuncture response may be enhanced by the dosage of needling-specific and nonspecific components, represented by different neural mechanisms.

Acupuncture treatment for functional gastrointestinal disorders: Identification of major acupoints using network analysis.

Background: Using network analysis, we sought to determine the acupoints most commonly used to treat functional gastrointestinal disorders (FGIDs), particularly functional dyspepsia (FD) and irritable bowel syndrome (IBS). Methods: To explore the acupoint patterns used for FGID, data on acupoint combinations for FD and IBS were gathered from systematic reviews. Network analysis was used to determine the degree, closeness centrality, betweenness centrality, and eigenvector centrality of each acupoint. The most common acupoint combinations for FD and IBS were examined based on the eigenvector centrality. Results: Network analysis revealed that CV12, ST25, ST36, CV10, and LR3, which had the highest eigenvector centrality values, were the main acupoints for treating FGID. CV12 was the main acupoint for treating FD, while ST25 was the hub acupoint for treating IBS in the abdomen. ST36, LR3, and PC6 were the key peripheral acupoints for FD and IBS. Conclusions: Using network analysis, we provided data that will aid the selection of both general and specific acupoints for FD and IBS, along with spatial information (i.e., the positions of acupoints on a body map). These findings could be applied in future acupuncture research on therapy for gastrointestinal system dysfunction. They may also help bridge the gap between the traditional meridian theory, which assumes that there is a link between diseases/symptoms and the specific body region being treated, and real-world clinical evidence.

A prospective observational study of optimal acupoint selection on patients with functional gastrointestinal disorders.

INTRODUCTION: Functional gastrointestinal disorders (FGIDs), which include irritable bowel syndrome (IBS) and functional dyspepsia (FD), are common gastrointestinal (GI) diseases that have a large financial impact on patients' quality of life (QoL). Traditional Korean medicine has a particular diagnostic pattern for treating FGIDs. However, FGIDs have not been thoroughly explored because of their complexity. In this proposed study, we will investigate the acupoint selection pattern for FGID patients with various disease patterns, and further determine the best acupoints for treating FGID patients using a machine-learning algorithm. METHODS: We will collect clinical data from 15 multi-center Korean medical clinics that treat FGID as part of an observational study registry. Patients who meet the criteria will be added to the registry after screening. They will receive a maximum 4-week treatment, and they will respond 3 times to a series of questions. We will investigate how doctors of FGID patients with diverse disease patterns choose the acupoints, and we will use a machine learning technique to identify the best acupoints for treating FGID patients. DISCUSSION: This will be the first multi-center observational registry study to assess how traditional Korean medical practitioners diagnose and treat patients in the real world. The findings will shed light on how traditional Korean medicine treats FGIDs and demonstrate the rationale for the diagnostic and acupuncture treatment flow.

ACURATE: a Guide for Reporting Sham Controls in Trials Using Acupuncture.

This paper presents the Acupuncture Controls gUideline for Reporting humAn Trials and Experiments (ACURATE) checklist, an extension of The Consolidated Standards for Reporting of Trials (CONSORT), which is to be used with STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) when real and sham acupuncture needles are used in a study. This checklist focuses on a clear depiction of sham needling procedures to enhance replicability and enable a precise appraisal. We encourage researchers to use ACURATE in trials and reviews involving sham acupuncture to assist in the reporting of sham acupuncture procedures and related components.

ACURATE: A guide for reporting sham controls in trials using acupuncture.

This paper presents the Acupuncture Controls gUideline for Reporting humAn Trials and Experiments (ACURATE) checklist, an extension of The Consolidated Standards for Reporting of Trials (CONSORT) and to be used along with STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) when both real and sham acupuncture needles are used in the study. This checklist focuses on a clear depiction of sham needling procedures to enhance replicability and enable a precise appraisal. We encourage researchers to use ACURATE in trials and reviews involving sham acupuncture to assist reporting of sham acupuncture procedures and the related components.

ACURATE: A guide for reporting sham controls in trials using acupuncture.

