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1. Appraising the safety and reporting quality of thread-embedding acupuncture: a protocol for a systematic review and meta-analysis

Author

Yongjoo Kim, Joo-Hee Kim, Dong Hyuk Lee, Yeonju Woo, Bo-In Kwon, Jin-woo Suh, Bonhyuk Goo, and Sang-Soo Nam

Subjects
Medicine
Abstract

Introduction Thread-embedding acupuncture (TEA) is a special type of acupuncture treatment in which medical threads are inserted into subcutaneous tissues or muscles at therapeutic points. TEA is a medical practice that combines acupuncture and medical threads. As such, it is necessary to evaluate the safety of TEA. This systematic review and meta-analysis aimed to assess the safety of TEA and reporting quality of studies regarding TEA.Methods and analysis The systematic review will be conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and the Cochrane Handbook for Systematic Reviews of Interventions. Searching strategies will be systemically conducted using the following databases from their inception date to September 2022: MEDLINE, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), CiNii, J-STAGE, Korean Medical Database, Korean Studies Information Service System (KISS), ScienceON and Oriental Medicine Advanced Searching Integrated System (OASIS). The search strategies will be adjusted for each database as appropriate. The risk of bias will be assessed using the McMaster tool to identify the quality of harm assessment and reporting in study reports (McHarm). A meta-analysis will be used to synthesise the frequency and incidence of adverse events.Ethics and dissemination No ethical approval and consent is required for this systematic review. The results of this systematic review will be disseminated through peer-reviewed publications and conference presentations.PROSPERO registration number CRD42022297123.

Published
2022
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2. Current status of the spontaneous reporting and classification/coding system for herbal and traditional medicine in pharmacovigilance

Author

Mikyung Kim, Yeonju Woo, and Chang-ho Han

Subjects
Classification system, Coding system, Herbal medicine, Spontaneous reporting system, Pharmacovigilance, Miscellaneous systems and treatments, RZ409.7-999
Abstract

Background: While the use of herbal and traditional medicine (H&TM) has been extensive worldwide, the current status of H&TM management in pharmacovigilance remains to be investigated. To date, there is little information regarding the use of the classification/coding system (CCS) to detect signals for certain drugs within databases built on the basis of the spontaneous reporting system (SRS). The purpose of this study is to investigate the status of the SRS and CCS for H&TM in the pharmacovigilance systems of various countries around the world. Methods: An e-mail survey was performed from late December 2018 to early January 2019 with 54 experts in pharmacovigilance. The results based on the information provided by the respondents were summarized. Results: Fourteen experts from 13 countries responded to the survey. Eleven countries/regions were found to already include H&TM in their SRSs, managing only limited range of H&TM. Of the 9 countries/regions that provided the information on the status of CCS for H&TM in their domestic pharmacovigilance systems, only China had a separate CCS for H&TM. Conclusion: Revising the current pharmacovigilance systems to include or expand the range of H&TM, and developing an internationally harmonized system to classify and code H&TM suitable to the unique characteristics of H&TM are critical and overall beneficial.

Published
2021
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3. World Congress Integrative Medicine & Health 2017: part two

