The Traditional Chinese Medicine Biology Essay

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Traditional Chinese medicine is an integral part of Chinese heritage, which has existed for thousands of years. Developing and contributing to the Chinese healthcare system ranging via different forms; herbal medicine, acupuncture, and other culturally unique forms of practice. 1The theory of TCM is long rooted in the traditional science, which is able to adjust to body conditions to cure diseases based on the Yin and Yang theory. The yin yang theory is form of logic which views everything as a whole. Yin and Yang are complimentary to each other and form a method to explain relationships between objects. TCM takes from this and views an illness as symptoms of a disease, and diseases are due to imbalances in the human body. The human body works to restore this rebalance rather than to treat symptoms via TCM.

One of the first originators of the TCM culture was Emperor Yan, who ruled China he tasted all different kinds of herbs and eventually died by tasting a poisonous herb. However his knowledge and discoveries were passed down verbally generation to generation. The first written complete reference to herbal prescriptions dates back to 1977 in the Chinese Materia Medica listing about 480 drugs of the plant origin. At present TCM have paved its own righteous way in the global market for medicine, where millions of people rely on TCM, United States being the biggest importer spending US$7.6 billion in 2010. Not far behind USA exports of TCM to European countries in 2010 was around US$ 2 billion and it is increasing by 10% each year.

Looking at Ginkgo Biloba extract (EGb 761) as a pioneer drug with its increased popularity and use in today's society as an example of traditional Chinese medicine I intend to explore its claims and effects by critical analysis of scientific trials which have already been carried out to establish efficacy.

Ginkgo Biloba

The tree Ginkgo Biloba also known as the maidenhair tree is unique species, being one of the first herbal prescriptions to appear in the Materia Medica. G. biloba has generated immense interest for treatment of memory-related remedies. The facts show that a billion dollars are spent annually on botanical medicines, where Ginkgo biloba ranks first among herbal medications about Fifty million Ginkgo biloba trees are grown, especially in China, France, and South Carolina, USA, to produce over 8000 dried leaves each year to address the commercial demand for Ginkgo.

At present TCM has paved its own righteous way in the global market for medicine, where millions of people rely on TCM, United States being the biggest importer spending US$7.6 billion in 20109. Not far behind USA exports of TCM to European countries in 2010 was around US$ 2 billion and it is increasing by 10% each year. Also alone in the United Kingdom one in ten people have complimentary alternative medicine (CAM). However there are some problems associated with TCM these include: Species and origin is important as there can be problems with naming as some herbs have the same name for different herbs which can lead to considerable amount confusion. The environment can also cause a considerate amount of impact for instance pollution, pesticides and heavy metals. Also the lack of knowledge on TCM is an important risk factor where using TCM drug without an appropriate diagnosis of patient it can be detrimental on healthy person, therefore they should be used under correct TCM theory guidelines. Individual factors such as age, gender, location and diet can also have a direct impact on efficacy and safety of drugs. These kinds of problems restrict future developments and tarnish the TCM industry reputation.

Leaf production

The leaves are collected during July and September when they are still green, next they are left to dry and thorough analysis of quality control is undergone of the leaves. The crude dried leaves are then extracted using acetone: water mixture (35 to 67:1). The use of Ginkgo leaves for pharmaceutical properties was originally developed in Germany 1965 and the first commercially available Ginkgo leaf was registered for human use in 1974 in France under the name EGb 761. Therefore the demand for Ginkgo Biloba has dramatically increased, to meet this sudden demand plantations have been developed throughout as it is the major producer of Ginkgo leaves.

The percentage of active ingredients in the leaf is can be affected by natural or human errors, where natural factors include climate, seasonal variation and the age of the plant. Human factors include drying of the leaves, the kind of fertiliser used and pruning which is cultivated on a large scale they would require regular pruning.

Origins

The Ginkgo Biloba tree is the only surviving genus to survive on earth, tracing back its origins to the Jurassic period. Coming from Ginkgoaceae family, the first definite description was given by Linnaeus (1771). Ginkgo derived from Yin- Kuo, "silver apricot" Biloba and is refered to the shape of its leaves which is derived from the maidenhair tree. With the longest geological history of fossil record it is the maidenhair tree which is a representation of a living fossil. Over 80 million years its greatest morphological change would be during the lower Cretaceous however during the upper Cretaceous a rapid decline occurred leaving only one type of single species. Ginkgo Biloba has survived due to its genetic tenacity and resistance to disease and pollution and therefore because it's not related to any other living plant it is classified as its own named Ginkgophyta, this taxon is distinguished on the Coniferophyta reproductive structures.

