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

Background. Anorexia occurs in about half of cancer patients and is associated with high mortality rate. However, safe and long-term use of anorexia treatment is still an unmet need. Objective. The purpose of the present study was to examine the feasibility of Sipjeondaebo-tang (Juzen-taiho-to, Shi-Quan-Da-Bu-Tang) for cancer-related anorexia. Methods. A total of 32 participants with cancer anorexia were randomized to either Sipjeondaebo-tang group or placebo group. Participants were given 3 g of Sipjeondaebo-tang or placebo 3 times a day for 4 weeks. The primary outcome was a change in the Anorexia/Cachexia Subscale of Functional Assessment of Anorexia/Cachexia Therapy (FAACT). The secondary outcomes included Visual Analogue Scale (VAS) of anorexia, FAACT scale, and laboratory tests. Results. Anorexia and quality of life measured by FAACT and VAS were improved after 4 weeks of Sipjeondaebo-tang treatment. However, there was no significant difference between changes of Sipjeondaebo-tang group and placebo group. Conclusions. Sipjeondaebo-tang appears to have potential benefit for anorexia management in patients with cancer. Further large-scale studies are needed to ensure the efficacy. Trial Registration. This trial is registered with ClinicalTrials.gov NCT02468141

A pilot study to evaluate the effect of Taeumjowi-tang on obesity in Korean adults: study protocol for a randomised, double-blind, placebo-controlled, multicentre trial

<p>Abstract</p> <p>Background</p> <p>Obesity, which is described as excessive or abnormal body fat, increases the risk of diet-related diseases. In Korea and around the world, the prevalence of obesity has grown annually from 1998 to 2008. This growth has continued despite various therapeutic efforts. The discovery of new and alternative treatments for obesity should be considered an important priority. Taeumjowi-tang (TJ001), a traditional Korean medicinal extract consisting of eight herbs, is a widely used herbal remedy for obesity in Korea. However, the efficacy and safety of TJ001 have not been fully investigated in a clinical trial. The purpose of this pilot study is to estimate obesity-related parameters and to assess the efficacy and safety of TJ001.</p> <p>Methods</p> <p>Our study is a randomised, double-blind, placebo-controlled, multicentre clinical trial of Taeumjowi-tang (TJ001). For this study, we will recruit obese Korean patients of both sexes, ages 18 to 65 years, from four university hospitals. A total of 104 subjects will be recruited. The participants will receive either 7 g of TJ001 or a placebo three times daily for 12 weeks. The primary end point will be the rate of subjects who lose at least 5% of their baseline body weight. The secondary end points will be changes in body weight, body mass index, waist circumference, hip circumference, waist/hip circumference ratio, lipid profiles, body fat composition, blood pressure, fasting glucose concentration, C-reactive protein and questionnaires related to the quality of life. The outcomes will be measured every 4 weeks. The study period will be 12 weeks and will include a total of five visits with each subject (at screening and at 0, 4, 8 and 12 weeks).</p> <p>Conclusions</p> <p>The results of our study will inform various estimates of TJ001 and will serve as the basis for a larger-scale trial. This study will assess the efficacy and safety of TJ001 as an alternative herbal remedy for obesity.</p> <p>Trial registration</p> <p>Current Controlled Trials <a href="http://www.controlled-trials.com/ISRCTN87153759">ISRCTN87153759</a></p

Overview on effectiveness of Qigong and Tai chi: a protocol for systematic review

