safety

[Weighing the efficacy and safety of herbal medicine: the case of Kava-Kava]: Harefuah. 2004 Aug;143(8):592-7, 621 Authors: Ben-Arye E, Reshef A, Berry E

Kava-Kava is an indigenous plant in the Pacific islands and has been traditionally used for centuries for both ceremonial and social purposes. The efficacy of the plant for treatment of anxiety states was recently acknowledged in randomized controlled trials. Although these trials support the safety of Kava for short term usage, a major concern was raised in accordance with emerging reports that relate Kava use to major hepatic damage, including a few cases of fulminant hepatitis that required liver transplantation or ended in death. As a result, most medical authorities in the West restricted or banned Kava use. This review discusses evidence of efficacy and safety in the use of Kava for treating patients with anxiety, as well as its meaning in the therapeutic context and patient-doctor dialogue.

PMID: 15523813 [PubMed - indexed for MEDLINE]

Challenges in the conduct of Thai herbal scientific study: efficacy and safety of phytoestrogen, pueraria mirifica (Kwao Keur Kao), phase I, in the alleviation of climacteric symptoms in perimenopausal women.: J Med Assoc Thai. 2007 Jul; 90(7): 1274-80 Chandeying V, Lamlertkittikul S

OBJECTIVE: To evaluate the preliminary efficacy and safety of Pueraria mirifica (Kwao Keur Kao), phytoestrogen, for the alleviation of climacteric symptoms. MATERIAL AND METHOD: Perimenopausal women attending with climacteric symptoms, such as hot flushes and night sweats, were invited to join the present study, conducted at the Menopausal Clinic, Hat Yai Regional Hospital. The patients were voluntarily enrolled and randomly received the raw material of Pueraria mirifica, oral 50 and 100 mg capsule, once daily for six months, as an open-label study. RESULTS: Of the 10 enrolled patients, 8 cases were completely evaluated. The modified Greene climacteric scale (MGCS) was satisfactorily decreased in both groups. The average scale declined from 44.1 at baseline, to be 26, 17, and 11.1 at 1-, 3-, and 6- month follow-up respectively. No other laboratory abnormalities, except one case had transiently increased the creatinine level, and one case of increased blood urea nitrogen. The mean serum estradiol was slightly increased, while the mean serum follicle-stimulating hormone (FSH) and luteinizing hormone (LH) were nearly stable. CONCLUSION: Pueraria mirifica is relatively safe and preliminarily alleviates the climacteric symptoms in perimenopausal. women, but the data is insufficient to draw definite conclusions regarding the estrogenic effect.

A review of the efficacy and safety of devil's claw for pain associated with degenerative musculoskeletal diseases, rheumatoid, and osteoarthritis.: Holist Nurs Pract. 2007 Jul-Aug;21(4):203-7 Authors: Denner SS

Harpagophytum procumbens, known as devil's claw, has been used traditionally for the treatment of pain, fevers, and dyspepsia. Recently, it has become popular for the treatment of rheumatoid and osteoarthritis. Studies have yet to establish a clear mechanism of action; however, current research is focusing on pro-inflammatory mediators as well as on potential antioxidant characteristics.

PMID: 17627199 [PubMed - indexed for MEDLINE]

Review of Clinical Trials Evaluating Safety and Efficacy of Milk Thistle (Silybum marianum [L.] Gaertn.).: Integr Cancer Ther. 2007 Jun;6(2):146-57 Authors: Tamayo C, Diamond S

Milk thistle extracts have been used as traditional herbal remedies for almost 2000 years. The extracts are still widely used to protect the liver against toxins and to control chronic liver diseases. Recent experimental and clinical studies suggest that milk thistle extracts also have anticancer, antidiabetic, and cardioprotective effects. This article reviews clinical trials of milk thistle conducted in the past 5 years including pharmacokinetic and toxicity studies, herb-drug interactions, and other safety issues. Several trials have studied the effects of milk thistle for patients with liver diseases, cancer, hepatitis C, HIV, diabetes, and hypercholesterolemia. Promising results have been reported in the protective effect of milk thistle in certain types of cancer, and ongoing trials will provide more evidence about this effect. In addition, new established doses and improvement on the quality and standardization of this herb will provide the much-awaited evidence about the efficacy of milk thistle in the treatment of liver diseases. Milk thistle extracts are known to be safe and well tolerated, and toxic or adverse effects observed in the reviewed clinical trials seem to be minimal. The future of milk thistle research is promising, and high-quality randomized clinical trials on milk thistle versus placebo may be needed to further demonstrate the safety and efficacy of this herb.