OBJECTIVE: To promote better reporting quality regarding sham acupuncture in clinical trials for a precise appraisal of the adequacy of the sham acupuncture procedure. METHODS: A three-stage online Delphi survey was conducted to a group of experts. Items with higher than 80% consensus from the initial checklist were selected as the final candidates. Further discussion among the working group was convened to preclude potential redundancy among the items. RESULTS: A total of 23 experts out of 35 (66%) responded to the Delphi process. The final checklist consists of 23 items in six categories: type of sham acupuncture, details of sham acupuncture manipulation, location of sham acupuncture, treatment regimen, practitioner, and protocol and settings. CONCLUSION: This paper presents the Acupuncture Controls gUideline for Reporting humAn Trials and Experiments (ACURATE) checklist, an extension of The Consolidated Standards for Reporting of Trials (CONSORT) and to be used along with STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) when sham acupuncture needles are used in the study. This checklist focuses on a clear depiction of sham needling procedures to enhance replicability and enable a precise appraisal. We encourage researchers to use ACURATE in trials and reviews involving sham acupuncture to assist reporting sham acupuncture procedures and the related components.

Acupuncture and Acupoints for Low Back Pain: Systematic Review and Meta-Analysis.

Acupuncture has been used as a therapeutic intervention for the treatment of numerous diseases and symptoms for thousands of years, and low back pain has been studied and treated the most in acupuncture clinics. Traditional theory strongly suggests that the selection of acupoints will influence their clinical effects and combinations (e.g., the clinical effects of a particular acupoint or combination on reducing pain), but this idea was not considered in earlier systematic reviews and meta-analyses. We performed a systematic review, meta-analysis, and network analysis to evaluate the magnitude of the effects of acupoints used to treat low back pain in randomized controlled clinical trials. We found that acupuncture significantly reduced pain in patients with low back pain compared with the control group. The most frequently prescribed acupoints were BL23, GV3, BL20, BL40, and BL25, whereas the acupoints with the highest average effect size scores were BL20, GV3, GB30, GB34, and BL25. Further, the combinations of BL23-BL40, BL23-B25, and BL23-BL60 were the most frequently prescribed, while BL23-GV3, BL40-GV4, and BL23-BL25 showed the largest average effect size. By calculating clinical outcomes based on average effect sizes, we found that the most popular acupoints might not always be associated with the best results. Although a more thorough investigation is necessary to determine the clinical effects of each acupoint and combination on patients, we suggest that our approach may offer a fresh perspective that will be useful for future research.

Comparison of the acupuncture manipulation properties of traditional East Asian medicine and Western medical acupuncture.

Background: Acupuncture treatments frequently use manipulation techniques. The therapeutic advantages of acupuncture differ depending on the acupuncture manipulation. The purpose of this article was to compare manipulation techniques in traditional East Asian medicine (TEAM) and Western medical acupuncture (WMA). Methods: Manipulation techniques in TEAM and WMA were compared according to purpose, modulating parameters, and indications. The practical understanding of manipulation in terms of acupuncture stimulation intensity was also explored. The TEAM manipulation techniques of twirling and lifting and thrusting are discussed in terms of the objectives of tonification and sedation. Results: The main therapeutic effect of WMA is mediated through activation of the nervous system, which is achieved with adequate intensity of needling. The TEAM tonification and sedation techniques were designed to produce mild or intense stimulation, respectively, to elicit varying degrees of deqi sensation. Conclusions: Further research is needed to clarify the differences between the TEAM and WMA practices, and to determine whether different needling manipulations affect treatment outcomes.

The role of visual expectations in acupuncture analgesia: A quantitative electroencephalography study.

Acupuncture is a complex treatment comprising multisensory stimulation, including visual and tactile sensations and experiences of body ownership. The purpose of this study was to investigate the role of these three components of acupuncture stimulation in acupuncture analgesia. 40 healthy volunteers participated in the study and received acupuncture treatment under three different conditions (real-hand, rubber-hand synchronous, and rubber-hand asynchronous). The tolerance for heat pain stimuli was measured before and after treatment. Brain oscillation changes were also measured using electroencephalography (EEG). The pain tolerance was significantly increased after acupuncture treatment under all three conditions. Noticeable deqi (needle) sensations in response to acupuncture stimulation of the rubber hand were found under both rubber-hand synchronous and rubber-hand asynchronous conditions. Deqi sensations were significantly correlated with acupuncture analgesia only under the rubber-hand synchronous condition. Increased delta and decreased theta, alpha, beta, and gamma waves were observed after acupuncture treatment under all three conditions. Our findings clarified the role of cognitive components of acupuncture treatment in acupuncture analgesia through the rubber-hand illusion. This study is a first step toward separating various components of acupuncture analgesia, i.e. visual, tactile, and body ownership, and utilizing those components to maximize analgesic effects.

