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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.

Background: Gyejibokryeong-hwan (GBH), a herbal mixture that is widely used for climacteric syndrome, is studied for its efficacy; however, no study evaluated the GBH indication, which is a blood-stasis pattern based on traditional Chinese medicine theory. Methods: This was a randomized, double-blinded, placebo-controlled clinical pilot trial. Fifty subjects with climacteric syndrome were recruited and randomly assigned to GBH group or placebo group. Subjects were administered GBH or placebo granules for 4 weeks followed by 4 weeks of observation period. For the primary outcome, the Menopause Rating Scale (MRS) was evaluated. For the secondary outcomes, quality of life, degrees of abdominal resistance and tenderness, blood-stasis pattern questionnaire and degree of upward movement of Qi were evaluated. Results: After 4-week intervention, the mean change of total MRS score significantly decreased in the GBH group compared to the placebo group (p = 0.037). The quality of life related to physical health (p = 0.008) and blood-stasis pattern (p = 0.018) significantly improved in the GBH group but not in the placebo group. Conclusion: Our findings provide evidence of the feasibility of recruiting subjects with GBH indications and show that GBH may have clinical efficacy for the treatment of menopausal symptoms, especially urogenital symptoms, without any significant adverse events. Trial registration: This trial was registered at Clinical Research Information Service (CRIS identifier: KCT0002040).

Background: The first treatment option for major depressive disorder (MDD) is antidepressants, however, there is substantial demand for alternative therapies due to its low compliance and remission rates. This study was aimed to explore the effectiveness, safety, and feasibility of electroacupuncture plus moxibustion therapy for MDD. Methods: Thirty adults with MDD were randomly assigned to the treatment group (TG) or control group (CG). The TG was treated with electroacupuncture plus moxibustion, and the CG received sham interventions at non-acupoints for 8 weeks. The primary outcome measure was the intergroup difference of the mean change of total score of the Hamilton rating scale for depression (HRSD) between baseline and week 9. Secondary outcome measures were Beck's depression inventory, insomnia severity index, the state-trait anxiety inventory, the EuroQol-5 dimension index, the measure yourself medical outcome profile version 2, and frontal alpha asymmetry measured by electroencephalography. Adverse events (AEs) were monitored for safety assessment. Results: The primary outcome measure was not significantly different between the two groups (p=0.2641), although the scores of HRSD in both groups improved significantly after treatment. No significant difference was identified between groups in secondary outcome measures. The incidence of AE was not significantly different between the two groups (p=0.1067). Conclusion: A clinical trial using electroacupuncture plus moxibustion for MDD seems feasible. However, further studies with the larger size, adopting ideal controls are warranted to provide a confirmative conclusion to the efficacy and safety of electroacupuncture plus moxibustion for MDD. Trial registration: The protocol was registered at Korean Clinical Trial Registry (CRIS-KCT0001810)

Background: The acupotomy is an acupuncture device recently used to stimulate lumbar vertebrae such as transverse processes (TPs) and facet joints (FJs). However, there are many organs, nerves, and blood vessels, which can lead to side effects if the needle misses the treatment target. Therefore, information regarding appropriate insertion depths, which is currently lacking, could facilitate its safe use. We retrospectively investigated the depth from the skin to the TP and FJ of the lumbar vertebrae, using magnetic resonance imaging (MRI). Methods: This retrospective chart review was conducted at a single medical centre in Korea. From 55,129 patient records, 158 subjects were selected. Perpendicular depth from the skin to the left and right TPs and FJs was measured using T1-weighted sagittal plane MRI. Depth differences between the left and right sides were evaluated using the paired t-test and analysis of covariance (body mass index [BMI] as a covariate). The influence of BMI on depth at each location was evaluated by simple linear regression analysis. Results: The mean age was 43.2 years and mean BMI was 23.6 kg/m2. The depth from skin to the TPs or FJs was unaffected by age, sex, or side. Mean depths (cm) were as follows: (TPs) L1 = 4.5, L2 = 4.9, L3 = 5.3, L4 = 5.7, L5 = 5.9; (FJs) L12 = 3.8, L23 = 4.0, L34 = 4.4, L45 = 4.6, L5S1 = 4.6. Depth was highly correlated with BMI at each location. Conclusion: The depth of TPs and FJs adjusted for BMI can safely and effectively be used for treatment via various invasive interventions, including acupotomy treatment, in the lumbar region.

