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INTRODUCTION: Beehive products are widely used in food supplements; however, their composition variability and allergenic components have raised some concerns. This work aims to provide information about the beehive products safety profile by evaluating the suspected adverse reactions (ARs). METHODS: The suspected report of ARs collected within the Italian Phytovigilance System (IPS) were evaluated. The clinical and demographic characteristics of the cases were described, and the causality assessment performed. RESULTS: 61 reports were analysed, mainly concerned women. Serious events were reported in 17 forms (28%). The ARs (n=116) referred to respiratory (25.0%), skin (24.1%), and gastrointestinal disorders (21.5%). Label warnings for atopic subjects were present only in 7 food supplements. The causality assessment was mostly probable (54.1%). CONCLUSIONS: Present findings outline relevant information about the safety issues of beehive product consumption, especially in atopic or allergic subjects, and strengthen the importance of IPS to point out safety signals.

Asunto(s)

Suplementos Dietéticos , Humanos , Suplementos Dietéticos/efectos adversos , Italia , Femenino , Masculino , Persona de Mediana Edad , Adulto , Anciano , Adulto Joven , Adolescente , Farmacovigilancia , Sistemas de Registro de Reacción Adversa a Medicamentos , Alérgenos/efectos adversos , Niño

RESUMEN

We present two cases of middle-aged men who developed Fanconi syndrome and renal dysfunction after consuming "foods with functional claims (FFC)" containing red yeast rice. In the first case, the patient had consumed an FFC for 1 year and another FFC suspected to have contained nephrotoxin for 3 weeks; kidney biopsy performed during the acute phase of renal injury showed severe acute tubular necrosis and tubular cell regeneration. He achieved near-complete recovery 40 days after the FFC was discontinued. In the second case, the patient had consumed FFC for 4 years and stopped 70 days prior to presentation; kidney biopsy revealed significant tubular recovery, persistent tubular injuries, and interstitial fibrosis. Although the manifestations of Fanconi syndrome subsided, mild renal dysfunction persisted. These cases suggest that FFC with nephrotoxins may induce Fanconi syndrome owing to acute tubular necrosis. Recovery is possible after discontinuing the FFC; while short-term ingestion of FFC allows for tubular regeneration, its long-term ingestion may cause irreversible damage and lead to chronic kidney disease. Long-term follow-up is crucial for preventing further renal deterioration.

Asunto(s)

Síndrome de Fanconi , Humanos , Masculino , Síndrome de Fanconi/inducido químicamente , Síndrome de Fanconi/patología , Persona de Mediana Edad , Necrosis Tubular Aguda/inducido químicamente , Necrosis Tubular Aguda/patología , Productos Biológicos/efectos adversos , Suplementos Dietéticos/efectos adversos , Contaminación de Alimentos , Adulto

