Lupine Publishers| Natural Rubber Latex and Gum Arabic: A Comparison of Physico-Chemical Properties

 Lupine Publishers| Journal of Material Science

Abstract

The present investigation deals with the determination of the physio-chemical properties of two commercial grade samples of local gums (Gum Arabic and Natural Rubber Latex (NRL)). The results revealed that the gum samples have high melting point that indicate thermal stability at room and moderate temperatures. The gum samples have about 95 % carbohydrate content and a corresponding high internal energy and can serve as a source of energy. The rheology of the samples revealed shear-thickening characteristics with gum Arabic being thixotropic and pseudo-plastic in nature while NRL was observed to be anti-thixotropic and rheopectic. Further results from the moisture absorption, contact angle and Fourier Transform Infrared Radioscopy (FTIR) analyses gave better insight into their hydroscopic behaviours. Gum Arabic has excellent water absorption capacity with less wettability as it consists mainly of more water-soluble compounds in comparison to Natural Rubber Latex. These insights from the study will enhance wider application of the gums with increased value-addition to the gums and the communities where they (can) thrive.

Keywords: Gums; Density; Wettability; Latex; Gum Arabic; Rheology

Introduction

Rubber latex and gum Arabic are gums which are water-soluble polysaccharides that are extractable land plants. They also contain some protein materials and are important agro-forestry resources in Nigeria [1]. They can enhance the viscosity and gelling ability with their dispersions. Hence, the key qualities of the gums are their water solubility and high viscosity in aqueous dispersions. Guar gums are harvested from the stems and branches of the resource gum trees as dry exudates. Hydrophobic affinity chromatography showed that gum Arabic is made up of three major constituents namely, Arabinogalactan (AG), Arabinogalactan protein (AGP), and Glycoprotein (GP). The highly branched polysaccharide part of the gum represents about 90% of the total gum [2]. The complex nature of plant gums is since each gum sample possess a special combination of sugar (monosaccharide unit) to form the polysaccharide. The most widely distributed sugar in plant gums are mannose, galactose, ramose, fructose, xylose, and the sugar acid. They contain residual amount of fats, protein, metabolites, metal ions, crude fibres etc. Raw materials of plant origin have proven to be relatively non-toxic, bio-compatible, readily accessible, economical, and cost effective. In this regard plant gums are used for wide industrial applications such as in the cosmetic, pharmaceuticals and in food industries [3].
The prediction of the properties of these gums is a challenge because of their heterogeneity in addition to their complex nature. Hence, their industrial applications require reliable information that can only be obtained from proper characterization of samples. The physicochemical properties of a compound are the measurable physical and chemical characteristics by which the compound may interact with other systems. This characteristic collectively determines the quality, applicability or the end-use of the compound. In plant gums, these properties are directly influenced by the botanical type, age, location, nature of the growing soil and the climatic condition around the resource gum tree [1]. Physicochemical characterization of gums therefore is an essential step towards establishing suitability for industrial application. This focus of this study is to determine the physio-chemical properties and characterization of natural lubber latex and guar gum as found in Nigeria. This is to enable us gain insight into their quality, applicability, and end use in industries. Information about these properties are scanty in open literature. Such physio-chemical properties include the ash content, moisture content, moisture absorption, pH, percentage lipid content, crude protein, carbohydrate content, and functional groups, among others. Just as other natural resources have been studied (Abdallah, Edomwonyi-Otu, Yusuf, & Baba, 2019; Edomwonyi-Otu & Aderemi, 2010; Edomwonyi-Otu, Aderemi, Ahmed, Coville, & Maaza, 2013; Gimba & Edomwonyi-Otu, 2020) The knowledge of their properties and applications for value addition and enhance the economic wellbeing of the communities where they thrive.

Experimental

Preparation of Samples

Gum Arabic: The crude sample consisted of mixture of large and small nodules mixed with the bark and other organic debris obtained from the bark of wounded Acacia Senegal plant and Frankincense plant. Hand picking method was used to separate the neat gum lumps from debris and other constituents. The lumps were then spread out under room temperature to dry. The dried sample was then ground into powder and 150 g of the sample weighed inside an empty dried weighed bucket by using the weighing balance (CWS Series with accuracy of ±0.05% FS). The sample was added to a 200 ml hot boiled water to dissolve the sample. Proper protective equipment was worn for safety purposes. The gumwater system was properly stirred to ensure complete dissolution of the gum in water. It was thereafter stored in a tight container at room temperature for 48 hours and stirred at 6 hours intervals to ensure a perfect dissolution, proper hydration and adsorption (Edomwonyi-Otu, Chinaud, & Angeli, 2015). The dissolved solution was centrifuged (strained) to remove air bubbles and any insoluble residual lumps through a muslin cloth (mesh) in a jug and sieved into another container. The undissolved lumps of the sample were transferred into a crucible and placed in the oven (Gallenkamp TM OV-420) at a temperature of 90 ̊C to dissolve further by gentle heating. The dissolved solution was then mixed, weighed and filtered using a mesh to separate the clear gum solution from dirt. The weight of the clear solution after filtration was measured. Formalin was added to the gum Arabic clear solution to prevent deterioration, and then stored^[1].

Natural Rubber Latex: 300 ml of the crude rubber latex gum was tapped from the stem of rubber latex plant (hevea brasiliensis) using a v-shaped knife. The raw latex was then centrifuged to remove water molecules. Ammonia solution was then added to the solution to prevent deterioration [4].

Analysing the Physio-Chemical Properties of The Gum Samples

Density and Specific Gravity Measurement

Density and specific gravity analysis of 1% w/v of the test samples was carried out using a density bottle and following methods described elsewhere [5]. The weight of the empty bottle was measured (W) using CWS Series weighing balance (accuracy of ±0.05% FS) and then weight of the bottle with 70ml of the test samples of gum acacia solution and rubber latex gum respectively as (W1). The difference was taken to obtain the actual weight of the liquid solution; the weight was divided by the volume to obtain the density as shown in equation (1)

(1)

Where, W1 is the weight of bottle and the test sample of the gum solution, W is the weight of the empty bottle and V is the volume of the gum samples.

Ash Content and Moisture Content

The analysis of moisture and ash content was determined using 2 clean crucibles of known weight dried in an oven at 102 ̊C for 30 minutes. 10g of both samples were placed in the crucibles and the put into an oven (Gallenkamp TM OV-420) at a regulated temperature of 125 ̊C for 6 hours. The Moisture content was taken as percentage ratio of the change in the weight to the original sample weight. The dry weight of the ash was taken, and the ash was ignited at 550 ̊C in a muffle furnace for 1 hour, content was cooled in a desiccator for 30 minutes and weighed. The ash content was taken as the percentage loss in weight after ignition to that of the original sample. Equation (2) and (3) gives the temperature for calculating % moisture and % ash content respectively.

(2)

Where; W₁ is the original weight of the gum samples, W₂ is weight of the gum samples after drying

(3)

Where; C₁ is the dry weight of ash, C₂ is the weight of ash after ignition

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Lupine Publishers| Do You Know Your New Molecular Entity (NME)?

 Lupine Publishers| Drug Designing & Intellectual Properties International Journal

Introduction

During the last decades, life science startup companies have relatively rapidly increased their presence in the pharmaceutical landscape. Pharmaceutical development has evolved because technology (analytical and process development) and clinical development (hybrid design in phase 1, including patients in phase 1B) have evolved in parallel allowing in certain cases to decrease the time to regulatory filings (IND, CTA, NDA, NDA 505 (b)(2),..), which seemed attractive for startup companies. However, new molecular entities have become more complex since polypeptides, proteins, and monoclonal antibodies drug products take more and more place in many therapeutic areas (more than 50% in the 50 best seller drugs) along with the more conventional small molecules. But it is not the end of small molecules; research institutes, startup companies are still busy working hard to develop more powerful small molecules, since the physiopathology has also evolved and helped finding some new targets to enhance their efficacy and decrease their lack of selectivity. Startup companies are mostly driven by high level scientists and few of them are familiar with the drug development process, including its early phases. Scientists do know their NMEs from a scientific point of view however, much less and, sometimes, not at all in terms of potential drug product candidates.

