Methods for the induction of labor: efficacy and safety.

This review assessed the efficacy and safety of pharmacologic agents (prostaglandins, oxytocin, mifepristone, hyaluronidase, and nitric oxide donors) and mechanical methods (single- and double-balloon catheters, laminaria, membrane stripping, and amniotomy) and those generally considered under the rubric of complementary medicine (castor oil, nipple stimulation, sexual intercourse, herbal medicine, and acupuncture). A substantial body of published reports, including 2 large network meta-analyses, support the safety and efficacy of misoprostol (PGE1) when used for cervical ripening and labor induction. Misoprostol administered vaginally at doses of 50 µg has the highest probability of achieving vaginal delivery within 24 hours. Regardless of dosing, route, and schedule of administration, when used for cervical ripening and labor induction, prostaglandin E2 seems to have similar efficacy in decreasing cesarean delivery rates. Globally, although oxytocin represents the most widely used pharmacologic agent for labor induction, its effectiveness is highly dependent on parity and cervical status. Oxytocin is more effective than expectant management in inducing labor, and the efficacy of oxytocin is enhanced when combined with amniotomy. However, prostaglandins administered vaginally or intracervically are more effective in inducing labor than oxytocin. A single 200-mg oral tablet of mifepristone seems to represent the lowest effective dose for cervical ripening. The bulk of the literature assessing relaxin suggests this agent has limited benefit when used for this indication. Although intracervical injection of hyaluronidase may cause cervical ripening, the need for intracervical administration has limited the use of this agent. Concerning the vaginal administration of nitric oxide donors, including isosorbide mononitrate, isosorbide, nitroglycerin, and sodium nitroprusside, the higher incidence of side effects with these agents has limited their use. A synthetic hygroscopic cervical dilator has been found to be effective for preinduction cervical ripening. Although a pharmacologic agent may be administered after the use of the synthetic hygroscopic dilator, in an attempt to reduce the interval to vaginal delivery, concomitant use of mechanical and pharmacologic methods is being explored. Combining the use of a single-balloon catheter with dinoprostone, misoprostol, or oxytocin enhances the efficacy of these pharmacologic agents in cervical ripening and labor induction. The efficacy of single- and double-balloon catheters in cervical ripening and labor induction seems similar. To date, the combination of misoprostol with an intracervical catheter seems to be the best approach when balancing delivery times with safety. Although complementary methods are occasionally used by patients, given the lack of data documenting their efficacy and safety, these methods are rarely used in hospital settings.

Black Cohosh Interactions with Prescription Medications Associated with Serotonin Toxicity and Rhabdomyolysis: A Case Report.

BACKGROUND: Serotonin toxicity is a well-described phenomenon that is commonly attributed to a variety of drug-drug combinations. Some unregulated herbal supplements have been implicated in the onset of serotonin toxicity, however, there is currently minimal literature available on the potential for black cohosh to contribute to rhabdomyolysis and serotonin toxicity, in spite of its known serotonergic properties. CASE REPORT: A middle-aged woman presented to the emergency department with serotonin toxicity and rhabdomyolysis shortly after taking black cohosh supplements in the setting of long-term dual antidepressant use. The serotonin toxicity and rhabdomyolysis resolved with IV fluids, benzodiazepines, and discontinuation of the offending drugs. WHY SHOULD AN EMERGENCY PHYSICIAN BE AWARE OF THIS?: Patients are sometimes not aware of how over-the-counter supplements might interact with their prescription medications. Female patients taking black cohosh to manage hot flashes and menopausal symptoms could be at risk for developing rhabdomyolysis and serotonin toxicity if they are also taking other serotonergic agents.

Characterization of kratom use and knowledge at a rural, Oregon community health center.