Background: Danggwijagyaksan (DJS) has been one of the most widely used herbal medicines for gynecological disorders in traditional East Asian medicine. Several clinical studies about DJS have shown improvement in menopausal symptoms. This pilot study aimed to evaluate the efficacy, safety and feasibility of DJS for treating climacteric syndrome with a blood-deficiency-dominant pattern. Methods: This was a randomized, double-blind, placebo-controlled pilot trial. A group of 45-to 60-year-old women with climacteric syndrome were registered for the trial. The participants received treatment over a 4-week period and were then followed for 4 weeks. The primary outcome measure was the mean change in the Menopause Rating Scale (MRS). Secondary outcome measures included the World Health Organization Quality of Life-BREF (WHOQOL-BREF), the Blood-Deficiency Scoring System (BDSS), lean body mass, and serum hormone levels, including follicle-stimulating hormone (FSH) and estradiol (E2) levels. Results: The MRS and BDSS scores decreased significantly in both groups, but the differences between two groups were not significant. The WHOQOL-BREF scores increased in the control group. No statistically meaningful differences in serum hormone levels or lean body mass were observed in both groups. There were no serious adverse events, and the laboratory tests were within the normal range. The recruitment rate, completion rate and medication adherence rate were over 90% in both groups, indicating high feasibility. Conclusions: DJS showed clinical effectiveness in the treatment of climacteric syndrome with a blood-deficiency-dominant pattern. Additionally, DJS was shown to be safe and feasible for a large-scale study to confirm the efficacy of the treatment. Trial registration: Clinical Research Information Service (CRIS, https://cris.nih.go.kr): KCT0002387.

Background: The first treatment option for major depressive disorder (MDD) is antidepressants, however, there is substantial demand for alternative therapies due to its low compliance and remission rates. This study was aimed to explore the effectiveness, safety, and feasibility of electroacupuncture plus moxibustion therapy for MDD. Methods: Thirty adults with MDD were randomly assigned to the treatment group (TG) or control group (CG). The TG was treated with electroacupuncture plus moxibustion, and the CG received sham interventions at non-acupoints for 8 weeks. The primary outcome measure was the intergroup difference of the mean change of total score of the Hamilton rating scale for depression (HRSD) between baseline and week 9. Secondary outcome measures were Beck's depression inventory, insomnia severity index, the state-trait anxiety inventory, the EuroQol-5 dimension index, the measure yourself medical outcome profile version 2, and frontal alpha asymmetry measured by electroencephalography. Adverse events (AEs) were monitored for safety assessment. Results: The primary outcome measure was not significantly different between the two groups (p=0.2641), although the scores of HRSD in both groups improved significantly after treatment. No significant difference was identified between groups in secondary outcome measures. The incidence of AE was not significantly different between the two groups (p=0.1067). Conclusion: A clinical trial using electroacupuncture plus moxibustion for MDD seems feasible. However, further studies with the larger size, adopting ideal controls are warranted to provide a confirmative conclusion to the efficacy and safety of electroacupuncture plus moxibustion for MDD.

Background: Cognitive impairment is an age-dependent chronic disorder that exponentially worsens with age; however, its treatment is mostly symptomatic. Moxibustion is widely accepted in East Asia as a treatment for cognitive impairment. This systematic review aimed to verify the efficacy and underlying mechanism of moxibustion in treating cognitive impairment. Methods: Sixteen trials involving 324 animals obtained from MEDLINE (PubMed), EMBASE, the Cochrane library, the Chinese National Knowledge Infrastructure, Wan-Fang, Cqvip, the Korean Studies Information Service System, and the Oriental Medicine Advanced Searching Integrated System met the inclusion criteria. We extracted the results of behavioral tests and immunohistochemical biomarkers from the included articles and evaluated the risk of bias and reporting quality. Results: The moxibustion group showed significantly decreased escape latency, increased crossing times, and prolonged dwelling times in the Morris water maze test. There was a significantly enhanced latency period and reduced error time in the step-down test and nerve behavior score. The effects of moxibustion were found to be mediated by suppression of oxidative stress and apoptosis, modulation of inflammation and Aβ genesis activation of vascular endothelial growth factor, and adjustment of metabolites in the tricarboxylic acid cycle and fatty acid metabolism. Conclusion: Our results demonstrated the therapeutic efficacy of moxibustion on cognitive impairment and suggested the putative mechanism. However, considering the small number of included studies, high bias risk, low reporting quality, and the limitations of animal experimentation, our results need to be confirmed by more detailed studies.

