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The conventional use of medicinal plants is in part based on the widespread belief that plant crude extracts are non-toxic. In South Africa, traditional preparations of Cassipourea flanaganii used to treat hypermelanosis have accordingly been regarded by many as non-toxic. Whether that is so impacts on the potential of bark extracts to be developed as a commercial drug to treathypermelanosis, given their documented capacity to inhibit tyrosinase activity. Our study investigated the acute and subacute toxicity of the methanol extract of C. flanaganii bark in rats. Wistar rats were randomly assigned into different treatment groups. The rats received a daily oral gavage of crude extract for acute and subacute toxicity tests. Haematological, biomechanical, clinical and histopathology examinations were carried out to evaluate the possible toxicity of C. flanaganii. The results were subjected to the Student’s t-test and ANOVA. For both acute and subacute toxicity, there was no statistical difference between the groups. There were no clinical or behavioral signs of toxicity observed in the rats. No treatment-related gross pathology lesions and no histopathology were observed. The findings of this study demonstrate the absence of acute or subacute toxicity after oral treatment with C. flanaganii stem bark extracts in Wistar rats at the levels administered. Chemical profiling of the total extract using LC-MS tentatively identified eleven (11) compounds as the major chemical constituents.

HIV-related weight loss and wasting were the most common malnutrition and AIDS-defining conditions before HAART. HAART has led to more obese PLHIV. HIV-positive patients should eat micro- and macronutrient-rich foods to maintain optimal nutrition. This study examined whetherA randomized, double-blind, controlled trial was conducted. Two hundred patients with informed consent were randomly assigned to either theOne hundred seventy-seven patients completed the 6-month follow-up (89 MOG vs. 88 COG). During the study period, the MOG and COG had similar weights and BMIs (p0.05). At baseline and six months, most participants in both study groups had a healthy BMI (18.5-24.9). Many participants were overweight; few were underweight ((BMI18.5). MOG and COG BMI differences at baseline and six months were not significant (p0.05). All experiments were 95CI.

BackgroundMelasma is one of the most encountered dermatoses in dermatology and skin care clinics. It is a challenging chronic, recurrent condition associated with hyperpigmentation. Its etiology is poorly understood. Melasma affects all races and gender but is more prevalent in women with darker skin types. Being a facial lesion, melasma has a severe impact on quality of life due to its disfigurement. While many modalities of treatment for melasma exists, unfortunately, effectiveness and safety remain a huge concern. Treatment modalities are variable and often unsatisfactory. The objective of this scoping review is to systemically map available evidence from literature regarding melasma, garner insight as to how melasma affects the quality of life and begin to investigate and gain understanding on effectiveness of different treatments used for melasma.MethodsA scoping review guided by Arksey and O’Malley’s framework, the enhancements and recommendations of Levac, Colquhoun and O’Brien, Daudt and associates and the 2015 Johanna Briggs Institute’s guidelines will be conducted. Systematic electronic searches of databases and search engines such as, Scopus, PubMed, CINAHL Complete, Cochrane, Science Direct, and Web of Science will be conducted to attain published peer-reviewed articles of all study designs excluding reviews. All literature that meets the inclusion criteria, research question and sub-question will be included in this review. All the retrieved literature will be exported to an Endnote X20 library. Quality appraisal of the included articles will be conducted using the mixed methods appraisal tool (MMAT) 2018 version.DiscussionWe anticipate mapping relevant literature on the prevalence of melasma, investigating the effectiveness of treatment options of melasma as well as evaluating its association with quality of life in darker skin types. This study is likely to reveal research gaps, which could guide future implementation research on melasma treatment interventions.Protocol registration: This protocol has been registered apriori with OSF and is accessible on this link: https://osf.io/ru3jc/

