Efficacy and safety of a colostrum- and Aloe vera-based oral care protocol to prevent and treat severe oral mucositis in patients undergoing hematopoietic stem cell transplantation: a single-arm phase II study.

Oral mucositis is one of the worst effects of the conditioning regimens given to patients undergoing hematopoietic stem cell transplantation. It is characterized by dry mouth, erythema, mucosal soreness, ulcers, and pain, and it may impact patient outcomes. Bovine colostrum and Aloe vera contain a wide variety of biologically active compounds that promote mucosal healing. A non-randomized phase II study was designed to assess the safety and efficacy of a combined bovine colostrum and Aloe vera oral care protocol to prevent and to treat severe oral mucositis in transplant patients. Two commercially available products were given to patients in addition to the standard protocol: Remargin Colostrum OS® mouthwash and Remargin Colostrum Gastro-Gel® taken orally. Forty-six (78.0%) patients experienced oral mucositis, 40 (67.8%) developed mild-moderate forms, and 6 (10.2%) severe ones. Comparing the study group's outcomes with those of a homogeneous historical control group, severe oral mucositis decreased significantly (10.2% vs. 28.4%; P < 0.01), as did its duration (0.5 ± 1.9 vs. 1.5 ± 3.0 days; P < 0.01). Febrile neutropenia episodes (69.5% vs. 95.1%; P < 0.01) and duration (4.0 ± 4.7 vs. 6.2 ± 4.5 days; P < 0.01) also decreased. These findings show that the experimental protocol seems effective in preventing severe forms of oral mucositis. However, a randomized controlled trial is necessary to confirm this.

Aloe vera and wound healing: a brief review

Abstract Aloe vera possesses a great therapeutic importance in traditional medicine. It has attracted the attention of modern medical fields due to its wide pharmacological applications. The bioactive substances in Aloe vera proved to have antioxidant, anti-inflammatory, antibacterial, and antiviral properties. Taken into our consideration the long history of clinical applications of Aloe vera in traditional medicine, especially for promoting the healing of cutaneous wounds with rare adverse effects, it provides a cheap alternative to many expensive synthetic drugs. Recent techniques in tissue engineering created novel scaffolds based on Aloe gel extracts for wound healing applications. Nonetheless, further guided researche is required to foster the development of Aloe vera based scaffolds for the benefit of worldwide populations. Here, I systemically summarize the main events following wounding and the mechanism of action of Aloe vera in promoting the healing process. I hope to provide a solid piece of information that might be helpful for designing new research studies into this topic.

Oesophageal ulcer due to a herbal remedy.

Herbal-induced oesophageal lesions are rare. We report the case of an 85-year-old male who presented with cough and odynophagia. An upper endoscopy showed white deposit under the proximal oesophageal sphincter. Biopsy of the lesion revealed an oesophageal ulcer with adherent plant material and ruled-out candidiasis. At this point, the patient divulged self-preparation of an herbal remedy consisting of Aloe Vera pulp, whisky, honey, ginger and turmeric. Aloe Vera, ginger and turmeric are commonly used to sooth some gastroenterological symptoms in Complementary and Alternative Medicine. Incorrect extraction of Aloe Vera pulp and adding honey to it transformed the recipe into a sticky paste that may have injured the oesophageal mucosa. Follow-up showed that the cough and odynophagia subsided after discontinuing this herbal remedy.

Small Bowel Obstruction Caused by Aloe vera Bezoars: A Case Report.

Small bowel obstruction is a clinical condition commonly caused by postoperative adhesion, volvulus, intussusceptions, and hernia. Small bowel obstruction due to bezoars is clinically uncommon, accounting for approximately 2-4% of all obstructions. Computed tomography (CT) is a useful method in diagnosing the cause of small bowel obstruction. However, small bowel obstruction caused by bezoars may not be detected by an abdominal CT examination. Herein, we report a rare case of small bowel obstruction by Aloe vera bezoars, which were undetected by an abdominal CT. Phytobezoars should be included in the differential diagnosis of small bowel obstruction in patients with predisposing factors, such as excessive consumption of high-fiber food and diabetes.

Aloe vera-induced acute liver injury: A case report and literature review.

Recent data suggest that herbal and dietary supplements are the second most common cause of liver injury. We herein report a case of acute liver injury in a 68-year old female caused by ingestion of Aloe vera. Upon discontinuation of the oral Aloe vera, liver function tests (LFT) returned to normal levels. Thus, it is crucial to consider the use of herbal products as causative agents of acute liver injury.

