Differences in Symptom Severity and Quality of Life among Patients with Cancer Using Conventional Therapies with/without Herbal Medicines in Uganda: A Cross-Sectional Study.

OBJECTIVE: Patients with cancer experience numerous symptoms related to cancer and treatment side effects that reduce their quality of life (QOL). Although herbal medicine (HM) is used to manage such symptoms by patients in sub-Saharan Africa, data on patients' perceived clinical outcomes are limited. We compared differences in QOL and symptom severity between patients with cancer using HM plus conventional therapies (i.e., chemotherapy, hormonal therapy, radiotherapy, surgery) and those using conventional therapies alone. METHODS: This cross-sectional study included patients with cancer aged >18 years who were consecutively sampled and completed a researcher-administered questionnaire between December 2022 and January 2023. Specifically, data was collected using The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the MD Anderson Symptom Inventory for Traditional Chinese Medicine (MDASI-TCM). Data were analyzed using descriptive statistics and chi-square and logistic regression analyses. RESULTS: Of 400 participants (67.5% female), 49% (n=195) used HM plus conventional therapies and 51% (n=205) used conventional therapies alone. Most participants were aged >38 years (73.3%; median age 47 years). A univariate analysis showed the HM plus conventional therapies group had better mean scores for most QOL and symptom severity measures than the conventional therapies alone group. However, only role functioning significantly differed (p=0.046) in the bivariate analysis. There were no statistically significant differences between the two groups after confounder adjustment for all others measures of symptom severity and QOL. CONCLUSION: HM plus conventional therapies may offer minimal benefits or differences for clinical outcomes among patients with cancer. However, our findings have clinical, research, and public health implications for Uganda and other sub-Saharan African settings.

The meaning of caring for patients with cancer among traditional medicine practitioners in Uganda: A grounded theory approach.

Traditional medicine practitioners (TMPs) are a critical part of healthcare systems in many sub-Saharan African countries and play vital roles in caring for patients with cancer. Despite some progress in describing TMPs' caring experiences in abstract terms, literature about practice models in Africa remains limited. This study aimed to develop a substantive theory to clarify the care provided by TMPs to patients with cancer in Uganda. This study adhered to the principal features of the modified Straussian grounded theory design. Participants were 18 TMPs caring for patients with cancer from 10 districts in Uganda, selected by purposive and theoretical sampling methods. Researcher-administered in-depth interviews were conducted, along with three focus group discussions. Data were analyzed using constant comparative analysis. The core category that represented TMPs' meaning of caring for patients with cancer was "Restoring patients' hope in life through individualizing care." TMPs restored patients' hope through five main processes: 1) ensuring continuity in the predecessors' role; 2) having full knowledge of a patient's cancer disease; 3) restoring hope in life; 4) customizing or individualizing care, and 5) improving the patient's condition/health. Despite practice challenges, the substantive theory suggests that TMPs restore hope for patients with cancer in a culturally sensitive manner, which may partly explain why patients with cancer continue to seek their services. The findings of this study may guide research, education, and public health policy to advance traditional medicine in sub-Saharan Africa.

Multilevel governance framework on grievance redressal for patient rights violations in India.

The notion of patient rights encompasses the obligations of the state and healthcare providers to respect the dignity, autonomy and equality of care-seeking individuals in healthcare processes. Functional patient grievance redressal systems are key to ensuring that the rights of individuals seeking healthcare are protected. We critically examined the published literature from high-income and upper-middle-income countries to establish an analytical framework on grievance redressal for patient rights violations in health facilities. We then used lawsuits on patient rights violations from the Supreme Court of India to analyse the relevance of the developed framework to the Indian context. With market perspectives pervading the health sector, there is an increasing trend of adopting a consumerist approach to protecting patient rights. In this line, avenues for grievance redressal for patient rights violations are gaining traction. Some of the methods and instruments for patient rights implementation include charters, ombudsmen, tribunals, health professional councils, separating rules for redressal and professional liability in patient rights violations, blame-free reporting systems, direct community monitoring and the court system. The grievance redressal mechanisms for patient rights violations in health facilities showcase multilevel governance arrangements with overlapping decision-making units at the national and subnational levels. The privileged position of medical professionals in multilevel governance arrangements for grievance redressal puts care-seeking individuals at a disadvantaged position during dispute resolution processes. Inclusion of external structures in health services and the healthcare profession and laypersons in the grievance redressal processes is heavily contested. Normatively speaking, a patient grievance redressal system should be accessible, impartial and independent in its function, possess the required competence, have adequate authority, seek continuous quality improvement, offer feedback to the health system and be comprehensive and integrated within the larger healthcare regulatory architecture.