Author

Carolyn Ee, Sharmala Thuraisingam, Marie Pirotta, Simon French, Charlie Xue, Helena Teede, Agnete E. Kristoffersen, Fuschia Sirois, Trine Stub, Jennifer Engler, Stefanie Joos, Corina Güthlin, Jennifer Felenda, Christiane Beckmann, Florian Stintzing, Roni Evans, Gert Bronfort, Daniel Keefe, Anna Taberko, Linda Hanson, Alex Haley, Haiwei Ma, Joseph Jolton, Lana Yarosh, Francis Keefe, Jung Nam, Liwanag Ojala, Mary J. Kreitzer, Careen Fink, Karin Kraft, Andrew Flower, George Lewith, Kim Harman, Beth Stuart, Felicity L. Bishop, Jane Frawley, Lilla Füleki, Eva Kiss, Tamas Vancsik, Tibor Krenacs, Martha Funabashi, Katherine A. Pohlman, Silvano Mior, Haymo Thiel, Michael D. Hill, David J. Cassidy, Michael Westaway, Jerome Yager, Eric Hurwitz, Gregory N. Kawchuk, Maeve O’Beirne, Sunita Vohra, Isabelle Gaboury, Chantal Morin, Katharina Gaertner, Loredana Torchetti, Martin Frei-Erb, Michael Kundi, Michael Frass, Eugenia Gallo, Valentina Maggini, Mattia Comite, Francesco Sofi, Sonia Baccetti, Alfredo Vannacci, Mariella Di Stefano, Maria V. Monechi, Luigi Gori, Elio Rossi, Fabio Firenzuoli, Rocco D. Mediati, Giovanna Ballerini, Paula Gardiner, Anna S. Lestoquoy, Lily Negash, Sarah Stillman, Prachi Shah, Jane Liebschutz, Pamela Adelstein, Christine Farrell-Riley, Ivy Brackup, Brian Penti, Robert Saper, Isabel Giralt Sampedro, Gilda Carvajal, Andreas Gleiss, Marie M. Gross, Dorothea Brendlin, Jonas Röttger, Wiebke Stritter, Georg Seifert, Noelle Grzanna, Rainer Stange, Peter W. Guendling, Wen Gu, Yan Lu, Jie Wang, Chengcheng Zhang, Hua Bai, Yuxi He, Xiaoxu Zhang, Zhengju Zhang, Dali Wang, Fengxian Meng, Alexander Hagel, Heinz Albrecht, Claudia Vollbracht, Wolfgang Dauth, Wolfgang Hagel, Francesco Vitali, Ingo Ganzleben, Hans Schultis, Peter Konturek, Jürgen Stein, Markus Neurath, Martin Raithel, Bianka Krick, Heidemarie Haller, Petra Klose, Gustav Dobos, Sherko Kümmel, Holger Cramer, Felix J. Saha, Anna Kowoll, Barbara Ebner, Bettina Berger, Kyung-Eun Choi, Lisha He, Han Wang, X. He, C. Gu, Y. Zhang, Linhua Zhao, Xiaolin Tong, Xinhui He, Chengjuan Gu, Ying Zhang, Robin S. T. Ho, Vincent C. H. Chung, Xinyin Wu, Charlene H. L. Wong, Justin C. Y. Wu, Samuel Y. S. Wong, Alexander Y. L. Lau, Regina W. S. Sit, Wendy Wong, Michelle Holmes, Felicity Bishop, Lynn Calman, Dave Newell, Jonathan Field, Win L. Htut, Dongwoon Han, Da I. Choi, Soo J. Choi, Ha Y. Kim, Jung H. Hwang, Ching W. Huang, Bo H. Jang, Fang P. Chen, Seong G. Ko, Wenjing Huang, De Jin, Fengmei Lian, Soobin Jang, Kyeong H. Kim, Eun K. Lee, Seung H. Sun, Ho Y. Go, Youme Ko, Sunju Park, Yong C. Shin, Hubert Janik, Natalie Greiffenhagen, Jürgen Bolte, Mariusz Jaworski, Miroslawa Adamus, Aleksandra Dobrzynska, Michael Jeitler, Jessica Jaspers, Christel von Scheidt, Barbara Koch, Andreas Michalsen, Nico Steckhan, Christian Kessler, Wen-jing Huang, Bing Pang, Feng-Mei Lian, Miek Jong, Erik Baars, Anja Glockmann, Harald