The authors of this paper cumulate more than 50 years in drug development at various phases with different kind of molecules; they will try to illustrate how what you do not know about your NMEs can and will hurt you and also present how to avoid surprises that may occur down the road of drug development.

People do not know their NME.... however the NME is the most important ingredient of a drug

These three (3) main questions should be asked:

a) Why do we not know our NME?

b) When and how does it hurt?

c) What can we do to prevent it?

a) Why do we not know our NME?

Figure 1: Drug Development Timeline by PhRMA.

As illustrated in (Figure 1) below and going through different Gantt charts coming from different websites, pharmaceutical development is not a popular topic in the overall drug development scheme and especially for startup companies. Below summarizes somehow most of the drug development pathways as illustrated in pharmaceutical companies and agencies. Two main conclusion scan be extracted from this above timeline:

a) Things are presented sequentially but that in reality they are done in parallel.

b) Clinical steps are starting right after the preclinical steps, increasing the statement that PR&D is not something very popular in drug development overall.

Figure 2: Interaction and timing of the different drug development steps. Adapted and modified from Modern Pharmaceutics (ref...).

The (Figure 2) above illustrates, in our sense how drug development should be done, regardless of the NME. The following things should be kept in mind then:

a) Many drug development activities are done in parallel (and not sequentially).

b) PR&D should start almost during drug discovery, or when lead compounds (and backups) have been selected.

From a regulatory standpoint, according to Pharmaceutical Development ICH Q8 Guideline, the aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. It means that irrespective of the development steps and the scale, both the NME and the dosage form should be reliable, reproducible, stable and develop in such a way thatthe changes (scale-up, fine tuning) through development should not require, in a ideal world, bridging studies. A lot of people working in the PR&D area have noticed that this last ICH Q8 was more than a challenge to achieve. It represents one of the reasons why drug development will hurt. Questions are then the following:

How it can and will hurt- Where does it start?

a) With the NME: although drug development requires a scientific approach, science should be used to meet regulatory requirements.

b) The NME needs to be developed into an active pharmaceutical ingredient (API) irrespective of its indication.

c) Even though outstanding results were obtained during the proof of concept (POC), a NME is not in itself an API, even less a dosage form.

Why do we not know our API?

Typical Biotech/start-up situation:

a) Licensed technology/molecule from a university or research center, where the scope and objectives (research is oriented to advance science and knowledge) do not totally meet those of the pharmaceutical industry (research is oriented to serve medical needs within the confines of regulations ultimately allowing bringing a drug product to market).

b) High knowledge of the chemistry, the biology, the proof of mechanism (not necessary the physiopathology).

c) Lack of knowledge of the pharmaceutical sciences /drug development process.

d) In the quest for nanomolar binding efficiency and biological potency, there has been a gradual shift of new pipeline compounds biopharmaceutical characteristics into less "druggable" compounds. The result then is a higher challenge to develop and maintain a reliable/reproducible dosage form regardless of the scale and the development steps.

Why do we not know our API?

Typical Biotech/start-up situation

a) Lack of available funds for several reasons (due diligence, overhead, routes of administration were different during nonclinical steps resulting in lack of reliability/efficacy, poor NME characterization at the gram scale, poor development plan).

b) Money is kept for what is perceived as absolutely necessary: the clinic whereas the phase 1 clinical trial may not be the most expensive step (depending the indication), CMC, formulation development and nonclinical could be extremely expensive for a sterile biological product.

c) Need to deliver something quickly.

d) Public companies are driven by market expectations.

e) Private companies need results to get financing.

f) Prepare samples for pre-clinical/toxicological studies with available material.

g) Most of the time, formulations used in preclinical and toxicological studies are not optimized and do not reflect the formulation to be brought to clinical studies.

h) Lack of knowledge of the regulatory requirements for drug development and therefore the associated cost.

i) Drug development is a lengthy process and the regulatory environment changes, so will the cost.

When does it hurt?

a) Throughout the drug development process.

b) Typical biotech situation: jumping in the drug development arena without required knowledge and expertise, relying on CMOs and CROs to fill the gap.

c) When trying to secure a business partner.

d) Typical biotech situation: licensing after a phase IIA, which needs an un neglect able amount funds.

e) Usually a Big Pharma with a high knowledge of drug development process.

f) Due diligence can be deadly: team of experts with high expectations on availability of data, QA audits.

g) When preparing the market application.

h) After commercialization middle size pharma are buying products to fill their pipelines where most of the challenges lie in chemistry, manufacture and controls.

i) Getting out of the laboratory: going to the pilot plant up to GMP facilities.

j) What works at the gram scale usually does not work at the kilo scale.

k) Process parameters change (equipment train, operating conditions, crystallization/purification solvents, mass and heat transfers, etc.)

l) Preparation of the test articles for GLP toxicological studies may not be reliable from the bench to the CRO, root cause being unknown because not investigated.

m) All these impact the quality attributes of the Apian therefore the rest of the drug development chain.

Due Diligence Topics

NME:

a) Synthesis: yield and scale-up feasibility.

b) Analytical development: wet and solid-state chemistry (which is neglected despite the lack of solubility, the high log P of the more recent NME).

c) Comments on whether there are any correlations between physical characteristics and formulation orbio availability (polymorphism is somehow neglected).

Non-clinical development and GLP toxicology:

a) How was the proof of mechanism demonstrated (versus gold standard? Route of administration? Reliability?).

b) There is evidence that most sponsors have a good understanding of the toxicology program that is required to bring a product to Phase I; however, the rest of the early phases of drug development (i.e. the development of the actual drug product in a suitable dosage form) is not given the same level of attention despite the increasing poor "drug ability" properties of modern-day NMEs.

c) Current Approaches to Fisrt-In-Human Phase I Clinical Supplies.

d) "Formulated" product approach: Clinical formulation that is a precursor of the desired commercial formulation.

e) Exploratory formulation approach: Uses the simplest possible formulation (e.g. NME only in bottles or capsules).

f) Keeping in mind that the focus of Phase I testing is mainly to evaluate safety, which approach is applicable and why?

g) Phase I-II clinical programs are rarely rejected from a clinical standpoint. But care should be taken with the clinical supplies: was the formulation the same than during non- clinical proof of concept and GLP toxicological studies? If the formulation has changed, has it modified the Maximum Tolerated Dose, the MEC (minimum effective concentration to get a PD effect), and the No Observed Adverse Event Level (NOAEL)?