RESUMEN

Importance: Use of herbal and dietary supplements (HDSs) accounts for an increasing proportion of drug hepatotoxicity cases. Turmeric or curcumin, green tea extract, Garcinia cambogia, black cohosh, red yeast rice, and ashwagandha are the most frequently reported hepatoxic botanicals, but their prevalence and reasons for use in the general population are unknown. Objective: To assess the prevalence and clinical characteristics of adult consumers of 6 potentially hepatoxic botanicals. Design, Setting, and Participants: This survey study analyzed nationally representative data from the National Health and Nutrition Examination Survey (NHANES), a nationally representative, cross-sectional survey of the general US population. Prescription drug and HDS exposure data in the past 30 days were analyzed, and 2020 US Census data were used for population estimates. Data were analyzed July 1, 2023, to February 1, 2024. Exposures: Adult NHANES participants enrolled between January 2017 and March 2020. Main Outcomes and Measures: Baseline weighted characteristics of HDS users and users of 6 potentially hepatotoxic botanical products were compared with non-HDS users. Multivariable analysis was undertaken to identify factors associated with HDS use or at-risk botanical use. Results: Among 9685 adults enrolled in this NHANES cohort, the mean (SE) age was 47.5 (0.5) years, and 51.8% (95% CI, 50.2%-53.4%) were female. The overall prevalence of HDS product use was 57.6% (95% CI, 55.9%-59.4%), while the prevalence of using the 6 botanicals of interest was 4.7% (95% CI, 3.9%-5.7%). Turmeric-containing botanicals were most commonly used (n = 236), followed by products containing green tea (n = 92), ashwagandha (n = 28), Garcinia cambogia (n = 20), red yeast rice (n = 20), and black cohosh (n = 19). Consumers of these 6 botanicals were significantly older (adjusted odds ratio [AOR], 2.36 [95% CI, 1.06-5.25]; P = .04 for 40-59 years of age and AOR, 3.96 [95% CI, 1.93-8.11]; P = .001 for ≥60 years of age), had a higher educational level (AOR, 4.78 [95% CI, 2.62-8.75]; P < .001), and were more likely to have arthritis (AOR, 2.27 [95% CI, 1.62-3.29]; P < .001) compared with non-HDS users. An estimated 15 584 599 (95% CI, 13 047 571-18 648 801) US adults used at least 1 of the 6 botanical products within the past 30 days, which was similar to the estimated number of patients prescribed potentially hepatotoxic drugs, including simvastatin (14 036 024 [95% CI, 11 202 460-17 594 452]) and nonsteroidal anti-inflammatory drugs (14 793 837 [95% CI, 13 014 623-16 671 897]). The most common reason for consuming turmeric and green tea was to improve or maintain health. Conclusions and Relevance: In this survey study, an estimated 15.6 million US adults consumed at least 1 botanical product with liver liability within the past 30 days, comparable with the number of people who consumed nonsteroidal anti-inflammatory drugs and a commonly prescribed hypolipidemic drug. Given a lack of regulatory oversight on the manufacturing and testing of botanical products, clinicians should be aware of possible adverse events from consumption of these largely unregulated products.

Asunto(s)

Enfermedad Hepática Inducida por Sustancias y Drogas , Suplementos Dietéticos , Encuestas Nutricionales , Humanos , Femenino , Masculino , Adulto , Persona de Mediana Edad , Estados Unidos/epidemiología , Estudios Transversales , Enfermedad Hepática Inducida por Sustancias y Drogas/epidemiología , Enfermedad Hepática Inducida por Sustancias y Drogas/etiología , Suplementos Dietéticos/efectos adversos , Curcuma , Anciano , Extractos Vegetales/efectos adversos , Adulto Joven , Garcinia cambogia , Prevalencia , Preparaciones de Plantas/efectos adversos , Cimicifuga/efectos adversos

RESUMEN

Hair thinning affects upwards of 50% of women by age 50, impacting their social-emotional wellbeing. It is a condition now thought to be driven by a multi-factorial etiology, including diet and nutrition. Women following vegan, vegetarian, or other plant-based diets have specific needs for nutrients traditionally sourced from animals, which could affect hair health. To support hair growth and quality in women following a plant-based diet, a novel vegan nutraceutical (Nutrafol Women's Vegan Capsules, Nutraceutical Wellness, Inc., New York, NY) was evaluated for its ability to support hair health. The objectives of this 6-month, multi-site, single-blind prospective clinical study was to evaluate the safety and efficacy of the nutraceutical to improve hair growth and quality in women consuming a plant-based diet. The primary endpoint in this study was an increase in terminal hair count at day 180 compared with baseline, as assessed through phototrichogram analysis. Ninety-five subjects completed the study. Daily intake of the nutraceutical resulted in a significant increase in the number of terminal hairs at day 90 (P<0.01) and day 180 (P<0.01). There was also an increase in total hair counts (P<0.01), the terminal-to-vellus ratio (P<0.01), and a decrease in shedding (P<0.01). Global Investigator Ratings revealed improved hair growth (P<0.00001) and overall quality (P<0.00001). In-person hair strength and brittleness assessments significantly improved as well (P<0.01 for both). A significant proportion of subjects reported improved hair quality, appearance, texture, and volume. Hair problems affecting the quality of life of the subjects were also reported as improved. This study demonstrated significant improvements in hair growth and quality in a plant-based population with a vegan nutraceutical. ClinicalTrials.gov Identifier: NCT05332743. J Drugs Dermatol. 2024;23(8):661-668.  doi:10.36849/JDD.8421.