Exploring Acupuncture Actions in the Body and Brain.

Acupuncture's actions have been explained by biomedical research. However, the meridian system used in acupuncture needs further clarification. This review describes how acupuncture affects the body and brain. From the perspective of traditional East Asian medicine, the meridian system is closely connected with acupuncture's treatment effects. In the body, the indications of acupoints, primarily established based on the meridian system, have spatial symptom patterns. Spatial patterns of acupoint indications are distant from the stimulated sites and strongly associated with the corresponding meridian's route. Understanding how acupuncture works based on the original meridian system is important. From a neuroscience perspective, an acupuncture-induced sensation originates from the bottom-up action of simple needling in the peripheral receptor and the reciprocal interaction with top-down brain modulation. In the brain, enhanced bodily attention triggered by acupuncture stimulation can activate the salience network and deactivate the default mode network regardless of the actual stimulation. The application of data science technology to acupuncture research may provide new tools to uncover the principles of acupoint selection and enhance the clinical efficacy of acupuncture treatment in various diseases.

Diachronic analysis of major acupoints used in ancient and current acupuncture treatments: Changes in main acupoints over time.

Background: Over time, a large body of knowledge on acupoint selection patterns has accumulated. This study compared the main acupoint selection patterns between ancient and current acupuncture treatments. Methods: Data on the 10 most frequently used acupoints were obtained from a current medical database, the Cochrane Database of Systematic Reviews, and the ancient medical text Donguibogam. Network analysis was used to identify the most commonly used major points across various diseases. Results: The most commonly used acupoints in both ancient and current acupuncture were ST36, SP6, LR3, LI4, and GV20. Acupoints CV3, CV4, CV6, CV8, and CV12 were more widely used in ancient acupuncture, while in current acupuncture, HT7, PC6, KI3, GB34, and EX-HN3 were more prevalent. Conclusions: Ancient and current acupuncture practice had similar and distinct acupoint selection patterns. Diachronic analysis sheds light on how patterns of acupoint selection have changed.

Reporting quality of sham needles used as controls in acupuncture trials: a methodological evaluation.

OBJECTIVE: The description of controls is important in acupuncture clinical trials to interpret its effectiveness without fallacy. This paper aims to evaluate the reporting quality of acupuncture studies on the characteristics of sham needles. STUDY DESIGN AND SETTING: Using a checklist developed from previously published reporting guidelines, the distribution of reported items and changes of reporting rates over time were investigated. Two-way ANOVA and linear regression were conducted. RESULTS: Original articles of RCTs of any design involving sham needles as controls were eligible for assessment. 117 trials from three 2-year time periods between 2009 and 2018 were included. Seven items out of 25 were reported in more than 50% of the studies. While significant differences of reporting scores among categories were observed, there were no significant differences among time periods; no significant improvement was observed over time. CONCLUSIONS: Low reporting qualities of sham needles used in acupuncture studies may influence how researchers understand the effectiveness of acupuncture. This study evaluated previous publications from 2009 to 2018 and found that reporting qualities on sham needles did not improve over time. Further studies are required to validate the items used in this study to endorse better reporting of controls in acupuncture trials.

Identifying Dose Components of Manual Acupuncture to Determine the Dose-Response Relationship of Acupuncture Treatment: A Systematic Review.

