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Good Practice in Traditional Chinese Medicine Research in
the Post-genomic Era
Report on the reviewed literature relating to clinical use of
Document description
Report on the reviewed literature relating to clinical use of CHM This document is a summary of the recent research into Chinese herbal medicine in selected conditions. Andrew Flower, George Lewith and Dan Jaing – edited by Ken Muir Date of last modification 30/06/10 Status TABLE OF CONTENTS

1. Introduction
2. Cochrane reviews
3. (Non Cochrane) Systematic reviews
4. Individual randomized controlled trials
5. Other research developments
6. Conclusions from the review.
7. References:
D6.5 - A SUMMARY OF THE RECENT RESEARCH INTO CHINESE
HERBAL MEDICINE IN SELECTED CONDITIONS

1. Introduction

Workpackage 6 discussed and chose to focus on a selection of clinical conditions prioritise their work
as clearly it would be impossible to review all the enormous available literature both in Asia and the
West.
In choosing the conditions of interest WP6 members used the following criteria to select the clinical
conditions of interest:
Were an important public health condition Did not have an effective western medicine A member within the work package had particular interest and expertise in. Other conditions in which there was recent evidence of promise with TCM. On this basis the following conditions were identified: Prostate diseases including benign, pre-malignant and malignant Breast cancer, including early disease and treatment of side effects on western therapy Selected skin disease - in particular, eczema/psoriasis Other conditions in which there had been recent studies into TCM clinical use: severe acute respiratory syndrome (SARS) This report, therefore, summarises the most recent evidence supporting Chinese herbal medicine (CHM) in some of the key selected conditions of interest to the WP6 members. It is not intended as a full systematic review of all published literature. It does not include systematic reviews that were inconclusive. It also excludes several hundred randomised controlled trials (RCT’s) reported in journals of Chinese medicine. Instead it focuses on systematic reviews published in the Cochrane library and other peer reviewed English language journals. These provide more robust evidence than can be obtained from most individual clinical trials. One exception to this is an interesting and methodologically rigorous RCT comparing CHM and a conventional drug in the treatment of rheumatoid arthritis that is published in a prestigious English language journal. Finally it provides details of the innovative CHM Database Project. The research does not provide conclusive evidence of the effectiveness of CHM. However it does provide preliminary evidence for the potential therapeutic benefit of CHM in the treatment of a wide range of medical conditions. Additional more rigorous research is required to verify these findings but, despite these limitations, it identifies and important contributions that were made to help establish an evidence base to support the developing role of CHM in the provision of healthcare in the UK. 2. Cochrane reviews
Cochrane reviews require the use of explicit and transparent methods, are peer-reviewed at both the protocol and complete review stage, and are regularly updated. For these reasons, they have been found to be of comparable or better quality than reviews published in even the leading print journals Manheimer et al (2009) systematically reviewed all Cochrane reviews relating to Chinese medicine. In total, at the time of writing, there were 36 reviews. 56% of these reviews provided evidence that CHM could have a useful therapeutic role in the management of the following medical conditions: severe acute respiratory syndrome (SARS) side effects of chemotherapy in breast cancer The evidence within these Cochrane reviews is not conclusive. The numbers involved were frequently too small, the methodological quality of the trials was generally poor, and the studies were highly heterogeneous. However these reviews do provide preliminary evidence supporting the use of CHM in the treatment of these conditions. These findings need to be verified by future research. In addition to Manheimer’s review there were two other Cochrane reviews published in 2009. CHM for endometriosis (Flower et al 2009) reviewed 110 clinical trials using CHM to treat this common and disabling gynaecological condition. Only 2 studies involving 158 women could be included and these trials indicated that post surgical administration of CHM may have comparable benefit to the conventional treatment of endometriosis but with fewer side effects. CHM for people with impaired glucose tolerance or impaired fasting blood sugar (Grant et al 2009) examined 16 trials involving 1391 participants and provided some evidence to support the role of CHM in normalising blood sugar levels and preventing the progression to diabetes over time. As with most Cochrane reviews more and better quality trials are required to substantiate these early findings. 3. (Non Cochrane) Systematic reviews
In addition to the above Cochrane reviews there were a further 7 systematic reviews produced in 2009 and published in peer reviewed English language journals. CHM as concomitant therapy for nasopharyngeal carcinoma (Cho & Chen 2009) A systematic review and meta-analysis of 18 RCT’s involving 1732 participants that combined conventional care and CHM provided preliminary data that the response to conventional treatment improved (6 studies) and quality of life improved with CHM (2 studies), adverse events from conventional treatment were reduced (5 studies) and that CHM induced an enhanced immune response ( 3 studies). CHM for mild cognitive impairment and age related memory loss (May et al 2009) 10 RCT’s were evaluated. In 8 out of 10 trials CHM showed some benefit for memory loss and cognitive impairment. A meta-analysis of 3 trials showed equivalent benefits to the conventional medical treatment ‘piracetam’ and no adverse effects reported. CHM may have a role to play in treating these increasingly common conditions. CHM in paediatric allergic disorders ( Li 2009) A review of recent studies indicated that TCM therapy, including herbal medicine and acupuncture, in children is well tolerated. There were promising clinical and objective physiological improvements. More controlled studies are needed to substantiate these findings. CHM for symptom management and improvement in quality of life in adult cancer patients (Molassiotis 2009). 49 trials that included 3992 participants were reviewed to assess the role of CHM in reducing chemotherapy related toxicities and in improving quality of life. The review showed that CHM reduced side effects, improved quality of life and performance status, and in some cases showed enhanced tumour regression and increased survival rates. Once again the methodological quality of the included trials were poor and more rigorous trials are required to investigate the possible role of CHM in cancer care. A meta-analysis of CHM in the treatment of managed withdrawal from heroin (Liu 2009). 21 studies involving 2,949 participants were included in this systematic review and met-analysis. Measurement of withdrawal symptoms over a 10 period showed that conventional treatments (opioid agonists and alpha2-adrenergic agonists) were superior to CHM in the first 3 days but CHM was equivalent to or superior than conventional treatment from Days 4-10. Adverse effects were lower in the CHM treatment groups. This analysis suggests CHM may have an important role in helping to manage heroin withdrawal. A systematic review of oral CHM as supportive treatment during chemotherapy for non small cell lung cancer (NSCLC) (Chen 2009). 15 trials involving 862 participants comparing chemotherapy alone with chemotherapy plus CHM were included in this review. In participants with advanced cancer (stages III and IV) CHM was shown to help improve quality of life (QoL), reduce anaemia and maintain immune function by helping to prevent destruction of white blood cells (neutropenia). It is possible that oral CHM used in conjunction with chemotherapy may improve QoL in NSCLC. This needs to be examined further with more rigorous methodology. A meta-analysis of RCT’s using CHM formula ‘modified xiao yao san’ (MXYS) for functional dyspepsia (indigestion and heartburn) (Qin 2009). 14 trials were included in this systematic review and meta-analysis. CHM (MXYS) alone was better at reducing the symptoms of dyspepsia than conventional treatment (prokinetic drugs eg domperidone) with no serious adverse effects reported. A combination of CHM (MXYS) and conventional treatment was most effective at reducing symptoms. These are preliminary findings which are limited by methodological weakness and possible publication bias so, once again, more rigorous studies are required. 4. Individual randomized controlled trials

