RESUMO
INTRODUCTION: Herbal medicines (HMs) are commonly used during the postpartum period in South Korea. However, the safety concerns associated with these medicines remain unresolved. This study aims to establish a registry of patients receiving HM treatment during the postpartum period and collect clinical data on treatments and adverse reactions to build evidence evaluating the safety of HM use. METHODS AND ANALYSIS: This study will use a prospective observational registry, including patients admitted to the obstetrics and gynaecology department of the Woosuk University Korean Medicine Hospital's postpartum care centre. A total of 1000 eligible patients visiting the Korean medicine hospital to recover from various postchildbirth symptoms and opting for HM treatment will be enrolled in the registry. For safety assessment, demographic information, medical history, adverse events (AEs) and treatment details, including HM prescription and concomitant medication usage, will be collected throughout the patient's hospitalisation period at the postpartum care centre for analysis. Adverse reactions will be monitored daily during hospitalisation, and collected AEs will be analysed for causality using the WHO Uppsala Monitoring Centre causality assessment and the Naranjo Algorithm Score. ETHICS AND DISSEMINATION: This study was approved by the Institutional Review Board of Woosuk University Korean Medicine Medical Center (WSOH IRB H2311-03-01). The results will be published in peer-reviewed journals or disseminated through conference presentations. TRIAL REGISTRATION NUMBER: KCT0009060.
Assuntos
Período Pós-Parto , Sistema de Registros , Humanos , Feminino , República da Coreia , Estudos Prospectivos , Gravidez , Medicina Tradicional Coreana , Fitoterapia/efeitos adversos , Adulto , Medicina HerbáriaRESUMO
Background: Consumption of herbal medicines among people living with HIV is a common practice in Sub-Saharan Africa. The utilization of herbal medicines was at 17.5% and 67.9% in Malawi and Nigeria, respectively. There is inadequate data on use and adverse reactions (ADRs) reporting of herbal medicines among people living with HIV (PLWHIV). This study was designed to investigate use and ADRs reporting of herbal medicines among PLWHIV at the University Teaching Hospitals in Blantyre, Malawi and Ibadan, Nigeria. Methodology: A cross-sectional study was conducted among PLWHIV attending Antiretroviral Therapy (ART) clinic at Queen Elizabeth Central Hospital, Blantyre, Malawi and University College Hospital, Ibadan, Nigeria. A structured questionnaire was administered to 360 and 370 participants in Blantyre and Ibadan respectively, through face-to-face interviews after obtaining their informed consent. Results: The prevalence of herbal medicines use among PLWHIV in Malawi and Nigeria was at 80.6% and 55.7% (p<0.001), respectively. The most frequently used herbal medicines in Malawi were Aloe vera (14.0%), Moringa oleifera (14.0%), Zingiber officinale (13.0%) and Allium sativum (7.0%). Likewise, in Nigeria, the most commonly used herbal medicines were Zingiber officinale (15.0%), Vernonia amygdalina (14.0%), Moringa oleifera (9.0%), and Allium sativum (11.0%). The major reason for herbal medicines' use in Malawi was ready availability (42.1%) and perception that it boosts immunity (44.6%) in Nigeria. The PLWHIV reported experiencing suspected herbal medicine ADRs in Malawi (3.9%) and in Nigeria (8.0%). Conclusion: A higher percentage of people living with HIV are using herbal medicines in Malawi as well as in Nigeria. In both countries, a few participants reported experiencing suspected ADRs related to herbal medicines.
Assuntos
Infecções por HIV , Hospitais de Ensino , Fitoterapia , Humanos , Estudos Transversais , Nigéria/epidemiologia , Feminino , Masculino , Adulto , Infecções por HIV/tratamento farmacológico , Malaui/epidemiologia , Pessoa de Meia-Idade , Inquéritos e Questionários , Fitoterapia/efeitos adversos , Fitoterapia/estatística & dados numéricos , Medicina Herbária/estatística & dados numéricos , Preparações de Plantas/efeitos adversos , Prevalência , Adulto Jovem , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Conhecimentos, Atitudes e Prática em Saúde , AdolescenteRESUMO
A 37-year-old woman presented with nausea, vomiting and headache. She was found to be profoundly hyponatraemic with a sodium of 121 mmol/L, which deteriorated following a fluid challenge. An initial hyponatraemia screen identified adrenal insufficiency, with cortisol of 48 nmol/L. History confirmed she had been taking the herbal plant, ashwagandha. After 3 days of fluid restriction and steroid replacement, her sodium returned to normal (139 mmol/L). This article reviews the possible harmful effects of over-the-counter herbal remedies and highlights the importance of considering a wide differential diagnosis in patients presenting with non-specific symptoms.
