Changes in lymph node surgery in breast cancer and preoperative drug prescription analysis for postoperative pain management: A retrospective, cross-sectional study.

This study aimed to investigate the changes in lymph node surgery types and prescription patterns of postoperative medications for pain management in patients with breast cancer using national health insurance claim data from South Korea. The study population comprised patients with at least one record of a principal diagnosis of breast cancer (ICD-10 code: C50) from the national health insurance claim database between 2010 and 2019. Patients who underwent mastectomy or lumpectomy only once were selected for the analysis. Patients who underwent axillary lymph node dissection (ALND) with mastectomy or lumpectomy on the day of surgery were included in the ALND group, whereas those who underwent sentinel lymph node biopsy (SLNB) were included in the SLNB group. Prescription records of opioids before, after and on the date of breast cancer surgery were collected and categorized according to the opioid type. Multivariate logistic regression modeling was used to compare postoperative opioid prescriptions. The proportion of those undergoing ALND among 3,080 patients decreased consistently after 2014, while the proportion undergoing SLNB increased. Although the rate of pain medication prescription on the day of surgery was similar between the two groups, the rate of prescription of postoperative pain medication and anticancer agents was lower in the SLNB group than in the ALND group. Logistic regression modeling showed that the SLNB group had lower odds of receiving opioids than did the ALND group (Odds ratio (OR) = 0.727, Confidence Interval (CI) = 0.546-0.970). A consistent trend was observed when the model was adjusted for neoadjuvant chemotherapy and the use of preoperative pain medications (OR = 0.718, CI = 0.538-0.959). To manage postoperative pain and prevent chronic pain with minimal side effects, sufficient discussion among clinicians, patients, and other healthcare professionals is imperative, along with adequate treatment planning.

Analysis of factors associated with the use of Korean medicine after spinal surgery using a nationwide database in Korea.

Many patients in Korea use Korean Medicine (KM) after spine surgery, but related research is lacking. Therefore, this retrospective cohort study aimed to analyze factors affecting the use and costs of KM using nationally representative data from the National Health Insurance Service-National Sample Cohort, South Korea. Patients who underwent spinal surgery for spinal diseases from 2011 to 2014 were followed up for 5 years, and their medical care was described. The association between patient and spinal surgery characteristics and the use of KM was analyzed. A two-part model was used to analyze factors affecting the use of KM in patients undergoing spinal surgery. Of 11,802 patients who underwent spinal surgery, 11,367 who met the inclusion criteria were included. Overall, 55.5% were female, 32.3% were aged ≥ 70 years, and 50.2% received KM treatment during the follow-up period. Open discectomy was the most common surgical procedure performed (58.6%), and 40.2% of surgeries were performed because of lumbar disc disorder. Female sex, older age, high Charlson Comorbidity Index score, and use of KM before surgery were associated with increased KM use and expenditure after surgery. In conclusion, patient characteristics, rather than surgical characteristics, appeared to be more strongly associated with the use of KM after surgery, particularly prior experience with KM use. This study is significant in that it analyzed the entire spine surgery to provide a comprehensive view of the use of KM after spine surgery and analyzed the impact of various factors related patients and surgical characteristics on KM use. The results of this study may be useful to patients with spinal diseases, clinicians, and policymakers.

Impact of extent of resection and postoperative radiotherapy on survival outcomes in intracranial solitary fibrous tumors: a systematic review and meta-analysis.

The knowledge of optimal treatments for patients with intracranial solitary fibrous tumor (SFT) is limited, with inconclusive results from previous studies. In this study, we conducted a meta-analysis of relevant studies to identify the prognostic impact of the extent of resection (EOR) and postoperative radiotherapy (PORT) on survival outcomes of patients with intracranial SFT. We searched the Medline, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) to identify relevant studies published till April 2022. Progression-free survival (PFS) and overall survival (OS) were the outcomes of interest. Differences between two cohorts (gross total resection [GTR] vs. subtotal resection [STR] and PORT vs. surgery only) were estimated by calculating hazard ratios. Twenty-seven studies were selected for the meta-analysis, including data of 1348 patients (GTR, n = 819 vs. STR, n = 381 and PORT, n = 723 vs. surgery only, n = 578). Pooled hazard ratios of PFS (1, 3, 5, and 10 years) and OS (3, 5, and 10 years) revealed that the GTR cohort showed sustained superiority over the STR cohort. In addition, the PORT cohort was superior to the surgery-only cohort with respect to all PFS periods. Although the 10-year OS between the two cohorts was not statistically different, PORT showed significantly better 3- and 5-year OS than surgery only. The study findings suggest that GTR and PORT provide significant benefits for PFS and OS. Aggressive surgical resection of tumors to achieve GTR followed by PORT should be implemented as optimal treatments for all patients with intracranial SFT when feasible.