A RCT comparing Tripterygium wilfordii (TW) versus Sulfasalazine in the treatment of Rheumatoid
Arthritis (RA) (Goldblach-Mansky et al 2009).
121 patients with active RA were randomized to treatment with either the Chinese herb TW or the
anti-inflammatory drug sulfasalazine. Assessment after 24 weeks of treatment showed that more
people improved with the Chinese herb than with the sulfasalazine. Side effects occurred with similar
frequency in both groups. This was a small trial with a high drop out rate but it suggests that TW may
offer an alternative treatment for patients with active rheumatoid arthritis.
5. Other research developments

The Chinese Database project
2009 saw the inauguration of the CHM database project resulting from the collaboration of the
Register of Chinese Herbal Medicine, the Southampton Complementary Medicine Trust, and the
Beijing Traditional Chinese Medicine Cochrane Centre. The aim of this project is to improve access to
the estimated 17,000 (Tang et al 1999 & Wang et al 2007) randomized controlled trials currently
stored on the Chinese database and to systematically identify high quality trials that will be translated
into English and reviewed. This will allow practitioners outside of China to benefit from the expertise of
Chinese specialists and will identify potentially fruitful areas for future research. In 2009 5 common
conditions were selected for review:
Results from these reviews will be continued and further extended to include the available Chinese literature as resources permit. 6. Conclusions from the review.
A literature review must incorporate both Chinese and English language sources and should collect both contemporary data and endeavour to include past records from the complete CHM medical works. As the vast majority of past and present literature relating to CHM is written in Chinese it is important that any literature review attempts to engage with the Chinese language database. There are currently over 17,000 RCT’s published in Chinese medical journals (Tang et al , Wu et al). Whilst these generally are of a poor methodological quality they can be used to explore the clinical decision making of experienced Chinese doctors. This can be used to help define diagnostic parameters, establish treatment principles, and provide useful data on the selection and dosage of key herbal medicines and formulae. In the past few years the quality of CHM clinical trials has shown signs of improvement with greater transparency and improved methodological rigour. If sufficient trials of reasonable quality are available then a systematic review and possibly a metanalysis should be considered. In addition to data from RCT’s the CHM journals also contain case histories and case series often from very senior CHM physicians. Data from these reports can also be included in a systematic review and may also be helpful in the development of the herbal protocol for the trial. Some CHM research is reported in English language medical journals. In addition abstracts of some East Asian research are available from the main English language medical databases and it is possible to access translations of the full text from the Chinese database. Data from classical Chinese texts can provide important insights into traditional concepts relating to the pathophysiology and treatment of disease. These can deepen understanding and ensure model validity in contemporary research. There are an increasing number of these classical texts that are being translated however most are still available only in Chinese language. The barrier of the Chinese language provides a serious obstacle for any attempt at a genuine systematic review of CHM literature. However it is a barrier that needs to be overcome. It remains very important therefore to further integrate with our Chinese speaking researchers both in the West and within China. 7. References:

