Efficacy is defined by a fasting blood glucose of <8.2 mmol/l plus symptoms relieving.
CHM is well tolerated and relatively safe in clinical use. Adverse reactions related to CHM use are uncommon. Approximately 5% of the total adverse events and drug-related deaths are caused by the use of CHM. Most of the trials in diabetes and metabolic syndrome revealed no adverse effects during CHM treatment . Nonserious adverse events associated with CHM treatment included diarrhea, abdominal pain, nausea, and loss of appetite .
The blood glucose-lowering effect of CHM may turn into adverse events such as hypoglycemia if misused. For example, Xiao Ke Wan is a widely used drug composed of six herbs (Di Huang, Ge Gen, Huang Qi, Shan Yao, Tian Hua Fen, Wu Wei Zi) and 0.25 mg glyburide. The drug is indicated for type-2 diabetic patients with a deficiency syndrome of both Yin and Qi. It is estimated that the incidence of hypoglycemia is 5% in Xiao Ke Wan users [60, 61]. The risk of hypoglycemia is even alarming in elderly subjects, individuals with impaired hepatic and renal function, patients with acute infection, and in patients who concomitantly use insulin or other antidiabetic drugs . Among 311 incidental cases with hypoglycemia reported in 15 clinical studies, 92 (29.6%), 9 (2.9%), 76 (24.4%), and 113 (36.3%) were caused by using Xiao Ke Wan, CHM, insulin and oral anti-diabetic drugs, respectively [60, 61]. Moreover, patients with Xiao Ke Wan-induced hypoglycemia had a high risk of death (3.3%) and stroke (9.8%) . Therefore, extreme caution should be taken to prevent hypoglycemia and other serious adverse events when the Chinese herbal medicine is con-comitantly used with orthodox drugs [64, 65].
TCM is an individualized treatment based on differentiation of the syndrome. CHM as a whole is effective and relatively safe in relieving symptoms, controlling hyperglycemia, and rescuing secondary failure in patients with diabetes. Long-term controlled clinical investigations will disclose the effectiveness of Chinese medicine in reducing the mortality and morbidity of chronic complications in patients with diabetes. The majority of Chinese patients with diabetes use both Chinese medicine and orthodox drugs. In parallel to the epidemic tend of diabetes and increased use of integrated Chinese and Western medicine, herb-drug interactions may substantially occur when herbs are misused. Overdoses, improper preparation, erroneous substitution, adulteration with Western drugs or heavy metals, and self-meditation in using CHM can cause serious problems including hypoglycemic coma and death. Chinese medicine should be used cautiously following doctors' prescription and supervision. Doctors should always obtain a complete history on the use of both Chinese medicine and Western drugs in the clinical assessment and prescription.
We thank Dr. Sui Yi for her assistance in the literature search and data analysis. This paper is dedicated to the late Prof. Julian A.J.H. Critchley.
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Dr. Katsilambros: I enjoyed your lecture very much. As I don't come from China I have no idea about rehmannia. What kind of substance is it? How long can rehmannia be administered for type-2 diabetes? What were the results with regard to glycemia, metabolic factors, complications, and other factors including mortality and survival? What was the greatest length of time that this medication could be given to type-2 diabetic people?