Hamre, Mosaburo Kainuma, Aya Murakami, Toshio Kubota, Daisuke Kobayashi, Yasuhiro Sumoto, Norihiro Furusyo, Shin-Ichi Ando, Takao Shimazoe, Olaf Kelber, S. Verjee, Eva Gorgus, Dieter Schrenk, Kathi Kemper, Ellie Hill, Nisha Rao, Gregg Gascon, John Mahan, Gunver Kienle, Jörg Dietrich, Claudia Schmoor, Roman Huber, Weon H. Kim, Mansoor Ahmed, Luzhu He, Jung Hye Hwang, Nora Meggyeshazi, Csaba Kovago, Anne K. Klaus, Roland Zerm, Danilo Pranga, Thomas Ostermann, Marcus Reif, Hans Broder von Laue, Benno Brinkhaus, Matthias Kröz, Daniela Rodrigues Recchia, Hans B. von Laue, Christien T. Klein-Laansma, Mats Jong, Cornelia von Hagens, Jean P. Jansen, Herman van Wietmarschen, Miek C. Jong, Seung-Ho Sun, Ho-Yeon Go, Chan-Yong Jeon, Yun-Kyung Song, Seong-Gyu Ko, Anna K. Koch, Sybille Rabsilber, Romy Lauche, Jost Langhorst, Milena Trifunovic-Koenig, Evi Koster, Diana Delnoij, Lena Kroll, Kathrin Weiss, Ai Kubo, Sarah Hendlish, Andrea Altschuler, Nancy Connolly, Andy Avins, Jon Wardle, David Lee, David Sibbritt, Jon Adams, Crystal Park, Gita Mishra, Johann Lechner, Inseon Lee, Younbyoung Chae, Jisu Lee, Seung H. Cho, Yujin Choi, Jee Y. Lee, Han S. Ryu, Sung S. Yoon, Hye K. Oh, Lyun K. Hyun, Jin O. Kim, Seong W. Yoon, Ju-Yeon Lee, Sang-Hoon Shin, Min Jang, Indra Müller, So-Hyun Janson Park, Lance Laird, Suzanne Mitchell, Xiaofei Li, Yunhui Wang, Jianhua Zhen, He Yu, Tiegang Liu, Xiaohong Gu, Hui Liu, Weiguo Ma, Xuezheng Shang, Yu Bai, Wei Liu, Collin Rooney, Amos Smith, Shirlene Lopes, Marcelo Demarzo, Maria do Patrocínio Nunes, Peter Lorenz, Carsten Gründemann, Miriam Heinrich, Manuel Garcia-Käufer, Franziska Grunewald, Silke Messerschmidt, Anja Herrick, Kim Gruber, Matthias Knödler, Carmen Steinborn, Taoying Lu, Lixin Wang, Darong Wu, Christina M Luberto, Daniel L. Hall, Emma Chad-Friedman, Suzanne Lechner, Elyse R. Park, Christina M. Luberto, Elyse Park, Janice Goodman, Sonja Luer, Matthias Heri, Klaus von Ammon, Ida Landini, Andrea Lapucci, Stefania Nobili, Enrico Mini, Clare McDermott, Selwyn Richards, Diane Cox, Sarah Frossell, Geraldine Leydon, Caroline Eyles, Hilly Raphael, Rachael Rogers, Michelle Selby, Charlotte Adler, Jo Allam, Xiangwei Bu, Honghong Zhang, Jianpeng Zhang, Michael Mikolasek, Jonas Berg, Claudia Witt, Jürgen Barth, Ivan Miskulin, Zdenka Lalic, Maja Miskulin, Albina Dumic, Damir Sebo, Aleksandar Vcev, Nasr A. A. Mohammed, Soo Jeung Choi, Hyea Bin Im, Anwesha Mukherjee, Amit Kandhare, Subhash Bodhankar, Prasad Thakurdesai, Niki Munk, Erica Evans, Amanda Froman, Matthew Kline, Matthew J. Bair, Frauke Musial, Terje Alræk, Harald J. Hamre, Lars Björkman, Vinjar M. Fønnebø, Feng-mei Lian, Qing Ni, Xiao-lin Tong, Xin-long Li, Wen-ke Liu, Shuo Feng, Xi-yan Zhao, Yu-jiao Zheng, Xue-min Zhao, Yi-qun Lin, Tian-yu Zhao, Xi-Yan Zhao, Hui Che Phd, Chen Zhang, Feng Liu, Lin-hua Zhao, Ru Ye, Cheng-juan Gu, Wenbo Peng, Diana De Carvalho, Mohamed El-Bayoumi, Bob Haig, Kimbalin