Efficacy and safety of acupuncture on oligomenorrhea due to polycystic ovary syndrome: An international multicenter, pilot randomized controlled trial.

BACKGROUND: Polycystic ovary syndrome (PCOS) is one of the most common disorders of reproductive endocrinology affecting women of reproductive age. Our study aims to explore the feasibility of a full-scale trial to evaluate the efficacy and safety of acupuncture for PCOS. METHODS: This study is a two-armed, parallel, multi-country, multi-center, pilot randomized controlled trial (RCT) for PCOS with oligomenorrhea. We will recruit 60 women aged 20 to 40 years with oligomenorrhea due to PCOS. The participants will be randomly assigned to acupuncture and control groups. The acupuncture group will undergo a total of 40 sessions for 16 weeks with usual care. The control group will be managed with usual care (regular meals, sufficient sleep, and appropriate exercise) only. The primary clinical outcome is mean change in menstrual frequency from baseline to 16 weeks and 32 weeks (follow-up) after the start of the trial. The secondary outcomes are menstrual period, levels of estradiol, luteinizing hormone (LH), follicle-stimulating hormone (FSH), and total testosterone, LH/FSH ratio, antral follicle count and ovarian volume, body mass index, waist hip ratio, acne severity, and health-related quality of life questionnaire scores at 16 and 32 weeks after the start of the trial. DISCUSSION: This is the first protocol for multi-country, multi-center RCTs for PCOS in Korea and China. The control group in this study will be subjected to usual care (regular meals, enough sleep, and appropriate exercise). The results of this study will provide evidence for future clinical decisions and guidelines.This trial has been registered at ClinicalTrials.gov (Identifier: NCT04509817).

Expenditure on complementary and alternative medicine and productivity losses in patients with primary dysmenorrhea: A survey of women in Korea.

In women with primary dysmenorrhea (PD), the use of complementary and alternative medicine (CAM) and productivity losses at both workplaces and schools have not been comprehensively assessed. In this study, researchers evaluated the disease burden in women with PD in patients' perspective in two categories: direct cost (the use of CAM and associated costs) and indirect cost (productivity losses). Women with PD aged 16-49 years were asked to fill an online survey in 2017. The survey consisted of 49 questions. CAM included traditional Korean medicines, over-the-counter products, dietary supplements, and traditional remedies. All costs were expressed in US dollars in this study. The survey data from 86 patients with PD were analyzed. The total mean annual cost per patient with PD was $4053, comprising direct costs ($1245) and indirect costs ($2807). PD causes considerable expenditure on CAM and impairs work productivity (especially in presenteeism).

Effectiveness and safety of Korean medicine for treating women with unexplained infertility: A multi-center observational study.

BACKGROUND: This study was conducted to demonstrate the effectiveness and safety of herbal medicine and acupuncture treatment in unexplained infertile females. METHODS: One hundred patients were recruited from 3 Korean Medicine hospitals in Korea and they voluntarily signed informed consent agreements. Participants took the Onkyeong-tang (120cc) twice daily between menstrual cycle day (MCD) 3 and 12, and herbal medicine for ovulation and implantation (120cc) twice daily between MCD 13 and 28. They also received acupuncture and moxibustion treatment during 4 menstrual cycles. After the 4 menstrual cycle treatment period, there were 3 menstrual cycle observation periods. The primary outcome is signified by clinical pregnancy rates (CPR) and the secondary outcomes were implantation rates (IR), ongoing pregnancy rates (OPR), and live birth rates. RESULTS: 90 patients completed the study. 13 of the 90 subjects became pregnant. The CPR and IR was 14.44%. 7 of 13 pregnant subjects had continuing pregnancy for over 12 weeks, so that the OPR was 53.85%. The birth rate was 7.78%. All 7 pregnant patients gave birth to their babies and all the babies were live singletons and healthy. There were no serious adverse events. CONCLUSIONS: The findings of this study may provide the possibility of effectiveness and safety of Korea medicine treatment for unexplained infertile women. Further study is required due to lack of control and small sample size in this study.