To maintain an optimal nutritional status and immunological function in PLHIV, a diet with adequate nutrients is of utmost importance. This is a major challenge among poor populations in developing worlds like Nigeria, where malnutrition and food insecurity are endemic. This study aimed to assess the type of regular diet consumed and assess the impact of supplementation of the diet withA double-blind, randomized trial was conducted. Two hundred consented patients were randomly allocated to either theOne hundred and seventy-seven patients completed the six-month follow-up (89 MOG versus 88 COG). At both baseline and sixth month, the foods most commonly consumed by the participants in both MOG and COG were cereals, spices and condiments, oils, fats and palm oil, and dark green vegetables. At baseline, significantly higher consumption of legumes, nutsseeds (p = 0.001) was observed in the MOG and higher consumption of other vegetables (p = 0.024) in COG. Consumption of cereals, roots, and tubers was significantly higher (p = 0.024; 0.045) in the COG in the sixth month. In both groups, participants were in the medium or low dietary diversity tercile. Throughout the study period, all the nutritional status variables observed were not significantly different between the two study groups [(p0.0001); weight; p = 0.5556; BMI; p = 0.5145; MUAC; p = 0.6456]. Over the study period, the treatment by time interaction shows a significant difference in CD4 counts by treatment group (p0.0001) and an estimate of fixed effects 10.33 folds greater in the MOG than COG. All tests were conducted at 95CI.This study revealed a poor dietary diversity amongst PLHIV. Supplementation of regular diet with

Background: Documentation of patient health information in the form of patient medical records (PMRs) is an essential, ethical and regulatory requirement in any healthcare system. African traditional medicine (ATM) exists parallel to biomedicine and continues to play a significant role in primary healthcare of the majority of South Africans. The World Health Organization (WHO) has promoted the integration of ATM into the national health system of South Africa. Patient health information documentation can facilitate this integration, and PMRs promote communication between the two health systems through referrals. Documentation in biomedicine is a clear, compulsory, routine activity, but does not occur regularly or routinely in ATM. Objective: To examine the attitudes and perceptions of traditional health practitioners (THPs) towards documentation of patient health information in their practice. Methods: This quantitative cross-sectional survey involved snowball sampling to recruit THPs in Umlazi Township and rural parts surrounding the township, in Durban, South Africa. A semi-structured questionnaire was used. Quantitative data were analysed using SPSS 25 and the Relative Importance Index (RII) and qualitative data were analysed using Excel for themes. Results: Sampling resulted in 248 THPs of whom 178 (72%) were females. The RII ranked the factors that negatively influenced the participants’ attitudes towards documentation of patient health information. Of the 178 females who participated in the study, 129 (72.5%) showed their willingness to introduce documentation in their practice. Of the 127 participants with less than 10 years of practice experience, 126 (99.2%) agreed to the importance of introducing PMRs in their practice. The majority of participants perceived documentation of patient health information as vital to improve their practice. A prominent theme was that the THPs regarded documenting patient health information as important and effective in their practice. Conclusion: More than half of participants showed positive attitudes and perceptions towards documenting of patient health information in ATM. The majority of the participants in this study acknowledged the importance of introducing documentation of patient health information in their practice even though they lacked experience and more knowledge. This reflects a need for essential intervention in developing specialised tools to begin promoting documentation of patient health information in ATM.

Background: To maintain an optimal nutritional status and immunological function in PLHIV, a diet with adequate nutrients is of utmost importance. This is a major challenge among poor populations in developing worlds like Nigeria, where malnutrition and food insecurity are endemic. This study aimed to assess the type of regular diet consumed and assess the impact of supplementation of the diet with Moringa oleifera Lam. leaves on the nutritional status and CD4 cell counts of PLHIV that are on ART in Nigeria. Method: A double-blind, randomized trial was conducted. Two hundred consented patients were randomly allocated to either the Moringa oleifera Lam. group (MOG) or control group (COG). The FAO individual dietary diversity questionnaire was used. The regular diets of participants at baseline and six months were monitored. The measurements of weight, BMI, MUAC, and CD4 cell counts were obtained from baseline to six months of Moringa oleifera Lam. leaves supplementation. Results: One hundred and seventy-seven patients completed the six-month follow-up (89 MOG versus 88 COG). At both baseline and sixth month, the foods most commonly consumed by the participants in both MOG and COG were cereals, spices and condiments, oils, fats and palm oil, and dark green vegetables. At baseline, significantly higher consumption of legumes, nuts & seeds (p= 0.001) was observed in the MOG and higher consumption of other vegetables (p= 0.024) in COG. Consumption of cereals, roots, and tubers was significantly higher (p= 0.024; 0.045) in the COG in the sixth month. In both groups, participants were in the medium or low dietary diversity tercile. Throughout the study period, all the nutritional status variables observed were not significantly different between the two study groups [(p > 0.0001); weight; p=0.5556; BMI; p=0.5145; MUAC; p=0.6456]. Over the study period, the treatment by time interaction shows a significant difference in CD4 counts by treatment group (p