Safety and efficacy of echinacea (Echinacea angustafolia, e. purpurea and e. pallida) during pregnancy and lactation.: Can J Clin Pharmacol. 2006; 13(3): e262-7 Authos: Perri D, Dugoua JJ, Mills E, Koren G

BACKGROUND: There is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbal medicines used in pregnancy and lactation. This is one article in a series that systematically reviews the evidence for commonly used herbs during pregnancy and lactation. OBJECTIVES: To systematically review the literature for evidence on the use, safety, and pharmacology of echinacea focusing on issues pertaining to pregnancy and lactation. METHODS: We searched 7 electronic databases and compiled data according to the grade of evidence found. RESULTS: There is good scientific evidence from a prospective cohort study that oral consumption of echinacea during the first trimester does not increase the risk for major malformations. Low-level evidence based on expert opinion shows that oral consumption of echinacea in recommended doses is safe for use during pregnancy and lactation. CONCLUSIONS: Echinacea is non-teratogenic when used during pregnancy. Caution with using Echinacea during lactation until further high quality human studies can determine its safety.

Safety, tolerance, and metabolism of broccoli sprout glucosinolates and isothiocyanates: a clinical phase I study.: Nutr Cancer. 2006;55(1):53-62 Authors: Shapiro TA, Fahey JW, Dinkova-Kostova AT, Holtzclaw WD, Stephenson KK, Wade KL, Ye L, Talalay P

Broccoli sprouts are widely consumed in many parts of the world. There have been no reported concerns with respect to their tolerance and safety in humans. A formal phase I study of safety, tolerance, and pharmacokinetics appeared justified because these sprouts are being used as vehicles for the delivery of the glucosinolate glucoraphanin and its cognate isothiocyanate sulforaphane [1-isothiocyanato-(4R)-(methylsulfinyl)butane] in clinical trials. Such trials have been designed to evaluate protective efficacy against development of neoplastic and other diseases. A placebo-controlled, double-blind, randomized clinical study of sprout extracts containing either glucosinolates (principally glucoraphanin, the precursor of sulforaphane) or isothiocyanates (principally sulforaphane) was conducted on healthy volunteers who were in-patients on our clinical research unit. The subjects were studied in three cohorts, each comprising three treated individuals and one placebo recipient. Following a 5-day acclimatization period on a crucifer-free diet, the broccoli sprout extracts were administered orally at 8-h intervals for 7 days (21 doses), and the subjects were monitored during this period and for 3 days after the last treatment. Doses were 25 micromol of glucosinolate (cohort A), 100 micromol of glucosinolate (cohort B), or 25 micromol of isothiocyanate (cohort C). The mean cumulative excretion of dithiocarbamates as a fraction of dose was very similar in cohorts A and B (17.8 +/- 8.6% and 19.6 +/- 11.7% of dose, respectively) and very much higher and more consistent in cohort C (70.6 +/- 2.0% of dose). Thirty-two types of hematology or chemistry tests were done before, during, and after the treatment period. Indicators of liver (transaminases) and thyroid [thyroid-stimulating hormone, total triiodothyronine (T3), and free thyroxine (T4)] function were examined in detail. No significant or consistent subjective or objective abnormal events (toxicities) associated with any of the sprout extract ingestions were observed.

Devil's Claw (Harpagophytum procumbens) as a Treatment for Osteoarthritis: A Review of Efficacy and Safety.: J Altern Complement Med. 2006 Dec; 12(10): 981-93. Authors: Brien S, Lewith GT, McGregor G

Background: Osteoarthritis (OA) is a highly prevalent musculoskeletal disorder. Conventional treatment (i.e., the use of nonsteroidal anti-inflammatory drugs-NSAIDs) is associated with well-documented adverse effects. Devil's Claw (Harpagophytum procumbens) a traditional South African herbal remedy used for rheumatic conditions, may be a safer treatment option. To date, 14 clinical trials have assessed its efficacy/ effectiveness in OA. Aim: To address the two main questions of importance to clinicians: (1) Does Devil's Claw work for the treatment of OA, and (2) Is it safe? Methods: A review of the literature on Devil's Claw and OA from 1966 to 2006 was performed using multiple search databases, monographs, and citation tracking. Relevant trials in all languages were identified and included. Both internal validity (i.e., adequacy of the dosage and period of treatment for this condition, reporting of randomization, rates of dropout, blinding, and statistical analysis) and external validity (i.e., inclusion/ exclusion criteria, baseline characteristics of the study populations, trial setting, and the appropriateness of the outcome measures of the trials) were assessed. Results: Fourteen studies were identified: eight observational studies; 2 comparator trials (1 open, the other randomized to assess clinical effectiveness); and 4 double-blinded, placebo-controlled, randomized controlled trials to assess efficacy. Many of the published trials lacked certain important methodological quality criteria. However, the data from the higher quality studies suggest that Devil's Claw appeared effective in the reduction of the main clinical symptom of pain. The assessment of safety is limited by the small populations generally evaluated in the clinical studies. From the current data, Devil's Claw appears to be associated with minor risk (relative to NSAIDs), but further long-term assessment is required. Conclusions: The methodological quality of the existing clinical trials is generally poor, and although they provide some support, there are a considerable number of methodologic caveats that make further clinical investigations warranted. The clinical evidence to date cannot provide a definitive answer to the two questions posed: (1) Does it work? And (2) is it safe? A definitive high-quality trial that addresses the necessary methodologic improvements noted is needed to answer these important clinical questions.