BACKGROUND: Kratom is an herbal supplement that has drawn attention for its use in the self-treatment of opioid withdrawal, and its widespread availability with minimal restrictions. Past web-based research has attempted to determine patterns and trends of use, but generalizability to underserved populations is unclear. OBJECTIVE: The purpose of this study was to characterize behavior related to kratom, attitudes toward kratom, and knowledge of kratom in a rural, underserved population. METHODS: We developed, refined, and administered a cross-sectional, 36-item survey to examine use, attitudes, and knowledge of kratom. We recruited participants and administered the survey alongside medical office appointments between January and April 2023. Data were summarized using descriptive statistics. RESULTS: A convenient sample of 186 patients (of the 907-patient clinic panel) were invited to participate and 150 returned the survey. A majority of patients were female (52.0%) and White (86.6%), and about half had an income below the federal poverty level (48.5%). Seventeen participants reported prior experience with kratom use, with one actively using kratom. The most commonly reported reasons for use were pain (47.1%) and mental health (41.2%). Kratom knowledge was low regardless of kratom use history, with the majority of respondents correctly answering between 1 and 3 questions (n = 71 of 86; 82.3%) of the 5 knowledge-focused items. CONCLUSION: Results suggest that while active kratom use is uncommon in this Oregon population, one in ten surveyed had used kratom. Regardless of past use, respondents had limited knowledge of kratom. Future research should focus on understanding trends in kratom use behaviors in underserved populations, addressing patient knowledge gaps, and evaluating patient safety and health equity implications.

DNA barcoding of herbal supplements on the US commercial market associated with the purported treatment of COVID-19.

INTRODUCTION: The COVID-19 pandemic was associated with an increased global use of traditional medicines, including Ayurvedic herbal preparations. Due to their growing demand, their processed nature, and the complexity of the global supply chain, there is an increased risk of adulteration in these products. OBJECTIVES: The objective of this study was to assess the use of DNA barcoding for species identification in herbal supplements on the US market associated with the Ayurvedic treatment of respiratory symptoms. METHODS: A total of 54 commercial products containing Ayurvedic herbs were tested with four DNA barcoding regions (i.e., rbcL, matK, ITS2, and mini-ITS2) using two composite samples per product. Nine categories of herbs were targeted: amla, ashwagandha, cinnamon, ginger, guduchi, tribulus, tulsi, turmeric, and vacha. RESULTS: At least one species was identified in 64.8% of products and the expected species was detected in 38.9% of products. Undeclared plant species, including other Ayurvedic herbs, rice, and pepper, were detected in 19 products, and fungal species were identified in 12 products. The presence of undeclared plant species may be a result of intentional substitution or contamination during harvest or processing, while fungal DNA was likely associated with the plant material or the growing environment. The greatest sequencing success (42.6-46.3%) was obtained with the matK and rbcL primers. CONCLUSION: The results of this study indicate that a combination of genetic loci should be used for DNA barcoding of herbal supplements. Due to the limitations of DNA barcoding in identification of these products, future research should incorporate chemical characterization techniques.

Therapeutic Medications and Illicit Medications and Supplements.

This article provides information on the toxicity of some therapeutic drugs, illicit drugs, and supplements. Medications in the therapeutic section are grouped into antibiotics, antipsychotic agents, bronchodilators, nonsteroidal anti-inflammatory drugs, opioids, and sedatives/tranquilizers. The section on illicit drugs and supplements provides information on more specific medications including commonly used or abused human medications and a few that are available only from Internet compounding pharmacies. Many drugs and supplements can be either therapeutic or illicit depending on the dosage and ultimate use of the horse. Some medications, however, are illicit no matter when and how they are administered.

Effect of phytogenic supplements on the reproductive physiology and metabolic hormones of rabbits exposed to heat stress conditions.

This study investigated the role of phytogenic supplements on the reproductive physiology and metabolic hormones of rabbits exposed to heat stress conditions. Fresh Moringa oleifera, Phyllanthus amarus and Viscum album leaves were obtained and processed into a leaf meal using standard procedure and served as a phytogenic supplements. Eighty rabbit bucks of 6 weeks old (514.84 ± 14.10 g) were randomly assigned to the four dietary groups consisting of Diet 1 without the leaf meal (control diet) and Diets 2 (D2); 3 (D3) and 4 (D4) contained 10% Moringa, 10% Phyllanthus and 10% Mistletoe, respectively, in an 84-day feed trial at the peak of thermal discomfort. Semen kinetics and seminal oxidative status, reproductive and metabolic hormones were assessed using standard procedure. Results reveal that sperm concentration and motility traits of bucks on D2, D3 and D4 were significantly (p < 0.05) higher than bucks on D1. Spermatozoa speed traits of bucks on D4 were significantly (p < 0.05) higher than bucks on other treatments. Seminal lipid peroxidation of bucks in D2-D4 was significantly (p < 0.05) lower than bucks on D1. Corticosterone of bucks on D1 was significantly higher than bucks on other treatments (D2-D4). Lutenizing hormone of bucks on D2 and testosterone of bucks on D3 was higher (p < 0.05) than in other groups, while follicle stimulating hormone of bucks on D2 and D3 were higher (p < 0.05) than bucks on D1 and D4. In conclusion, the three phytogenic supplements improved sex hormones, enhanced spermatozoa kinetics, viability and seminal oxidative stability of bucks during heat stress condition.