1. Review title. Overview on Effectiveness of Qigong and Taichi: a protocol for systematic review 2. Anticipated or actual start date. (Give the date when the systematic review commenced, or is expected to commence.) 24/08/2020 3. Anticipated completion date. (Give the date by which the review is expected to be completed.) 31/05/2021 4. Stage of review at time of this submission. Preliminary searches: Completed Piloting of the study selection process: Completed Formal screening of search results against eligibility criteria: Completed Data extraction: Started Risk of bias (quality) assessment: Started Data analysis: Started Provide any other relevant information about the stage of the review here (e.g. Funded proposal, protocol not yet finalised). 5. Named contact. (The named contact acts as the guarantor for the accuracy of the information presented in the register record.) Chunhoo Cheon Email salutation (e.g. "Dr Smith" or "Joanne") for correspondence: Dr Cheon 6. Named contact email. (Give the electronic mail address of the named contact.) [email protected] 7. Named contact address (PLEASE NOTE this information will be published in the PROSPERO record so please do not enter private information. Give the full postal address for the named contact.) Department of Preventive medicine, Korean medicine College, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea 8. Named contact phone number. (Give the telephone number for the named contact, including international dialling code.) +822-961-2382 9. * Organisational affiliation of the review. (Full title of the organisational affiliations for this review and website address if available. This field may be completed as 'None' if the review is not affiliated to any organisation.) Kyung Hee University http://kmc.khu.ac.kr/eng/ 10. Review team members and their organisational affiliations. (Give the personal details and the organisational affiliations of each member of the review team. Affiliation refers to groups or organisations to which review team members belong. NOTE: email and country are now mandatory fields for each person.) Dr Chunhoo Cheon. Kyung Hee University Miss Su Hyeon Lee. Kyung Hee University Miss Yerim Jeon. Kyung Hee University Professor Seong-gyu Ko. Kyung Hee University 11. * Funding sources/sponsors. (Give details of the individuals, organizations, groups or other legal entities who take responsibility for initiating, managing, sponsoring and/or financing the review. Include any unique identification numbers assigned to the review by the individuals or bodies listed.) This work was supported by an undergraduate research program (URP) grant from Kyung Hee University College of Korean Medicine. 12. * Conflicts of interest. (List any conditions that could lead to actual or perceived undue influence on judgements concerning the main topic investigated in the review.) None 13. Collaborators. (Give the name and affiliation of any individuals or organisations who are working on the review but who are not listed as review team members. NOTE: email and country are now mandatory fields for each person.) None 14. Review question. (State the question(s) to be addressed by the review, clearly and precisely. Review questions may be specific or broad. It may be appropriate to break very broad questions down into a series of related more specific questions. Questions may be framed or refined using PI(E)COS where relevant.) 1. Do Qigong and Tai chi have an effect on various health conditions? 2. For which diseases were Qigong and Tai Chi studies conducted? 15. Searches. (State the sources that will be searched. Give the search dates, and any restrictions (e.g. language or publication period). The following electronic databases will be searched: PubMed, EMBASE, Cochrane Library, Korean databases and Chinese databases. The search terms will be the MeSH terms of 'qigong', 'taichi', and 'systematic review'. 16. Condition or domain being studied. (Give a short description of the disease, condition or healthcare domain being studied. This could include health and wellbeing outcomes.) Any type of health conditions 17. * Participants/population. (Give summary criteria for the participants or populations being studied by the review. The preferred format includes details of both inclusion and exclusion criteria.) People who have performed Qigong or Tai chi for the purpose of improving health 18. Intervention(s), exposure(s). (Give full and clear descriptions or definitions of the nature of the interventions or the exposures to be reviewed.) Qigong or Taichi 19. Comparator(s)/control. (Where relevant, give details of the alternatives against which the main subject/topic of the review will be compared (e.g. another intervention or a non-exposed control group). The preferred format includes details of both inclusion and exclusion criteria.) No specific restriction 20. * Types of study to be included. (Give details of the types of study (study designs) eligible for inclusion in the review. If there are no restrictions on the types of study design eligible for inclusion, or certain study types are excluded, this should be stated. The preferred format includes details of both inclusion and exclusion criteria.) Systematic review 21. Main outcome(s). (Give the pre-specified main (most important) outcomes of the review, including details of how the outcome is defined and measured and when these measurement are made, if these are part of the review inclusion criteria.) All health-related outcomes observed after performing Qigong or Taichi * Measures of effect (Please specify the effect measure(s) for you main outcome(s) e.g. relative risks, odds ratios, risk difference, and/or 'number needed to treat.) Not specific 22. Additional outcome(s). (List the pre-specified additional outcomes of the review, with a similar level of detail to that required for main outcomes. Where there are no additional outcomes please state ‘None’ or ‘Not applicable’ as appropriate to the review) For what diseases qigong or Taichi applies. * Measures of effect (Please specify the effect measure(s) for you additional outcome(s) e.g. relative risks, odds ratios, risk difference, and/or 'number needed to treat.) Not applicable 23. Data extraction (selection and coding). (Describe how studies will be selected for inclusion. State what data will be extracted or obtained. State how this will be done and recorded.) Two independent researchers will review all articles and extract the data using a standard data extraction form. Any disagreement between the authors will be resolved by discussion or third party arbitration. 24. * Risk of bias (quality) assessment. (Describe the method of assessing risk of bias or quality assessment. State which characteristics of the studies will be assessed and any formal risk of bias tools that will be used.) AMSTAR (A MeaSurement Tool to Assess systematic Reviews) will be used to assess risk of bias. Two researchers will assess the AMSTAR independently. 25. Strategy for data synthesis. (Provide details of the planned synthesis including a rationale for the methods selected. This must not be generic text but should be specific to your review and describe how the proposed analysis will be applied to your data.) The data will be narratively synthesized. 26. Analysis of subgroups or subsets. (State any planned investigation of ‘subgroups’. Be clear and specific about which type of study or participant will be included in each group or covariate investigated. State the planned analytic approach.) Subgroup analysis will be conducted according to the disease and the type of qigong. 27. Type and method of review. (Select the type of review and the review method from the lists below. Select the health area(s) of interest for your review.) Type of review- Intervention, Narrative synthesis, Review of reviews, Systematic review Health area of the review-Complementary therapies 28. Language. English 29. Country. South Korea 30. Dissemination plans. (Give brief details of plans for communicating essential messages from the review to the appropriate audiences. Do you intend to publish the review on completion?) Yes 31. Current review status. (Review status should be updated when the review is completed and when it is published. For new registrations the review must be Ongoing.) Ongoin