Kelly, Darrell J. Wade, Emanuela Portalupi, Giampietro Gobo, Luigi Bellavita, Chiara Guglielmetti, Christa Raak, Myriam Teuber, Friedrich Molsberger, Ulrich von Rath, Ulrike Reichelt, Uta Schwanebeck, Sabine Zeil, Christian Vogelberg, Dolores Rodríguez Veintimilla, Guerrero Tapia Mery, Marisol Maldonado Villavicencio, Sandra Herrera Moran, Christian Sachse, Peter W Gündlin, Monirsadat Sahebkarkhorasani, Hoda Azizi, Dania Schumann, Tobias Sundberg, Matthew J. Leach, Susana Seca, Henry Greten, Sugir Selliah, Anu Shakya, Ha Yun Kim, Hyea B. Im, Anna Sherbakova, Gudrun Ulrich-Merzenich, Heba Abdel-Aziz, Erica Sibinga, Lindsey Webb, Jonathan Ellen, Kari Skrautvol, Dagfinn Nåden, Rhayun Song, Weronika Grabowska, Kamila Osypiuk, Gloria V. Diaz, Paolo Bonato, Moonkyoung Park, Jeffrey Hausdorff, Michael Fox, Lewis R. Sudarsky, Daniel Tarsy, James Novakowski, Eric A. Macklin, Peter M. Wayne, Inok Hwang, Sukhee Ahn, Myung-Ah Lee, Min K. Sohn, Oleg Sorokin, Dagmar Heydeck, Astrid Borchert, Christoph-Daniel Hohmann, Harmut Kühn, Clemens Kirschbaum, Tobias Stalder, Barbara Stöckigt, Michael Teut, Ralf Suhr, Daniela Sulmann, Chris Streeter, Patrica Gerbarg, Marisa Silveri, Richard Brown, John Jensen, Britta Rutert, Angelika Eggert, Alfred Längler, Christine Holmberg, Jin Sun, Xin Deng, Wen-Yuan Li, Bin Wen, Nicola Robinson, Jian-Ping Liu, Hyun K. Sung, Narae Yang, Seon M. Shin, Hee Jung, Young J. Kim, Woo S. Jung, Tae Y. Park, Kiyoshi Suzuki, Toshinori Ito, Seiya Uchida, Seika Kamohara, Naoya Ono, Mitsuyuki Takamura, Ayumu Yokochi, Kazuo Maruyama, Patricio Tapia, Katarzyna Thabaut, Anja Thronicke, Megan Steele, Harald Matthes, Cornelia Herbstreit, Friedemann Schad, Jiaxing Tian, Libo Yang, Tian Tian, Hewei Zhang, Xia Tian, CongCong Wang, Qian Yun Chai, Lijuan Zhang, Ruyu Xia, Na Huang, Yutong Fei, Jianpin Liu, Natalie Trent, Mindy Miraglia, Jeffrey Dusek, Edi Pasalis, Sat B. Khalsa, Milena Trifunovic-König, Anna Koch, Lisa Uebelacker, Geoffrey Tremont, Lee Gillette, Gary Epstein-Lubow, David Strong, Ana Abrantes, Audrey Tyrka, Tanya Tran, Brandon Gaudiano, Ivan Miller, Gerhild Ullmann, Yuhua Li, Sujata Vaidya, Vinod Marathe, Ana C. Vale, Jacquelyne Motta, Fabíola Donadão, Angela C. Valente, Luana C. Carvalho Valente, Ricardo Ghelman, Dusan Vesovic, Dragan Jevdic, Aleksandar Jevdic, Katarina Jevdic, Mihael Djacic, Dragica Letic, Drago Bozic, Marija Markovic, Slobodan Dunjic, Gordana Ruscuklic, Dezire Baksa, Kenan Vrca, Ann Vincent, Dietlind Wahner-Roedler, Mary Whipple, Maria M. Vogelius, Iris Friesecke, Peter W. Gündling, Saswati Mahapatra, Rebecca Hynes, Kimberly Van Rooy, Sherry Looker, Aditya Ghosh, Brent Bauer, Susanne Cutshall, Harald Walach, Ana Borges Flores, Michael Ofner, Andreas Kastner, Gerhard Schwarzl, Hermann Schwameder, Nathalie Alexander, Gerda Strutzenberger, Xianwei Bu, Jianping Zhang, Shang Wang, Jinfeng Shi, Yu Hao, Jun Wu, Zeji Qiu, Yuh-Hai Wang, Chi-Jung Lou, Sam