Background: Dry eye syndrome is the most common complication of refractive surgery. Acupuncture is widely used for the treatment of ophthalmologic diseases, but to date, few have explored the effects of acupuncture for the treatment of this condition following refractive surgery. The objective of this study is to assess the feasibility of a study design for evaluating the effectiveness of acupuncture treatment along with usual care compared with usual care only for dry eye syndrome after refractive surgery. Methods: A total of 18 patients with dry eye syndrome occurring after refractive surgery participated in this study. For 4 weeks, the acupuncture plus usual care and usual care only groups received treatment three times a week. A series of assessments, namely the ocular surface disease index (OSDI), visual analog scale for ocular discomfort, quality of life, tear film break-up time, Schirmer 1 test, and fluorescein-stained corneal-surface photography, along with other general assessments were carried out. Results: Although preliminary, changes in OSDI from the baseline values were significantly different between the two groups at week 5 (p = 0.0003). There was a significant difference in the trends of OSDI changes between the acupuncture plus usual care and the usual care only groups (p = 0.0039). No serious adverse events were reported during the study. Conclusion: Four weeks of acupuncture treatment in addition to usual care is a feasible treatment for dry eye syndrome after refractive surgery. A full-scale randomized controlled trial is needed to confirm the clinical effectiveness of acupuncture.

Background: This study aims to review the current quantity and quality of case reports and case series published by clinical doctors who worked in local Korean medicine clinics. Methods: Seven electronic databases, one in English and six in Korean, were searched for case studies authored by clinically-based Korean Medicine doctors (KMDs) and published in academic journals between January 2000 and December 2018. The following data were extracted: the number of cases per article, authorship order, types of academic journals, the number of articles published in the domestic or international academic journals by publication year, citation counts, and classification of diseases. We assessed the quality of the reports based on 28 items from the CAse REport (CARE) checklist. Results: A total of 266 case reports or case series met the inclusion criteria. There were 125 articles (47.0%) in which all authors consist of who worked in Korean medicine clinics. The overall increase in the number of published articles by year showed a sharp increase after 2010. Articles were focused primarily on Korean medicine therapeutic and diagnostic approaches. The most commonly reported cases were diseases of the skin (346 or 40.9%). Overall, the quality of the reports was acceptable (75.3%) but several items such as diagnostic challenges, patient perspective, informed consent, intervention adherence and tolerability, and adverse events were substantially underreported. Conclusions: To improve disease diagnosis and treatment, KMDs in clinical practice should be encouraged to report and publish case studies, using the CARE checklist to ensure quality.

Background: Currently, there is no clearly established therapy to treat mild cognitive impairment (MCI); consequently, alternative therapies, such as acupuncture, have been attempted. In many clinical studies, the potential benefits of acupuncture for cognitive improvement have been identified in clinical outcomes; however, the mechanism remains unclear. Accordingly, this study aims to investigate the therapeutic mechanism of acupuncture therapy using functional near-infrared spectroscopy and its feasibility in treating individuals with impaired cognitive function., Methods: This study is designed to be a prospective, two-arm, parallel clinical trial involving 24 participants. The patient group will be treated with acupuncture twice per week for 12 weeks; meanwhile, the healthy control group will not undergo acupuncture treatment. Functional near-infrared spectroscopy assessment and a working memory test will be performed at baseline and every 6 weeks to investigate the therapeutic mechanism of acupuncture. The primary outcome will be measured using the Korean version of the Montreal Cognitive Assessment. The secondary outcomes will be the Alzheimer's Disease Assessment Scale-cognitive subscale score, working memory task accuracy, response rate, response time, and hemodynamic response of the prefrontal lobe. The outcomes will be evaluated at baseline, and at 6 and 12 weeks after subject allocation., Discussion: This clinical pilot trial is designed to determine the feasibility of acupuncture as an effective and safe treatment for improving cognitive function in patients with MCI. Results of this study may provide guidance for future larger-scale clinical trials., Trial Registration: Clinical Research Information Service (CRIS), Republic of Korea: KCT0002451. Registered September 5, 2017.