The Opioid-Sparing Effect of Acupuncture After Abdominal Surgery: A Systematic Review and Meta-Analysis Protocol.

Purpose: Routine overprescribing of postoperative opioid analgesics may induce side effects and correlate with chronic opioid use following surgery. This review aims to evaluate the effectiveness and safety of acupuncture for opioid-sparing effects in patients who underwent abdominal surgery. Methods: Eleven databases in different languages, including English (Ovid MEDLINE, CENTRAL, EMBASE, CINAHL), Chinese, Korean, and Japanese, will be searched. Randomized controlled trials using acupuncture for postoperative pain control in adult patients undergoing abdominal surgery will be screened. All randomized controlled trials comparing acupuncture with no treatment, sham acupuncture, and conventional treatments will be included. The Cochrane risk of bias tool will be used to assess the risk of bias. The primary outcome will consist of a cumulative opioid consumption. Additionally, the number of cumulative opioid analgesic demands/requests, the time to initial opioid analgesic usage, postoperative pain, opioid-related side effects, and adverse events of acupuncture will be assessed. The mean differences or risk ratios with a 95% confidence interval will be calculated to estimate the pooled effect of acupuncture when it is possible to conduct a meta-analysis. Results: This study could confirm the effect of opioid-sparing on acupuncture after abdominal surgery. Conclusion: This study would evaluate the evidence on the effectiveness of acupuncture after abdominal surgery with a focus on opioid intake. It provides evidence to support decision-making on applying acupuncture for postoperative management. Registration Number: CRD42022311155.

A Study on the Perceptions of Korean Older Adult Patients and Caregivers about Polypharmacy and Deprescribing.

Polypharmacy is continuously increasing among older adults. The resultant potentially inappropriate medications (PIMs) can be harmful to patient health. Deprescribing refers to stopping or reducing PIMs. In this study, the current status of polypharmacy and willingness of older adults to deprescribe were investigated among patients and caregivers who are not associated with one another. The survey used the Korean translated version of the revised Patients' Attitude Towards Deprescribing (rPATD) Scale. Data were collected through an online survey of 500 participants (250 patients and caregivers each) in this study. The following results were found for patients and caregivers, respectively: 74.8% and 63.6% felt their number of medications was high, 64.4% and 55.6% desired to reduce their medications, 70.4% and 60.8% were concerned about medication discontinuation, 63.2% and 61.2% had a good understanding of their medications, 77.6% and 76.4% were willing to be well informed, and 79.6% and 72% wanted to reduce the number of medications if medically feasible. Patients and caregivers commonly agreed to the burden of the number of medications they were taking, and were willing to reduce the number of medications if the doctor said it was possible. Doctors should consider this information during the deprescribing process, and promote deprescription while involving patients and caregivers in the decision-making process.

Peer support for smoking cessation: a protocol of systematic review and meta-analysis.

