Curr Drug Metab. 2011 Dec;12(10):989-96.
Efferth T, Kaina B.
Department of Pharmaceutical Biology, Institute of Pharmacy and Biochemistry, University of Mainz, Staudinger Weg 5, 55128 Mainz, Germany. efferth@uni-mainz.de
It is estimated that three quarters of the world population rely on herbal and traditional medicine as a basis for primary health care. Therefore, it is one of the most important and challenging tasks for scientists working in drug research to investigate the efficacy of herbal medicine, to dissect favorable from adverse effects, to identify active principles in medicinal plants and to ban poisonous plants or contaminations from herbal mixtures. In the present review, some problems are critically discussed. Botanical misidentification or mislabeling of plant material can play a role for toxic reactions in humans. Some plant descriptions in traditional herbal medicine (e.g. traditional Chinese medicine) have changed over time, which may lead to unintended intoxication by using wrong plants. A problem is also the contamination of herbals with microorganisms, fungal toxins such as aflatoxin, with pesticides and heavy metals. Unprofessional processing, which differs from safe traditional preparation represents another potential source for herbal poisoning. Unwanted effects of herbal products may also develop by the interaction of herbs with conventional drugs upon concomitant intake. The art of herbal medicine is to dissect pharmacologically and therapeutically valuable herbal drugs from harmful and toxic ones and to develop combinations of medicinal plants as safe and efficient herbal remedies. Standardization and strict control measures are necessary to monitor sustainable high quality of herbal products and to exclude contaminations that badly affect patients consuming herbal medicine.
PMID: 21892916 [PubMed - indexed for MEDLINE]
Tags: adverse events research side effects
Chin J Integr Med. 2011 Dec;17(12):889-92. doi: 10.1007/s11655-011-0931-8. Epub 2011 Dec 3.
Wang XY, Nie GN, Yang HY, Zong LL.
The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine. jiaoshouw@163.com
The use of Chinese medicine (CM) for the management of: menopausal syndrome is considered effective both at home and abroad, and more and more clinical studies are confirming its efficacy. However, many problems still exit in current studies, such as the standard of CM syndrome differentiation, the design methodology and criteria to assess the quality of clinical trials and the efficacy of interventions. In this paper, the authors present the CM research and treatment strategies for menopausal syndrome with concepts explaining the CM understanding of the mechanism of the disorder. It is concluded that CM is effective for menopausal syndrome, but improvement in both study methodology and treatment strategy is needed. In detail, it is firstly necessary to conduct clinical studies to evaluate the difference of various CM treatments for menopausal syndrome manifesting different symptoms, so as to establish a comprehensive treatment protocol of CM. Secondly, an acknowledged evaluation system needs to be founded, which embodies the characteristics of CM, and covers appropriate endpoint indices and parameters to objectively evaluate the effect and study quality of CM. Finally, an epidemiological survey with large sample size should be implemented with robust statistical design and CM expertise to collect data for establishing diagnostic criteria for menopause in different stages and with different symptoms.
PMID: 22139539 [PubMed - indexed for MEDLINE]
Tags: menopause research
Zhongguo Zhong Yao Za Zhi. 2011 Dec;36(23):3371-4.
[Article in Chinese]
Wang J, Zhou C.
Pharmacy of Beijisi Retired Cadre Service Administration Clinic, PLA General Staff Administration and Guarantee Ministry, Beijing 100191, China. wjl63833@sohu.com
The adverse reactions caused by Chinese herbal medicine and traditional Chinese medicine are reported increased in recent years, among which the acute liver injury caused by Chinese herbal medicine accounts for 21.5% of total liver injuries. Despite the misuse of traditional Chinese medicine not in accordance with differentiation of symptoms and signs, the adverse reaction of Chinese herbal medicine itself can't be little to these adverse events. The paper summarizes the most common categories of traditional Chinese medicine resulting in liver injury, the mechanism, pathological characteristics, clinical symptom of liver injury, the reasons of the reaction and how to prevent. The research aims to enhance the clinical physician recognition of liver injury caused by Chinese herbal medicine, in order to ensure the safe and rational usage of traditional Chinese medicine.
PMID: 22393753 [PubMed - indexed for MEDLINE]
Al's note: We need to get this translated into English and shared with the AOM community in the English-speaking world.
Tags: adverse events liver research side effects (add +)
Br J Nutr. 2012 Mar;107(5):712-8. Epub 2011 Aug 25.