Dr Zhao: In contrast to chemical drugs synthesized with monomers, traditional Chinese medications contain lots of plant-derived substances and compounds including alkaloids, flavonoids, glycosides, peptides, saponins, triterpenoids and xanthones . Compounds purified from Chinese herbal medicines are disappointing because of their decreased therapeutic effects and increased toxicity when compared to the traditional Chinese decoction. I speculate that all six herbs in the rehmannia recipe work synergistically to enhance the body's self-healing capacity in correcting multiple metabolic abnormalities. Animal studies have shown that Cornus officinalis is the major contributor to the hypoglycemic action of rehmannia six . In type-2 diabetic rats, an alcohol extract of cornus improved glucose tolerance associated with an elevation in the blood insulin level  and enhanced muscle GLUT4 expression . In strep-tozotocin-induced diabetic rats, iridoid glucoside of the cornus extract attenuated microalbuminuria and glomerular damage . In the clinical practice of traditional Chinese medicine, a minimal 1-month duration of treatment is required for patients with type-2 diabetes to show the benefits of symptom relief and improved glycemic and other metabolic control [6, 7]. Intervention with rehmannia six and lifestyle modification for 18-24 months significantly prevent the development of type-2 diabetes from impaired glucose tolerance [8, 9]. In a 3-month controlled clinical trial of 68 type-2 diabetic patients with microalbuminuria, combined treatment with rehmannia six and captopril was better than captopril alone in delaying renal treatment . To my knowledge, no clinical data are available regarding the efficacy of Chinese medicines on mortality and survival. Treatment is not the most important concept of traditional Chinese medicine. The most important thing for our physicians is the right judgment. If the right judgment is made as well as a very early diagnosis, then with some medical prescription there is a better chance of successful treatment of the patient.
Dr. Chiasson: I also enjoyed your presentation very much and I think that it shows how one can take advantage of these thousands of years of experience with traditional Chinese medicine and bring it to the clinical bedside with a better understanding of how it works. Is there any effort being made to try to isolate the active ingredients in rehmannia six? You said that the toxicity may be increased by purification, but I thought that toxicity was due mainly to the heavy metal in those plants. All plants will carry different ingredients depending on where they grow, so the substances within the plant can vary. How is the dosage of rehmannia six decided upon?
Dr. Zhao: Traditional medicine is widely used in most counties and communities. Significant efforts have been directed toward the safe and effective practice of this history-proven medicine. Today it is relatively easy to combine Chinese with modern Western medicine. However, it is very difficult to validate these two medical systems in terms of one another. Firstly, traditional Chinese medicines are defined neither by chemical structures nor by indications of specific diseases. Instead, traditional Chinese medicines are characterized by four properties of cold, hot, cool or warm, five flavors of bitter, pungent, salty, sour or sweet, and four actions in the downward (lowering), upward (lifting), outward (floating) or inward (sinking) directions . A classic prescription of traditional Chinese medications usually contains several herbs to help the body to restore homeostasis. In the case of the rehmannia six recipe, the dosages are 24 g rehmannia, 12 g of cornus and dioscorea, and 9g of mutan bark, alisma and poria. All six raw herbs are prepared in decoction and are taken orally 2-3 times/day. The dosages may be modified individually, tailored to the patient's clinical conditions. This time-honored antidiabetic remedy has proven efficacy and safety profiles. In contrast, chemical substances purified with all the modern technologies were more toxic and even less effective compared with the classic preparation of decoction. The development of new chemical drugs from Chinese medications is a great challenge. Secondly, Chinese medicines are mostly derived from natural products of plants, animals and minerals. Due to environmental pollution, widespread use of chemical fertilizers and pesticides, the population explosion, overspending and other reasons, large numbers of wild plants and animals are endangered, and the natural resources for Chinese medications have decreased. Moreover, heavy metal contaminations , adulteration with chemical drugs, and abuse of Chinese medications are the eminent problems associated with increased severe adverse events. Genetic heterogeneity was found in the marketing of Chinese herbs including rehmannia . To assure the safety and effectiveness of Chinese medications, good agricultural, manufacturing and clinical practices are implemented. Despite the shared therapeutic goals, traditional Chinese medicine and modern Western medicine use significantly different approaches in the treatment of diabetes. Traditional Chinese medicine is a holistic and individualized treatment in terms of diagnosis, prescription, medication, and dosages.
Dr. T. Wilkin: Early in your presentation you showed us a slide suggesting that the insulin level rose when rehmannia six was given, and in the latter part of your presentation that insulin resistance fell. This is conceptually very important in the management of type-2 diabetes because the view is generally held that stimulation of insulin is perhaps not the appropriate approach but that insulin sensitization would rather be appropriate. Can you tell us which is happening, and which is the more dominant factor because the glucocentric view is probably not the one that we would tend to go with?