Contact dermatitis as an adverse reaction to some topically used European herbal medicinal products - part 1: Achillea millefolium-Curcuma longa.

This review focuses on contact dermatitis as an adverse effect of a selection of topically used herbal medicinal products for which the European Medicines Agency has completed an evaluation up to the end of November 2013 and for which a Community herbal monograph has been produced. Part 1: Achillea millefolium L.-Curcuma longa L.

Herbal hepatotoxicity: analysis of cases with initially reported positive re-exposure tests.

BACKGROUND: Positive re-exposure tests are diagnostic hallmarks for hepatotoxicity. OBJECTIVE: To test validity of positive re-exposures in herb induced liver injury. METHODS: We searched Medline database for cases of herb induced liver injury with positive re-exposures and analysed 34 cases for positive re-exposure test criteria of baseline alanine aminotransferase< 5N before re-exposure, and re-exposure alanine aminotransferase ≥ 2× baseline alanine aminotransferase. Re-exposure test was negative, if baseline alanine aminotransferase< 5N combined with re-exposure alanine aminotransferase< 2× baseline alanine aminotransferase, or if baseline alanine aminotransferase≥ 5N regardless of the re-exposure alanine aminotransferase including no available re-exposure alanine aminotransferase result. RESULTS: In 21/34 cases (61.8%), criteria for a positive re-exposure were fulfilled, with negative tests in 6/34 cases (17.6%) or uninterpretable ones in 7/34 cases (20.6%). Confirmed positive re-exposure tests established potential of herb induced liver injury for Aloe, Chaparral, Chinese herbal mixtures, Chinese Jin Bu Huan, Chinese Syo Saiko To, Germander, Greater Celandine, Green tea, Kava, Mistletoe, Polygonum multiflorum, and Senna, with up to 4 case reports per herb. CONCLUSIONS: Among 34 cases of herb-induced liver injury with initially reported positive re-exposure tests, 61.8% of the cases actually fulfilled established test criteria and provided firm diagnoses of herb induced liver injury by various herbs.

Propriedades farmacológicas da Aloe vera (L. ) Burm. f / Pharmacological activities of Aloe vera (L. ) Burm. f

A Aloe vera (L.) Burm.f. tem sido utilizada há milhares de anos na medicina tradicional para o tratamento de diversos males. O intuito desse trabalho foi o levantamento bibliográfico de artigos que evidenciassem a atividade farmacológica da Aloe vera. A revisão contemplou livros e periódicos nacionais e internacionais indexados nas bases de dados MEDLINE, LILACS e SciElo, nos idiomas português, inglês e espanhol, utilizando as palavras-chave citadas. Após o levantamento bibliográfico, constatou-se que várias atividades biológicas são atribuídas a Aloe vera. Evidências sugerem eficácia no tratamento da psoríase, herpes genital, queimaduras e hiperglicemia. Além disto, também foram demonstradas atividades antineoplásica, antimicrobiana, anti-inflamatória e imunomodulatória por estudos in vitro e in vivo, entretanto, na cicatrização de feridas, os resultados foram conflitantes. No tratamento de dermatite por radiação e em queimaduras solares sua eficácia não foi comprovada e foram relatados casos de hepatite aguda devido ao consumo de preparações orais. Tendo em vista as várias atividades comprovadas e poucos relatos acerca de sua contra indicação, conclui-se que o uso desta espécie corrobora o vasto uso popular.

The Aloe vera (L.) Burm.f. has been used for thousands of years in traditional medicine to treat various ailments. The aim of this study was to carry out a bibliographical review on the pharmacological activity of Aloe vera. This review included books and national and international journals indexed to MEDLINE, LILACS and SciELO, in Portuguese, English and Spanish, using the key words mentioned. After the literature review, we found that several biological activities have been attributed to Aloe vera. Evidence suggests efficacy in the treatment of psoriasis, genital herpes, burns and hyperglycemia. Moreover, antineoplastic, antimicrobial, anti-inflammatory and immunomodulatory activities have also been demonstrated by in vitro and in vivo studies; however, in wound healing, the results were conflicting. In the treatment of radiation dermatitis and sunburn, its efficacy has not been proven, and cases of acute hepatitis from the consumption of oral preparations have been reported. Considering the various proven activities and the few reports about the contraindications of Aloe vera, we conclude that the use of this species confirms its wide popular usage.

