Acupuncture and Herbs Stop Shingles Pain, Outperforms Drugs

Posted on by Dr. Evan F.J. Murao
Needles being inserted perpendicular to the paraspinal muscles bilaterally.

Acupuncture and herbs prove effective for the treatment of shingles. Researchers from three independent studies conclude that acupuncture and herbal medicine significantly relieve rashes and pain associated with the herpes zoster virus (shingles). Importantly, acupuncture and herbal medicine outperformed antiviral and anti-inflammatory medications, indicating that usual care protocols are suboptimal without inclusion of acupuncture and herbal medicine.

The shingles viral infection is characterized by painful blisters, usually located in a single strip on either side of the trunk, neck, or face. Even once the blisters have subsided, patients can be left with severe neuralgia (nerve pain), which may last for several weeks or months. According to Traditional Chinese medicine (TCM) principles, this condition usually falls into the category of either excess liver fire, liver and gallbladder damp heat, or spleen deficiency with accumulated pathogenic dampness. Rashes associated with shingles are sometimes referred to as “snake string sores” in TCM, reflecting the nature of their physical presentation.

People’s Hospital

The first study we will look at today was conducted by researchers at the People’s Hospital of Shenyang Economic and Technological Development Zone. [i] A total of 88 patients with a clinical diagnosis of a herpes zoster infection were recruited and randomly assigned to an acupuncture and herbal medicine observation group or a drug control group (including anti-inflammatory and antiviral medications).

The acupuncture and herbal medicine group produced significantly greater patient outcomes. This includes a higher cure rate, a higher overall effective rate, and a lower failure rate. The results indicate that standard procedures to alleviate shingles in hospital and outpatient settings absent acupuncture and herbs are definitively not the most effective means to provide relief to patients.

The observation group comprised 20 male and 24 female participants with a mean age of 43.6 years. Their mean duration of disease was 3.4 days. The control group comprised 18 male and 26 female participants, with a mean age of 42.8 years. The mean duration of disease in this group was 3.6 days. There were no statistically significant differences in baseline characteristics between the two groups at the outset of the investigation.

Treatment Procedures

The control group was treated with conventional drug therapy including:

• Acyclovir (200mg, three times a day)

• Vitamin B1 (10mg, three times a day)

• Ibuprofen slow release capsules (300mg daily)

• Acyclovir topical ointment

The observation group was treated with a modified version of the herbal formula Long Dan Xie Gan Tang containing the following herbs:

• Sheng Di 30g

• Che Qian Zi 30g

• Ban Lan Gen 30g

• Huang Qin 15g

• Chi Shao 15g

• Zhi Zi 15g

• Da Qing Ye 15g

• Long Dan Cao 12g

• Ze Xie 12g

• Chai Hu 10g

• Dang Gui 10g

Modifications

• For patients suffering from concurrent constipation, Da Huang (10g) was added to the formula.

• For patients with symptoms of exuberant heat, Sheng Shi Gao (30g), Zhi Mu (15g), and Mu Dan Pi (15g) were added.

• For patients with pus-filled blisters, Pu Gong Ying (30g) was added.

• For patients with severe pain, Zhi Ru Xiang (10g) and Zhi Mo Yao (10g) were added.

The herbs were decocted in water and one dose was taken daily, divided into two portions for morning and evening consumption. The patients in the observation group were also treated with acupuncture at the following acupoints:

• Huatuojiaji (MBW35)

• Zhigou (TB6)

• Yanglingquan (GB34)

• Yinlingquan (SP9)

Acupuncture was also administered locally in the area of herpetic rashes. Needles were inserted into the spaces between blisters, approximately 1.5 cun apart. The needles were manipulated slightly then withdrawn immediately, and the puncture was not sealed with cotton. The incidental drawing of a small drop of blood was considered a beneficial effect. The affected area was also warmed with a moxa cigar. Treatment was administered once daily. Both groups underwent treatment for a total of ten days, with an initial assessment of rashes after five days.

Clinical Outcomes

Patients with a complete resolution of rashes and clinical symptoms (including pain) were classified as cured. In patients with at least a 30% improvement in rashes and pain reduction, the treatment was classified as effective. In patients showing less than 30% improvement in rashes and no change or worsening of pain, the treatment was classified as ineffective.