Dr. Zhao: Thank you for your comments. You have just highlighted that rehmannia six improves glycemia by enhancing insulin secretion and decreasing insulin resistance. It is very true that improvement of insulin resistance is central to the management of the metabolic syndrome.
Dr. Slama: I recall a study perhaps 15 years ago here in China in the region of Beijing and Shanghai. It was a study between France and China, trying to compare traditional medicine and a Western drug called glibenclamide in type-2 diabetic people. There were 3 groups, and in fact randomization was according to centers and not patients. At some centers patients were treated only with glibenclamide, other centers treated patients only with traditional Chinese medicine, and the third group of centers, most interestingly, combined the two approaches. We found that after 6 months glibenclamide was efficient in improving blood glucose control, and that the traditional treatment didn't do anything significant in terms of blood glucose control but, most interestingly, the combination of the two treatments did better than gliben-clamide alone.
Dr. Zhao: Thank you for sharing your findings. Traditional Chinese medicine may have limited advantages in lowering blood glucose. Beyond the glucocentric view, Chinese medicine can contribute to the prevention of diabetes in high-risk individuals, prevention of diabetic complications, relieving symptoms, reducing drug resistance and toxicities, and rescuing secondary failure to chemical drugs . In our survey of 3,904 patients with diabetes, 93% used both Chinese and Western medicines . The advantage of integrative medicine is unclear .
Dr. Slama: Would you agree that we have a double task when treating diabetic patients. The first one is the prevention of macrovascular complications, but also we have to fight against blindness, neuropathy and nephropathy, and only by lowering the blood glucose level can we reach this goal. So really we should act on both sides to prevent macro- and microvascular complications and also focus on blood glucose-lowering agents.
Dr. Zhao: I agree with you that high blood glucose is a risk factor associated with the development of macro- and microvascular complications. In a systematic review of 66 randomized trials involving 8,302 subjects, some Chinese herbal medicines show hypoglycemic effects in type-2 diabetes . Novel hypoglycemic agents might be identified from enriched Chinese medications. But the focus of traditional Chinese medicine is not glucose. The ultimate goal of Chinese medications is to help the body to restore balances for maintaining health.
Dr. Halimi: I have a question about insulin secretion or insulin sensitivity in your studies with rehmannia six. You have shown that, in normal Wistar rats receiving this plant, insulin levels are multiplied about 5 times. Then you presented some data related to diabetes prevention in patients with impaired glucose tolerance, or dys-metabolic syndrome, all subjects having normal or subnormal fasting blood glucose levels. Did they exhibit hypoglycemic episodes with rehmannia six or did they only normalize glycemia and insulinemia? Is this situation comparable to sulfonylureas or metformin?
Dr. Zhao: The philosophical basis of traditional Chinese medicine is the dynamic balance of Yin-Yang. Eating too much and exercising too little cause imbalances reflected by syndromes of deficiency and excess in diabetes. In the rehmannia six recipe, the deficient syndrome of Yin is supplemented by the herbs rehmannia, dioscorea, and cornus, whereas the excessive syndrome of Yang is cleared by the other three herbs, mutan bark, alisma, and poria. The approaches of Chinese and Western medicine to healing are completely different. With our ignorance of the philosophical basis, it is impossible to make critical judgments of Chinese medicine using the Western approach.
Dr. Gerasimidi-Vazeou: Is the dose of rehmannia six you tested in animal studies equivalent to the one you gave to humans? What is the toxicity of the ingredients? Have you performed any toxicity experiments?
Dr. Zhao: Repeated oral administration of rehmannia six at dosages of 26mg/kg for 3 days significantly improved insulin resistance in obese Zucker rats . The corresponding clinical dose of each single herb is 8g of rehmannia, 4g of cornus and dioscorea, and 3 g of mutan bark, alisma and poria. Each ingredient herb is potentially toxic. However, when the six herbs are prepared as a decoction, adverse events are rare and minor. The major problem associated with rehmannia six is overuse.
