1.Characterization and Comparison Analysis of WHO Monographs on Selected Medicinal Plants and ISO Standards of Chinese Materia Medica.
Jing-Yi YANG ; Zhen SANG ; Rui WANG ; Yan-Hong SHI ; Yi-Ran HUANG
Chinese journal of integrative medicine 2023;29(6):540-548
Medicinal plants or Chinese materia medica (CMM) are now attracting worldwide attention as they have increasingly prominent advantages over chemical drugs in disease treatment and healthcare. Since the 1990s, World Health Organization (WHO) and International Organization for Standardization established the Technical Committee of Traditional Chinese Medicine (ISO/TC 249) have carried out the development of quality standards on medicinal plants or CMMs respectively, and a considerable number of monographs and international standards have been published. Since the two international organizations adhere to different principles, the standards they develop naturally have different emphasis. Driven by market demand and international trade, ISO mainly takes quality, efficacy and safety into consideration when developing standards, while WHO pays more attention to clinical practice, quality control and medication guidance. Up to now, there is a lack of comparative analysis on the records, background, principles, basic content, and main requirements of quality standards on medicinal plants or CMMs respectively published by WHO and ISO. Therefore, based on international standards of CMM developed by ISO/TC 249 platform and WHO Monographs on Selected Medicinal Plants, this paper systematically compares the purposes, selected principles, standard-developing process, basic content, and main quality requirements to summarize their similarities and differences, and find their merits, aiming to serve as a reference to the development of international standards for CMMs that helps them go global.
Materia Medica/therapeutic use*
;
Plants, Medicinal
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Commerce
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Internationality
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Medicine, Chinese Traditional
;
Reference Standards
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Drugs, Chinese Herbal/therapeutic use*
;
China
2.Homeopathy for COVID-19 in primary care: A randomized, double-blind, placebo-controlled trial (COVID-Simile study).
Ubiratan Cardinalli ADLER ; Maristela Schiabel ADLER ; Ana Elisa Madureira PADULA ; Livia Mitchiguian HOTTA ; Amarilys DE TOLEDO CESAR ; José Nelson Martins DINIZ ; Helen DE FREITAS SANTOS ; Edson Zangiacomi MARTINEZ
Journal of Integrative Medicine 2022;20(3):221-229
BACKGROUND:
Different homeopathic approaches have been used as supportive care for coronavirus disease 2019 (COVID-19) cases, but none has been tested in a clinical trial.
OBJECTIVES:
To investigate the effectiveness and safety of the homeopathic medicine, Natrum muriaticum LM2, for mild cases of COVID-19.
DESIGN, SETTING, PARTICIPANTS, AND INTERVENTIONS:
A randomized, double-blind, two-armed, parallel, single-center, placebo-controlled clinical trial was conducted from June 2020 to April 2021 in São-Carlos, Brazil. Participants aged > 18 years, with influenza-like symptoms and positive result from a real-time polymerase chain reaction test for severe acute respiratory syndrome coronavirus 2 were recruited and randomized (1:1) into two groups that received different treatments during a period of at-home-isolation. One group received the homeopathic medicine Natrum muriaticum, prepared with the second degree of the fifty-millesimal dynamization (LM2; Natrum muriaticum LM2), while the other group received a placebo.
OUTCOME MEASURES:
The primary endpoint was time until recovery from COVID-19 influenza-like symptoms. Secondary measures included a survival analysis of the number and severity of COVID-19 symptoms (influenza-like symptoms plus anosmia and ageusia) from a symptom grading scale that was informed by the participant, hospital admissions, and adverse events. Kaplan-Meier curves were used to estimate time-to-event (survival) measures.
RESULTS:
Data from 86 participants were analyzed (homeopathy, n = 42; placebo, n = 44). There was no difference in time to recovery between two groups among participants who were reporting influenza-like symptoms at the beginning of monitoring (homeopathy, n = 41; placebo, n = 41; P = 0.56), nor in a sub-group that had at least 5 moderate to severe influenza-like symptoms at the beginning of monitoring (homeopathy, n = 15; placebo, n = 17; P = 0.06). Secondary outcomes indicated that a 50% reduction in symptom score was achieved significantly earlier in the homeopathy group (homeopathy, n = 24; placebo, n = 25; P = 0.04), among the participants with a basal symptom score ≥ 5. Moreover, values of restricted mean survival time indicated that patients receiving homeopathy might have improved 0.9 days faster during the first five days of follow-up (P = 0.022). Hospitalization rates were 2.4% in the homeopathy group and 6.8% in the placebo group (P = 0.62). Participants reported 3 adverse events in the homeopathy group and 6 in the placebo group.
