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1.  Safety Profile of a Polyherbal Formulation (Gynocare capsules) in Female Rats by Subchronic Oral Toxicity Study 
Toxicology International  2012;19(2):106-111.
Gynocare capsules, is a polyherbal formulation, are used as uterine tonic and for treating gynaecological ailments like infertility, leucorrhea, and menstrual disorders. The formulation contains ingredients of herbal origin, such as, extracts of Ashoka, Vasaka, Durva, Chandan, Musk, and so on. It was evaluated for its safety at the therapeutic dose level by a repeated dose oral toxicity study in albino Wistar rats. The herbal formulation was administered orally at a therapeutic dose of 100 mg/kg/day, for 90 days. All animals were monitored daily for their health status and signs of abnormalities. The body weight, water consumption, and food intake were measured once weekly. At the end of the experimental period, various hematological and biochemical parameters were estimated and histopathologies of selected organs were conducted. The study resulted from the long-term oral administration of Gynocare capsules (100 mg/kg), did not cause any relevant signs of toxicity nor significant changes in the physical, hematological and biochemical parameters. However, statistically significant differences were seen in the relative organ weights of adrenal gland, ovary, and serum creatinine levels. The reduction in ovary weight revealed the possibility of the drug targeting the ovary. Moreover, no pathological features were identified in the treated group as monitored by the histopathological analysis of the internal organs. The study established that Gynocare capsules at the dose given (100 mg/kg) did not induce any remarkable or significant toxic effects, indicating that it was safe in rats following oral administration for 90 consecutive days.
doi:10.4103/0971-6580.97196
PMCID: PMC3388751  PMID: 22778505
Polyherbal formulation; repeated dose oral toxicity; sub-chronic oral toxicity
2.  Herbal products in Canada. How safe are they? 
Canadian Family Physician  1997;43:697-702.
OBJECTIVE: To examine existing evidence and inform family physicians about issues concerning herbal product use in Canada. QUALITY OF EVIDENCE: The Canadian Food and Drug Act and findings of an Expert Advisory Committee on Herbs and Botanical Preparations were consulted to provide an overview of the issues regarding herbal product regulation in Canada. Case reports of herbal toxicity were identified to illustrate some of the hazards of herbal products, and references provided to guide health professional in searching the literature for clinical trials that evaluate these drugs' efficacy. MAIN FINDINGS: Herbal products not registered as drugs in Canada are sold as foods and are exempt from the drug review process that evaluates product efficacy and safety. This places the public at risk of unwanted effects from the use of herbal products that are adulterated with other substances and of forgoing effective conventional therapy. Moreover, consumers are exposed to a plethora of information portraying herbal products as harmless. Some progress has been made to address these concerns by facilitating the registration of herbal products as drugs. CONCLUSIONS: Most herbal products that were evaluated were unsafe or ineffective, or no information was available to evaluate their efficacy. Despite the perception that herbal products are innocuous, family physicians need to be aware that herbal therapy can be harmful in order to help their patients make informed choices.
Images
PMCID: PMC2255469  PMID: 9111986
3.  Nutritional Content and a Phase - I Safety Clinical Trial of a Herbal-Nutritional Supplement (Imuniti) with Putative Immune-Modulating Properties 
The relationship between HIV and AIDS and poor nutrition has been well established. Poor nutrition hastens the progression of HIV infection to AIDS. The rising pandemic of HIV and AIDS and high toxicity associated with anti-retroviral use are major factors that have compelled research to explore traditional herbal medicines as potential alternatives or supplements to anti-retroviral agents. A Phase I clinical trial was conducted on IMUNITI Wellness Pack, a herbal product with putative immune-modulating properties. The product is a combination of 7 herbal preparations, minerals, vitamins, and a specially formulated soya-maize meal porridge and a bottle of water purifier. The aim was to evaluate the safety and tolerability of IMUNITI, with a purpose of developing it for use in HIV-infected patients. The phase I study was conducted at the MRC clinic in Botha's hill and the study lasted 5 weeks from date of participant dosing. The study was a randomised blinded placebo-controlled phase I clinical trial conducted on 48 healthy males. The participants were randomly divided into 4 groups of 12. The 3 groups received different escalating doses of IMUNITI while the forth group received placebo tablets. Participants consumed IMUNITI daily for a period of 5 weeks. Assessments were done at baseline, week 1 and week 5 to determine the safety parameters in all participants. In this study, IMUNITI did not show any safety concerns. In all study participants, there were no significant changes above the upper limit of the reference ranges of the laboratory tests for full blood count, INR, renal and biochemical safety parameters. IMUNITI was well tolerated. Furthermore, the nutritional content analysis of IMUNITI showed that it is a high kilojoule, high protein content product which contains a mixture of sugars, vitamins, traces of calcium, phosphorus and minerals.