Dietary and herbal supplements for weight loss: assessing the quality of patient information online.

BACKGROUND: Given the high prevalence of dietary and herbal supplement (DHS) use in tandem with the growing ease of internet access, patients commonly search online for consumer health information about these products. One common reason for DHSs use includes weight loss. Healthcare providers need to be aware of the quality of online information about DHSs for weight loss so they can adequately counsel their patients and provide them with guidance surrounding the identification of high-quality information resources. This study aimed to assess the quality of online DHSs consumer health information for weight loss that a "typical" patient might access online. METHODS: Six search terms were used to generate the first 20 websites on the Google search engine in four countries: Australia, Canada, the United Kingdom, and the United States (n = 480 websites). After applying exclusion criteria, eligible websites were quality assessed using the DISCERN instrument. This tool is comprised of 16 questions, each evaluated on a 5-point scale. The averages and standard deviations for each DISCERN instrument item, in addition to overall summed scores between 15 and 75 were calculated. RESULTS: Across 87 eligible websites, the mean summed score was 44.80 (SD = 11.53), while the mean overall DISCERN score of each website was 2.72 (SD = 0.99). In general, websites detailed and achieved their specified aims and described treatment benefits. However, most websites failed to describe the impact of treatment on overall quality of life and the impact of a no treatment option. The highest-scoring websites were largely government or health portal websites, while the lowest-scoring websites were largely commercial in nature. CONCLUSION: High variability in DISCERN instrument scores was found across all websites assessed. Healthcare providers should be aware of the fact that their patients may be accessing misinformation online surrounding the use of DHSs for weight loss. Therefore, it is important for healthcare providers to ensure that they are providing their patients with guidance on how to identify high-quality resources online, in order that safe, effective, and evidence-based decisions are made surrounding the use of DHSs for weight loss.

Alternative Treatment for Erectile Dysfunction: a Growing Arsenal in Men's Health.

PURPOSE OF REVIEW: To highlight and review encouraging preliminary studies behind several alternative products and interventions for erectile dysfunction (ED). RECENT FINDINGS: Alternative treatments for ED are becoming more prevalent with increased consumer interest. "Natural" products are sold online, and numerous clinics offer various off-label and investigational interventions. These alternative treatments have demonstrated varying degrees of efficacy in randomized trials and meta-analyses, but none of these interventions has robust enough evidence to be considered first-line therapy. These treatments may find a role in combination with guideline treatments or may be used in novel penile rehabilitation research protocols. With growing interest in alternative treatment for men's health, an awareness of the literature is imperative for patient counsel. Alternative treatments, like L-arginine, have a growing body of evidence for efficacy in combination with PDE5i, and low-intensity shock wave therapy and stem cell therapy continue to demonstrate encouraging outcomes in ED trials.

[The use of complex herbal supplements for the prevention and treatment of urinary tract infections. The analysis of active components].

Urinary tract infections, especially recurrent cases, are caused by uropathogens, which, after repeated courses of antibiotic therapy, can develop antibiotic resistance, which requires a search for an alternative treatment strategy. In this regard, the restoration of nonspecific protective factors that normally prevent the adhesion and colonization of pathogens is of interest for clinicians. To date, scientific data has been accumulated about the anti-uropathogenic and antiadhesive activity of many plant extracts. However, studies on the specific action of herbal components are limited. Data on the chemical composition, mechanisms of action, in vivo and in vitro efficacy of medicinal plants growing on the European continent and used for the prevention or treatment of acute and chronic (recurrent) urinary tract infections are presented in the review.

Intestinal and Hepatocellular Transporters: Therapeutic Effects and Drug Interactions of Herbal Supplements.

Herbal supplements are generally considered safe; however, drug disposition is influenced by the interactions of herbal supplements and food constituents with transport and metabolic processes. Although the interference of herbal supplements with drug metabolism has been studied extensively, knowledge of how they interact with the drug transport processes is less advanced. Therefore, we describe here specific examples of experimental and human interaction studies of herbal supplement components with drug transporters addressing, for example, organic anion transporting polypeptides or P-glycoprotein, as such interactions may lead to severe side effects and altered drug efficacy. Hence, it is clearly necessary to increase the awareness of the clinical relevance of the interference of herbal supplements with the drug transport processes.

