Evidence and Equilibrium
Balancing Research and Clinical Care
When we as providers of Chinese medicine compose a medicinal prescription, there are numerous factors which influence our prescribing. These include:
Antecedents, or classic prescriptions from our formulary
Modern research, generally based on biomedical disease entities
Empirical findings, both that of others and one’s own experience
We discussed the concept of lǐ fǎ fāng yào (principles, methods, formulas, medicinals) in an earlier post. Generally after the pattern diagnosis and principles are determined, a guiding formula is chosen, and modified by adding, subtracting, and/or substituting ingredients to suit the individual patient conformation. Assuming the treatment principles involved in the patient presentation have been adequately covered, there may still be reasons why medicinal substitutions are made
The patient may have particular dietary or ethical concerns about the formula ingredients, for example wanting a formula with no zoological substances (vegetarian or vegan, in other words).
There may be allergies, for example to tree nuts or wheat.
There may be unwanted interactions with other substances the patient is taking, for example with conventional medications.
Some of the ingredients may not be available, or unavailable in the desired form of administration, for example in granule extracts.
There may be concerns about safety and/or toxicity, for example hepatotoxicity with herbs like Shǒu Wū (Rx Polygoni Multiflori) or nephrotoxicity with Aristolochia plants (or other plants for which Aristolochia plants may be substituted).
There may be concerns over cost, with patients frequently spending out-of-pocket for their care.
Applying A Research Formula
This topic came to me recently with a patient who suffers from a very painful nerve impingement due to a lumbar disk herniation. The acupuncture and prepared Chinese herb formula were helpful in reducing the pain, but the patient had read some research on healing disk injuries with Chinese medicine. They directed me to a paper (Dai et al. 2021) detailing a formula that was almost identical to the one I had written about a couple of years ago, which I have linked below. In this post I will be referring to my old article, so you may want to have a look at it first – it’s a fairly short read.
Here is the link:
The formula in the paper the patient found is called Yì Qì Huó Xuè Tāng [益氣活血湯, Qì-Boosting Blood-Quickening Decoction, or YQHXT], and the composition is as follows:
Huáng Qí (Rx Astragali), 20g
Dāng Guī (Rx Angelicae Sinensis), 10g
Chuān Xiōng (Rx Ligusticum Chuanxiong), 15g
Dì Lóng (Lumbricus seu Pheretima), 15g
Hàn Fáng Jǐ (Rx Stephaniae), 10g
Mù Guā (Fr Chaenomelis), 10g
Wēi Líng Xiān (Rx Clematidis), 10g
Bái Jiè Zǐ (Sm Sinapis), 6g
The formula I had previously written about, called Xiāo Suǐ Huà Hé Tāng (消髓化核湯, Marrow-Dispersing Nodule-Transforming Decoction, or XSHHT), was virtually the same, but with the addition of Bái Zhú (Rz Atractylodis Macrocephalae) 10g and Shuǐ Zhì (Hirudo) 6g (Dai et al. 2020). You can find my analysis of that formula at the link above. Since the two additional ingredients in XSHHT are already in categories which are addressed by YQHXT, they mainly accentuate the effects of the herbs in that formula.
Modifying A Research Formula
After some discussion, we decided to use YQHXT as a base formula to try to help the disk resorb. I wanted to stay as close to the principles in that formula as I could; however I decided to make some medicinal substitutions for a few reasons:
Cost: The patient has limited ability to work and has considerable out-of-pocket costs for both conventional and complementary medical care, so keeping the expense of the formula down without compromising the effectiveness was a consideration.
Dietary considerations: The formula would ideally only use plant-based medicinals (minerals were a possibility, as well).
A granule formula in vegetarian capsules was strongly preferred.
Avoiding potentially toxic substances was also a consideration.
Substitutions and additions
Since the formula would be dispensed in granules, I converted the grams in YQHXT listed above to a straight percentage. Since the formula in the research paper was 96 grams in total, this left us four grams short, which would be addressed before finalizing the prescription.
The Chief
YQHXT (and by extension XSHHT) can be seen as a kind of combination of Bǔ Yáng Huán Wǔ Tāng (Yáng-Supplementing Five-Returning Decoction) and Fáng Jǐ Huáng Qí Tāng (Fangji and Astragalus Decoction), two formulas with the common chief ingredient of Huáng Qí. Huáng Qí is somewhat expensive, but it is the main ingredient of the formula, and so it stays at the recommended dosage.
Quicken Blood, Free the Network Vessels
Bǔ Yáng Huán Wǔ Tāng is a Wáng Qīngrèn (1768-1831) formula, and Wáng was very keen on quickening blood. So Bǔ Yáng Huán Wǔ Tāng combines a huge dose of Huáng Qí together with a small dose of Táo Hóng Sì Wù Tāng (Peach Kernel and Carthamus Four Agents Decoction). However there is a key substitution involved: instead of Dì Huáng (Rx Rehmanniae), Wáng substituted Dì Lóng. This addressed not only the wind-extinguishing effects - to treat hemiplegia – but also exploited Dì Lóng’s ability to enter the network vessels and eliminate static blood there.
However, Dì Lóng bumps up against a few of our concerns listed above. It is an animal (earthworm), and it is expensive. Among the granulated ingredients, it was the most costly, and replacing it would knock at least few dollars off the price. To substitute, I looked primarily at botanical agents which would unblock the network vessels and eliminate wind in the channels.