Introduction: Despite the recognition of Traditional Medicine systems as a critical component of health care by the WHO and the African Union, its integration into the health care mainstream remains very subdued in South Africa. This is partly due to the lack of empirical data pertinent to traditional healer training that could inform the accreditation process. Objective: To determine core competencies acquired by Traditional Health Practitioners (THP) of KwaZulu-Natal Province, South Africa during their apprenticeship. Materials and methods: Purposeful, convenient and snowballing sampling and the sequential data collection methods of questionnaires, journaling and focus groups was used to collect data from the THP tutors and their trainees in rural, peri-urban and urban areas of eThekwini and uThungulu Districts of Kwa Zulu Natal (KZN). Results: Eleven core competencies were identified: consultation, diagnoses, holistic patient care and treatment, integrative and holistic healing, application of healing procedures and cultural rituals, spiritual development, ethical competencies, problem solving, herbalism, ancestral knowledge and end of life care. Conclusion: The apprenticeship of THPs in KZN is based on eleven core competencies. These competencies are fundamental pillars for critical health care provided by THPs and are crucial for setting standards for the accreditation of traditional training in South Africa if the THP Act 22 of 2007 is to achieve its purpose of providing for the management of and control over the registration, training and conduct of the practitioners. Hence, the appointed interim THP Council should include the identified competencies when articulating bases for accreditation of the training and assessments. Keywords: Indigenous training, traditional health practitioners, Kwazulu-Natal.

Background: Documentation of patient health information (PHI) is a regulatory requirement and hence a standard procedure in allopathic healthcare practice. The opposite is true for African traditional medicine (ATM) in most African countries, including South Africa, despite legal and policy frameworks that recognise and mandate the institutionalisation of ATM. Developing good practice standards for PHI documentation is an essential step in the institutionalisation of ATM. Objective: This study examined the knowledge and practices of documentation of PHI by traditional health practitioners (THPs) in Durban, eThekwini Municipality, KwaZulu-Natal Province, South Africa. Methods: In this quantitative cross-sectional study, snowball sampling was used to identify and recruit THPs. An interviewer-administered questionnaire was used to gather data. Chi-square tests and logistic regression were used to assess associations of knowledge and practice of documentation of PHI with potential predictors; age, gender, education, type of practitioner, experience, number of patients seen per day and location of the practice. Results: Of the 248 THPs who participated, 71.8% were female. Mean (SD) age was 47.4 (14.2), ranging 18–81 years. The majority (65.7%) were Izangoma (diviners). Overall, 42.9% of the THPs reported knowledge of patient medical records (PMRs). In logistic regression, only number of patients seen per day remained a significant predictor of knowledge about PMR. THPs who reported seeing 6–10 patients were five times more likely (Odds Ratio (OR): 5.164, 95% Confidence Interval (CI): 1.270–20.996; p = 0.022) to report knowledge of PMR than those seeing Conclusion: Knowledge of PMR is low, and the practice of documenting PHI is even lower among THPs in eThekwini. That knowledge of PMR was a strong predictor of documentation practice, and the most common reason for not documenting was lack of knowledge about what and how to document suggests that training could improve PHI documentation in traditional medicine practice.

The combined effects of water activity (aw), temperature, incubation time, and medium composition on cyclopiazonic acid (CPA) production by an isolate of Penicillium commune was studied using a full-factorial experimental design. An analysis of variance for the mycotoxin showed that there was a complex interaction between all these factors and that this affected the production of CPA. The minimum aw for CPA production (0.025 to 0.238 μg ml-1) in yeast extract agar was 0.90 whereas in Czapek yeast autolysate agar it was 0.85 (0.048 to 0.123 μg m1-1). The temperature range for CPA production was 20 to 30°C. The optimum temperature for CPA production was 25°C. CPA was maximally produced (3.199 to 3.993 μg ml-1) at an aw of 0.996 after 15 days of incubation.