When and how does it hurt?

a) If the NME is not well characterized (frequent), the changes that occur are difficult to identify and the basic quality attributes cannot be properly maintained. It will then generate a snow balling effect throughout drug development.

b) What is the impact of the NME manufacturing (physicochemical characteristics) and formulation development processes (differences in the formulation from non-clinical POC, GLP tox studies, and from phase I to III, scale up) on drug product performance, especially since drug are getting less and less soluble and then "druggable".

c) CMC: preparation of early phase clinical application documents, and modules 2 and 3 of the CTD.

d) Happens after years of drug development initiation.

e) Very often, data was generated way back by people that are no longer in the organization.

f) Characterizing the impurity profile is important not only from a CMC standpoint but also for toxicology and clinical studies. Impurities present at levels above ICH standards should be qualified.

g) If the NME is not well characterized, changes that occurred through the various phases of development cannot be identified and the basic quality attributes cannot be properly maintained.

h) Wet chemical characterization is not enough to portray the complete NME behavior Physical characterization is essential.

i) If there a relationship between the structure and the activity of an NME, (complex NME and biologics), bioassays are more than recommended (and mandatory for most of the agencies).

j) Both the NME and the dosage form will go through "Site changes", going from "laboratory" to "pilot" and then to production scale.

k) Site change: bench top scale to cGMP (kilo and pilot scales) facility.

l) cGLP non-clinical, phase I/II clinical studies: safety and "exploratory (dose ranging/finding)" efficacy data acquisition.

m) Impurities? (Safety and CMC are concerned).

n) Polymorphic forms? (CMC, safety and efficacy are concerned) ite changes: from cGMP pilot to cGMP commercial scales.

o) Phase III clinical studies: generation of safety and efficacy data.

p) Pivotal clinical studies.

q) Should use the « final and best » NME and dosage form.

r) Surprises are not welcome at this late stage.

s) When submitting a market application, it is necessary to demonstrate a similarity between the batches used in the clinic and the formula of the proposed commercial product.

t) This applies to both the NME and the dosage form.

u) Late surprises can lead to questioning the validity of clinical batches that have generated data and support the safety and efficacy of the commercial product.

Pre clinical and non-clinical sections

a) How has the POC been demonstrated (Which lot? Which physico-chemical characteristics? Versus standard of care? Route of administration? Animal model? Reproducibility and reliability? (Ex: IC50 (in vitro)/Cmax (in vivo) if the formulation may impact the way the NME may be absorbed, the Cmax may change form one formulation/experiment to another, the ratio may become biased.

Clinical

a) Closely connected with the above mentioned poor "druggability", the current approaches for early clinical phases (I/IIa) in drug development

b) Approach with formulated products, where clinical batches will be precursors based on commercial formulation (almost 90% of the final formulation).

c) Exploratory approach: use the simplest formulation: powder in a bottle or capsule.

d) Keep in mind that the goal of Phase I is safety and pharmacokinetics (even if cohort (s) of patients are part of phase IB).

e) (Figure 3) illustrates the risks of using a non-optimal formulation in phase I/IIa:

f) Increased nonlinear or proportional AUC due to solubility problems (saturation of absorption).

Figure 3: Observed AUC and PK linearity Vs dose in mg.

g) No conclusions can be drawn about MTD (maximum tolerated dose, NOAEL, and safety margin,....p

What can be done to prevent this?

a) A good knowledge of the drug development process

b) Get familiar with regulatory requirements at the various stages of development; do not rely only on CROs or consultants.

c) Get the required expertise and build strategies early for pharmaceutical development.

Evolving Regulatory Requirements

Phase I studies

a) Brief and focus is on safety, PK and if possible, trend of efficacy (biomarkers, endpoint,..).

b) Clinical design are evolving: SAD/MAD studies, food effects, patients, Therefore the goal of getting an "almost" final formulation is getting more and interesting to increase the reliability form one phase to another. Sponsors do not want the formulation to be held responsible of unexpected results.

Phase II studies

a) Evidence to reasonably support the proposed chemical structure of the drug substance should be provided: what is the impact on tox, formulation development, clinical studies (dose ranging-finding) and primary efficacy results.

Phase III studies

a) Final market image! Biobatches, product monograph and expiry date will be based on this scale.

Late surprises may lead to question the validity of clinical batches to support efficacy and safety of the propose commercial product.

Conclusion

In conclusion, a NME should be developed with complementary people, such as the steps illustrated in (Figure 3) the fact that people get a scientific degree does not make them specialist in all the fields. The regulations will change over time: and so will scientific knowledge and technical/analytical capabilities. It should be kept in mind that Guidance/Guideline documents represent current thinking of regulators and that some are withdrawn and new ones are issued. These documents must be interpreted in the context of the product being developed. There should be a harmonized balance between regulatory and technical/scientific requirements. Knowledge about the NEM should let people streamline their drug product correctly (safety and efficacy) through the whole drug development process, keeping in mind that everything is done in parallel, not sequentially. Since people (from investors to scientists and developers) do not share the same language, it is highly recommended to try to hire the relevant expertise as early as possible, at the early stage, better drug development strategies will be developed planned and well budgeted resulting in a nice risk management position, where "manageable" surprises only may occur down the road, without jeopardizing any launching.

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Lupine Publishers | The Prevention and Treatment of Malaria in Traditional Medicine of Tetun Ethnic People in West Timor Indonesia

Lupine Publishers | Open Access Journal of Complementary & Alternative Medicine 

Abstract

Native people in West Timor Indonesia have been exposed to malaria since long time ago. Because of this experience, it is believed that this community has developed their local concept about malaria, and how to manage it. This research was intended to document and analyze local knowledge and practices of malaria prevention and treatment developed by Tetun ethnic people in West Timor. The research was a field study, conducted through some interviews, discussions and observations. The results of this study showed that this community has long been developing various methods to prevent and threat malaria. The prevention and treatment of malaria in traditional medicine of Tetun ethnic people consists of both herbal and non-herbal methods and supported by some prohibitions and restrictions. The results also showed that the practice of traditional medicine for prevention and treatment of malaria by Tetun ethnic people can be explained scientifically. Medicinal plants that widely used like Strychnos ligustrina, Carica papaya, Momordica sp., Cleome rutidosperma, Physalis angulata, Alstonia spectabilis, Alstonia scholaris and Melia azedarach have been proven to have antimalarial activities as anti-plasmodial, antipyretic, analgesic, anti-inflammatory and immunostimulant.

Introduction

Traditional communities in ancient times developed their local knowledge about the prevention and treatment of a disease based on their experience interacting with the disease for a long time. This local knowledge was then become a guidance for them to establish strategies to prevent and treat the disease, which were practiced widely in the community, and become their traditional medicine [1,2]. Traditional medicine is a term imposed on pre-scientific medical systems, and defines as a sum total of knowledge, skills and practices based on theories, beliefs and experiences of different cultural customs used in health care, disease prevention and increased physical and mental performance, which have been used for generations from one generation to the next [3,4]. Malaria is an ancient disease that has not been fully eradicated until this time [5]. Since long time ago, malaria was the main infectious disease that often attacks Timorese people, especially in Belu and Malaka Districts in West Timor (Indonesia). Several old manuscripts noted that Timorese people in early of 19th century were suffered from malaria which caused many deaths [6,7]. Until this time, Belu and Malaka Districts are still hyper-endemic areas of malaria. According to the Global Fund report, in 2014, Belu and Malaka Districts were classified as high malaria endemic areas, with the Annual Parasite Insidence (API) of 12.87o/oo and 11.58o/oo respectively, higher than Indonesian average API 1.38o/oo. Various programs for malaria prevention and eradication sponsored by the Indonesian Ministry of Health and World Health Organization such as insecticide-impregnated net, fogging, mass blood survey for early diagnosis and prompt treatment, and treat malaria patient using Artemisinin Combination Therapy (ACT) have been implemented, but decreasing of the API value is still not too convincing [8]. Cultural factors that influence public attitudes and acceptance on the programs of prevention and treatment of malaria are estimated to be one of the obstacles to the success of these programs. The implementation of various disease control programs and strategies often faces major challenges stemming from the social and cultural situation of the community. The social and cultural situation of a community in a particular place can negatively influence the choice, acceptance and use of interventions in disease control. Many programs of disease control and eradication are unsuccessful because of these social and cultural barriers. Therefore, it is very necessary to understand the local knowledge of the community, including an understanding of the health-illness concept that they believe in. An understanding of this can help policy makers in designing a sustainable and more effective disease control programs [9]. The Tetun ethnic is one of native communities that inhabit territories from the central part of Timor island (in Belu and Malaka districts, Indonesia) to the east (in Republic Democratic de Timor Lester, RDTL). Tetun people are still using traditional medicines to date, and often running various traditional medication rituals [10]. Because of their long-time interaction with malaria, it should be assumed that they have developed their own local knowledge about malaria and methods to prevent and treat it. Therefore, this research was intended to study the local knowledge of the Tetun ethnic people regarding malaria and the methods they have developed for the prevention and treatment of this disease.