Antitumor Effects of Ursolic Acid through Mediating the Inhibition of STAT3/PD-L1 Signaling in Non-Small Cell Lung Cancer Cells.

Targeted therapy based on natural compounds is one of the best approaches against non-small cell lung cancer. Ursolic acid (UA), a pentacyclic triterpenoid derived from medicinal herbs, has anticancer activity. Studies on the molecular mechanism underlying UA's anticancer activity are ongoing. Here, we demonstrated UA's anticancer activity and the underlying signaling mechanisms. We used Western blotting and real-time quantitative polymerase chain reaction for molecular signaling analysis. We also used in vitro angiogenesis, wound healing, and invasion assays to study UA's anticancer activity. In addition, we used tumorsphere formation and chromatin immunoprecipitation assays for binding studies. The results showed that UA inhibited the proliferation of A549 and H460 cells in a concentration-dependent manner. UA exerted anticancer effects by inducing G0/G1 cell cycle arrest and apoptosis. It also inhibited tumor angiogenesis, migration, invasion, and tumorsphere formation. The molecular mechanism underlying UA activity involves UA's binding to epidermal growth factor receptor (EGFR), reducing the level of phospho-EGFR, and thus inhibiting the downstream JAK2/STAT3 pathway. Furthermore, UA reduced the expressions of vascular endothelial growth factor (VEGF), metalloproteinases (MMPs) and programmed death ligand-1 (PD-L1), as well as the formation of STAT3/MMP2 and STAT3/PD-L1 complexes. Altogether, UA exhibits anticancer activities by inhibiting MMP2 and PD-L1 expression through EGFR/JAK2/STAT3 signaling.

Prescription patterns of herbal medicine for menopausal disorders in major Korean medicine hospitals: a multicenter retrospective study.

BACKGROUND: This study aimed to obtain the symptom, prescription and therapeutic patterns for the treatment of patients with menopausal syndrome in major Korean medicine (KM) hospitals. METHODS: We used a retrospective chart review of climacteric disorder and postmenopausal syndrome patients by examining medical records (ICD-10, menopausal and female climacteric states: N95.1, Menopausal and perimenopausal disorder, unspecified: N95.9) from eight university KM hospitals in South Korea. RESULTS: The main symptoms of 1,682 patients with menopausal disorders visiting eight college-affiliated oriental medicine hospitals were hot flush, hyperhidrosis, fatigue, insomnia, and chest tightness. Guipi decoction, Si-wu guipi decoction, Qing-xin lianzi-yin, Jiawei xiao-yao-san and Guipi wen-dan decoction were the most commonly prescribed treatments for menopausal disorders. Patients were most often treated with a combination of herbal medicine and acupuncture. CONCLUSION: Our study shows that the current prescribed herbal medicines were used for treating menopausal disorders in Korean medicine hospitals. However, the objectivity of the efficacy assessment should be studied further.

Effectiveness of non-pharmacological interventions for treating post-stroke depressive symptoms: Systematic review and meta-analysis of randomized controlled trials.

OBJECTIVE: To compare the effectiveness of non-pharmacological interventions on depressive symptoms in people after stroke. DATA SOURCES: A literature search was performed through databases from January 2000 to August 2018: MEDLINE; CINAHL Plus; Scopus; Academic Search Complete; Cochrane Central Register of Controlled Trials; Scopus; and Library, Information Science and Technology Abstracts. Search terms included depression, stroke, non-pharmacologic, and intervention. STUDY SELECTION: We included randomized controlled trials comparing non-pharmacological interventions to controls for depressive symptoms in people after stroke. Of 1703 identified articles, 22 trials were included in narrative synthesis, of which 13 were eligible for meta-analysis. DATA EXTRACTION: Two reviewers extracted characteristics of participants, interventions, and results from all included trials. DATA SYNTHESIS: Thirteen interventions were categorized into four types: complementary and alternative therapy (five trials, n=228), exercise (four trials, n=263), psychosocial therapy (two trials, n=216), and multifactorial therapy (two trials, n=358). Overall beneficial effects of non-pharmacological interventions on depressive symptoms were found both post-intervention (effect size [ES] = -0.24, 95% confidence Interval [CI]: -0.37 to -0.11, p < 0.05) and at follow-up (ES = -0.22, CI: -0.36 to -0.07, p< 0.05). We found individual beneficial effects for complementary and alternative therapy (ES = -0.29, CI: -0.55 to -0.02, p < 0.05) and psychosocial therapy (ES = - 0.33, CI: -0.60 to -0.06, p < 0.05) post-intervention. CONCLUSIONS: Complementary and alternative therapy and psychosocial therapy appear to be promising strategies for improving post-stroke depression. Future studies target  a personalized approach for people with specific conditions such as cognitive impairment.

