The SOP Panel of the GP-TCM Consortium

Kelvin Chan, Pierre Duez, Debbie Shaw, Monique Simmonds and Qihe Xu

(with comments by Rudolf Bauer, Christine Leon and Rob Verpoorte)

Version: 1.9

Date: 3rd February 2011

Modifications included in this update

SOP Panel Membership list has been updated

A section on the quality assessment of GP-TCM deliverables has been added

The Quality Assessment reviewer feedback form has been included at the end of the document as Annex 4

Updated Eastlinden web address

Added a section on construction of Pharmacopoeia names in Section 6.3.

Completed with some additional remarks on Pharmacopoeia names

Objectives of this SOP

This SOP and handbook aim to (i) provide references/advice to all work packages (WPs); (ii) propose good practice and quality control for data collection; (iii) provide technical support and a series of technical annexes.

This draft SOP consists of the following information:

  • Introduction
  • General principles
  • Central questions
  • Technical support
  • Technical Annexes

Introduction

Based on nomination of consortium members and invited by the Coordination Office (CO) of the FP7 GP-TCM Consortium, a SOP panel has been set up, including the following members: Prof Kelvin Chan (Co-Chair) (WPs 1, 3, 7 and 10); Prof Pierre Duez (Co-Chair) (WPs 1, 3, and 10); Dr Debbie Shaw (Co-Chair) (WPs 3 and 10); Prof. Rudi Bauer (WPs 1 and 10), Dr. Alessandro Buriani (WP4), Prof. Meng Cui (WP10), Prof. De-An Guo (WP10), Prof. Michael Heinrich (WP1), Dr. Wei-Guo Jia (WP5), Ms. Christine Leon (WPs 1 and 10), Prof. Yanhuai Liu (WP10), Prof. Aiping Lu (WPs 6 and 10), Prof. Olavi Pelkonen (WP3), Prof. Nicola Robinson (WP8), Dr. Jandirk Sendker (WP2), Prof. Monique Simmonds (WPs 1, 2, 4 and 10), Prof. Ian Sutherland (WPs 1, 7 and 10), Prof. Rob Verpoorte (WPs 1, 9 and 10), Prof. Liz Williamson (WPs 3 and 10), Dr. Qihe Xu (WPs 4, 5, 7 and 10), Dr. Shouming Zhong (WP10), and Dr. Youping Zhu (WP1).

As requested by the CO, the SOP of GP-TCM Literature Review should be concise, easy to understand and follow. We should emphasise effective methods of literature review, critical analysis, productive high-quality reports and publications rather than inputting  forms and devising comprehensive databases, although we do appreciate the importance of the latter and will not discourage any WPs that have a strong desire, extraordinary expertise and/or extra funding to do so.

Key functions of the SOP are to provide principles, quality control protocols and technical support throughout the 3-year lifespan of the GP-TCM project. It is expected that the SOP will need continuous refinement throughout the 3-year period. In another word, developing such a SOP is an important deliverable of the whole consortium and will need continued inputs and efforts from all consortium members, especially SOP Panel members.

Progress of each WP is centrally monitored and coordinated by the Management team (WP10), in particular the CO, the SOP Panel, the Science and Technological Committees and the Steering Committee. Whenever necessary, relevant data from each WP will be inserted in the SOP and a specific update calendar will be generated by the CO.

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General principles

There is a need for common guidelines on literature review. Reliable data indeed form the basis of scientific evidence and evidence-based practice. Data management, including collectionanalysiscriteria for selectionstorageretrievalaccesssharingdispatching and subsequent updating, is thus crucial for accuracy and correctness.

Although working on similar problems, not all Work-Packages (WPs) have the same approaches and/or requirements for building up data collection. Overlapping and specific approaches will be needed to present data in a format usable by other WPs to facilitate sharing of resources and to avoid duplication of efforts and costs.

GP-TCM literature reviews have a clear purpose, that is, to help in developing evidence-based deliverables and high quality reports and publications. To ensure this, key deliverables-linked central questions are mandatory to be listed in the 3-year plan of each WP to guide focused reviews.

In general, central questions of all WPs must base on their proposed deliverables (see Table B1.3.4 of the Technical Annex I of the GP-TCM Project) and serve high-quality authoritative reports and publications. Special care should be taken to make sure that all GP-TCM WPs keep in mind the following key phrases while proposing their central questions: application of functional genomics and other emerging new technologiesstate-of-the-art TCM researchproblemspotential solutionsgood practice and guidelines and priorities for the EU and its member states.

In particular, priorities should be given to “difficult diseases” in EU, which refer to common diseases and top killers in EU member states, which cannot be treated satisfactorily by conventional medicine.