Ecology

The wild species is also native to China only, where the last report of the wild refugia was known to be in the province of Zhejiang in China, on the west Peak of Tianmu Mountain. Due to a history of human habitation in the area it is plausible that ginkgo could be used as ornamental species in the area. However, due to the surrounding habitat of a large forest, it can be concluded that it is in fact wild Ginkgo along with scientific studies to support that there is low degree of genetic diversity among the plants indicating that Ginkgo is descended from the cultivated tree. Tianmu Ginkgos possess more than one trunk, where most of these trunks originate from lignotubers which are located below or just on top of ground level. Lignotubers develop in all Ginkgo seedlings from the buds which locate themselves in the axils of the two cotyledons. When the cotyledons are stimulated or under severe stress one of the cotyledonary buds grows out, from the trunk forming a woody lignotuber which has the sprouting ability to produce aerial shoots and adventitious roots which may have a direct role in the survival and morphological stability of the genus since the tertiary.

Quality control

Quality control for herbal products is vital for herbal products to ensure maximum safety as there are a lot of concerns for traditional medicine in areas of efficacy, safety and quality. However there are problems with TCM due to not knowing the active ingredients of a plant also the lack of availability of some medicinal plants. Therefore there are three levels of drug standards in China these are the Chinese Pharmacopoeia, the Drug Standards of the Ministry of Public Health which are recognised nationally and provincial Drug Standards which are only effective within China.

Having these regulatory bodies allows for better standards for efficacy also demonstrating that herbal industry enforces effective controls and safety. Quality control is very important for Chinese medicine as it's constantly being disregarded. In order to evaluate the quality of a drug you have to identify it and then determine its purity and potency. The authenticity of the herb is mainly characterised using the Chinese Pharmacopoeia and other scientifically approved publications. As a result to ensure safety and efficacy of TCM there is state food and drug administration (SFDA) in China which is the main authority of drug regulation in mainland China which supervises the safety management of food, health food and cosmetics. SFDA have implemented many regulations to ensure effective quality. For instance evaluating and registering TCM, licensing approaches, pre- marketing assessment of the quality and safety of the product, post marketing observations. This can include product recalls, enforcing good GMP by manufacturers and the development of standards of the products.

Also having regulatory bodies allows for better standards for efficacy also demonstrating that herbal industry enforces effective controls and safety. Quality control is very important for Chinese medicine as it's constantly being disregarded. In order to evaluate the quality of a drug you have to identify it and then determine its purity and potency. The authenticity of the herb is mainly characterised using the Chinese Pharmacopoeia and other scientifically approved publications. As a result to ensure safety and efficacy of TCM there is state food and drug administration (SFDA) in China which is the main authority of drug regulation in mainland China which supervises the safety management of food, health food and cosmetics. SFDA have implemented many regulations to ensure effective quality. For instance evaluating and registering TCM, licensing approaches, pre- marketing assessment of the quality and safety of the product, post marketing observations. This can include product recalls, enforcing good GMP by manufacturers and the development of standards of the products.

Comparing this to the USA FDA guidelines for botanicals this includes having systematic review due to the fact of the little knowledge that is known of the active constituent(s) of the botanical drug. Therefore the FDA relies heavily on thorough tests to ensure the quality, safety and purity of the drug. These tests include: multiple testing for the drug this can be via HPLC chromatography or spectroscopic, raw materials using firm quality controls and an efficient process, and process validation for the drug substances. Similar to the European guidelines require authorisation where phytomedicines are included in the general legislation and are therefore subjected to the same process as normal medicines where safety, efficacy and quality is checked via clinical trial data already present, therefore the level of safety is paramount in these trials and the literatures should follow certain criterion which is claimed for the product. Therefore the literature should show the safety and effectiveness aspect of the herbal medicine methodically. For trivial issues with the drug a review of literature should contain low levels of evidence with the most recent clinical trials with experimental data to establish sufficient level of efficacy. In addition the regulatory authorities require the data to meet good laboratory practice (GLP), good clinical practice (GCP) and good manufacturing practice (GMP).

Clinical trials

Comparison of the studies done on dementia using GB

Health effects

Reference

Ginkgo Biloba dose specification

Study design

conclusion

Memory effects in middle aged healthy volunteers.

