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At least 19 recordsLinked to original sources

Different standards for reporting ADRs to herbal remedies and conventional OTC medicines: face-to-face interviews with 515 users of herbal remedies.

AIMS: To determine whether adverse drug reactions (ADRs) to herbal remedies would be reported differently from similar ADRs to conventional over-the-counter (OTC) medicines by herbal-remedy users. METHODS: Face-to-face interviews (using a structured questionnaire) with 515 users of herbal remedies were conducted in six pharmacy stores and six healthfood stores in the UK. The questionnaire focused on the likely course of action taken by herbal-remedy users after experiencing an ADR associated with a conventional OTC medicine and a herbal remedy. RESULTS: Following a 'serious' suspected ADR, 156 respondents (30.3%) would consult their GP irrespective of whether the ADR was associated with the use of a herbal remedy or a conventional OTC medicine, whereas 221 respondents (42.9%) would not consult their GP for a serious ADR associated with either type of preparation. One hundred and thirty-four respondents (26.0%) would consult their GP for a serious ADR to a conventional OTC medicine, but not for a similar ADR to a herbal remedy, whereas four respondents (0.8%) would consult their GP for a serious ADR to a herbal remedy, but not for a similar ADR to a conventional OTC medicine. Similar differences were found in attitudes towards reporting 'minor' suspected ADRs. CONCLUSIONS: Consumers of herbal remedies would act differently with regard to reporting an ADR (serious or minor) to their GP depending on whether it was associated with a herbal remedy or a conventional OTC medicine. This has implications for herbal pharmacovigilance, particularly given the increasing use of OTC herbal remedies. The finding that a high proportion of respondents would not consult their GP or pharmacist following ADRs to conventional OTC medicines is also of concern.

Adult↗

Evaluation of the ability of seven herbal resources to answer questions about herbal products asked in drug information centers.

STUDY OBJECTIVE: To evaluate the ability of seven widely known herbal references and electronic databases to answer questions about herbal products asked at drug information centers. DESIGN: Cross-sectional study. SETTING: Five academic and institutional drug information centers. METHODS: Fifty-seven herbal-related questions were obtained from academic and institutional drug information centers. Seven herbal references and electronic databases were evaluated for their ability to answer these 57 questions: The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines, 1st edition; Physicians' Desk Reference (PDR) for Herbal Medicines, 2001 edition; Tyler's Honest Herbal: A Sensible Guide to the Use of Herbs and Related Remedies, 4th edition; The Lawrence Review of Natural Products, 2001; Natural Medicines Comprehensive Database (electronically updated, 2001); The Natural Pharmacist (electronically updated, 2001); and AltMedDex (electronically updated, 2001). RESULTS: Natural Medicines Comprehensive Database outperformed all other products evaluated, providing direct answers to 61% of questions. AltMedDex and The Natural Pharmacist performed similarly to one another, answering 49% and 44% of questions, respectively. The Lawrence Review of Natural Products, PDR for Herbal Medicines, The Complete German Commission E Monographs, and Tyler's Honest Herbal were the least helpful in providing direct answers to the questions (24%, 21%, 11%, and 9%, respectively). CONCLUSION: Natural Medicines Comprehensive Database, AltMedDex, and The Natural Pharmacist outperformed all other evaluated herbal references and electronic databases in their ability to answer questions about herbal products posed in clinical practice.

Cross-Sectional Studies↗

An evaluation of selected herbal reference texts and comparison to published reports of adverse herbal events.