Clinical efficacy and safety of sublingual immunotherapy with tree pollen extract in children.: Allergy. 2006 Oct;61(10):1177-83 Authors: Valovirta E, Jacobsen L, Ljørring C, Koivikko A, Savolainen J

BACKGROUND: Subcutaneous immunotherapy has been the principal approach of immunotherapy in the treatment of allergic diseases. Several clinical studies with birch, alder or hazel pollen extract conducted as subcutaneous immunotherapy have been published suggesting a well-tolerated and clinically effective treatment. Only a few clinical studies of sublingual immunotherapy (SLIT) with these allergens have been published. This study investigated the clinical efficacy, safety and dose-response relationship of SLIT in children suffering from rhinoconjunctivitis with/without asthma. METHODS: Eighty-eight children (5-15 years) with a history of tree pollen-induced allergic rhinoconjunctivitis with/without seasonal asthma for >or=2 years were included. Allergy to tree pollen was confirmed by positive skin-prick test, positive specific IgE and positive conjunctival provocation test. The extract used was a glycerinated mixture of Betula verrucosa, Corylus avellana and Alnus glutinosa 100,000 SQ-U/ml. Children were randomized into three groups receiving SLIT 5 days a week for up to 18 months; dose group 1: accumulated weekly dose of 24,000 SQ-U; dose group 2: accumulated weekly dose of 200,000 SQ-U; and placebo. RESULTS: In the birch pollen season, dose group 2 showed a significant reduction of symptom (P = 0.01) and medication scores (P = 0.04) compared with placebo. Dose group 1 showed a significant reduction of symptom scores (P = 0.03). There were no statistical differences between dose groups 1 and 2. All children tolerated the treatment well. CONCLUSION: SLIT with tree pollen extract provided dose-dependent benefits in tree pollen-allergic children in terms of significantly reduced symptoms and medication use. The treatment was well tolerated.

Herbal medicine and anesthesia.: Curr Opin Anaesthesiol. 2001 Dec;14(6):667-9 Authors: Dorman T

Complementary and alternative medicine is one of the fastest growing areas in health care. Many patients worldwide utilize these additional health care strategies in conjunction with standard medical therapies. Unfortunately little is understood about many of the interactions that can occur and as many as 50% of the patients do not inform their health care providers about these complementary and alternative therapies. The interactions that are most important in the perioperative period include sympathomimetic, sedative, and coagulopathic effects. Given the overall paucity of information regarding herbal medicines and their potential pertinent perioperative implications this domain requires a significant amount of further study and in my opinion would be fertile ground for federally funded requested projects.

Efficacy and safety of butterbur herbal extract Ze 339 in seasonal allergic rhinitis: postmarketing surveillance study.: Adv Ther. 2006 Mar-Apr; 23(2): 373-84 Käufeler R, Polasek W, Brattström A, Koetter U

The efficacy and safety of the butterbur leaf extract Ze 339 (carbon dioxide extract from the leaves of Petasites hybridus L., 8 mg petasines per tablet) were tested in patients with seasonal allergic rhinitis. In an open postmarketing surveillance study, 580 patients were treated with an average of 2 tablets of Ze 339 daily for 2 weeks. Symptoms of rhinorrhea, sneezing, nasal congestion, itchy eyes and nose, red eyes, and skin irritation were evaluated on a visual analogue scale. Symptoms of seasonal allergic rhinitis improved in 90% of patients. Differences observed before and after therapy were significant and clinically relevant for all symptoms. Improvement reported by the end of the study was found to be inversely related to symptom severity as described at baseline. Efficacy, tolerability, and improvement in quality of life were positively rated by 80%, 92%, and 80% of patients, respectively. A total of 44% of patients were given an antiallergic comedication. This combination did not result in a better effect than was attained with Ze 339 monotherapy. Adverse events occurred at a rate of 3.8%, and gastrointestinal complaints were predominantly nonspecific. Results of this postmarketing surveillance trial are consistent with observations documented in previous randomized, double-blind, prospective, controlled trials of the same extract that were conducted according to Good Clinical Practice (GCP). Butterbur leaf special extract Ze 339 was confirmed by 3 GCP trials and 2 postmarketing surveillance trials to be safe and efficacious in the treatment of patients with seasonal allergic rhinitis.