Watts, Peter Wayne, Gloria Vergara-Diaz, Brian Gow, Jose Miranda, Lewis Sudarsky, Eric Macklin, Kathrin Wode, Jenny Bergqvist, Britt-Marie Bernhardsson, Johanna Hök Nordberg, Lena Sharp, Roger Henriksson, Yeonju Woo, Min K. Hyun, Hao Wu, Tian-Fang Wang, Yan Zhao, Yu Wei, Lei Tian, Lei He, Xue Wang, Ruohan Wu, Mei Han, Patrina H. Y. Caldwell, Shigang Liu, Jing Zhang, Jianping Liu, Qianyun Chai, Zhongning Guo, Congcong Wang, Zhijun Liu, Xun Li, I. J. Yang, V. Ruberio Lincha, S. H. Ahn, D. U. Lee, H. M. Shin, Lu Yang, N. Yang, H. Sung, S. M. Shin, H. Y. Go, H. Jung, Y. Kim, T. Y. Park, Angela Yap, Yu H. Kwan, Chuen S. Tan, Syed Ibrahim, Seng B. Ang, Alfred Yayi, Jeong E. Yoo, Ho R. Yoo, Sae B. Jang, Hye L. Lee, Ala’a Youssef, Shahira Ezzat, Amira Abdel Motaal, Hesham El-Askary, Xiaotong Yu, Yashan Cui, Younghee Yun, Jin-Hyang Ahn, Bo-Hyung Jang, Kyu-Seok Kim, Inhwa Choi, Augustina Glinz, Fadime ten Brink, Arnd Büssing, Christoph Gutenbrunner, Bert Helbrecht, Tiesheng Fang, Fengxion Meng, Zhiming Shen, Ruixin Zhang, Fan Wu, Ming Li, Xinyun Xuan, Xueyong Shen, Ke Ren, Brian Berman, Zian Zheng, Yuxiang Wan, Xueyan Ma, Fei Dong, Suzie Zick, Richard Harris, Go E. Bae, Jung N. Kwon, Hye Y. Lee, Jong K. Nam, Sang D. Lee, Dong H. Lee, Ji Y. Han, Young J. Yun, Ji H. Lee, Hye L. Park, Seong H. Park, Chiara Bocci, Giovanni B. Ivaldi, Ilaria Vietti, Ilaria Meaglia, Marta Guffi, Rubina Ruggiero, Marita Gualea, Emanuela Longa, Massimo Bonucci, Sarah Croke, Lourdes Diaz Rodriguez, Juan C. Caracuel-Martínez, Manuel F. Fajardo-Rodríguez, Angélica Ariza-García, Francisca García-De la Fuente, Manuel Arroyo-Morales, Maria S. Estrems, Vicente G. Gómez, Mónica Valero Sabater, Rosaria Ferreri, Simonetta Bernardini, Roberto Pulcri, Franco Cracolici, Massimo Rinaldi, Claudio Porciani, Peter Fisher, John Hughes, Ariadna Mendoza, Hugh MacPherson, Jacqueline Filshie, Antonia Di Francesco, Alberto Bernardini, Monica Messe, Vincenzo Primitivo, Piera A. Iasella, Monica Taminato, Jaqueline Do Carmo Alcantara, Katia R. De Oliveira, Debora C. De Azevedo Rodrigues, Juliana R. Campana Mumme, Olga K. Matsumoto Sunakozawa, Vicente Odone Filho, Joshua Goldenberg, Andrew Day, Masa Sasagawa, Lesley Ward, Kieran Cooley, Thora Gunnarsdottir, Ingibjorg Hjaltadottir, Mahdie Hajimonfarednejad, Nicole Hannan, Rut Hellsing, Susanne Andermo, Maria Arman, Iris von Hörsten, Patricia Vásquez Torrielo, Carmen L. Andrade Vilaró, Francisco Cerda Cabrera, Henny Hui, Eric Ziea, Dora Tsui, Joyce Hsieh, Christine Lam, Edith Chan, Mark P. Jensen, Samuel L. Battalio, Joy Chan, Karlyn A. Edwards, Kevin J. Gertz, Melissa A. Day, Leslie H. Sherlin, Dawn M. Ehde, Bo-Hyoung Jang, Anja Börner, Jihong Lee, Boram Lee, Gyu T. Chang, Alejandra Menassa, Yoshiharu Motoo, Jürgen Müller, Sabine Rabini, Bettina Vinson, Martin Storr, Martin Niemeijer, Joop Hoekman, Wied Ruijssenaaars, Faith C. Njoku, Arne J. Norheim, Filiz Okumus, and Halime Oncu-Celik