Effect of Acupuncture Intervention and Manipulation Types on Poststroke Dysarthria: A Systematic Review and Meta-Analysis.

This study aimed to evaluate the effect of acupuncture intervention and manipulation types on poststroke dysarthria. Electronic database, including PubMed, CENTRAL, Scopus, RISS, and CNKI, were searched for randomized controlled trials (RCT), treating dysarthria using acupuncture, speech-language therapy (SLT), and general management (GM), published before April 2019. The number, distribution, intensity, depth, and repetition of acupuncture and bleeding therapy on the sublingual veins were considered as manipulation types. Risk of bias of the included trials was evaluated, and their efficacy was assessed using risk ratio (RR) and the standard mean differences in the Frenchay Dysarthria Assessment and Speech Function Grading, with 95% confidence intervals (CIs).Fifteen RCT trials involving 1453 patients were isolated. Electroacupuncture plus SLT and manual acupuncture plus SLT were more effective than SLT only, respectively (RR = 1.520, 95% CI [1.183-1.952], RR = 1.380, 95% CI [1.281-1.488]). The clinical efficacy of acupuncture plus GM was higher than that of GM alone (RR = 1.165, 95% CI [1.050-1.293]). Meta-ANOVA showed that none of the manipulation types increased the clinical efficacy of acupuncture on dysarthria. The methodological quality was low. In conclusion, our study suggests that the effect of acupuncture on poststroke dysarthria may be maximized when manual acupuncture or electroacupuncture is combined with SLT, irrespective of manipulation types.

Herbal medicine (Taohong Siwu Tang) for the treatment of primary dysmenorrhea: A systematic review and meta-analysis.

OBJECTIVES: This systematic review aimed to evaluate the efficacy and safety of Tao-Hong Siwu Tang (TST) for the treatment of primary dysmenorrhea. METHODS: We searched four English databases (MEDLINE, EMBASE, Allied and Complementary Medicine Database, and Cochrane Central Register of Controlled Trials [CENTRAL, Cochrane Library]), three Chinese databases (China National Knowledge Infrastructure, Wanfang, and Chinese Science and Technology Periodical Database), two Korean databases (Oriental Medicine Advanced Searching Integrated System and Korean traditional Knowledge Portal), and one Japanese database (Citation Information by NII). All randomized controlled trials (RCTs) using TST or modified TST (MTST) were included. Three independent reviewers extracted the data, assessed the risk of bias according to the Cochrane criteria, and performed a meta-analysis. RESULTS: A total of 85 possibly relevant articles were identified, and five trials met our inclusion criteria. The meta-analysis showed a favorable effect of MTST compared to non-steroidal anti-inflammatory drugs (NSAIDs) (n = 486, risk ratio [RR] = 1.53, 95% confidence interval [95% CI] = 1.37-1.72, I2 = 39%). Among the included trials, one RCT showed superior effects of MTST on primary dysmenorrhea recurrence rate compared to NSAIDs (n = 246, RR = 0.31, 95% CI = 0.15-0.63, P = 0.001). Another RCT revealed a beneficial impact of oral contraceptives (OCs) used in combination with TST compared to OCs alone (n = 60, RR = 1.35, 95% CI = 1.02-1.79, P = 0.04). CONCLUSION: This systematic review and meta-analysis provides moderate quality evidence for the superiority of MTST over NSAIDs as well as that of TST plus OCs over OCs in the treatment of primary dysmenorrhea.