Prevalence of the Use of Herbal Medicines among Patients with Cancer: A Systematic Review and Meta-Analysis.

BACKGROUND: Although herbal medicines are used by patients with cancer in multiple oncology care settings, the magnitude of herbal medicine use in this context remains unclear. The purpose of this review was to establish the prevalence of herbal medicine use among patients with cancer, across various geographical settings and patient characteristics (age and gender categories). METHODS: Electronic databases that were searched for data published, from January 2000 to January 2020, were Medline (PubMed), Google Scholar, Embase, and African Index Medicus. Eligible studies reporting prevalence estimates of herbal medicine use amongst cancer patients were pooled using random-effects meta-analyses. Studies were grouped by World Bank region and income groups. Subgroup and meta-regression analyses were performed to explore source of heterogeneity. RESULTS: In total, 155 studies with data for 809,065 participants (53.95% female) met the inclusion criteria. Overall, the pooled prevalence of the use of herbal medicine among patients with cancer was 22% (95% confidence interval (CI): 18%-25%), with the highest prevalence estimates for Africa (40%, 95% CI: 23%-58%) and Asia (28%, 95% CI: 21%-35%). The pooled prevalence estimate was higher across low- and middle-income countries (32%, 95% CI: 23%-42%) and lower across high-income countries (17%, 95% CI: 14%-21%). Higher pooled prevalence estimates were found for adult patients with cancer (22%, 95% CI: 19%-26%) compared with children with cancer (18%, 95% CI: 11%-27%) and for female patients (27%, 95% CI: 19%-35%) compared with males (17%, 95% CI: 1%-47%). CONCLUSION: Herbal medicine is used by a large percentage of patients with cancer use. The findings of this review highlight the need for herbal medicine to be integrated in cancer care.

Total polyphenols and antihyperglycemic activity of aqueous fruits extract of Abelmoschus esculentus: Modeling and optimization of extraction conditions.

Aqueous fruits extract of Abelmoschus esculentus (L.) Moench (Malvaceae) has been used traditionally in several communities to alleviate elevated blood glucose levels. However, optimized extraction conditions have not been reported. Thus, this study determined the optimal extraction conditions for extracting polyphenols from A. esculentus fruits and evaluated antihyperglycemic activity in vivo. Extraction time, temperature, and solid-to-solvent ratio were optimized using Response Surface Methodology (RSM). Total polyphenols and flavonoids were quantified using the Folin-Ciocalteu and aluminium chloride colorimetric methods, respectively. The fingerprint and quantification of quercetin-a major flavonoid with an antihyperglycemic effect was done using the chromatographic method. The antihyperglycemic activity was determined in a high-fat diet-Streptozotocin rat model. The rats were assigned to five groups (n = 6): Group 1 and 2 were normal and diabetic control received distilled water 1 mL/100g; Treatment group 3 and 4 received standardized A. esculentus fruit extract (AEFE) at a dose of 100 and 200 mg/kg, respectively; Group 5 received 5 mg/kg glibenclamide. All treatments were given orally for 14 days. Measurements of fasting plasma glucose (FPG) and body weight were done weekly. The RSM quadratic model predicted total polyphenols of 22.16 mg GAE/g DW. At optimal conditions of a solid-to-solvent ratio of 5%, extraction time 1 h, and extraction temperature of 70°C, confirmation experiments yield 20.2 [95% CI; 16.7 to 27.6] mg GAE/g DW, implying the model successfully predicted total polyphenols. The extract HPLC fingerprint showed 13 characteristic peaks with 0.45 ± 0.02 µg/g DW of quercetin. Compared with diabetic control, the standardized AEFE reduced FPG level dose-dependently (P < 0.001) with an EC50 of 141.4 mg/kg. Together, at optimal extraction conditions, extract with a high content of total polyphenols and good antihyperglycemic activity can be obtained. Studies are needed to identify additional polyphenolic compounds and determine their antidiabetic effects.

