Traditional Chinese Medicine treatment study

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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.

TCM's bollocks.

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.

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.

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.

At best

/Mats

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.