Efficacy and safety of herbal medicine (Dangguijagyag-san) for primary dysmenorrhea: study protocol for a randomized, double-blind, placebo-controlled, parallel-group, multi-center trial.

BACKGROUND: Dangguijagyag-san, also known as Dangguishaoyao-san in Chinese and Toki-shakuyakui-san in Japanese, has been frequently used to treat symptoms associated with dysmenorrhea. The purpose of this trial is to evaluate the efficacy and safety of the herbal medicine, Dangguijagyag-san, relative to those of active control, Gamisoyo-san, and a placebo control for primary dysmenorrhea. METHODS: This protocol details a randomized, double-blind, parallel-group, multi-center, investigator-initiated, controlled trial evaluating treatment of primary dysmenorrhea. Two hundred and forty participants will be randomly divided into one of three groups: 1) the Dangguijagyag-san experimental group (EG) (n = 105), 2) the Gamisoyo-san active control group (ACG) (n = 30), and 3) the placebo control group (PCG) (n = 105). The interventions will be administered for two menstrual cycles, and the follow-up will be carried out for the following six menstrual cycles. The primary outcomes are difference in response rates between the EG and the ACG (non-inferiority comparison) and difference in changes from baseline in average pain intensity measured by the visual analogue scale between the EG and PCG (superiority comparison). The secondary outcomes are pain scores derived from pain assessment tools (verbal multidimensional scoring system, retrospective symptom scale, and short form McGill pain questionnaire), dosage of analgesics, pattern diagnosis questionnaires, and short form 36 health survey. Adverse events and vital signs will be checked at every visit, and laboratory tests will be performed for safety evaluation. DISCUSSION: The results of this clinical trial will offer evidence for the efficacy and safety of Dangguijagyag-san for primary dysmenorrhea. TRIAL REGISTRATION: Clinical Research Information Service of Korea: KCT0003005.

Efficacy and safety of ucha-shinki-hwan on korean patients with cold hypersensitivity in the hands and feet: Study protocol clinical trial (SPIRIT Compliant).

BACKGROUND: Cold hypersensitivity in the hands and feet (CHHF) is a common complaint in Asian female population especially in Korea. Due to the symptoms of CHHF the quality of individual's daily life can be degraded. Ucha-Shinki-Hwan (UCHA) is widely used in the treatment of various diseases including CHHF by harmonizing Yin and Yang, and improving the vitality of whole body. However, the efficacy of UCHA as a treatment option of CHHF has not been assessed in trials. Thus, we aimed to investigate the efficacy and safety of UCHA in Korean women with CHHF through this trial. METHODS: This study will be an exploratory, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. Korean women aged 19 to 59 years who complaint with CHHF will be enrolled from 5 university affiliated Korean medicine hospitals. A total of 164 subjects will be randomly assigned to a treatment group (UCHA) or a placebo group at a 1:1 ratio. The subjects will receive 2.5 g of either UCHA or placebo three times a day for 8 weeks. The primary outcome will be evaluated with the visual analog scale score of CHHF. The secondary outcome measures will be changes in skin temperature in extremities as measured by using a thermometer and the Korean version of the World Health Organization Quality of Life Scale Abbreviated Version. DISCUSSION: This study will be the first trial to explore the efficacy and safety of UCHA for CHHF patient. This will provide meaningful clinical information on herbal medicine treatment of CHHF and a clinical evidence for planning a full randomized clinical trial. DISCLOSURES AND ACKNOWLEDGMENTS: The authors report no competing interests. TRIAL REGISTRATION: This study is registered at ClinicalTrials.gov, ID: NCT03790033. Registered on (31 December 2018) PROTOCOL VERSION:: The final approved version of the trial protocol is V1.3. (25 January 2019).

Drug Discovery Platform Targeting M. tuberculosis with Human Embryonic Stem Cell-Derived Macrophages.