PMCID: PMC3746619  PMID: 23983351
HIV and AIDS; Immune booster; herbal product; traditional medicines
4.  Evaluation of Antiseizure Activity of Essential Oil from Roots of Angelica archangelica Linn. in Mice 
In the present study, the effect of essential oil of the root of Angelica archangelica Linn. was evaluated against electrically and chemically induced seizures. The seizures were induced in mice by maximal electroshock and pentylenetetrazol. The effect of essential oil of the root of Angelica archangelica on seizures was compared with standard anticonvulsant agents, phenytoin and diazepam. The essential oil of the root of Angelica archangelica suppressed duration of tonic convulsions and showed recovery in maximal electroshock induced seizures while it delayed time of onset of clonic convulsions and showed mortality protection in pentylenetetrazol induced seizures. The essential oil of the root of Angelica archangelica also produced motor impairment at the antiseizure doses. The study indicated that the essential oil exhibited antiseizure effect. The antiseizure effect may be attributed to the presence of terpenes in the essential oil.
doi:10.4103/0250-474X.70487
PMCID: PMC3003174  PMID: 21188050
Angelica archangelica (Umbelliferae); convulsions; pentylenetetrazol; medicinal plants; maximal electroshock
5.  Microbial Load and Antimicrobial Property of Two Nigerian Herbal Remedies 
The use of herbal remedies had increased significantly in the last one decade in Nigeria. This has led to the production of herbal products with bogus claims. The microbial quality and antibacterial properties of two Nigerian herbal remedies with such claimed efficacy of curing all manners of microbial diseases were assessed. The herbal remedies were discovered to be contaminated with the following microorganisms: Bacillus subtilis, Bacillus coagulans, Bacillus cereus, Basidiobotrytis sp, Oedocephalum sp, Varicosporium sp and Articulospora inflata. Antibacterial analysis using the killing rate revealed that the herbal remedies had bacteriostatic and not bacteriocidal effect. Qualitative phytochemical screening of the herbal remedies revealed the presence of saponin, tannins, alkaloids, anthraquinone and cardiac glycosides which suggest possible antimicrobial effect. However, the presence of microbial contaminants in the herbal remedies suggests that they may serve as source of infection to end users.
PMCID: PMC2816595  PMID: 20162058
Microbial; load; antibacterial; herbal; remedies
6.  Use of Herbal Products and Potential Interactions in Patients With Cardiovascular Diseases 
More than 15 million people in the United States consume herbal remedies or high-dose vitamins. The number of visits to providers of complementary and alternative medicine exceeds those to primary care physicians, for annual out-of-pocket costs of $30 billion. Use of herbal products forms the bulk of treatments, particularly by elderly persons who also consume multiple prescription medications for comorbid conditions, which increases the risk of adverse herb-drug-disease interactions. Despite the paucity of scientific evidence supporting the safety or efficacy of herbal products, their widespread promotion in the popular media and the unsubstantiated health care claims about their efficacy drive consumer demand. In this review, we highlight commonly used herbs and their interactions with cardiovascular drugs. We also discuss health-related issues of herbal products and suggest ways to improve their safety to better protect the public from untoward effects.
doi:10.1016/j.jacc.2009.07.074
PMCID: PMC2831618  PMID: 20152556
cardiovascular agents; complementary therapies; drug approval; herbal medicine; herb-drug interaction
7.  Hypoglycemic and anti-hyperglycemic activity of Guduchi Satva in experimental animals 
Ayu  2013;34(4):417-420.
Over the centuries, herbs have served as a major source of medicines for prevention and treatment of diseases including diabetes mellitus. These herbs are getting more importance around the globe and many studies have provided safety and efficacy of such herbal drugs in different condition. Guduchi (Tinospora cordifolia [Willd.] Miers) is reported as highly potent Pramehahara (anti-diabetic) herb in Ayurveda and Guduchi Satva (GS) is popularly used to treat Paittika type of Prameha. In the present study, GS prepared from the stem of T. cordifolia was evaluated for hypoglycemic and anti-hyperglycemic activity in 18 h fasted mice. GS was suspended in distilled water and administered to animals at the dose of 130 mg/kg that showed the marginal reduction in blood sugar level (BSL) at all the time intervals in normoglycemic mice. In anti-hyperglycemic activity, administration of GS prior to glucose over load failed to attenuate BSL at all-time interval in comparison to glucose control group. The study concludes that mild hypoglycemic insignificant anti-hyperglycemic activities of GS.
doi:10.4103/0974-8520.127726
PMCID: PMC3968707  PMID: 24695802
Guduchi Satva; anti-hyperglycemic; hypoglycemic
8.  A 90 day chronic toxicity study of Nigerian herbal preparation DAS-77 in rats 
Background
The herbal preparation DAS-77, used for the treatment of various ailments in Nigeria, contains the milled bark of Mangifera indica L. and root of Carica papaya L. Toxicological assessment of the preparation was carried out in this study.
