La Cooperativa: concepto, marco jurídico y encaje en la figura

The methods used in this section follow the principles and standard operating procedures developed by the China-Australia International Research Centre for Chinese Medicine (a collaborative partnership between RMIT University and the Guangdong Provincial Hospital of Chinese Medicine) and the work of Dr Brian May [174, 175].

4.2.1 Search strategies 4.2.1.1 Database

Search of the CM historical literature was conducted in the 5^th Edition of the Zhong Hua Yi Dian 中华医典 (ZHYD, Encyclopedia of Traditional Chinese Medicine). The ZHYD is the largest collection of CM historical literature with a searchable feature

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[174]. It is in CD-ROM format and contains the contents of 1156 books in the field of CM [176]. All books in the ZHYD are categorised according to their bibliographical properties and grouped as Theory Classics, Diagnostics, Materia Medica, Formularies (Prescriptions), Acupuncture and Moxibustion etc., and a search scope can be specified in one or more of the above groups. Searching can be performed in three ways: a search of headings, a search of book names, and a search of body texts (Figure 4-1).

Figure 4-1 Search interface of Zhong Hua Yi Dian

4.2.1.2 Search terms

The definition and diagnosis of DKD are based on modern laboratory tests and the term

‘DKD’ is not available in the historical literature. Zhang et al. developed a set of classical terms which are representative of DKD [170]. Briefly, the method that Zhang et al. used to develop the set of terms included collecting information from medical dictionaries, CM textbooks, DKD monographs and publications about classical terms of DKD. The frequency of 31 classical terms in different sources was calculated and summarised. Then, a questionnaire survey was conducted among 35 nephrologists from tertiary CM hospitals across China, to obtain their opinions on the consistency between each candidate term and DKD. Finally, eight out of the 31 terms recommended by over

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50% of nephrologists were cross checked for their corresponding modern diseases in modern CM textbooks, monographs and dictionaries.

Among the eight expert-recommended terms, ancient expressions about the symptoms of oedema (Shui zhong 水肿), turbid urine (Niao zhuo 尿浊), fatigue (Xu lao 虚劳) and anuria with vomiting (Guan ge 关格) were not representative enough for DKD as they also refer to other kidney or internal diseases in the modern literature. Another expert-recommended term, the Xiao Ke (消渴), referrs to the whole process of diabetes therefore it is too broad for the concept of DKD. The classical terms that best represent DKD, as it is known today, is Shen Xiao 肾消, Xia Xiao 下消, and Xiao Shen 消肾.

There was consensus by the nephrologists that these three terms were suitable, and they only referred to DKD in the modern textbooks and monographs. Considering their sensitivity and specificity, the terms Shen Xiao, Xia Xiao and Xiao Shen were adopted as search terms in this research.

4.2.2 Data collection and screening 4.2.2.1 Data collection

Searching was conducted by looking up the three search terms in body texts. The hit number for each search term was recorded. The passages of text containing the search terms were copied into a Microsoft Excel spreadsheet with information about identified term, location in ZHYD, book name and whether it provided treatment data. After removing duplicates, the preliminary dataset of DKD relevant historical literature was obtained.

The second step was searching for literature with herbal treatment information from the preliminary dataset. Historical literature with treatment data but in the form of case reports were excluded due to their different nature. A citation referred to one formula with its treated symptoms/signs. If a passage of text mentioned more than one formula, two or more citations were generated. All citations were retrieved and documented in a new spreadsheet with information about the identified term, book name, original texts, symptoms/signs description, formula name and herbal ingredients. For the purpose of characteristics analysis, information including author, publication dynasty and

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publication year was added for each citation. The reference sources and procedures were adapted from the methods of May et al. [177].

For those citations that only mentioned the formulae name without ingredients, additional sources were consulted in order to find the missing ingredients. Firstly, the formula name was used as a search term to identify its ingredient descriptions within the same book. If text of ingredient descriptions was not found in the same book, then other books written by the same author were searched. If ingredients were still not found, then the corresponding formulae were excluded from the frequency analysis of ingredients. As a result, DKD treatment data from historical literature was developed in the form of a citations pool.

4.2.2.2 Data screening

Citations that met one of the following criteria were excluded:

 Originating from books published after the modernisation of CM, defined as after 1949 [178]

 Originating from the Prescriptions book (方剂书), which was written to assist memory of formulae ingredients (e.g. Prescriptions in Rhymes 汤头歌诀);

 Describing exclusive aetiologies or symptoms/signs of DKD such as priapism (original text: 强中) and haematuria (original text: 小便赤似血色).

The screening was first finished by one researcher and then was checked by another.

Each excluded citation was marked in a separate column in the spreadsheet with a justification. Any disagreement was resolved by consulting a CM nephrologist who was experienced in historical literature.

4.2.3 Data rating

Since searches in ZHYD may find many references, a rating system was developed to categorise citations with varing degrees of relevance to modern DKD.

49 4.2.3.1 Rating system development

Firstly, current diagnosis criteria of DKD in the guidelines and textbooks of contemporary medicine were reviewed [2, 5, 108]. Long-term diabetic history, typical symptoms/signs of diabetes and manifestations of kidney injury were found to be the key aspects in modern clinical diagnosis of DKD. Thus, the rating categories include presentation of typical symptoms/signs, duration of condition, symptoms/signs of retinopathy and exclusive symptoms for differential diagnosis. The details of the rating items are shown in Table 4-1.