OBJECTIVE: There has been a recent proliferation of medical reference texts intended to guide practitioners whose patients use herbal therapies. We systematically assessed six herbal reference texts to evaluate the information they contain on herbal toxicity. METHODS: We selected six major herbal references published from 1996 to 2000 to evaluate the adequacy of their toxicological information in light of published adverse events. To identify herbs most relevant to toxicology, we reviewed herbal-related calls to our regional California Poison Control System, San Francisco division (CPCS-SF) in 1998 and identified the 12 herbs (defined as botanical dietary supplements) most frequently involved in these CPCS-SF referrals. We searched Medline (1966 to 2000) to identify published reports of adverse effects potentially related to these same 12 herbs. We scored each herbal reference text on the basis of information inclusiveness for the target 12 herbs, with a maximal overall score of 3. RESULTS: The herbs, identified on the basis of CPCS-SF call frequency were: St John's wort, ma huang, echinacea, guarana, ginkgo, ginseng, valerian, tea tree oil, goldenseal, arnica, yohimbe and kava kava. The overall herbal reference scores ranged from 2.2 to 0.4 (median 1.1). The Natural Medicines Comprehensive Database received the highest overall score and was the most complete and useful reference source. All of the references, however, lacked sufficient information on management of herbal medicine overdose, and several had incorrect overdose management guidelines that could negatively impact patient care. CONCLUSION: Current herbal reference texts do not contain sufficient information for the assessment and management of adverse health effects of botanical therapies.

Drug Evaluation↗

Survey of herbal use by Kansas and Wisconsin WIC participants reveals moderate, appropriate use and identifies herbal education needs.

OBJECTIVE: To examine herbal use by a sample of low-income, nutritionally vulnerable children. DESIGN: Caregivers completed a survey of child and caregiver herbal usage practices. SUBJECTS/SETTING: A convenience sample of 2,562 caregivers to children participating in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) in Kansas and Wisconsin who were attending a WIC clinic was selected. WIC project selection was random, with stratification for geographic and ethnic representation. STATISTICAL ANALYSES PERFORMED: Herbal usage profiles were described with measures of central tendency. Groups were compared with a two-tailed independent t test and chi2 for continuous and categorical variables, respectively. RESULTS: Child herbal use was reported on 917 surveys, representing 1,363 children ranging in age from 1 week to 17.5 years; 820 were younger than age 5 years. Herb use was greater among Latino children (48.4% vs 31.4%) and caregivers (43.4% vs 37.2%). Caregivers had a mean age of 27.8+/-8.32 years and 38.8% (n=994) denoted using herbs. Herbs most commonly used by children were aloe vera, chamomile, garlic, peppermint, lavender, cranberry, ginger, echinacea, and lemon. Reasons for herbal use paralleled recommendations. Family (78.9%) and friends (32.9%) were predominant information sources. Herbs with safety issues, such as St John's wort, dong quai, and kava were used. Herbal use characteristics did not differ between states, but were unique for Latino clients. CONCLUSIONS: Herbal use by WIC children is mostly congruent with known indications; however, practices with potential to harm urge herbal education in WIC clinics, especially for Latinos.

Adolescent↗

Herbal supplements and skin testing: the lack of effect of commonly used herbal supplements on histamine skin prick testing.

BACKGROUND: The use of herbal supplements is common, yet little is known about their pharmacologic properties. The purpose of this study was to assess the effects of 23 commonly used herbal supplements on histamine skin prick testing (SPT). METHODS: Fifteen healthy volunteers participated in a double-blind, placebo-controlled, single-dose, crossover study. Wheal and flare responses to SPT with histamine phosphate (1 mg/ml) were measured before and 4 h after administration of each of the 23 popular herbal supplements, fexofenadine (60 mg) and placebo. Wheal and flare areas were recorded with tracings performed 10 min after the prick test and measured with a PC-digitizer using stereometric software. RESULTS: Fexofenadine significantly suppressed the wheal (P < 0.001) and flare (P = 0.02) areas compared with placebo. None of the herbal supplements caused significant suppression of the wheal and flare areas compared with placebo (P > 0.10). CONCLUSION: When taken in single-doses, the popular herbal supplements tested did not significantly affect the histamine skin response. Therefore, it seems unnecessary for clinicians to ask patients to discontinue these herbal supplements prior to allergy skin testing.