Review of the efficacy of green tea, isoflavones and aloe vera supplements based on randomised controlled trials.

We assess the evidence for health benefits of three commonly consumed plant food supplements (PFS), green tea, isoflavone and aloe vera, based on published systematic reviews of randomised controlled trials (RCTs). Whilst the potential benefits of green tea have been reported in a wide range of health areas, it is only in the area of the metabolic syndrome that the number of RCTs is approaching sufficient to judge such efficacy. Isoflavone supplements are widely used, and RCTs indicate that they affect bone resorption at lower doses in postmenopausal women undergoing estrogen-related bone loss, but this is only translated to attenuation of bone loss at higher doses of isoflavones. A systematic review on RCTs concluded that the effects of isoflavones on hot flashes in postmenopausal women were highly variable and no conclusions could be drawn. Despite the popularity of aloe vera as a PFS, the evaluation of its efficacy as a coadjuvant therapy for certain metabolic or digestive pathologies remains scarce; it constitutes a typical example of a naturally occurring ingredient whose efficacy in topical applications presupposes its efficacy in systemic applications. Nevertheless, its possible toxic effects on oral consumption call for caution in its utility as a PFS. Since 2007, efficacy evaluation of PFS in Europe has been covered by European Union Nutrition and Health Claims legislation. The European Food Safety Authority has adopted an approach relying on RCTs, while medicinal effects are accepted based on traditional use. In general, there are insufficient RCTs for claims to be made, and conclusive results on PFS should be obtained in the future by conducting studies with more homogeneous populations, by using supplements with optimised and measured bioavailability, and by conducting larger RCTs.

Utilização da babosa no cotidiano de usuários portadores de câncer / Use of aloe in the daily life of patients with cancer / Utilización de la aloe en el cotidiano de pacientes portadores de cáncer

O estudo teve como objetivo investigar a utilização da Aloe spp. pelos usuários portadores de câncer, no tratamento da doença. Trata-se de um estudo qualitativo, descritivo e exploratório, realizado em um município do Sul do Rio Grande do Sul com onze usuários portadores de câncer internados no Programa de Internação Domiciliar Interdisciplinar (PIDI)Oncológico. Destes, nove sabiam sobre a possibilidade de utilização da Aloe spp. para o câncer e apenas três referiram sua utilização para auxiliar no tratamento. A Aloe spp. foi utilizada pelos usuários, visando auxiliar no tratamento do câncer, sem abandonar o tratamento convencional. Concluiu-se que, apesar de os entrevistados terem relatado o uso da babosa, não se encontraram estudos que confirmassem suas propriedades anticancerígenas.

The objective of this study is to investigate the use of Aloe spp. by users with cancer,in the treatment of the disease. This is a descriptive, exploratory and qualitative study carried out in a municipality of Rio Grande do Sul with 11 users with cancer interned interned at the Oncological Interdisciplinary Home Care Program (IHCP). Nine out of the eleven patients had heard of the possibility of using Aloe spp. for cancer treatment and the remaining three reported having used it as a support in the treatment. Aloe spp. was used by the patients as an auxiliary a cancer treatment, without abandoning the conventional one. It was concluded that inspite of the fact that the interviewees reported having used of Aloe, no studies were found to confirm its anti-cancer properties.

El estudio tuvo como objetivo investigar el uso de la Aloe spp., por pacientes portadores de cáncer, en el tratamiento de la enfermedad. Se trata de un estudio cualitativo, descriptivo y exploratorio, realizado en un municipio, del Sur del Rio Grande do Sul, con once pacientes portadores de cáncer internados en el Programa de Internación Domiciliario Interdisciplinario (PIDI)Oncológico. De estos, nueve sabían sobre la posibilidad de la utilización del Aloe spp. para el cáncer y solo tres refirieron su uso como auxiliar en el tratamiento. El Aloe spp. fue utilizado por los pacientes, con la finalidad de auxiliar en el tratamiento del cáncer, sin abandonar el tratamiento convencional. Se concluye que, a pesar de que los encuestados hayan relatado sobre el uso del Aloe, no se encontraron estudios que confirmasen sus propiedades anticancerígenas.

Oral Aloe vera as a treatment for osteoarthritis: a summary.