(Kaschel 2011)

Receive EGb 761(240mg once daily) or placebo for 6 weeks

Assessed by separating immediate, delayed and quantitative free recall measures.

188 healthy male and female subjects aged 45-56 years randomised. Recall was measured using standardised free recall (list of appointments) and less demanding standardised recognition test driving route.

After six weeks EGb 761-treated subjects quantative memory recall had improved dramatically in middle aged volunteers.

Determining the effectiveness Of G Biloba in improving memory in those suffering from dementia

(Williamson et al. 2008)

Twice-daily dose of 120mg extract of G Biloba (n=1545) or placebo (n=1524).

Randomised, double blind, placebo controlled.

Conducted using 5 academic medical centres in the united states 2000 till 2008 with follow up 6.1 years later.

3,069 Volunteers aged 75 years or older with normal cognition.

In this study GB at 120 mg twice daily was shown not to be effective.

Demonstrating the efficacy and safety of Ginkgo Biloba extract in patients with mild to moderate dementia.

(Herrschaft et al. 2012)

240 mg once-daily formulation of Ginkgo Biloba extract EGb 761, multi-centre, double-blind, randomised, placebo-controlled, trial

24-week trial with 410 outpatients tested using SKT cognitive battery, Neuropsychiatric Inventory (NPI) standardised tests.

EGb 761 extract once-daily dose was proven to be safe and resulted in a significant and clinically beneficial improvement in cognition

Efficacy and safety of Ginkgo Biloba extract in dementia

32 (Ihl et al. 2010)

Once daily extract of EGb 761, randomly allocated to double-blind treatment, 240 mg of EGb 761

410 outpatients with mild to moderate dementia scoring between 9 and 23 on SKT cognitive test were given a placebo once daily for 24 weeks.

GB had significantly made an impact on patients with dementia.

Demonstrating the efficacy and safety of Ginkgo Biloba extract in patients with mild to moderate dementia.

33(Herrschaft et al. 2012)

240 mg once-daily formulation of Ginkgo Biloba extract EGb 761, multi-centre, double-blind, randomised, placebo-controlled, trial

24-week trial with 410 outpatients tested using SKT cognitive battery, Neuropsychiatric Inventory (NPI) standardised tests.

EGb 761 extract once-daily dose was proven to be safe and resulted in a significant and clinically beneficial improvement in cognition

Discussion

Looking at the table above shows a comparison of recent studies done on the extract EGb 761. The results show mixed findings, this can be due to variety of reasons such as; different procedural ways of testing GB effects on the brain for dementia. This main factor is very important since if the studies did not /have not used the same 'procedural' methods it does not fully prove that Ginkgo Biloba produces the intending enhancing effect. Why? Since other factors are not accounted for therefore the results may not be trusted meaning Ginkgo may not have had an opportunity to test the efficacy as equally in healthy individuals.

If we look at each trial individually starting with (Kaschel 2011) where the study design was as follows; "188 healthy male and female subjects, aged 45-56 years randomised both female and male". The aims of this was to assess the long- term memory using a recall test, using male and female healthy subjects with no memory disabilities, aged 45-65.

Using an appropriate approved trial method randomised double-blind, placebo-controlled, mono-centre trial was performed. Out of the 188 healthy male and female people aged 45-56, analysed following the trial all three aims of the study were met and in return found that short term free recall had improved as well as long term memory improvements in difficult tasks. The problem with the results is that they had shown no effect in simple tests of immediate recognition even whilst they were done in natural environments and yet they had shown rapid long term improvement in more difficult tests of immediate recognition whilst also in natural environments. As a result we can say that the findings do show that GB does affect long term memory 'in terms of more complex tasks'.

The only real flaw we can suggest in this study was that the participants were young an average age of 54.5 years old compared to the other studies and so as younger individuals have a 'natural' ability to grasp information much more quickly than those older it could have influenced the results, and the fact that there was only a small sample size compared to the other studies meant it was not a very reliable study. This meant that the end result could have been influenced by age i.e. age has different effects on the ability of Ginkgo Biloba to produce the intended enhancing effects. We cannot quite prove this to be true or even say if there is not a link since no trial yet has been conducted where the participants are off the same age. By this I mean using the same study design but doing 5 different trials just altering the age for example one trial consisting of people aged between 10-15 another 16-20 keeping all the other variables constant i.e. healthy people.