Subjects
Other systems of medicine, RZ201-999
Published
2017
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4. Effectiveness of Integrative Therapy for Parkinson’s Disease Management

Author

Yeonju Woo and Min Kyung Hyun

Subjects
Parkinson’s disease, integrative medicine, medicine, Korean traditional, complications, patient care, Neurosciences. Biological psychiatry. Neuropsychiatry, RC321-571
Abstract

Objectives: To investigate the effectiveness of integrative therapy on prevalence and length of hospitalization and management of major complications of Parkinson’s disease (PD) in the South Korea.Methods: This study was a retrospective cohort analysis conducted using the National Health Insurance Service-National Sample Cohort in the South Korea. Patients over 65 years old who were newly diagnosed with PD during 2007–2011 were identified. The integrative therapy group was defined as patients treated with both Korean medicine (KM) and biomedicine, and the monotherapy group consisted of patients treated with biomedicine alone. From PD diagnosis to 2013, the prevalence and annual length of hospitalization because of PD and major complications (dementia, depression and pneumonia/sepsis) were analyzed using logistic regression, ANOVA and t-tests after propensity score (PS) matching with a 1:1 ratio.Results: After PS estimation and matching, the cohort used in the analysis included 228 subjects (114 integrative therapy group, 114 monotherapy group). Sex, age, index year, comorbidity, severity of disability, neurologic care, and anti-parkinsonism medication (levodopa, ropinirole, pramipexole, selegiline) were adjusted in both groups. The prevalence of hospitalization due to pneumonia/sepsis was 0.50 times (95% C.I.: 0.26–0.96) lower in the integrative therapy group than the monotherapy group, which was statistically significant (p = 0.038). The prevalence and annual length of total hospitalization and hospitalization because of PD, dementia, and depression in the integrative therapy group showed positive results compared to the monotherapy group, but these differences were not statistically significant.Conclusion: It has not been clearly identified that integrative therapy with KM and biomedicine for PD management is better treatment for patients compared to biomedicine monotherapy; however, we found a clue of better result in integrated therapy. Therefore, further investigation by increasing the number of subjects is needed to confirm the findings presented herein.

Published
2019
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5. Appraising the safety and reporting quality of thread-embedding acupuncture: a protocol for a systematic review and meta-analysis

Author

Yeonju Woo, Bo-In Kwon, Dong Hyuk Lee, Yongjoo Kim, Jin-woo Suh, Bonhyuk Goo, Sang-Soo Nam, and Joo-Hee Kim

Subjects
Medicine, East Asian Traditional, Bias, Meta-Analysis as Topic, Research Design, Acupuncture Therapy, Humans, General Medicine, Systematic Reviews as Topic
Abstract

IntroductionThread-embedding acupuncture (TEA) is a special type of acupuncture treatment in which medical threads are inserted into subcutaneous tissues or muscles at therapeutic points. TEA is a medical practice that combines acupuncture and medical threads. As such, it is necessary to evaluate the safety of TEA. This systematic review and meta-analysis aimed to assess the safety of TEA and reporting quality of studies regarding TEA.Methods and analysisThe systematic review will be conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and the Cochrane Handbook for Systematic Reviews of Interventions. Searching strategies will be systemically conducted using the following databases from their inception date to September 2022: MEDLINE, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), CiNii, J-STAGE, Korean Medical Database, Korean Studies Information Service System (KISS), ScienceON and Oriental Medicine Advanced Searching Integrated System (OASIS). The search strategies will be adjusted for each database as appropriate. The risk of bias will be assessed using the McMaster tool to identify the quality of harm assessment and reporting in study reports (McHarm). A meta-analysis will be used to synthesise the frequency and incidence of adverse events.Ethics and disseminationNo ethical approval and consent is required for this systematic review. The results of this systematic review will be disseminated through peer-reviewed publications and conference presentations.PROSPERO registration numberCRD42022297123.

