Traditional Chinese Medicine treatment study

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ASPartOfMe
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02 Nov 2021, 11:57 am

Traditional Chinese Medicine Approach for treatment of neurodevelopmental conditions

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Founded in 2014, Hong Kong-based Regencell Bioscience (NASDAQ:RGC) is an early clinical stage bioscience company using a traditional Chinese medicine (TCM) approach to develop standardized TCM formulas to holistically treat different elements of autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD) in adolescents, and infectious diseases affecting people’s immune system such as COVID.

Regencell Bioscience’s formulation for the treatment of ASD and ADHD disorders was developed by Mr. Sik-Kee Au, a TCM practitioner, who has used the formula in his practice for over 30 years to treat patients with ASD and ADHD. Currently, the Company is working towards standardization and commercialization of its formula.

The formula is based on the hypothesis (“Sik-Kee Au TCM Brain Theory”) that ASD and ADHD stem from inadequate blood flow and creation of neurotransmitters in the developing brain. As we discuss later, this hypothesis is complementary to the western medicine view that ASD and ADHD are present at birth and arise from developmental differences in brain function.

Regencell Bioscience’s first clinical trial was designed to establish benchmarks for treatment, dosing, adverse effects (AEs) and measuring patient response in a systematic and repeatable way. The study, conducted in 2018-2019, included seven adolescents, aged five to eleven, with professionally-diagnosed ASD or ADHD. After discontinuing any current therapies, subjects received a customized version of the TCM formula for up to three months. Patient response was measured through parental interviews and four validated assessment instruments including the Autism Treatment Evaluation Checklist (ATEC), Gilliam Autism Rating Scale (GARS) and the Vanderbilt ADHD Diagnostic Parent Rating Scale (VADRS). All seven patients showed a lessening of symptoms during the treatment period across all four scales.

The second clinical study will evaluate patient response to three standardized mixtures of the TCM formula (for mild, moderate and severe impairment). The study will enroll 100 patients, aged 6-12 years, with a professional diagnosis of ASD or ADHD. Subjects will be dosed twice daily for three to 12 months, meet with the practitioner weekly and assessed monthly using similar assessments as the first clinical study. The Company has begun enrollment this quarter and plans to have readouts in late 2022. The results will be used to file for proprietary Chinese medicine (pCm) registration in Hong Kong making the product available to for sale in other clinics as well as over the counter.

Traditional Chinese medicine (TCM) has been practiced continuously over 3,000 years and during that time, knowledge and modalities have evolved as a result of treatment and observation. TCM includes a range of disciplines including: herbal medicine, acupuncture, bone setting, nutritional changes, body manipulation and exercise. Herbal medicine is the most common form of TCM practiced in Hong Kong (Lam 2001).

TCM is based on the concept of balance in Qi (or “chi”). Health arises from a balance in Qi, while disease and illness are the result of an imbalance. Although there are common underlying principles in TCM, treatment is personalized for each patient and individual practitioners may utilize different approaches to the same condition.

TCM classifies patterns/conditions according to Zheng or Syndrome differentiation. (Lu 2012). TCM pattern is not only the interpretation of the symptoms of a disease, but also how a patient is classified. So, under TCM, patients with the same condition may have different TCM patterns, and different diseases may be classified as having the same TCM pattern. This seeming duality reflects the holistic nature of TCM and how it often defies easy comparison to allopathic (western) medicine in terms both of patient classification and treatment classification.

In TCM, patients are classified based on visual presentation of external features, palpation, olfaction, pulse detection, and interview. TCM interventions are determined after the initial therapeutic principles and general rules are established. Based on these determinations, the practitioner will create personalized combinations of Chinese material medica (CMM) and other therapeutic measures. Interventions are designed to bring the patient’s Qi back into balance.

In allopathic medicine, patient symptoms are assessed through visual and physical examination. Disease is diagnosed based on pathological diagnosis of physical or chemical function. Interventions are targeted to alleviating specific conditions/symptoms usually with pharmaceutical and/or surgical intervention. Treatment doesn’t usually address other co-morbidities unless contraindicated. For example, in OM, treatment for depression wouldn’t consider the role of high blood pressure.

In Hong Kong, TCM and allopathic medicine are both embraced, and patients will use both concurrently. However, patients will initially choose either TCM or allopathic medicine based on their symptomology. For example, patients will often select TCM first for mild illness (like a cold), because TCM is considered better for “clearing” a disease from the body. Other times, TCM is used to mediate side effects of western medications, or when allopathic treatments fail to work.

TCM has its weaknesses from a patient standpoint. Preparing and boiling the herbs is a time-consuming process and the tea more often than not has a very unpleasant, bitter taste. TCM treatments take longer to show improvement and may require lifestyle changes (such as dietary changes) – both of which tend to reduce patient compliance.