In the drug control group, 15 patients were cured, 21 cases were classified as effective, and 8 cases were classified as ineffective, yielding a total effective rate of 81.8%. In the acupuncture and herbal medicine observation group, 25 patients were cured, 18 cases were classified as effective, and one case was classified as ineffective, yielding a total effective rate of 97.7%.

A combination of acupuncture and herbal medicine has been used for the treatment of shingles for over 1,000 years. This modern study confirms the efficaciousness of a common TCM protocol for the treatment of herpes zoster. A rethinking of usual care standards seems appropriate based on the findings. At the Healthcare Medicine Institute (HealthCMi), we examine traditional acupuncture continuing education standards and repeatedly find that an integrative medicine model for the treatment of shingles is superior to drug monotherapy. Let’s take a look at the second study in our review of shingles treatments.

Changjizhou and Jimusa’erxian TCM Hospital

The second study conducted by researchers at the Changjizhou and Jimusa’erxian TCM Hospital (department of acupuncture and moxibustion) determined that acupuncture and herbal medicine are effective for the treatment of shingles. [ii] For this study, a total of 40 patients were recruited and randomly assigned to either an observation or control group.

The observation group was comprised of 12 male and 8 female participants, ages 18–63 years (mean age 35.5 years). Their duration of disease was 1–10 days (mean duration 5.5 days) at the outset. The control group was comprised of 13 male and 7 female participants, ages 18–65 years (mean age 36.5 years). Their duration of disease was 1–8 days (mean duration 4.5 days). There were no statistically significant differences in baseline characteristics between the two groups at the outset of the investigation.

Treatment Procedures

Both groups were treated with herbal decoctions according to their TCM differential diagnoses. Patients diagnosed with excessive heat in the liver channel were prescribed a version of Qing Re Zhi Tong Tang containing the following herbs:

• Lian Qiao 15g

• Jin Yin Hua 15g

• Huang Qin 10g

• Zhi Zi 10g

• Huang Lian 10g

• Long Dan Cao 5g

• Gan Cao 5g

• Da Qing Ye 25g

• Ling Ci Shi 25g

Patients diagnosed with spleen deficiency with accumulation of pathogenic dampness were prescribed a version of Chu Shi Wei Ling Tang containing the following ingredients:

• Cang Zhu 10g

• Chen Pi 10g

• Shao Bai Zhu 10g

• Che Qian Zi 15g

• Ze Xie 15g

• Fu Ling 15g

• Jin Yin Hua 15g

• Long Dan Cao 5g

• Ling Ci Shi 25g

Both decoctions were taken as a daily dose for a total of 21 days. Patients in the observation group also received acupuncture in the area affected by the herpetic rash. Following standard disinfection, 3–6 needles were inserted surrounding the rash at a distance of approximately 0.5–1cm. The needles were inserted transversely to a depth of 20–50mm, angled towards the midpoint of the rash. The needles were manipulated using a balanced reinforcing-reducing method and were retained for 30 minutes. Treatment was administered daily for 14 days.

Clinical Outcomes

For patients whose rash and clinical symptoms fully resolved, treatment was classified as markedly effective. For those whose rash improved by more than 70% and experienced some reduction in pain, treatment was classified as effective. For those whose rash improved by less than 30% and experienced no reduction in pain, treatment was classified as ineffective.

In the control group, there were 10 markedly effective, 6 effective, and 4 ineffective cases, yielding a total effective rate of 80%. In the observation group, there were 15 markedly effective, 4 effective, and one ineffective cases, yielding a total effective rate of 95%.

The patients also rated their pain using a visual analog scale (VAS). VAS scores of 7–10 indicated severe, unbearable pain. Scores of 4–6 indicated severe but tolerable pain, 1–3 indicated mild pain, and scores of 0 indicated a complete absence of pain. At the beginning of the study, mean VAS scores in the control group and observation group were 7.36 and 7.25 respectively. By the end of the study, scores decreased significantly to 4.20 and 2.04 respectively, with significantly greater improvements in the observation group. The results indicate that a combination of acupuncture and herbs is more effective than using only herbal medicine.