South Africa is currently experiencing an increase in the number of traditional medicine preparations which purport to have immune boosting effects. This is largely related to the high prevalence of HIV infections. This study therefore aimed to evaluate the possible immunomodulatory mechanisms of uMakhonya ® , one of the widely used commercial immune boosters, using THP-1 monocyte cells. Endotoxin-free doses of uMakhonya ® ranging from 1000 μg/mL to 10 μg/mL were used to evaluate the cytotoxic effects, cell migration, secretion of twelve different chemokines and possible modulation of nuclear factor kappa Beta (NF-κβ) transcriptional activity. This commercial traditional medicine product was shown to induce dose dependent cytotoxicity with high doses significantly ( p 50 of 100.08 and 107.68 μg/mL for normal and LPS stimulated THP-1 cells respectively) when compared to untreated cells. The lower doses were shown to have no significant ( p > 0.05) chemo-attractant effects in the cell migration assay. UMakhonya ® at these lower and less cytotoxic doses induced a significant ( p uMakhonya ® increased transcriptional activity of NF-κβ which may explain the increase in chemokines secretion. Therefore this in vitro study showed that uMakhonya ® is cytotoxic at high doses, did not show any chemo-attractant effects and induced significant increases in chemokines secretion. Increased transcriptional activity of NF-κβ in treated cells may contribute to increased chemokines secretion. This study on uMakhonya ® should form the benchmark for the research of the high number of related products that are sold commercially in South Africa.

Background With the burden of HIV and AIDS still very high, South Africa has seen an increase in commercial traditional medicines claiming to have immune-enhancing effects. Because of lack of regulation of the traditional medicine sector, these products have proliferated. This study aimed to evaluate the immunomodulatory effects of uMakhonya®, a commercial traditional immune booster, using various models of normal human peripheral blood mononuclear cells (PBMCs). Methods Immunosuppressed, mitogen-, and peptidoglycan (PG)-stimulated PBMCs were treated with various doses of uMakhonya® and incubated for 24 h. The treated and control samples were analyzed for cytotoxicity, secretion of 12 different inflammatory cytokines, soluble interleukin-2 receptor (sIL-2R) levels, and nitric oxide (NO) secretion. Results In cytotoxicity assays, uMakhonya® induced dose-dependent cytotoxic effects in all three models, with IC50 values of 512.08, 500, and 487.91 μg/mL for immunosuppressed, phytohaemagglutinin (PHA)-, and PG from Staphylococcus. aureus (PG-S. aureus)-stimulated PBMCs, respectively. UMakhonya® at 100 and 10 μg/mL induced a significant (p 0.05) decreased NO levels in PBMCs after PG-S. aureus stimulation. Conclusions These results showed that uMakhonya® can induce both pro-inflammatory and anti-inflammatory effects depending on the initial stimuli applied to immune cells.

Introduction: Developed from centuries of oral knowledge passed from generation to generation, African traditional medicines (ATM) are at a crossroads. In order for these ATMs to evolve with time similarly to modern medical sciences, there is an urgent need to scientifically evaluate their mechanism of action, safety and efficacy. Case report: In this short commentary we report on the progress we have made in scientifically evaluating traditional herbal immune boosters at a period where the African continent finds itself ravaged by a plethora of infectious diseases. Discussion: While the South African government has gone a long way in building an effective modern health system, many people still use ATMs such as immune boosters for a variety of infectious diseases and general wellbeing. The high prevalence of HIV infections is one of the reasons that have led to an increase in the use of ATMs which purport to have immune boosting capabilities. In our laboratory we have developed various models and carried out extensive in vitro and in vivo biochemical and molecular experiments on the immunomodulatory effects of these immune boosters and have shown that these products can modulate the expression and secretion of both cytokines and chemokines. Therefore the potential uses of immune boosters in clinical medicine does not only apply in treating immunodeficiency caused by HIV but can be useful in managing tuberculosis (TB), various forms of cancer and various other diseases that can be managed by modulating the immune response. Such research studies are very promising and present opportunities for further clinical studies to develop unique ATMs. Conclusion: As medicines meant to stimulate the body’s immune system to defend itself, immune boosters can be useful alone or as immune adjuvants along with pharmaceutical drugs. Therefore further studies on the effectiveness of these immune boosters are justified along with those that will ensure that there are no drug interactions with other pharmaceutical products.

The ability of traditional amahewu fermentation to increase protein digestibility and detoxify mycotoxins commonly contaminating maize in southern Africa was investigated. Commercial maize meal, with or without a range of added ingredients, was fermented, following the traditional way, and the levels of proteins and amino acids assessed. Traditional amahewu samples (and the maize meal used to prepare them) were also collected from a neighbouring rural village. Mycotoxin levels (aflatoxin B1, fumonisin B1 and zearalenone) in maize meal and amahewu were analysed and compared in the two sets of samples. Increased levels of protein were observed in amahewu, especially in the samples with added yeast and bread flour (up to 149%), in comparison to the levels in starter maize. In addition, the mycotoxins detected in maize samples were drastically reduced, by 76.5–100%, following fermentation. This observation shows that traditional amahewu fermentation may improve the nutritional quality of maize-based foods and reduce the levels of toxic/carcinogenic mycotoxins.