CONCLUSION:
Results showed that Natrum muriaticum LM2 was safe to use for COVID-19, but there was no statistically significant difference in the primary endpoints of Natrum muriaticum LM2 and placebo for mild COVID-19 cases. Although some secondary measures do not support the null hypothesis, the wide confidence intervals suggest that further studies with larger sample sizes and more symptomatic participants are needed to test the effectiveness of homeopathic Natrum muriaticum LM2 for COVID-19.
TRIAL REGISTRATION
UMIN Clinical Trials Registry ID: JPRN-UMIN000040602.
COVID-19/therapy*
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Double-Blind Method
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Homeopathy
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Humans
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Influenza, Human/drug therapy*
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Materia Medica/therapeutic use*
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Primary Health Care
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Treatment Outcome
3.Generalized science of Chinese material medica-from preventive treatment of disease to Chinese medicine health industry.
Jun-Ning ZHAO ; Hua HUA ; An-Dong YANG ; Yi-Guan ZHANG ; Ying DAI ; Qing-Miao LI ; Liang-Chun YAN ; Xiao-Lu LI ; Li LI ; Jin ZENG ; Si-Chong REN ; Jian-Bo WANG
China Journal of Chinese Materia Medica 2018;43(21):4177-4181
Based on the systematic summary of the results of the fourth general survey of traditional Chinese medicine resources, the cultivation of large varieties of Chinese material medica and the latest research on health industrial development, the novel concepts and scientific connotations of generalized science of Chinese material medica are put forward, and the basic ideas and methods of a new Chinese medicine academic system, the cultivation system of large varieties of Chinese medicinal materials and the application system of the large health industry are constructed. This kind of generalized science of Chinese material medica, rooted in the traditional Chinese culture and the theory of "preventive treatment of disease", can avoid the narrow prospect induced by the increasing specialization and refinement of knowledge of science of Chinese material medica. It will play an important role in the modernization, industrialization, internationalization of traditional Chinese medicine.
Drug Industry
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Humans
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Materia Medica
;
therapeutic use
;
Medicine, Chinese Traditional
;
Research
5.Analysis on medication principles for cough based on experience of Xu Di-hua, descendant of Meng He Medical School.
Xiao-jing XU ; Li-min XU ; Chun-feng SHEN ; Cai-hua WANG ; Chun-ti SHEN
China Journal of Chinese Materia Medica 2015;40(21):4301-4305
Based on the software of traditional Chinese medicine inheritance support system (TCMISS), this article aims to analyze the experience and composition rules for cough from the descendant of Meng He Medical School, Xu Di-hua. The cough cases treated by Xu Di-hua were collected, and recorded into TCMISS (V2.0). Data mining methods such as Apriori algorithm and complex system entropy cluster were used to analyze the medication principles of Xu Di-hua for cough from pathogenesis and therapeutie aspects, and dig out the frequency of the herbs in prescription, core medicine and new combinations. The experience of curing cough from Professor Xu Di-hua were well found in the research. He is good at choosing prescriptions accurately, and pays attention to simultaneous use of cold and moisture drugs with combination of tonification and purgation. He is skilled in adding or reducing materia medica flexibly, as well as regulating lung to relieve cough and eliminating phlegm by clearing heat.
Algorithms
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Cough
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drug therapy
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Data Mining
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Drug Therapy, Combination
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Drugs, Chinese Herbal
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chemistry
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therapeutic use
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Female
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Humans
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Male
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Materia Medica
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Medicine, Chinese Traditional
6.Traditional Chinese medicine for treatment of liver diseases: progress, challenges and opportunities.
Chang-qing ZHAO ; Yang ZHOU ; Jian PING ; Lie-ming XU ; E-mail: XULIEMING@126.COM.
Journal of Integrative Medicine 2014;12(5):401-408
Traditional Chinese medicine (TCM) is commonly used in treating liver diseases worldwide, especially in China. The advantages of using TCM for treatment of liver diseases include: protecting hepatocytes, inhibiting hepatic inflammation and antifibrosis in the liver. In this article, we introduce TCM herbal preparations from the Chinese materia medica (such as Fuzheng Huayu) that are typically used for the treatment of liver diseases. Literature surrounding the mechanisms of TCM therapy for treatment of liver diseases is presented and discussed. We propose that side effects of herbal compounds are often under-appreciated, and that more care should be taken in the prescription of potentially hepatotoxic medicines. Further, to deepen the understanding of TCM mechanisms, new techniques and methodologies must be developed. Future studies will lead to the enhancement of clinical outcomes of TCM. As complementary and alternative therapies, TCMs will play an expanding role in the future of liver disease treatment.