The safety and efficacy of Momordica charantia L. in animal models of type 2 diabetes mellitus: A systematic review and meta-analysis.

Type 2 diabetes mellitus is a chronic hyperglycemic condition due to progressively impaired glucose regulation. Momordica charantia L. could potentially improve hyperglycemia because its fruit extracts can alleviate insulin resistance, beta-cell dysfunction, and increase serum insulin level. We evaluated the effect of M. charantia L. in comparison with a vehicle on glycemic control in animal models of type 2 diabetes mellitus. MEDLINE, Web of Science, Scopus, and CINAHL databases were searched without language restriction through April 2019. About 66 studies involving 1861 animals that examined the effect of M. charantia L. on type 2 diabetes mellitus were included. Fruits and seed extracts reduced fasting plasma glucose (FPG) and glycosylated hemoglobin A1c in comparison to vehicle control: (42 studies, 815 animals; SMD, -6.86 [95% CI; -7.95, -5.77], 3 studies, 59 animals; SMD; -7.76 [95% CI; -12.50, -3.01]) respectively. Also, the extracts have hepato-renal protective effects at varying doses and duration of administration. Despite the observed significant glycemic control effect, poor methodological quality calls for future researches to focus on standardizing extract based on chemical markers and adopt measures to improve the quality of preclinical studies such as sample size calculation, randomization, and blinding.

Pharmacological reflection of plants traditionally used to manage diabetes mellitus in Tanzania.

ETHNOPHARMACOLOGICAL RELEVANCE: The increasing national prevalence of diabetes mellitus (DM) and its complications have overstretched the health care system in Tanzania and influenced patients to use herbal medicines as alternative therapeutic strategies. Therefore, an urgent need exists to validate the safety and efficacy of plants used locally. AIM OF THE STUDY: To identify plants used for the management of DM in Tanzania and analyses their pharmacological, phytochemistry, and safety evidence with a special focus on the mechanism of action. METHODS: Researchers searched Medline, web of science, and Scopus for published articles. Also, specialized herbarium documents of Muhimbili Institute of traditional medicine were reviewed. Articles were assessed for relevance, quality, and taxonomical accuracy before being critically reviewed. RESULTS: We identified 62 plant species used locally for DM management. Moringa oleifera Lam. and Cymbopogon citratus (D.C) stapf were the most mentioned. Fifty-four phytochemicals from 13 species had DM activities. These were mainly; polyphenolics, phytosterols, and triterpenoids. Extracts, fractions, and pure compounds from 18 species had in vitro antidiabetic activities of which 14 had α-glucosidase and α-amylase inhibition effects. The most studied -Momordica charantia L. increased; glucose uptake and adiponectin release in 3T3-L1 adipocytes, insulin secretion, insulin receptor substrate-1 (IRS-1), GLUT-4 translocation, and GLP-1 secretion; and inhibited protein tyrosine phosphatase 1 B (PTP1B). Preclinical studies reported 30 species that lower plasma glucose with molecular targets in the liver, skeletal muscles, adipose tissues, pancreases, and stomach. While three species; Aspilia mossambiscensis (Oliv.) Willd, Caesalpinia bonduc (L.) Roxb, and Phyllanthus amarus Schumach. & Thonn. had mild toxicity in animals, 33 had no report of their efficacy in DM management or toxicity. CONCLUSION: Local communities in Tanzania use herbal medicine for the management of DM. However, only a fraction of such species has scientific evidence. A. mossambiscensis, C. bonduc., and P. amarus had mild toxicity in animals. Together, our findings call for future researches to focus on in vitro, in vivo, and phytochemical investigation of plant species for which their use in DM among the local communities in Tanzania have not been validated.

Systematic review and meta-analysis protocol for efficacy and safety of Momordica charantia L. on animal models of type 2 diabetes mellitus.