Aims: Aflatoxin B1 (AFB1) is a mycotoxin which is known to frequently contaminate poorly stored food products destined for human consumption. This study was carried out to investigate the potential activity of lactic acid fermentation in reducing AFB1 level in fermented maize meal products. Methods and Results: Maize meal was spiked with 60 μg g−1 AFB1 and fermented, with or without starter culture, for 4 days at 25°C. Unbound AFB1 in solution and the pH of the media were monitored daily. A significant decrease (P 0·05). Conclusions: These results indicate that lactic acid fermentation can significantly reduce the concentration of AFB1 in maize to trace levels. However, the safety of fermented products has not been well studied, as the mechanism of AFB1 removal is not well understood. Significance and Impact of the Study: Natural fermentation may potentially reduce exposure to natural toxins occurring in food.

Polymorphisms in the promoter region of the Cytochrome P4502E1 (CYP2E1) gene reportedly modify the metabolic activity of CYP2E1 enzyme, and have been associated with increased susceptibility to squamous cell carcinoma (SCC) of the oesophagus in high prevalence areas such as China. To assess the frequency of these polymorphisms in Black South Africans, a population with a high incidence of oesophageal SCC, this study examined genomic DNA from 331 subjects for restriction fragment length polymorphisms in theCYP2E1(RsaIandPstIdigestion). The frequency of theCYP2E1c1/c1 and c1/c3 genotypes was 95% and 5% respectively. The frequency of theCYP2E1allele distribution was found to be markedly different between Chinese and South African populations; hence it is important to place racial differences into consideration when proposing allelic variants as genetic markers for cancer.

We surveyed households in rural and urban areas of KwaZulu Natal, South Africa, to assess the exposure of the inhabitants to fumonisin B(1) (FB(1)), a mycotoxin produced by Fusarium verticillioides. In southern African regions maize, used as a staple food by the population, is prone to F. verticillioides infection. Furthermore, high levels of FB(1) in maize have been associated with esophageal cancer in South Africa. We assessed exposure of the population to FB(1) at three levels, namely, by analyzing stored maize, plate-ready food, and feces. The positions of participating households in the rural area were recorded using geographic information systems (GIS) for ease and accuracy of follow-up. Of the 50 rural maize samples examined, 32% had levels of FB(1) ranging from 0.1-22.2 mg/kg, whereas 29% of the 28 cooked maize (phutu) samples contained FB(1) ranging from 0.1-0.4 mg/kg. The incidence and levels of FB(1) in feces were 33% and 0.5-39.0 mg/kg, respectively. Of the 49 urban maize samples analyzed 6.1% had a range of 0.2-0.5 mg/kg FB(1), whereas 3 of 44 fecal samples (6%) ranged between 0.6 and 16.2 mg/kg. No FB(1) was detected in urban phutu samples. Because these levels are lower than those published from regions in South Africa with high incidence of esophageal cancer, it may be concluded that the risk of esophageal cancer from FB(1) exposure is lower in the KwaZulu Natal region.

Fumonisin B1 (FB1) is a compound that occurs frequently in rural foods and feeds, creating health hazards. When ingested, FB1 does not appear to change in structure and is mostly excreted unchanged in faeces within 24 h. Twenty human stool samples obtained from rural school children of Vulamehlo, south of Durban (South Africa), were analysed for FB1, as well as 23 urban control samples obtained from various households within the Durban metropolitan area. The samples were freeze-dried and ground to a fine powder. A fraction of each sample was extracted three times with aqueous ethylenediaminetetraacetic acid at pH 5.2. The pooled extracts were purified using reversed phase C18 solid phase extraction cartridges. Analytical high performance liquid chromatography was used to quantitate the amount of FB1 as an o-phthaldialdehyde (OPA) derivative in the extracts. The rural (35%) and the urban samples (9%) showed the presence of FB ranging from 790 to 19 560 ng g(-1) of freeze dried stool. It was concluded that this method could be used as a routine biomarker for short term human exposure to FB1 in contaminated food.

