The effects of music therapy on labor pain, childbirth experience, and self-esteem during epidural labor analgesia in primiparas: a non-randomized experimental study.

PURPOSE: This non-randomized study was performed to evaluate the effects of music therapy on labor pain, the childbirth experience, and self-esteem in women during vaginal delivery. METHODS: In total, 136 primiparous women over 37 weeks of gestation receiving epidural analgesia during vaginal delivery were recruited via convenience sampling. To minimize diffusion effects, data from the control group (n=71) were collected first (April 2020 to March 2021), followed by data from the music group (n=65; April 2021 to May 2022). Participants in the music group listened to classical music during labor, while the control group was offered usual care (no music). Labor pain was measured using a numeric rating scale (NRS), and self-esteem and childbirth experience were collected using self-report questionnaires. Data were analyzed using the independent t-test, chi-square test and Cronbach's α coefficients. RESULTS: The overall pain level (NRS) at baseline was 0 in both groups. Mothers in the music therapy group had lower levels of latent pain (t=1.95, p=.005), active pain (t=3.69, p<.001) and transition-phase pain (t=7.07, p<.001) than the control group. A significant difference was observed between the two groups, and the music therapy group expressed more positive perceptions of the childbirth experience (t=-1.36, p=.018). For self-esteem, the experimental group's score was slightly higher, but without a statistically significant difference from the control group. CONCLUSION: Using music therapy during labor decreased labor pain and improved the childbirth experience. Music therapy can be clinically recommended as a non-pharmacological, safe, and easy method for nursing care in labor. Clinical trail number: KCT008561.

Effects of herbal medicine (Danggwijagyaksan) for treating climacteric syndrome with a blood-deficiency-dominant pattern: A randomized, double-blind, placebo-controlled pilot trial.

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.

Effects of dangguijakyaksan on lower-extremity blood circulation disturbances in climacteric and postmenopausal women: Study protocol for a randomized, double-blind, placebo-controlled pilot trial.

BACKGROUND: Climacteric women experience various disorders, including hot flush, depression, insomnia, arthralgia, and hand and foot numbness. Dangguijakyaksan is among the most common treatments for climacteric syndrome, and its effect on depression, insomnia, hot flush and quality of life (QOL) in climacteric women has been reported multiple times. A recent animal study found dangguijakyaksan decreased serum lipid factors and improved blood circulation in a menopausal rat model; however, these effects have not been assessed in clinical trials. This study aims to assess the clinical effects and safety of dangguijakyaksan for lower-extremity blood circulation disturbances in climacteric women. METHODS: This is a single-center, randomized, double-blinded, placebo-controlled pilot study that will be conducted at Dunsan Korean Medicine Hospital at Daejeon University. Forty-six climacteric women with lower-extremity blood circulation disturbances will be recruited and randomized (1:1) into either the dangguijakyaksan or placebo group. After 8 weeks of administration, the effects and safety of dangguijakyaksan will be assessed.The primary outcome is the visual analogue scale for lower-extremity blood circulation disturbances, and it will be assessed on visits 1, 2, and 3. The secondary outcomes, Kupperman's index and blood deficiency scoring system, will be assessed on visits 1, 2, and 3, and accelerated photoplethysmography and digital infrared thermal imaging will be performed on visits 1 and 3. Moreover, blood lipid profile, follicle-stimulating hormone, and estradiol levels will be measured at the screening visit and visit 3. Blood tests will be performed at the screening visit and visit 3 to assess the safety of dangguijakyaksan. Statistical analysis will be performed using R-3.3.3 (Another Canoe), and within-group study variable differences after drug administration will be analyzed using paired t-test or Wilcoxon signed-rank test. DISCUSSION: We expect to confirm the effects and safety of dangguijakyaksan on lower-extremity blood circulation disturbances in menopause, which would provide foundational data for planning subsequent studies.

Danggwijagyaksan for climacteric syndrome in peri- and postmenopausal women with a blood-deficiency dominant pattern: study protocol for a randomized, double-blind, placebo-controlled pilot trial.