Owing to fund and manpower limitations, we will discourage any un-necessary re-spinning of the wheel and our reviews must NOT start from scratch. Instead, we have to build our reviews on existing quality reviews and authoritative reports. For example, for WP2, the application of countercurrent chromatography (CCC) technology in Traditional Chinese Medicine (TCM) research, Prof Ian Sutherland’s database and extensive review should be taken as a foundation for further discussions and exploration of the topic. Additional excellent examples are Prof Liz Williamson’s recent book on herbal drug-drug interactions and the University of western Sydney database of the side effects of herbal products (Dr Debbie Shaw & Alan Bensousson), which should lay an invaluable foundation for the related topics in WP3 and WP6. For WP6 and WP8 reviews, the Cochrane library should be investigated first, although these limited reviews cannot be expected to serve all the objectives of our own reviews and thus, by NO means, these reviews will take the place of our own efforts.

http://www.cochrane.org/reviews/en/topics/22_reviews.html

In particular, it should be reminded that data from international, EU and EU member state official regulatory bodies, such as those published by WHO, NIH, FDA and in national and international pharmacopoeia, have been verified by experts. These should be taken as important references by related WPs.

Based on this, central questions should be addressed through critical analysis of existing reviews, reports and documents, followed by more in-depth reviews to fill the gap of knowledge and to update knowledge. We hope that, by doing so, each WP can make evidence-based deliverables, and generate high-quality reports and publications.

Conflict of interest should be avoided and stated where applicable to prevent giving priorities to only ones’ own research interests.

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Central questions

Based on the aforementioned principles, the different WPs have proposed Central Questions that will help to achieve the work requested for the different deliverables. These Central Questions are presented in Annex 1.

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Pending questions

Kelvin Chan recently raised some important questions still to be discussed.

  • Grading system is rather subjective. It is assumed that most of the published papers in good (reputable) journals pass some sort of grading. But can we give points to journals? High impact-factors ones may not be the relevant ones.
  • Database access poses another problem. Not many universities outside China have full accesses; even within china not all universities have direct access for all the journals.
  • Even if one gets hold of an article published in Chinese, regardless in simplified or traditional text, the accuracy of translation is crucial so that the content can be included as literature source. Many difficulties reside in interpreting true meaning in the TCM diagnosis and treatment terminology; it is not easy to carry out good scientific approaches for assessing efficacy of TCM treatment of diseases that have different conceptual interpretation even in side effects, toxicity and efficacy aspects. This is probably less problematic for science papers.

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Technical support

Guidelines for questions formulating and literature reviewing

  • Formulate the question and define the backbone of the review with a planned focus BEFORE starting the reviewing process
  • Think about possible topics to develop a roadmap for compiling evidence-based TCM: “Specific Chinese materia medica (CMM)” [by WPs1-5 & 7]; “Extracts” [by WPs 1-5 & 7], “TCM products” (WPs 1-5 & 7), “Difficult diseases” [WP4-6 & 8] …
  • Carefully think about the structure of reviews: intro, questions investigated, how to, deliverables important to FP7 project (Note: Deliverables may not be enough for paper publication purpose)
  • Strive for high quality work and especially quality control: how to ensure the review is good quality and can be used as a basis for publications and future grant applications from EU?

In summary, reviews should be highly focused => Focus on deliverables and focus on questions important to the FP7 project => Major keywords => Quality of objectives and outcomes => Aim at publications.

Short list of priority herbs for GP-TCM

This list of species has taken over a year to compile and many people were involved, supporting Monique Simmonds in getting the data together to target the species. At the start of the project it was agreed that we would target popular herbs used in TCM, but soon realised we needed to define what we meant by “popular”. Members of the WP1 obtained lists from companies trading species used in TCM in main land China, Hong Kong and Europe as well as lists from colleagues in China and Hong Kong. Once the data were collated, we had a list of over 100 species commonly used in traditional Chinese medicines in China and Europe. However, this list was too long.  We had feedback from WP6 about the diseases they would like to focus on, which included cancer, diabetes, irritable bowel and skin diseases. We checked for the use of the 100+ species in the treatment of these conditions. The list of plants was reduced from over 100 to 53.  At Henley, it was suggested we look at some popular TCM formula and it was agreed to select the six species used in “Liu Wei Di Huang Wan”. Others in the audience requested a few more species used in many other formula so a further six species were added.  We thus have a list of 11 species.

This shorter list of species is important in assisting the consortium meets the contractual targets for the GP-TCM project. It is hoped that each WP will collate information on these species as well as the formula “Liu Wei Di Huang Wan”. If the WPs can collate information that is relevant to the remit of their WP, then we should be able to provide a good overview of the traditional and modern data known about these species as well as a gap analysis for what needs to be done to provide scientific evidence to support the use of these species in Western medicine. In compiling this list, it should not exclude each WP from working on other species.  However, we hope all WP’s will include the 11 key species on the list as well as their recognised substitutes and adulterants.