Methods
In the acute toxicity study, DAS-77 was administered to mice p.o. up to 20 g/kg in divided doses and i.p. at 250–3000 mg/kg. Mortality within 24 h was recorded. In the chronic toxicity study, rats were treated p.o. for 90 days at doses of 80, 400 (therapeutic dose, TD) and 2000 mg/kg. By 90 days, animals were sacrificed and blood samples collected for hematological and biochemical analysis. Organs were harvested for weight determination, antioxidants and histopathological assessments.
Results
DAS-77 did not produce any lethality administered p.o. up to 20 g/kg in divided doses but the i.p. LD50 was 1122.0 mg/kg. At TD, DAS-77 produced significant (p < 0.05) reductions in body weight, food intake and K+, and increases in ovary weight, neutrophils and HDL, which were reversible. Histopathological presentations were generally normal. Effects at the other doses were comparable to those at TD except for reversible increases in antioxidants in the liver, kidney and testes, and sperm abnormality, and reductions in liver enzymes, sperm motility and count.
Conclusions
Findings in this study revealed that DAS-77 is relatively safe with the potential for enhancing in vivo antioxidant activity. However, possibly reversible side-effects include electrolyte imbalance and sterility in males.
doi:10.1186/1472-6882-12-79
PMCID: PMC3522554  PMID: 22892317
DAS-77; Herbal preparation; Toxicological assessment; Acute toxicity; Chronic toxicity
9.  Antimalarial Effects of Iranian Flora Artemisia sieberi on Plasmodium berghei In Vivo in Mice and Phytochemistry Analysis of Its Herbal Extracts 
Malaria Research and Treatment  2012;2012:727032.
The aim of this study is pharmacochemistry of Iranian flora Artemisia sieberi and its antimalarial effects on Plasmodium berghei in vivo. This is the first application of A. sieberi for treatment of murine malaria. A. sieberi were collected at flowering stage from the Khorassan and Semnan provinces of Iran; the aerial parts were air-dried at room temperature and then powdered. The powder was macerated in methanol, filtered with Bokhner hopper and solvent was separated in rotary evaporator. Total herbal extract was subsequently processed for ether and chloroform extracts preparation. The toxicity of herbal extract was assessed on naive NMRI mice with high, average and low doses; then pathophysiological signs were assessed. Finally, the antimalarial efficacy was investigated on two groups of Plasmodium berghei infected mice. Percentage of parasitaemia and pathophysiology were also evaluated. The results of this assessment showed no toxicity even by high concentration of herbal extract. A significant reduction in percentage of parasitaemia was observed; no alterations of hepatosplenomegaly and body weight were indicated in study group. A. sieberi extracts showed antimalarial effects against murine malaria with some efficacies on reducing pathophysiology. However, there is requirement to find the major component of this herbal extract by further studies.
doi:10.1155/2012/727032
PMCID: PMC3270465  PMID: 22315701
10.  Herbal Medicines: Can We Do Without Pharmacologist? 
The increase of herbal medicine use led many scientists to contribute to the research in this field. Also a few pharmacologists, after an initial phase of correct criticisms, today recognize the possibility of investigating the scientific value of medicinal products composed essentially of vegetable extracts. However, it is logical to pose the questions: (i) is there a role for the pharmacologist in herbal medicine (or phytotherapy)? (ii) can we do without pharmacologists’? First, two worlds—drug researchers (pharmacologists) and herbal medicines—yesterday appearing in opposition, are today closer and it is not unusual to read scientific works describing herbal extracts in journals traditionally dedicated to the study of synthetic drugs. Second, clinical application of herbal medicines is evaluable through the methods of modern clinical pharmacology. Efficacy and safety of medicinal plants represent naturally the object of interest for the pharmacologist and it is surely this aspect which gives the most important information on herbal medicine use. Many plants have been studied and results published showing, one time good or another poor, efficacy. Safety aspects of some of the most frequently used plants are now well known. For example, today we learn to use hypericum and we do not give it to patients taking other drugs because the interactions of hypericum with them. Contraindications of other plants, often represented by interactions with drugs, are finally known (Ginkgo biloba and drugs acting on blood coagulation). In conclusion, antagonistic behavior of pharmacologists versus herbal medicines is not useful. On the contrary, modern phytotherapy needs the contribution of researchers usually trained to evaluate efficacy and safety of medicinals.