BACKGROUND: This study aims to explore the safety, efficacy, and feasibility of Danggwijagyaksan (DJS) for alleviating climacteric syndrome in peri- and postmenopausal women with a blood-deficiency dominant pattern. METHODS/DESIGN: This is a randomized, double-blind, placebo-controlled pilot clinical trial. A total of 34 women with climacteric syndrome who have signed informed consent forms will be registered in this study. Placebo or DJS will be randomly assigned to the participants in an equal proportion. The participants will visit the clinical trial center every 2 weeks and receive placebo or DJS granules. The treatment period is 4 weeks and the administration frequency is three times daily. Data will be collected from the participants at baseline, at week 5, and at week 9 after random allocation. The primary outcome measure will be the mean change in the Menopause Rating Scale from baseline to week 5. Secondary outcome measures will include the World Health Organization Quality of Life-BREF (WHOQOL-BREF) score, the Blood Deficiency Scoring System score, lean body mass, and blood tests, including serum follicle-stimulating hormone and estradiol concentration. To assess the safety of DJS, a laboratory test will be conducted before and after treatment and the participants will be asked about any occurrence of adverse events every visit. The recruitment rate, completion rate, and medication adherence will also be calculated, to assess feasibility. DISCUSSION: The findings of this study will provide the basis for a full-scale randomized controlled trial to confirm the safety and efficacy of DJS for the treatment of climacteric syndrome in peri- and postmenopausal women. TRIAL REGISTRATION: Clinical Research Information Service (CRIS), Republic of Korea, KCT0002387 . Registered on 25 July 2017.

Current status and future prospects of research and development operations in traditional and complementary and alternative medicine manufacturing small- and medium-sized enterprises: a 2014 company-based survey.

BACKGROUND: Small- and medium-sized enterprises (SMEs) have played key roles in the economic growth and technical innovation of traditional and complementary and alternative medicine (T&CM). Research and development (R&D) are critical activities for industrial progress. This study aimed to characterize the current status of SME R&D activities and to explore manufacturers' perceptions of R&D expansion. METHODS: Records of the distribution of T&CM SMEs and R&D resources detailed in the 2014 Statistics of Korea T&CM Industries survey, a previously conducted survey on the industrial status of the T&CM field, were reviewed. Data on the perceptions of R&D activities were investigated through a company-based survey covering 285 T&CM-manufacturing SMEs. RESULTS: Greater than 99% of the 13,636 T&CM manufacturers at the time of the study were SMEs employing less than 50 workers. Natural cosmetics manufacturing SMEs (NC SMEs) had the highest R&D expenditures. NC SMEs rely heavily on internal R&D operations, which may contribute to their strong need for R&D collaboration with public research institutions and expanded T&CM-promoted R&D programs. "Digestive system disorders" are the main target diseases for current herbal and dietary supplement manufacturing SMEs and herbal medicine manufacturing SMEs. These SMEs tend to view their own product-related business as a priority for future R&D investment. CONCLUSION: This study represents the first attempt to assess SME perceptions of R&D activities. The findings herein can inform the design of sustainable programs that support R&D by reducing the gaps between the perspectives of T&CM product makers and policymakers.

The Hot-Water Extract of Smilacis Chinae Rhizome Suppresses 2,4-Dinitrochlorobenzene and House Dust Mite-Induced Atopic Dermatitis-Like Skin Lesions in Mice.

Smilacis Chinae Rhizome (SCR) has been used as an oriental folk medicine for various biological activities. However, its effect on atopic dermatitis (AD) remains undetermined to date. We assessed the effect of orally administered hot-water extract of SCR on AD-like skin lesions in mice and its underlying mechanisms. AD-like murine model was prepared by repeated alternate application of house dust mite (Dermatophagoides farinae) extract (DFE) and 2,4-dinitrochlorobenzene (DNCB) for 4 weeks, topically to the ears. Daily oral administration of SCR for 3 and 4 weeks significantly reduced inflammatory ear thickening, with the effect being enhanced at the earlier start and longer period of administration. This effect was accompanied by a significant decrease in both Th2 and Th1 serum antibodies (total IgE, DFE-specific IgE, and IgG2a). Histological analysis showed that SCR markedly decreased the epidermal/dermal ear thickening and the dermal infiltration of inflammatory cells. Furthermore, SCR suppressed DFE/DNCB-induced expression of IL-4, IL-13, IL-17, IL-18, TSLP, and IFN-γ genes in the ear tissue. Taken together, our observations demonstrate that chronic oral administration of SCR exerts beneficial effect in mouse AD model, suggesting that SCR has the therapeutic potential as an orally active treatment of AD by modulating both Th1 and Th2 responses.

Effects of coffee consumption on serum uric acid: systematic review and meta-analysis.

OBJECTIVE: Study results on the effects of coffee consumption on serum uric acid (UA) have been conflicting. The aim of this study is to analyze the literature regarding the effect of coffee consumption on serum UA. METHODS: We searched MEDLINE, EMBASE, the Cochrane library, and KoreaMed for all articles published before January 2015. Studies with quantitative data on coffee consumption and serum UA level were included. Coffee consumption and serum UA level were identified with/without the risk of gout. RESULTS: Nine studies published between 1999 and 2014 were included, containing a total of 175,310 subjects. Meta-analysis demonstrated that coffee has a significantly lowering effect on serum UA, where there are gender differences in the amount of coffee required to lower serum UA. Women (4-6 cups/day) need more coffee to lower serum UA than men (1-3 cups/day). Meta-analysis showed that coffee intake of 1 cup/day or more was significantly associated with reduction of the risk of gout, with a negative correlation with the amount of daily coffee intake for both genders. CONCLUSIONS: This is the first systematic review on the effects of coffee consumption on serum UA. Based on our study, moderate coffee intake might be advocated for primary prevention of hyperuricemia and gout in both genders.

