Research Studies on Chinese Herbal Medicine – Seeking FDA Approval

Traditional Chinese Herbal Medicine is making headway among medical researchers. In the past, many studies on Chinese Herbal Medicine were dismissed or lacked the credibility of western designed research studies because they were done in China, Japan and other Asian countries. Though theses studies had definite validity, they were not performed using western laboratory study protocol.

Recently, many studies of Chinese Herbal Medicine have been initiated in the US and Canada. The importance of this fact that cannot be under estimated U.S. designed studies by leading universities, such as Stanford, Yale, UCSF and UCLA lend a legitimacy to Chinese herbs that has been lacking in this country in the past.

Interestingly enough, many recent studies are on herbal formulas rather than single herbs. In Chinese herbal medicine, rarely is one herb used alone. Rather a combination of herbs are prescribed in one formula to increase or decrease the potency of a single herb, to ameliorate side effects and/or target certain areas of the body. The concept of using herbs in a cohesive formula was often lost on western researchers who persisted in studying the actions and efficacy of single herbs, such as Rx. Hypericum, commonly known as St. John’s Wort. This herb, which in fact, is a Chinese herb, but one that is rarely used, was very popular for a time as a self-treatment for depression until it was found to have significant antagonist effect on other prescription medications.

Invariably, herbs are found to have significant side effects when they are used alone. When an herb is used by itself, the dosage is often way to high, causing patients to have unwanted side effects. In combination with other herbs, an unwanted effect of an herb can be ameliorated by another herb, or group of herbs, in the formula. For example, a very cold herb when used alone can cause gastric upsets and/or diarrhea, similar to antibiotics. If combined in a formula, the cold aspect of the herb can be balanced with warmer herbs that allow the desired effect if the herb to act while not causing the unwanted side effect of gastric problems.

What are the herbal formulas that are being studied? There are three very interesting ones. All three are in clinical trials and, significantly, two are in the third phase of FDA approval.

MF101 – This twenty plus herb formula is being tested for menopausal symptoms of hot flashes, night sweats, and resulting insomnia. Data from phase 1 and 2 of the research is promising. Subjects of the study had a significant reduction in hot flashes and night sweats with this formula. The drug did not activate the estrogen receptor as in hormone replacement therapy (HRT), making it a possible treatment for breast cancer patients who are being treated with drugs, such as Taxol, that suppress the body’s estrogen, causing subsequent severe hot flashes, insomnia and night sweats. If this drug passes the third phase of the clinical trial, it could bring significant relief to the many thousands of women suffering from the side effects of chemotherapy for breast cancer.

PHY906 – this eighteen hundred year old formula of four ingredients is being investigated by Yale University and a start up company, PhytoCeutica. This classic formula of four herbs, Huang Qin (Rx. Scuttelleria), Bai Shao(Rx Peaonia), Da Zhao (Fr. Ziziphus jujuba), and Gan Cao (Glycyrrhiza) has been traditionally used for diarrhea, stomach cramps, nausea and vomiting. The aim of the study is to see whether the formula can be used to enhance the effect of anticancer agents. The drug is currently in the third phase of testing and looks promising for reducing chemotherapy-induced toxicities and enhancing the effectiveness of chemotherapeutic agents in the treatment of pancreatic, liver, and colorectal cancers.

T89 – this three herb combination of Dan Shen (Rx. Salviae Miltiorrhizae), San Qi (Rx. Notoginseng), and Borneol is under study to determine its effectiveness in treating angina pectoris. Both Dan Shen and San Qi have been used for centuries to move the blood and are known in Traditional medicine as being effective for coronary heart disease.
The formulation is being tested by Tasly Industries, a Chinese pharmaceutical company specializing in modernizing Traditional Chinese Medicine (TCM). T89, also called Dantonic pill, was approved by the SFDA (State Food and Drug Administration) of China in 1993. Since that time, more than 2 billion doses have been taken by 10 million patients. T89 is also used in Russia, South Africa, South Korea, Mongolia, Singapore and Vietnam. This product is in the Global Phase 3 clinical trial and FDA approval is being sought.

All three of these herbal pharmaceuticals show promise in providing significant relief for patients. Hopefully, with the clinical trials drawing to an end for T89 and PHY 906, FDA approval will come quickly.

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Parkinson’s Disease treatment

Recently, a 67 year old woman was referred to me for treatment of her Parkinson’s Disease.  Mrs. C. had been diagnosed with PD 4 years previously.  She was primarily effected on her left side.  She had a tremor in her left arm.  Her left foot and leg felt very rigid, and unresponsive.  She did not experience many of the other symptoms of PD such as a mask-like expression.  She did have  problems initiating movement and the typical Parkinson’s shuffling gait.  She reported a decrease in energy and was very constipated.  As a result of urinary incontinence, she did not like to drink liquids, contributing to her constipation.  She had been on PD medication but experienced significant side effects.  She did not want to continue taking the medication and wanted to see if she could improve her symptoms with acupuncture and herbs.