Asunto(s)

Dieta Vegana , Suplementos Dietéticos , Cabello , Adulto , Anciano , Femenino , Humanos , Persona de Mediana Edad , Adulto Joven , Alopecia/dietoterapia , Dieta Vegana/efectos adversos , Suplementos Dietéticos/efectos adversos , Cabello/crecimiento & desarrollo , Cabello/efectos de los fármacos , Estudios Prospectivos , Método Simple Ciego , Resultado del Tratamiento

RESUMEN

BACKGROUND: Syndrome of apparent mineralocorticoid excess (AME) is characterized by excessive MR stimulation despite low levels of aldosterone. 11Beta-hydroxysteroid dehydrogenase-2 (11ßDSH-2) inactivates cortisol to cortisone, preventing cortisol-induced MR activation. Genetic defects in 11ßDSH-2 cause AME through accumulation of cortisol in the distal nephron, leading to MR activation induced hypertension, hypokalemia and metabolic alkalosis. Acquired AME can occur due to the ingestion of glycyrrhizic acid, found in licorice root, which inhibits 11ßDSH-2 and has additional effects on cortisol homeostasis through inhibition of 11ßDSH-1. CASE REPORT: We present a case of acquired AME with a hyperadrenergic symptoms induced by ingestion of Advanced Liver Support, a nutritional supplement produced by Advanced BioNutritionals(R), in a 65-year-old Caucasian female who presented with accelerated hypertension, hypokalemia, metabolic alkalosis and adrenergic symptoms. Cessation of the licorice-containing supplement resulted in complete resolution of the patient's hypertension, symptoms and abnormal lab values. To our knowledge this is the first reported case of AME from this supplement, and the first to describe accompanying hyperadrenergic symptoms. CONCLUSIONS: Glycyrrhizic acid is increasingly being found in unregulated nutritional supplements and has the potential to induce a reversable syndrome of AME. Acquired AME should be suspected in individuals who present with hypertension along with hypokalemia, metabolic alkalosis and low plasma renin and serum aldosterone levels.

Asunto(s)

Ácido Glicirrínico , Hipertensión , Hipopotasemia , Síndrome de Exceso Aparente de Mineralocorticoides , Humanos , Femenino , Síndrome de Exceso Aparente de Mineralocorticoides/inducido químicamente , Hipopotasemia/inducido químicamente , Anciano , Hipertensión/tratamiento farmacológico , Suplementos Dietéticos/efectos adversos , Glycyrrhiza/efectos adversos , Alcalosis/inducido químicamente , Hidrocortisona/sangre , Aldosterona/sangre

RESUMEN

Multiple sclerosis (MS) is a chronic, debilitating neurological condition for which current treatments often focus on managing symptoms without curing the underlying disease. Recent studies have suggested that dietary supplements could potentially modify disease progression and enhance quality of life. This systematic review aims to evaluate the efficacy and safety of epigallocatechin-3-gallate (EGCG) as a dietary supplement in patients with MS, with a specific focus on its impact on disease progression, symptom management, and overall quality of life. We conducted a comprehensive systematic review following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, utilizing an exhaustive search across the databases PubMed, Scopus, and Web of Science up to 23 February 2024. Eligible studies were randomized controlled trials. Nine clinical trials involving 318 participants were analyzed, with dosages ranging from 600 mg to 1200 mg of EGCG daily, although most studies had only a 4-month follow-up period. Results indicated that EGCG supplementation, particularly when combined with coconut oil, led to significant improvements in metabolic health markers and functional abilities such as gait speed and balance. One trial observed significant improvements in the Berg balance scale score from an average of 49 to 52 after four months of treatment with 800 mg of EGCG daily. Additionally, interleukin-6 levels significantly decreased, suggesting anti-inflammatory effects. Measures of quality of life such as the Beck Depression Inventory (BDI) scale showed significant improvements after EGCG supplementation. However, primary outcomes like disease progression measured by the Expanded Disability Status Scale (EDSS) and Magnetic Resonance Imaging (MRI) of lesion activities showed minimal or no significant changes across most studies. EGCG supplementation appears to provide certain symptomatic and functional benefits in MS patients, particularly in terms of metabolic health and physical functionality. However, it does not significantly impact the primary disease progression markers such as EDSS scores and MRI lesions. These findings underscore the potential of EGCG as a supportive treatment in MS management, though its role in altering disease progression remains unclear. Future research should focus on long-term effects and optimal dosing to further elucidate its therapeutic potential.