Yungang Community Sanitation Service Center

The final study we will examine was conducted by researchers at the Chinese medicine and acupuncture department of the Yungang Community Sanitation Service Center in Beijing. [iii] A total of 36 herpes zoster patients were recruited for the study and were treated with acupuncture, herbs, and cupping therapy. The study group was comprised of 8 male and 28 female patients, ages 25–78 years. Of these participants, 8 had a disease duration of less than 2 days, 11 had a disease duration of 2–14 days, and the remaining 17 participants had a disease duration of over 14 days at the outset of the study.

Treatment Procedure

All patients were treated with a version of Long Dan Xie Tang and Wu Wei Xiao Du Yin. The ingredients were as follows:

• Sheng Di 20g

• Hei Shan Zhi 15g

• Long Dan Cao 10g

• Huang Bai 10g

• Chai Hu 10g

• Huang Qin 10g

• Che Qian Zi 10g

• Ze Xie 10g

• Mu Tong 10g

• Sheng Gan Cao 10g

• Jin Yin Hua 10g

• Lian Qiao 10g

• Ye Ju Hua 10g

• Zi Hua Di Ding 10g

• Pu Gong Ying 10g

Modifications

• For patients suffering from concurrent constipation, Da Huang (10g) and Lai Fu Zi (10g) were added to the formula.

• For patients with symptoms of excessive heat, Huang Lian (10g) was added.

• For patients with severe pain, Chuan Lian Zi (10g) and Yuan Hu (10g) were added.

The herbs were decocted in water on a daily basis and were subsequently divided into three portions to be taken morning, noon, and evening. Acupuncture was administered in the area of the herpetic rashes. Needles were inserted between blisters and were stimulated using a reducing method to elicit a distending pain in the region. Needles were retained for 30 minutes.

Modifications

• For patients whose symptoms originated in the area of the limbs, Quchi (LI11), Taichong (LV3), and Chezi (LU5) were added.

• For those whose symptoms originated on the back of the torso, Huatuojiaji (MBW35) and Hegu (LI4) were added.

• For those with a TCM diagnosis of liver fire blazing, Taichong (LV3), Chize (LU5), and Zhigou (TB6) were added.

• For those with a TCM diagnosis of damp-heat in the Stomach and Spleen, Xuehai (SP10) and Sanyinjiao (SP6) were added.

• For those with a TCM diagnosis of qi stagnation and blood stasis, Geshu (BL17) was added.

Needles at Huatuojiaji points were inserted perpendicularly to a depth of 0.7–0.8mm. The needles were manipulated using a balanced reinforcing-reducing method, and after the arrival of deqi, were retained for 20 minutes. Needles at the remaining acupoints were inserted and manipulated using a lifting, thrusting, and rotating reducing technique. These needles were also retained for 20 minutes. Treatment was administered daily for a total of ten days.

Cupping therapy was administered on every third day of the treatment period. A three-edged needle was used to puncture the skin surrounding the herpetic blisters. For those with a relatively small area affected by the rash, a single puncture was made. For those with a larger rash, the punctures were made approximately 3–5cm apart. A cup was then placed over the puncture(s) and were retained for 10 minutes.

Clinical Outcomes

Patients with a complete resolution of both rashes and associated pain were classified as recovered. For patients whose symptoms resolved almost completely, the treatment was classified as markedly effective. For patients whose symptoms partially resolved, the treatment was classified as effective. For patients whose symptoms did not improve or worsened, the treatment was classified as ineffective.

For patients whose symptoms had been present for less than two days, all 8 were fully recovered, yielding a 100% effective rate. Among those whose symptoms had been present for 2–14 days, 5 were classified as recovered and 2 were classified as markedly effective, yielding a total effective rate of 63.6%. For those whose symptoms had been present for over 14 days, one was classified as recovered and one was classified as effective, yielding a total effective rate of 11.8%.

Results

The results of three independent studies indicate that acupuncture combined with herbal medicine is a highly effective treatment combination for rashes and pain associated with the herpes zoster virus. Additionally, treatment is significantly more effective the earlier it is administered. For more information, contact us at Inner Chi Hawai’i to learn about treatment options tailored uniquely to you.