Zhuang SR, Chiu HF, Chen SL, Tsai JH, Lee MY, Lee HS, Shen YC, Yan YY, Shane GT, Wang CK.
Department of Nutrition, Chung Shan Medical University Hospital, No. 110, Section 1, Jianguo North Road, Taichung 40201, Taiwan, ROC.
Rose geranium (Pelargonium graveolens, Geraniaceae) has anti-cancer and anti-inflammatory properties, and promotes wound healing. Similarly, Ganoderma tsugae (Ganodermataceae), Codonopsis pilosula (Campanulaceae) and Angelica sinensis (Apiaceae) are traditional Chinese herbs associated with immunomodulatory functions. In the present study, a randomised, double-blind, placebo-controlled study was conducted to examine whether the Chinese medicinal herb complex, RG-CMH, which represents a mixture of rose geranium and extracts of G. tsugae, C. pilosula and A. sinensis, can improve the immune cell count of cancer patients receiving chemotherapy and/or radiotherapy to prevent leucopenia and immune impairment that usually occurs during cancer therapy. A total of fifty-eight breast cancer patients who received chemotherapy or radiotherapy were enrolled. Immune cell levels in patient serum were determined before, and following, 6 weeks of cancer treatment for patients receiving either an RG-CMH or a placebo. Administration of RG-CMH was associated with a significant reduction in levels of leucocytes from 31·5 % for the placebo group to 13·4 % for the RG-CMH group. Similarly, levels of neutrophils significantly decreased from 35·6 % for the placebo group to 11·0 % for the RG-CMH group. RG-CMH intervention was also associated with a decrease in levels of T cells, helper T cells, cytotoxic T cells and natural killer cells compared with the placebo group. However, these differences between the two groups were not statistically significant. In conclusion, administration of RG-CMH to patients receiving chemotherapy/radiotherapy may have the capacity to delay, or ease, the reduction in levels of leucocytes and neutrophils that are experienced by patients during cancer treatment.
PMID: 21864416 [PubMed - indexed for MEDLINE]
Tags: breast cancer cellular immunity research
Phytother Res. 2012 Feb;26(2):291-8. doi: 10.1002/ptr.3548. Epub 2011 Sep 2.
Yang TY, Wei JC, Lee MY, Chen CM, Ueng KC.
Department of Medicine, Chung Shan Medical University Hospital, Taichung 402, Taiwan.
Hypertension generally requires the use of a combination therapy to achieve the satisfactory control of blood pressure. A traditional Chinese herb, Danshen (Salvia miltiorrhiza), has been shown to have cardioprotective effects in animals and humans. The study investigated the add-on effect of Fufang Danshen extract capsule in Taiwanese hypertensive patients with uncontrolled blood pressure. This was a double-blind, placebo-controlled, randomized, single-center study clinical trial. Fifty-five patients with uncontrolled mild to moderate hypertension were enrolled under current conventional antihypertensive treatment, randomized equally to receive a Fufang Danshen capsule (formula mixture) 1000 mg twice-daily or a placebo capsule for 12 weeks. Primary endpoints were the control rate and the response rate. By ITT analysis at week 12, the control rates were 25.5% in the Fufang Danshen group and 7.3% in the control group (p = 0.016). The response rates were 45.6% in the Fufang Danshen group and 38.2% in the placebo group (p = 0.946). A significant reduction of systolic blood pressure at week 12 was noted in the Fufang Danshen group compared with the placebo group (13.8 vs 4.2 mmHg, p = 0.005). A decrease of pulse rate was also noted in the Fufang Danshen group (- 3.2 vs +2.7/min, p = 0.027). Adverse events were not statistically different between the two groups. It was concluded that Fufang Danshen (Salvia miltiorrhiza) extract reduced systolic blood pressure and pulse rate, and was well tolerated in patients with hypertension.
Copyright © 2011 John Wiley & Sons, Ltd.
PMID: 21887804 [PubMed - indexed for MEDLINE]
Tags: dan shen high blood pressure hypertension research salvia
Chin Med J (Engl). 2011 Sep;124(18):2925-33.
Duan ZP, Jia ZH, Zhang J, Liu S, Chen Y, Liang LC, Zhang CQ, Zhang Z, Sun Y, Zhang SQ, Wang YY, Wu YL.
Beijing You-An Hospital, Capital Medical University, Beijing 100069, China.