[1] Chen S, Flower A, Ritchie A, Liu JP, Molassiotis A, He Y and Lewith GOral Chinese herbal
medicine (CHM) as an adjuvant treatment during chemotherapy for non-small cell lung cancer: a
systematic review. Lung Cancer. Accepted for publication Nov 2009.
[2] Cho WC, Chen HY.Clinical efficacy of traditional Chinese medicine as a concomitant therapy for
nasopharyngeal carcinoma: a systematic review and meta-analysis. Cancer Invest. 2009
Mar;27(3):334-44
[3] Flower A, Liu JP, Chen S, Lewith G, Little P. Chinese herbal medicine for endometriosis. Cochrane
Database Syst Rev
. 2009 Jul 8;(3):CD00656
[4] Grant SJ, Bensoussan A, Chang D, Kiat H, Klupp NL, Liu JP, Li X. Chinese herbal medicines for
people with impaired glucose tolerance or impaired fasting blood glucose. Cochrane Database of
Systematic Reviews 2009, Issue 4. Art. No.: CD006690
[5] R. Goldbach-Mansky, M. Wilson,R. Fleischmann, N. Olsen,J. Silverfield, P. Kempf, A. Kivitz,Y.
Sherrer, F. Pucino, G. Csako,R. Costello, T.H. Pham,C. Snyder, D. van der Heijde,X. Tao, R. Wesley,
andP.E. Lipsky. Comparison of Tripterygium wilfordii Hook F Versus Sulfasalazine in the Treatment of
Rheumatoid Arthritis: A Randomized Trial. Annals of Internal Medicine 2009; 151: 229-240.
[6] Li XM. Complementary and alternative medicine in pediatric allergic disorders. Curr Opin Allergy
Clin Immunol
. 2009 Apr;9(2):161-7
[7] Liu TT, Shi J, Epstein DH, Bao YP, Lu L. A meta-analysis of Chinese herbal medicine in treatment
of managed withdrawal from heroin. Cell Mol Neurobiol. 2009 Feb;29(1):17-25.
[8] Manheimer E, Wieland S, Kimbrough, Ker Cheng K and Berman BM. Evidence from the Cochrane
Collaboration for Traditional Chinese Medicine Therapies. The Journal of Alternatice and
Complementary Medicine.
Volume 15, Number 9, 2009, pp. 1001–1014
[9] May BH, Yang AW, Zhang AL, Owens MD, Bennett L, Head R, Cobiac L, Li CG, Hugel H, Story
DF, Xue CC. Chinese herbal medicine for Mild Cognitive Impairment and Age Associated Memory
Impairment: a review of randomised controlled trials. Biogerontology. 2009 Apr;10(2):109-23.
[10] Molassiotis A, Potrata B, Cheng KK. A systematic review of the effectiveness of Chinese herbal
medication in symptom management and improvement of quality of life in adult cancer patients.
Complement Ther Med. 2009 Apr;17(2):92-120. Epub 2008 Dec 25.
[11] Qin F, Huang X, Ren P. Chinese herbal medicine modified xiao yao san for functional dyspepsia:
meta-analysis of randomized controlled trials. J Gastroenterol Hepatol. 2009 Aug;24(8):1320-5.
Tang JL, Zhan SY, Ernst E (1999). Review of randomised controlled trials of traditional Chinese
medicine. BMJ, 319:160-161.
[12] Wang G, Mao B, Xiong ZY, Fan T, Chen XD, Wang L, Liu GJ, Liu J, Guo J, Chang J, Wu TX, Li
TQ (2007); CONSORT Group for Traditional Chinese Medicine. The quality of reporting of
randomized controlled trials of traditional Chinese medicine: a survey of 13 randomly selected
journals from mainland China. Clin Ther. Jul;29(7):1456-67.

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