Synergistic effects of herbal medicines and anticancer drugs: A protocol for systematic review and meta analysis

1. Review title. Synergistic effects of herbal medicines and anticancer drugs: A protocol for systematic review and meta analysis 2. Anticipated or actual start date. 01/10/2021 3. Anticipated completion date. 31/03/2022 4. Stage of review at time of this submission. Preliminary searches: No Started Piloting of the study selection process: No Started Formal screening of search results against eligibility criteria: No Started Data extraction: No Started Risk of bias (quality) assessment: No Started Data analysis: No Started 5. Named contact. Chunhoo Cheon 6. Named contact email. [email protected] 7. Named contact address Department of Preventive medicine, Korean medicine College, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea 8. Named contact phone number. +822-961-2382 9. Organisational affiliation of the review. Kyung Hee University Korean Medicine-Based Drug Repositioning Cancer Research Center http://kdcrc.kr 10. Review team members and their organisational affiliations. Dr Chunhoo Cheon. Kyung Hee University 11. Funding sources/sponsors. This research was supported by a grant of the National Research Foundation of Korea (NRF) grant funded by the Korea government (MSIT) (No. 2020R1A5A2019413) and the Korea Health Technology R&amp;D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health &amp; Welfare, Republic of Korea (grant number: HI18C2382). 12. Conflicts of interest. None 13. Collaborators. None 14. Review question. Which herbal medicines show a synergistic effect when combined with anticancer drugs? 15. Searches. The following electronic databases will be searched: PubMed, EMBASE, Cochrane Library, Korean databases and Chinese databases. The search terms will be the MeSH terms of ' Antineoplastic Agents', 'Phytotherapy', and 'Drug Synergism'. 16. Condition or domain being studied. Cancer 17. Participants/population. Patient with cancer or cancer model 18. Intervention(s), exposure(s). Herbal medicine combined with anticancer drug 19. Comparator(s)/control. No specific restriction 20. Types of study to be included. no restriction 21. Main outcome(s). Synergistic effect of herbal medicine and anticancer drug 22. Additional outcome(s). None 23. Data extraction (selection and coding). Two independent researchers will review all articles and extract the data using a standard data extraction form. Any disagreement between the authors will be resolved by discussion or third party arbitration. 24. Risk of bias (quality) assessment. RoB 2 tool (revised tool for Risk of Bias in randomized trials) will be used to assess risk of bias of randomized controlled trials. 25. Strategy for data synthesis. The data will be narratively synthesized. 26. Analysis of subgroups or subsets. Subgroup analysis will be conducted according to the herbal medicine and anticancer drug. 27. Type and method of review. Type of review- Intervention, Narrative synthesis Health area of the review-Complementary therapies 28. Language. English 29. Country. South Korea 30. Dissemination plans. Do you intend to publish the review on completion? Yes 31. Current review status. Ongoin