Comparing the (Kaschel 2011) study to another study (Williamson et al 2008) whose main aims were similar to (Kaschel 2011) which was to investigate if GB would lead to improvement in memory, but the main role this time to see if it actually improves memory recall in those suffering from dementia not just those healthy individuals.

The results from the trial showed complete opposition to the aims and hypothesis suggesting that both the Ginkgo Biloba participants (those actually taking the drug) and placebo participants (those taking the drug without any active ingredient) showed similar results in the trials and hence the Ginkgo Biloba actually did not bring about any enhancing effects. As a result follow up trials were carried out and completed in April 2008.

From all the trials done on Ginkgo Biloba this is the largest and the very first randomized clinical trial conducted in order to evaluate the effect of Ginkgo Biloba ability to improve memory recall and hence reduce dementia using a mean age of 75 years old. Therefore this is a major strength in the support of the effectiveness of GB in this study since; the large sample size, high event rate and follow up, continuous recruitment of diverse range of individuals, random allocations of participants which meant this was large enough to suggest that Ginkgo Biloba did not actually produce it's intended enhancing effects by reduced the dementia in order to improve memory recall.

We could however argue the limitation of this trial is the long delay from brain changes to clinical dementia therefore this could affect the results as it does not take into account the time gap. We have to remember that these are older people and hence the brain processes on general take more time and hence in the long run Ginkgo Biloba can actually prove to produce its intended enhancing effects.

Finally looking at (Ihl et al.2010) defiantly reinforces that fact that using Ginkgo Biloba produces the intended enhancing effects. How? Well the result of the trial was that it clearly reduced dementia and therefore improved the memory recall ability vastly meaning it is effective. The patients in the trial being at the age of 50 verify improving patient's cognitive performance and functional abilities similar to a recent study done by (Herrschaft et al. 2012) both these studies are consistent with the findings thus confirming efficacy and safety of the standardised extract EGb761. In addition to this the age of 50 was used which is a suitable age 'not too old not too young' and hence gives a good indication. But it could be argued to improve the results use a much wider range of ages.

Gingko Biloba As a Smart Drug

The therapeutic use of Ginkgo Biloba may be effective however how about those who use it and don't have any disorders? Due to its nature and properties it is commonly used to improve memory. How does Ginkgo Biloba do that? Scientifically controlled double blind tests have shown that Ginkgo Biloba increases blood circulation to the brain, thereby improving the oxygen content of brain tissue and cells. More oxygen to the brain means more clarity, increased ability to focus, increased attention span and a general feeling of being more awake. This is the reason that ginkgo Biloba is an ingredient in some energy drinks.

However, it is questionable whether the small amount of ginkgo biloba extract in the drinks is actually effective. Most of the drinks contain large amounts of caffeine, which can increase energy, if a person is not sensitive to caffeine. http://voices.yahoo.com/ginkgo-biloba-its-good-works-645085.html

While the drugs are undeniably fantastic study aids, when they're used as such they tend to be abused. And, studies still need to be conducted as to the long-term side-effects on people who don't have the conditions for which the drugs were originally intended. Some doctors are keen to explore these unanticipated side-effects, while others are far more cautious, especially where children are concerned.

The reputation of these Traditional Chinese Medicines like Ginkgo Biloba when not used for therapeutic reasons is massively growing and have their own street name; Smart Drugs.

These smart drugs are available without prescriptions are generally safe since they have thorough quality control tests. However long term effects are unknown since one may experience nuisance side effects of brain overstimulation: jitteriness, euphoria, depression, insomnia, vivid dreams and other wired. Perhaps the biggest danger of smart drugs is psychological dependence. That is to say, always taking the easy way out, a dose for every study session. It can be difficult to study natural after feeling the power of smart drugs. The more you use, and more often you use, the higher the chance of side effect dangers which can graduate to serious things like heat attacks and psychoses.

Because this drug can be used without prescription and available as an over the counter drug it is not showing the true ability of the candidate and considered by many cheating. This is since it is not showing the candidates natural true ability and the dependency factor plays a major role in the debate as well as not everyone getting a chance to have these 'Smart Drugs'.

Advised by all doctors in the UK smart drugs should not be used under 18 years of age or if pregnant without consulting your doctors. If this is the case, the majority of students I the UK would take these drugs without the warning since they are so widely available and the side effect risks are high. http://www.studycram.com/smart-drugs.html

Clinical Trials Of Ginkgo Biloba on 'Healthy' individual with no disorders

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