BACKGROUND: Peer-support programs are a useful social support strategy for populations trying to quit smoking who are willing to maintain smoking abstinence. This study is a protocol for a systematic review and meta-analysis to assess the effectiveness of peer support for smoking cessation. METHODS: This protocol will be conducted in accordance with the Cochrane Handbook of Systematic Reviews of Interventions 6.2. We will conduct a comprehensive search in the Cochrane Central Register of Controlled Trials, ovidEmbase, PsycINFO, the Cumulative Index to Nursing and Allied Health Literature, ovidMEDLINE, Google Scholar, and Open Grey, as well as the Trials Register of Promoting Health Interventions in EPPI-Centre, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform, and reference lists of included papers. The review will include randomized controlled trials of peer support interventions aimed to stop smoking in any population. Two reviewers will independently screen and select relevant studies. Version 2 of the Cochrane tool that assesses risk of bias in randomized trials will be used to assess the risk of bias in the included studies. The primary outcomes will be defined as the tobacco abstinence rate and adverse events. If a quantitative synthesis is not appropriate, a synthesis without meta-analysis will be undertaken. DISCUSSION: This review will provide the best available evidence regarding the effects of peer support interventions to quit smoking. The results from this study will help to inform healthcare providers on the optimal peer support intervention modalities such as intensity, delivery methods, type of support provider, and duration of the intervention. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020196288.

Acupuncture as an adjuvant therapy for management of treatment-related symptoms in breast cancer patients: Systematic review and meta-analysis (PRISMA-compliant).

BACKGROUND: Although randomized controlled trials have revealed the considerable effectiveness of acupuncture in breast cancer patients, there have been no studies exploring current acupuncture research trends for treatment induced various symptoms in breast cancer patients. This review evaluated the effectiveness of acupuncture for treatment-induced symptoms in breast cancer patients. METHODS: We performed a systematic review and meta-analysis of the literature regarding acupuncture to treat symptoms associated with breast cancer therapies. The following databases were searched for relevant RCTs published before June 2018: MEDLINE, EMBASE, the Cochrane Library, AMED, CINAHL, OASIS, CNKI, and CiNii. RESULTS: Among the 19,483 records identified, 835 articles remained after screening titles and abstracts. A total of 19 RCTs were included in this qualitative synthesis. Among the studies, 8 explored climacteric symptoms, 4 explored pain, 2 explored lymphedemas, 2 explored nausea and vomiting and 3 investigated miscellaneous symptoms.explored miscellaneous symptoms due to cancer treatments. Most of the studies reported that acupuncture can alleviate various symptoms of breast cancer treatment. However, there is a lack of evidence as to whether accupuncture can alleviate chemotherapy associated side effects CONCLUSIONS:: Acupuncture may alleviate the treatment-related symptoms of breast cancer; however, further studies are necessary to obtain conclusive evidence of the effectiveness of acupuncture in treating breast cancer. REGISTRATION NUMBER: CRD42018087813.

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).

Effectiveness, safety, and economic evaluation of adjuvant moxibustion therapy for aromatase inhibitor-induced arthralgia of postmenopausal breast cancer stage I to III patients: Study protocol for a prospective, randomized, assessor-blind, usual-care controlled, parallel-group, pilot clinical trial.

INTRODUCTION: This study is a prospective, assessor-blinded, parallel-group, randomized controlled pilot trial to explore the effectiveness of 12-week adjuvant moxibustion therapy for arthralgia in menopausal females at stage I to III breast cancer on aromatase inhibitor (AI) administration, compared with those receiving usual care. METHODS/DESIGN: Forty-six menopausal female patients with breast cancer who completed cancer therapy will be randomly allocated to either adjuvant moxibustion or usual care groups with a 1:1 allocation ratio. The intervention group will undergo 24 sessions of adjuvant moxibustion therapy with usual care for 12 weeks, whereas the control group will receive only usual care during the same period. The usual care consists of acetaminophen administration on demand and self-directed exercise education to manage AI-related joint pain. The primary outcome is the mean change of the worst pain level according to the Brief Pain Inventory-Short Form between the initial visit and the endpoint. The mean changes in depression, fatigue, and quality of life will also be compared between groups. Safety and pharmacoeconomic evaluations will also be included. DISCUSSION: Continuous variables will be compared by an independent t test or Wilcoxon rank-sum test between the adjuvant moxibustion and usual care groups. Adverse events will be analyzed using the chi-square or Fisher exact test. The statistical analysis will be performed by a 2-tailed test at a significance level of .05.

Epidemiology and medical service use for spontaneous pneumothorax: a 12-year study using nationwide cohort data in Korea.