doi:10.1093/ecam/nem095
PMCID: PMC2206237  PMID: 18227932
herbal medicines; herbal medicine; herbs; medicinal plants; phytotherapy
11.  Why is Research on Herbal Medicinal Products Important and How Can We Improve Its Quality? 
Research on herbal medicinal products is increasingly published in “Western” scientific journals dedicated primarily to conventional medicines. Publications are concerned mainly not only on the issues of safety and interactions, but also on efficacy. In reviews, a recurring complaint has been a lack of quality studies. In this opinion article, we present the case of Chinese herbal medicines as an example, as they have been extensively used in the global market and increasingly studied worldwide. We analyze the potential reasons for problems and propose some ways forward. As in the case of any drug, clinical trials for safety, efficacy, and/or effectiveness are the ultimate demonstration of therapeutic usefulness of herbal products. These will only make scientific sense when the tested herbal products are authentic, standardized, and quality controlled, if good practice guidelines of evidence-based medicine are followed, and if relevant controls and outcome measures are scientifically defined. Herbal products are complex mixtures, and for such complexity, an obvious approach for mechanistic studies is network pharmacology based on omic tools and approaches, which has already begun to revolutionize the study of conventional drugs, emphasizing networks, interactions, and polypharmacological features behind the action of many drugs.
doi:10.4103/2225-4110.124323
PMCID: PMC4032837  PMID: 24872927
Herbal medicinal products; Network pharmacology; Omic tools; Polypharmacology; Traditional chinese herbal medicines
12.  Herbal medicine use among urban residents in Lagos, Nigeria 
Background
Over three-quarter of the world's population is using herbal medicines with an increasing trend globally. Herbal medicines may be beneficial but are not completely harmless.
This study aimed to assess the extent of use and the general knowledge of the benefits and safety of herbal medicines among urban residents in Lagos, Nigeria.
Methods
The study involved 388 participants recruited by cluster and random sampling techniques. Participants were interviewed with a structured open- and close-ended questionnaire.
The information obtained comprises the demography and types of herbal medicines used by the respondents; indications for their use; the sources, benefits and adverse effects of the herbal medicines they used.
Results
A total of 12 herbal medicines (crude or refined) were used by the respondents, either alone or in combination with other herbal medicines. Herbal medicines were reportedly used by 259 (66.8%) respondents. 'Agbo jedi-jedi' (35%) was the most frequently used herbal medicine preparation, followed by 'agbo-iba' (27.5%) and Oroki herbal mixture® (9%). Family and friends had a marked influence on 78.4% of the respondents who used herbal medicine preparations. Herbal medicines were considered safe by half of the respondents despite 20.8% of those who experienced mild to moderate adverse effects.
Conclusions
Herbal medicine is popular among the respondents but they appear to be ignorant of its potential toxicities. It may be necessary to evaluate the safety, efficacy and quality of herbal medicines and their products through randomised clinical trial studies. Public enlightenment programme about safe use of herbal medicines may be necessary as a means of minimizing the potential adverse effects.
doi:10.1186/1472-6882-11-117
PMCID: PMC3252251  PMID: 22117933
13.  Risks and Benefits of Commonly used Herbal Medicines in México 
Toxicology and applied pharmacology  2007;227(1):125-135.
In Mexico, local empirical knowledge about medicinal properties of plants is the basis for their use as home remedies. It is generally accepted by many people in Mexico and elsewhere in the world that beneficial medicinal effects can be obtained by ingesting plant products. In this review, we focus on the potential pharmacologic bases for herbal plant efficacy, but we also raise concerns about the safety of these agents, which have not been fully assessed. Although numerous randomized clinical trials of herbal medicines have been published and systematic reviews and meta-analyses of these studies are available, generalizations about the efficacy and safety of herbal medicines are clearly not possible. Recent publications have also highlighted the unintended consequences of herbal product use, including morbidity and mortality. It has been found that many phytochemicals have pharmacokinetic or pharmacodynamic interactions with drugs. The present review is limited to some herbal medicine that are native or cultivated in Mexico and that have significant use. We discuss the cultural uses, phytochemistry, pharmacological and toxicological properties of the following following plant species: Nopal (Opuntia ficus), Peppermint (Mentha piperita), Chaparral (Larrea divaricata), Dandlion (Taraxacum officinale), Mullein (Verbascum densiflorum), Chamomile (Matricaria recutita), Nettle or Stinging Nettle (Urtica dioica), Passionflower (Passiflora incarmata), Linden Flower (Tilia europea), and Aloa (Aloa vera). We conclude that our knowledge of the therapeutic benefits and risks of some herbal medicines used in Mexico is still limited and efforts to elucidate them should be intensified.
doi:10.1016/j.taap.2007.10.005
PMCID: PMC2322858  PMID: 18037151
14.  Classic yin and yang tonic formula for osteopenia: study protocol for a randomized controlled trial 
Trials  2011;12:187.