References

[i] Cao Bo (2018) “Clinical Study of Longdan Xiegan decoction Combined with Acupuncture and Moxibustion for Herpes Zoster” Guide of China Medicine Vol.16(25) pp. 174-175.

[ii] Zhang Qin, Ding Yujie (2018) “Study on the Effect of Dialectical Treatment with Chinese Medicine and Acupuncture on Clinical Symptoms of Herpes Zoster Neuralgia” Cardiovascular Disease Journal of Integrated Traditional Chinese and Western Medicine Vol.6(25) pp. 134.

[iii] Zhao Yun (2018) “Observation on the Effect of Combined Chinese Medicine and Cupping Method on 36 Patients with Herpes Zoster” Traditional Chinese Medicine Vol.16(16) pp.172-174.

Dietary Nutrition within an Eastern Perspective

Posted on by Dr. Evan F.J. Murao

Dieting and nutrition are subjects for which there are many differing, often conflicting, viewpoints. Within the debates there are political, sociological, cultural, environmental, scientific, ethical and financial influences which flavor our theories and ultimately our food choices. Eastern medicine provides us with a framework for viewing nutrition which is above all of the debates and choices which we will still have to make for ourselves.

The eastern view of nutrition works in the same way that the eastern view of medicine works. That is to provide a global framework that is flexible enough to be uniquely suited to an individual based on their state of health and also allowing room, in the case of nutrition, for an individuals preferences.

The information in this section is intended to provide you with a clear understanding of the way that a practitioner of eastern medicine may view nutrition as well as to provide you with some clear guidelines to assist in the decisions that we all must make surrounding our food choices.

Within traditional chinese medical theory there are a number of factors which either cause a/or are the result of disease. The factors can be physical/climatic factors such as heat, cold, wind, dampness and dryness. These can be both internal and external such as a cold condition from using too much internal energy or a heat condition from an external source such as radiation. There are also emotional factors which tie into the five element theory above, such as anger effecting the functioning of the liver leading to headaches, for example, or excessive joy effecting the heart leading to insomnia.

From a practitioners perspective an eastern medicine diagnosis does not usually carry any association with the western medical diagnosis. For example, using eastern medical theory we might call a “headache” Qi or Blood stagnation. From a nutritional standpoint it is important to understand what each diagnosis means and how you might aid your healing by choosing appropriate foods.

The following information below describes the food choices which may be helpful for a particular general TCM diagnosis. It should be mentioned that the Spleen is of the utmost importance in the majority of these disorders when looked at from a nutritional perspective. The Spleen is the foundation of digestion and consequently plays a primary role in the production of Qi and Blood in the body. Thus, food choices, cooking styles and eating habits which benefit the Spleen, benefit the person overall regardless of their condition.

In general terms, the Spleen benefits from eating a balanced diet with ample amounts of grains, fruits and vegetables, not eating too much raw food including salads, limiting damp producing foods such as dairy, greasy foods and alcohol, as well as having regular meals which are eaten in as peaceful of an environment as possible.

Qi Deficiency Diagnosis:
» symptoms – fatigue, dizziness, shortness of breath, pale face, weak spirit
» tongue – pale w/thin coat
» pulse – empty

Supportive Foods For Qi Deficient Patients:
– Indicates an imbalance of the Spleen.
– Foods which are easy to digest, warming and nourishing should be used. Those from the Earth element below are helpful choices.
– Millet, Garbanzo Beans
– Pine Nuts
– Figs, Dates
– Squash, Carrots, Cabbage
– Small portions of Meat, if desired
________________________________________

Qi Stagnation Diagnosis:
» symptoms – similar signs as qi deficiency but also pain that is not fixed in the chest a/or hypochondriac areas
» tongue – white coat
» pulse – wiry or tight

Supportive Foods For Qi Stagnation Patients:
– An imbalance of the Spleen.
– Food choices similar to those for Qi Deficiency are good choices.
-Preparing them in ways which are even easier to digest such as soups may also be helpful.
– Adding small amounts of strongly moving substances such as black pepper, aid to support patient’s wellbeing.
________________________________________