Published
2022

8. Current status of the spontaneous reporting and classification/coding system for herbal and traditional medicine in pharmacovigilance

Author

Yeonju Woo, Mikyung Kim, and Chang-ho Han

Subjects
Traditional medicine, business.industry, 0211 other engineering and technologies, 02 engineering and technology, lcsh:RZ409.7-999, 030205 complementary & alternative medicine, 03 medical and health sciences, Coding system, Pharmacovigilance, 0302 clinical medicine, Complementary and alternative medicine, Spontaneous reporting, 021105 building & construction, Medicine, Original Article, Herbal medicine, business, lcsh:Miscellaneous systems and treatments, Spontaneous reporting system, Classification system
Abstract

Background While the use of herbal and traditional medicine (H&TM) has been extensive worldwide, the current status of H&TM management in pharmacovigilance remains to be investigated. To date, there is little information regarding the use of the classification/coding system (CCS) to detect signals for certain drugs within databases built on the basis of the spontaneous reporting system (SRS). The purpose of this study is to investigate the status of the SRS and CCS for H&TM in the pharmacovigilance systems of various countries around the world. Methods An e-mail survey was performed from late December 2018 to early January 2019 with 54 experts in pharmacovigilance. The results based on the information provided by the respondents were summarized. Results Fourteen experts from 13 countries responded to the survey. Eleven countries/regions were found to already include H&TM in their SRSs, managing only limited range of H&TM. Of the 9 countries/regions that provided the information on the status of CCS for H&TM in their domestic pharmacovigilance systems, only China had a separate CCS for H&TM. Conclusion Revising the current pharmacovigilance systems to include or expand the range of H&TM, and developing an internationally harmonized system to classify and code H&TM suitable to the unique characteristics of H&TM are critical and overall beneficial.

Published
2021

9. The effectiveness and safety of Simiao Xiaobi decoction on rheumatoid arthritis

Author

Soo-Yeon, Chae, Yeonju, Woo, Joo-Hee, Kim, Eun-Jung, Kim, Byung-Kwan, Seo, Yong-Hyeon, Baek, Seong-Sik, Park, and Won-Suk, Sung

Subjects
Arthritis, Rheumatoid, Meta-Analysis as Topic, Rheumatoid Factor, Antirheumatic Agents, Humans, General Medicine, Systematic Reviews as Topic
Abstract

Rheumatoid arthritis (RA) is a common chronic autoimmune disease that contributes to progressive disability, systemic complications, higher mortality, and societal burden. Typical symptoms of RA include symmetrical pain and swelling in multiple joints, morning stiffness, and elevated levels of erythrocyte sedimentation rate, C-reactive protein, and rheumatoid factor. The representative treatment for RA is medication, including disease-modifying antirheumatic drugs, glucocorticoids, and nonsteroidal anti-inflammatory drugs. However, these medications are not yet curative nor preventative and are associated with several adverse effects, leading to their discontinuation. Recent articles reported that Simiao Xiaobi decoction (SXD) could relieve the symptoms of RA by clinical trial and experimental study, but an evidence-based review on the effectiveness and safety of SXD on RA has not yet been provided.Searching for randomized controlled trials on the use of SXD for RA will be performed by using multiple electronic databases, manual search, and contacting the authors by e-mail if needed. Studies will be selected according to the predefined criteria and the data collected on study participants, interventions, control groups, outcome measurements, their results, adverse events, and risk of bias will be summarized. The primary outcome will be the disease activity score (including effective rate, swollen joint count, tender joint count, and morning stiffness), and the secondary outcomes will be blood tests (including erythrocyte sedimentation rate, C-reactive protein, and rheumatoid factor) and adverse events. We will use Review Manager software to perform a meta-analysis, the Cochrane Collaboration "risk of bias" tool for assessing the risk of bias, and grades of recommendation, assessment, development and evaluation for the determination of the quality of evidence.https://inplasy.com; INPLASY202230026.We are going to investigate the effectiveness and safety of SXD for RA.This study will provide reliable evidence on whether SXD is effective on RA.