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Insuficiência Adrenal , Hiponatremia , Humanos , Feminino , Adulto , Insuficiência Adrenal/induzido quimicamente , Insuficiência Adrenal/diagnóstico , Insuficiência Adrenal/tratamento farmacológico , Fitoterapia/efeitos adversos , Preparações de Plantas/efeitos adversos , Diagnóstico DiferencialRESUMO
BACKGROUND: Herbal decoctions (HDs) are the oldest and most common herbal medicine formulations. Different HDs exist, and some consumers are concerned that they may become contaminated during manufacturing. Therefore, the need for a safety assessment of HDs has been raised. This study aimed to investigate the adverse events (AEs) associated with HDs by comprehensively analyzing randomized controlled trials (RCTs) using systematic reviews and meta-analyses. METHODS: A systematic search was conducted on PubMed, Embase, and the Cochrane Library for articles published up to November 2022. The included RCTs compared HDs with other treatments published between 2013 and 2022, and the risk of bias was assessed using RevMan 5.4. Meta-analyses of the number of AEs associated with HDs reported in the included RCTs were also performed. RESULTS: The systematic review included 26 RCTs, and the meta-analysis included 17 RCTs that reported AEs. The meta-analysis comparing HDs with active controls showed that both the number of AEs (14 studies; risk ratio (RR)= 0.50 cases, 95 % confidence interval (CI) [0.29, 0.88]; I2 = 42 %) and the number of patients who complained of AEs (seven studies; RR=0.51 patients, 95 % CI [0.28, 0.94]; I2 =9 %) were fewer in the HDs group than in the active control groups. CONCLUSION: This study showed that HDs are safer than other conventional medications based on the results of qualitative and quantitative syntheses of RCTs.
Assuntos
Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Medicamentos de Ervas Chinesas/efeitos adversos , Medicamentos de Ervas Chinesas/uso terapêutico , Fitoterapia/efeitos adversos , Preparações de Plantas/efeitos adversos , Preparações de Plantas/uso terapêuticoRESUMO
Use of herbal medications and supplements has experienced immense growth over the last two decades, with retail sales in the USA exceeding $13 billion in 2021. Since the Dietary Supplement Health and Education Act (DSHEA) of 1994 reduced FDA oversight, these products have become less regulated. Data from 2012 shows 18% of U.S. adults used non-vitamin, non-mineral natural products. Prevalence varies regionally, with higher use in Western states. Among preoperative patients, the most commonly used herbal medications included garlic, ginseng, ginkgo, St. John's wort, and echinacea. However, 50-70% of surgical patients fail to disclose their use of herbal medications to their physicians, and most fail to discontinue them preoperatively. Since herbal medications can interact with anesthetic medications administered during surgery, the American Society of Anesthesiologists (ASA) and the American Association of Nurse Anesthetists (AANA) recommend stopping herbal medications 1-2 weeks before elective surgical procedures. Potential adverse drug effects related to preoperative use of herbal medications involve the coagulation system (e.g., increasing the risk of perioperative bleeding), the cardiovascular system (e.g., arrhythmias, hypotension, hypertension), the central nervous system (e.g., sedation, confusion, seizures), pulmonary (e.g., coughing, bronchospasm), renal (e.g., diuresis) and endocrine-metabolic (e.g., hepatic dysfunction, altered metabolism of anesthetic drugs). During the preoperative evaluation, anesthesiologists should inquire about the use of herbal medications to anticipate potential adverse drug interactions during the perioperative period.