Sutherlandia frutescens (SF), a popular traditional medicinal plant found in various parts of southern Africa, is used for treatment or management of HIV/AIDS and other diseases including cancer. However, its toxicity profile has not been fully established. The aims of this study were to examine the effects of 70% ethanol (SFE) and deionised water (SFW) extracts on normal isolated human T cells. An experimental study on normal human lymphocytes treated with doses SF extract doses ranging from 0.25 to 2.5 mg/ml. Untreated, vehicle-treated (Ethanol) and camptothecin (CPT) treated normal T cells were used as controls. Induction of cell death, changes in intracellular ATP, caspase-3/-7 activity and nuclear changes were analysed using flow cytometry, luminometry and nuclear staining (Hoechst) respectively. The highest concentration (2.5 mg/ml) of SFE extract induced significant necrosis (95%), depletion of ATP (76%), and inhibition of caspase-3/-7 activity (11%) following a 24 hour incubation period (p< 0.001). The 2.5 mg/ml concentration of SFW showed the same trend but were less effective (necrosis- 26%, ATP- 91%, & caspase-3/-7- 15%). These effects showed a time-dependence over 48 hours of incubation, with high doses of SFE extracts eliminating viable cells by necrosis, depleting ATP levels and decreasing caspase-3/-7 activity (p< 0.001). The activity of SFE extract was independent of ethanol. The SFW extract dilutions were less toxic than the SFE extracts. Significant DNA fragmentation as demonstrated by Hoechst staining was also seen over 48-hour incubation for high doses of both types of SF extracts. These results showed that although high concentrations of SF extracts can be toxic to normal T cells in vitro, SFW fractions were relatively safe for use.

The combined effects of water activity (a(w)) and temperature on mycotoxin production by Penicilium commune (cyclopiazonic acid - CPA) and Aspergillus flavus (CPA and aflatoxins - AF) were studied on maize over a 14-day period using a statistical experimental design. Analysis of variance showed a highly significant interaction (P ≤ 0.001) between these factors and mycotoxin production. The minimum a(w)/temperature for CPA production (2264 ng g(-1) P. commune, 709 ng g(-1) A. flavus) was 0.90 a(w)/30 °C while greatest production (7678 ng g(-1) P. commune, 1876 ng g(-1) A. flavus) was produced at 0.98 a(w)/20 °C. Least AF (411 ng g(-1)) was produced at 0.90 a(w)/20 °C and most (3096 ng g(-1)) at 0.98 a(w)/30 °C.

Background: Regulation and standardization of African traditional medicines (ATM) prescribed by traditional healers in South Africa is still far from being implemented. This is despite the fact that more people are using ATM products than ever. In an effort to demonstrate that collaboration with traditional health practitioners (THPs) can yield standardized TM products, this study aimed to evaluate the immunomodulatory effects of an herbal immune booster formulated by traditional healers from the Vaal Region, South Africa. Materials and Methods: Using normal and lipopolysaccharide (LPS) stimulated human peripheral blood mononuclear cells (PBMCs) models, doses of the immune booster ranging from 1000 to 10 μg/mL were evaluated for their cytotoxicity, inflammatory cytokines and chemokines secretion, nitric oxide (NO) secretion, malondialdehyde (MDA) assay, and 1,1-diphenyl-2-picrylhydrazyl (DPPH) assay. Results: The immune booster induced a dose dependent cytotoxic effect on both normal and LPS stimulated PBMCs with higher doses showing cytotoxicity while lower dose from 100μg/mL did not show any cytotoxicity. When re-dissolved in aqueous PBS immune booster doses up to 100 μg/mL showed better DPPH radical inhibition (41%) than ascorbic acid at 40μg/mL (33%). The immune booster also decreased lipid peroxides significantly (p< 0.05) and this was comparable to ascorbic acid. There was also a significant (p< 0.05) increase in nitrite (NO) after treatment of LPS stimulated PBMCs with immune booster doses when compared to untreated samples. The immune booster stimulated inflammatory cytokines secretion in normal PBMCs (IL 1α, IL 1β, IL 6, IL 10 and TNFα while showing a decrease in IFNγ at the higher dose) while in LPS stimulated PBMCs some cytokines were decreased (IL 1α, IL 17α and at lower doses IL 10 and TNFα) and others were increased (IFNγ, TNFα and GM-CSF) depending on the dose used. In both normal and LPS stimulated PBMCs the immune booster significantly (p< 0.05) increased (MIP 1α) while causing significant (p< 0.05) decreases in IP 10 (high dose), I-TAC and MIG secretion. Conclusions: This immune booster showed potential immunostimulatory effects by increasing nitric oxide, inflammatory cytokines and chemokines secretion in both normal and LPS stimulated PBMCs. This TM also showed promising antioxidant potential in the MDA and DPPH assays. Further in vitro and animal studies are warranted.