Retrieval, differentiation and aggregation of publications using non-standardised terms

For Chinese herbal medicines, the names used in the literature are very variable. The same medicinal plant products can be described using different terms, including Latin binomials, pharmaceutical names, English names, simplified and traditional Chinese characters, Chinese Pinyin names, names in Japanese and other Asian languages and their different English transliterations. Different translations are also involved in the description of the medicinal parts of the herbs, processing, cooking and extraction methods, types of preparation, composition of Fufang (herbal remedies comprising more than two TCM products) and doses of individual TCM products. More complicatedly, some Pin Yin, pharmaceutical names and any non-standardised names might refer to different species of herbs.

Because there are so many ways of naming the medicinal herbs used in Chinese medicine we need a comprehensive linked index of names to as a scientific resource, to reduce risk of confusion and aid literature searches.  In addition it would be practical to have a consistent naming system for the herbs under investigation by the different WPs.

The Short list of plant species (Table 1) provides most of the possible names that might be used for the herbal drug and that can be used for literature searches. If any WPs wish to add other plants to the list they will need to refer to WP1 for assistance in correctly completing Table 1.

Some general principles on naming Chinese medicinal plants:

  • The English Common name (e.g. Scute for Scutellaria) should be avoided as far as possible as it is too variable and may lead to confusion. If it is used in literature searches then some additional identification of the herbal drug in the papers that are retrieved is essential.
  • The use of Latin binomials contributes to scientific rigor.  However these can only be used if the plant material or herbal drug has been fully authenticated by an appropriate botanist.
  • The Latin binomial only applies to the plant; the part of the plant and details of processing must be added if referring to the herbal drug.
  • If only the Pin Yin or other transliterated name is given in a paper without any botanical authentication then the Latin genus and species cannot be assumed.
  • Construction of Pharmacopoeial names : these names should not be confused with Latin binomials (which regularly happens on web sites!) and are designated as follows : Latin word designating the considered organ + Latin name of the plant (often only the genus is indicated) declined as a Latin genitive (this is the latin terminaison that means “of”).

The order can be reversed in some Pharmacopoeias : Latin name as genitive + organ.
A few common Latin names for organs :

Latin word English word
Radix Root
Semen Seed
Caulis Stem
Cortex Bark
Fructus Fruit
Flos Flower
Folium Leaves
Herba Aerial parts
….

Some examples [1]:

Rhizoma Alimatis                           translates as      rhizoma of Alisma

Alimatis rhizoma                             translates as      rhizoma of Alisma

Radix Angelicae pubescentis      translates as      root of Angelica pubescens

Angelicae pubescentis radix        translates as      root of Angelica pubescens

There is some confusion about the meaning of some words. For example, in the Chinese Pharmacopeoia (2005), “Herba” has a loose definition since it is used to describe herbs where either the aerial parts only are used (e.g. Herba Violae) or where both aerial and below-ground parts are used (e.g. Herba Potentilla Chinensis).  Only by reading the text under the heading is it clear which parts are officially included.   No doubt other pharmacopoeia have other conventions but it is quite common that the Latin title does not exactly reflect the plant part used (also in Eur. Ph.; Hyperici herba = mainly flowers; Salicis cortex = containing twigs; Belladonnae folium = herba, etc, etc). If one wanted to differentiate herbs sourced from aerial plants only versus all parts then the latter could be covered by the term ‘planta tota’ but we’ve not seen this used.

It is absolutely necessary to keep the latin title of the pharmacopoeia monographs in the list otherwise we end up in a complete confusion. Two possible solutions from a TCM perspective :

  • Go with the convention used in the CP (i.e. Herba to infer either above and/or  below-ground parts) BUT add a qualify in English to explain exactly which parts are covered. Include such a qualifier in the Guidelines not only for this situation but also because the Chinese Pharmacopoeia can be imprecise for other plant parts too; there are e.g. botanical inaccuracies when the terms ‘Fructus’, ‘Semen’ and ‘Radix’ are used.   ‘Fructus’ has been mistakenly used in the title to describe certain TCM seeds and vice versa, likewise with ‘Radix’ when in fact botanically they mean ‘rhizomes’. This English qualifier (if included in the Guideline) would not be a translation of the Latin plant part given in the title of the account, but instead would be the plant part(s) officially intended to be used according to the Chinese Pharmacopoeia (stating which edition).
  • Each monograph has an exact definition, which clearly defines what is used. This definition should be included in the master table.
  • If the pharmacopoeial name is given then it may refer to any species in the Chinese Pharmacopoeia (or other national pharmacopoeia) listed as being used as that herbal drug.
  • Once the table is finalised the individual herbs can be given code number to aid computer modelling or other electronic manipulation.

