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Critical appraisal of clinical studies in Chinese herbal medicine
Simon DAGENAIS
Zhong Xi Yi Jie He Xue Bao , 2006,
Abstract: The use of complementary and alternative medicine (CAM) is currently widespread and appears to be growing. As an increasing proportion of the population turns to CAM therapies, whether singly or in combination with allopathic medicine, the need for quality research in this area is reinforced. Much of this research consists of clinical studies aimed primarily at clinicians, yet challenges arising from poor methodological quality will occur when interpreting study findings and their implications. For clinicians to be effective consumers of the scientific literature, familiarization with the principles of evidence-based medicine (EBM) is essential. The goal of this review is to introduce clinicians to the concept of critical appraisal of clinical studies and foster critical thinking when reading research articles in order to best evaluate and incorporate study findings into their daily practice. Topics discussed in this article include: (1) fundamentals of EBM; (2) types of clinical studies; (3) hierarchy of evidence; (4) Consolidated Standard of Randomized Trials (CONSORT) statement to evaluate the quality of reporting in randomized controlled trials (RCTs); (5) methodologic quality rating scales for RCTs; and (6) issues specific to evaluating studies of Chinese herbal medicine.
Clinical Evaluation of Herbal Medicine for Oligospermia  [PDF]
Muhammad Hafeez,Afzal Ahmed,Khan Usmanghani,E. Mohiuddin
Pakistan Journal of Nutrition , 2011,
Abstract: Infertility is one of the most tragic of all marital problems. Despite recent advances in the treatment of male infertility, the problem has not been satisfactorily tackled. The infertility may be due to an inadequate number of spermatozoa in the semen, the failure of the spermatozoa to move with sufficient vigor towards their goal or that they are deficient in other respects. Aims of the study is to investigate the safety and efficacy of Xperm (Herbal Medicine) in test group in comparison with Sulfonylureas plus (Allopathic) in control group. A Causi experimental randomized controlled, two-arm parallel group clinical trial conducted at Shifa-ul-Mulk Memorial Hospital for Eastern Medicine, Hamdard University Karachi. Hundred patients in the age group of 20-50 years with idiopathic infertility with a total sperm count less than 20 million/ml. Comparison of data recorded by participants relating to these variables showed significant differences between test and control groups (p<0.05) despite the fact that no side effects were at all recorded in test group. Overall clinical success was observed in both treatment groups however the efficacy of the test treated medication (Xperm) was superior as p = 0.03. Xperm is more effective than the Sulfonylureas plus in the treatment of Oligospermia and male infertility.
Herbal Wisdom: memory and migration  [PDF]
Cathy Avila,Sue Evans,Annette Morgan
Coolabah , 2011,
Abstract: Within contemporary Western herbal medicine, traditional knowledge andmodern science are combined to provide a unique meeting of patient, practitioner andplant. In the Australian context, herbalists have based their practice on knowledgewhich originates from the traditions of Europe, and has more recently been influencedby traditional medicine from Asia. The combination of these diverse ways ofknowing—traditional and modern, Eastern and Western—means herbal practitioners areinfluenced by ancient philosophy alongside phytochemistry and biomedical sciences.The challenge for herbal medicine today is that faced by all living (as opposed toossified) traditions: how is a practice forged which retains what is valuable from thepast while establishing relevance to the 21st century? We illustrate these issues in thecontext of the conference theme of ‘food for thought’ and consider medicinal plantswhich are used for the improvement of cognition. We focus on the therapeutic use ofcommon herbs from the Eastern and Western traditions and present the scientificresearch which shows their ability to facilitate cognitive function and the laying downof memory. We also tell their traditional stories which indicate that these actions havebeen recognised and utilised for centuries. We go on to demonstrate, via case studies,the clinical application of this knowledge and in particular the importance of ancientpractice of synergistic prescribing which occurs when a number of herbs are prescribedtogether in a formula. Scientific understanding of the basis of this practice is beingdeveloped which further complements and validates traditional herbal wisdom.