 

Introduction

Study Design

This study is a kind of research in the field of medical anthropology. This study was conducted as a qualitative exploratory research, with a field study as main technique, supported by a literature study.

Profile of Study Site and People

This research was conducted in Belu and Malaka Districts located in the central part of Timor island. These areas are located at 9°15’ S-9°34’ S and 124°40’ E-124°54’ E. Belu and Malaka are two of Indonesian territories that border directly with the Republic Democratic Timor Leste (RDTL). The topography of Belu Districts is mainly hilly, while Malaka is generally a stretch of flat land. Some areas of Malaka at the south part meet the rainy season twice in a year, while the areas of north part and also Belu areas are only have one rainy season. The main rainy season takes place between November-March due to wind that brings rain from the Indonesian Ocean. This rain occurs evenly in Malaka and Belu regions. The additional rainy season in April-June, which is limited in some areas of Malaka, is affected by wind from Australia that carries moisture from the Timor Sea. Based on the ethnolinguistics, there are four indigenous ethnic groups that live in Belu and Malaka Districts, namely Tetun, Dawan, Kemak, and Bunaq (Marae). Tetun ethnic is the majority ethnic group in Belu and Malaka, consists of approximately 80% of the population. They scaterred in almost all sub-districts of Belu and Malaka [11].

The Informants

The informants of this study were people of Tetun ethnic who have lived for long time in Belu or Malaka Districts. They were people with good knowledge and experiences of traditional medicine practices. The informants were selected through the purpossive and snowball tehniques. A total of 94 informants (42 men and 52 women) with the age of 40-90 years old were involved in this study. They came from 15 vilages of five sub-districts in Malaka (Wewiku, Malaka Barat, Weliman, Malaka Tengah and Kobalima Timur Subdistricts), and 14 vilages of ten sub-districts in Belu (Raimanuk, Tasifeto Barat, Nanaet Duabesi, Tasifeto Timur, Lasiolat, Raihat, Lamaknen, Kakuluk Mesak, Atambua Barat and Atambua Selatan Sub-districts). These informants consist of traditional public healers, home healers, and traditional medicine users.

Data Collection

Data were collected through several interviews, discussions, and observation. Interviews were conducted with a semi-structured questionnaire. Interviews were intended to collect informations about local knowledge on health-illness concept, symptoms, signs and causes of malaria, traditional methods for the prevention and treatment of malaria, and medicinal plants used for the prevention and treatment of malaria. More deep questions were developed spontaneously based on the answers given by the informants to the previous questions. Interviews and discussions were conducted in Tetun (local language) and Indonesian. We recorded the contents of every interview by wrote a detailed essence of the conversation, but not fully word by word. Several interviews were recorded with audio and video recorder. In this field study, we were assisted by several local guides to search for informants, accompanied in the interviews, to interpreted specific local terms that strange for us, and help us to search, document and collect plant specimens. All plants mentioned by informants were collected in-situ and documented by making photographs and herbaria for taxonomic identification. This field study was conducted from April 2017 to December 2017.

Data Analysis

Data obtained from interviews, discussions and observations were analyzed qualitatively, and presented in narrative or qualitative descriptions [12]. The steps of qualitative analysis are as follows:

a) Transcription of data: first of all, the interview data, discussions and field observation records were well-transcribed in a neat text.

b) Data reduction: transcripts were analyzed to marked meaningful parts, and then grouped based on the same characteristics into certain categories, i.e. the local knowledge about health-illness, local concepts about malaria, methods for the prevention and treatment of malaria, and plants used for the prevention and treatment of malaria.

c) Presentation of data: data that has been grouped were arranged regularly according to each category to make them easy to understand. Data of plants used in malaria prevention and treatment were presented in a table.

d) Verification and conclusion: determined the meaning of the data presented.

Results and Discussion

Local Concepts about Health-Illness

The concept of health and illness in Tetun community is very simple. Tetun people define health as a condition of normal, good and not sick. Illness is interpreted as a condition in which someone feels unwell or sick or has a disease in the body. Tetun traditional people state a condition as health or ill by seeing physical signs. A person is said to be health if he/she looks physically strong, fresh, agile, has a bright face and good appetite; and vice versa, if the physical performance seems weak, lethargic, pale face, lack of appetite, then the person is said to be sick or has an illness in the body. Someone is said to have recovered from illness when showing physical signs such as being able to get up, not feel dizzy anymore, being able to walk quickly and to work again, and his/her appetite is back and improved. The concept of Tetun people about health and illness is also associated with the ability to carry out daily life activities. Someone who is still able to work or move without feeling bad or pain in his body, then that person is not said to be sick. People who are clinically suffering from a certain disease but not feel sick and still able to carry out daily activities without being disturbed by the disease, then that person is not considered sick. WHO and Indonesian Ministry of Health define health as a state of complete physical, mental and social well-being, and not merely the absence of diseases or infirmity [13]. Comparing the concept of health according to Tetun people’s understanding with this official definition, it can be concluded that the concept of health of Tetun ethnic people is inadequate to describes whole condition called health, because for this community, health and illness are more related to physical performance than psychological and social performance.

Local Concept about Symptoms and Signs, and Causes of Malaria

The indigenous people of Tetun know malaria as is in mana’s (hot body, fever) with primary signs and symptoms are high fever, shivering, intermittent fever, headache, muscle and joint pain, pale, yellow eyes, and abdominal pain and/or diarrhea. Many informants did not know that swollen spleen (splenomegaly) is also one of the signs of malaria that is already severe, but they assumed that the swollen spleen can cause fever (they say “malaria”). In general, almost all the informants assumed that malaria is a common, mild and not serious disease, only a sick of hot body or fever. This local concept seems to greatly influences people’s perceptions of the danger of malaria and result in reduction of their alertness on malaria and the seriousness of managing this disease. In the local knowledge of Tetun ethnic people, the causes of malaria are: sweet food and drink, chilled, sunburn, fatigue, presence of other disease in the body, magic, cold food and drink, lack of sleep, inadequate post-natal care, spicy food, alcohol, and oily or fatty food. Tetun ethnic people assumed that sweet food and drink, sunburn, magic, spicy food, alcohol, and oily or fatty food cause an excessive heat in the body, and as a result, someone will get high fever malaria. Chilled, cold food and drink, lack of sleep is assumed to cause cold entering the body, and as the result, someone will get shivering malaria. The fatigue, presence of other disease in the body and inadequate post-natal care for mother and infant are assumed to destroy the equilibrium of hot and cold in the body and result in malaria with high fever and/or shivering. According to some informants, mosquito as malaria transmitter was a new knowledge that coming from outside, introduced by the Catholic missionaries from Europe. According to Foster dichotomous on causes of disease [14], the causes of malaria in the local concept of Tetun people are naturalistic, not personalistic. Factors such as sweet foods or drinks, long time in rain, water or cold places, long working under the hot sun, fatigue and the presence of other diseases in the body are naturalistic properties that cause heat-cold balance in the human body to be disrupted, and then causes someone to get malaria. Many Tetun people do not consider mosquito as carrier of malaria, causing them to have low awareness of the threat of mosquitoes. This may be one of the causes of the still high endemic of malaria in Belu and Malaka until this time [15].