See attached file for species that are frequently used in TCM and it is hoped that the different WPs can assist us to gather data on these species – especially the first 6 species (please click here to download the file).

(i)     We also need to decide on a standard naming system for reports/tables and interim documents used by the different WPs – this can be one or two names from the master list.

This will provide a ‘shorthand’ for reports and other documents.  This will reduce the chance of mistakes and also provide a consistent appearance across all groups.  If one of the outcomes of the project is to be developing protocols for research practice or clinical trials and reporting results then we will need to include naming guidelines for the protocols. This will evolve over the course of the project.

It is recommended that we use:

a)  Pinyin name plus the Chinese Pharmacopoeia name (CP05/10)

Zexie (Rhizoma Alismatis)

This name is cited in the pharmacopoeia and includes all species used (as that herbal drug; as such it does not necessarily indicate a specific species.

An alternative option is:

b)  Pin Yin plus Latin binomial (CP05/10) plus plant part

Zexie (Alisma orientalis (Sam.) Juzep. rhizome)

This name is more scientifically accurate as it includes the species name and authority.  This is the most specific name.

Processed herbs will be identified with ‘preparata’

Although (b) is the preferred naming system for scientific accuracy, there are times when (a) is more accurate.

Given that the species complex of a single herbal drug entity tends to vary between the different editions of the Chinese Pharmacopoeia (and no doubt for other pharmacopoiea too), it is necessary to reference the edition of the pharmacopoiea to which both Pharmacopoeia and Pin Yin names refer.

e.g. in the 2005 ed. of the Chinese Pharm, Yinyanghuo (Herba Epimedii) refers to 5 species of Epimedium, but in the 2010 edition, one of these species, E. wushanense, has been separated out as a new medicinal entity under the name ‘Folium Epimedii Wushanensis’  or more precisely ‘Epimedii Wushanensis Folium’. Therefore to ensure rigour, when using the name ‘Yinyanghuo’ or ‘Herba Epimedii’ it would be helpful to know in which sense these names are meant (2005 ed. or 2010 ed).

Note that that the current (2010) edition of the Chinese Pharmacopoeia has chosen for the first time since its inception in 1956 to place the plant part at the end of the pharmacopoeia name rather than at the front: “Alismatis radix” instead of “Radix Alismatis”.  This may lead to even greater confusion amongst non-botanists when trying to decipher whether the name in a paper is a Latin scientific name as opposed to a Pharmacopoeia name.

(ii)    The choice of name

Depends on the source (of the material or the name) and level of botanical identification that has been carried out.

  • When preparing a review the full identification (Latin binomial, authority and Chinese, pinyin and pharmacopoeial name should be given in an introductory section.
  • When reviewing the literature, if only the Pin Yin, Pharmacopoeia or other vernacular name is given (without any botanical identification) then the Latin species (sometimes genus) cannot be assumed (unless only one species is used clinically) and a more pragmatic approach is needed. The more specific scientifically accurate name cannot be used if the identity of the herbal drug has not been botanically authenticated. Otherwise the use of a scientific name suggests the material concerned has been competently identified.
  • The Latin scientific name only applies to the plant species.
  • Plant parts and processing details are assigned irrespective of the plant species.
  • For any clinical trial or scientific investigation it is desirable that the Latin binomial (+authority) can be used. This requires botanical verification of genus and species.
(iii)   Important implications

All WP members need to realise the significance of assigning a species name when preparing reviews or conducting studies. For example, in the literature Mutong is often considered to be Akebia quinata (without botanical verification) but in fact there is very little of this species available on the market and most of the herbs sold as Mutong are either Clematis armandii or Aristolochia manshuriensis.

An Excel form including possible names of most commonly used medicinal plants has been prepared by Prof Pierre Duez based on Internet data (see Annex 2 for a sample). It would need to add additional medicinal plants, naming authorities, names in simplified and/or traditional Chinese characters, etc, to make a more commonly useful reference tool.

Animal and mineral products are often used in TCM and especially in Fufang. Although animal products might come across some barriers in the market entry to the EU due to one reason and another, the analysis of different names of these non-herbal TCM products, (Latin, English, Chinese characters, Chinese Pinyin, etc) is crucial for correct analysis of a specific research if these products are involved in a given remedy. Prof Monique Simmonds might provide information about the rules and regulations currently we have and this should form additional two Technical Annexes, on animal products and minerals, respectively.