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Interações Ervas-Drogas , Preparações de Plantas , Humanos , Preparações de Plantas/efeitos adversos , Preparações de Plantas/administração & dosagem , Período Perioperatório , Suplementos Nutricionais/efeitos adversos , Assistência Perioperatória/métodos , Anestésicos/efeitos adversos , Anestésicos/administração & dosagem , Fitoterapia/efeitos adversos , Estados Unidos , Interações MedicamentosasRESUMO
BACKGROUND: The use of herbal medicines is on the rise throughout the world due to their perceived safety profile. However, incidences of herb-drug, herb-herb and herb-food interactions considering safety aspects have opened new arenas for discussion. OBJECTIVE: The current study aims to provide comprehensive insights into the various types of herb interactions, the mechanisms involved, their assessment, and historical developments, keeping herbal safety at the central point of discussion. METHODS: The authors undertook a focused/targeted literature review and collected data from various databases, including Science Direct, Wiley Online Library, Springer, PubMed, and Google Scholar. Conventional literature on herbal remedies, such as those by the WHO and other international or national organizations. RESULTS: The article considered reviewing the regulations, interaction mechanisms, and detection of herb-herb, herb-drug and herb-food interactions in commonly used yet vital plants, including Glycyrrhiza glabra, Mentha piperita, Aloe barbadensis, Zingiber officinale, Gingko biloba, Withania somnifera, etc. The study found that healthcare professionals worry about patients not informing them about their herbal prescriptions (primarily used with conventional treatment), which can cause herb-drug/herb-food/herb-herb interactions. These interactions were caused by altered pharmacodynamic and pharmacokinetic processes, which might be explained using in-vivo, in-vitro, in-silico, pharmacogenomics, and pharmacogenetics. Nutrivigilance may be the greatest method to monitor herb-food interactions, but its adoption is limited worldwide. CONCLUSION: This article can serve as a lead for clinicians, guiding them regarding herb-drug, herb-food, and herb-herb interactions induced by commonly consumed plant species. Patients may also be counseled to avoid conventional drugs, botanicals, and foods with a restricted therapeutic window.
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Interações Ervas-Drogas , Humanos , Plantas Medicinais/efeitos adversos , Plantas Medicinais/química , Preparações de Plantas/efeitos adversos , Animais , Interações Alimento-Droga , Fitoterapia/efeitos adversosRESUMO
The use of herbal drugs as alternative and complementary medicine has increased in popularity, raising concerns about their safety profile. Aloe vera, a plant with diverse therapeutic properties, has been extensively used for centuries. This review aims to assess the therapeutic activity and safety profile of Aloe vera. A comprehensive literature search was conducted to gather relevant information from various biomedical databases. The chemical composition, mechanism of action, and therapeutic activities of Aloe vera were analyzed. Aloe vera contains numerous active components such as vitamins, enzymes, minerals, sugars, lignin, saponins, and anthraquinones. Its mechanisms of action involve collagen synthesis, anti-inflammatory effects, immune modulation, laxative properties, and antiviral activity. Aloe vera has demonstrated potential therapeutic benefits in wound healing, diabetes management, liver and kidney protection, and glycemic control. However, it is essential to consider potential side effects, such as skin irritation and allergic reactions. This review provides evidence-based information to improve patient safety and promote informed decisions regarding the use of Aloe vera as a therapeutic agent.
Assuntos
Aloe , Aloe/efeitos adversos , Aloe/química , Humanos , Extratos Vegetais/efeitos adversos , Extratos Vegetais/uso terapêutico , Animais , Fitoterapia/métodos , Fitoterapia/efeitos adversos , Anti-Inflamatórios/uso terapêutico , Anti-Inflamatórios/efeitos adversos , Anti-Inflamatórios/farmacologiaRESUMO
The use of herbal medicines is increasing worldwide. While the safety profile of many herbal medicines is promising, the data in the literature show important interactions with conventional drugs that can expose individual patients to high risk. The aim of this study was to investigate the experience of the use of herbal medicines and preparations and the risks of interactions between herbal and conventional medicines among Latvian citizens. Data were collected between 2019 and 2021 using a structured questionnaire designed for pharmacy customers in Latvia. Electronic databases such as Drugs.com, Medscape, and European Union herbal monographs were reviewed for the risk of drug interactions and potential side effects when herbal medicines were involved. The survey included 504 respondents. Of all the participants, 77.8% used herbal preparations. Most of the participants interviewed used herbal remedies based on the recommendation of the pharmacist or their own initiative. A total of 38.3% found the use of herbal remedies safe and harmless, while 57.3% of respondents regarded the combination of herbal and regular drugs as unsafe. The identified herbal medicines implicated in the potential risk of serious interactions were grapefruit, St. John's wort, and valerian. As the risks of herb-drug interactions were identified among the respondents, in the future, both pharmacy customers and healthcare specialists should pay more attention to possible herb-drug interactions of over-the-counter and prescription medications.