While pain relief is a basic tenet of health care, pain is under-treated in the UK (Davies and Mcvicar, 2000) and this issue remains unresolved. This paper suggests that oral Aloe vera could be used in the treatment of chronic non-cancer pain (CNCP), particularly that caused by osteoarthritis (OA). Despite being used as arthritis treatment for centuries (Yoo et al, 2008), evidence of effectiveness of Aloe vera is anecdotal or from small studies. The perceived benefits of prescribing Aloe vera for OA may be twofold: it has utility as an anti-inflammatory agent and also as a prophylactic against the gastrointestinal irritant effects of non-steroidal anti-inflammatory drugs (NSAIDs). Long-term, randomized, controlled studies are still needed to address the lack of evidence informing optimum prescribing of pain medication for people with OA (Cowan, 2007). There is no reason that so called 'nutraceutical' agents should not be subjected to the same rigorous randomized, controlled, double-blind trials as other 'mainstream' drugs. Therefore, it is appropriate to ask whether NSAID treatment and side effects can be improved by the addition of oral Aloe vera. Thus, we may then be in a more informed position to resolve the ongoing 'Pandemonium over Painkillers' (Cowan, 2007).

Aloe-induced toxic hepatitis.

Aloe has been widely used in phytomedicine. Phytomedicine describes aloe as a herb which has anti-inflammatory, anti-proliferative, anti-aging effects. In recent years several cases of aloe-induced hepatotoxicity were reported. But its pharmacokinetics and toxicity are poorly described in the literature. Here we report three cases with aloe-induced toxic hepatitis. A 57-yr-old woman, a 62-yr-old woman and a 55-yr-old woman were admitted to the hospital for acute hepatitis. They had taken aloe preparation for months. Their clinical manifestation, laboratory findings and histologic findings met diagnostic criteria (RUCAM scale) of toxic hepatitis. Upon discontinuation of the oral aloe preparations, liver enzymes returned to normal level. Aloe should be considered as a causative agent in hepatotoxicity.

Aloe vera as a functional ingredient in foods.

The main scientific discoveries on Aloe vera published mainly in the last three decades are presented in this work. After describing Aloe from a botanical point of view, the papers related with the chemical composition of different parts of the leaf of Aloe, particularly those in which the gel is described and are presented in a synthetic manner. The chemical analyses reveal that Aloe gel contains mannose polymers with some glucose and other sugars, among which the most important is Acemannan. Besides these, other components such as glycoproteins, enzymes, amino acids, vitamins, and minerals are described. Different factors also affecting the chemical composition of the gel, such as species and variety, climatic and soil conditions, cultivation methods, processing and preservation, are enumerated and discussed. On the other hand, the main therapeutic applications have been revised and the possible damaging effects of Aloe are also commented upon. A special emphasis is placed on the biologically active compounds or groups of compounds responsible for the therapeutic applications and which are their action mechanisms. The paper concludes that more research is needed to confirm the therapeutic and beneficial effects and to definitively clarify the myth surrounding Aloe vera. A general view on the problem of the commercialization and establishment of the quality and safety of Aloe products in the food industry has been offered here. The main points and European regulations that need to be considered regarding the quality control of prepared Aloe products are presented in this paper.

Determinación de microelementos en acíbar de hojas de zábila (Aloe vera (L.) Burm. f.) / Determination of microelements in exudate from leaves of zábila (Aloe vera (L.) Burm. f.)

En esta investigacion se estudio la concentracion de microelementos tales como cobre, zinc, manganeso y hierro en el acibar de hojas de zabila, por espectrometria de absorcion atomica en llama (FAAS); asimismo, la concentracion de cromo por espectrometria de absorcion atomica electrotermica (ETAAS). Las plantas fueron cultivadas en la ciudad de Coro, estado Falcon, Venezuela. Las muestras de aci bar se recolectaron en hojas internas, medias y externas de la planta. Luego, se secaron por liofilizacion y se mineralizaron: 0,25 g de muestra de acibar se sometio a digestion humeda por 1 hora a 70 oC en una plancha de calentamiento, con 1:2 HNO3 y H2O2. No se encontro efecto de matriz, ya que no hubo diferencia estadisticamente significativa entre la pendiente de la curva de calibracion acuosa y la obtenida por adicion de estandar. El estudio de recuperacion fue satisfactorio, siendo el valor promedio 97,02 ± 4,65%. La exactitud del metodo se evaluo utilizando material certificado de la National Bureau of Standards (NBS) 1572, no encontrandose diferencias estadisticamente significativas entre los valores de los metales contenidos en el material de referencia con los valores obtenidos con el metodo aplicado en esta investigacion. Con relacion a la precision, el promedio de la desviacion estandar relativa fue de 1,26%, lo que certifica la precision del metodo empleado. Las concentraciones de metales (media poblacional ± intervalos de confianza) encontradas fueron las siguientes: Cu: 1.604 ± 0.296 mg/g, zn: 6.381 ± 0.974 mg/g, Fe: 14.609 ±3.161 mg/g, Mn: 5.058 ± 0.307 mg/g y Cr: 13.174 ± 3.046 mg/g. El metodo empleado fue exacto, preciso y libre de interferencias.

