Developing Traditional Chinese Medicine in the Era of Evidence-Based Medicine: Current Evidences and Challenges

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Abstract

Evidence-based medicine (EBM), by integrating individual clinical expertise with the best available clinical evidence from systematic research, has in recent years been established as the standard of modern medical practice for greater treatment efficacy and safety. Traditional Chinese Medicine (TCM), on the other hand, evolved as a system of medical practice from ancient China more than 2000 years ago based on empirical knowledge as well as theories and concepts which are yet to be mapped by scientific equivalents. Despite the expanding TCM usage and the recognition of its therapeutic benefits worldwide, the lack of robust evidence from the EBM perspective is hindering acceptance of TCM by the Western medicine community and its integration into mainstream healthcare. For TCM to become an integral component of the healthcare system so that its benefits can be rationally harnessed in the best interests of patients, it is essential for TCM to demonstrate its efficacy and safety by high-level evidence in accordance with EBM, though much debate remains on the validity and feasibility of applying the EBM model on this traditional practice. This review aims to discuss the current status of research in TCM, explore the evidences available on its efficacy and safety, and highlight the issues and challenges faced in applying EBM to TCM.

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Most cited references 56

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Artesunate versus quinine for treatment of severe falciparum malaria: a randomised trial.

Arjen Dondorp, François Nosten, Kasia Stepniewska … (2005)

In the treatment of severe malaria, intravenous artesunate is more rapidly acting than intravenous quinine in terms of parasite clearance, is safer, and is simpler to administer, but whether it can reduce mortality is uncertain. We did an open-label randomised controlled trial in patients admitted to hospital with severe falciparum malaria in Bangladesh, India, Indonesia, and Myanmar. We assigned individuals intravenous artesunate 2.4 mg/kg bodyweight given as a bolus (n=730) at 0, 12, and 24 h, and then daily, or intravenous quinine (20 mg salt per kg loading dose infused over 4 h then 10 mg/kg infused over 2-8 h three times a day; n=731). Oral medication was substituted when possible to complete treatment. Our primary endpoint was death from severe malaria, and analysis was by intention to treat. We assessed all patients randomised for the primary endpoint. Mortality in artesunate recipients was 15% (107 of 730) compared with 22% (164 of 731) in quinine recipients; an absolute reduction of 34.7% (95% CI 18.5-47.6%; p=0.0002). Treatment with artesunate was well tolerated, whereas quinine was associated with hypoglycaemia (relative risk 3.2, 1.3-7.8; p=0.009). Artesunate should become the treatment of choice for severe falciparum malaria in adults.

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Risk and safety assessment on the consumption of Licorice root (Glycyrrhiza sp.), its extract and powder as a food ingredient, with emphasis on the pharmacology and toxicology of glycyrrhizin.

R Isbrucker, George A Burdock (2006)

Licorice (or 'liquorice') is a plant of ancient origin and steeped in history. Licorice extracts and its principle component, glycyrrhizin, have extensive use in foods, tobacco and in both traditional and herbal medicine. As a result, there is a high level of use of licorice and glycyrrhizin in the US with an estimated consumption of 0.027-3.6 mg glycyrrhizin/kg/day. Both products have been approved for use in foods by most national and supranational regulatory agencies. Biochemical studies indicate that glycyrrhizinates inhibit 11beta-hydroxysteroid dehydrogenase, the enzyme responsible for inactivating cortisol. As a result, the continuous, high level exposure to glycyrrhizin compounds can produce hypermineralocorticoid-like effects in both animals and humans. These effects are reversible upon withdrawal of licorice or glycyrrhizin. Other in vivo and clinical studies have reported beneficial effects of both licorice and glycyrrhizin consumption including anti-ulcer, anti-viral, and hepatoprotective responses. Various genotoxic studies have indicated that glycyrrhizin is neither teratogenic nor mutagenic, and may possess anti-genotoxic properties under certain conditions. The pharmacokinetics of glycyrrhizin have been described and show that its bioavailability is reduced when consumed as licorice; this has hampered attempts to establish clear dose-effect levels in animals and humans. Based on the in vivo and clinical evidence, we propose an acceptable daily intake of 0.015-0.229 mg glycyrrhizin/kg body weight/day.