The dose-response relationship is a hallmark of pharmacological studies. However, this relationship has not been fully established in acupuncture research. This systematic review aims to provide the characteristics of the dose-response relationship in acupuncture research. We further summarized the differences in acupuncture effects according to dose components. Dose components of acupuncture were categorized into three groups: number of needles, stimulation intensity, and total number/frequency of treatments. The PubMed database was used to identify studies examining the effects of different doses of acupuncture from the establishment of the database to August 13, 2020. Dose components and responses were extracted from each study, and the results of low- and high-dose conditions were compared. Fourteen studies were included in this study. Of the included studies, 37.5% showed statistically significant enhanced responses to acupuncture treatment under high-dose conditions compared to low-dose conditions. Significant differences between high- and low-dose conditions were observed most frequently in studies that used various stimulation intensities (four out of six studies), followed in order by studies that used various numbers of needles (two out of seven studies), and those that used various numbers or frequencies of treatment (none of the three studies). Responses were categorized into symptom changes, physiological changes, experimentally induced pain/stimuli perception, and needling sensation. Stimulation intensity, which is considered one of the most important needling components, might indeed have a great impact on clinical responses to acupuncture.

Open-Label Placebo Treatment for Experimental Pain: A Randomized-Controlled Trial with Placebo Acupuncture and Placebo Pills.

Objective: An open-label placebo (OLP) is a placebo treatment in which the patient is aware that the treatment is a placebo. OLPs are considered effective for reducing pain, and previous studies have shown a stronger placebo effect for placebo acupuncture than for placebo pills. In this study, the authors compared the analgesic effects of OLP pills, OLP acupuncture, and a no treatment condition in healthy participants, and then examined the factors contributing to the OLP effect. Design: Randomized controlled crossover trial. Settings/Location: College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea. Subjects: 34 healthy participants. Intervention: Participants received three different treatments ("OLP-pill," "OLP-acupuncture," and "no treatment") on three separate days in random order. Outcome Measurements: Before and after the treatment, heat pain stimuli were applied to the participants' hands, and pain tolerance, intensity, and unpleasantness were measured using a visual analog scale (range, 0-10). Results: Data of 31 participants were included in the analysis. The authors found significant analgesic effects of the placebo pill and placebo acupuncture in the OLP condition. Regression analyses revealed that expectations regarding treatment and practitioner identity influenced the analgesic effects of OLP acupuncture. There was no adverse event. Conclusions: Expectations regarding treatment and practitioner identity influenced the analgesic effect of placebo acupuncture without deception. These findings provide new information regarding the cognitive factors underlying pharmacologic and nonpharmacologic treatments. Clinical Trial Registration Number: KCT0004928.

Special Issue: State of the Art in Research on Acupuncture Treatment.

Acupuncture is a medical treatment that involves inserting a needle into the body [...].

Effect of acupuncture treatment in patients with mild to moderate atopic dermatitis: a randomized, participant- and assessor-blind sham-controlled trial.

BACKGROUND: Atopic dermatitis (AD) is a chronic recurrent inflammatory skin disease that affects 1-3% of adults worldwide. Currently, it is not possible to completely cure AD; therefore, alternative treatments need to be developed to meet the patients' needs. Here, based on our previous pilot study, we conducted the first confirmatory randomized controlled trial to evaluate the effect of acupuncture in patients with mild to moderate AD. METHODS: A randomized, participant- and assessor-blinded, sham-controlled trial was designed with an intervention period twice-weekly for 4 weeks and a 4-week follow-up. We equally allocated 36 participants to the verum acupuncture (VA) and sham acupuncture (SA) groups. The main outcome measure was the change in SCORing Atopic Dermatitis index (SCORAD) score before and after treatment. RESULTS: A total of 36 participants, aged 19 to 38 years, were enrolled, and 35 were included in the intention-to-treat analyses. The mean change in total SCORAD score differed significantly among the two groups at 4 weeks after randomization (P < .0001): the mean difference was - 11.83 (7.05) in the VA group and 0.45 (7.77) in the SA group. The mean SCORAD score substantially decreased 2-weeks after starting the acupuncture treatment and continued to improve for at least 4 weeks after the end of the treatment in the VA group compared to the SA group (each P < .0001). No serious adverse events were observed. CONCLUSIONS: Twice-weekly acupuncture treatment was effective in reducing AD symptoms in patients with mild to moderate AD without serious adverse events. TRIAL REGISTRATION: Clinical Research Information Service Identifier: KCT0002796 .