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Plantas Medicinais , Medicamentos sob Prescrição , Humanos , Letônia , Fitoterapia/efeitos adversos , PrescriçõesRESUMO
PURPOSE: To mitigate side effects of conventional cancer care and improve quality of life, many patients with breast cancer in German-speaking countries opt for mistletoe therapy in addition to standard treatment. To understand the value for users, we evaluated the domain "Patient and Social aspects" in a health technology assessment on complementary mistletoe therapy in patients with breast cancer. METHODS: A systematic review was conducted according to PRISMA guidelines. Fifteen electronic databases and the internet were searched. Qualitative studies were analyzed using qualitative content analysis; quantitative studies were systematically summarized in evidence tables. RESULTS: Seventeen studies out of 1203 screened publications with 4765 patients and 869 healthcare professionals were included in the review. The median proportion of patients using mistletoe therapy was 26.7% (range: 7.3-46.3%). Predictors for use were younger age and higher educational level. Main reasons for patients' use of mistletoe therapy were to leave nothing untried and to be actively involved in the treatment process. Reasons against use were related to a lack of knowledge or uncertainty regarding effectiveness and safety. Physicians mainly aimed to support the patient's physical condition as main reason for use and a lack of resources and knowledge as main reason against use. CONCLUSION: Mistletoe therapy was commonly used in the treatment of breast cancer despite a lack of scientific knowledge among patients and physicians. Transparent communication on motivation for use and its potential effect enables realistic expectations. Relatively small samples of mistletoe therapy users limit the representativeness and validity of our results.
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Antineoplásicos Fitogênicos , Neoplasias da Mama , Erva-de-Passarinho , Viscum album , Humanos , Feminino , Extratos Vegetais/uso terapêutico , Fitoterapia/efeitos adversos , Fitoterapia/métodos , Qualidade de Vida , Avaliação da Tecnologia Biomédica , Antineoplásicos Fitogênicos/efeitos adversos , Neoplasias da Mama/tratamento farmacológicoRESUMO
PURPOSE OF REVIEW: Pathologies of the prostate in men are one of the most prevalent clinical conditions today [1]. Specifically, pelvic inflammatory disease such as prostatitis can cause symptoms and syndromes different from urological ones, such as bowel or nervous system manifestations. This has a largely negative impact on the quality of life of patients. Therefore, it is convenient to know and update the information about the therapeutic approach to prostatitis, which is a challenge that involves different medical specialties. The aim of this article is to provide summarized and focused evidence to help in the therapeutic approach of patients with prostatitis. A computer-based search of the PubMed and Cochrane Library databases was used to perform a comprehensive literature review on prostatitis, with special interest in recent findings and latest therapeutic guideline recommendations. RECENT FINDINGS: Recent discoveries about the epidemiology and clinical classifications of prostatitis seem to incur in an increasingly individualized and directed management, with the aim of covering all the confluent factors in prostatic inflammatory pathology. In addition, the role of new drugs and combination with phytotherapy open up a range of new treatment possibilities, although future randomized studies will be necessary to better understand how to use all treatment modalities. Despite all the knowledge acquired about the pathophysiology of prostate diseases, and due to their interrelation with other pelvic systems and organs, there are still gaps that make it difficult for us to provide an optimal and standardized treatment in many of our patients. Being aware of the influence of all the factors potentially involved in prostate symptoms is crucial for a correct diagnosis and establishing an effective treatment plan.