Synergistic effect of herbal medicines and anticancer drugs: A protocol for systematic review and meta analysis

This is a protocol for systematic review on synergistic effect of herbal medicines and anticancer drugs. 1. Review title. Synergistic effect of herbal medicines and anticancer drugs: A protocol for systematic review and meta analysis 2. Anticipated or actual start date. 01/10/2021 3. Anticipated completion date. 31/03/2022 4. Stage of review at time of this submission. Preliminary searches: No Started Piloting of the study selection process: No Started Formal screening of search results against eligibility criteria: No Started Data extraction: No Started Risk of bias (quality) assessment: No Started Data analysis: No Started 5. Named contact. Chunhoo Cheon 6. Named contact email. [email protected] 7. Named contact address Department of Preventive medicine, Korean medicine College, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea 8. Named contact phone number. +822-961-2382 9. Organisational affiliation of the review. Kyung Hee University Korean Medicine-Based Drug Repositioning Cancer Research Center http://kdcrc.kr 10. Review team members and their organisational affiliations. Dr Chunhoo Cheon. Kyung Hee University 11. Funding sources/sponsors. This research was supported by a grant of the National Research Foundation of Korea (NRF) grant funded by the Korea government (MSIT) (No. 2020R1A5A2019413). 12. Conflicts of interest. None 13. Collaborators. None 14. Review question. Which herbal medicines show a synergistic effect when combined with anticancer drugs? 15. Searches. The following electronic databases will be searched: PubMed, EMBASE, Cochrane Library, Korean databases and Chinese databases. The search terms will be the MeSH terms of ' Antineoplastic Agents', 'Phytotherapy', and 'Drug Synergism'. 16. Condition or domain being studied. Cancer 17. Participants/population. Patient with cancer or cancer model 18. Intervention(s), exposure(s). Herbal medicine combined with anticancer drug 19. Comparator(s)/control. No specific restriction 20. Types of study to be included. no restriction 21. Main outcome(s). Synergistic effect of herbal medicine and anticancer drug 22. Additional outcome(s). None 23. Data extraction (selection and coding). Two independent researchers will review all articles and extract the data using a standard data extraction form. Any disagreement between the authors will be resolved by discussion or third party arbitration. 24. Risk of bias (quality) assessment. RoB 2 tool (revised tool for Risk of Bias in randomized trials) will be used to assess risk of bias of randomized controlled trials. 25. Strategy for data synthesis. The data will be narratively synthesized. 26. Analysis of subgroups or subsets. Subgroup analysis will be conducted according to the herbal medicine and anticancer drug. 27. Type and method of review. Type of review- Intervention, Narrative synthesis Health area of the review-Complementary therapies 28. Language. English 29. Country. South Korea 30. Dissemination plans. Do you intend to publish the review on completion? Yes 31. Current review status. Ongoin

Synergistic effect of herbal medicine and anticancer drug: A protocol for systematic review