Dampness Diagnosis:
» symptoms – poor appetite, chest/epigastric oppression, loose stools
» tongue – thick white or yellow coat
» pulse – slippery and slow or rapid

Supportive Foods For Dampness Patients:
– Dampness is also a Spleen related imbalance.
– Generally it is the result of long-term qi deficiency but may also arise quickly from a diet that contains too many cold, raw foods, excessive dairy products or excessive amounts of greasy foods, animal products and/or alcohol.
– Food choices similar to those above are helpful.
– Adding foods which dry dampness such as rye, scallions and turnips and limiting the foods listed above which contribute to dampness.
________________________________________

Blood Deficiency Diagnosis:
» symptoms – fatigue, palpitations, dizziness, numbness, blurred vision
» tongue – pale w/thin coat
» pulse – thin

Supportive Foods For Blood Deficient Patients:
– Blood deficiency is usually seen as a result of long-term qi deficiency.
– The Chinese term, Blood is used in a much broader way than the western idea of blood. However, blood deficiencies may still arise from traumas, child birth and menstrual issues such as heavy bleeding.
– Generally foods which supplement the Spleen, as above, are considered good choices.
– Dark leafy greens, spinach, grapes, lotus root, cayenne pepper, and small amounts of meat products, especially liver, are beneficial additions to help the production and circulation of Blood.
________________________________________

Blood Stagnation Diagnosis:
» symptoms – dull complexion, petechiae, pain that is fixed in location
» tongue – purple a/or purple spots
» pulse – deep, choppy, maybe wiry

Supportive Foods For Blood Stagnation Patients:
– Often a deeper manifestation of qi stagnation but may also arise from trauma.
– The foods mentioned above for Blood deficiency are useful.
– Adding to those which strongly move the Blood in the body such as turmeric, garlic, scallions, chives, egg plant and aduki beans aid to the patient’s wellbeing.
________________________________________

Heat Condition Diagnosis:
» symptoms – sweating, sore throat, thirst, red face, headache, skin outbreaks, anxiety
» tongue – red, dry, yellow coat
» pulse – rapid, maybe floating a/or wiry

Supportive Foods For Heat Condition Patients:
– Heat may show up in a variety of ways depending on the underlying condition.
– From a nutritional perspective it is most important to understand whether it is a “full-heat” syndrome or a “false-heat” syndrome.
– “Full-heat” is a pure excess condition which can be helped by consuming cool foods.
– “False-heat”, however, indicates heat from an underlying deficiency which could be worsened by an excessive consumption of cool foods.
– Fruits and raw vegetables, including salads, are generally cooling and beneficial for a heat condition.
– Limiting foods which create heat in the body such as dairy, meats and alcohol is also important.
________________________________________

Cold Condition Diagnosis:
» symptoms – fatigue, poor appetite, pain that improves with heat
» tongue – white coat, possibly blue body
» pulse – slow, maybe floating a/or tight

Supportive Foods For Cold Condition Patients:
– As with heat, cold may show up in a variety of conditions and appear as “full-cold” or a “false-cold” condition where a person has a heat condition but is experiencing a sensation of cold (chills with a fever, for example).
– Warming and moving foods such as cayenne, cinnamon, ginger and onions are important for this condition.
– Limiting cooling foods especially raw foods and fruit juices is also important.
________________________________________

Chinese nutrition lies at the root of Chinese medicine and is fully integrated into social eating habits in China. This ancient cultural knowledge is now being spread into western society and with that, greater understanding of how food can be used as nutritional medicine. By applying the ancient theories of Chinese medicine to our modern society, we can learn how to live in better harmony with the surrounding environment, reduce our impact on the climate, improve our health and prevent disease.

For practitioners of Traditional Oriental Medicine, nutritional strategies whether TCM based, western nutrition based or other-principle based are common and patients often need guidance on diet and nutrition strategies.  At present, it is difficult to assess from an evidence-based perspective whether classic TCM diets could influence diseases or act in the treatment of any disease or condition.  However in clinical practice, using TCM tenets of nutrition along with individualization of treatment strategies for individuals with conditions that will likely benefit from nutritional interventions are feasible.  This could include many conditions such as gastrointestinal disorders, chronic metabolic conditions and even stress, anxiety and general lifestyle recommendation.

