Vitamin D deficiency and oral candidiasis in patients with HIV infection: A case‒control study.

BACKGROUND: Oral candidiasis is a common opportunistic infection in patients with human immunodeficiency virus (HIV). In addition, most of these patients suffer from vitamin D deficiency. This study aimed to investigate the association between vitamin D levels and oral candidiasis in patients with HIV infection. METHODS: This case‒control study was conducted on HIV-infected patients. Cases were patients with oral candidiasis diagnosed based on physical examinations. Controls were age- and sex-matched individuals without oral candidiasis. The levels of 25-OH vitamin D and other laboratory markers (CD4 count and viral load) were compared between the case and control groups. RESULTS: A total of 104 cases and 102 controls were included in the study. The cases had significantly lower 25-OH vitamin D3 levels (MD = 33.86 ng/mL, 95% CI= (31.85, 35.87), P < 0.001) and CD4 counts (MD = 267.48 cells/mm3, 95% CI= (189.55, 345.41), P < 0.001) than the controls. In addition, viral load was significantly higher in cases than in controls (MD = 7.03 × 105 copies/mL, 95% CI= (4.46 × 105, 9.61 × 105), P < 0.001). The multivariate logistic regression analysis revealed that educational status (OR = 0.032, 95% CI= (0.002, 0.100), P < 0.001), current HAART (OR = 0.005, 95% CI= (0.001, 0.014), P < 0.001), history of oral candidiasis (OR = 20.114, 95% CI= (18.135, 21.957), P < 0.001), CD4 count (OR = 0.004, 95% CI= (0.001, 0.006), P < 0.001), viral load (OR = 12.181, 95% CI= (1.108, 133.392), P < 0.001), and vitamin D level (OR = 0.011, 95% CI= (0.008, 0.015), P < 0.001) were significantly associated with the risk of developing oral candidiasis. CONCLUSIONS: Based on the findings, most patients with HIV infection suffer from vitamin D deficiency, especially those with oral candidiasis. Hypovitaminosis D was significantly associated with an increased risk of oral candidiasis. Thus, vitamin D supplementation may assist HIV-positive patients in improving their oral health and preventing oral candidiasis.

Efficacy of a multiple-indication antiviral herbal drug (Saliravira®) for COVID-19 outpatients: A pre-clinical and randomized clinical trial study.

BACKGROUND: The scientific researches on COVID-19 pandemic topics are headed to an explosion of scientific literature. Despite these global efforts, the efficient treatment of patients is an in-progress challenge. Based on a meta-study of published shreds of evidence about compounds and their botanic sources in the last six decades, a novel multiple-indication herbal compound (Saliravira®) has been developed. Based on the antiviral, anti-inflammatory, and immune-enhancing properties of its ingredients, we hypothesized that Saliravira® has the potential to act as an antiviral agent, accelerate treatment, and reduce undesirable effects of COVID-19. METHODS: In this randomized, controlled, open-label clinical trial, COVID-19 outpatients were included by RT-PCR test or diagnosis of physicians according to the symptoms. Participants were randomly divided into intervention and control groups to receive Saliravira® package plus routine treatments of COVID-19 or routine treatments of COVID-19 alone, respectively. Saliravira® package includes tablets, nasal-sinuses spray, oral-pharynx spray, and inhaler drops. The treatment was for 10 days and followed up till 23 days after admission. RESULTS: On the 8th day, the "mean reduction rates" of viral load of the patients in the intervention group was 50% lower compared to the control group with a p-value < 0.05. The improvement of 10 out of 14 COVID-19 symptoms in the intervention group was significantly accelerated. The mean treatment duration of patients in the intervention group was 4.9 days less than the control group. In addition, no patients in the intervention group were hospitalized compared to 28% of the control group needed to be hospitalized.

Safety and effectiveness of high-dose vitamin C in patients with COVID-19: a randomized open-label clinical trial.

BACKGROUND: Vitamin C is an essential water-soluble nutrient that functions as a key antioxidant and has been proven to be effective for boosting immunity. In this study, we aimed to assess the efficacy of adding high-dose intravenous vitamin C (HDIVC) to the regimens for patients with severe COVID-19 disease. METHODS: An open-label, randomized, and controlled trial was conducted on patients with severe COVID-19 infection. The case and control treatment groups each consisted of 30 patients. The control group received lopinavir/ritonavir and hydroxychloroquine and the case group received HDIVC (6 g daily) added to the same regimen. RESULTS: There were no statistically significant differences between two groups with respect to age and gender, laboratory results, and underlying diseases. The mean body temperature was significantly lower in the case group on the 3rd day of hospitalization (p = 0.001). Peripheral capillary oxygen saturations (SpO2) measured at the 3rd day of hospitalization was also higher in the case group receiving HDIVC (p = 0.014). The median length of hospitalization in the case group was significantly longer than the control group (8.5 days vs. 6.5 days) (p = 0.028). There was no significant difference in SpO2 levels at discharge time, the length of intensive care unit (ICU) stay, and mortality between the two groups. CONCLUSIONS: We did not find significantly better outcomes in the group who were treated with HDIVC in addition to the main treatment regimen at discharge. Trial registration irct.ir (IRCT20200411047025N1), April 14, 2020.