Background
Osteoporosis is a growing worldwide problem, with the greatest burden resulting from fractures. Nevertheless, the majority of fractures in adults occur in those with "osteopenia" (bone mineral density (BMD) only moderately lower than young normal individuals). Since long-term drug therapy is an expensive option with uncertain consequences and side effects, natural herbal therapy offers an attractive alternative. The purpose of this study is to evaluate the effect on BMD and safety of the Classic Yin and Yang Tonic Formula for treatment of osteopenia and to investigate the mechanism by which this efficacy is achieved.
Methods/design
We propose a multicenter double-blind randomized placebo-controlled trial to evaluate the efficacy and safety of the Classic Yin and Yang Tonic Formula for the treatment of osteopenia. Participants aged 55 to 75 with low bone mineral density (T-score between -1 and -2.5) and kidney deficiency in TCM will be included and randomly allocated into two groups: treatment group and control group. Participants in the treatment group will be treated with Classic Yin and Yang Tonic Granule, while the controlled group will receive placebo. Primary outcome measure will be BMD of the lumbar spine and proximal femur using dual-energy X-ray absorptiometry. Secondary outcomes will include pain intensity measured with visual analogue scales, quality of life, serum markers of bone metabolism, indices of Neuro-endocrino-immune network and safety.
Discussion
If the Classic Yin and Yang Tonic Formula can increase bone mass without adverse effects, it may be a novel strategy for the treatment of osteoporosis. Furthermore, the mechanism of the Chinese medical formula for osteoporosis will be partially elucidated.
Trial registration
This study is registered at ClinicalTrials.gov, NCT01271647.
doi:10.1186/1745-6215-12-187
PMCID: PMC3170217  PMID: 21806837
15.  Use of Herbal Treatments in Pregnancy 
American journal of obstetrics and gynecology  2010;202(5):439.e1-439.e10.
Objective
Interest in herbal treatments has increased without data on safety, efficacy, or rates of use in pregnancy. We examined antenatal herbal and natural product use among mothers of nonmalformed infants in five geographic centers.
Study Design
We used data on nonmalformed infants from the Slone Epidemiology Center’s case-control surveillance program for birth defects to examine rates and predictors of herbal use. Exposures were identified through maternal interview. In addition to overall use, five categories based on traditional uses and two natural product categories were created; topical products and herbal-containing mulitivitamins were excluded.
Results
Among 4,866 mothers of nonmalformed infants, 282 (5.8%) reported use of herbal or natural treatments. Use varied by study center, and increased with increasing age.
Conclusion
Although rates of use are low, there remains a need for investigation of the safety of these products. Given sparse data on efficacy, even small risks might well outweigh benefits.
doi:10.1016/j.ajog.2010.01.055
PMCID: PMC2867842  PMID: 20452484
complementary medicine; drug safety; herbal treatments; pregnancy
16.  Periplasmic protein related to the sn-glycerol-3-phosphate transport system of Escherichia coli. 
Journal of Bacteriology  1976;126(2):951-958.
Two-dimensional gel electrophoresis of shock fluids of Escherichia coli K-12 revealed the presence of a periplasmic protein related to sn-glycerol-3-phosphate transport (GLPT) that is under the regulation of glpR, the regulatory gene of the glp regulon. Mutants selected for their resistance to phosphonomycin and found to be defective in sn-glycerol-3-phosphate transport either did not produce GLPT or produced it in reduced amounts. Other mutations exhibited no apparent effect of GLPT. Transductions of glpT+ nalA phage P1 into these mutants and selection for growth on sn-glycerol-3-phosphate revealed a 50% cotransduction frequency to nalA. Reversion of mutants taht did not produce GLPT to growth on sn-glycerol-3-phosphate resulted in strains that produce GLPT. This suggests a close relationship of GLPT to the glpT gene and to sn-glycerol-3-phosphate transport. Attempts to demonstrate binding activity of GLPT in crude shock fluid towards sn-glycerol-3-phosphate have failed so far. However, all shock fluids, independent of their GLPT content, exhibited an enzymatic activity that hydrolyzes under the conditions of the binding assay, 30 to 60% of the sn-glycerol-3-phosphate to glycerol and inorganic orthophosphate.
Images
PMCID: PMC233233  PMID: 770459
17.  Herbal Medicine in the United States: Review of Efficacy, Safety, and Regulation 
Introduction
Herbal products have gained increasing popularity in the last decade, and are now used by approximately 20% of the population. Herbal products are complex mixtures of organic chemicals that may come from any raw or processed part of a plant, including leaves, stems, flowers, roots, and seeds. Under the current law, herbs are defined as dietary supplements, and manufacturers can therefore produce, sell, and market herbs without first demonstrating safety and efficacy, as is required for pharmaceutical drugs. Although herbs are often perceived as “natural” and therefore safe, many different side effects have been reported owing to active ingredients, contaminants, or interactions with drugs.