OBJECTIVE: This study aimed to promote an understanding of spontaneous pneumothorax by analysing the prevalence rate and medical service use by patients with spontaneous pneumothorax according to sociodemographic characteristics. DESIGN: A 12-year nationwide study. SETTING: Data obtained from the Korean National Health Insurance Service Sharing Service. PARTICIPANTS: A total of 4658 participants who used medical services due to spontaneous pneumothorax between 2002 and 2013 in Korea. OUTCOME MEASURES: For those diagnosed with spontaneous pneumothorax, use of medical services, hospitalisation data, sociodemographics, comorbidity, treatment administered and medication prescribed were recorded. RESULTS: The annual prevalence of spontaneous pneumothorax ranged from 39 to 66 per 100 000 individuals, while the prevalence of hospitalisation due to spontaneous pneumothorax ranged from 18 to 36 per 100 000 individuals. The prevalence rate of spontaneous pneumothorax in Korea has increased since 2002. The male to female ratio was approximately 4-10:1, with a higher prevalence rate in men. By age, the 15-34 years old group, and particularly those aged 15-19 years old, showed the highest prevalence rate; the rate then declined before increasing again for those aged 65 years or older. In total, 47%-57% of patients with spontaneous pneumothorax underwent hospitalisation. The average number of rehospitalisations due to pneumothorax was 1.56 per person, and more than 70% of recurrences occurred within 1 year. Chronic obstructive pulmonary disease was the most common comorbidity. The average treatment period was 11 days as an outpatient and 14 days in-hospital. The average medical costs were $94.50 for outpatients and $2523 for hospital admissions. The most common treatment for spontaneous pneumothorax was oxygen inhalation and thoracostomy, and the most commonly prescribed medications were analgesics, antitussives and antibiotics. CONCLUSIONS: We here detailed the epidemiology and treatments for spontaneous pneumothorax in Korea. This information can contribute to the understanding of spontaneous pneumothorax.

[Complementary and Alternative Medicine for Breast Cancer Patients: An Overview of Systematic Reviews].

The application of systematic review (SR) has been increased rapidly in the field of cancer treatment. Complementary and alternative medicine (CAM) for cancer is no exception. The aim of this review is to evaluate and summarize systematic reviews on the CAM use in breast cancer patients. Search sources were Centre for Reviews and Dissemination (CRD), Cochrane Database of Systematic Reviews (CDSR), and PubMed. In addition, we assessed the quality of SR with the Assessing the Methodological Quality of Systematic Reviews (AMSTAR). This review did not consider control groups and outcomes. Thirty-four SRs met a set of criteria. According to interventions, there were twenty SRs which included yoga, acupuncture, and herbal medicines. Meta-analysis of 19 out of 34 reviews showed the followings: (1) acupuncture had a beneficial effect on the frequency of hot flushes, (2) yoga had a beneficial effect on depression and health-related QOL, (3) mindfulness-based stress reduction (MBSR) had a beneficial effect on anxiety and depression, (4) combination of herbal medicine and chemotherapy synergistically improved clinical outcomes, (5) acupuncture did not show significant effect on the severity of hot flushes and cancer-related pain, (6) yoga was unable to be confirmed as having an effect on cancer-related pain and physical well-being. Given the results of AMSTAR, 9 out of 34 reviews were of high quality and 3 reviews were deemed to be of low quality. In conclusion, since most SRs were at moderate or high quality levels, CAM could be helpful for treating specific symptoms related to breast cancer.

Complementary medicine use and costs in patients with breast cancer who experienced treatment-related side effects: A cross-sectional survey in Korea.