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Prostatite , Masculino , Humanos , Doença Crônica , Prostatite/diagnóstico , Qualidade de Vida , Dor Pélvica/terapia , Fitoterapia/efeitos adversosRESUMO
BACKGROUND: Plant remedies are often used next to conventional standard of care by cancer patients. However, user rates are often underestimated and physicians usually feel not equipped to counsel patients. Hence, routinely recording the use of phytotherapy and sufficient knowledge on herbal medicine of the medical staff are required to improve the situation. Appraising the current state of knowledge of medical students may offer insight if education on herbals needs improvement. Here, we propose a simple anamnesis tool to assess knowledge and usage pattern of medical plants and demonstrate how to extrapolate symptom cluster participants associated with plants investigated in this study focussing on the common symptom of oral discomfort. METHODS: By screening German literature (popular science, specialist's literature, books for the interested layman) on medical plants used for treating oral discomfort, we were able to deviate a list of plants most often recommended for treating oral discomfort and to develop an anamnesis tool to assess knowledge and usage of 16 different plants. A group of 120 head-neck cancer patients (under surveillance, after receiving treatment) and 168 medical students were questioned at a collaborating out-patient clinic and via an online survey, respectively, in 2020. Students were additionally asked to write down indications of the plants they used in daily life. Knowledge and usage pattern were compared between both groups. Primary component analysis and heat-map analysis were used to visualize common and distinguishing features. Network analysis and VENN diagrams were used to extrapolate data of the medical students' cohort. RESULTS: Head-neck cancer patients and students show similar knowledge. However, students used significantly more plants in daily life than patients (p < 0.001). Overall, the user rate of patients and students were 82.50 and 93.94%, respectively. The top five most commonly known plants were similar in both groups (Marticaria recutita L., Zingiber offinicale ROSCOE, Taraxacum Wigg. Calendula officinalis L.) with the exception of Salvia officinalis L. (patients' cohort) and Carum carvi/Cuminum cyminum L. (students' cohort). Despite this slight difference, usage pattern of the top five most commonly used plants was the same between the groups. Students' indications were compared to indications found in the literature, unmasking several differences between commonly practiced and written knowledge on German phytotherapy. Network analysis revealed, that students associated certain plants with corresponding symptom clusters (e.g., coughing, oral mucositis). CONCLUSION: The majority of surveyed cancer patients as well as medical students use phytotherapy for treating oral discomfort. Both groups know and use similar plants. However, indications of written folk medicine differ from the lived and practiced tradition.
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Neoplasias de Cabeça e Pescoço , Plantas Medicinais , Estudantes de Medicina , Humanos , Fitoterapia/efeitos adversos , Alemanha/epidemiologia , Neoplasias de Cabeça e Pescoço/tratamento farmacológicoRESUMO
BACKGROUND: Complementary and alternative medicine (CAM) is used by about 40-90% of all patients with cancer. CAM also includes phytotherapy, which is considered to be a biologically based therapy. Depending on the survey, the users of phytotherapy account for up to 80%. The intention of the users is to fight cancer or to alleviate its symptoms. OBJECTIVES: Frequently used phytotherapeutics with their level of evidence and possible pitfalls are presented in a narrative review. Special attention is given to the uro-oncological context. MATERIALS AND METHODS: Popular phytotherapeutics (mistletoe, pomegranate, aloe vera, sage, ginger, ginseng) as well as three uronephrological plants (juniper, horsetail, bearberry) are classified and evaluated according to existing guidelines and by using a selective literature search. RESULTS: A total of nine plants were considered. Currently, there is no sufficient evidence for the use of pomegranate or mistletoe for tumor therapy. Guideline recommendations for or against symptom-oriented use exist for ginger (nausea; may be used), ginseng (fatigue; may be used), aloe vera (radiation dermatitis, should not be recommend), and bearberry (recurrent cystitis, may be used). A small number of studies on other symptoms and medicinal plants could be found (e.g., ginger - xerostomia, aloe vera - constipation, sage - oral mucositis or sweating). CONCLUSIONS: An integration of phytotherapeutic drugs into uro-oncological treatments concept can be considered. The benefits and risks of complementary herbal medicines (e.g., potential interactions with tumor therapy) must always be carefully weighed.