The traditional medicines sector in South Africa is still largely unregulated despite legislation aimed at regulating the practice being in place. The HIV and AIDS epidemic has fuelled demand for traditional medicines, with many patients consulting traditional health practitioners who offer different treatments, including herbal immune boosters. This study investigated the mutagenic and antioxidant effects of the widely sold herbal immune booster, uMakhonya®. The Ames test was used for analysis of the genototoxic effects while the adenosine triphosphate (ATP) assay was used to evaluate cell cytotoxicity in peripheral blood mononuclear cells (PBMCs) and THP-1 monocytes. To evaluate the antioxidant effects the malondialdehyde (MDA) quantification, the nitric oxide and 1,1-diphenyl-2-picryl-hydrazyl (DPPH) assays were used. UMakhonya® doses of up to 5000 μg/mL were not genotoxic in the Ames test. UMakhonya® was shown to induce dose-dependent cytotoxicity in both PBMCs and THP-1 cells with doses ranging from 500 μg/ mL to 1000 μg/mL, showing significant (p

Sutherlandia frutescens (SF) is one of the medicinal plants used as an immune booster in the treatment of chronic ailments such as HIV/AIDS and cancer. Limited data suggest that its efficacy is based on its regulatory effect on cytokines, the critical components of the immune response. In this study, we investigated the in vitro immunomodulatory effects of SF extracts on normal human peripheral blood mononuclear cells (PBMCs). An ELISA-based assay was used to assess the levels of expression of 12 cytokines in treated cells. An adenosine triphosphate (ATP) assay was used to assess cell viability in relation to cytokine secretion. SF ethanol extracts induced changes in cytokine secretion relative to the dose of the extract. Generally cytokine expression and secretion was low in concentration because were not stimulated with any endotoxin. The high SFE dose (2.5 mg/ml) significantly (p

African Traditional Medicines (ATMs) serve as a major source of primary healthcare for African people. The reasons for their use range from easy access, affordability, beliefs in traditional systems and long term safety. ATMs have been used to treat individuals infected with HIV and therefore need scientific validation; a view supported by Traditional Health Practitioners (THPs). This study aimed to evaluate the in vitro cytotoxicity, immune modulatory and anti-HIV activities of traditional multiple herbal preparations from local THPs. Ugambu, Ihashi, Product Nene, Product Blue, SPNa and SDKc ATM were supplied by local THPs. Changes in adenosine triphosphate (ATP) & glutathione (GSH) over 24 hours were measured using luminometry. Changes in 12 cytokines were assayed using an ELISA-based absorbance assay. Protective effects against HIV killing of MT-4 cells were tested using the XTT assay and antiviral activity was measured using an HIV-1 viral load assay. Cyclosporine and AZT were used as positive controls. Ugambu, Ihashi, Product Nene and SDKc induced a dose dependent toxicity on treated PBMCs by reducing ATP and GSH at high doses (p< 0.001). These medicinal preparations, along with SPNa, showed immunomodulatory activity by significantly (p< 0.001) changing the secretion of pro-inflammatory cytokines. Product Blue stimulated the levels of ATP and GSH in treated PBMCs at all doses however this product did not show any immunomodulatory activity on cytokine secretion when compared to control cells. Ugambu, Ihashi, Product Nene showed promising anti-HIV activity relative to AZT (p< 0.01). This study has shown that some of these traditional medicinal preparations have at least one or all the properties of immunostimulation, immunomodulation or antiretroviral effects. The mechanism of action of the shown activities should further be investigated.