Cross-Over Studies↗

When is it herbal intoxication? A retrospective study of children admitted with herbal intoxication at Umtata General Hospital, South Africa.

OBJECTIVE: To establish the profile and fate of children admitted with a "herbal intoxication" label. DESIGN: Retrospective cross sectional study of records for all children admitted with "herbal intoxication" for the years 1998 to 2001 inclusive. SETTING: The Paediatrics Department at Umtata General Hospital, the main teaching hospital for the University of Transkei Faculty of Health Sciences. MAIN OUTCOME MEASURES: Demographic profile, herbal medication history and clinical progress and fate of children admitted with "herbal intoxication". RESULTS: There were 156 case records for the period under review. The age range was a few days to 12 years, being neonates 30 (19.2%); one to six months, 77 (49.4%); seven months to one year 34 (21.8%); one to five years, 11 (7.0%); five years and older, four (2.6%). The reasons for giving the herbal preparations were stated in only 52 cases (33.3%), of which five were for diarrhoea and vomiting, four for constipation and abdominal pain, three to change stool colour, and 41 for "playte" (generic term given to all types of ill health). The preparations were administered orally (n=95), by enema (n=12), and both orally and by enema (n= 12), while route of administration was not stated in 37 of the cases. Sixty eight (43.6%) of the children died, 84 (53.8%) improved, while the fate of four (2.6%) was not indicated. Most of the deaths (63.2%) were among the zero to six months age group, and most deaths occurred within two days of admission. The average duration of stay (days) in hospital was 2.94 +/- 0.65 (range 1 to 39) for the group that succumbed and 8.88 +/- 0.73 (range 1 to 40) for the survivors (p < 0.001). CONCLUSION: There is a high mortality rate among children admitted with suspicion of herbal intoxication, and there is need to manage such children with vigilance.

Child↗

Effect of herbal medicine Saiko-keishi-to (TJ-10) on rat spontaneous chronic pancreatitis: comparison with other herbal medicines.

BACKGROUND: In an attempt to obtain evidence of the beneficial effects of TJ-10, we investigated the gene expression of PAP, an acute phase protein specific for pancreatitis in rat spontaneous chronic pancreatitis. METHODS: Four-wk-old male WBN/Kob rats were fed with MB-3 pellet diet containing herbal medicine. There were two administration groups for each drug: the prophylactic group administered from 4-12 wk, and the therapeutic group administered from 12-20 wk. Untreated control rats were fed with MB-3 alone. Histopathologic changes and PAP gene expressions were analyzed at 12 and 20 wk. RESULTS: In the prophylactic group, TJ-10-treated WBN/Kob rats showed no evidence of pancreatitis, and there was the amelioration of pancreatitis in the pancreata of the rats treated with other herbal medicines except TJ-24 at 12 wk. PAP mRNA was not expressed in the TJ-10-treated rats, and PAP gene expression was suppressed in rats treated with other drugs except TJ-107. In the therapeutic group, the amelioration of pancreatitis was seen only in TJ-10-treated rats, but PAP gene expression was significantly suppressed in the rats treated with all herbal medicines tested, compared with that in untreated control rats. CONCLUSION: An herbal medicine Saiko-keishi-to (TJ-10) delayed the onset of chronic pancreatitis in the WBN/Kob rat, and suppressed the pancreatitis-associated protein (PAP) gene expression more significantly than other herbal medicines.

Acute-Phase Proteins↗

[Profiles of effects of traditional oriental herbal medicines on central nervous systems in humans--assessment of saiboku-to and saiko-ka-ryukotsu-borei-to using EEG and pharmacokinetics of herbal medicine-derived ingredients as indices].