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Terapias Complementares , Essências Florais , Neoplasias , Plantas Medicinais , Estomatite , Humanos , Fitoterapia/efeitos adversos , Neoplasias/tratamento farmacológico , Estomatite/tratamento farmacológicoRESUMO
La diabetes mellitus tipo 2 representa uno de los principales problemas de salud pública a nivel mundial hoy en día. Entre las principales complicaciones generadas por esta enfermedad se encuentra la retinopatía diabética, la cual puede conducir a pérdida de la visión de manera permanente, por lo que investigaciones sobre tratamientos para esta patología van en aumento. Es por esto que tratamientos en base a químicos obtenidos de plantas medicinales están siendo ampliamente investigados debido a que podrían proveer una alternativa más segura, de menor costo y menor toxicidad que la medicina estándar para el tratamiento de esta patología ocular de alta incidencia mundial. El objetivo de este estudio fue identificar los principales fitoquímicos con potencial para ser usados como tratamiento de la retinopatía diabética. Para lograr este cometido se llevó a cabo una revisión de la literatura publicada entre el enero 2017 y de junio 2021 utilizando las bases de datos WOS, PubMed y Scopus en inglés y español, con el fin de recopilar evidencia científica actualizada sobre el uso y efectos de fitoquímicos en la retinopatía diabética. Diversas familias de fitoquímicos útiles fueron identificadas, entre estas las más comunes fueron las de origen fenólico, aunque menos comunes también se encontraron carotenoides, terpenos y preparaciones constituidas por varias especies de plantas y fitoquímicos. Sus mecanismos de acción también fueron identificados, siendo los más comunes la supresión de la neovascularización mediada por VEGF, la protección y restauración de la barrera hematorretinal, la reducción en la actividad de las especies reactivas del oxígeno y el efecto antiinflamatorio. Dada la evidencia respecto a la utilidad de los fitoquímicos para el tratamiento de la retinopatía diabética, mayores investigaciones deben ser realizadas(AU)
Type 2 diabetes mellitus represents one of the main public health problems worldwide today. Among the main complications generated by this disease is diabetic retinopathy, which can lead to permanent vision loss. For this reason, research on treatments for this pathology is increasing. This is why treatments based on chemicals obtained from medicinal plants are widely investigated as they could provide a safer, less costly and less toxic alternative to standard medicine for the treatment of this eye disease of high incidence worldwide. The aim of this study was to identify the main phytochemicals with potential to be used as treatment for diabetic retinopathy. In order to achieve this purpose, a review of the literature published between January 2017 and June 2021 was conducted using the WOS, PUBMED and Scopus databases in English and Spanish, in order to compile updated scientific evidence on the use and impact of phytochemicals in diabetic retinopathy. Several families of useful phytochemicals were identified. Among these, the most common were those of phenolic origin, although less common were also found carotenoids, terpenes and blends consisting of various plant species and phytochemicals. Their mechanisms of action were also identified, the most common being suppression of vascular endothelial growth factor-mediated neovascularization, protection and restoration of the blood-retinal barrier, reduction in reactive oxygen species activity and anti-inflammatory effect. Given the evidence regarding the usefulness of phytochemicals for the treatment of diabetic retinopathy, further research should be conducted(AU)
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Humanos , Diabetes Mellitus Tipo 2/etiologia , Retinopatia Diabética/complicações , Fitoterapia/efeitos adversos , Literatura de Revisão como Assunto , Bases de Dados BibliográficasRESUMO
PURPOSE: In Tanzania, patients with cancer present late with advanced stages. Among other reasons, the use of herbal medicine (HM) might contribute to delay in diagnosis and treatment. This study aims to understand the utilization of HM and the reasons for its' use. METHODS: A semistructured 30-item questionnaire with closed- and open-ended questions was applied to a cohort of patients with cancer at Kilimanjaro Christian Medical Centre. Content analysis was performed for answers to open-ended questions. RESULTS: Three hundred two patients were interviewed, 50.9% males and 49.1% females. The mean age was 64 years. 71.6% were in stages III/IV. 70.5% patients used HM and 67.1% started conventional medicine after stopping HM, 7.5% started HM after conventional medicine, and 24.9% combined both. Stage IV patients used HM as first line significantly more often in comparison: stage I 55.6%; II 58.1%; III 57.2%; and IV 70.6%. 77.5% did not tell their doctors about the use of HM. Commonest reasons to use HM were belief in cure, hope of symptom relief, lack of cancer services, and tradition. CONCLUSION: The majority of patients used HM before consulting a doctor, which contributes to stage IV presentation. Use of HM alongside with chemotherapy is mostly not known to the treating physician and may lead to interactions. These findings must alert health care workers and health policymakers to further foster health education about cancer and its treatment. Further research is needed to understand the wide use of HM among Tanzanian patients with cancer and the role that traditional and spiritual healers play in the field of cancer care.