Asunto(s)

Catequina , Suplementos Dietéticos , Esclerosis Múltiple , Calidad de Vida , Humanos , Catequina/administración & dosificación , Catequina/efectos adversos , Catequina/análogos & derivados , Suplementos Dietéticos/efectos adversos , Progresión de la Enfermedad , Esclerosis Múltiple/diagnóstico , Esclerosis Múltiple/dietoterapia , Esclerosis Múltiple/psicología , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento

RESUMEN

Insulin autoimmune syndrome (IAS) is a rare condition triggered by exposure to various drugs containing sulfhydryl compounds, proton pump inhibitors, supplements, plasma proteins, viral infections like measles, influenza, hepatitis C, and autoimmune conditions like Graves' disease and systemic lupus erythematosus.1,3 We report two patients with recurrent episodes of hypoglycemia who were then diagnosed with IAS due to the consumption of α-lipoic acid (ALA) present in a multivitamin supplement. Eating small, frequent meals containing complex carbohydrates and steroids helps normalize blood glucose levels and reduce the insulin autoantibodies (IAA) to undetectable levels.3.

Asunto(s)

Hipoglucemia , Vitaminas , Humanos , Hipoglucemia/inducido químicamente , Hipoglucemia/diagnóstico , Vitaminas/efectos adversos , Femenino , Ácido Tióctico/efectos adversos , Enfermedades Autoinmunes/tratamiento farmacológico , Masculino , Adulto , Suplementos Dietéticos/efectos adversos , Persona de Mediana Edad , Insulina/efectos adversos

RESUMEN

BACKGROUND Over-the-counter (OTC) supplement use is a very common practice within the United States. Supplements are not tightly regulated by the Food and Drug Administration. There are many case reports involving OTC supplement adverse effects and medication interactions, but there remains minimal clinical research regarding these subjects. Rhabdomyolysis is one interaction and adverse effect frequently documented in case reports among a variety of OTC supplements, although, to date, there is no documentation of rhabdomyolysis occurring from an interaction between the supplement Tribulus terrestris and atorvastatin. CASE REPORT A 71-year-old man presented to the Emergency Department in rhabdomyolysis with a mild transaminitis after taking the over-the-counter supplement Tribulus terrestris while on long-term atorvastatin. His rhabdomyolysis peaked at day 4 after cessation of the Tribulus and atorvastatin and aggressive fluid resuscitation with a normal saline bolus at admission followed by a D5 sodium bicarbonate drip later transitioned to a normal saline drip with subsequent down-trending of the creatinine phosphokinase levels. CONCLUSIONS Tribulus terrestris is an herbal supplement used for erectile dysfunction and energy. Recent research suggests it to be a moderate CYP 3A4 inhibitor that plays a significant role in metabolism of statin and many other commonly prescribed medications. This may put patients at increased risk of developing serious adverse effects, including rhabdomyolysis and drug-induced liver injury. Screening patients for over-the-counter supplement use and educating them on the potential risks of their use is extremely important for inpatient and outpatient healthcare professionals to avoid dangerous medication interactions.

Asunto(s)

Suplementos Dietéticos , Medicamentos sin Prescripción , Rabdomiólisis , Tribulus , Humanos , Rabdomiólisis/inducido químicamente , Masculino , Anciano , Tribulus/efectos adversos , Medicamentos sin Prescripción/efectos adversos , Suplementos Dietéticos/efectos adversos , Atorvastatina/efectos adversos , Interacciones de Hierba-Droga , Inhibidores de Hidroximetilglutaril-CoA Reductasas/efectos adversos

RESUMEN

Are all food ingredients, dietary supplement ingredients and even foods, required to meet the same safety standards? Are they all equally safe? If so, then why do the various categories have different expressions describing their safety, such as "reasonable certainty of no harm" for food ingredients and "reasonable expectation of no harm" for dietary supplement ingredients? The basis for these different expressions is that they are not standards of safety, but standards of proof of safety. Just as in criminal vs. civil courts, the threshold for proving guilt or fault is different, so too are there differences between various categories of consumer products regulated by the US Food and Drug Administration. This manuscript describes the threshold requirements for each standard, as well as to the identity of the decision makers on what is safe, their credentials as decision makers and the databases mandated for their use.