To elucidate usefulness of traditional oriental herbal medicines in psychiatric fields, we investigated their influences on central nervous systems in humans by using EEG and pharmacokinetics of herbal medicine-derived ingredients as the indices. The subjects were 12 healthy male volunteers who received single oral administration and after that received repeated oral administrations at a daily dose of Saiko-ka-ryukotsu-borei-to or Saiboku-to; EEG was recorded before administration, 1, 3, 6 hours and 10 days after administration. On direct comparison of global field powers calculated from 19-lead EEG before and after administration, it was verified that Saiboku-to possessed effects on central nervous systems. For assessment of pharmacokinetics of ingredients derived from Saiboku-to, pre- and post-treatment serum samples were assayed by HPLC and two ingredients were detected, besides individual differences being observed in their pharmacokinetic profiles. Given that these pharmacokinetics could be interpreted as the phenomena associated with Sho (traditional physical status classifications of patients), the subjects were classified into groups according to individual differences whereby quantitative pharmaco-EEG were employed to elucidate neurotropic effects of Saiboku-to. As the result, following two groups were evidenced: (1) a group demonstrating the mood elevator type after a single administration despite of no changes after repeated administrations, and (2) a group with a shift from the mood elevator type to the nootropics type being observed over time, delineating overt differences in EEG profiles among groups. Consequently, individual differences were evidenced to be involved in onset of neurotropic effects of Saiboku-to, permitting prediction of possible responses following repeated administrations by using EEG profiles. It was also suggested that neurotropic effects of respective ingredients could be anticipated by monitoring the time-course changes of both EEG and plasma levels of these ingredients. In summary, once further studies on oriental herbal medicines might progress based on efficacy assessments of respective ingredients with a clue of the present study, it is conceivable that these findings would play an important role as the objective indices in clinical application of herbal medicines in psychiatric fields, resulting in broadening the usefulness of oriental herbal medicines.

Adult↗

Intellectual property protection in the natural product drug discovery, traditional herbal medicine and herbal medicinal products.

Traditional medicine is an important part of human health care in many developing countries and also in developed countries, increasing their commercial value. Although the use of medicinal plants in therapy has been known for centuries in all parts of the world, the demand for herbal medicines has grown dramatically in recent years. The world market for such medicines has reached US $ 60 billion, with annual growth rates of between 5% and 15%. Researchers or companies may also claim intellectual property rights over biological resources and/or traditional knowledge, after slightly modifying them. The fast growth of patent applications related to herbal medicine shows this trend clearly. This review presents the patent applications in the field of natural products, traditional herbal medicine and herbal medicinal products. Medicinal plants and related plant products are important targets of patent claims since they have become of great interest to the international drug and cosmetic industry.

Herbal Medicine↗

Immunologic enhancement of compound Chinese herbal medicinal ingredients and their efficacy comparison with compound Chinese herbal medicines.

Two compound Chinese herbal medicinal ingredients (cCIs) were prepared respectively with epimedium polysaccharide (EPS) plus propolis flavone (PF) and astragalus polysaccharide (APS) plus ginsenoside (GS). Also, two compound Chinese herbal medicines (cCMs) with the same ingredient content as corresponding cCIs were made with the extracts of epimedium plus propolis and astragalus plus ginseng. In rabbit immune trial, two cCIs, physiological saline in the control, were respectively injected to the rabbits vaccinated with inactivated rabbit hemorrhagic disease vaccine. On Days 3, 7, 10, 14, 21, 28, 35 and 42 after vaccination, the dynamic changes of serum antibody titers were determined by hemagglutination inhibition (HI) test. In chicken immune trial, all of cCIs and cCMs were mixed respectively with inactivated Newcastle disease vaccine virus to vaccinate chickens, taking oil-adjuvant and non-adjuvant vaccine as controls. On Days 7, 14, 21, 28, 35 and 42 after vaccination, the dynamic changes of peripheral lymphocyte proliferation and serum antibody titers were tested respectively by MTT method and HI test method. The results showed that both cCIs could significantly raise antibody titer in rabbits, which the effect of compound Chinese herbal medicinal ingredients 1 (cCIs 1) was better than that of compound Chinese herbal medicinal ingredients 2 (cCIs 2). All of cCIs and cCMs could markedly promote lymphocyte proliferation and enhance antibody titer in chickens, which was similar to oil adjuvant, the immunologic enhancement of cCIs were slightly superior to that of the cCMs.