OBJECTIVES: Population-based information on the costs of complementary medicine for treatment-related side effects in patients with breast cancer is scarce. We aimed to investigate the prevalence and expenditure on complementary medicine in patients with breast cancer who experienced treatment-related side effects. DESIGN AND SETTING: Two datasets were analyzed: 1) a 2017 survey on direct and indirect costs for treatment-related side effects, which was completed by 100 patients with stage 0-IV breast cancer, and 2) a Korean representative cross-sectional survey (Patient Survey 2014) that examined the prevalence of integrative medicine in 41 patients with breast cancer. MAIN OUTCOME MEASURES: The direct and indirect costs for treatment-related side effects. RESULTS: In the first dataset, the mean total direct medical cost for complementary medicine was US$1,584 and the mean indirect cost was US$6,988 per patient per year. Some patients (6%) visited non-medical institutions to utilize complementary medicine and additionally spent US$460 per patient per year. Approximately one-third of participants reported a substantial-to-heavy financial burden for using complementary medicine. However, only 17% of patients got information about complementary medicine through their physician. In the second dataset, 49% of patients with breast cancer who were discharged from Korean Medicine hospitals in Patient Survey 2014 data indicated that integrative medicine had been used. CONCLUSIONS: Despite some complementary medicine could be reimbursed by National Health Insurance in Korea, a considerable number of patients reported an economic burden associated with their use of complementary medicine. Strategies for guiding patients to receive evidence-based and cost-effective complementary medicine are needed.

Clinical Effectiveness of Traditional and Complementary Medicine Interventions in Combination with Nicotine Replacement Therapy on Smoking Cessation: A Randomized Controlled Pilot Trial.

Background: Smoking is associated with many preventable diseases and deaths. Globally, more than 6 million deaths per year are related to smoking. This study aimed to evaluate the pragmatic effectiveness of traditional and complementary medicine (T&CM) interventions for the smoking cessation treatment and to calculate the incremental cost-effectiveness ratio (ICER) of these interventions. Methods: The study design was a pragmatic, open-label randomized trial. The hypothesis of this trial was that the smoking cessation success rate increases with the addition of T&CM methods. The intervention group was provided T&CM interventions in addition to nicotine replacement therapy (NRT) and counseling, whereas the control group was treated with only NRT and counseling. Individuals received treatment for 4 weeks, then follow-up care for 20 weeks. Results: Forty-one participants were enrolled and assigned to either an intervention group or a control group at a ratio of 1:1. The odds ratio values at 4 weeks were 1.96 (0.51-8.51) in intention-to-treat analysis and 3.27 (0.75-17.75) in per-protocol analysis. The amount of smoking (cigarettes) decreased in both groups: from 17.2 ± 10.31 (baseline) to 1.7 ± 3.02 (4 weeks) in the intervention group and from 12.9 ± 5.47 (baseline) to 3.3 ± 5.96 (4 weeks) in the control group. The total medical costs per patient were $212.20 USD in the intervention group and $170.80 in the control group. The adjusted ICER of T&CM interventions was $13,355. Conclusions: This pilot study evaluated the clinical feasibility of T&CM used in conjunction with NRT and counseling for the smoking cessation treatment. However, there was no statistically significant effectiveness of T&CM interventions to raise cessation success rate. This study demonstrates the necessity for further studies based on large-scale randomized controlled trials.

Effectiveness, safety, and economic evaluation of topical application of a herbal ointment, Jaungo, for radiation dermatitis after breast conserving surgery in patients with breast cancer (GREEN study): Study protocol for a randomized controlled trial.

INTRODUCTION: This is a prospective, open-label, parallel-group, randomized controlled trial that evaluates the effectiveness and safety of adjuvant application of Jaungo (JUG) for radiation-induced dermatitis (RD) in breast cancer patients undergoing radiation therapy, in comparison with general supportive care (GSC). METHODS/DESIGN: Eighty female patients, who have been diagnosed with unilateral breast cancer, will be allocated to either the JUG or GSC group with an allocation ratio of 1:1 after breast conservation surgery, in the Kyung Hee University Korean Medicine Hospital, Seoul, Republic of Korea. Both the groups will be subjected to GSC, but only the JUG group participants will apply adjuvant JUG ointment on the irradiated skin for 6 weeks, twice a day. The primary outcome of this study is the assessment of incidence rate of RD using the Radiation Therapy Oncology Group (RTOG) for toxicity gradation of 2 or more. Maximum pain level, quality of life, adverse reactions, and pharmacoeconomic evaluations will also be included. DISCUSSION: The primary outcome will be statistically compared using the logrank test after estimating the survival curve using the Kaplan-Meier method. Continuous variables will be tested using independent t test or Mann-Whitney U test. The adverse events will be evaluated with Chi-square or Fisher exact test. All the data will be analyzed at a significance level of 0.05 (two-sided) with R software (The R Foundation). TRIAL REGISTRATION: CRIS (Clinical Research Information Service), KCT0003506, 14 February 2019.