Use of Dietary Supplements in Living Kidney Donors: A Critical Review.

Dietary supplement use is high among US adults, with the intention by users to promote overall health and wellness. Kidney donors, who are selected based on their overall good health and wellness, can have high utilization rates of dietary supplements. We provide a framework for the evaluation of living kidney donors and use of dietary supplements. In this review, dietary supplements will include any orally administered dietary or complementary nutritional products, but excluding micronutrients (vitamins and minerals), food, and cannabis. Use of dietary supplements can influence metabolic parameters that mask future risk for chronic illness such as diabetes and hypertension. Dietary supplements can also alter bleeding risk, anesthesia and analgesic efficacy, and safety in a perioperative period. Finally, postdonation monitoring of kidney function and risk for supplement-related nephrotoxicity should be part of a kidney donor educational process. For practitioners evaluating a potential kidney donor, we provide a list of the most commonly used herbal supplements and the effects on evaluation in a predonation, perioperative donation, and postoperative donation phase. Finally, we provide recommendations for best practices for integration into a comprehensive care plan for kidney donors during all stages of evaluation. We recommend avoidance of dietary supplements in a kidney donor population, although there is a paucity of data that identifies true harm. Rather, associations, known mechanisms of action, and common sense suggest that we avoid use in this population.

Herbal supplements interactions with oral oestrogen-based contraceptive metabolism and transport.

The increased use of herbal supplements as complementary or alternative medicines has become a clinical conundrum due to the potential for herb-drug interactions. This is exacerbated by an increased supply of new herbal supplements in the market claiming various health advantages. These herbal supplements are available as over-the-counter self-medications. Herbal supplements are generally perceived as efficacious without side effects commonly associated with conventional drugs. However, despite regulations, claims related to their therapeutic effects are mostly unsupported by scientific evidence. These products often lack suitable product quality controls, labelled inadequately and with batch to batch variations, potentially compromising the safety of the consumer. Amongst health practitioners, the greatest concern is related to the lack of chemical characterization of the active compounds of the herbal supplements. The interaction between these different active components and their concomitant effects on other conventional drugs is generally not known. This review will focus on herbal supplements with the potential to effect pharmacokinetic and pharmacodynamic properties of oestrogen-based oral contraceptives. The use of herbal supplements for weight management, depression, and immune boosting benefits were selected as likely herbal supplements to be used concomitantly by women on oral contraceptives.

Risk assessment of herbal supplements containing ingredients that are genotoxic and carcinogenic.

Botanicals and botanical preparations including plant food supplements as well as medicinal herbal supplements can contain possible beneficial health compounds, but also ingredients of concern. Compounds that are both genotoxic and carcinogenic have been found in herbal supplements and may raise a safety concern. Genotoxic carcinogens that can be present in botanicals and botanical preprations include especially pyrrolizidine alkaloids (PAs), aristolochic acids (AAs) and alkenylbenzenes (ABs). The present manuscript provides an overview of the levels of these compounds reported to date to be present in herbal supplements with an associated risk assessment. Exposure was estimated based on levels of PAs, AAs and ABs in individual supplements and their proposed uses. In addition a probabilistic exposure assessment was performed based on the distribution of the level of the compounds of concern in the food supplements and of the recommended uses, resulting in 5th to 95th percentile consumer exposure values. To evaluate the risk of these exposures, the margin of exposure (MOE) approach for lifetime exposure was used. To correct exposure estimates for shorter than lifetime exposure, Haber's rule as a first tier approach was applied. It is concluded that the proposed uses and use levels as well as the presence of AAs, ABs and PAs in food supplements should be carefully monitored to manage potential consumer risks. More information on estimated daily intake resulting from supplement use, as well as consequences of concomitant exposure will further improve the risk evaluation of products containing these compounds of concern.

Suspected adverse reactions associated with herbal products used for weight loss: spontaneous reports from the Italian Phytovigilance System.