Methods for The Prevention and Treatment of Malaria

The Tetun ethnic people have their own patterns or habits of life that they do for generations to prevent malaria attacks. The methods that are considered effective in preventing attacks of malaria are: luli or hale’u, drink medicinal concoction of bitter herbs, eat bitter food, and drink tua moruk. Luli or hale’u means avoiding things that can cause malaria (according to their local concepts about the cause of malaria), which are: not eating sweets frequently, not working for long time under the rain or hot sun, and not too tired at work or physical activities. Eating bitter foods, especially papaya and bitter melon, and drinking bitter palm sap tua moruk are also considered effective to prevent someone from being attacked by malaria. Some informants who previously linked malaria with mosquitoes stated that repelling mosquitoes using smoke of burned aromatic plants and sleeping under mosquito nets are effective for malaria prevention. The treatment of malaria in traditional medicine of Tetun ethnic consists of herbal and non-herbal methods. Herbal method consists of drinking herbal concoction, inhaling the vapor of boiled medicinal plant, massage with paste of medicinal plant, bath with water of boiled medicinal plant, and attach the paste of medicinal plant as a cataplasm on the swollen spleen. A non-herbal method is sunu kok, that is burning the waist above the swollen spleen using a piece of coconut shell coal or a heated metal. The results of the interviews showed that most traditional medication for malarial patient usually combine two or more methods. It was found also that the role of traditional healer in the treatment of malaria patient is not so important. Tetun ethnic people assumed that malaria is a common and not a serious disease, thus the treatment of malaria does not require a high competency healer. Several informants stated that they usually conducted self- and home-medication for malaria complaint. In the traditional medicine of Tetun ethnic people, the treatment of malaria is a simple treatment for reducing heat or fever [15]. The assumption of malaria as a common, mild and not a serious disease results in lack of awareness about dangers of malaria. It was found that in many cases, health workers often complain of disobedience of patients who stop taking antimalarial drugs immediately after they feel cured (being able to get up, not feel dizzy anymore, being able to work again, and the appetite is improved), even though Plasmodium in their blood has not been completely eliminated. As the result, the success of the malaria eradication program in this area has increased very slowly [8].

Plants Used for The Prevention of Malaria

Tetun ethnic people believe that consumption of bitter food or drink can prevent someone from malaria attacks. Therefore, small children are often forced by their parents to eat stew and drink decoctions of flowers, leaves and young fruit of Carica papaya, or young fruit of Momordica sp. (M. charantia or M. balsamina). Some informants gave information that if they feel tired, achy and lack of appetite, they will drink decoction of Carica papaya leaves, fruit of Momordica charantia, Melia azadarach leaves, Alstonia scholaris, Alstonia spectabilis or Strychnos ligustrina stem bark. Consumption of these plants’ decoction is believed to restoring body freshness, increasing appetite, eliminating fatigue, and thus, preventing from malaria attack. Some informants also believed that drinking tua moruk is effective in malaria preventon. Tua moruk is a traditional drink made by fresh tapped palm sap soaked with the stem bark of Alstonia scholaris, Alstonia spectabilis or Strychnos ligustrina soaked in it. Several publications of other previous studies showed that the bitter plants used by Tetun people to prevent malaria has been shown to have pharmacological activities as antiplasmodium and immunostimulant [16-18].

Plants Used for The Treatment of Malaria

In this study, we recorded a total of 96 species from 39 families used by Tetun people in various formula for drink, massage, bath, inhalation and cataplasm (Table 1). Strychnos ligustrina, Carica papaya, Cleome rutidosperma, Physalis angulata, Alstonia spectabilis, Alstonia scholaris and Melia azedarach are some of the most widely plants used in various formula for drink. For massage, Garuga floribunda, Jatropha curcas, Acorus calamus, Allium cepa, Drynaria quercifolia, Ocimum sp. and Ruta graveolens are common. For bathing, people use Tamarindus indica, Psidium guajava, Melicope latifolia and Blumea balsamifera. Leaves of Brucea javanica, Annona muricata and Annona reticulata are used in inhalation method. Root of Moringa oleifera and leaves of Ficus hispida are used as cataplasm to reduce the swollen spleen [19]. Several plants were found in various formula for more than one mode of application. Several previous publications showed that most of these plants are also used in other traditional medicine for the same purpose in many areas of Indonesia and the world [16,18], and have been scientifically proven to have pharmacological activities as true antimalarial (antiplasmodial) and/or indirect antimalarial such as antipyretic, analgesic, anti-inflammatory and immunostimulant [20].

Table 1: Plants used by Tetum ethnic people for the treatment of malaria.

Conclusion

The practice of preventing and treating malaria in the traditional medicine of Tetun ethnic people is a direct implementation of their local knowledge about malaria. The local concept of signs and symptoms and the causes of malaria encourage traditional people to create methods to prevent and treat malaria. The local concept of the Tetun ethnic people about malaria is the main reference in the creation of rules regarding prohibitions and restrictions, and recommendations for preventing attacks of malaria. The local concept of the causes of malaria determines the choice of plants for the treatment of malaria. Scientifically, these plants have been proven to have activities as true antimalarial and indirect antimalarial. The local concept of malaria as a common, mild and harmless disease causes that the role of traditional healer is not always needed in the treatment of malaria. Methods for the prevention and treatment of malaria developed by Tetun ethnic people consist of both herbal and non-herbal methods and supported by the implementation of several prohibitions and restrictions to provide healing for the sufferers of malaria.

Acknowledgement

We thank to Indonesian Ministry of Research, Technology and Higher Education, for financial support (Research Contract No. 0668/K8/KM/2018).

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Lupine Publishers | Hamstring Injuries in Taekwondo: Injury Patterns and Performance Following Conservative Therapy-A Case Series Involving Four Elite Athlete

Lupine Publishers | Journal of Orthopaedics

Abstract

Background: Hamstring injuries frequently occur in sports involving explosive movement patterns and can cause lengthy downtimes. Data on hamstring injuries in Taekwondo is completely lacking. In a case study with four top Taekwondo athletes we describe the specific characteristics of this type of injury, the resulting downtimes and the athletes’ performance following conservative treatment, for the first time.
Methods: In a retrospective study, the hamstring injuries of four top international athletes were examined. Injuries were diagnosed by means of MRI. All injuries were classified according to severity and given an MRI score (min. 3, max. 19 points). Performance parameters for assessment included the number match points achieved in the 12 months prior to and following injury, tournament participation and downtime. Recurrent ruptures and contra lateral injuries were also taken into consideration.
Results: Athletes were aged between 16 and 25 (average age 20.3 years).Injuries were exclusively proximal ruptures. The MRI score was between 5 and 9 (mean value 6.5 points). All injuries involved the semi membranous muscle. Ruptures did not extend significantly into the cross-section of the muscle. Manifestation of all injuries in the MRI was without retraction. The average downtime before returning to competition was 69.2 days. The number of match points gained in the 12 months following injury dropped by an average of 19.8. Two athletes suffered recurrent ruptures and two had contra lateral ruptures.
Conclusion: The most frequent form of hamstring injuries in Taekwondo appears to be the stretching type. They result in downtime and a considerable decline in performance. The high incidence of ruptures and the contralateral ruptures within the subsequent year emphasises the extreme biomechanical strain on this muscle group. Parameters are needed to determine the best time to return to the competitive level following conservative therapy.
Keywords: Conservative Treatment; Hamstring Injuries; Return to Competition Taekwondo

Introduction

Taekwondo (TKD) is a traditional martial art that originated in Korea. It is currently practiced in more than 200 countries throughout the world and became an Olympic discipline for the first time at the 2000 Games in Sydney. TKD is a full-contact martial art characterised by its emphasis on dynamic attack and kicking techniques requiring rapid reactions, speed, agility and endurance. TKD is a popular sport in Germany, where the number of active athletes has risen considerably in the last few years. Injuries to the hamstring group of muscles generally occur in the two-articulated sections following sudden over-extension of the muscles with a maximum degree of hip flexion and knee extension [1]. So far, sprint sports such as American football, in which the rapid changeover from muscle contraction to relaxation occurs, were known to be high-risk sports [2]. In TKD such movement patterns during explosive high kicks are especially important, as attacks to the opponent’s head are only permitted with the feet and generally score highly. The frequency of general injuries to the hip is approx. 11 % [3-5] and to the lower extremities 44.5 % [6]. To date there is no explicit data on the frequency and patterns of hamstring injuries in TKD, as information on the occurrence of TKD injuries in the literature is unspecific [3,4]. This retrospective study is based on a case series and describes injury patterns to the proximal hamstrings among top TKD athletes for the first time.