Assuntos
Neoplasias , Plantas Medicinais , Feminino , Medicina Herbária , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/tratamento farmacológico , Fitoterapia/efeitos adversos , Inquéritos e Questionários , Tanzânia/epidemiologiaRESUMO
BACKGROUND: Gyejibokryeong-hwan (GBH) is an herbal medicine composed of five herbs. It has been widely used to treat gynaecological diseases in traditional East Asian medicine. Recent animal studies suggest antidepressant effects of GBH. In this trial, we explore the efficacy and safety of GBH in patients with major depressive disorder and to identify the optimal dose for the next phase III trial. METHODS: This trial will enrol 126 patients diagnosed with major depressive disorder and not treated with antidepressants. Participants will be randomised to receive a high or a low dose of GBH or placebo granules. The study drugs will be administered three times a day, for 8 weeks. The 17-item Hamilton Depression Rating Scale (HDRS) will be used to measure the severity of depressive symptoms at weeks 2, 4, 6, 8, and 12. The primary efficacy endpoint is the change from baseline in HDRS-17 total score post-treatment at week 8. Analysis of covariance will be based on the baseline HDRS-17 total score and site as the covariates. Safety assessment will be based on the frequency of adverse events. The severity and causality of the study drug will be assessed. DISCUSSION: This study is designed to evaluate the efficacy and safety of GBH granules compared with placebo in patients with major depressive disorder. TRIAL REGISTRATION: Clinical Research Information Service KCT0004417 . Registered on November 1, 2019 (prospective registration).
Assuntos
Antidepressivos , Transtorno Depressivo Maior , Fitoterapia , Antidepressivos/efeitos adversos , Transtorno Depressivo Maior/tratamento farmacológico , Humanos , Estudos Multicêntricos como Assunto , Fitoterapia/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: Shenling Baizhu San (SBS), a well-known Chinese medicine herbal formula, has been widely used for treating chronic diarrhea for thousands of years. However, the efficacy and safety of SBS in treating chronic diarrhea have not been fully assessed. OBJECTIVE: This study evaluates the efficacy and safety of the herbal formula SBS in symptomatic relief of chronic diarrhea. METHODS: English and Chinese language databases (PubMed, Cochrane Library, China National Knowledge Infrastructure, China Science and Technology Journal Database, Wanfang Data, and SinoMed electronic databases) were searched through April 2020 for relevant randomized controlled trials (RCTs). The outcomes in these RCTs included stool frequency, stool consistency, patient-reported satisfaction of chronic diarrhea treatment, quality of life and adverse events. Paired reviewers independently extracted data and conducted qualitative and quantitative analyses. The Cochrane revised risk of bias RoB-2 tool was applied to assess the risk of bias for each trial whereas the RevMan 5.3 software was used for outcomes data synthesis and meta-analysis. Mean difference (MD) and the 95% confidence interval (CI) were used to measure continuous data. The dichotomous data were analyzed via the relative risk (RR) with 95% CIs. RESULTS: Fourteen RCTs including 1158 participants (54% males) with chronic diarrhea were included. Shenling Baizhu San combined with or without conventional medicine (CM) was associated with greater patient-reported satisfaction than CM alone. There was no increased risk of adverse events (AEs) during treatment. CONCLUSION: Treatment with SBS was associated with significant improvement in patient-reported satisfaction, irrespective of conventional medicine use. Rigorous and powered RCTs with objective outcome measures are needed to confirm the effects of SBS in specific gastrointestinal disease populations with chronic diarrhea symptoms. SYSTEMATIC REVIEW REGISTRATION NUMBER (PROSPERO): CRD42020178073.