Asunto(s)

Seguridad de Productos para el Consumidor , United States Food and Drug Administration , Estados Unidos , United States Food and Drug Administration/normas , Humanos , Seguridad de Productos para el Consumidor/normas , Seguridad de Productos para el Consumidor/legislación & jurisprudencia , Suplementos Dietéticos/normas , Suplementos Dietéticos/efectos adversos , Inocuidad de los Alimentos , Animales , Medición de Riesgo

RESUMEN

The use of exogenous glucocorticoids is a common cause of Cushing syndrome. We present a case of exogenous Cushing syndrome caused by Binahong: an over-the-counter 'herbal' supplement. A 54-year-old woman presented with weight gain, joint pain, hypertension and poorly regulated type 2 diabetes mellitus despite the start of semaglutide one year before presentation. Physical examination revealed signs of steroid excess with a moon face and abdominal obesity. Her serum cortisol level and ACTH level were suppressed. Synthetic glucocorticoid screening revealed a positive dexamethason level in the herbal supplement. After stopping the supplement her serum cortisol and dexamethason increased to normal levels. This case emphasizes the importance of awareness for the use of supplements containing hidden glucocorticoids causing Cushing syndrome.

Asunto(s)

Síndrome de Cushing , Suplementos Dietéticos , Humanos , Femenino , Persona de Mediana Edad , Síndrome de Cushing/inducido químicamente , Suplementos Dietéticos/efectos adversos , Hidrocortisona/sangre , Glucocorticoides/efectos adversos , Glucocorticoides/uso terapéutico

RESUMEN

Background: Potential calcium-related adverse events of vitamin D supplement use have not been addressed in large-scale, real-world data so far. Methods: Leveraging data from the UK Biobank, encompassing 445,493 individuals aged 40-69, we examined associations of high 25-hydroxyvitamin (25(OH)D) levels ≥ 100 nmol/L and vitamin D supplementation with hypercalcemia (serum calcium > 2.6 mmol/L), kidney stones, and atherosclerosis assessments (pulse wave arterial stiffness index and carotid intima-medial thickness). Regression models were comprehensively adjusted for 49 covariates. Results: Approximately 1.5% of the participants had high 25(OH)D levels, 4.3% regularly used vitamin D supplements, and 20.4% reported regular multivitamin use. At baseline, the hypercalcemia prevalence was 1.6%, and 1.1% was diagnosed with kidney stones during follow-up. High 25(OH)D levels were neither associated with calcium-related adverse events nor atherosclerosis assessments. Vitamin D and multivitamin supplementation were associated with an increased prevalence of hypercalcemia (odds ratios and 95% confidence intervals: 1.46 [1.32-1.62] and 1.11 [1.04-1.18], respectively) but were neither associated with atherosclerosis nor future kidney stones. Conclusions: High 25(OH)D levels observable in routine care were not associated with any adverse outcome. Vitamin D users have a slightly higher prevalence of hypercalcemia, possibly due to co-supplementation with calcium, but without a higher atherosclerosis prevalence or risk of kidney stones.

Asunto(s)

Aterosclerosis , Suplementos Dietéticos , Hipercalcemia , Cálculos Renales , Vitamina D , Humanos , Hipercalcemia/epidemiología , Hipercalcemia/inducido químicamente , Vitamina D/análogos & derivados , Vitamina D/sangre , Vitamina D/administración & dosificación , Persona de Mediana Edad , Masculino , Femenino , Suplementos Dietéticos/efectos adversos , Reino Unido/epidemiología , Cálculos Renales/epidemiología , Cálculos Renales/sangre , Anciano , Aterosclerosis/epidemiología , Aterosclerosis/etiología , Adulto , Prevalencia , Bancos de Muestras Biológicas , Factores de Riesgo , Calcio/sangre , Calcio/administración & dosificación , Biobanco del Reino Unido