Chemical and Drug Induced Liver Injury
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prevention & control
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Humans
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Liver Diseases
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drug therapy
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Materia Medica
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therapeutic use
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Medicine, Chinese Traditional
7.Effect of oviductus ranae and oviductus ranae eggs on bone metabolism and osteoporosis.
Dan-Hui WANG ; Wei WU ; Jian-Ming TIAN ; Zhao-Hui WANG ; Dan-Tong WANG ; Ke XIANG ; Guo-Ying ZHU ; Tie HAN
Chinese journal of integrative medicine 2013;19(7):532-538
OBJECTIVETo evaluate the roles or effects of oviductus ranae (OR) or oviductus ranae eggs (ORE) in preventing and treating postmenopausal osteoporosis.
METHODSIn vivo experiment: Sixty female adult Wistar rats were randomly divided into 5 groups of 12. To provide an osteoporosis model 4 groups of rats were ovariectomized (OVX), with the 5th being sham operated. Medication commenced 7 days after the operation and lasted continuously for 12 weeks. Sham operated and OVX groups were given equivalent volumes of 5% Tween-80. The other three groups intragastrically received conjugated estrogens (CE), OR or ORE of the corresponding doses. At the 12th week, serum estrogen, bone gla protein (BGP), serum calcium, phosphorus, and alkaline phosphatase (ALP) were assayed; bone mineral densities (BMD) were measured and bone scanning was conducted; uteri were weighed, and weight, volume and length of the femoral bones were determined; and cortical thickness of femoral heads and area of bone trabecula were measured by image analyzer. In vitro experiment: Eighty 10-month old SD rats, with equal numbers of males and females, were randomly divided into 8 groups. Osteoblasts were isolated from neonatal rat calvariae, and the cells were exposed to various concentrations of serum from OR and ORE groups to study the impact of these sera on osteoblastic proliferation, ALP activity and mineralization. Osteoclastic numbers were determined using tartrate resistant acid phosphatase (TRAP).
RESULTSIn vivo experiment: The body weight of the four OVX groups increased significantly (P<0.01). Uterine weight of the CE group was the highest (P<0.01); Compared with the model group, estrogen level, BMD, bone scanning/bone imaging index weight of the femoral bones, cortical thickness of femoral heads in the OR and ORE groups increased significantly (P<0.05, P<0.01); femoral volume in the ORE group increased significantly (P<0.05); and the content of osteocalcin, phosphorus, and ALP in serum decreased significantly (P<0.05, P<0.01). In vitro experiment: Sera from OR and ORE groups had notable effects on the proliferation of osteoblasts (P<0.05 and P<0.01, repsectively) and stimulated the formation of calcium nodes (P<0.05, P<0.01), while the enhancement of ALP activity in osteoblasts was significant (P<0.05, P<0.01). The number of TRAP-positive cells was significantly reduced as well (P<0.01).
CONCLUSIONSOR and its eggs could effectively suppress OVX-induced osteoporosis in rats, and increase bone turnover possibly by both an increase in osteoblastic activity and a decrease in osteoclastic activity. The present study provides evidence that OR and its eggs could be considered a complementary and alternative medicine for the treatment of postmenopausal osteoporosis.
Acid Phosphatase ; metabolism ; Alkaline Phosphatase ; metabolism ; Animals ; Biomarkers ; blood ; Body Weight ; drug effects ; Bone Density ; drug effects ; Bone and Bones ; metabolism ; Calcification, Physiologic ; drug effects ; Cell Count ; Cell Differentiation ; drug effects ; Cell Proliferation ; drug effects ; Female ; Femur ; drug effects ; metabolism ; pathology ; Isoenzymes ; metabolism ; Male ; Materia Medica ; pharmacology ; therapeutic use ; Organ Size ; drug effects ; Osteoblasts ; drug effects ; enzymology ; pathology ; Osteoclasts ; drug effects ; enzymology ; pathology ; Osteoporosis ; blood ; drug therapy ; metabolism ; physiopathology ; Ovariectomy ; Ovum ; metabolism ; Rats ; Rats, Wistar ; Tartrate-Resistant Acid Phosphatase ; Uterus ; drug effects ; pathology
8.Status of reaching meridian research for Chinese matria medica and to raise "point-medicine" method.
China Journal of Chinese Materia Medica 2013;38(10):1643-1648
OBJECTIVETo analyze the status of reaching meridian research for the Chinese Matria Medica and to raise point-medicine method.
METHODTo review and analyze the studied situation of the corresponding relationships between "materials", as the constituents in the Chinese materia medica (CMM) as reaching meridian material foundation, and "image", as the function states of the zang-fu viscera, to investigate the problems and the measures to solve it.