In this investigation was studied the concentration of microelements such as: Cu, zn, Fe and Mn in Aloe vera (L.) Burm. f. leaves exudates by atomic absorption spectrometry (FAAS), also the Cr concentration was determined by electrothermal atomic absorption spectrometry (ETAAS). The plants were cultivated in Coro city, Falcon state, Venezuela. The exudates samples were recollected from internal external and intermediate leaves of the plant. It was digested for 1 hour in a hot plate at 70 oC 0.25g of lyophilized exudates with 1:2 nitric acidic and hydrogen peroxide. It was no found significatives statistics difference at 95% of confidence between the standard calibration curve and the aqueous calibration curve, so no matrix effect was observed. The recovery studies was satisfactory, the mean value was 97.02 ± 4.65%. It was no found significatives statistics differences at 95% of confidence between the certificated values from The National Bureau of Standards (NBS) 1572 of studied metals and the values found with the applied methodology, so the method applied was accurate. The precision of the method was 1.26%. The concentrations of these elements in the real samples were: Cu: 1,604 ± 0,296 mg/g; zn: 6,381 ± 0,974 mg/g; Fe: 14,609 ± 3,161 mg/g; Mn: 5,058 ± 0,307 mg/g and Cr: 13,174 ± 3,046 mg/g. The method used to determine these elements was exact, precise and free from interferences.

Estimation of tolerable upper intake level (UL) of active aloe.

It has been reported that an active aloe polysaccharide isolated from Aloe barbadensis Miller exerted various pharmacological effects, such as anti-inflammatory, wound healing, anti-hepatitis, anti-gastric ulcer, and anti-tumorigenicity in animals. Adverse health effects of aloe are of concern in humans. Therefore, this study was conducted to investigate a tolerable upper intake level (UL) of active aloe or a maximal allowable daily intake (ADImax) of active aloe based on 4-wk oral toxicity investigation in ICR mice. An active aloe was daily administered to male and female ICR mice for 4 wk at different dose levels (0, 120, 600, 3000, or 15,000 mg/kg body weight [bw]). All animals were sacrificed at the end of the experiment and changes of body weight, food consumption, organ weights, and hematological and biochemical parameters were recorded. In this study, no changes in clinical signs, urinalysis, or hematological or biochemical analysis were observed. In females, a dose-dependent quantitative decrease in albumin (ALB) levels was observed, but it was not significant, due to wide interindividual variations. A significant decrease in male kidney weight was observed from the 120-mg/kg to the 15,000-mg/kg bw treatment groups, and blood urea nitrogen (BUN) levels were also quantitatively lower. A dose-dependent reduction in the body weight of females was also observed, which might be related to less food consumption. Based on the reduced kidney weights in males, the lowest-observed-adverse-effect level (LOAEL) of an active aloe was estimated to be 120 mg/kg bw in male ICR mice, and the UL or ADImax was 0.4 mg/kg bw/d [(120 mg/kg bw/d)/(100 for safety factor) x (3 for modifying factor)], or 24 mg for a 60-kg adult (24 mg x 200 = 4.8 g of aloe gel/d/adult), assuming that consumers utilize active aloe for a month. Data showed that an active aloe did not induce any remarkable subacute toxic effects, but decreased male kidney weights, which requires further investigation.

[Severe acute hepatitis associated with intake of Aloe vera tea]. / Hepatitis aguda grave asociada al consumo de té de Aloe vera.

We present a 26-year-old man who developed severe acute hepatitis after consumption of an Aloe vera tea. On admission, the patient showed characteristic biochemical and clinical features of acute hepatitis and liver failure. The patient reported that he had been drinking an Aloe vera tea 2-4 weeks before symptom onset. Other causes of acute hepatitis were excluded and the patient improved after withdrawal of the Aloe vera tea. Aloe vera should be considered as a possible cause in cases of acute hepatitis.