Materials and Methods

This retrospective study involves four top elite TKD athletes from an Olympic training centre who suffered hamstring injuries during training or a tournament between 2012 and 2016. All were top international athletes from the German national Taekwondo team with regular participation in national and international tournaments. The parameter for the athletes’ performance was the number of World Taekwondo Federation ranking points attained twelve and six months prior to and after injury [8]. This ranking system allows the comparison of different athletes throughout the world. Each athlete is awarded competition points according to the place achieved in an international tournament. The more matches the athlete wins, the more points he is awarded in the tournament.
All athletes were examined by a qualified sports physician. In the case of suspected injury in the hamstring area an advanced MRI diagnosis was made within three days to allow scores and the time interval since injury to be compared [9]. A record was also made of athletes’ other injuries. An experienced sports physician was in charge of the conservative therapy and treatment was based on an adapted training plan. This ensured the avoidance for six weeks of forced flexion in the region of the hip due to high kicks. This was accompanied by measures and exercises to reduce muscle tone in the affected area and stabilise the pelvic muscles. The MRI images were analysed retrospectively by a radiology specialist for musculoskeletal MRI diagnostics. Injuries were classified according to the radiological criteria of the MRI signal and a previously validated MRI score; which denoted the severity of the hamstring injury and was determined on the basis of age, number of injured muscles, and location of rupture, retraction, diameter of injury and intensity of T2 signal [10]. A minimum of 3 and maximum of 19 points were allocated depending on the severity of the injury (Table 1).

Table 1: Competition points 12 month bevor/ after Injury and time for return to competition.

Results

The athletes examined were aged between 16 and 25 (average age 20.3 years). All athletes participated in international tournaments with points system during the examination period (Tables 2 & 3). The MRI score for the hamstring injury was between 5 and 9. The mean value for all athletes was 6.5 points. Injuries and partial injuries were also differentiated (Table 2). With one exception, all athletes suffered injuries to the proximal hamstrings at the tuber are chiadicum. The semi membranous free tendon was involved in all injuries. Ruptures did not extend significantly into the cross-section of the muscle. Just one athlete exhibited an ectasia >75% with an injury at the musculo tendinous junction, the diameters of other ruptures were <25%.Manifestation of all injuries in the MRI was without retraction (Table 2). The athletes competed in an average of 2.8 tournaments in the six months prior to injury, this dropped to 2 tournaments, equivalent to a reduction of 29%, in the six-months following injury [8].

Table 2: Characteristics of Hamstring Injuries and MRI scoring.

Table 3: Involved Muscles and Re-Injuries.

The interval between injury and the return to international competition was between 28 and 158 days (average 69.2 days) (Table 3). The average number of points scored in a tournament during the examination period dropped from 57.8 points before injury to 38 points in the 12 months after injury [8]. This is equivalent to an average reduction of 19.8 points. None of the athletes achieveda score that equal ledor exceeded this level of performance in the six months prior to injury. Just one athlete achieved a higher score in the 12 months after the injury compared to the 12 previous months. It was interesting to note that this athlete also took the longest break before returning to competition after injury (Table 4). One athlete suffered Re-Injury during the examination period, while two athletes suffered contralateral ruptures of the proximal hamstrings (Table 2). No further serious injuries requiring downtime were recorded for any of the athletes during the 12 months after the return to competition.

Discussion

Hamstring injuries are often found in sports requiring sudden sprints such as soccer, football [10,11] and track and field athletics [12]. The result for the athlete, depending on the sport, is often considerable downtime. Sprinting in these sports involves hamstring extension with increasing hip flexion, which is compensated by a relative decrease in knee extension. This means, the hamstrings have a braking effect on the knee during maximum sudden hip flexion [13]. This study deals exclusively with proximal hamstring injuries, which can only be explained as taking place during high kicks with eccentric muscle contraction, inflected hip and (hyper)extended knee [14,15].Hamstring injuries are known to occur often at the myotendinous junction [16].
Risk factors under discussion are insufficient warming up, malalignment of the pelvis, exhaustion and previous injury [17-20]. Due to the insufficient contraction potential, the ischiocrural muscle group does not attain its full range of movement in the hip and the knee joints at the same time [15]. In TKD the opponent is kept at a distance by raising the leg and slightly bending the knee, meaning that initial flexion is usually greater at the hip than at the knee. When the athlete aims for the opponent’s head he or she adopts a position of full hip flexion to allow the leg to reach as high up towards the opponent’s head as possible with almost simultaneous knee extension to make full use of the entire length of the leg. The high kick in TKD is therefore preceded by considerable pretension at the hamstring origin.TKD athletes often exhibit muscular imbalance in the hip to accommodate the heavy demands on the hip flexors. The quadriceps femoris and iliopsoas muscles are generally more developed. The resultant pelvic tilt also increases pre-tension in the proximal hamstrings.
In sprinting sports the most common injury is to the long head of biceps femoris [21]. In this study, however, it was found that almost all athletes suffered injury to the proximal free tendon of semi membranous, also known to be common amongst dancers. The reason for this injury pattern could lay in the small source area with additional muscle adduction moment. In TKD it could therefore more likely to be a stretching type injury rather than a high-speed type [22]. The general limitation of extension and retraction in the injured muscles is also consistent with this observation. A certain predisposition to this injury pattern could also be due to chronic pre-existing damage at the myotendinous junction of this muscle group. The fact that ruptures and injuries to the contralateral muscle group occurred during the study period supports this observation. In a study involving NFL players, the classification of hamstring injuries correlated strongly with the players’ downtimes [23]. The average MRI score of 6.5 among TKD athletes is moderate but resulted in a relatively major downtime of 61 days, comparable to professional dancers with similar injury patterns [22]. The wide range of values (28-158 days) before returning to competition can be explained by the irregular tournament cycle and the systematic competition training plan before important tournaments. Downtimes are therefore more difficult to define than they are in sports with regular match schedules. No statistical correlation between the ascertained parameters could be shown due to the small number of cases.
In American football and rugby [23,24] it could be shown that players with moderate hamstring injuries did not necessarily have to miss an entire season. Good mid-term functional results have been achieved following surgical reification of the proximal hamstrings, however, this is only indicated for high-grade injuries (involvement of the conjoint tendon as avulsion at tuber ischiadicum and retraction > 2 cm) [25-27]. On average, a return to pre-injury performance was not possible until six months after surgery. There is no data whatsoever on outcomes following conservative treatment in TKD. In this study, top TKD athletes returned to the competitive level after an average of 61 days, albeit with significant performance deficits. The direct comparison with the results of surgical intervention is however futile, as injury patterns only exhibited minor retraction. It therefore remains to be seen whether a return to TKD competition is possible, despite the moderate severity of hamstring injuries in an MRI Score. A closer investigation of this question in Taekwondo would require a longterm follow-up study of the injured athletes taking all injuries into account.

Conclusion

There has been no study on the extent and effects of hamstring injuries in world-class TKD. This is the first study to describe in detail the injury patterns and effects on the competitive success of a small number of athletes following conservative treatment. All of them were found to be stretching-type proximal injuries with mid-range MRI scores, which resulted in less frequent participation in competitions and a significant drop in performance. The incidence of ruptures or injury of the contralateral muscles within the subsequent year emphasises the extreme biomechanical strain on this muscle group in TKD. The provision of further recommendations for optimised treatment and parameters for the best time to return to competition in this sport requires the longterm functional follow-up study of a greater number of cases.