Results
Unfortunately, there is limited scientific evidence to establish the safety and efficacy of most herbal products. Of the top 10 herbs, 5 (ginkgo, garlic, St. John’s wort, soy, and kava) have scientific evidence suggesting efficacy, but concerns over safety and a consideration of other medical therapies may temper the decision to use these products.
Conclusions
Herbal products are not likely to become an important alternative to standard medical therapies unless there are changes to the regulation, standardization, and funding for research of these products.
doi:10.1007/s11606-008-0632-y
PMCID: PMC2517879  PMID: 18415652
herbal medicine; efficacy; safety; regulation
18.  A “reverse pharmacology” approach for developing an anti-malarial phytomedicine 
Malaria Journal  2011;10(Suppl 1):S8.
A “reverse pharmacology” approach to developing an anti-malarial phytomedicine was designed and implemented in Mali, resulting in a new standardized herbal anti-malarial after six years of research. The first step was to select a remedy for development, through a retrospective treatment-outcome study. The second step was a dose-escalating clinical trial that showed a dose-response phenomenon and helped select the safest and most efficacious dose. The third step was a randomized controlled trial to compare the phytomedicine to the standard first-line treatment. The last step was to identify active compounds which can be used as markers for standardization and quality control. This example of “reverse pharmacology” shows that a standardized phytomedicine can be developed faster and more cheaply than conventional drugs. Even if both approaches are not fully comparable, their efficiency in terms of public health and their complementarity should be thoroughly considered.
doi:10.1186/1475-2875-10-S1-S8
PMCID: PMC3059466  PMID: 21411019
19.  Flor-Essence® herbal tonic does not inhibit estrogen receptor negative mammary tumor development in a transgenic mouse model 
Journal of complementary & integrative medicine  2011;8:10.2202/1553-3840.1157.
Women who are diagnosed with breast cancer often self-administer complementary and alternative medicines to augment their conventional treatments, improve health, or prevent recurrence. Flor-Essence® herbal tonic is a complex mixture of eight herbal extracts used by cancer patients because of anecdotal evidence that it can treat or prevent disease. In this study four experimental groups of female MMTV-Neu mice were left untreated or treated with 3% Flor-Essence® in utero, from birth until 5 weeks of age, or throughout their lifetime. Palpable mammary tumor incidence and body weight was determined weekly for each group. The mice were sacrificed at 28 weeks of age and mammary tumors were enumerated to determine average tumor incidence and multiplicity for each group. Female mice exposed to Flor-Essence® herbal tonic in utero weighed significantly more than the control group (p < 0.001). The average tumor incidence and tumor multiplicity in the experimental mice treated with Flor-Essence® herbal tonic did not differ from the control animals. Flor-Essence® does not inhibit mammary tumor incidence or mammary tumor multiplicity in MMTV-Neu transgenic mice. Flor-Essence® exposure in utero causes increased body weight in experimental animals. This conclusion challenges widely available anecdotal information as well as the hopes of the consumer that this product will inhibit or suppress tumor development.
Lay Abstract
Flor-Essence® herbal tonic is a complex mixture of eight herbal extracts often used by women with breast cancer in hopes that it will help cure disease or prevent recurrence. There is currently very little scientific data to support or refute its self-administration. We tested whether Flor-Essence® would influence tumor development in the mammary glands of a mouse model of Her2/neu breast cancer. The tonic was given at different life stages to determine if timing of the exposure influenced the response to treatment. This report shows that Flor-Essence® did not inhibit mammary tumor development in the treated mice challenging anecdotal information, as well as the hopes of the consumer, that this product will inhibit or suppress tumor development. This report also shows that Flor-Essence® exposure in utero causes increased body weight in experimental animals.
PMCID: PMC3518418  PMID: 22754942
complementary and alternative medicine; MMTV-Neu; herbal tonic; mammary tumors; transgenic; mouse; dietary supplement; essiac
20.  Safety, tolerability, and immunologic effects of a food allergy herbal formula in food allergic individuals: a randomized, double-blinded, placebo-controlled, dose escalation, phase 1 study 
Background
Food allergy is a common and serious health problem. A new herbal product, called food allergy herbal formula 2 (FAHF-2), has been demonstrated to have a high safety profile and potent long-term efficacy in a murine model of peanut-induced anaphylaxis.
Objective
To evaluate the safety and tolerability of FAHF-2 in patients with food allergy.