The South Durban Health Study is a population-based study that examined the relationship between exposure to ambient air pollutants and respiratory disease among school children with high prevalence of asthma who resided in two purposely-selected communities in north and south Durban, KwaZulu-Natal, South Africa. From these participants, a subgroup of 135 families was selected for investigation of household characteristics potentially related to respiratory health. In these households, a walkthrough investigation was conducted, and settled dust and air samples were collected for allergen and fungal measurements using standardised techniques. Asp f1 allergen was detected in all homes, and Bla g1 allergen was detected in half of the homes. House dust allergens, Der f1 and Der p1 exceeded concentrations associated with risk of sensitization and exacerbation of asthma in 3 and 13%, respectively, of the sampled homes, while Bla g1 exceeded guidance values in 13% of the homes. Although airborne fungal concentrations in sleep areas and indoors were lower than outdoor concentrations, they exceeded 1000 CFU/m3 in 29% of the homes. Multivariate analyses identified several home characteristics that were predictors of airborne fungal concentrations, including moisture, ventilation, floor type and bedding type. Airborne fungal concentrations were similar indoors and outdoors, which likely reduced the significance of housing and indoor factors as determinants of indoor concentrations. Conclusion Allergen concentrations were highly variable in homes, and a portion of the variability can be attributed to easily-recognised conditions.

The regulation and registration of traditional medicines (TM) continues to present challenges to many countries regardless of the fact that an increased number of the population utilises TM for their health care needs. There have been improvements in the legal and policy framework of South Africa based on the WHO guidelines. However, there are currently no guidelines or framework for the registration of TM in South Africa. This article reviews literature and existing guidelines of specific countries and regions and makes recommendations for South African guidelines.Keywords: Regulation, Registration, Traditional Medicines, South Africa

Sutherlandia frutescens (SF), a popular traditional medicinal plant found in various parts of southern Africa, is used for treatment or management of HIV/AIDS and other diseases including cancer. However, its toxicity profile has not been fully established. The aims of this study were to examine the effects of 70% ethanol (SFE) and deionised water (SFW) extracts on normal isolated human T cells. An experimental study on normal human lymphocytes treated with doses SF extract doses ranging from 0.25 to 2.5 mg/ml. Untreated, vehicle-treated (Ethanol) and camptothecin (CPT) treated normal T cells were used as controls. Induction of cell death, changes in intracellular ATP, caspase-3/-7 activity and nuclear changes were analysed using flow cytometry, luminometry and nuclear staining (Hoechst) respectively. The highest concentration (2.5 mg/ml) of SFE extract induced significant necrosis (95%), depletion of ATP (76%), and inhibition of caspase-3/-7 activity (11%) following a 24 hour incubation period (p< 0.001). The 2.5 mg/ml concentration of SFW showed the same trend but were less effective (necrosis- 26%, ATP- 91%, & caspase-3/-7- 15%). These effects showed a time-dependence over 48 hours of incubation, with high doses of SFE extracts eliminating viable cells by necrosis, depleting ATP levels and decreasing caspase-3/-7 activity (p< 0.001). The activity of SFE extract was independent of ethanol. The SFW extract dilutions were less toxic than the SFE extracts. Significant DNA fragmentation as demonstrated by Hoechst staining was also seen over 48-hour incubation for high doses of both types of SF extracts. These results showed that although high concentrations of SF extracts can be toxic to normal T cells in vitro, SFW fractions were relatively safe for use.

BackgroundSutherlandia frutescens (L.) R. Br. is widely used as an over the counter complementary medicine and in traditional medications by HIV seropositive adults living in South Africa; however the plant's safety has not been objectively studied. An adaptive two-stage randomized double-blind placebo controlled study was used to evaluate the safety of consuming dried S. frutescens by HIV seropositive adults with CD4 T-lymphocyte count of >350 cells/μL.MethodsIn Stage 1 56 participants were randomized to S. frutescens 400, 800 or 1,200 mg twice daily or matching placebo for 24 weeks. In Stage 2 77 additional participants were randomized to either 1,200 mg S. frutescens or placebo. In the final analysis data from Stage 1 and Stage 2 were combined such that 107 participants were analysed (54 in the S. frutescens 1,200 mg arm and 53 in the placebo arm).ResultsS. frutescens did not change HIV viral load, and CD4 T-lymphocyte count was similar in the two arms at 24 weeks; however, mean and total burden of infection (BOI; defined as days of infection-related events in each participant) was greater in the S. frutescens arm: mean (SD) 5.0 (5.5) vs. 9.0 (12.7) days (p = 0.045), attributed to two tuberculosis cases in subjects taking isoniazid preventive therapy (IPT).ConclusionA possible interaction between S. frutescens and IPT needs further evaluation, and may presage antagonistic interactions with other herbs having similar biochemical (antioxidant) properties. No other safety issues relating to consumption of S. frutescens in this cohort were identified.Trial registrationClinicalTrials.gov NCT00549523.