Procalcitonin as a prognostic marker for outcomes in post-cardiac arrest patients: A systematic review and meta-analysis.

AIM: This study aimed to seek evidence for the usefulness of the procalcitonin as a prognostic blood biomarker for outcomes in post-cardiac arrest patients. METHODS: We systematically searched MEDLINE, EMBASE, and the Cochrane Library (search date: 8 January, 2019). Studies on patients who experienced return of spontaneous circulation, who had out of hospital cardiac arrest and had their level of procalcitonin measured and outcomes assessed at and after hospital discharge, were included. We additionally performed subgroup analyses for confounding factors affecting patients' outcomes. To assess the risk of bias of each included study, the Quality in Prognosis Studies tool was used. RESULTS: A total of 1065 patients from 10 studies were finally included. Elevated procalcitonin level during hospital admission (at 0-24 h) was associated with in-hospital mortality (standardized mean difference (SMD) 0.64, 95% confidence interval (CI) 0.33-0.95, I2 = 26%). The elevation of procalcitonin level (at 0-48 h) was also associated with poor neurologic outcomes (at 0-24 h, SMD 0.61; 95% CI 0.44-0.79, I2 = 0%; at 24-48 h, SMD 0.58, 95% CI 0.35-0.82, I2 = 0%) as well as at 1-6 months (at 24-48 h, SMD 0.62; 95% CI 0.36-0.88, I2 = 0%). CONCLUSIONS: Overall, the findings suggested that an elevated procalcitonin level measured at 0-48 h of post-cardiac arrest syndrome was associated with poor outcomes.

Utilization patterns of traditional medicine in Taiwan and South Korea by using national health insurance data in 2011.

BACKGROUND: The growing popularity of traditional medicine (TM) is reflected in the increasing trend for its use worldwide. Many people are turning to use TM as a complementary or integrative treatment. The aim of this study is to present the first nationwide report describing the use of TM in two countries (South Korea and Taiwan). MATERIALS AND METHODS: To present the TM utilization patterns between South Korea and Taiwan, we analyzed data from the National Health Insurance cohorts in each country, each of which has approximately one million inhabitants. RESULTS: In total, 261,478 (25.5%) of 1,025,340 people in South Korea and 260,529 (26.8%) of 970,866 people in Taiwan used TM services at least once under the National Health Insurance in 2011. Using multivariable logistic regression, TM users in South Korea were significantly more likely to be female, 61-80 years of age and individuals with a high income, and those in Taiwan were significantly more likely to be female, 21-40 years of age and individuals with a middle income. The two countries showed similar utilization patterns in visit seasons. People visited TM clinics more frequently than TM hospitals in both countries. The most common TM treatment in South Korea was acupuncture, whereas in Taiwan, various powdered Chinese herbal preparations were the most commonly used treatment. The most common diseases for people seeking TM services were musculoskeletal system and connective tissue diseases in South Korea and Symptoms, signs, and ill-defined conditions in Taiwan. CONCLUSION: According to the National Health Insurance database, about one fourth of the NHI beneficiaries of South Korea and Taiwan had TM use in 2011. Different TM utilization patterns existed between South Korea and Taiwan, which might be due to the differences in insurance coverage between the two countries.

Corrigendum to "Efficacy and Safety of Sipjeondaebo-Tang for Anorexia in Patients with Cancer: A Pilot, Randomized, Double-Blind, Placebo-Controlled Trial".

[This corrects the article DOI: 10.1155/2017/8780325.].

Single-arm, open-label, dose-escalation phase I study to evaluate the safety of a herbal medicine SH003 in patients with solid cancer: a study protocol.