A major limitation in anti-tuberculosis drug screening is the lack of reliable and scalable models for homogeneous human primary macrophage cells of non-cancer origin. Here we report a modified protocol for generating homogeneous populations of macrophage-like cells from human embryonic stem cells. The induced macrophages, referred to as iMACs, presented similar transcriptomic profiles and characteristic immunological features of classical macrophages and were permissive to viral and bacterial infection, in particular Mycobacterium tuberculosis (Mtb). More importantly, iMAC production was amenable to scale up. To evaluate iMAC efficiency in high-throughput anti-tuberculosis drug screening, we performed a phenotypic screening against intracellular Mtb, involving a library of 3,716 compounds that included FDA-approved drugs and other bioactive compounds. Our primary screen identified 120 hits, which were validated in a secondary screen by dose-intracellular and -extracellular Mtb assays. Our confirmatory studies identified a novel anti-Mtb compound, 10-DEBC, also showing activity against drug-resistant strains.

Ultrasensitive Electrical Detection of Hemagglutinin for Point-of-Care Detection of Influenza Virus Based on a CMP-NANA Probe and Top-Down Processed Silicon Nanowire Field-Effect Transistors.

Rather than the internal genome nucleic acids, the biomolecules on the surface of the influenza virus itself should be detected for a more exact and rapid point-of-care yes/no decision for influenza virus-induced infectious diseases. This work demonstrates the ultrasensitive electrical detection of the HA1 domain of hemagglutinin (HA), a representative viral surface protein of the influenza virus, using the top-down complementary metal oxide semiconductor (CMOS) processed silicon nanowire (SiNW) field-effect transistor (FET) configuration. Cytidine-5'-monophospho-N-acetylneuraminic acid (CMP-NANA) was employed as a probe that specifically binds both to the aldehyde self-aligned monolayer on the SiNWs and to HA1 simultaneously. CMP-NANA was serially combined with two kinds of linkers, namely 3-aminopropyltriethoxysilane and glutaraldehyde. The surface functionalization used was verified using the purification of glutathione S-transferase-tagged HA1, contact angle measurement, enzyme-linked immunosorbent assay test, and isoelectric focusing analysis. The proposed functionalized SiNW FET showed high sensitivities of the threshold voltage shift (ΔVT) ~51 mV/pH and the ΔVT = 112 mV (63 mV/decade) with an ultralow detectable range of 1 fM of target protein HA1.

The efficacy and safety of Sipjeondaebo-tang in Korean patients with cold hypersensitivity in the hands and feet: a protocol for a pilot, randomized, double-blind, placebo-controlled, parallel-group clinical trial.

BACKGROUND: Cold hypersensitivity in the hands and feet (CHHF) is frequent in Asian countries including Korea. The quality of life can be degraded by the symptoms of CHHF. In particular, gynecological disorders such as menstrual pain, infertility, leucorrhea, and irregular bleeding may be related to CHHF. Sipjeondaebo-tang (SDT) is widely used in the treatment of various diseases including CHHF by balancing Yin and Yang, restoring the deterioration of physiological function, and improving immunity. However, the efficacy of SDT in the treatment of CHHF has not been assessed in clinical trials. Therefore, we aimed to investigate the feasibility of a full randomized clinical trial of SDT for the treatment of CHHF in Korean women through this trial. METHODS: This study will be a pilot, randomized, double-blind, two-arm, placebo-controlled, parallel-group, multicenter clinical trial. Women aged 19-59 years who present with CHHF will be recruited from five university hospitals. A total of 60 subjects will be randomly assigned to a treatment group (SDT) or a placebo group at a 1:1 ratio. The subjects will receive 3 g of either SDT or placebo three times daily for 8 weeks. The primary outcome measures will be the Visual Analogue Scale scores of CHHF. The secondary outcome measures will be changes in body temperature in both the hands and the feet as measured using a thermometer and the Korean version of the World Health Organization Quality of Life Scale Abbreviated Version. DISCUSSION: This will be the first trial to investigate the efficacy and safety of SDT in the treatment of CHHF. This study will provide basic clinical information regarding Korean herbal medicine treatment of CHHF and a clinical basis for designing a full randomized clinical trial. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03374345 . Registered on 15 February 2018.

