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BACKGROUND: Spirulina platensis, a cynobacterium used frequently as a dietary supplement had been found to exhibit many immune-stimulating and antiviral activities. It had been found to activate macrophages, NK cells, T cells, B cells, and to stimulate the production of Interferon gamma (IFN-γ) and other cytokines. Natural substances isolated from Spirulina platensis had been found to be potent inhibitors against several enveloped viruses by blocking viral absorption/penetration and some replication stages of progeny viruses after penetration into cells. We aimed to study whether this dietary supplement possesses any therapeutically feasible activity worthy of further larger controlled clinical evaluation. METHODS: Sixty six patients with chronic hepatitis C virus infection and eligible for inclusion had been randomized to either Spirulina or Silymarin treated groups for a period of six months treatment.The two groups were followed up and blindly compared for early (after 3 months) and end of 6 months treatment virological response. The effects of both treatments on each of alanine aminotransferase (ALT), Chronic Liver Disease Questionnaire scores (CLDQ), Arizona Sexual Experience Scale scores (ASEX) and the occurrence of any attributable adverse events were also compared. RESULTS: Among the 30 patients who had been treated with Spirulina and completed the 6 months protocol, 4 patients (13.3%) had a complete end of treatment virological response and 2 patients (6.7%) had a partial end of treatment response defined as significant decrease of virus load of at least 2-logs10. Though the proportion of responders in Spirulina group was greater than in the Silymarin group, the difference was not statistically significant at the end of both 6 months (p = 0.12) and 3 months treatment (p = 0.22) by Exact test. Alanine aminotransferase as well as CLDQ and ASEX scores were found to be more significantly improved in Spirulina than in Silymarin treated group. CONCLUSIONS: Our results could suggest a therapeutically feasible potential for Spirulina platensis in chronic HCV patients, worthy to conduct a larger sized and longer study to confirm these safety and efficacy encouraging results. TRIAL REGISTRATION: WHO Clinical Trial Registration ID: ACTRN12610000958088http://apps.who.int/trialsearch/trial.aspx?trialid=ACTRN12610000958088.
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Antivirais/uso terapêutico , Suplementos Nutricionais , Hepatite C Crônica/tratamento farmacológico , Silimarina/uso terapêutico , Spirulina , Alanina Transaminase/sangue , Antivirais/efeitos adversos , Hepatite C Crônica/enzimologia , Humanos , Projetos Piloto , Silimarina/efeitos adversos , Inquéritos e Questionários , Carga ViralRESUMO
Hepatocellular carcinoma (HCC) is the second most common cause of cancer-related deaths worldwide with chronic hepatitis C virus (HCV) infection as a major risk factor of HCC. Circulating microRNAs are deregulated in HCC and are candidate biomarkers. The aim of this study was to explore the expression profile of miRNA-122, miR-483, and miR-335 in the serum of HCV-related hepatocellular carcinoma (HCC). 90 HCV-related hepatocellular carcinoma (HCC) patients, 90 non-malignant HCV patients, and 60 healthy controls were included. Serum microRNAs were measured by a qRT-PCR custom array. The expression levels of miR-122 and miR-483 were upregulated in HCC patients, while the miR-335 expression level was downregulated versus controls and HCV groups. Receiver-operating characteristic (ROC) curve analysis was created to examine miRNAs. miR-483 presented the best diagnostic potential because it showed the highest diagnostic accuracy for distinguishing HCV-related HCC patients from controls (AUC = 0.98) with 100% sensitivity. Moreover, there was obvious prognostic power in distinguishing HCV from HCC (AUC = 0.95) with 88% sensitivity. In conclusion, studied microRNAs (miR-122, miR-483, and miR-335) could serve as potential non-invasive early diagnostic biomarkers for HCC, and we identified a panel of three serum microRNAs with high accuracy in HCC diagnosis. Additional studies are required to confirm this panel and test its prognostic significance.
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To assess the potential role of serum serotonin level in hepatocellular carcinoma (HCC) diagnosis. A case-control study that involved 100 Egyptian adults. Subjects were divided into 4 groups: Group I: 21 patients with late-stage HCC on top of liver cirrhosis, Group II: 28 patients with early-stage HCC on top of liver cirrhosis, Group III: 26 patients with cirrhosis with no evidence of HCC, and Group IV: 25 healthy age- and sex-matched subjects were as a control group. Serum serotonin level was determined in all recruited subjects using high-performance liquid chromatography-fluorescent detection method. Alpha-fetoprotein had a statistically significant elevation in group I with a median of 1300 ng/L (195-2544 ng/L) compared to groups II and III (P ≤ 0.01). Regarding serum serotonin level, it had a statistically significant elevation in group II with a median of 275 ng/µL (204.7-400 ng/µL) compared to groups I, III, and IV with median of 33 ng/µL (30-50 ng/µL), 50 ng/µL (30-60 ng/µL), and 102 (85-150 ng/µL), respectively (P = 0.001). Receiver operating characteristic curve showed that serum serotonin at cutoff value of 108 ng/µL had a sensitivity of 100% and specificity of 92.3% in discriminating early-stage HCC from cirrhosis. Serum serotonin level is a rapid, sensitive, noninvasive diagnostic biomarker for the detection of early-stage HCC.