INTRODUCTION: Cancer is a major health problem worldwide and the leading cause of death in many countries. The number of patients with cancer and socioeconomic costs of cancer continues to increase. SH003 is a novel herbal medicine consisting of Astragalus membranaceus, Angelica gigas and Trichosanthes Kirilowii Maximowicz. Preclinical studies have shown that SH003 has therapeutic anticancer effects. The aim of this study is to determine the maximum tolerated dose of SH003 in patients with solid cancers. METHODS AND ANALYSIS: This study is an open-label, dose-escalation trial evaluating the safety and tolerability of SH003. The traditional 3+3 dose-escalation design will be implemented. Patients with solid cancers will be recruited. According to dose level, the patients will receive one to four tablets of SH003, three times a day for 3 weeks. Toxicity will be evaluated using common terminology criteria for adverse events (CTCAE). Dose-limiting toxicities are defined as grade 3 or higher adverse events based on CTCAE. The maximum tolerated dose will be determined by the highest dose at which no more than one of six patients experiences dose-limiting toxicity. ETHICS AND DISSEMINATION: This study has been approved by the institutional review board of the Ajou University Hospital (reference AJIRB-MED-CT1-16-311). The results of this study will be disseminated through a scientific journal and a conference. TRIAL REGISTRATION NUMBER: NCT03081819; Pre-results.

Maekmoondong-tang in treatment of postoperative cough in patients with lung cancer: Study protocol for a randomized, double-blind, placebo-controlled, multicenter trial.

BACKGROUND: Cough is a common symptom that occurs in 25% of patients after lung cancer surgery. It might last a long time and degrade the quality of life of patients. Maekmoondong-tang (Bakumondo-to in Japanese or Mai-Men-Dong-Tang in Chinese) is a herbal medicine which has been widely used for respiratory diseases with cough in Korea, China, and Japan. AIMS: The aim of the present study is to evaluate the efficacy and safety of Maekmoondong-tang for postoperative cough in patient with lung cancer. METHODS/DESIGN: This study is a randomized, double-blind, placebo-controlled, multicenter trial of Maekmoondong-tang. A total of 96 participants will be enrolled and allocated to 2 parallel groups: the Maekmoondong-tang group and the placebo group from 5 university hospitals. The participants will be administered either Maekmoondong-tang or a placebo 3 times a day for 4 weeks. The primary outcome measurement is the change in the Leicester Cough Questionnaire (LCQ) score. The secondary outcome measurements are the changes in the cough visual analog scale and Yin Deficiency Scale. The participants will visit 4 times in total for 4 weeks of trial period. DISCUSSION: The present study will be the first multicener study to evaluate the efficacy and safety of Maekmoondong-tang for postoperative cough in patient with lung cancer surgery. The results of this study will provide a new treatment for cough using herbal medicine and will be a reference for planning clinical trial of herbal medicine in patient with cough.

Sipjeondaebo-tang in patients with breast cancer with fatigue: a protocol for a pilot, randomised, double-blind, placebo-controlled, cross-over trial.

INTRODUCTION: Cancer-related fatigue is a frequent symptom in patients with cancer and one of the most distressing symptoms in patients with breast cancer. Sipjeondaebo-tang (Juzen-taiho-to in Japanese or Shi-Quan-Da-Bu-Tang in Chinese) is a widely used herbal medicine for the treatment of fatigue in Korea, China and Japan. The purpose of the present study is to evaluate the feasibility of Sipjeondaebo-tang for cancer-related fatigue. METHODS AND ANALYSIS: The present study is a randomised, double-blind, placebo-controlled, cross-over study. Forty-eight patients with breast cancer who are indicated for doxorubicin and cyclophosphamide will be recruited. The participants will receive 3 g of Sipjeondaebo-tang or a placebo three times a day for 56 days. The primary outcome measurement is the change in the Brief Fatigue Inventory scores. The secondary outcome measurements include the changes in the Visual Analogue Scale (VAS) of fatigue, and quality of life measured by the European Organization for Research and Treatment of Cancer-QLQ-C30 and QLQ-BR23. VAS of fatigue will be measured on every visit, and other outcomes will be measured on visits 2, 4, 6 and 7. The total study period is 14 weeks. ETHICS AND DISSEMINATION: This study has been approved by the Institutional Review Board of the Catholic Kwandong University International St Mary's Hospital (reference IS16MNSI0011). The results of this study will be published in a peer-reviewed journal and presented at a scientific conference. TRIAL REGISTRATION NUMBER: NCT02858856; Pre-results.