The recommendation is to assess each patient individually in order to determine which nutritional approaches may work best based on both their constitution and current complaint and modify those suggestions appropriately.  Finally regardless of what nutritional strategies you employ or if the foods are native to Asia or not, the most important things for the clinician to suggest are choosing clean, uncontaminated foods when possible, selecting the least processed food, and finally encouraging patients to be in calm and enjoyable settings when preparing and eating food. The longer the shelf life the shorter your life. Eat to live, don’t live to eat.

Eat, Drink, & Be Mindful 🙂

Aloha

Overview of Traditional Chinese Herbal Medicine

Posted on by Dr. Evan F.J. Murao

Traditional Chinese medicine (TCM) is a holistic form of medicine with a 5,000- year history. It comprises traditional Chinese herbal medicine (TCHM), acupuncture, acupressure, massage (Tui Na), energy therapy (Chi Kung) and other practices. The core concepts of TCM have influenced the development of other oriental therapeutic systems, such as Kampo and traditional Korean medicine. TCM was introduced to western countries in the 1970s after US president Richard Nixon officially visited China.

Basic theory of TCM

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TCM concerns harmony of the body, differentiation of symptoms and signs, and holistic treatments. The full theoretical system was established 2,300 years ago, when philosophical theories of yin-yang and the five elements were applied.

Yin-yang theory focuses on the opposite characteristics of different substances and phenomena. Yin represents negative, passive and internal features, while yang represents positive, active and external features. The yin-yang symbol (also called tai chi or tai ji), interprets the relationship between the two: yin (the black part) contains the seed of yang (the white spot), and vice versa. All phenomena in nature have yin and yang features. They are opposite but interdependent and can alternate through a cyclical movement. If yang declines, yin will rise, and vice versa.

In TCM physiology, the stomach is a yang organ because it is in contact with the external environment through the gastrointestinal tract and has yang functions, such as absorbing foods and extracting nutrients (“food essence”) to produce “vital energy” (qi). Yin organs, such as the heart, liver, spleen, kidneys and lungs, are less dynamic and store energy. Symptoms are also categorised as yin (cold, slow, wet, chronic) or yang (hot, rapid, dry, acute). Yin and yang symptoms are trans- formable; at the early stage of illness, cold symptoms (yin) can transfer into heat in the body (yang). In treatment, “cold” conditions are generally treated with herbs having “hot” properties.

The five-element theory further explains the Chinese medical system, using wood, fire, earth, metal and water to describe different substances and phenomena of similar natures. For example, in TCM, the function of the spleen is to transform food essence to produce qi and blood.These are similar to the nature of earth — growing, planting and generating — so the spleen is considered to belong to the earth element. The kidneys, ears, salty taste and fear are associated with water. Thus, chronic tinnitus could be a symptom of kidney deficiency, which could cause anxiety and fear, possibly associated with a salty diet.

The five elements have complex relationships. An excess or deficiency of any one element is believed to disrupt balance and cause disease. Medical language used in TCM needs to be distinguished from that of conventional western medicine, particularly in describing organ function. In TCM, each organ is a holistic complex energy system, (eg, the heart is responsible for the mind and blood circulation, and has a sense of happiness, which does not correspond with western medical thinking).These differences are probably due to the fact that dissecting the human body was prohibited in ancient China.

Another essential concept in TCM is that of vital substances: qi, blood, essence (jing), body fluids and mind. These constitute the human body and maintain the functions of the organs. Deficiency in any of the substances will result in an imbalance of yin- yang and cause disease. Other important principles in the TCM framework include the theories of viscera and meridians (longitudinal pathways across the body, along which acupuncture points are distributed) and the identification of patterns.

Diagnostics and therapeutics Observation (wàng), listening and smelling (wén), interrogation (wèn), and palpation and pulse taking (qiè) are the four principal diagnostic techniques used in TCM. A practitioner will observe the patient’s face and tongue, ask for details of symptoms, medical history and life style, listen to the patient’s voice, palpate the skin and abdomen and feel his or her pulse.