Assuntos
Medicamentos de Ervas Chinesas , Medicina Tradicional do Leste Asiático , Adulto , Diarreia/tratamento farmacológico , Medicamentos de Ervas Chinesas/efeitos adversos , Feminino , Humanos , Masculino , Fitoterapia/efeitos adversosRESUMO
Hydroxyl-methyl-glutaryl-Co-A reductase (HMGCR) immune mediated necrotising myopathy (IMNM) is a rare autoimmune myositis that is thought to be triggered by statins and responds to immunomodulation. We report a case of a woman in her 30s with HMGCR IMNM without a history of statin exposure who had a clear flare of her myositis after beginning mushroom supplements. Mushrooms are natural HMGCR inhibitors, and this is the first case to demonstrate a flare triggered by mushrooms in a patient with known HMGCR IMNM. This case highlights the importance of reviewing diet and supplements in patients with IMNM. It also emphasises the importance of strict statin avoidance for patients with IMNM even when the myositis is under good control.
Assuntos
Agaricales , Doenças Autoimunes , Suplementos Nutricionais , Doenças Musculares , Adulto , Autoanticorpos/imunologia , Doenças Autoimunes/induzido quimicamente , Doenças Autoimunes/diagnóstico , Doenças Autoimunes/imunologia , Doenças Autoimunes/patologia , Suplementos Nutricionais/efeitos adversos , Feminino , Humanos , Hidroximetilglutaril-CoA Redutases/efeitos adversos , Hidroximetilglutaril-CoA Redutases/imunologia , Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos , Músculo Esquelético/imunologia , Músculo Esquelético/patologia , Doenças Musculares/induzido quimicamente , Doenças Musculares/diagnóstico , Doenças Musculares/imunologia , Doenças Musculares/patologia , Miosite/induzido quimicamente , Miosite/diagnóstico , Miosite/imunologia , Miosite/patologia , Necrose/induzido quimicamente , Necrose/imunologia , Fitoterapia/efeitos adversos , Exacerbação dos SintomasRESUMO
INTRODUCTION AND OBJECTIVES: Our objective is to assess the long-term results of phytotherapy, focusing on the interval between phytotherapy and pharmacological treatment and the predisposing risk factors to such switch on a 10-year follow-up. MATERIAL AND METHODS: The data of patients taking phytotherapy for mild to moderate male lower urinary tract symptoms (LUTS) from January to December 2010 were retrospectively reviewed from a prospectively maintained database. Patients were followed for 10 years through medical visits and telephone consultations. RESULTS: 102 patients underwent at least one cycle of phytotherapy for LUTS. Twenty (19.6%) patients resolved their symptoms after one phytotherapy cycle and stopped any treatment, 27 (26.4%) continued phytotherapy, and 52 (51%) switched to alpha-blockers and/or 5a-reductase inhibitors after a median interval of 24 months. The reasons for treatment switch were symptoms (nâ¯=â¯45) or clinical progression (increased residual volume nâ¯=â¯15; urinary retention, nâ¯=â¯5). Patients switching to synthetic drugs had median higher age (60 vs 49), prostate volume (40 vs 26â¯cc), prostate specific antigen (PSA) (1.9 vs 0.9â¯ng/ml), residual volume (40 vs 0â¯cc), and a lower maximum flow rate (Qmax) (12 vs 15â¯ml/s) at presentation. CONCLUSIONS: 46% patients with mild to moderate LUTS undergoing phytotherapy will be either free of treatment or still on phytotherapy at 10 years from disease presentation. Older patients with larger prostates, increased residual volume and PSA, should be informed regarding their higher risk of symptomatic or clinical progression: the risk of a treatment switch to alpha-blockers or 5a-reductase inhibitors becomes an actual fact after an average span of 2 years.