Adjuvants, Immunologic↗

Effects of topical instillation of traditional herbal medicines, herbal extracts, and their components on prostaglandin E2-induced aqueous flare elevation in pigmented rabbits.

PURPOSE: To evaluate the effect of topical instillation of traditional herbal medicines, herbal extracts, and their components on the elevation of aqueous flare induced by prostaglandin E(2) (PGE(2)) in pigmented rabbits. METHODS: Transcorneal diffusion of 25 micro g/mL of PGE(2) was carried out through a glass cylinder placed on the cornea to induce aqueous flare elevation in pigmented rabbits. Traditional herbal medicines, herbal extracts, and their components were topically instilled before the PGE(2) application. Aqueous flare was measured with a laser flare-cell meter. RESULTS: Two instillations, 60 and 30 minutes before PGE(2), of Kakkon-to, Sairei-to, Orengedoku-to, Senkanmeimoku-to, Scutellariae radix extract, Coptidis rhizoma extract, Gardeniae fructus extract, Phellodendri cortex extract, baicalein, baicalin, wogonin, crocetin, berberine, or glycyrrhizine did not inhibit the elevation induced by PGE(2). Two instillations, 60 and 30 minutes before PGE(2), of a Ligusticum wallichii extract (100 mg/mL) inhibited the elevation by 20%. Two instillations (5 and 3 hours before PGE(2)) of baicalein (1 mg/mL) or baicalin (5 mg/mL) inhibited the elevation by 16% and 24%, respectively. Two instillations, 5 and 3 hours before PGE(2), of wogonin, crocetin, berberine, or glycyrrhizine did not inhibit the elevation. CONCLUSION: Two instillations of Ligusticum wallichii extract 60 and 30 minutes before the PGE(2), and two instillations of baicalein or baicalin, 5 and 3 hours before the PGE(2), inhibited the PGE(2)-induced aqueous flare elevation in pigmented rabbits.

Administration, Topical↗

Herbal supplements: Facts and myths--talking to your patients about herbal supplements.

The use of herbal supplements in the United States is steadily growing and raises concerns about safety, efficacy, and how they affect safe patient care. The direct health risks associated with herbal supplements include hypertension, prolonged bleeding, and the potential for drug-herb interactions. These potential drug interactions are of particular concern for patients undergoing anesthesia. This article provides a review of literature on the 10 most popular herbal supplements and addresses the herbal supplements' reported use, possible adverse effect(s), patient teaching, possible drug interaction(s), and recommendations regarding discontinuation before surgery.

Androgen Antagonists↗

Characterization of commercial kava-kava herbal drug and herbal drug preparations by means of nuclear magnetic resonance spectroscopy.

The efficiency of one- and two-dimensional NMR experiments in characterizing the content of the constituents of both herbal drugs and herbal drug preparations is demonstrated for kava-kava. These experiments directly detect active constituents represented by kavalactones in both a finely powdered herbal drug and a commercial extract. In addition, NMR spectroscopy can detect all other compounds present in the extract. As previously evidenced, NMR experiments can represent a generally applicable technique for rapid screening and are a complement to the classical analytical techniques such as high-performance thin-layer chromatography, high-performance liquid chromatography, capillary gas chromatography, and electrophoresis. These experiments can be considered a very simple and fast analytical method to obtain a fingerprint of the herbal drugs and their preparations, and to quantify the content of the active principles of the extract.

Kava↗

Herbal Medicine: Is it an Alternative or an Unknown? A Brief Review of Popular Herbals Used by Patients in a Pain and Symptom Management Practice Setting.

This article will briefly discuss herbals frequently used by patients in a pain and symptom management practice setting with regard to common indications, potential side effects, and drug interactions, as well as a review of available research on each substance. An overview of the regulatory morass that continues to surround the herbal products industry will be presented. The author will examine possible ethic implications of providing care to patients utilizing alternative therapies. Future developments and studies in the field of herbal therapies will be considered.