Methods
In this randomized, double-blinded, placebo-controlled, dose escalation, phase 1 trial, patients received 1 of 3 doses of FAHF-2 or placebo: 2.2 g (4 tablets), 3.3 g (6 tablets), or 6.6 g (12 tablets) 3 times a day for 7 days. Four active and 2 placebo patients were treated at each dose level. Vital signs, physical examination results, laboratory data, pulmonary function test results, and electrocardiogram data were monitored. Immunomodulatory studies were also performed.
Results
Nineteen food allergic participants were included in the study. Two patients (1 in the FAHF-2 group and 1 in the placebo group) reported mild gastrointestinal symptoms. One patient withdrew from the study because of an allergic reaction that was unlikely related to the study medication. No significant differences were found in vital signs, physical examination results, laboratory data, pulmonary function test results, and electrocardiogram data obtained before and after treatment visits. Significantly decreased interleukin (IL) 5 levels were found in the active treatment group after 7 days. In vitro studies of peripheral blood mononuclear cells cultured with FAHF-2 also demonstrated a significant decrease in IL-5 and an increase in culture supernatant interferon γ and IL-10 levels.
Conclusions
FAHF-2 appeared to be safe and well tolerated in patients with food allergy.
doi:10.1016/j.anai.2010.05.005
PMCID: PMC3026589  PMID: 20642207
21.  DNA barcoding detects contamination and substitution in North American herbal products 
BMC Medicine  2013;11:222.
Background
Herbal products available to consumers in the marketplace may be contaminated or substituted with alternative plant species and fillers that are not listed on the labels. According to the World Health Organization, the adulteration of herbal products is a threat to consumer safety. Our research aimed to investigate herbal product integrity and authenticity with the goal of protecting consumers from health risks associated with product substitution and contamination.
Methods
We used DNA barcoding to conduct a blind test of the authenticity for (i) 44 herbal products representing 12 companies and 30 different species of herbs, and (ii) 50 leaf samples collected from 42 herbal species. Our laboratory also assembled the first standard reference material (SRM) herbal barcode library from 100 herbal species of known provenance that were used to identify the unknown herbal products and leaf samples.
Results
We recovered DNA barcodes from most herbal products (91%) and all leaf samples (100%), with 95% species resolution using a tiered approach (rbcL + ITS2). Most (59%) of the products tested contained DNA barcodes from plant species not listed on the labels. Although we were able to authenticate almost half (48%) of the products, one-third of these also contained contaminants and or fillers not listed on the label. Product substitution occurred in 30/44 of the products tested and only 2/12 companies had products without any substitution, contamination or fillers. Some of the contaminants we found pose serious health risks to consumers.
Conclusions
Most of the herbal products tested were of poor quality, including considerable product substitution, contamination and use of fillers. These activities dilute the effectiveness of otherwise useful remedies, lowering the perceived value of all related products because of a lack of consumer confidence in them. We suggest that the herbal industry should embrace DNA barcoding for authenticating herbal products through testing of raw materials used in manufacturing products. The use of an SRM DNA herbal barcode library for testing bulk materials could provide a method for 'best practices? in the manufacturing of herbal products. This would provide consumers with safe, high quality herbal products.
doi:10.1186/1741-7015-11-222
PMCID: PMC3851815  PMID: 24120035
22.  The growing use of herbal medicines: issues relating to adverse reactions and challenges in monitoring safety 
The use of herbal medicinal products and supplements has increased tremendously over the past three decades with not less than 80% of people worldwide relying on them for some part of primary healthcare. Although therapies involving these agents have shown promising potential with the efficacy of a good number of herbal products clearly established, many of them remain untested and their use are either poorly monitored or not even monitored at all. The consequence of this is an inadequate knowledge of their mode of action, potential adverse reactions, contraindications, and interactions with existing orthodox pharmaceuticals and functional foods to promote both safe and rational use of these agents. Since safety continues to be a major issue with the use of herbal remedies, it becomes imperative, therefore, that relevant regulatory authorities put in place appropriate measures to protect public health by ensuring that all herbal medicines are safe and of suitable quality. This review discusses toxicity-related issues and major safety concerns arising from the use of herbal medicinal products and also highlights some important challenges associated with effective monitoring of their safety.
doi:10.3389/fphar.2013.00177
PMCID: PMC3887317  PMID: 24454289
herbal medicines; adverse reactions; monitoring safety; challenges; public health
23.  Normal acute behavioral responses to moderate/high dose ethanol in GABAA receptor α̣4 subunit knockout mice 
Background
γ-Aminobutyric acid type A receptors (GABAA-Rs) have been implicated in mediating some of the behavioral effects of ethanol (EtOH), but the contribution of specific GABAA-R subunits is not fully understood. The GABAA-R α4 subunit often partners with β2/3 and δ subunits to form extrasynaptic GABAA-Rs that mediate tonic inhibition. Several in vitro studies have suggested that these extrasynaptic GABAA-Rs may be particularly relevant to the intoxicating effects of low doses of EtOH. In α4 subunit knockout mice tonic inhibition was greatly reduced, as were the potentiating effects of EtOH. We therefore hypothesized that those behavioral responses to EtOH that are mediated by α4-containing GABAA-Rs would be diminished in α4 knockout mice.