RESUMEN

BACKGROUND: Glucosamine is a dietary supplement commonly used to support joint health. However, there has been interest in exploring other effects of glucosamine on health outcomes due to its ant-inflammation effect. OBJECTIVE: This study compared the risks of major adverse liver outcomes (MALOs) between regular users and non-users of glucosamine among patients with type 2 diabetes and metabolic dysfunction associated steatotic liver disease (MASLD) using the data from a large prospective cohort study. METHODS: Demographic, anthropometric, laboratory and medication prescription information among 18 753 patients with type 2 diabetes and MASLD was obtained from the UK Biobank. MASLD was identified based on hepatic steatosis defined by fatty liver index ≥60 plus the presence of any clues of metabolic dysregulation and cardio-metabolic risk factors, excluding patients with moderate to severe alcohol consumption. RESULTS: During a mean follow-up of 11.4 years, 826 incident MALOs events were recorded. Patients not regularly using glucosamine compared with patients using glucosamine showed a significantly higher risk of the composite MALOs (HR 1.36, 95% confidence interval [CI] 1.09-1.69) as well as most individual MALOs except for ascites. The multivariable-adjusted HRs of MALOs within 3, 5 and 10 years among non-users of glucosamine compared with regular users were 1.79 (95% CI .69-2.03), 1.88 (95% CI 1.21-2.54) and 1.32 (95% CI 1.05-1.72), respectively. Further subgroup analyses in participants with different baseline characteristics and sensitivity analyses excluding participants who regularly took any other supplements and participants who used self-reports to diagnose diabetes confirmed the findings. CONCLUSIONS: The present study indicated that habitual use of glucosamine was associated with a low risk of individual and composite MALOs among patients with type 2 diabetes and MASLD.

Asunto(s)

Diabetes Mellitus Tipo 2 , Suplementos Dietéticos , Glucosamina , Humanos , Diabetes Mellitus Tipo 2/complicaciones , Glucosamina/uso terapéutico , Glucosamina/efectos adversos , Femenino , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Anciano , Reino Unido/epidemiología , Factores de Riesgo , Suplementos Dietéticos/efectos adversos , Hígado Graso

Asunto(s)

Suplementos Dietéticos , Aceites de Pescado , Cardiopatías , Humanos , Suplementos Dietéticos/efectos adversos , Ácidos Grasos Omega-3/efectos adversos , Aceites de Pescado/efectos adversos , Cardiopatías/inducido químicamente , Riesgo , Adulto , Persona de Mediana Edad , Anciano

RESUMEN

BACKGROUND: In April 2022, French Lentil and Leek Crumble (FLLC), a new frozen food preparation manufactured by Daily Harvest™ (containing Tara flour) was offered as a natural high-protein meal product. Soon thereafter, widespread anecdotal reports of acute gastrointestinal symptoms with liver injury were reported, leading to its voluntary withdrawal in June 2022, after shipment of 28,000 preparations. AIMS: To summarise the clinical and laboratory features of 17 patients with FLLC associated liver injury from the Drug Induced Liver Injury Network (DILIN). METHODS: Patients with FLLC-associated liver injury were enrolled into a prospective protocol and followed for 6 months. Cases were adjudicated by expert opinion causality assessment with summary statistics for data analysis. RESULTS: Enrolled subjects had a mean age of 41 years, 82% were female with mean BMI of 24 kg/m2. All were Caucasian without underlying liver disease. In most cases, abdominal pain and nausea arose within hours of FLLC ingestion. Mean days from ingestion to identification of liver injury was 3.1 days (±2.8). On enrolment, 53% had jaundice, 47% nausea, 24% fever, 59% abdominal pain, 41% itching and 12% rash. The mean initial serum ALT was 475 U/L (±302), AST 315 U/L (±315), alkaline phosphatase 190 U/L (±76), with a total bilirubin of 2.6 mg/dL (±2). In this study, 63% presented with a hepatocellular pattern of liver injury, 6% cholestatic and 31% mixed as determined by the R value. In addition, 24% of patients were hospitalised, and there were no fatalities or liver transplants. Liver biopsy in one subject revealed acute hepatitis with mild ductular reaction, mild lymphocytic and eosinophilic portal inflammation, mild lobular inflammation, preserved bile ducts and absence of interface hepatitis, steatosis, granulomatous reaction or cholestasis. Phylogenetic analysis confirmed the presence of Tara spinosa, the source of Tara flour. CONCLUSIONS: Natural food products are increasingly ubiquitous and may unexpectedly cause significant illness. All clinicians should inquire whether patients are consuming natural food products or herbal supplements and consider them as a potential cause of liver injury.