Journal Article↗

Mycotoxins of fungal strains from stored herbal plants and mycotoxin contents of Nigerian crude herbal drugs.

The ability of fungi isolated from stored herbal drug plants to produce mycotoxins in semisynthetic media was studied. The results obtained show that aflatoxins and ochratoxin A, were produced by Aspergillus flavus, A. parasiticus and A. ochraceus isolates. The time-production courses of aflatoxins B1, B2, 1 and ochratoxin A in crude herbal drug preparations show that more of these toxins were produced with increase in time of storage of the drugs. The results indicate that the potential exists for the toxigenic strains to elaborate mycotoxins in a large quantity in herbal drug substrates than in semisynthetic media.

Aflatoxin B1↗

Improving the quality of randomized controlled trials in Chinese herbal medicine, part III: quality control of Chinese herbal medicine used in randomized controlled trials.

OBJECTIVE: To discuss quality control of Chinese herbal medicine (CHM) in randomized controlled trials (RCTs), and to provide suggestions for improving this aspect in future clinical study in this therapeutic area. METHODS: A search of the Cochrane Library was conducted to identify RCTs of CHM. Quality control information reported in those RCTs was then assessed independently. RESULTS: The search yielded a total of 167 RCTs of CHM for a variety of conditions. A total of 11 CHM preparations were used in those RCTs. Only one trial discussed quality control of the CHM interventions used. Issues affecting the safety and efficacy of CHM products used in RCTs were discussed including standardization of raw herbal materials, processing methods, screening for product contamination, and effects of combination products. CONCLUSION: The overall quality of reporting of RCTs of CHM was poor, reflecting the need for improvements in reporting future clinical trials in this area. RECOMMENDATIONS: To improve quality control of CHM used in RCTs in future, we recommend developing and implementing guidelines such as Good Agricultural Practice (GAP) for Chinese crude drugs, and current Good Manufacturing Practice (GMP) specific to CHM products. Chemical analyses of individual herbs of CHM and combination products are also recommended to provide reference standards for quality control.

Drugs, Chinese Herbal↗

[Cadmium and lead content in some herbs, herbal preparation and herbal infusions used by children and adults].

The object of the study were some herbs and preparations of herbs used by children and adults from Lublin's drug-stores and herbal-stores in 2001. The samples of herbs, preparations of herbs and their infusions after evaporation were mineralized in "dry" method in the temp. of 450 degrees C. Cadmium and lead contents were estimated by AAS method from the organic phase. In preparations for children, 56% of the examined samples contained Cd amounts exceeding accepted limits. Levels of Pb were innormal. In herbs and herbal preparations for adults the norm was exceeded in 70% of samples for Cd and 42% for Pb.

Adult↗

Are national quality standards for traditional Chinese herbal medicine sufficient? Current governmental regulations for traditional Chinese herbal medicine in certain Western countries and China as the Eastern origin country.

Traditional Chinese herbal Medicine (TCHM) has been gaining interest and acceptance world wide. TCHM provides on the one side promising perspective of scientific interest and on the other side possible health risks if TCHM drugs are not controlled with respect to quality standards or if practitioners for TCHM are not well trained. This paper outlines an introduction to the scientific aspects and potential risks of TCHM therapy followed by a brief, exploratory overview of the current status of TCHM regulations in certain Western countries like the USA, United Kingdom, Germany, Australia and in China as the Eastern origin country of TCHM. Legal foundations to establish quality and safety standards for TCHM crude drugs and ready-made formulas exist in some countries on a local basis but in practice are poorly enforced, where this products have no drug status. In addition practitioners treating patients with TCHM should be well versed in the pharmacology, side effects, and interactions of these substances with Western medicines and should be certified on a regular basis.

Consumer Product Safety↗