Methods
We investigated behavioral responses to acute administration of moderate/high dose EtOH or pentylenetetrazol in α4 subunit knockout mice. We compared behavioral responses to EtOH in α4 knockout and wild type littermates in the elevated plus maze (0.0, 1.0 g/kg EtOH), screen test (1.5, 2.0 g/kg), hypothermia (1.5, 2.0 g/kg), fixed speed rotarod (1.5, 2.0. 2.5 g/kg), open field (0.0, 1.0, 2.0 g/kg), radiant tail flick (2.0 g/kg), loss of righting reflex (3.5 g/kg), and EtOH metabolism and clearance assays. Sensitivity to pentylenetetrazol-induced seizures was also analyzed.
Results
No differences were observed between α4 knockout mice and wild type controls in terms of the baseline behavior in the absence of EtOH treatment or in the behavioral effects of EtOH in the assays tested. In contrast, α4 knockout mice were significantly more sensitive to pentylenetetrazol-induced seizures.
Conclusions
We conclude that GABAA-Rs containing the α4 subunit are not absolutely required for the acute behavioral responses to moderate/high dose EtOH that were assessed with the elevated plus maze, screen test, hypothermia, fixed speed rotarod, open field, radiant tail flick, and loss of right reflex assays. We further suggest that these findings are complicated by the demonstrated compensatory alterations in synaptic GABAA-R EtOH sensitivity and function in α4 knockout mice.
doi:10.1111/j.1530-0277.2007.00563.x
PMCID: PMC2896280  PMID: 18076749
GABA; GABA type A receptor; gene knockout mice; alcohol; extrasynaptic receptors
24.  Does Oral Ingestion of Piper sarmentosum Cause Toxicity in Experimental Animals? 
The prevalence of diabetes mellitus has reached epidemic proportion in Malaysia and worldwide. Scientific studies have shown that herbal plant Piper sarmentosum exhibits an antidiabetic property. Despite the extensive usage and studies of this herb as alternative medicine, there is paucity of the literature on the safety information of this plant. Thus, the present study aimed to observe the subacute toxic effects of Piper sarmentosum aqueous extract (PSAE) on the haematological profile, liver, and kidney in rats. The extract was administered by oral gavage to 6 male and female Sprague Dawley rats in daily dose of 50 mg/kg, 300 mg/kg, and 2000 mg/kg for 28 consecutive days. The control group received normal saline. General behavior of the rats, adverse effects, and mortality were observed for 28 days. The haematological and biochemical parameters were determined at baseline and after the treatment. PSAE did not show abnormality on the body weight and gross observation of internal organs. The haematological, biochemical and histopathological profiles showed minimal changes and variation within normal clinical range except for significant increase in serum potassium level that suggests the need of regular monitoring. Nevertheless, these findings suggested that PSAE up to 2000 mg/kg/day did not show subacute toxicity in Sprague Dawley rats.
doi:10.1155/2013/705950
PMCID: PMC3817794  PMID: 24228062
25.  Phytochemical and Pharmacological Properties of Gymnema sylvestre: An Important Medicinal Plant 
BioMed Research International  2014;2014:830285.
Gymnema sylvestre (Asclepiadaceae), popularly known as “gurmar” for its distinct property as sugar destroyer, is a reputed herb in the Ayurvedic system of medicine. The phytoconstituents responsible for sweet suppression activity includes triterpene saponins known as gymnemic acids, gymnemasaponins, and a polypeptide, gurmarin. The herb exhibits a broad range of therapeutic effects as an effective natural remedy for diabetes, besides being used for arthritis, diuretic, anemia, osteoporosis, hypercholesterolemia, cardiopathy, asthma, constipation, microbial infections, indigestion, and anti-inflammatory. G. sylvestre has good prospects in the treatment of diabetes as it shows positive effects on blood sugar homeostasis, controls sugar cravings, and promotes regeneration of pancreas. The herbal extract is used in dietary supplements since it reduces body weight, blood cholesterol, and triglyceride levels and holds great prospects in dietary as well as pharmacological applications. This review explores the transition of a traditional therapeutic to a modern contemporary medication with an overview of phytochemistry and pharmacological activities of the herb and its phytoconstituents.
doi:10.1155/2014/830285
PMCID: PMC3912882  PMID: 24511547

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