Summary:

  • Latin name are not often used!

WPs should aim to obtain / aggregate publications published under different vernacular names (Chinese, Japanese, etc.); note that, very often, the names are translated in English names (as abstracts are often required in English)

  • The following nomenclature problems should be taken into consideration
  1. Chinese Pinyin names: sometimes difficult to relate to single plant species
  2. Animal products: Latin names, conservation status
  3. Minerals: Latin names => risk of mistakes
  4. Fufang complex mixtures?
  5. Note that Kampo medicines use Japanese names, usually in high-quality Japanese publications. The species used in Kampo may not be the same as that used in Chinese medicine.
  6. Processing methods are important

Scoring systems for literature

In any extensive review of the literature, it is useful to have a scoring system to evaluate the quality of the papers.  Two scoring systems have been proposed by P Duez and WP4, respectively.

Scoring systems can be used to calculate how many percent of papers meet different stringency of quality control, and in good, acceptable and bad practice in naming herbal products in scientific publications and how much these issues affect the reliability of published research.  Papers of poor quality may require more careful interpretation but should not be dismissed as some are likely to contain useful information.

The following has been proposed by P. Duez for scoring papers and is open to discussion. WP4 has developed scoring criteria that overlap with these ones; all these criteria should be carefully combined. WP4 has also added criteria for biological testing reporting and analysis. The experiences and lessons from WP1, WP2 and WP5 pilot reviews should also be included.

Preliminary proposal for grading papers

Each paper could be given a 3-score grading: botanical origin (0 to 10); processing (0 to 5) and extraction (0 to 10)

Bot 7/10 Proc 3/5 Extr 6/10
Botanical origin: a mark from 0 to 10
Score
Sufficient information Insufficient information
Herb provenance indicated? 1 0
Herb harvested:

Identification information (botanist, reference)?

Voucher specimens deposited?

DNA bar-coding? (unlikely in majority of papers)

Post-harvesting treatment?

Quality and reproducibility of treatment? Can’t judge this from the papers?

2

3

2

1

1

0

0

0

0

0

Herb bought in commerce:

Shop location?

Voucher specimens deposited?

DNA bar-coding? Unlikely?

Post-harvesting treatment (drying, washing, etc.)?

Quality and reproducibility of treatment? Unlikely ?

2

3

2

1

1

0

0

0

0

0

Processing: a mark from 0 to 5

In grading the paper the identity of the herb, the fact that it was processed in the standard method is important.

Score
Sufficient information Insufficient information
Herb processing indicated? 1 0
Wet cutting? (highly probable for some herbs, but often not mentioned)

Eventual processing of the herb?

Perceived quality and reproducibility of process?

1

1

2

0

0

0

Not sure of the value of grading the processing details.

Extraction: a mark from 0 to 10
Score
Sufficient information Insufficient information
Detailed extraction procedure? 1 0
Yield? Not sure of value of this

Perceived quality and reproducibility of process?

2

2

0

0

Are the extracts characterised?

Chromatographic profile?

Chromatographic profile with determination of presumed key constituent(s)?

3

5

0

0

  • One of the ultimate goals of GP-TCM will be to define the minimum standards for reporting a paper in the literature (Rob Verpoorte); but GP-TCM reviewing work deals with papers that are far from this “ideal” and were published with very different types of standards. This does not mean the information is wrong, but that its reliability can be more or less questioned. And so a grading system common to GP-TCM should be defined
  • The Cochrane group has an extensive set of guidelines for clinical reviews => they drop down “not-so-good” studies. For GP-TCM, we cannot afford that “luxury” (we often do not have so many papers) and so we need to include “not-top papers” in the review è identify what needs to be done to improve things (which is a long prospective).
  • Possibility to drop down some paper indicating something like: “xxxx studies have also been published but are not reviewed here because of xxx problems”.
  • The use of such criteria is currently under testing by WP4 on a series of papers to evaluate the difficulties in using them in practice. Once WP4 preliminary review is summarised, we should have more inputs from them about literature grading, etc.
  • Have we had any feedback from Peter about the outcome of this testing?
  • We have to consider carefully what we are grading in the paper; we are not looking at a very high tech area, as you would find in pharmaceutical research, so we have to be careful about excluding useful information.
  • We need to include in RefMan all the papers that the WPS identify – even if they aren’t useful to the group that finds them, they may be useful to a different WP (even some of the poor quality papers). There isn’t enough data out there on most of the herbs that will give us the luxury of excluding information from papers.