BACKGROUND: Studies on several preclinical models of type 2 diabetes mellitus have been conducted to establish the hypoglycemic activity of Momordica charantia L. Concerned with appropriateness of these models, we designed a systematic review to establish the efficacy and safety of M. charantia L. in preclinical models of type 2 diabetes mellitus. METHODS: Review authors will search without language restriction in MEDLINE/PubMed, Web of Science, Embase, Scopus, and CINAHL databases through April 2019. Search filters will be applied to enhance search efficiency. The authors will search for gray literature in Google and Google Scholar, OpenGrey, and ProQuest Dissertations & Theses. Two authors will evaluate full texts, extract data, and asses risk of bias independently. The review will include randomized or non-randomized studies that assessed the efficacy or safety of M. charantia L. with vehicle control group. The primary endpoint will be fasting blood glucose level. We will use Egger's test to assess publication biases. Chi-square test and I2 will be used to assess heterogeneity in effect size of the primary outcome. Using RevMan software version 5.3, the authors will perform a meta-analysis of quantitative data. DISCUSSION: The strength of evidence will be rated as high, moderate, low, or very low using GRADE framework for animal studies. This systematic review will potentially improve research practice by identifying risks of bias and design features that compromise translatability and contribute to evidence-based clinical trial design. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42019119181.

Momordica charantia L. lowers elevated glycaemia in type 2 diabetes mellitus patients: Systematic review and meta-analysis.

ETHNOPHARMACOLOGICAL RELEVANCE: Momordica charantia Linnaeus (Cucurbitaceae) has been extensively used traditionally as food and herbal medicine for type 2 diabetes mellitus in Asia, Brazil, and east Africa. In vitro and in vivo studies suggest its glycemic control potential; however, clinical studies produced conflicting results. AIM OF THE STUDY: To evaluate the efficacy of M. charantia preparations in lowering elevated plasma glucose level in prediabetes and type 2 diabetes mellitus patients. METHODS: Electronic search of the Cochrane library, PubMed®, CINAHL, and SCOPUS databases was done from 1st January 1960-30th April 2018 without language restriction. Two independent reviewers extracted data and assessed risk of bias of articles. Revman var. 5.3 software was used for data synthesis in meta-analysis. Heterogeneity was assessed using Chi-square and I2 tests. Treatment effect was estimated using mean difference at follow up in outcome measures between M. charantia preparations and placebo or oral hypoglycemic agents control group. The protocol of this study has a registration number PROSPERO CRD42018083653. RESULTS: Ten studies of type 2 diabetes mellitus (n = 1045) were included in the meta-analysis. They had 4-16 weeks follow up and overall moderate to high risk of bias. Compared to placebo, M. charantia monoherbal formulation significantly reduces FPG, PPG and HBA1c with mean difference of - 0.72 mmol/L, (95% CI: -1.33, -0.12), I2 = 14%, - 1.43 mmol/L, (95% CI: -2.18, -0.67), I2 = 0, - 0.26%, (95% CI: -0.49, -0.03), I2 = 0 respectively. M. charantia also lowered FPG in prediabetes (mean difference -0.31 mmol/L, n = 52); the evidence was downgraded to low quality because the study had unclear risk of bias and inadequate sample size. No serious adverse effects were reported. CONCLUSION: M. charantia adjunct preparations improved glycemic control in T2DM patients. However, this conclusion is based on low to very low quality evidences for the primary outcomes and sparse data for several safety outcomes, thus, warrant further research. Particularly needed are the researches that focus on standardizing M. charantia formulation and determine its efficacy and safety in clinical trials with adequate sample size, designed with random sequence generation, allocation concealment of intervention and blinding of both research personnel and participants.

Safety and efficacy of Momordica charantia Linnaeus in pre-diabetes and type 2 diabetes mellitus patients: a systematic review and meta-analysis protocol.