Asunto(s)

Enfermedad Hepática Inducida por Sustancias y Drogas , Suplementos Dietéticos , Brotes de Enfermedades , Humanos , Femenino , Adulto , Masculino , Enfermedad Hepática Inducida por Sustancias y Drogas/etiología , Suplementos Dietéticos/efectos adversos , Estudios Prospectivos , Persona de Mediana Edad , Adulto Joven

Asunto(s)

Suplementos Dietéticos , Humanos , Suplementos Dietéticos/efectos adversos

RESUMEN

Importance: Knee osteoarthritis is disabling, with few effective treatments. Preliminary evidence suggested that krill oil supplementation improved knee pain, but effects on knee osteoarthritis remain unclear. Objective: To evaluate efficacy of krill oil supplementation, compared with placebo, on knee pain in people with knee osteoarthritis who have significant knee pain and effusion-synovitis. Design, Setting, and Participants: Multicenter, randomized, double-blind, placebo-controlled clinical trial in 5 Australian cities. Participants with clinical knee osteoarthritis, significant knee pain, and effusion-synovitis on magnetic resonance imaging were enrolled from December 2016 to June 2019; final follow-up occurred on February 7, 2020. Interventions: Participants were randomized to 2 g/d of krill oil (n = 130) or matching placebo (n = 132) for 24 weeks. Main Outcomes and Measures: The primary outcome was change in knee pain as assessed by visual analog scale (range, 0-100; 0 indicating least pain; minimum clinically important improvement = 15) over 24 weeks. Results: Of 262 participants randomized (mean age, 61.6 [SD, 9.6] years; 53% women), 222 (85%) completed the trial. Krill oil did not improve knee pain compared with placebo (mean change in VAS score, -19.9 [krill oil] vs -20.2 [placebo]; between-group mean difference, -0.3; 95% CI, -6.9 to 6.4) over 24 weeks. One or more adverse events was reported by 51% in the krill oil group (67/130) and by 54% in the placebo group (71/132). The most common adverse events were musculoskeletal and connective tissue disorders, which occurred 32 times in the krill oil group and 42 times in the placebo group, including knee pain (n = 10 with krill oil; n = 9 with placebo), lower extremity pain (n = 1 with krill oil; n = 5 with placebo), and hip pain (n = 3 with krill oil; n = 2 with placebo). Conclusions and Relevance: Among people with knee osteoarthritis who have significant knee pain and effusion-synovitis on magnetic resonance imaging, 2 g/d of daily krill oil supplementation did not improve knee pain over 24 weeks compared with placebo. These findings do not support krill oil for treating knee pain in this population. Trial Registration: Australian New Zealand Clinical Trials Registry Identifier: ACTRN12616000726459; Universal Trial Number: U1111-1181-7087.

Asunto(s)

Euphausiacea , Aceites de Pescado , Osteoartritis de la Rodilla , Anciano , Animales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Artralgia/tratamiento farmacológico , Artralgia/etiología , Suplementos Dietéticos/efectos adversos , Método Doble Ciego , Imagen por Resonancia Magnética , Aceites/uso terapéutico , Osteoartritis de la Rodilla/tratamiento farmacológico , Osteoartritis de la Rodilla/complicaciones , Dimensión del Dolor , Sinovitis/tratamiento farmacológico , Sinovitis/etiología , Aceites de Pescado/uso terapéutico

Asunto(s)

Receptores ErbB , Zinc , Humanos , Receptores ErbB/antagonistas & inhibidores , Zinc/efectos adversos , Erupciones por Medicamentos/etiología , Suplementos Dietéticos/efectos adversos , Femenino , Masculino , Persona de Mediana Edad , Antineoplásicos/efectos adversos , Anciano