Literature retrieval from English searching engines:

To simplify and standardise searching engines, we should use PUBMED and Google Scholar as main literature-retrieving tools, which are free, and Scopus and SciFinder for those who have institutional access. PUBMED and SciFinder are the most comprehensive database of biomedical and chemical literatures, respectively; Google Scholar and Scopus can provide valuable information on the popularity of any individual papers, listed according the frequency of citations, through which comments by peer scientists can be taken as a reference for analysis. For any literature published in English and Chinese, we encourage members in the EU and China to get free access through their own libraries and online sources or purchase papers using the 3000-5000 Euros awarded to their accounts. In case any key papers need be purchased through the CO, especially for those non-beneficiary consortium members, a request can be submitted to the CO so that we can get hold of them through various sources and the costs will be covered by the 10.000 Euro of unforeseeable costs under the control of the management team.

=>  a list of “who has which paper” would be quite interesting to establish to avoid duplication of costs and efforts.

Literature retrieval from Chinese searching engines:

To be recommended by SOP Panel members in China. Example search engines include… Chinese medicine patent database – Eastlinden information on TCM patents can be found at:

http://www.eastlinden.net/NewsShow.aspx?news_id=20081127102018850246

Prof. Meng Cui’s TCMonline at the China Academy of Chinese Medical Sciences and its English IT platforms Traditional Chinese Medical Literature Analysis & Retrieval System (TCMLARS) and Traditional Chinese Drug Database (TCDBASE) can be powerful retrieving tools of Chinese literature. We should further discuss the means of access to these tools, although these databases do not provide access to full publications.

http://www.cintcm.com

http://cowork.cintcm.com/engine/windex1.jsp
Dr. Zhouhua Cao at Wanfang Data Ltd has agreed to help the CO to get original Chinese publications for our consortium: http://www.wanfangdata.com/.

The parties interested in obtaining a given paper are requested to contact Dr. Halil Uzuner ([email protected]) with the full details of the paper that they are after. He will then pass this information to Dr.  Zhouhua Cao, and once obtained, will send the paper(s) to the related parties.

Chinese-English translation

(i) Google web Chinese-English translation

For Chinese literature that is available through Google search, Google web translation is an easy way of getting a flavour of a paper of interest.

This Google translation method is purely based on statistics:

  1. Creation of a database containing groups of words already translated: the database is automatically built up by learning from aligned bilingual texts
  2. Association of segments of phrases from the text to translate with groups of words from the database

This statistical approach gives quite fluid texts but requires a database of more than 2 millions words to give acceptable results. The Google motors automatically explore web pages, detect bilingual texts and create a gigantic database with millions of words to propose translations between 23 couples of languages… Two limitations to the approach:
(i) technical documents with a dedicated vocabulary (a dedicated database should be built up from relevant technical documents); (ii) short sentences (the correct sequence is selected based on the sentence context; short sentences do not give clues enough for correct choice).

For example, if one is interested in a paper by Wei, Lian-Bo and Huang, Li-Wen, entitled Strategies and methods of integrated traditional Chinese and Western medicine in preventing and treating chronic kidney disease (中西医结合防治慢性肾脏病的思路与方法), published in Zhong Xi Yi Jie He Xue Bao, 2008; 6(5):449-53.

You can easily get hold of this paper by Googling the Chinese title of the paper. On top of the searching outcome, you will see the following:

中西医结合防治慢性肾脏病的思路与方法–《中西医结合学报》–医学期刊 -[ Translate this page ]

Click [Translate this page], you will get a readable translation of the paper (the full contents, as it is an open-access journal)

(ii) Systran web Chinese-English translation

To overcome such limits, the company Systran more recently developed a hybrid method, mixing linguistic and statistic techniques:

  1. The linguistic approach determines from a classical dictionary the different possible translations for each word or group of words and proposes several solutions
  2. The statistical approach checks the generated solutions and makes choices by limiting the error risks.

A major advantage of this approach is the use of a classical dictionary; this lexical dictionary can be amended by the user to require that a word is always translated the same way, which considerably increases the homogeneity of translations. The hybrid method considerably reduces the size of the statistical database and a textual corpus of 200.000 words is now enough for statistical refinement of the text. This allows the user to create a terminology database related to his domain by using a corpus of already translated documents.

More information on: http://www.systran.co.uk/translation-products/desktop/systran-premium-translator

An automatic translator can be directly accessed on: http://www.systranet.com/

However, in the absence of a TCM dictionary, here again results remain quite imperfect.

Warning: the result is still somewhat “primitive” and cannot be used to understand all details from a scientific paper. It may however help you to determine if a given paper is interesting to further translate…

(iii) Computerised translation in collaboration with Eastern Linden Website

Prof. Yanhuai Liu, President of East Linden, has developed a powerful TCM translation tool and agreed to share this tool with the consortium; the tool might be available for November 2009.

http://www.eastlinden.net/NewsShow.aspx?news_id=20081029103545483043

A collection of translational tools will be assembled as a Technical Annex.