Numerical codes were used in each rating item according to:

 Code 0: the citation did not mention the relevant information

 Code 1: the citation included relevant information but was not explicit

 Code 2: the citation included the target expression.

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Table 4-1 Rating categories, items and possible expression in CM literature

Category and items Possible expression (Pin yin & Chinese) History of diabetes

Terms relating to diabetes Xiao Ke 消渴, Nei Xiao 内消, San Xiao 三消, Shang Xiao 上消, Xiao Zhong 消中, Zhong Xiao 中消

Profuse drinking and profuse urine Yin yi sou yi 饮一溲一, Yin yi sou er 饮一溲二

Sweet urine Tian 甜, Gan 甘, Tang 糖, Mi 蜜

Symptoms of diabetes

Frequent urination Shuo 数, Duo 多, Da li 大利, Wu du 无度, Bu jin 不禁 Increased thirst Ke 渴, Duo yin 多饮, Yin shui 饮水, Shan yin 善饮 Increased appetite Xiao Shi 消食, Ji 饥, Yu shi 欲食, Shan shi 善食

Weight loss Shou 瘦, Wei 痿, Xi 细

Symptoms of kidney injury

Turbid urine (protein urine) Bai zhuo 白浊, Zhi ye 脂液, Gao you 膏油, Gao 膏 Oedema of lower limbs Shui zhong 水肿, Tui zhong 腿肿

Disease duration

Chronic or long-term Jiu 久, Bu cuo 不瘥, Bu yu 不愈 Symptoms/signs of retinopathy

Blurred vision Mu hun 目昏, Shi zhan hun miao 视瞻昏渺, Shi wu mo hu 视物模糊

Exclusive symptoms

Haematuria Niao xie 尿血, Xiao bian chi 小便赤

Secondly, a hierarchy of relevance to DKD in the rating system was constructed based on the following criteria (Table 4-2): (1) history of diabetes; (2) symptoms/signs of diabetes; and (3) symptoms/signs of kidney injury. Citations fulfilling all three criteria were most likely to refer to DKD as it is known today. Citations that satisfied the third criterion plus the first or second criteria were possibly DKD. Citations only meeting the third criterion were conditional DKD. Other citations were unclear as to their relevance to DKD. The overall score ranged from 0 to 3 representing a low to high degree of similarity of the historical citations to modern DKD.

51 Table 4-2 Hierarchy of relevance to DKD

Relevance to DKD Score Score criterion

Unclear 0 Does not include any symptoms of kidney injury or not enough information to judge

Conditional DKD 1 Only includes symptoms of kidney injury

Possible DKD 2 Includes diabetes history and symptoms of kidney injury, or symptoms of diabetes and symptoms of kidney injury

Most likely DKD 3 Includes diabetes history and symptoms of diabetes and symptoms of kidney injury

4.2.3.2 Data rating procedure

Each rating category and its items were listed in separate columns in the spreadsheet for each citation. Based on the original texts for each citation, codes were allocated to each rating item under different categories. Judgements of relevance scoring were made based on the coding results of all rating categories. Four citations pools with different relevance to DKD were obtained.

The rating procedure was independently conducted by two reviewers. Before all citations were rated, a pilot trial was done to test the consistency of coding results between the two reviewers and to test the validity of the rating system. Any disagreement on rating and relevance scoring was resolved by discussion with a third CM nephrologist or by consulting CM dictionaries.

4.2.4 Data analysis

Data analysis included two parts. The first part was a descriptive analysis of the citation characteristics to present an overview of DKD records in historical literature. The second part was a frequency analysis of the formulae and herbal ingredients, leading to discovery of the most frequently used formulae and herbs for DKD in antiquity. The analysis was performed in the Statistical Package for the Social Sciences (SPSS) software (version 21, IBM).

4.2.4.1 Descriptive analysis of citation characteristics

The dynasty distributions of citations and search terms were analysed for all treatment

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citations. The dynasty of each citation and term was determined based on the written or publication years of the cited CM books. In addition, the hit frequency of each search term in ZHYD and different citation pools was calculated.

4.2.4.2 Frequency analysis of formulae and herbs

The herb names were standardised before analysis, to ensure the same herb with multiple names was calculated altogether (Appendix 1 includes a list of herbs and their corresponding Pin yin and scientific names that are referenced in this thesis). For example, shan yao 山药 and huai shan 淮山 were both considered to be the same herb;

thus it was standardised to be the same name. Formulae were evaluated and standardised based on formulae names and composite ingredients. If two formulae had the same names but different ingredients, a number was added after the formulae names, for instance Ba wei wan 1 八味丸 1 and Ba wei wan 2 八味丸 2. If two formulae shared identical ingredients but with different names, the name that appeared earlier was kept.

The changes were separately documented in the spreadsheet.

After herbs and formulae standardisation was completed, frequency analysis was conducted for the “treatment citation”, “conditional DKD citation”, “possible DKD citation” and “most likely DKD citation” pools separately. Frequency analysis of herbs for turbid urine and oedema was also conducted based on different citation pools.