Dr. Gerasimidi-Vazeou: You said that the ingredients of the recipe change according to the physician's estimate of his patients. In animal studies you used a standardized recipe but what about humans? What happens with the dosage of several ingredients you use to make the recipe for every single patient? How do you change the dosage of the ingredients, and how much is this standardized?
Dr. Zhao: Documented in the China Pharmacopoeia 2000 are the standards for traditional Chinese medicines. One gram of rehmannia six should contain at least 1.0mg of paeonol (Dan Pi Fen).
Dr. Gerasimidi-Vazeou: What I am trying to ask you is whether there are consistent standardized ingredients in the recipe you use for humans because you said that you change the ratio between ingredients? What about the data related to the human studies you presented, have you tested a standard recipe or not?
Dr. Zhao: Paeonol is the standard ingredient extracted from mutan bark.
Dr. Bantle: I have a question about the rehmannia six supply. Where does it come from? Is it made by pharmaceutical companies? What other sort of preparation does it undergo?
Dr. Zhao: There are over 10 manufacturers producing rehmannia six with different dosage forms. Rehmannia six may be prepared as a decoction by boiling the six herbs.
Dr. Hill: You mentioned that almost 77% of the population use both traditional and Western medicine. Does this mean that a lot of the physicians are trained in both, or does it mean that people go both to a traditional physician and a Western medicine physician?
Dr. Zhao: Doctors may prescribe both Chinese and Western medicine. Western medicines are available both by prescription and 'over the counter', as is also the case for Chinese medicines. Alternatively, patients can also see physicians who practice traditional Chinese medicine as well as Western medical doctors.
Dr. Hill: Are there many physicians who are trained in both traditional and Western medicine?
Dr. Zhao: In mainland China, most doctors have been trained in both Chinese and Western medicine. General hospitals in China provide services in both Western and traditional Chinese medicine. So the patients can benefit from both systems.
Dr. Mingdao Chen: Most doctors are trained in Western style medicine but they still use the traditional Chinese medicine to complement Western medicine. They learn traditional Chinese medicine at university, as I did, over several months. I use traditional Chinese medicine to supplement normal treatment, and on the other hand the traditional Chinese medical doctors also use Western medicine. This system is particularly important in China and the patients benefit from this system.
Dr. Zhao: Indeed, two opinions are better than one. In the future I expect to see an increase in adverse events and drug interactions published in the literature because of the increased use of combined traditional Chinese and Western medicine.
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14 Chen P, Zhu ZZ, Lang JM, et al: Clinical observation on effect of Yiqi Yangyin Huoxue Tongfu principle in treating diabetes mellitus type 2 of secondary failure to sulfonylurea agents (in Chinese). Zhongguo Zhong Xi Yi Jie He Za Zhi 2004;24:585-588.
15 Chen Q, Zhu ZZ, Lang JM, et al: Chinese herbal medicine in diabetes management (P1962). Diabetes Metab 2003;29(suppl):170.
16 Shi ZX: Peculiar clinical dominance of integrative Chinese and Western medicine (in Chinese). Zhongguo Zhong Xi Yi Jie He Za Zhi 2005;25:101-102.
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18 Wu YC, Hsu JH, Liu IM, et al: Increase of insulin sensitivity in diabetic rats received die-huang-wan, a herbal mixture used in Chinese traditional medicine. Acta Pharmacol Sin 2002;23:1181-1187.
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Breakfast is the most vital meal. It should not be missed in order to refuel your body from functional metabolic changes during long hours of sleep. It is best to include carbohydrates, fats and proteins for an ideal nutrition such as combinations of fresh fruits, bread toast and breakfast cereals with milk. Learn even more tips like these within this health tips guide.