Intellectual property rights (IPR):

The GP-TCM Consortium does not wish to keep the copyrights of any intellectual properties generated through GP-TCM activities. We encourage publication in Open-access journals and any patents generated through GP-TCM activities can be legally owned by the consortium beneficiaries and non-beneficiary institutions that contributed to the products. Importantly, IPR and copyright issues are indeed to be regulated in data storage, transfer and storage. Please consult your local libraries and the SOP Panel if there are any doubts in these issues. It is advisable to generate a Technical Annex to regulate the GP-TCM policy in IPR.

Publication of GP-TCM reviews in international journals:

Prof. Rob Verpoorte, Editor-in-chief of the Journal of Ethnopharmacology (Annex 3), a leading Journal of the area of Traditional medicines and phytomedicines, has agreed to consider having a GP-TCM special issue in this particular journal, given that the consortium members produce sufficient number of high quality reviews. Of course, such a decision is subject to approval by his board members.

The Coordination Office (CO) had a meeting to discuss this issue, and concluded that it is highly desirable to have all our main reviews published in a special issue, so that these collective reviews can make a bigger impact. Main reviews of each Work Package (WP) should include the overview of the current status of research in areas covered by each WP, the problems, possible solutions (in particular by applying emerging new technologies in the post-genomic era), priorities, perspectives and guidelines. In addition, if any groups of consortium members are interested in contributing additional reviews focused on particular diseases or herbs, it is also encouraged to propose, so that it can be invited by the journal (provided that the journal shows interest in these reviews).

Draft Foreword to the Special Issue

Proposed title: Good Practice of Traditional Chinese Medicine Research in the Post-genomic Era

In contrast to the reductionist approach of Western medicine that is based on modern anatomy, cell and molecular biology, Traditional Chinese Medicine (TCM) uses a unique theory system and an individualised and holistic approach to describe health and disease, based on the philosophy of Yin-Yang balance and an emphasis on harmony of functions. Supported by a European Union (EU) Framework Programme 7 coordination action grant, a group of scientists from 14 EU member states, China, USA and Australia formed a consortium named “Good Practice of Traditional Chinese Medicine Research in the Post-genomic Era (GP-TCM)” in 2009. They have worked together for 3 years to review the current status of TCM research, the problems and potential solutions by applying emerging technologies developed in the post-genomic era, which allow a high-throughput observation of a whole profile of molecules at different levels and furthermore link them to clinically relevant biological functions. The Consortium includes the following working groups: (i) quality control of Chinese herbal medicines (CHMs); (ii) extraction and analysis methodology of CHMs; (iii) toxicology and safety of CHMs; (iv) in vitro pharmacology of CHMs; (v) animal studies of CHMs; (vi) clinical studies of CHMs; (vii) market entry and industrialisation of CHMs; (viii) acupuncture and moxibustion; (ix) coordination and sustainable development of Chinese medicine in EU member states. This special issue consolidates the main research findings of these working groups and proposes perspectives, which we hope to help the European Commission and other funding bodies to decide their future funding directions and also help scientists to find authoritative guidelines to achieve good practice in this emerging area of research in Europe.

Furthermore, the format of the journal can be used as the official format of our GP-TCM reports so that review, reports and publications can be best integrated to avoid waste of time on format adjustment, etc.

http://www.elsevier.com/wps/find/journaldescription.cws_home/506035/description#description

Any other journals to be nominated? How about the reviews on acupuncture (WP8), which does not sound very well fit in the remit of The Journal of Ethnopharmacology…

Quality assessment for GP-TCM deliverables

During the 7th CO teleconference (18th November 2009), the consortium CO members agreed that a robust quality assessment (QA) procedure is required for GP-TCM deliverable reports. Previously there was no standard quality control method to ensure the consortium deliverable reports are of high quality. With the introduction of systematic QA, each report has to be quality assessed before the final version can be produced.

As part of this process, a reviewer feedback form presented in Annex 4 must be completed and sent to thedeliverable coordinator and the project manager by every QA reviewer. The form consists of a series of questions; the responses to which need to be satisfied by the deliverable coordinator to ensure the deliverable is of an acceptable standard for submission. Internal reviewers for each deliverable are assigned by the management team.

There are two ways the form can be completed (this is also described on the form itself), either will be fine:

1)    Short answers, but accompanied by a copy of the deliverable with track changes .

2)    Expansive answers , referring to sections of the deliverable and describing the improvements that need to be made.