I settled on Sī Guā Luò (Luffae Fasciculus Vascularis), the loofah whose reticular structure enters the network vessels and which also eliminates wind-damp and disperses swelling. It also addresses some of the patient’s presenting symptoms of spasm, numbness and tingling, similar to Dì Lóng. It is balanced and sweet as opposed to the cold and salty Dì Lóng, but we do still have the saltiness of Wēi Líng Xiān in the formula.
Beyond that, Dāng Guī was somewhat costly, and I decided to substitute the less expensive Jī Xuè Téng (Caulis Spatholobi). The two herbs have a lot of similarities: acrid and warm, enter the liver channel, supplement blood, quicken blood, frequently used in menstrual complaints. However, Jī Xuè Téng is a vine, so it enters the channels and network vessels to free up the static blood, and eliminate wind and dampness. Thus it helps to make up some of the function of the Dì Lóng that was removed from the formula.
I decided to keep Chuān Xiōng, and to balance its amount with that of Jī Xuè Téng, which is usually prescribed in higher dosages than Dāng Guī.
Eliminate Wind-Damp
YQHXT not only boosts qi and quickens blood, it has a significant complement of wind-damp medicinals as well. I decided to leave these ingredients as is, with one exception. Hàn Fáng Jǐ is not only one of the most expensive herbs in the formula, it is also sometimes substituted with Aristolochia species. In granules, this is less of a concern these days, as the granule manufacturers test for the presence of aristolochic acid, which is nephrotoxic. Stephania, Hàn Fáng Jǐ, is generally considered safe as long as the correct species is used, but its cost as well as the nagging sense of “what-if” caused me to look for an alternative. I considered Zé Xiè (Rhizoma Alismatis), which I have seen mentioned as a Fáng Jǐ substitute, as well as Yì Yǐ Rén (Semen Coicis). But I decided instead to use Bì Xiè (Rz Dioscoreae Hypoglaucae), which is in the damp-draining category but also dispels wind-damp. In addition, it is noted for separating the clear from the turbid, thus helping preserve physiological fluids while eliminating pathological fluids when aiding resorption of the disk.
Mù Guā, Wēi Líng Xiān and Bái Jiè Zǐ all remain from the original formula. Their actions with regard to aiding disk resorption are found at the link above. One more herb from XSHHT was added, namely Bái Zhú, which supplements the spleen and dries dampness, so aiding both Huáng Qí and the damp-draining medicinals in the formula.
Finalizing the Formula
Thus, the finalized formula, in granule percentages, was as follows:
Huáng Qí 20.00%
Chuān Xiōng 12.00%
Jī Xuè Téng 12.00%
Sī Guā Luò 10.00%
Bì Xiè 10.00%
Wēi Líng Xiān 10.00%
Mù Guā 10.00%
Bái Zhú 10.00%
Bái Jiè Zǐ 6.00%
By adjusting the ingredients and the markup I was able to get the encapsulated formula to a price comparable to the MSRP of many premade Chinese herb brands, while customizing the prescription to address some patient concerns and to conform to the treatment principles of the original formula.
Conclusion
This was a formula that was chosen largely on the basis of research into TCM treatment of a biomedical condition. The prescription, under various names and versions, has been the subject of numerous published papers. At the same time, though I omitted the TCM diagnostic information from this post, the formula aligns well with the patient’s current presentation as well as past medical history. There was scant reason not to try it. However, some of the patient’s concerns warranted judicious substitution of a few ingredients, which were selected while keeping the biomedical goals and TCM principles as well as patient preferences in mind.
This process of balancing research findings with the concerns of both patient and clinician brings to mind the description of evidence-based (or maybe evidence-informed) practice. According to an article from the American Physical Therapy Association (2020), the three components of evidence-based practice are:
Best Available Evidence
Clinician's Knowledge and Skills
Patient's Wants and Needs
The question on whether “evidence-based” or “evidence-informed” practice is the most befitting term is a little more than I want to delve into in this article. Miles & Loughlin (2011) has an interesting discussion on the nuances between the two.
In our own practices, we need to pay attention not only to recent developments in Chinese medicine research and practice, but continually delve into the ocean of knowledge left to us by our forebears, while serving the people who come to us every day seeking our help. Finding equilibrium among all of these concerns is no small task; one moment we may acheve it and the next moment it may be lost. But that is all part of the constant flux of yīn and yáng in our daily practice.
Okay, that’s all for now. Thanks for reading.
Note: this publication is for information purposes only and is not intended as medical advice. Please seek the opinion of a health care professional for any specific medical issues you may have.
References
American Physical Therapy Association. (2020, March 23). Components of evidence-based practice. APTA. https://www.apta.org/patient-care/evidence-based-practice-resources/components-of-evidence-based-practice
Dai, F., Dai, Y.X., Jiang, H., Yu, P.-F., & Liu, J.-T. (2020). Non-surgical treatment with XSHHD for ruptured lumbar disc herniation: a 3-year prospective observational study. BMC Musculoskeletal Disorders 21, 690. https://doi.org/10.1186/s12891-020-03723-2
Dai, F., Yu, P.F., Yu, Z.H., Jiang, H., Ma, Z.J., & Liu, J.T. (2021). Yiqi Huoxue Recipe Delayed Intervertebral Disc Degeneration by Activating Autophagy. Frontiers in Pharmacology, 12:705747. https://doi.org/10.3389/fphar.2021.705747
Miles A, & Loughlin M. (2011). Models in the balance: evidence-based medicine versus evidence-informed individualized care. Journal of Evaluation in Clinical Practice, 17:531–536. doi:10.1111/j.1365-2753.2011.01713.x