Ethical Considerations for Acupuncture and Chinese Herbal Medicine Clinical Trials: A Cross-Cultural Perspective  [PDF]
Christopher Zaslawski
Evidence-Based Complementary and Alternative Medicine , 2010, DOI: 10.1093/ecam/nen055
Abstract: Many ethical concerns revolve around the four basic principles of research: merit and integrity, respect for human beings, weighting of risk–benefit and justice. These principles form the basis for any discussion concerning human research ethics and are applicable to all areas of research including acupuncture and Chinese herbal medicine. World Health Organisation document, Guidelines for Clinical Research on Acupuncture, states that ‘consideration should be given to the different value systems that are involved in human rights such as social, cultural and historical issues’ and that ‘further studies should be conducted in relation to ethical issues involved in clinical research on acupuncture’. In addition to outlining the four basic principles, this paper will also examine the effect of Asian culture on Western human research ethics and how this may impact upon issues such as informed consent and weighting of risk–benefit.
Methodological issues and suggestions for improvement in randomized controlled trials of Chinese herbal medicine for recurrent miscarriage
Hui Luo,Qing Li,Jian-ping Liu
Zhong Xi Yi Jie He Xue Bao , 2012,
Abstract: OBJECTIVE: Recurrent miscarriage is a common disease in clinical obstetrics and gynecology. There is no curative treatment for recurrent miscarriage in conventional medicine. Traditional Chinese medicine (TCM) has been widely used in the treatment of recurrent miscarriage in China for thousands of years. However, randomized controlled trials (RCTs) with high quality evaluating the effectiveness and safety of Chinese herbal medicine (CHM) still lack. This study was conducted in order to identify methodological problems in published or unpublished RCTs of CHM in the treatment of recurrent miscarriage, and provide suggestions for TCM researchers to conduct high-quality clinical research.METHODS: Literature searching was conducted to collect published and unpublished RCTs from six electronic literature databases, including China National Knowledge Infrastructure, Chongqing VIP Chinese Scientific Journals Database, Chinese Biomedical Literature Database, Wanfang Data, PubMed, and Cochrane Library, till December 15, 2011. The Cochrane Handbook, the CONSORT Statement and the CONSORT for TCM statement were used to assess the methodological quality in the designing and reporting of included trials.RESULTS: A total of 49 RCTs were included in this critical appraisal. Most of the trials were of high risk of bias with flawed study design and poor methodological quality. The main problems included: no report on random methods or sequence concealment; no calculation of sample size; no flow chart of enrollment and outcomes; no report on blinding methods; no or incomplete report on baseline data such as diagnosis criteria and causes of miscarriage recurrent, age, times of spontaneous abortion, TCM syndrome differentiation; complex CHM treatments and inappropriate control interventions; no report on follow-up and withdrawals; inappropriate outcome measurements such as middle-outcome or laboratory test results; no report on final outcome (live-birth rate).CONCLUSION: There are many methodological problems in RCTs of CHM for recurrent miscarriage. It is suggested that four issues should be taken into consideration for TCM research: basic principles of clinical research are needed in design and reporting of RCTs; definite diagnosis criteria and baseline data should be reported in detail; appropriate treatment and control interventions should be selected according to the assumption and objective of research; final outcome (live-birth rate) should be reported in outcome evaluation.
Herbal medicine research and global health: an ethical analysis
Tilburt,Jon C; Kaptchuk,Ted J;
Bulletin of the World Health Organization , 2008, DOI: 10.1590/S0042-96862008000800011
Abstract: governments, international agencies and corporations are increasingly investing in traditional herbal medicine research. yet little literature addresses ethical challenges in this research. in this paper, we apply concepts in a comprehensive ethical framework for clinical research to international traditional herbal medicine research. we examine in detail three key, underappreciated dimensions of the ethical framework in which particularly difficult questions arise for international herbal medicine research: social value, scientific validity and favourable risk-benefit ratio. significant challenges exist in determining shared concepts of social value, scientific validity and favourable risk-benefit ratio across international research collaborations. however, we argue that collaborative partnership, including democratic deliberation, offers the context and process by which many of the ethical challenges in international herbal medicine research can, and should be, resolved. by "cross-training" investigators, and investing in safety-monitoring infrastructure, the issues identified by this comprehensive framework can promote ethically sound international herbal medicine research that contributes to global health.
ISSUES IN MEDICINE: Will clinical associates be effective for South Africa?
J Doherty, I Couper, S Fonn
South African Medical Journal , 2012,
Abstract: South Africa has developed an innovative mid-level medical worker model that can contribute substantively to the development of quality district-level health care. These clinical associates entered the South African job market in 2011 and have reportedly been received favourably. The first cohorts performed well on local and national examinations, with pass rates >95%. They have demonstrated confidence and competence in the common procedures and conditions encountered in district hospitals; reportedly fitted in well at most of the sites where they commenced working; and made a significant contribution to the health team, resulting in a demand for more clinical associates. Universities and provinces involved in producing clinical associates are enthusiastic and committed. However, priorities are to establish sustainable funding sources for training and deployment, provide adequate supervision and support, monitor the initial impact of the new cadre on health services, and manage the sensitivities of the medical and nursing professions around scopes of practice and post levels. Longer-term concerns are national leadership and support, scaling up of training, the development of career pathways, and the improvement of working conditions at district hospitals.