It is the responsibility of the deliverable coordinator to ensure this procedure is followed and that recommendations are implemented in time for deliverable submission. The management team will require the completed forms/draft deliverables (with track changes) before the reports can be accepted as final.

The following quality control method will be used for all future deliverable reports:

  • Relevant WP coordinator and all relevant WP members will work together to prepare the report;
  • WP coordinator will contact one of their WP members with good command of English (preferably a native English speaker) to check the grammar of the report;
  • During the last month of the deliverable deadline (4 weeks before the deadline given in the Annex I), the report will be sent to the assigned internal reviewers (composed of members from the Steering Committee,theTechnical Advisory Committee, Ethics and SOP Panel members) for their review via the project manager;
  • Committee members will have one week to review the report, fill in the QA review document (please see  Annex 4), and return the report to the WP coordinator via the project manager;
  • WP coordinator will implement the committee members’ suggestions (one week) and return the report to the committee members via the project manager for second round of review if necessary;
  • Committee members will review the report again (if necessary) and return their feedback form to the WP coordinator via the project manager (one week);
  • WP coordinator will implement the final changes recommended by the committee members and upload the final copy to the project website (via document repository) and also send a copy to the project manager on the given deadline.

Some useful software for handling data

Data collecting and storing in a useful and ordered way is very important for the future use of data and a SOP is being considered to take care of the particularities of TCM.

Bibliography searching and reference managing

Both EndNote (www.niles.com) and Refworks (www.refworks.com) can be used by consortium members. They both allow a very easy way to collect (by connecting to PubMed and many other on-line sources) and store references; both can directly insert and format citations in Word documents (EndNote is even interfaced with Word and can be used straight from Word and Refworks allows operation in a number of language environments including English and Chinese). References can be transferred from one to the other and can also be exported in a format usable in a database software. A bit of manipulation is required, but it is nearly straightforward. For details of Endnote, please contact Prof Pierre Duez: [email protected]; for details of Refworks, please contact Prof Javier Lucio-Cazana: [email protected].

Data collecting

Although the SOP Panel does not encourage extensive data input, in view of a clear need of intensive and focused data input in the consortium, the SOP panel would also provide guidelines on how to create simple databases using relational database softwares such as Access 2007 (in Windows, the software is included in Office Professional and Office Ultimate; apparently no version available for Mac http://office.microsoft.com/en-us/products/FX101635841033.aspx) or Filemaker pro (http://www.filemaker.com/products/fmp/tech_specs.html; available in Mac and Windows environments) as they should allow efficient standardisation of data collection and have the following advantages:

  • high standardisation of data input (plant names, TCM, benefit and risk data…)
  • standardised forms help users not to forget inputting important data
  • relational: important data are entered only once (plant names, methods of preparation, etc) and referred to in forms
  • data are in order and ready for further exploitation and expanding (when funds are available for real standardised reviews)

Prof Pierre Duez and colleagues have developed a prototype database (rough for the moment, but gives an idea of what can be achieved) in Access 2007. Given the high percentage of Microsoft Office users, this software might be one of the most easily accessible. For any further information about data collection using Access or Filemaker Pro, please contact Prof Pierre Duez: [email protected].

Possible procedure for data handling using Microsoft Access as an example

A logical way to work would be as follows:

(i)      Once you have a paper interesting, enter the bibliographic information in the table Biblio (this can be done in batch operations either from EndNote or Refworks)

(ii)     Enter the information on the plants composing the preparation in the table Plants using the form Plant (ideally, an “official” plant table should be compiled e.g. by importing an existing database; so everybody would use the same info)

(iii)    An adulterant/falsification table should also be developed

(iv)    Enter information on the TCM products in the table TCM (an advantage of Access 2007: several plants can be put in the field “Plants used” in a single operation which means we can define any TCM products very rapidly); here also an “official” TCM table could be compiled.

(v)     Enter information in the table of interest. Prof Pierre Duez has created for the moment a series of prototype “martyr” tables (Annex 2); each table should be thoroughly examined by panel members and can be tailored to the demands of WPs.

Suggestion: adding a table for Mode of administration and one for Mode of preparation. This info can be easily standardised and need not re-typing each time; thus allowing real standardisation of data input. For details of this suggested data collection methodology, please contact Prof Pierre Duez: [email protected].

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Annexes

Please find below the Annexes referred in the manual above:

 – Central Questions of GP-TCM Work Packages

 Annex 2 – Proposed forms for entry of risk/benefit data

 Annex 3 – The “rules of 5” from Journal of Ethopharmacology

 Annex 4 – Quality Assessment reviewer feedback form

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 On some web sites, we can even find stupid constructions such as: Rhizoma Alismatidis or root of Angelicae pubescentis (which are obviously wrong)

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