1. Review title. Synergistic effect of herbal medicine and anticancer drug: A protocol for systematic review 2. Anticipated or actual start date. 01/10/2021 3. Anticipated completion date. 31/03/2022 4. Stage of review at time of this submission. Preliminary searches: No Started Piloting of the study selection process: No Started Formal screening of search results against eligibility criteria: No Started Data extraction: No Started Risk of bias (quality) assessment: No Started Data analysis: No Started 5. Named contact. Chunhoo Cheon 6. Named contact email. [email protected] 7. Named contact address Department of Preventive medicine, Korean medicine College, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea 8. Named contact phone number. +822-961-2382 9. Organisational affiliation of the review. Kyung Hee University Korean Medicine-Based Drug Repositioning Cancer Research Center http://kdcrc.kr 10. Review team members and their organisational affiliations. Dr Chunhoo Cheon. Kyung Hee University 11. Funding sources/sponsors. This research was supported by a grant of the National Research Foundation of Korea (NRF) grant funded by the Korea government (MSIT) (No. 2020R1A5A2019413). 12. Conflicts of interest. None 13. Collaborators. None 14. Review question. Which herbal medicines show a synergistic effect when combined with anticancer drugs? 15. Searches. The following electronic databases will be searched: PubMed, EMBASE, Cochrane Library, Korean databases and Chinese databases. The search terms will be the MeSH terms of ' Antineoplastic Agents', 'Phytotherapy', and 'Drug Synergism'. 16. Condition or domain being studied. Cancer 17. Participants/population. Patient with cancer or cancer model 18. Intervention(s), exposure(s). Herbal medicine combined with anticancer drug 19. Comparator(s)/control. No specific restriction 20. Types of study to be included. no restriction 21. Main outcome(s). Synergistic effect of herbal medicine and anticancer drug 22. Additional outcome(s). None 23. Data extraction (selection and coding). Two independent researchers will review all articles and extract the data using a standard data extraction form. Any disagreement between the authors will be resolved by discussion or third party arbitration. 24. Risk of bias (quality) assessment. RoB 2 tool (revised tool for Risk of Bias in randomized trials) will be used to assess risk of bias of randomized controlled trials. 25. Strategy for data synthesis. The data will be narratively synthesized. 26. Analysis of subgroups or subsets. Subgroup analysis will be conducted according to the herbal medicine and anticancer drug. 27. Type and method of review. Type of review- Intervention, Narrative synthesis Health area of the review-Complementary therapies 28. Language. English 29. Country. South Korea 30. Dissemination plans. Do you intend to publish the review on completion? Yes 31. Current review status. Ongoin

Epidemiology and Seasonal Variation of Ménière’s Disease: Data from a Population-Based Study

&lt;b&gt;&lt;i&gt;Introduction:&lt;/i&gt;&lt;/b&gt; Ménière’s disease (MD) is a disease of the inner ear. In Asian countries, there is one previous epidemiologic study that used a retrospective survey of a specific district. Previous studies have demonstrated that weather variables are strongly associated with symptom aggravation in MD. However, no study has reported on seasonal variation of MD. &lt;b&gt;&lt;i&gt;Methods:&lt;/i&gt;&lt;/b&gt; We conducted a retrospective population-based study using the Korean national health insurance claims database (NHICD). In the present study, the prevalence and incidence of MD from 2013 to 2017 were calculated. Prevalence and incidence of MD according to sex, age group, and monthly incidence are presented. Seasonal incidence was calculated for four seasons. The seasonal average humidity and atmospheric pressure were also calculated. &lt;b&gt;&lt;i&gt;Results:&lt;/i&gt;&lt;/b&gt; The incidence rate of MD showed a rapid yearly increase from 2013 to 2017 in Korea. The prevalence and incidence rate by age group continued to increase up to the 70 year olds. The female-to-male ratio was 2.17. The seasonal incidence of MD was relatively high in summer and autumn and relatively low in winter and spring; however, there were no significant differences. &lt;b&gt;&lt;i&gt;Discussion/Conclusions:&lt;/i&gt;&lt;/b&gt; The rapid progression to an aging society, increase in medical accessibility, and lifestyle changes could be the reasons for the elevation of the incidence rate in the Korean population. Consistent with a previous study, the incidence of MD was higher in seasons with high humidity and low atmospheric pressure; however, there were no significant differences. Further studies about the relationship between diet and MD, seasonality of MD with long-term analysis, and investigating the underlying mechanisms connecting weather and MD are needed.</jats:p