Correlations of clinical symptoms and treatment efficacy in patients with rheumatoid arthritis treated with Chinese herbal drugs or Western medicine
LU Ai-Ping
Zhong Xi Yi Jie He Xue Bao , 2005,
Abstract: Objective: To evaluate the correlations between clinical symptoms and treatment efficacy in patients with rheumatoid arthritis (RA). Methods: Four hundred and thirteen patients were included in the clinical trial from 9 clinical centers. They were randomly divided into Western medicine-treated group with 204 cases and Chinese herbal drug-treated group with 209 cases. Eighteen clinical symptoms were evaluated before and after treatment. The Western medicine therapy included voltaren extended release tablets, methotrexate and sulfasalazine. The Chinese herbal drug therapy included glucosidorum Tripterygii totorum tablets and Yishen Juanbi Tablets combined with treatment based on syndrome differentiation. The American college of rheumatology 20 (ACR20) was used as efficacy evaluation criteria. Results: In the Chinese herbal drug-treated group, clinical symptoms such as arthralgia and tenderness of joints were positively correlated with the efficacy after 12-week treatment, while frequent urination at night was negatively correlated. In the same group, tenderness of joints and fever were positively correlated with the efficacy after 24-week treatment, while deep-colored and turbid urine was negatively correlated. In the Western medicine-treated group, tenderness of joints and thirst were positively correlated with the efficacy after 12-week treatment, while vertigo was negatively correlated. And in the same group, tenderness of joints was positively correlated with the efficacy after 24-week treatment, while heaviness of limbs was negatively correlated to the efficacy. The statistical results showed that the treatment efficacy was improved when the correlated symptoms were included in the indications. Conclusion: The treatment efficacy of RA is correlated with some symptoms, so further studies should proceed on these correlations in order to achieve better treatment outcome.
Experience on clinical application of Chinese herbal medicine Yi Guan Jian decoction  [cached]
Xing-jiang Xiong
Zhong Xi Yi Jie He Xue Bao , 2011,
Abstract: Yi Guan Jian decoction is a traditional Chinese medicine formula noted in Wei Yu-huang’s Xu Ming Yi Lei An (Supplement to the Classified Medical Records of Famous Physicians). Acne vulgaris and chronic pelvic inflammation could be successfully treated by the decoction following the principle of formula corresponding to syndromes. The identical characteristics of constitution are found among the patients treated by the decoction, known as the “Yi Guan Jian constitution”. It indicates that patients can be treated according to the constitutional characteristics.
Laboratory medicine today
Dujmovi? Ferenc,?eri? Mirjana,Sto?i? Zoran
Medicinski Pregled , 2007, DOI: 10.2298/mpns0712543d
Abstract: Introduction. Laboratory medicine today is a well-established branch of medicine which has an important role in improving of diagnostics, research and all forms and levels of education at the Faculty of Medicine in Novi Sad. The value of laboratory medicine is particularly important in team work within the Clinical Center of Novi Sad, nowadays - Clinical Center of Vojvodina. Institute of Laboratory Medicine of the Clinical Center of Vojvodina. The institute of Laboratory Medicine of the Clinical Center of Vojvodina is a contemporary organized, integrated system of laboratories, employing highly educated professional staff, and with the exception of the nuclear-medicine laboratory, has all necessary equipment for providing the highest level of laboratory diagnostics. The Institute is a part of the international RIQAS (Randox International Quality Assessment Scheme) quality control and in the process of getting and accreditation. Today, the Institute offers a variety of over 400 different laboratory analyses and functional tests. The capacity of laboratory services is being significantly increased and is permanently growing. In addition, it is necessary to establish a PCR laboratory and a Department of Microbiology. Contemporary trends in organization of laboratory services. The Institute of Laboratory Medicine is also engaged in research, publishing and projects. It is a teaching hospital for the Department of Pathophysiology. This kind of approach to education of medical students ensures that pathophysiology provides a solid foundation for clinical studies at the Faculty of Medicine in Novi Sad.
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