BACKGROUND: Momordica charantia Linnaeus (Cucurbitaceae) has been used traditionally as a nutritious food and as a herbal medicine for type 2 diabetes mellitus. However, human studies that investigated its glycemic control have generated inconsistent findings. Therefore, this systematic review and meta-analysis is aimed at evaluating the safety and efficacy of M. charantia L. preparations in human studies that have investigated its role in glycemic control. METHODS: This protocol has been prepared according to Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). The review will include randomized clinical trials and non-randomized clinical trials. The included studies will have assessed glycemic control of M. charantia preparations with placebo or standard oral anti-hyperglycemic agents in adult pre-diabetes and/or type 2 diabetes mellitus patients and have at least 4 weeks of follow-up. The primary outcomes of review are fasting blood glucose levels, glycosylated hemoglobin A1c, and post-prandial blood glucose level. Electronic database search for published literatures will be conducted without language restriction in EMBASE, MEDLINE/PubMed, the Cochrane Library, SCOPUS, Web of Sciences, and CINAHL databases. Search for gray literatures and references of the retrieved full-text articles will be conducted in Google, Google Scholar, OpenGrey, ProQuest dissertations & Theses, British Library EThos, and university digital library systems. Two independent reviewers will later evaluate full texts, extract data, and assess risk of bias of eligible articles. Publication biases will be assessed by testing asymmetry of funnel plot using Egger's or Begg's tests while heterogeneity will be assessed using Cochran Q test, P value, and I2. Revman software version 5.3 will be used for meta-analysis including subgroup and sensitivity analysis. DISCUSSION: This systematic review and meta-analysis will investigate both safety and efficacy of M. charantia preparations in type 2 diabetes mellitus. The review results will be published in a peer-reviewed journal. The results will bring better understanding of clinical outcomes in treatment of type 2 diabetes mellitus patients and highlight gaps for future research. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018083653 .

Differential Diagnosis of Malaria on Truelab Uno®, a Portable, Real-Time, MicroPCR Device for Point-Of-Care Applications.

BACKGROUND: Sensitive and specific detection of malarial parasites is crucial in controlling the significant malaria burden in the developing world. Also important is being able to identify life threatening Plasmodium falciparum malaria quickly and accurately to reduce malaria related mortality. Existing methods such as microscopy and rapid diagnostic tests (RDTs) have major shortcomings. Here, we describe a new real-time PCR-based diagnostic test device at point-of-care service for resource-limited settings. METHODS: Truenat® Malaria, a chip-based microPCR test, was developed by bigtec Labs, Bangalore, India, for differential identification of Plasmodium falciparum and Plasmodium vivax parasites. The Truenat Malaria tests runs on bigtec's Truelab Uno® microPCR device, a handheld, battery operated, and easy-to-use real-time microPCR device. The performance of Truenat® Malaria was evaluated versus the WHO nested PCR protocol. The Truenat® Malaria was further evaluated in a triple-blinded study design using a sample panel of 281 specimens created from the clinical samples characterized by expert microscopy and a rapid diagnostic test kit by the National Institute of Malaria Research (NIMR). A comparative evaluation was done on the Truelab Uno® and a commercial real-time PCR system. RESULTS: The limit of detection of the Truenat Malaria assay was found to be <5 parasites/µl for both P. falciparum and P. vivax. The Truenat® Malaria test was found to have sensitivity and specificity of 100% each, compared to the WHO nested PCR protocol based on the evaluation of 100 samples. The sensitivity using expert microscopy as the reference standard was determined to be around 99.3% (95% CI: 95.5-99.9) at the species level. Mixed infections were identified more accurately by Truenat Malaria (32 samples identified as mixed) versus expert microscopy and RDTs which detected 4 and 5 mixed samples, respectively. CONCLUSION: The Truenat® Malaria microPCR test is a valuable diagnostic tool and implementation should be considered not only for malaria diagnosis but also for active surveillance and epidemiological intervention.

Ethnobotanical survey of malaria prophylactic remedies in Odisha, India.

AIM OF THE STUDY: To investigate the plants traditionally used for prevention of malaria in Cuttack, Gajapati and Koraput districts of Odisha state, eastern India. MATERIALS AND METHODS: An ethnobotanical survey was carried out among 20 traditional healers who were sampled based on recommendations of local elders and local non-government organizations. Data were collected through semi-structured interview. RESULTS: The study revealed the use of 16 traditional plant species belonging to 12 families for prevention of malaria. Andrographis paniculata, Azadirachta indica, Nyctanthes arbor-tristis, Ocimum sanctum, Piper nigrum, Zingiber officinale were the most commonly reported plants for their malaria prophylactic use by the healers of three districts of Odisha. Most of the remedies were used in decoction form. CONCLUSIONS: Findings of this study provide a lead to explore traditional plants for malaria preventive potential through further pre-clinical and clinical studies.