RESULTThere are imprinting relationships among "materials", as the constituents alike metabolic pathway in the CMM as reaching meridian material foundation, and "image", as the function of the zang-fu viscera related with meridians, and "symptom", the states of them, retroacted, represented and explored by the corresponding meridianed constituents in the CMM as quantitative pharmacologic parameters,also modified by special acupuncture points, finally to establish the new method of reaching meridian according to meridian point-medicine action and also to investigate the relations between the constituents in the CMM and network targets of disease as to kill two birds with one arrow.
CONCLUSIONThere are imprinting relationships among "materials", "image", "symptom" versus CMM, zang-fu viscera function related with meridians, their function status respectively, which are modified by acupuncture merisian points. The point-medicine method for assuring reaching meridian is the most simple way to investigate reaching meridian for CMM, is also a important way to investigate visceral and meridianal manifestations.
Acupuncture Points ; China ; Drugs, Chinese Herbal ; history ; therapeutic use ; History, Ancient ; Humans ; Materia Medica ; chemistry ; history ; Meridians ; Phytotherapy ; history
9.Application of zebrafish model organism in the research of Chinese materia medica.
Lei CHEN ; Yi LIU ; Sheng-Wang LIANG
Acta Pharmaceutica Sinica 2012;47(4):434-439
Zebrafish has become an important model organism in many fields of biomedical studies and been increasingly used in Chinese materia medica studies in recent years. This article summarized the achievements and prospect for zebrafish as a pharmacological and toxicological tool in the study and development of Chinese materia medica.
Angiogenesis Inducing Agents
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pharmacology
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Angiogenesis Inhibitors
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pharmacology
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Animals
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Disease Models, Animal
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Materia Medica
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pharmacology
;
therapeutic use
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toxicity
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Medicine, Chinese Traditional
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Memory Disorders
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prevention & control
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Neovascularization, Physiologic
;
drug effects
;
Zebrafish
10.Efficacy observation of combination of Lumbrukinase Capsule and Probucol Tablet in treating cerebral infarction patients' unstable atheromatous plaque of the carotid artery.
Xiao-feng PAN ; Wei SHAO ; Guo-hua CHEN
Chinese Journal of Integrated Traditional and Western Medicine 2011;31(11):1479-1482
OBJECTIVETo observe the effects of combination of Lumbrukinase Capsule (LC) and Probucol Tablet (PT) in treating cerebral infarction (CI) patients' unstable atheromatous plaque of the carotid artery.
METHODS150 patients were randomly assigned to the PT group and the LC group, 75 cases in each. Patients in the PT group took 0.5 g PT each time, twice daily. On the basis of PT, patients in the LC group also took 600 thousand U LC, thrice daily. The treatment course was 12 months for all. The serum levels of TC, TG, HDL-C, LDL-C, fibrinogen (FIB), and changes of the carotid atherosclerotic plaque were measured before treatment, 6 and 12 months after treatment. Meanwhile, adverse events were recorded.
RESULTSThe serum levels of TC, TG, and LDL-C were all lower 6 months after treatment than before treatment in the two groups, showing statistical significance (P < 0.05). The serum level of HDL-C was higher 6 months after treatment than before treatment in the two groups, showing no statistical significance (P > 0.05). When compared with before treatment in the same group, the serum level of FIB significantly decreased after treatment. Besides, there was statistical difference between the two groups (P < 0.05). There was no statistical difference in the serum levels of blood lipids or FIB between 12-month treatment and 6-month treatment in the same group (P > 0.05). The plaque effective rate in the LC group was superior to that of the PT group, showing statistical significance (P < 0.01). During the treatment period, the occurrence of cerebrovascular event was lower in the LC group than in the PT group (P < 0.05). Partial patients in the two groups had gastric discomfort.
CONCLUSIONSThe combination of LC and PT could prevent and treat arteriosclerosis, stabilize the plaque, effectively lower the occurrence of ischemic events. Its clinical application did not increase the risk of hemorrhage. It was safe and effective, worthy of spreading. It was necessary to further observe whether combination of LC and PT could increase side effects of the digestive tract.
Adult ; Aged ; Animals ; Biological Products ; therapeutic use ; Carotid Artery Diseases ; drug therapy ; Cerebral Infarction ; drug therapy ; pathology ; Female ; Humans ; Male ; Materia Medica ; therapeutic use ; Middle Aged ; Oligochaeta ; enzymology ; Plaque, Atherosclerotic ; drug therapy ; Probucol ; therapeutic use ; Serine Endopeptidases ; therapeutic use ; Treatment Outcome

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