Herbal medicine (Hyeolbuchukeo-tang or Xuefu Zhuyu decoction) for treating primary dysmenorrhea: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Primary dysmenorrhea is a condition characterized by painful menstrual cramps that usually occurs in the absence of any identifiable pathological condition among menstruating women, with the prevalence estimates varying between 45% and 95%. Nonsteroidal anti-inflammatory drugs (NSAIDs) are considered as a standard treatment for primary dysmenorrhea; however, the failure rate of NSAIDs is often 20% to 25% and these drugs commonly cause adverse effects. In this review, we investigated the current evidence related to the effectiveness of Xuefu Zhuyu decoction (XZD) or Hyeolbuchukeo-tang, a traditional herbal formula, as a treatment for primary dysmenorrhea. METHODS: Literature search was conducted about randomized controlled trials (RCTs) for XZD on primary dysmenorrhea. PubMed, Cochrane Library, Embase, China National Knowledge Infrastructure Database, Oriental Medicine Advanced Searching Integrated System, and other Chinese, Korean, Japanese databases were searched up to December 20, 2017. Two independent reviewers extracted and assessed the data. The main outcome domains were visual analogue scale (VAS) score and response rate. RESULTS: Among 475 publications, 8 RCTs involving 1048 patients were finally included. Methodological quality of included RCTs was relatively low. In 4 add-on design studies, XZD plus western medication (WM) group showed better response rate as compared to the WM sole therapy (relative risk 1.18, 95% confidence interval [1.11, 1.25], P < .01). VAS score after the 3rd month of treatment in the XZD plus WM group was also lower than that in the WM group (mean difference -0.45, 95% confidence interval [-0.79, -0.12], P < .01). In 4 XZD versus WM design studies, XZD sole therapy showed better response rate than did WM sole therapy (relative risk 1.26, 95% confidence interval [1.06, 1.49], P < .01). CONCLUSION: The existing trials showed a favorable effect of XZD for the management of primary dysmenorrhea. However, the efficacy of XZD on primary dysmenorrhea is not conclusive owing to the small number of studies and the high risk of bias. Large-scale, long-term RCTs with rigorous methodological input are needed to clarify the role of XZD for the management of primary dysmenorrhea. TRIAL REGISTRATION NUMBER: CRD42016050447 in PROSPERO 2016.

Efficacy and safety of Ojeok-san in Korean female patients with cold hypersensitivity in the hands and feet: study protocol for a randomized, double-blinded, placebo-controlled, multicenter pilot study.

BACKGROUND: This study aims to evaluate the safety, efficacy, and feasibility of a full randomized clinical trial of Ojeok-san in Korean female patients with cold hypersensitivity in the hands and feet. METHODS: This study is a multicenter, double-blinded, randomized, placebo-controlled, two-arm, parallel-group pilot clinical trial. A total of 60 participants will be enrolled and randomly assigned to the Ojeok-san treatment group or the placebo control group, in a 1:1 ratio using an Internet-based randomization system. Each group will be administered Ojeok-san or placebo three times per day for 8 weeks. The primary outcome will be the mean change in the Visual Analog Scale scores of cold hypersensitivity in the hands from baseline to week 8. Secondary outcomes will include the mean changes in the skin temperature of the extremities, recovery rate of the skin temperature of hands after cold stress test, and the score of Korean version of the WHO Quality of Life Scale abbreviated version. DISCUSSION: The findings of this study should provide meaningful information for a further large-scale, randomized controlled trial to confirm the safety and efficacy of Ojeok-san on cold hypersensitivity in the hands and feet in female patients. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03083522 . Registered on 20 March 2017.

Relationship between Tongue Temperature Estimated by Infrared Thermography, Tongue Color, and Cold-Heat Pathological Patterns: A Retrospective Chart Review Study.