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Lupine Publishers | Challenges in Learning and Understanding Traditional Chinese Medicine and Acupuncture

Lupine Publishers | Open access journal of Complementary and Alternative Medicine

Abstract

Logic thinking is the base of developing TCM and acupuncture theories. Pattern identification developed with Y-n-Yang and the Five Element theories should be the key principle in practice, especially for prescriptions and the scientific research verifying efficacy of TCM and acupuncture.
Keywords: Yin-Yang; The Five Element; Logic Thinking; Pattern Identification

Abstract

  Both Traditional Chinese medicine (TCM) and acupuncture originated in ancient China and has evolved for more than two thousand years. However, most of the people generally in Taiwan present themselves to the medical doctors first when they are in need of medical treatments. Part of this fact is because there are not sufficient scientific researches to prove the efficacy and safety of TCM, acupuncture, moxibustion, acupressure, cupping, Tui na, and tai chi. In Asia, such as Taiwan, Korea, Japan, Hong Kong, etc., herbs, acupuncture, moxibustion, acupressure, cupping, Tui na, and tai chi are often used by TCM practitioners to integrate mind and body to treat or prevent health issues. Compared to the current TCM and acupuncture developments in Taiwan, acupuncture and TCM have gained more and more popularity in the past 40 years and been considered “essential health benefits” by people in the United States and the West, seeing and using acupuncture and TCM primarily as a complementary health approach [1]. TCM and acupuncture have established its status in the health system in the West, though they’re totally different from the Western medicine with the philosophy, diagnosis approaches, and pattern identification for treatment. Challenges exist at present, which deserves attention for those who are determined to learn or interested in understanding TCM and acupuncture. This paper, therefore, tries to present some issues for the better future of TCM, including acupuncture, and the Western medicine when there are integrated.

Fundamental Differences between TCM and West Medicine

TCM, including acupuncture, and Western Medicine have been viewed as two distinct and divergent medicines for long with the approaches to physiology and healing techniques. Therefore, the fundamental differences in both Western medicine and TCM deserve attention when healthcare providers are considering the feasible choices in clinical practice to patients [1].

In Theory

The philosophical concepts like Yin-Yang, the Five Element, pattern identification, and Qi and Blood are, to a certain extent, unique and abstract for learners to catch the whole picture with the functions broader than the anatomical knowledge in the Western medicine and are absolutely different from the theories of the Western medicine. In terms of relation of the human beings and the Heaven that can interact with each other in providing solutions to the health, it is totally different from the Western medicine that TCM sees the human body as a whole and as a microcosm of the universe in diagnosis and treatment, bringing the body, mind and spirit into harmony with Yin-Yang balance. It is believed that the concept of Yin-Yang balance is the unique concept indicating the harmony of internal organs and the dominating key of the TCM, which has served as the foundation and the guideline for the explanation of etiology of diseases, diagnosis, and treatments throughout the history of Chinese medicine and absolutely distinguishes TCM from the Western medicine [1]. Based on this concept, a disease thus refers to the loss of the balance of Yin-Yang [2].
On the other hand, TCM focuses on the “congenital constitution” of the body that can result in “root” problems in health, which can scientifically correspond to the core thesis of Precision medicine (PM), which proposes the customization of healthcare with medical decisions, treatments, practices, or products tailored to the individual patient’s genetic content. In TCM, constitutions of humans are categorized into the five patterns for understanding the “root” causes and predicting the health conditions in the future, based on the Five Element theory [1]. Western medicine is seeking the minor difference from the perspective of etiology and only concerned about diagnosing and treating the symptoms alone. The theory develops with seeing the organs separately and treating parts of the body like a machine. Each part of the organs has its function, and when a particular part fails, it needs the replacement or resection [1,3].

In Practice

Treatments by medical doctors directly target at the pathogen or etiology with the evidence by a large number of modern scientific instruments, such as blood, urine, and stool tests, X-rays, CT, and MRI, to check on the human body. In addition to history taking and physical examination, doctors do not make diagnosis until all evidence are collected. Without scientific instruments, TCM doctors or acupuncturists can only make diagnosis, based on symptoms related to the imbalance of Yin and Yang rather than diseases itself through analyzing a patient’s tongue, pulse, voice, and whole-body situation, including reaction, hair, and posture [1,3]. The most important key to the successful results is that an experienced TCM doctors and acupuncturists can only rely on four skills for diagnosis to identify the patterns and write up the prescriptions. In other words, patterns, which distinguish TCM from the Western medicine, should be the key concern for the TCM and acupuncture practitioners in making the decisions of treatments. Since diseases are understood to be a loss of balance between Yin and Yang as shown in Figure 1, good results cannot be expected without the positive consideration of Yin and Yang [2,4].

Figure 1: Characteristics of Yin and Yang.

Challenging Issues

Challenging issues for those who are interested in and learning TCM and acupuncture are presented in this section. These issues may have been discussed in the previous research, but new viewpoints are presented to attract more attention.

Language

There is no doubt that cultural decoding relies mostly on words. It is strongly accepted that “word-for-word” literal translation method is the way paraphrasing the accurate lexical meaning. However, this cannot be applied to TCM and acupuncture. Language is therefore the most challenging issue that needs to be addressed first. With the popularity of TCM and acupuncture, language barrier surely needs learners’ attention. The fact in the West currently is that not all of the TCM and acupuncture classics are translated into English. On the other hand, correct translation requires good translators excellent in both Chinese and English. In addition to the good command of these two languages, the meanings of the characters used in the ancient time may be different from those at the present time, which may confuse and frustrate readers. Chinese characters, different from alphabet languages which only represent forms and sounds, are called ideographs with three features of forms, sounds and meanings [5]. The difficulties in understanding Chinese characters in the TCM and acupuncture classics can be classified in the following ways [5]:
A. Simplified Chinese is widely used all over the world; however, traditional Chinese is accepted and used in ancient classics and areas like Taiwan, Hong Kong, and Macao. For example, 黃帝內“經” in simplified Chinese is 黄帝内“经” in writing.
B. Pronunciation changed with usage. “能” is correctly pronounced neng in the modern Chinese, referring to “can” in English and. However, this character in Huang Di Nei Jing ( 黃帝內經, Yellow Emperor’s Inner Classic) means “state (態)” and the pronunciation is tai. This condition occurs when the characters were not enough for use in the ancient time.
C. “內” can be used either as a verb or a noun. It is pronounced na (equals納) when used as verb and nee when used as a noun referring to “inner” or “inside” in the modern use.
D. “平” is pronounced pin when it is related to an adjective “flat” in English. With writing mistakes, the pronunciation of this character is bian when it is used as a verb to mean “distinguish” in medical Chinese.
E. Different characters bear the identical meanings. “输”, “ 输”, and “腧” are different characters referring to the identical meaning of acupoint, and all of these three characters are pronounced shu.
The ability to understanding Chinese characters deserves attention as well in learning and understanding acupoints. For mastering acupuncture, understanding the real Chinese meanings of the acupoints is required. ST29-Guilai is the typical example for this aspect because Guilai (歸來) literally in Chinese means “return” and this acupoint is usually used for prolapse of uterus, menstrual irregularity, and dysmenorrhea [6]. 神(Shen) is translated differently into English in acupoints; for example, HT7-Shenmen ( 神門, Spirit gate) refers to the gate for Heart qi to get into and out of the body, while Heart governs Shen in TCM. Compared with the DU24-Shenting (神庭, Shen court), 門refers to gate in Chinese and 庭, court, which suggests that one must go through the “gate (HT7)” first and then get into the “court (DU24)” to hold or calm Shen. This difference highlights the importance of choosing acupoints in calming Shen. An acupoint may have different names with the historical developments. The nickname of KD3-Taixi (太溪) is呂細 (Lvxi) alternatively used in the acupuncture classics. On the other hand, the nickname of HT7 is 中都 (Zhongdu) completely identical with LV6 in Chinese, which may confuses learners.