PURPOSE: Overweight and obesity represent worldwide a rising health problem. In this context, dietary supplements and herbal preparations are often used as self-medication for weight loss. The aim of this study was to describe the safety profile of dietary supplements for weight control by analyzing spontaneous reports of suspected adverse reactions (ARs) received by the Italian Phytovigilance System, from July 2010 to October 2017. METHODS: The suspected ARs were collected using an ad hoc reporting form, registered in a database at the National Institute of Health and evaluated by a multidisciplinary group of experts. The causality assessment was performed using the WHO-UMC system or the CIOMS/RUCAM score. In case of serious adverse reactions, a feedback is provided to the reporter by e-mail. RESULTS: Sixty-six spontaneous reports were collected. ARs involved cardiovascular system (26%), liver (14%), central nervous system (12%), skin (9%), gastrointestinal system (17%), thyroid (8%), kidney (4%), and other organs/systems (10%). In 64% of cases, the reaction was serious. Dechallenge was positive in 46 cases; three cases of positive rechallenge were reported. After the causality assessment, the association between the product intake and the adverse reaction was judged as possible in the majority of the cases (n = 43; 65%). CONCLUSIONS: The data collected confirmed the existence of safety concerns on herbal dietary supplements used for body weight control, mainly related to quality of products and their use as self-medication. In this scenario, spontaneous reports represent the only tools available to monitor safety of these products.

Herb-drug interactions: a novel algorithm-assisted information system for pharmacokinetic drug interactions with herbal supplements in cancer treatment.

PURPOSE: To develop a system to estimate the risk of herb-drug interactions that includes the available evidence from clinical and laboratory studies, transparently delineates the algorithm for the risk estimation, could be used in practice settings and allows for adaptation and update. METHODS: We systematically searched Drugbank, Transformer, Drug Information Handbook, European and German Pharmacopoeia and MEDLINE for studies on herb-drug interactions of five common medicinal plants (coneflower, ginseng, milk thistle, mistletoe and St. John's wort). A diverse set of data were independently extracted by two researchers and subsequently analysed by a newly developed algorithm. Results are displayed in the form of interaction risk categories. The development of the algorithm was guided by an expert panel consensus process. RESULTS: From 882 publications retrieved by the search, 154 studies were eligible and provided 529 data sets on herbal interactions. The developed algorithm prioritises results from clinical trials over case reports over in vitro investigations and considers type of study, consistency of study results and study outcome for clinical trials as well as identification, permeability, bioavailability, and interaction potency of an identified herbal perpetrator for in vitro investigations. Risk categories were assigned to and dynamically visualised in a colour-coded matrix format. CONCLUSIONS: The novel algorithm allows to transparently generate and dynamically display herb-drug interaction risks based on the available evidence from clinical and laboratory pharmacologic studies. It provides health professionals with readily available and easy updatable information about the risk of pharmacokinetic interactions between herbs and oncologic drugs.

Heavy metal content of herbal health supplement products in Dubai - UAE: a cross-sectional study.

BACKGROUND: Lead, mercury, cadmium, chromium, and arsenic intoxication have been associated with the use of health supplement (HS) products. The aim of this study is to estimate the concentration of heavy metals in HS products that are on sale in Dubai, United Arab Emirates, premises and to compare estimated daily metal intake with regulatory standards. METHODS: Dubai-area premises selling HS products were identified by searching the Dubai Municipality database to identify all pharmacies, para-pharmacies and nutrition and healthcare shops. A total of 859 premises were identified in the Deira and Bur-Dubai areas. Data collection was performed between September 1 and December 12, 2016. During that period, all premises that had been identified within Dubai were visited and samples for laboratory testing were collected. RESULTS: A total of 200 HS products were tested for lead, mercury, cadmium, chromium and arsenic. High proportion of samples were found to contain metals less than the limits of the detection (LOD) of the method. It was found that 93% of products contained Arsenic (As) < LOD, 94.5% of lead (Pb) < LOD, 100% of Cadmium (Cd) < LOD, 99% of Mercury (Hg) < LOD and 23.5% of Chromium (Cr) < LOD. Using the single imputation method to account for LOD, estimates for the average daily intake of lead was 0.88 µg compared to the tolerable daily intake (TDI) of 20 µg, daily intake of mercury was 0.09 µg (TDI = 20 µg), daily intake of cadmium was 0.83 µg (TDI = 6 µg) while for arsenic it was 0.92 µg compared to the tolerable daily intake of 10 µg. The average daily intake of chromium was 7.57 µg with no internationally established TDI. Assuming users followed the manufacturers' instructions, daily intake of arsenic, lead and mercury would not exceed TDI for any of the 200 products. However, the daily intake of cadmium exceeded or approximated the TDI for three products. CONCLUSIONS: In this study we found low levels of metals in the products that were available for sale in Dubai. With few exceptions, if the products were used according to the suppliers' instructions, average daily intake of heavy metals will be well below the recommended tolerable daily intakes.