The 2009 influenza A (H1N1) virus infection is associated with the high risk of severe complications and is spreading more rapidly throughout the world than other reported seasonal influenzas. This study aimed to evaluate the efficacy and safety of the nature herbal medicine Lianhuaqingwen capsule (LHC) in patients infected with influenza A (H1N1) virus.
A total of 244 patients aged 16 - 65 years confirmed with influenza A (H1N1) virus infection by the real time RT-PCR were randomized to one of two treatment groups of 122 patients each. Each group assigned to receive either LHC or Oseltamivir (Tamiflu) for five days and observation for seven days. The patients were enrolled within 36 hours of illness onset if they had an axillary temperature of ≥ 37.4°C and with at least one of the following symptoms: nasal obstruction, runny nose, cough, sore throat, fatigue, headache, myalgia, chills and sweating. The primary end point was the duration of illness.
Of 244 patients, 240 (98.36%) patients with a median age 21 years completed the study between October 24, 2009 and November 23, 2009. There were no significant overall differences between LHC treated and Oseltamivir (Tamiflu) treated patients in the median duration of illness (LHC 69 hours vs. Oseltamivir 85 hours P > 0.05) or the median duration of viral shedding (LHC 103 hours vs. Oseltamivir (Tamiflu) 96 hours, P > 0.05). However, it was worthwhile to note that LHC significantly reduced the severity of illness and the duration of symptoms including fever, cough, sore throat, and fatigue (P < 0.05). Both study medications were well tolerated. No drug related serious adverse events occurred during the study.
Compared with Oseltamivir (Tamiflu), LHC achieved a similar therapeutic effectiveness reduction of the duration of illness and duration of viral shedding. Therefore, LHC might be an alternative therapeutic measure for influenza A (H1N1) virus infections.
PMID: 22040504 [PubMed - indexed for MEDLINE] Free full text
Tags: H1N1 Oseltamivir research Tamiflu
Altern Ther Health Med. 2011 Jul-Aug;17(4):48-53.
Azizi H, Feng Liu Y, Du L, Hua Wang C, Bahrami-Taghanaki H, Ollah Esmaily H, Azizi H, Ou Xue X.
School of Traditional and Complementary Medicine, Mashhad University of Medical Sciences, Iran. azizih@mums.ac.ir
To compare the therapeutic effect of Chinese herbal medicine (CHM), acupuncture, and hormone therapy on menopause- related symptoms of peri- and postmenopausal women.
Fifty-seven Chinese women completed 2 months of treatment with either CHM (5 g twice daily, n = 22), acupuncture plus CHM (Kun Bao Wan) 5 g twice daily plus sessions of acupuncture, n = 20), or hormone therapy (n = 15).
Kupperman index score, levels of follicle-stimulating hormone (FSH) and estradiol, and the number of symptoms before and after treatment were the main outcome measures.
CHM, acupuncture plus CHM, and hormone therapy significantly decreased Kupperman score (P < .001 in each group) and number of symptoms (P < .05). The mean difference in Kupperman score between baseline and 2 months among the three groups was significantly varied (P = .02). The difference was only between acupuncture plus CHM and CHM with significantly better results by acupuncture plus CHM. Acupuncture plus CHM, as well as hormone therapy, significantly reduced the level of FSH (P < .05), but CHM alone didn't cause any significant decrease in FSH levels (P > .05). The mean difference in the level of FSH between baseline and 2 months among the three groups was significantly different (P = .02). This difference was only between CHM and hormone therapy with significantly better results by hormone therapy. The three treatments didn't make any significant increase in the level of E2 (P > .05).
application of the combination of Chinese herbal medicine and acupuncture proved as effective as hormone therapy in the treatment of menopause-related symptoms, and it achieved better outcomes than herbal medicine alone.
PMID: 22314633 [PubMed - indexed for MEDLINE]
Tags: acupuncture hormone therapy HRT menopause research
J Tradit Chin Med. 2011 Dec;31(4):277-81.
Zhou YH, Wei KM, He LY, Sun XM, Shao KD, Fang BM, Shen YP, Ye BD, Shen JP, Lin SY, Chen ZL, Cai GL, Chen J, Gao YT, Wang XQ, Zhu JJ.
The First Hospital Affiliated to Zhejiang TCM University, Hangzhou 310006, China. zyhblood@163.com
To probe the effects of qi-supplementing and yin-nourishing therapy (blood-increasing decoction and blood generating powder) on chronic thrombocytopenia.