Figure 2: Protocol matrix in using traditional acupoints and extra acupoints.
Note: Ea for Extra acupoints and Ta for Traditional acupoints.

In addition to the names of acupoints, extra acupoints also deserve close attention in consideration of combining regular acupoints with extra acupoints. Extra acupoints distinguish themselves from the regular acupoints on the traditional fourteen meridians with the unique indications, actions, and the great effectiveness in acupuncture theory and treatment, even though some of extra acupoints have not been verified with scientific evidence [7]. Pattern identification which derives from the Yin- Yang theory is surely the key concept of TCM. Unfortunately, this concept cannot apply to extra acupoints because they are not incorporated into the traditional meridians with the lack of Yin- Yang. The challenge acupuncture practitioners face is when it is the best time to consider extra acupoints in a protocol. The historical developments of extra points show that an extra point can surely play an essential role in acupuncture and be used alone or with the traditional regular acupoints for the treatment. Unfortunately, the actions and indications of extra acupoints have not be scientifically researched and verified as traditional regular acupoints. In strategy, a practitioner may take the principle of “Least needling for best results” into consideration to keep patients from pain, fear, or worry. The goal can be achieved with the following four choices shown in Figure 2 when it comes to the tactic [8].

Characterizations of Chinese Material Medica

The use of Chinese herb must be based on the patient’s conditions with accurate diagnosis, following the principles of pattern identification. Channels, properties, indications, and actions of the Chinese herbs in the different material medica classics are not always discussed in the same ways. The actions of Radix Ledebouriellae Divaricatae (Fangfeng) in Compendium of Materia Medica (Bencao Gangmu, 本草綱目), for example, are night sweat, migraine and headache, and constipation. However, actions like aversion to Wind, sweating, blurry vision, and vertigo are presented in The Classic of Herbal Medicine (Shennong Bencaojing, 神農本草經).
Licorice root (Gancao, 甘草) with properties of sweet and neutral to tonify and strengthen the Spleen qi is effective for sore throat, bronchitis, cough, and infections caused by bacteria or viruses. This herb is the good example that highlights the time to collect herb is an attention that cannot be ignored. Literature shows the best time to collect and dry Licorice root is in the autumn two to three years after planting [9], but no detailed information is found for the reasons. The possible explanation for harvest time and cultivation time may be much to do with the compound differentiation, which can vary with moisture, temperature, and sunshine. The Chinese term 木瓜 (Mugua) refers to both Chinese herb Fructus Chaenomelis and papaya. In other words, confusing situation like this Chinese herb occurs quite often to TCM and acupuncture learners.

Processing

The nature and indications of Chinese herbs change with processing for the required actions in treatment.
It is beyond doubt that Radix Bupleuri (RB) is one of the most popular traditional Chinese medical herbs in terms of treating diseases related to the Liver. Radix Bupleuri, named “Chaihu ( 柴胡)” in Chinese, is derived from the dried roots of Bupleurum Chinense DC. (Pei Chaihu, 北柴胡) and Bupleurum scorzonerifolium Willd (Nan Chaihu, 南柴胡) [10], which is the main ingredient of the most famous and frequently used preparations Xiao Chai Hu decoction and Da Chai Hu decoction. The major differences between Bupleurum Chinense DC. and Bupleurum Scorzonerifolium Willd are that the indication of Bupleurum Chinense DC. is dispersing stagnated Liver qi while Bupleurum scorzonerifolium Willd is raising Yang Qi in the Middle Jiao deficiency pattern.
For clinical use with indications changed to meet the patients’ needs, Radix Bupleuri is commonly selected in crude, fried, and vinegar-baked [11]. Among the characterizations of Chines herbs discussed above, dosage and ration are also two of the most important issues. Historic evolutions in the measurement show dosage, actually the top secret in learning Chinese formulas, has changed a lot and been a concern in practice for more than thousands of years. Quin (錢), the unique unit of weight measurement always used in TCM herbs, is different from that used in the Han dynasty, in which the author of Treatise on Cold Damage Disorders (The Shanghan Lun, 傷寒論) Zhang Zhongjing was born. In the meantime, one Quin equals 3.125g in China, but 4g in Taiwan, which suggests TCM and acupuncture learns need to bear the differences in mind when doing research. Another attention that should be given to the clinical use of Chinese herbs is dosage, which should draw attention with geographical factor. Zhang Zhongjing was born in Henan located in the south of China, where the temperate climate is humid subtropical. The climate may be one of the factors affecting his logic reasoning in the formulas; for example, the most used herbs in treating gastrointestinal diseases are licorice root, jujube, dried ginger, ginger, and Guizhi (Ramulus Cinnamomi) for the property of spicy to disperse stagnated Qi and tonify Yang. In other words, adjustments must be made, considering geographical factors.
In addition to weight, ration is also the concern that must been taken into consideration for the ingredient percentage of a formula. Liu Yi San (Six to One Powder, 六一散) indicates that the ratio of Talcum and Radix Glycyrrhizae (Licorice root) is 6:1. Actually, for learners who understand Chinese can easily catch the meaning of this formulas from the character 六 referring to six and-, 1. Dosages in practice must be adjusted, depending on the patients’ conditions. This is the most difficult to learn and understand because it reflects the experience of a TCM doctor or an acupuncturist. In other words, there is not golden rule to follow at all, and it is hard to be verified with quantitative analysis.

Discussion

The logic thinking of the Chinese is inductive reasoning, compared to deductive reasoning of the Western people. Based on this logic model, TCM, including acupuncture, features similarities in theories with Yin-Yang, the Five Element, Qi-Blood, and Pattern identification. It is noted that most of the scientific researches for verification of efficacy of TCM and acupuncture only focuses on diseases, instead of following the Pattern identification of TCM, which cannot accurately exemplify the TCM and acupuncture theories to a great extent [11]. The historical developments prove that there are challenges ahead of TCM and acupuncture learners, such as when to combine regular acupoints with extra acupoints, how to decide the accurate dosage and whether or not select dried herbs, etc. More and more population in the Chinese communities like China, Taiwan, Hong Kong, and Macao seems to suggest that TCM and acupuncture benefit public health with its efficacy. This study may recommend that having a good command of Chinese can play a key role to learning and mastering TCM and acupuncture. Unfortunately, it is not easy at all for the Western learners to make a right decision when it comes to learning traditional or simplified Chinese characters. The debate on traditional Chinese characters and simplified Chinese characters has been an ongoing dispute concerning Chinese orthography among users of Chinese characters for years with the establishment of the People’s Republic of China (PRC) in 1949. Looking back at the history of Chinese medicine, all of the great classics are written in traditional Chinese. This fact may give the learners the right direction that learning traditional Chinese enable the Western learners to acquire more profound knowledge of TCM and acupuncture. It is believed that “Englishword- for-Chinese-character” translation surely hinders learners from acquiring accurate understanding of TCM and acupuncture. However, there is not any Chinese medical terminology curriculum offered in the West.

Conclusion

Challenges exist before those who are learning or interested in TCM and acupuncture. Only accurate decoding of Chinese characters can exactly explain TCM and acupuncture concepts, so it is highly suggested that learning traditional Chinese characters must be considered for the Western learners when they really expect to explore and enjoy the beauty of TCM and acupuncture. With the natural and human restrictions, there is a long way to go for the contemporary learners and researchers to verify the efficacy of TCM and acupuncture with evidence-based research.

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