Tongue diagnosis is a technique used to determine cold-heat pathologic patterns (CHPPs). Herein, we reviewed electronic medical records of tongue temperature measured using infrared thermography (IRT), tongue color (luminance, green/red, and blue/yellow balance), cold-heat pattern questionnaires (CHPQ), and body temperature for 134 women with gynecological problems (age, 38.97 ± 11.49 years). The temperatures of seven tongue regions (root, center, tip, and both sides of the center and root) were determined, and the effects of age, regional differences, and their correlations with color parameters were examined. Factor analysis was conducted separately with the 10 cold pattern (CP) and 10 heat pattern (HP) items. Tongue temperature showed an age effect (ß; -0.198 to -0.210) and regional differences (both sides of the root > center and root > tip). Tongue temperature was positively correlated with luminance (r: 0.236-0.246), indicating that a higher temperature was associated with a brighter color. The factor analysis extracted two factors (cold sensitivity-pain and discharge-complexion factors) from the CP items and three factors (heat sensation-pain, discharge-breath, and cold preference-thirst factors) from the HP items. Tongue temperature was negatively correlated with the discharge-complexion factor of CP and the discharge-breath factor of HP (r: -0.171 to -0.203), indicating that a lower tongue temperature may be a consequence of emission of excessive heat in HP and a lower blood perfusion in CP. Body temperature did not correlate with the CHPQ factor scores. In conclusion, tongue temperatures measured using IRT may be a partial indicator of CHPPs.

The efficacy and safety of acupuncture in women with primary dysmenorrhea: A systematic review and meta-analysis.

BACKGROUND: This systematic review aimed to evaluate the current evidence regarding the efficacy and safety of acupuncture on primary dysmenorrhea. METHODS: Ten electronic databases were searched for relevant articles published before December 2017. This study included randomized controlled trials (RCTs) of women with primary dysmenorrhea; these RCTs compared acupuncture to no treatment, placebo, or medications, and measured menstrual pain intensity and its associated symptoms. Three independent reviewers participated in data extraction and assessment. The risk of bias in each article was assessed, and a meta-analysis was conducted according to the types of acupuncture. The results were expressed as mean difference (MD) or standardized mean difference (SMD) with 95% confidence intervals (CIs). RESULTS: This review included 60 RCTs; the meta-analysis included 49 RCTs. Most studies showed a low or unclear risk of bias. We found that compared to no treatment, manual acupuncture (MA) (SMD = -1.59, 95% CI [-2.12, -1.06]) and electro-acupuncture (EA) was more effective at reducing menstrual pain, and compared to nonsteroidal anti-inflammatory drugs (NSAIDs), MA (SMD = -0.63, 95% CI [-0.88, -0.37]) and warm acupuncture (WA) (SMD = -1.12, 95% CI [-1.81, -0.43]) were more effective at reducing menstrual pain. Some studies showed that the efficacy of acupuncture was maintained after a short-term follow-up. CONCLUSION: The results of this study suggest that acupuncture might reduce menstrual pain and associated symptoms more effectively compared to no treatment or NSAIDs, and the efficacy could be maintained during a short-term follow-up period. Despite limitations due to the low quality and methodological restrictions of the included studies, acupuncture might be used as an effective and safe treatment for females with primary dysmenorrhea.

Herbal medicine (Hyeolbuchukeo-tang or Xuefu Zhuyu decoction) for treating primary dysmenorrhoea: protocol for a systematic review of randomised controlled trials.

INTRODUCTION: Primary dysmenorrhoea is menstrual pain without pelvic pathology and is the most common gynaecological condition in women. Xuefu Zhuyudecoction (XZD) or Hyeolbuchukeo-tang, a traditional herbal formula, has been used as a treatment for primary dysmenorrhoea. The purpose of this study is to assess the current published evidence regarding XZD as treatment for primary dysmenorrhoea. MATERIALS AND METHODS: The following databases will be searched from their inception until April 2017: MEDLINE (via PubMed), Allied and Complementary Medicine Database (AMED), EMBASE, The Cochrane Library, six Korean medical databases (Korean Studies Information Service System, DBPia, Oriental Medicine Advanced Searching Integrated System, Research Information Service System, Korea Med and the Korean Traditional Knowledge Portal), three Chinese medical databases (China National Knowledge Infrastructure (CNKI), Wan Fang Database and Chinese Scientific Journals Database (VIP)) and one Japanese medical database (CiNii). Randomised clinical trials (RCTs) that will be included in this systematic review comprise those that used XZD or modified XZD. The control groups in the RCTs include no treatment, placebo, conventional medication or other treatments. Trials testing XZD as an adjunct to other treatments and studies where the control group received the same treatment as the intervention group will be also included. Data extraction and risk of bias assessments will be performed by two independent reviewers. The risk of bias will be assessed with the Cochrane risk of bias tool. All statistical analyses will be conducted using Review Manager software (RevMan V.5.3.0). ETHICS AND DISSEMINATION: This systematic review will be published in a peer-reviewed journal. The review will also be disseminated electronically and in print. The review will benefit patients and practitioners in the fields of traditional and conventional medicine. PROSPERO REGISTRATION NUMBER: CRD42016050447.