The term “pattern” is used in TCM to describe symptoms and classify disease. Particular patterns are looked for among overall symptoms and the corresponding treatment applied.Treatments are highly individualised, and may include use of TCHMs as well as physical therapies such as acupuncture, acupressure and massage. One prescription could be used for several health problems and similar health problems are treated differently if they are not in the same TCM pattern. Follow-up consultations with prescription changes are common.

Materia medica of TCHM

In China, more than 5,000 species of animals and plants, plus minerals, are used in TCHM. In total, 538 Chinese crude “herbal” medicines were included in the 2005 Chinese Pharmacopoeia. Most are plant parts but animal products make up 9.5 per cent and minerals constitute 4.5 per cent.

Chinese herbal medicines are prescribed by their Chinese common names and different herbal species can be used under one name. For example, Mu Tong, a Chinese herb for promoting diuresis, includes various plant species: Aristolochia manshuriensis, Clematis armandi, C montana, Akebia quinata and A trifoliata. The number of herbal ingredients in a prescription can vary from one to more than 15. Herbs have different functions within a formula. The principal herbs target the main symptoms and associate herbs assist the function of the principal herbs and target other symptoms. Next are adjuvant herbs to strengthen the functions of the principal herb(s) and reduce toxicity, and last is the messenger herb which guides the function of all the ingredient herbs into the right pattern and harmonises the function of the formula.

Chinese herbal formulae are available as mixtures of crude herbs for internal use as a decoction, and Chinese patent medicines (CPMs), which are finished or formulated products (eg, capsules) made from crude herbs. Some modern CPMs combine herbal medicines with pharmaceutical drugs to improve efficacy and reduce the possibility of side effects. In the UK, some of these combination products are supplied by TCHM shops as herbal medicines and this has become an important quality and safety issue.

Efficacy of TCHM

Obtaining scientific evidence for TCM theory is complicated because it is based on abstract philosophy. In China, the reputation of TCHM as a therapeutic option remains strong, possibly due to its history of use and the understanding of its philosophy. In western countries, there is generally uncertainty about its efficacy. In the UK, a House of Lords report classified TCHM as being a traditionally established health care system with a philosophical background, but as having insufficient scientific evidence of efficacy.

Scientific evidence for TCHM is generally achieved through assessing the efficacy of specific herbs or formula. For example, the efficacy of a standardised herbal formula for atopic dermatitis has been assessed in several double-blind, placebo controlled trials. One randomised, double-blind, placebo-controlled trial involving 116 patients with irritable bowel syndrome assessed both individualised TCHM treatment (reflecting how TCHM is prescribed in practice) and standard prepared TCHM products. Patients’ bowel symptoms scale scores improved significantly in both TCHM groups, compared with placebo (P=0.001), but only the individualised TCHMs group still had improvements at 14 weeks. However, it is beyond the scope of this article to review all clinical trials for TCHMs.

A review of randomised controlled trials (RCTs) of TCHMs shows that most trials have been conducted in China and published in Chinese, and that their methodological quality does not meet European criteria. To date, the Cochrane Library has published nine systematic reviews of clinical trials of Chinese herbal medicine or medicinal herbs for atopic eczema, schizophrenia, diabetes, chemotherapy side effects, acute bronchitis, acute pancreatitis, hepatitis B virus infection, chronic hepatitis and influenza. These provide limited evidence of efficacy for TCHM: conclusions of these reviews are generally that there is a lack of high-quality RCTs and that rigorous studies are needed. Eighteen protocols for new systematic reviews of clinical trials of Chinese herbal medicines have been published in the Cochrane database, including herbs or formulas for cancer and gynaecological and digestive problems.

The constituent chemical compounds of Chinese medicinal herbs are diverse. The absence of rigorous toxicological information for many herbs does not necessarily indicate safety. Toxic herbs used in TCHM are traditionally classed as slightly toxic, toxic, extremely toxic and deadly toxic, based on the experiences of ancient Chinese. For example, croton seed (Ba Dou) is classified as extremely toxic and aconite root (Fu Zhi) as toxic. Dosage limitations have been documented for each herb.

Some crude herbs are processed to reduce toxicity. For example, Jiang Ban Xia is a traditional processed product of raw pinellia tuber (Ban Xia), and is boiled with gingers and alum for internal use. Raw pinellia tuber is believed to be toxic and should only be used topically. Tests have demonstrated that the processed pinellia tuber is less toxic than unprocessed tuber.