The focus of  her acupuncture treatments was to increase circulation of Qi and Blood throughout the left side of her body.  Needles were placed in her ear, the back of her head at the occiput (point GB 20) on both sides, down her left arm, in her low back and down her left leg, into her foot.  As usual, the needles were left in place for approximately 30 minutes.  After the treatment, the patient felt an immediate response of a decrease in her left arm tremor and an increase in control of her left leg and foot.

The herbal formula I made for her was composed of herbs to build the Kidney energy, moisten the intestines, and increase circulation.  Additional herbs were added to help relieve the tremors.  The herb, Niu Xi, was added to the forumla to help move the Qi and Blood in her lower body.

Mrs. C. returned the next week and reported that she had felt better than she had in a very long time.  She had more control of her foot and leg and experienced a decrease in the tremor of her left arm.  Her energy had improved and her sense of well-being was greatly enhanced.  Based on her positive feedback, the second treatment was very similar to the first.

I have been treating Mrs. C. for approximately 2 months, seeing her on a weekly basis for acupuncture and Chinese Herbal Medicine regularly.  She states that she feels better than she has in years.  Her bowel movements are much more regular, her urinary incontinence has improved dramatically, her energy is better and her PD symptoms are greatly reduced. 

It is very rewarding to work with Mrs. C. as she is making remarkable progress and is a delightful person to work.  At this point, she has discontinued all of her PD medication.

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Post-surgery recovery & tremor in geriatric patient

Mrs. Smith is an 86 year old patient who has been coming to me periodically for the last 10 years.  Sometimes I wouldn’t see her for  several years.   She usually came in when her  low back  and neck pain were bothering her.  She had scoliosis and arthritis.    This time  she returned complaining of low energy and fatigue after a hernia surgery three months before.  Though she was tired, she still did water aerobics come rain or shine three days per week!  She was generally in good health and enjoyed her life at Rossmoor.  I am always happy to see her as she is a charming and interesting person.  She had lived all over the world and delighted me with stories of her life in South America and Asia.

In addition to her lack of energy, she complained of an increasingly severe tremor.  Her handwriting had become more and more illegible and difficult.  Due to her age, a light acupuncture treatment was most appropriate for her.  I began by using the Kidney shu or command points on the back and ST 36, known to increase energy and the immune system.  As always, I used  ear acupuncture and needled points the  spine, Kidney, Liver,  and Spleen points.  In Chinese medical theory, the Kidney energy declines with age.  It is also said to rule the spine.  Due to Mrs. Smith’s advanced age, tonifying her Kidney energy would help with the fatigue and back pain.  The Spleen commands the energy in the body so by needling that point in the ear, it would build the energy of her body.  The Liver is usually involved in conditions of spasm.  Needling the Liver point in the ear would help control her tremor.

Mrs. Smith came in for a series of weekly treatments.  Each week, I would treat her back using the Kidney points, her ear and build her energy with ST36.  Gradually, Mrs. Smith’s condition began to improve.  In particular, she said her energy was better and she was able to do more during the day.   I  did not see any improvement in her tremor.  Prior to this time, Mrs. Smith had not wanted to drink Chinese Herbal Medicine.  I thought I could help her tremor with herbs so she agreed to try them.  I made her a formula to build the Kidney energy, tonify the Liver and build the blood.   There are numerous special herbs for tremors.  The three I used for Mrs. Smith were Tian Ma, Gou Teng and Se Kuet Ming (abalone shell).  She drank her herbs faithfully every week.

One week she came in complaining that she had woken up that morning with her lips, jaw and lower face numb.  I added points for the face and GB 20 at the occiput to treat the numbness.  In Chinese medicine, tremors, numbness and spasms are considered “internal wind”.  I increased the dosage of the herbs for tremors.  The next week she reported that the numbness was completely gone after the treatment.

Mrs. Smith has continued to drink herbs and come in for treatment.  At her last visit, I immediately noticed that her hands were not shaking nearly as much.  I asked her how her week had been and she reported that she was continuing to have more energy but that she hadn’t paid her bills yet to know whether or not her tremor had improved.  I pointed out that her hands were not nearly as shaky and she agreed.  When it came to write her check to me, her writing was more legible and she had more control of her hand.  We’ll see how she progresses today…

I wrote about Mrs. Smith in the fall of 2010.  I did not hear from her for a long time when suddenly in early 2013, she phoned and came in for an appointment.  As always, Mrs. Smith was an engaging and delightful patient, now nearing 90 years old.  She reported that she had developed an infection from the hernia surgery she had had three years before and had a long period of hospitalization.   She had been very sick for a long time and still had very poor energy.  She wasn’t able to take her water aerobics class and wondered if I might be able to help her regain some of her strength. 

Mrs. Smith came in for a number of treatments during which time her energy substantially improved.  This time, she wasn’t interested in drinking herbs but loved having acupuncture.  After a number of weeks, she reported that her energy had improved and she was ready to return to water aerobics with her Rossmoor buddies!

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