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Oseltamivir compared with the Chinese traditional therapy maxingshigan-yinqiaosan in the treatment of H1N1 influenza: a randomized trial.

Chen Wang, Bin Cao, Qing-Quan Liu … (2011)

Observational studies from Asia suggest that maxingshigan-yinqiaosan may be effective in the treatment of acute H1N1 influenza. To compare the efficacy and safety of oseltamivir and maxingshigan-yinqiaosan in treating uncomplicated H1N1 influenza. Prospective, nonblinded, randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00935194) Eleven hospitals from 4 provinces in China. 410 persons [corrected] aged 15 to 69 [corrected] years with laboratory-confirmed H1N1 influenza. Oseltamivir, 75 mg twice daily; maxingshigan-yinqiaosan decoction (composed of 12 Chinese herbal medicines, including honey-fried Herba Ephedrae), 200 mL 4 times daily; oseltamivir plus maxingshigan-yinqiaosan; or no intervention (control). Interventions and control were given for 5 days. Primary outcome was time to fever resolution. Secondary outcomes included symptom scores and viral shedding determined by using real-time reverse transcriptase polymerase chain reaction. Significant reductions in the estimated median time to fever resolution compared with the control group (26.0 hours [95% CI, 24.0 to 33.0 hours]) were seen with oseltamivir (34% [95% CI, 20% to 46%]; P < 0.001), maxingshigan-yinqiaosan (37% [CI, 23% to 49%]; P < 0.001), and oseltamivir plus maxingshigan-yinqiaosan (47% [CI, 35% to 56%]; P < 0.001). Time to fever resolution was reduced by 19% (CI, 0.3% to 34%; P = 0.05) with oseltamivir plus maxingshigan-yinqiaosan compared with oseltamivir. The interventions and control did not differ in terms of decrease in symptom scores (P = 0.38). Two patients who received maxingshigan-yinqiaosan reported nausea and vomiting. Participants were young and had mild H1N1 influenza virus infection. Missing viral data precluded definitive conclusions about viral shedding. Oseltamivir and maxingshigan-yinqiaosan, alone and in combination, reduced time to fever resolution in patients with H1N1 influenza virus infection. These data suggest that maxingshigan-yinqiaosan may be used as an alternative treatment of H1N1 influenza virus infection. Beijing Science and Technology Project and Beijing Nova Program.

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Author and article information

Journal

Journal ID (nlm-ta): Evid Based Complement Alternat Med

Journal ID (iso-abbrev): Evid Based Complement Alternat Med

Journal ID (publisher-id): ECAM

Title: Evidence-based Complementary and Alternative Medicine : eCAM

Publisher: Hindawi Publishing Corporation

ISSN (Print): 1741-427X

ISSN (Electronic): 1741-4288

Publication date (Print): 2015

Publication date (Electronic): 8 April 2015

Publication date PMC-release: 8 April 2015

Volume: 2015

Electronic Location Identifier: 425037

Affiliations

¹Traditional Medicine Information Service, Department of Pharmacy, Singapore General Hospital, Singapore

²Department of Haematology, Singapore General Hospital, Academia, 20 College Road, Singapore 169856

Author notes

*Yeh Ching Linn: linn.yeh.ching@ 123456sgh.com.sg

Academic Editor: Felice Senatore

Article

DOI: 10.1155/2015/425037

PMC ID: 4407626

PubMed ID: 25949261

SO-VID: ea7d7248-0130-41ff-ad3a-5eb33394caea

License:

This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Developing Traditional Chinese Medicine in the Era of Evidence-Based Medicine: Current Evidences and Challenges

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Most cited references 56

Artesunate versus quinine for treatment of severe falciparum malaria: a randomised trial.

Risk and safety assessment on the consumption of Licorice root (Glycyrrhiza sp.), its extract and powder as a food ingredient, with emphasis on the pharmacology and toxicology of glycyrrhizin.

Oseltamivir compared with the Chinese traditional therapy maxingshigan-yinqiaosan in the treatment of H1N1 influenza: a randomized trial.

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