Herb-to-herb interactions are also used to reduce toxicity, to increase potency or to modify properties of herbs in a formula. There are seven basic types of interactions (single use, mutual reinforcement, mutual assistance, mutual detoxication, mutual restraint, mutual inhibition and mutual incompatibility) so it is important to choose the correct herb combination. In addition, there are 18 incompatible herbs and 19 antagonistic herbs.

Awareness of safety issues concerning specific herbs increased following the inadvertent misuse of toxic Aristolochia species by a slimming clinic in Belgium. There were over 100 cases of renal failure in Belgium and at least four cases were identified in the UK. Furthermore, a five-year toxicity study on traditional medicines identified 21 cases of liver problems associated with TCHMs, but no single hepatotoxic herb has been identified.8 In addition to intrinsic toxic effects of some TCHMs, there is a potential for interactions between TCHMs and other medicines, although this has been poorly investigated. However, not all interactions are clinically relevant, and some may even be therapeutically useful.

While TCM theory recognises the potential for adverse effects, including herb-to-herb interactions, traditional descriptions and information on herbal toxicology are largely inadequate from a western scientific perspective. At the same time, there is a lack of reliable information for most herbs on other aspects, including dosage regimens, pharmacokinetics, adverse effects, interactions and effects in special patient groups. Some data are available in primary literature, but pharmacists are likely to require summarised information provided in a familiar format.

Another issue is the use of animal material in TCHM. This carries a latent risk of various infectious diseases passing from animals to humans. Some animal products used in TCHM, such as tiger bone and bear gall, are listed by the Convention on International Trade in Endangered Species (CITES) and despite efforts to stop the practice, some endangered species are still used and included in TCHM textbooks.

Quality Many of the safety problems with TCHMs concern poor-quality products, including contamination with heavy metals, adulteration with prescription drugs, and quantitative variations in constituents.9 For example, in the UK, the CPM Fufang Luhui Jiaonang was found to contain 11.7 percent mercury and, despite attempts to withdraw this product, it is still being sold. Other adulterant drugs include dexamethasone and fen-fluramine.

A phytochemical study of 12 paeoniae samples collected in London, showed the content of paeoniflorin varied from 0.01–4.57 percent.10 The legitimate substitution of Chinese medicinal materials under a given Chinese name brings another difficulty in quality control. For example, the species Aristolochia debilis, Saussurea lappa and Vladimiria souliei can all be supplied under the name “Muxiang”. The latter two herbs are relatively safe but Aristolochia debilis contains toxic aristolochic acids.

Chinese patent medicines with the same formula name can also vary in ingredients when produced by different manufacturers. For example, the number of labelled ingredients in each of the eight CPMs all named “Gui Pi” was found to vary between 2 and 13.11.

Other issues relevant to safety include the behaviors and practices of TCHM practitioners and users. It is common practice in TCHM to change herbal prescriptions as frequently as every few days. TCHM practitioners consider some adverse effects (eg, diarrhea) to be part of the normal response to treatment. Frequent consultations are useful in identifying acute adverse effects, and prescriptions can be modified to reduce these. However, adverse reactions that develop only with chronic use, or that have a delayed onset may not be easily identified.

Pharmacovigilance practices for herbal medicines are still developing. Suspected adverse drug reactions (ADRs) associated with unlicensed herbal medicines have been reportable using yellow cards since 1996. Recognised reporter groups now include doctors, pharmacists, nurses, midwives and health visitors and, recently, patients but not herbal medicine practitioners. Some practitioner groups, for example the Register of Chinese Herbal Medicine, have systems to collect reports of ADRs from their members.

Pharmacists receive information on safety concerns with TCHMs and other herbal medicines in Current Problems in Pharmacovigilance. Further information is available in Herbal Safety News. Despite these initiatives, important safety and quality problems with TCHMs continue and pharmacists should be vigilant to the possibility of their patients experiencing ADRs associated with these products. At present, the distribution and use of TCHMs goes beyond formal surveillance systems; this situation is likely to continue until there is regulation of herbal practitioners.

References

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