We established a protocol for the traditional Korean medicine examination (KME) and methodically gathered data following this protocol. Potential indicators for KME were extracted through a literature review; the first KME protocol was developed based on three rounds of expert opinions. The first KME protocol’s feasibility was confirmed, and data were collected over four years from traditional Korean medicine (KM) hospitals, focusing on healthy adults, using the final KME protocol. A literature review identified 175 potential core indicators, condensed into 73 indicators after three rounds of expert consultation. The first KME protocol, which was categorized under questionnaires and medical examinations, was developed after the third round of expert opinions. A pilot study using the first KME protocol was conducted to ensure its validity, leading to modifications resulting in the development of the final KME protocol. Over four years, data were collected from six KM hospitals, focusing on healthy adults; we obtained a dataset comprising 11,036 healthy adults. This is the first protocol incorporating core indicators of KME in a quantitative form and systematically collecting data. Our protocol holds potential merit in evaluating predisposition to diseases or predicting diseases.

Background: This study was the development of a protocol for the comparison between the efficacy of non-pharmacological and pharmacological treatment approaches for lumbar disc herniation in a pragmatic environment to obtain real-world based study data.Methods: The protocol sets out a two-armed, parallel, multicenter pragmatic, randomized-controlled trial (RCT) which will be conducted in four spine specialist hospitals in Korea to determine cost-efficiency.Results: The study will enroll 36 participants and allocate patients into either the non-pharmacological treatment group or the pharmacological treatment group in a 1:2 ratio. Patients must have evidence of disc-related disease diagnosed using MRI, as well as having lower back pain or radiating leg pain (numeric rating scale score ≥ 5). The treatment will last for 8 weeks with a 26-week follow-up. The primary outcome will be measured using the Oswestry Disability Index score from Week 9. Secondary outcomes related to lower back pain and radiating leg pain will be measured using the scores from the numeric rating scale, the visual analogue scale, the European Quality of Life 5 Dimensions 5 Level Version), the 12-item Short Form Survey, and the patient global impression of change.Conclusion: This is the first protocol for a pragmatic RCT evaluating the efficacy, safety, and cost-efficiency of non-pharmacological and pharmacological treatment strategies in a clinical setting. Following the basis of this protocol, RCTs may play an important role in establishing guidelines for treating radiating leg pain and lower back pain and provide effective information to clinicians in practical settings.

Introduction: Chronic pruritus persists for > 6 weeks and is known to decrease patients’ quality of life. Due to the complex pathological mechanism of chronic pruritus, there is still a lack of satisfactory therapeutic agents; therefore, complementary therapies are required to improve itching symptoms. In the Republic of Korea, Sopoongsan, an herbal formula, has been used to treat itching, dizziness, and skin paralysis. To our knowledge, this is the first study to evaluate whether Sopoongsan improves chronic pruritus and to identify Sopoongsan-related changes in the immune response in patients with chronic upper body pruritus. Methods: A randomized, double-blind, placebo-controlled parallel trial will be conducted to assess 20 patients with chronic upper body pruritus for 3 months who have been diagnosed with allergic atopic dermatitis or seborrheic dermatitis. The patients will be randomly allocated to either the placebo-control (n = 10) or treatment (n = 10) group. The total study period will be 8 weeks (i.e., administration of Sopoongsan or placebo drugs for 4 wk and follow-up for 4 wk). Participants will be allowed to receive external treatment, except for antipruritic medications administered orally, throughout the study period. The primary outcome measure will be the numeric rating scale results for itching, whereas the secondary outcome measures will be questionnaire survey (Dermatological Life Quality Index and Epworth Sleepiness Scale) findings and the immune response index, including interferon gamma, interleukin-4, immunoglobulin E, thymic stromal lymphopoietic protein, and histamine, to investigate the biological mechanisms underlying chronic pruritus. Discussion and Conclusions: We expect that the results of this study will provide important clinical evidence regarding the effectiveness of Sopoongsan on itching symptoms, quality of life, sleep disturbance, and changes in the immune response. The findings will help elucidate the mechanism underlying the therapeutic effect of Sopoongsan for chronic pruritus and lay the foundation for further studies in this area.

Purumea Jun, HuiYan Zhao, Suk-Yun Kang, Chang-Hyun Han. Korean J Acupunct 2021;38:122-32. https://doi.org/10.14406/acu.2021.020

Soyoung Kim, Purumea Jun, Sanghun Lee. Korean J Acupunct 2024;41:68-78. https://doi.org/10.14406/acu.2024.010

Objectives: This randomized controlled trial evaluated the effects of acupuncture on oligomenorrhea in women with polycystic ovary syndrome (PCOS), and assessed its safety. Design: International, multicenter, parallel, two-arm randomized controlled trial. Setting: Three outpatient centers in China and the Republic of Korea. Participants: Women aged 20– 40 years diagnosed with PCOS (Rotterdam criteria) and oligomenorrhea (cycles > 35 days or < 8 episodes/year). Of 99 screened, 60 were enrolled and randomized (30/group); two control group participants were subsequently excluded from the full analysis set due to baseline misdiagnosis. Twenty-two (73.3%) in the acupuncture group and 25 (83.3%) in the control group completed the trial. Interventions: The acupuncture group received 40 sessions of manual acupuncture over 16 weeks at standardized acupoints, plus usual care (lifestyle advice). The control group received usual care alone. Primary and Secondary Outcome Measures: The primary outcome was the mean change in menstrual frequency (menstruations/month) from baseline to week 16. Secondary outcomes included menstrual cycle length, body mass index (BMI), hormonal profiles, and adverse events, and these were considered exploratory. Results: In the full analysis set (acupuncture, n=30; control, n=28), acupuncture significantly improved menstrual frequency vs control (mean difference: 0.20; 95% CI: 0.11 to 0.28; p=0.002). Significant improvements favoring acupuncture were also observed for menstrual cycle length (mean difference: − 19.69 days; 95% CI: − 29.42 to − 9.97; p< 0.001). No serious adverse events occurred. At week 32, the improvement in menstrual frequency was not sustained (mean difference: 0.14; 95% CI: − 0.06 to 0.34; p=0.646). Conclusions: Acupuncture was associated with short-term improvements in menstrual frequency and cycle length, with no serious adverse events reported, but these improvements were not sustained at week 32. Given the pilot nature of this study, these findings should be considered preliminary. Trial Registration: NCT04509817 (ClinicalTrials.gov).