Two hundred patients with chronic thrombocytopenia were randomly divided into control (n = 100) and test groups (n = 100) with Amino-polypeptide as a basic treatment for both. Test group patients consumed a blood-increasing decoction and blood-generating powder for 1-3 months. Improvements in platelet counts and TCM syndrome were observed.
One hundred and sixty-four (80 in the test group and 84 in the control group) of 189 total participants were treated for 3 months. The total effective rate in improving TCM syndrome was 95.00% in the test group and 79.76% in the control group (P < 0.05). There was significant difference (P < 0.05) in the accumulated score of TCM syndrome between the two groups treated at different time points. The total effective rate of platelet counts was 86.25% in the test group and 59.52% in the control group (P < 0.05). There was a significant difference in platelet counts before and after treatment in the two groups (P < 0.05). There was no significant differences in platelet count between the two groups treated for 1-2 months; however, a significant difference was found between the two groups after treatment for 3 months (P < 0.05).
After a 3-month treatment of chronic thrombocytopenia patients with qi-supplementing and yin-nourishing therapy, TCM syndrome was improved and platelet counts increased with no obvious side effects, and the quality of life of the participants was enhanced with noticeable long-term curative effects.
PMID: 22462231 [PubMed - indexed for MEDLINE]
Tags: research thrombocytopenia
J Tradit Chin Med. 2011 Dec;31(4):282-7.
Deng X, Liang J, Wu FS, Li YB, Tang YF.
Ruikang Hospital of Guangxi Traditional Chinese Medical University, Nanning 530011, Guangxi, China.
To investigate the clinical efficacy and safety of the Ganning formula for the treatment of liver fibrosis in patients with chronic hepatitis B.
In a multicenter, randomized, controlled clinical trial, 150 patients with liver fibrosis secondary to hepatitis B virus (HBV) infection were randomly assigned in equal numbers to receive either the Ganning formula (a Chinese herbal decoction; active treatment group) or oral entecavir (control group) for two 3-month courses. Patients were monitored for any treatment-induced changes in liver function test parameters (ALT, AST, and GGT), liver fibrosis markers (LN, HA, IV-C, and PCIII), HBV DNA level, hepatosplenic imaging, quality of life scores, or psychological and social functioning scores. Patients were also observed for any adverse effects.
After treatment, patients in both groups experienced significant improvements in liver function, HBV DNA load, hepatosplenic B-mode ultrasonography, quality of life, and psychological and social functioning (P < 0.05 or P < 0.01). Patients receiving the Ganning formula achieved greater improvements in HA, IV-C, quality of life, and psychological and social functioning compared with those on entecavir (P < 0.05 or P < 0.01). There were no abnormal changes in blood tests, urine, feces, renal function, or electrocardiogram. Additionally, no adverse effects were observed in any patients in either group.
The Ganning formula appears to have the potential to inhibit liver fibrosis and therefore improve liver function by inhibiting HBV replication in patients with chronic hepatitis B. Additionally, this formula is helpful in improving quality of life and psychological and social functioning.
PMID: 22462232 [PubMed - indexed for MEDLINE]
Tags: Baraclude entecavir hepatitis B liver fibrosis research
In the April 9th, 2012 online edition of the Proceedings of the National Academy of Science, an article appeared titled:Aristolochic acid-associated urothelial cancer in Taiwan. This article describes a higher incidence of a particular kidney cancer in Taiwan, where herbs containing aristolochic acid (AA) were used with some frequency leading to a public health concern.
In the USA, news like this brings out those who call for banning of all Chinese herbal medicines, stricter regulations or any of a number of knee-jerk reactions to a problem that the FDA had solved years ago. This article describes that import ban as well as provides some of the background information on herbs that contain aristolochic acid.
The FDA Banned Herbs that Contain Aristolochic Acid in 2000
Aristolochic acid (AA) is a chemical found in a few Chinese herbs, some of which were widely used in mainland China from the 1930's through 2003 when they were banned for medicinal use in mainland China [source]. The US FDA also moved to alert the acupuncture and Oriental medicine (AOM) community of the dangers of AA as early asMay 31, 2000. Since then, AA containing herbs have disappeared from professional distributors that supply practitioners with their bulk herbs and herb extracts.