RESUMEN

BACKGROUND: Muscle mass is important for metastatic prostate cancer survival and quality of life (QoL). The backbone of treatment for men with metastatic castration sensitive prostate cancer (mCSPC) is androgen deprivation therapy (ADT) with an androgen signaling inhibitor. ADT is an effective cancer treatment, but it facilitates significant declines in muscle mass and adverse health outcomes important to mCSPC survivors, such as fatigue, and reductions in physical function, independence, insulin sensitivity, and QoL. In non-metastatic CSPC survivors, resistance training (RT) preserves muscle mass and improves these related health outcomes, but the biggest barrier to RT in CSPC survivors of all stages is fatigue. Creatine monohydrate supplementation coupled with RT (Cr + RT) may address this barrier since creatine plays a critical role in energy metabolism. Cr + RT in cancer-free older adults and other clinical populations improves muscle mass and related health outcomes. Evidence also suggests that creatine supplementation can complement cancer treatment. Thus, Cr + RT is a strategy that addresses gaps in survivorship needs of people with mCSPC. The purpose of this parallel, double-blind randomized controlled trial is to test the effects of 52-weeks of Cr + RT compared with placebo (PLA) and RT (PLA + RT) on muscle mass, other related health outcomes, and markers of cancer progression. METHODS: We will carry out this trial with our team's established, effective, home-based, telehealth RT program in 200 mCSPC survivors receiving ADT, and evaluate outcomes at baseline, 24-, and 52-weeks. RT will occur twice weekly with elastic resistance bands, and an established creatine supplementation protocol will be used for supplementation delivery. Our approach addresses a major facilitator to RT in mCSPC survivors, a home-based RT program, while utilizing a supervised model for safety. DISCUSSION: Findings will improve delivery of comprehensive survivorship care by providing a multicomponent, patient-centered lifestyle strategy to preserve muscle mass, improve health outcomes, and complement cancer treatment (NCT06112990).

Asunto(s)

Neoplasias de la Próstata , Entrenamiento de Fuerza , Masculino , Humanos , Anciano , Creatina/uso terapéutico , Creatina/farmacología , Calidad de Vida , Antagonistas de Andrógenos/uso terapéutico , Neoplasias de la Próstata/patología , Andrógenos , Fuerza Muscular , Composición Corporal , Procesos Neoplásicos , Método Doble Ciego , Suplementos Dietéticos/efectos adversos , Músculos/patología , Poliésteres/farmacología , Poliésteres/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto

RESUMEN

Protein powders, including those containing herbal and dietary supplements such as vitamins, minerals, and other natural or synthetic ingredients, can be associated with hepatotoxicity. Protein supplements are often mislabeled and deceptive in their contents. In this self-funded transparent study, we extensively analyzed popular protein supplements in India to identify potential hepatotoxic substances based on industrial standards. All products underwent extensive analysis, including total protein content, fungal aflatoxin detection, pesticide residue estimation, heavy metal quantification, steroid detection, and complete organic and inorganic profiling, according to industry standards. Most protein supplements did not meet the labeled and advertised protein content, while certain brands surpassed the stated levels, raising concerns about potential "protein/amino-spiking." In addition, the major brands contained detectable fungal toxins and pesticide residues. Furthermore, many major formulations contained harmful heavy metals such as lead and arsenic, and some featured hepatoxic herbal extracts, particularly green tea extract, turmeric, Garcinia cambogia, and Ashwagandha. Indian-made products were inferior to those manufactured by multinational companies. The presence of various potentially toxic compounds, such as cycloheptatriene, benzene derivatives, toluene, and isopropyl alcohol, within a nonstandardized and unregulated diverse ingredient mix added to the overall concern. We demonstrate that the protein-based herbal and dietary supplement industry requires stringent scrutiny, regulation, and basic safety studies before being marketed. Manufacturers must consider reducing "ingredient complexities" of their protein powders to prevent adverse interactions between herbal and nonherbal components in consumers. Manufacturers must avoid using known toxic ingredients to reduce the avoidable disease burden within the public community.

Asunto(s)

Arsénico , Metales Pesados , Humanos , Metales Pesados/análisis , Suplementos Dietéticos/efectos adversos , Vitaminas , Antioxidantes

RESUMEN

The highly addictive dietary supplement mimics opioid effects.

Asunto(s)

United States Food and Drug Administration , Estados Unidos , Humanos , Suplementos Dietéticos/efectos adversos , Heroína/efectos adversos , Etiquetado de Medicamentos/normas