Oral complementary medicine use and first-cycle in vitro fertilisation - What are the effects on the oocyte, the embryo and the pregnancy rate?

AIM: To assess the effect of oral complementary and alternative medicine (CAM) on the oocyte, embryo and pregnancy rate in first-cycle in vitro fertilisation (IVF). METHOD: A prospective cohort study using the International CAM Questionnaire, reviewing patient IVF outcomes. Local ethics approval was obtained. RESULTS: Over 18 months (October 2015 to April 2017) 25 patients were prospectively recruited, with 52% (n = 13) using herbal or dietary supplements, including Chinese medicine, fish oil, liver 'detox', co-enzyme Q10, spirulina, probiotics and maca root. Comparing users to non-users, there was no statistical difference in age, body mass index, primary infertility, gravidity or parity. Total follicle-stimulating hormone dose was equivalent (2760 vs 2451 IU, P = 0.60), but there was a significant difference in maximum oestradiol response (4134 vs 8335, P = 0.045), on univariate analysis alone. While no difference was found in the number of follicles >11 mm (7.5 vs 11.5, P = 0.80), or eggs collected (8.0 vs 12.5, P = 0.91), there was a lower number of eggs fertilised in users (3.0 vs 4.0, P = 0.046). There was no difference in the chemical or clinical pregnancy rate. CONCLUSION: This small study demonstrates a high use of oral CAM in first-cycle IVF patients, with a wide range of types. There appears to be a lower fertilisation rate in the women who used oral CAMs. It is unclear whether this is a negative effect of the CAM or selection bias. This concern about confounders supports the need for further research into unregulated herbal medicine on IVF outcomes, given that so many women are using these substances.

Over-the-Counter Herbal Weight Loss Supplements in Egypt: Label Claim, Microbiological and Pharmaceutical Quality, and Safety Assessments.

OBJECTIVES: Nutraceuticals are advertised and sold with the label claim of being natural and safe herbal products. Due to the absence of clear regulations and guidelines for safety assessments of these products, nutraceuticals are commonly adulterated in order to increase sales. The objective of the current study was to design a comprehensive evaluation system to assess the safety, efficacy, authenticity according to label claim, and pharmaceutical quality of herbal slimming products in between 2015 and 2017. METHODS: We designed a comprehensive assessment system to evaluate the safety, authenticity according to label claim, and pharmaceutical quality of slimming nutraceuticals. Six different popular products were evaluated (Zotreem Plus®, Zotreem Extra®, Malaysian Super Slim®, AB Slim®, Chinese Super Slim®, and Metabolites®). The pharmaceutical evaluation included analyzing the samples via high-performance liquid chromatography to determine any possible adulterants. Additionally, the products' physical properties were assessed via pharmacopeial tests. Finally, a microbial evaluation and a cross-sectional observational retrospective prevalence study were conducted to assess the products' safety and efficacy. -Results: The tested products were found to be adulterated with unreported active pharmaceutical ingredients such as sibutramine, sildenafil, phenolphthalein, and orlistat. Furthermore, they contained heterogeneous amounts of adulterants and exhibited an unsatisfactory pharmaceutical and microbial quality. Finally, the observational survey conducted on users showed that high percentages of participants suffered from common side effects such as depression, diarrhea, and hypertension. CONCLUSIONS: These products threaten the health of consumers. There is a need to raise awareness of the lethal consequences of illegal nutraceuticals.

Electrocardiographic effects of hawthorn (Crataegus oxyacantha) in healthy volunteers: A randomized controlled trial.

The objective of this study was to evaluate the electrocardiographic effects of hawthorn in healthy adult volunteers. It was double-blind cross-over trial randomized 20 healthy adult volunteers to receive either a single oral 160-mg dose of hawthorn or matching placebo. Triplicate 12-lead electrocardiograms were taken before treatment and at 1-, 2-, 4-, and 6-hr post-dose. Following at least a 7-day washout period, participants were crossed over to the opposing treatment arm and had the measurements repeated. The primary endpoint was the change in corrected (Fridericia) QT intervals (QTc I) at 4 and 6 hr. Maximum post-dose QTc I and changes in PR and QRS intervals were measured. No significant differences in 4- or 6-hr QTc I were seen between hawthorn and placebo. Maximum post-dose QTc I in the hawthorn and placebo groups were similar (346 ± 35 vs 346 ± 40 ms; p = .979). No significant adverse events were seen. In conclusion, a single dose of oral hawthorn had no effect on electrocardiographic parameters in healthy volunteers.