Effect of Valerian in Preventing Neuropsychiatric Adverse Effects of Efavirenz in HIV-Positive Patients: A Pilot Randomized, Placebo-Controlled Clinical Trial.

BACKGROUND: Several neuropsychiatric adverse effects of efavirenz are known. Preventing these adverse effects may improve patients' adherence to antiretroviral therapy (ART). OBJECTIVES: To evaluate the efficacy and safety of valerian in preventing neuropsychiatric adverse effects of efavirenz in HIV-positive patients. METHOD: In this pilot randomized, double-blinded, placebo-controlled, clinical trial, 51 HIV-positive patients who were receiving efavirenz were recruited into the valerian (n = 25) or placebo (n = 26) group. Patients received valerian (530 mg) or placebo nightly 1 hour before sleep for 4 weeks. The neuropsychiatric status (sleep, anxiety, depression, suicidal thought, and psychosis) of patients was assessed at baseline and week 4 using validated questionnaires. RESULTS: Sleep ( P ≤ 0.001) and anxiety ( P = 0.001) significantly improved in the valerian group compared with the placebo group. Dizziness was the most common complaint of patients in first days of the intervention. In the valerian and placebo groups, 92% and 84.6% of patients experienced dizziness, respectively ( P = 0.35). Nausea was the second common adverse effect that 84% and 76.9% of patients in the valerian and placebo groups experienced ( P = 0.39). CONCLUSION: In the first 4 weeks of ART including efavirenz, valerian significantly improved sleep and anxiety in HIV-positive patients. Valerian may be considered as a potential option in preventing neuropsychiatric adverse effects of efavirenz in HIV-positive patients.

Effect of Omega-3 Fatty Acids on Depressive Symptoms in HIV-Positive Individuals: A Randomized, Placebo-Controlled Clinical Trial.

BACKGROUND: The antidepressant effect of omega-3 fatty acids has been described in the non-HIV population. The effect of omega-3 fatty acid supplementation on the mood status of HIV-positive patients has not been evaluated yet. OBJECTIVE: In this study, the effect of omega-3 fatty acids on depressive symptoms was evaluated in HIV-positive individuals. METHOD: A total of 100 HIV-positive patients with Beck Depression Score ≥16, were assigned to receive either omega-3 fatty acids or placebo twice daily for 8 weeks. Depressive symptoms of each participant were evaluated at baseline (month 0) and at the end of months 1 and 2 of the study. Beck Depression Inventory Second Edition, depression subscale of the Hospital Anxiety and Depression Scale, and Patient Health Questionnaire were used for assessment of depressive symptoms. RESULTS: Reduction in mean ± SD of all depression scores during the study period was statistically significant within the omega-3 group and when compared with the placebo group (for both comparisons, P < 0.001). Also, the mean differences of all depression scores were decreased significantly during the intervals: months 0, 1, and 2 (P < 0.001 for all comparisons). Among the participants, 7 (7%) and 4 (4%) patients in the omega-3 and the placebo group, respectively, experienced mild gastrointestinal problems, but the incidence of adverse drug reactions related to the interventions was not statistically different between the groups (P = 0.09). CONCLUSION: Omega-3 fatty acids improved depressive symptoms in HIV-positive individuals without any significant adverse reaction.

Ginger for prevention of antiretroviral-induced nausea and vomiting: a randomized clinical trial.

OBJECTIVE: In this randomized clinical trial ginger efficacy for prevention of antiretroviral-induced nausea and vomiting (N/V) was investigated. METHODS: From July 2011 until the end of June 2013, 102 HIV positive patients attending the HIV clinic of Imam Khomeini Hospital participated in the study. In a double blinded manner, participants randomly received either 500 mg ginger or placebo two times per day, 30 min before each dose of antiretroviral regimen for 14 days. The severity of nausea was assessed based on the visual analogue scale. The number of vomiting episodes were also recorded during the study period. RESULTS: A total of 46 (90.2%) and 29 (56.4%) of the patients in placebo and ginger groups experienced some degree of nausea during the first 2 weeks of antiretroviral therapy (ART), respectively (p = 0.001). Frequency of mild, moderate and severe nausea were significantly lower in the ginger than placebo group (p = 0. 001). Also, 24 (47.1%) and 5 (9.8%) of the patients in the placebo and ginger groups reported at least one episode of vomiting during their time on ART, respectively (p = 0.01). CONCLUSION: Ginger was effective in ameliorating of antiretroviral-induced N/V.