Perspectives on the Market Globalization of Korean Herbal Manufacturers: A Company-Based Survey.

The growth of herbal markets has increased substantially in South Korea, but the worldwide market share remains small despite significant governmental efforts. This study aimed to characterize manufacturing employment and identify employees' general perceptions of market expansion. A survey study covering 567 companies was conducted using face-to-face interviews in 2012. Data were analyzed using comparisons among three manufacturing groups (i.e., the herbal dietary supplement manufacturing group, the herbal medicine manufacturing group, and the personal care product manufacturing group) or among the manufacturers themselves. We found that the majority of the manufacturing employee respondents were regular permanent and production workers. The domestic distributors were primarily chain stores/direct outlets or retailers/wholesalers, and the dominant product was red ginseng (hongsam). Although the responding companies exhibited a variety of perspectives, "advertisement/public relations" was cited as the most important factor in the development of the herbal industry. In contrast, "low manpower/seeking business partners" were the most crucial limiting and challenging factors for market globalization. Our results can be used to design a proper national plan by reducing the gaps in perspective between herbal product producers and policy makers.

Changes in attitudes toward and patterns in traditional Korean medicine among the general population in South Korea: a comparison between 2008 and 2011.

BACKGROUND: Traditional Korean medicine (TKM) is acknowledged to be prevalent among the Korean public, but few follow-up studies are available to confirm this commonly held belief. Whereas most survey studies have focused on the demographic factors influencing the usage of TKM, only a few studies have conducted a pattern or trend analysis over time. The purpose of this paper is to observe and document recent trends in the usage of TKM in South Korea and to compare overall patterns of TKM use over a period of several years. METHODS: A cross-sectional survey was conducted in 2011 to assess TKM usage patterns and public perceptions regarding TKM. An online questionnaire was administered to consenting respondents that focused upon individual preferences between TKM and current Western medicine, respondents' reasons for using TKM, the frequency of respondents' visits to TKM clinics, the reasons respondents visited TKM clinics, and respondents' perceived satisfaction. RESULTS: The results revealed that 66.6% of the respondents showed a positive attitude toward TKM. In addition, 69.3% of the respondents had visited TKM clinics one to four times during the previous year. Patients used TKM with the intentions of receiving acupuncture (95.3%), moxibustion (40.1%), and cupping (36.0%) treatments or to take herbal medicines (35.7%). Most respondents who had visited TKM clinics were largely satisfied with the clinics' effectiveness (56.1%). The factors most commonly associated with TKM usage included sex (female), age (50s), and education (college or higher), but the within-factor differences were not significant. Compared with a previous survey of other groups, TKM usage was found to have increased from 45.8% in 2008 to 69.3% in 2011. With the exception of acupuncture and physical therapy, most usage doubled or more than doubled. CONCLUSIONS: The attitudes toward and usage of TKM in South Korea have improved between 2008 and 2011. This result will be used to explain outcomes of certain social phenomena and to argue for national support in the promotion of TKM.

Evaluation of metabolism-mediated herb-drug interactions.

As the use of herbal medicines increases, the public health consequences of drug-herb interactions are becoming more significant. Herbal medicines share the same drug metabolizing enzymes and drug transporters, including cytochrome P450 enzymes (CYPs), glucuronosyltransferases (UGTs), and P-glycoprotein, with several clinically important drugs. Interactions of several commonly used herbal medicines, such as Ginko biloba, milk thistle, and St. John's wort, with therapeutic drugs including warfarin, midazolam, alprazolam, indinavir, saquinavir, digoxin, nifedipine, cyclosporine, tacrolimus, irinotecan, and imatinib in humans have been reported. Many of these drugs have very narrow therapeutic indices. As the herb-drug interactions can significantly alter pharmacokinetic and pharmacodynamic properties of administered drugs, the drugs interacting with herbal medicines should be identified by appropriate in vitro and in vivo methods. A good understanding of the mechanisms of herb-drug interactions is also essential for assessing and minimizing clinical risks. In vitro methods are useful for providing mechanistic information and evaluating multiple components in herbal medicines. This review describes major factors affecting the metabolism of herbal medicines, mechanisms of herb-drug interactions mediated by CYPs and UGTs, and several in vitro methods to assess the herb-drug interactions. Finally, drug interactions of Ginkgo biloba and St. John's wort, as representative herbal medicines, are described.