As far as professional Chinese medicine herbalists go, this is a problem that was solved years ago, but it continually arises in the press and so we must continually remind consumers that AA containing herbs are no longer available in the US. However, there may be some old "patent formulas" that remain on store shelves with the banned ingredients. These are the over-the-counter equivalent of what AOM practitioners use in practice. These pre-made herbal products that are imported from China represent where consumers may still run into adulterated or contaminated products that can represent a potential health risk.
Which products are safe, and which are not? That is not something I can answer because there are unfortunately numerous counterfeit products on the market as well as name-brands that are respected and trusted in China and the US. As a rule, practitioners of AOM purchase their herbs from distributors that support the professional-use market. However some practitioners grew up with or have some other affinity for many of the common pre-made formulas available in herb pharmacies such as you might find in a Chinatown and so their in-house pharmacies may carry these products.
Working directly with a practitioner in your area is the best choice, however the major herb brands that you may find available online also have a vested interest in your health and welfare. That's why one of the better methods to determine if your brand of herbs is playing by the rules is to purchase from brands, manufacturers or retailers that have become a member of the American Herbal Products Association which supports companies that have shown an interest in protecting the good name of herbal medicines.
All of this being said, AA is a dangerous adulterant and I support the FDA's work to screen AA out of any of our products being used for health and healing.
39 Dead in Belgium
I would like to address one frightening statistic that often arises in any discussion of AA, and some of the lessons learned from the horrific outcomes that appeared after a weight loss clinic in Belgium used some Chinese herbs. In the 90's, a weight loss clinic was throwing anything and everything at their patients under the treatment principle that more is better (ironic for a weight loss protocol).
One of the ingredients of their proprietary weight loss formula included "fang ji" (or fangchi) which is a diuretic herb most often used for arthritic pains associated with edema. However, due to a number of errors, the following incidents took place:
The take-home message here is that these were physicians who were not trained in the safe and efficacious use of Chinese medicine. As it turns out, we have many really safe diuretics if that is needed for weight loss. I have yet to understand why they chose either of the "fang ji" herbs.
Fallacy: Chinese Herbal Medicines Aren't as Safe as the Better Researched Western Drugs
I bring up this fallacy because of the Belgium weight loss clinic described above wasn't killing their patients with only AA containing herbs, but with an FDA approved drugfor weight loss known colloquially as "Fen Phen" (fenfluramine/phentermine). This drug causes heart valve issues and deadly pulmonary hypertension. There were 113 adverse events recorded before the FDA acted.
While AOM practitioners often cite the 2000 years of safe usage of medicinal herbs in China, the fact remains that over those 2000 years, many herbs have fallen into disuse because of observed adverse events such as those arising with AA containing herbs.
In this regard, Chinese and Western medicine both get to learn from their mistakes.
Consumers Can Check Their Medicine Cabinets
According to the Proceedings of the National Academy of Science article, the damage done by AA is irreversible, and patients treated with Aristolochia herbal preparations at any time in their life are at significant risk of developing kidney cancer or chronic kidney disease.
Aristolochic acid herbs appeared in a few Chinese herb formulas that were imported into the US, however it is unknown to what extent. It does not appear that the FDA asked for a recall of these products at the time, only the raw herbs (branches, roots, etc.) that contain AA were recalled.
In the formula called "Longdan Xiegan Tang" the herb "mu tong" is used, however as is the case with "fang ji" there are varieties of mu tong that contain AA and those that do not. If you have any Longdan Xiegan Tang, look for the ingredient Guanmutong (Aristolochia manchuriensis). That's the ingredient you'll want to avoid. If you see "mu tong" with no latin, then you should perhaps pass on that version as well. FDA regulations (DSHEA) require that herbal product labels list ingredients using the "latin binomial" botanical name of the plant or material used. So it should be easy to see the word "Aristolochia" there. If the product is not compliant with this basic DSHEA requirement of providing the latin names, then they may not be compliant with other good manufacturing practices, either. Something to think about.
First, Do No Harm
These were the first words my own clinical supervisor impressed upon me early in my education, and this is not unique to my experience. Licensed practitioners of Oriental medicine have a vested interest in your health. It is inconsistent with our economic or humanistic goals to provide our patients with known carcinogens. Aristolochic acid is one example of the way in which a profession learns and grows. While we learn more from mistakes than successes, they are fortunately very few and far between.
-Al Stone, L.Ac., DAOM
Related:
Over-the-counter analgesics are also known to increase the risk of renal cell carcinoma(kidney cancer).
Consumer guidance from AHPA
Tags: adulterated aristolochic acid contamination herb safety
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