Published
2022
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11. Safety of herbal medicine for elderly patients with chronic disease in the Republic of Korea

Author

Yeonju Woo and Min Kyung Hyun

Subjects
Polypharmacy, medicine.medical_specialty, business.industry, 030205 complementary & alternative medicine, Malaise, 03 medical and health sciences, Adverse Event Reporting System, 0302 clinical medicine, Complementary and alternative medicine, Internal medicine, Pharmacovigilance, medicine, Nocturia, Anxiety, 030212 general & internal medicine, medicine.symptom, business, Adverse effect, Depression (differential diagnoses)
Abstract

Introduction Elderly patients with chronic diseases may experience unintended adverse events (AEs) related to medication. This study investigated the detection of drug safety signals associated with herbal medicine by analyzing spontaneous AE reports in this patient group to generate new safety information. Methods The “Korea Institute of Drug Safety and Risk Management Korea Adverse Event Reporting System database (KIDS-KD)” was used to investigate patients over 65 years old with chronic disease from 2013 to 2016. The target of analysis is seven herbal medicines such as ginkgo leaf extracts, ivy leaf extracts, herbal cough suppressants and expectorants. AEs associated with herbal medicine were considered a signal if they accounted for greater than 0 of the 95% lower confidence interval of the Information Component (IC025). The relevance of unexpected Adverse Drug Reactions (ADRs) was determined based on a review of the KIDS-KD and then derived as safety information. Results Among 113 types of herbal medicine-AE combinations, 56 drug-event combinations (DECs) in elderly patients with chronic disease were detected as signals. Of those, 12 types of DECs were investigated as unexpected ADR and finally 9 types were assessed as necessitating reporting of safety information: ginkgo leaf extracts (depression, thrombocytopenia), ivy leaf extracts (bullous eruption, muscle weakness, nocturia, lip ulceration, neuropathy peripheral, anxiety, malaise). Conclusions The elderly have a high prevalence of chronic diseases, resulting in polypharmacy, and potentially creating a high risk of ADRs. Establishing a pharmacovigilance system for herbal medicine is of great importance.

Published
2019
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12. Evaluation of cardiovascular risk associated with SKI306X use in patients with osteoarthritis and rheumatoid arthritis

Author

Yeonju Woo and Min Kyung Hyun

Subjects
Adult, Male, medicine.medical_specialty, Naproxen, Time Factors, Analgesic, Anti-Inflammatory Agents, Osteoarthritis, Arthritis, Rheumatoid, Cohort Studies, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Risk Factors, Internal medicine, Drug Discovery, medicine, Humans, 030212 general & internal medicine, Aged, Retrospective Studies, Pharmacology, business.industry, Incidence, Retrospective cohort study, Middle Aged, medicine.disease, Comorbidity, Cardiovascular Diseases, Celecoxib, Rheumatoid arthritis, Antirheumatic Agents, Cohort, Physical therapy, 030211 gastroenterology & hepatology, Female, business, medicine.drug, Drugs, Chinese Herbal
Abstract

Ethnopharmacological relevance SKI306X (Joins ® ) is an anti-inflammatory analgesic herbal medicine extract that was clinically approved for treatment of osteoarthritis in the previous trials and shown to be effective on follow-up studies. However, its potential cardiovascular risk has yet to be investigated. Aim of the study This retrospective cohort study investigated the cardiovascular safety of SKI306X, celecoxib and naproxen. Materials and methods We used the National Health Insurance Service–National Sample Cohort (NHIS-NSC) to investigate patients over 20 years old with osteoarthritis and rheumatoid arthritis who received a single prescription of SKI306X, celecoxib or naproxen at least once from January 1, 2011 through December 31, 2012. Patients who received SKI306X, celecoxib or naproxen from January 1, 2009 to December 31, 2010 were excluded. Data pertaining to the included patients were investigated to determine the risk of major cardiovascular events associated with the aforementioned prescription using the Cox proportional hazards model after being adjusted for sex, age and comorbidity. Results A total of 27,253 patients were selected, among which 10,983 were prescribed SKI306X, 12,311 celecoxib and 3959 naproxen. The incidence of major cardiovascular events was highest for celecoxib (15.4%), followed by SKI306X (8.6%) and naproxen (8.0%). Celecoxib had a higher cardiovascular risk than naproxen, while SKI306X did not have a higher risk of cardiovascular events than naproxen. Upon sensitivity analysis, SKI306X was associated with 1.36 times (95%CI: 1.08–1.72) more cardiovascular events than naproxen during 15–60 days of prescription, but not at less than 14 days or more than 61 days. Conclusions Evaluation of the cardiovascular safety of the anti-inflammatory analgesic herbal medicine SKI306X revealed that it did not differ from that of naproxen, which is known to have low cardiovascular risk.

Published
2016

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