The efficacy and safety of Danggui-Sayuk-Ga-Osuyu-Saenggang-tang on Korean patients with cold hypersensitivity in the hands: study protocol for a pilot, double-blind, randomized, placebo-controlled, parallel-group clinical trial.

BACKGROUND: In recent years, cold hypersensitivity in the hands (CHH) has become a common ailment of women in Korea. It can lead to gynecological problems such as irregular menstruation, miscarriage, and infertility. Traditionally, Korean herbal medicine has been the primary treatment method used to balance thermoregulation in the human body; however, its effectiveness has not been confirmed through systematic study. Thus, in this trial, we will investigate the feasibility of a full randomized clinical trial, Danggui-Sayuk-Ga-Osuyu-Saenggang-tang (DSGOST) in Korean women with CHH. METHODS: This study will be a pilot, multicenter, double-blind, randomized, parallel-group, two-arm, placebo-controlled clinical trial. A total of 66 participants will be randomly divided into two groups, a DSGOST treatment group and a placebo control group, in a 1:1 ratio using a web-based randomization system. Each group will take DSGOST or placebo three times daily for 6 weeks. The primary outcome will be measured using Visual Analogue Scale (VAS) scores of CHH. Secondary outcomes will include changes in skin temperature of the hands, Clinical Global Impressions (CGI) scale scores, recovery rate of skin temperature of the hands after the cold stress test, and the Korean version of the WHO Quality of Life Scale, abbreviated version (WHOQOL-BREF). DISCUSSION: This trial will be the first trial to reflect the newly defined disease range of CHH which was compiled by Korean medicine expert consensus. This study will provide considerable evidence for further large-scale trials and general clinical guidelines for CHH in the Korean medical field. TRIAL REGISTRATION: This study is registered at ClinicalTrials.gov, ID: NCT02645916 . Registered on 30 December 2015.

Reliability and validity of tongue color analysis in the prediction of symptom patterns in terms of East Asian Medicine.

OBJECTIVE: To examine whether color parameters of tongue inspection (TI) using a digital camera was reliable and valid, and to examine which color parameters serve as predictors of symptom patterns in terms of East Asian medicine (EAM). METHODS: Two hundred female subjects' tongue substances were photographed by a mega-pixel digital camera. Together with the photographs, the subjects were asked to complete Yin deficiency, Phlegm pattern, and Cold-Heat pattern questionnaires. Using three sets of digital imaging software, each digital image was exposure- and white balance-corrected, and finally L* (luminance), a* (red-green balance), and b* (yellow-blue balance) values of the tongues were calculated. To examine intra- and inter-rater reliabilities and criterion validity of the color analysis method, three raters were asked to calculate color parameters for 20 digital image samples. Finally, four hierarchical regression models were formed. RESULTS: Color parameters showed good or excellent reliability (0.627-0.887 for intra-class correlation coefficients) and significant criterion validity (0.523-0.718 for Spearman's correlation). In the hierarchical regression models, age was a significant predictor of Yin deficiency (ß = 0.192), and b* value of the tip of the tongue was a determinant predictor of Yin deficiency, Phlegm, and Heat patterns (ß = - 0.212, - 0.172, and - 0.163). Luminance (L*) was predictive of Yin deficiency (ß = -0.172) and Cold (ß = 0.173) pattern. CONCLUSION: Our results suggest that color analysis of the tongue using the L*a*b* system is reliable and valid, and that color parameters partially serve as symptom pattern predictors in EAM practice.