In contrast, allopathic medicine is usually the first choice for complicated or “serious” illness.

A 2020 meta-analysis (Qiu et al., 2020), reports pooled prevalence of ASD cases in Asia at 0.36%, considerably lower than global estimates; however, there is currently no ASD monitoring system in Asia. The study notes prevalence estimates vary widely depending on the source population and metrics used. In Hong Kong, the prevalence of ASD is estimated at 37 cases per 1,000 people in both children and adults.


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Kerch
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02 Nov 2021, 3:10 pm

TCM's bollocks.



mohsart
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02 Nov 2021, 3:35 pm

Kerch wrote:
TCM's bollocks.

At best

/Mats


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02 Nov 2021, 9:59 pm

I disagree.
There's nothing wrong with TCM.

The only difference between TCM and "western" medicine is that TCM uses the entire plant/herb containing the therapeutic agent rather than extracting and concentrating it in pill form. And it relies on compounds produced in nature rather than chemical formulation.

If TCM products are properly tested as in the proposed study, and shown to be beneficial, there is no reason not to accept them as genuine medicine.



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02 Nov 2021, 10:43 pm

In the part of the article that got quoted above, I see no mention of controlled experiments, e.g. giving the proposed treatment to some people while giving other people either a placebo or some alternative treatment. Without controlled experiments, it is impossible to know for sure whether any effects of giving people the medicine are due to the medicine itself or due to placebo effect.


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03 Nov 2021, 2:12 am

There's all kinds of weird with TCM, some aspects not strictly part of TCM, but rather cultural, however in practice they are very much a part of it.
For example
Eating animals close to extinction is good for your health.
Drinking alcohol with snakes in it is good for your sexual abilities.
Eating pulverized "dragon bones" (actually turtle shells) is good for you.
And then the whole idea of hot/cold food/drink making a difference, same with mild/spicy food.
And the zodiac, like if it is the same zodiac year as when you were born, you're supposedly going to have bad luck.

/Mats


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misha00
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01 Jan 2022, 5:20 pm

MrsPeel wrote:
I disagree.
There's nothing wrong with TCM.

The only difference between TCM and "western" medicine is that TCM uses the entire plant/herb containing the therapeutic agent rather than extracting and concentrating it in pill form. And it relies on compounds produced in nature rather than chemical formulation.

If TCM products are properly tested as in the proposed study, and shown to be beneficial, there is no reason not to accept them as genuine medicine.


Actually sometimes only certain sections of the plant are used.



DanielW
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01 Jan 2022, 5:39 pm

This Study doesn't seem to know just what it's studying. What test will they be using to test for increased blood flow (the suspected cause of ADHD/ASD) and if this increased blood flow is discovered, how will they measure the reduction of either condition?

A mere reduction of observable symptoms means nothing except that the participants can mask in order to stop treatment.



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03 Jan 2022, 7:50 am

TCM falls short in areas of biological mechanisms such as cold, heat, damp, dry. However centuries of experimentation have produced formulations such as ones for improved circulation for heart problems.

While there is much to be doubtful about TCM, I don't think it is fair to dismiss the field entirely. The NIH has summaries of many TCM formulations that have been studied and often with effective results. If one is researching a particular remedy, it might not be a bad idea to include "NIH" as a search parameter.



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03 Jan 2022, 1:27 pm

Mona Pereth wrote:
In the part of the article that got quoted above, I see no mention of controlled experiments, e.g. giving the proposed treatment to some people while giving other people either a placebo or some alternative treatment. Without controlled experiments, it is impossible to know for sure whether any effects of giving people the medicine are due to the medicine itself or due to placebo effect.

I noticed that. I also noticed "All seven patients showed a lessening of symptoms during the treatment period across all four scales" shied away from giving any numbers. In fact for such a long article, it seems pretty short on the kind of hard, salient facts that might have convinced a clear thinker that they've got something that works. Hmm......private company, appears to be selling medicines and services but I see no prices.

None of that proves it doesn't work, but if it does, they could have done a lot more to make it plain. I don't feel particularly motivated to spend a lot of time finding out more.



CinderashAutomaton
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03 Jan 2022, 7:22 pm

Regardless of TCM specifically, traditional medicine has had remedies that were proven to be effective...but it's also had a lot proven BS, propagated both ignorantly and knowingly.

Treating TCM as some kind of legitimate alternative medicine is just as BS as other attempts to validate well developed scams.

The vast majority of actually effective medicine would have long since been packaged and sold long ago. The idea from budding legitimate medical doctors to use their newfound knowledge to peruse TCM remedies for gold nuggets is something that would have been thought of millions of times by now. I mean, who would hate easy money?

At best, all that's likely to be left are a few rare things at the fringe of economic viability.


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03 Jan 2022, 8:41 pm

CinderashAutomaton wrote:
The vast majority of actually effective medicine would have long since been packaged and sold long ago. The idea from budding legitimate medical doctors to use their newfound knowledge to peruse TCM remedies for gold nuggets is something that would have been thought of millions of times by now.


TCM is actually big business - in China and Korea.

I think the western medical establishment has actually been slow to catch on to its potential, because there's been this long-standing bias against it - probably because it has not been developed using a scientific approach.

It is only in the last decade or so that medical schools in places like Hong Kong have started trying to integrate TCM and western medical practices, and undertake more scientific type of trials of these traditional medicines.

So I don't think it is true to say that perusing TCM for gold nuggets is fruitless - I think it is still too early to tell. My feeling is that there is a lot that western medicine could learn from TCM (and vice versa).



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03 Jan 2022, 8:54 pm

mohsart wrote:
Kerch wrote:
TCM's bollocks.

At best

/Mats

Bologna on your bullocks. I have a year's worth of basal body temperatures and cycle charts to indicate that TCM is positively impactful, and also medical results for my husband (but less data, so not as compelling). I can't imagine the placebo effect would have been that impactful. That said, placebo effect is useful and effective also. Friendly teasing: But maybe not for you two.



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07 Jan 2022, 8:21 am

By 'gold nuggets' I meant the development of a treatment product that can be sold across the globe. I don't mean to say that it isn't already a big industry.

But that being said, I'd like to apologize as a good bit of what I said was conjecture and I didn't properly qualify my statements, and I spent most of my time just pushing out my opinion of TCM rather than reading and directly addressing what was written in the full paper....all behaviors I typically find reprehensible in others. So that was pretty hypocritical of me and I apologize for that.

Although I don't rescind my stand against unfounded science and medicine, which to my understanding TCM is a frequent offender of, approaching it with an unfounded and absolute bias isn't the right way to do things. I should, at the very least, acknowledge that at least some parts of TCM have merit.

I've been living essentially as a hermit for the past few years and it just gets tougher to rein in empassioned tirades as time goes on and no one to respectfully and intelligently call me out for my mistakes. And I have a bit of a history with unhelpful help, so potentially and likely bogus sources of knowledge and medicine are kind of a sore point for me.

So for anyone who actually bothers to read my long-ass comments, I apologize and please take what I say with a dash of salt. I realize I can get a bit over the top. Much of those times I'm just making the most of the opportunities when I'm not being held back by one mental disorder or another preventing me from talking at all, and just push to say something rather than nothing, leaving certain tasks by the wayside that would go a long way towards tempering and shaping what I say to be a bit more proper and pleasant.

To be clear, I'm not trying to excuse my less-than-ideal behaviors. I'm just apologizing for them, and explaining where I'm coming from so that at the very least there's a bit of understanding towards my actions.


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07 Jan 2022, 8:40 am

timf wrote:
TCM falls short in areas of biological mechanisms such as cold, heat, damp, dry. However centuries of experimentation have produced formulations such as ones for improved circulation for heart problems.

While there is much to be doubtful about TCM, I don't think it is fair to dismiss the field entirely. The NIH has summaries of many TCM formulations that have been studied and often with effective results. If one is researching a particular remedy, it might not be a bad idea to include "NIH" as a search parameter.


I suspect that with TCM and other traditional medicine systems (such as Ayurveda), if they were properly researched you'd see the following results:

Medicines based on ingredients that were traditionally cheap and easy to obtain in that part of the world, such as common herbs: surprisingly effective. If people are regularly using something that just grows wild around the edges of fields, you'd expect them to learn from experience whether it works or not.

Medicines based on historically rare, expensive and exotic ingredients such as rhino horn: ineffective or downright harmful. A total scam, invented by quacks to screw money out of the desperate.


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07 Jan 2022, 1:25 pm

TCM apart, traditional herbal medicine kind of works.
It is undeniable that many herbs do indeed work, but there are two problems.
1. Dosage, in conventional medicine, the effective ingredient in a herb is extracted and put in a pill, one pill will have the same amount of the effective drug as another one, while a stalk of weed or a flower or whatever can vary quite a lot in how much of the effective substance is present.
2. Side effects are less likely in conventional medicine, since only the effective drug is extracted from the herb. Consuming the herb directly may mean the consumtion of other, not so helpful, substances.

Now, that's traditional herbal medicines in general, TCM, or indeed Anthroposophy and other alternatives to science adds a whole other dimention.

You know what they call alternative medicine that works?
Medicin.

/Mats


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