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Biomarcadores Tumorais/sangue , Carcinoma Hepatocelular/sangue , Carcinoma Hepatocelular/diagnóstico , Neoplasias Hepáticas/sangue , Neoplasias Hepáticas/diagnóstico , Serotonina/sangue , Estudos de Casos e Controles , Feminino , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
BACKGROUND: Renal colic is typically characterized by the sudden onset of severe pain radiating from the flank to the groin and its acute management in emergency departments essentially aims at rapid pain relief. Spasmofen(®) is a brand of Amriya Pharmaceutical Industries in the form of rectal suppositories containing ketoprofen 100 mg and hyoscine butylbromide 10 mg. This combination is intended for the rapid relief of severe colicky pain in the renal system, hepatobiliary system, or gastrointestinal tract. This trial aims to compare a single-dose of Spasmofen rectal suppository to a single intravenous (IV) ketorolac tromethamine 30 mg/2 mL dose in patients with acute renal colic. METHODS: A total of 80 eligible consecutive patients presenting to the emergency departments of two medical centers with acute renal colic were included in the study. Eligible patients who signed the informed consent were randomly assigned into two treatment groups: an experimental group (Spasmofen group) who received one Spasmofen rectal suppository plus an IV injection of 2 mL of normal saline solution; and a control group (ketorolac group) who received one ketorolac 30 mg/2 mL ampoule IV plus one placebo suppository. Treatment success, defined as a change in the verbal rating score from severe or moderate pain to none or mild at 60 minutes after the dose, was compared between groups using the chi-square/Fisher's exact test. Percentage reductions in visual pain analog scale (VPAS) scores at 15 and 60 minutes after the dose were compared between groups using the Z-test for proportions. RESULTS: Successful treatment at 60 minutes occurred in 35 of 40 (87.5%) of Spasmofen-treated patients and in 33 of 40 (82.5%) of ketorolac-treated patients. The difference was not statistically significant by Fisher's exact test (P=0.755). The mean percentage reduction of VPAS after 15 minutes was 61.82% in the Spasmofen-treated group and 64.76% in the ketorolac-treated group. The difference was also not statistically significant by the Z-test for proportions (P=0.795). Sixty minutes after being treated, Spasmofen was associated with a statistically significant greater reduction in VPAS (mean% reduction =92.36%) than ketorolac (75.06%; P=0.0466). CONCLUSION: Single-dose Spasmofen rectal suppository might be a safe and effective first-aid treatment for the emergency department relief of acute renal colic.
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Codeína/administração & dosagem , Morfina/administração & dosagem , Noscapina/administração & dosagem , Papaverina/administração & dosagem , Cólica Renal/tratamento farmacológico , Derivados da Escopolamina/administração & dosagem , Administração Retal , Adulto , Codeína/efeitos adversos , Método Duplo-Cego , Combinação de Medicamentos , Tratamento de Emergência , Feminino , Humanos , Cetorolaco/administração & dosagem , Masculino , Pessoa de Meia-Idade , Morfina/efeitos adversos , Noscapina/efeitos adversos , Medição da Dor , Papaverina/efeitos adversos , Derivados da Escopolamina/efeitos adversosRESUMO
BACKGROUND: Mild cognitive impairment encompasses the clinical continuum between physiologic age-related cognitive changes and dementia. A variety of medications, including herbal preparations (in particular Ginkgo biloba and Panax ginseng), have been advocated as treatments for cognitive impairment in the elderly. In this study, we investigated the effect of an already marketed dietary supplement (Memo®) combining 750 mg of lyophilized royal jelly with standardized extracts of G. biloba 120 mg and P. ginseng 150 mg on Mini-Mental State Examination (MMSE) scores in patients with mild cognitive impairment. METHODS: Sixty-six subjects presenting with forgetfulness and satisfying the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) clinical criteria for mild cognitive impairment were randomly divided into an experimental group treated with one Memo capsule before breakfast daily for 4 weeks and a control group who took placebo. The mean change in MMSE score from baseline and reported adverse effects were compared between the two groups. RESULTS: The mean change in MMSE score in the group treated with Memo for 4 weeks was significantly greater than in the control group (+2.07 versus +0.13, respectively) by the Student's t-test (t = 6.485, P < 0.0001). This was also true after adjusting for age as a covariate and educational level as a factor nested within the treatment groups in a general linear model (analysis of covariance, F = 9.675 [corrected model], P < 0.0001). CONCLUSION: This combined triple formula may be beneficial in treating the cognitive decline that occurs during the aging process as well as in the early phases of pathologic cognitive impairment typical of insidious-onset vascular dementia and in the early stages of Alzheimer's disease. Larger-sized studies with longer treatment durations are needed to confirm this.
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Disfunção Cognitiva/tratamento farmacológico , Ácidos Graxos/uso terapêutico , Ginkgo biloba , Panax , Fitoterapia , Idoso , Idoso de 80 Anos ou mais , Envelhecimento , Suplementos Nutricionais , Combinação de Medicamentos , Egito , Feminino , Liofilização , Humanos , Masculino , Pessoa de Meia-Idade , Testes Neuropsicológicos , Resultado do TratamentoRESUMO
OBJECTIVE: To study the potential efficacy and tolerability of a natural multiherbal formula (Immumax) containing Echinacea extract 120 mg, garlic powder 100 mg, Nigella sativa oil 200 mg, and Panax ginseng extract 50 mg plus vitamin C 50 mg and elemental zinc 7.5 mg in the treatment of patients suffering from the common cold. DESIGN AND SETTING: The study was conducted in a prospective, double-blind, randomized, controlled study design in an outpatient setting. PATIENTS AND METHODS: Sixty-two eligible patients with symptoms of the common cold were randomized to either Immumax or placebo treatment groups for the duration of their symptoms or a maximum of 14 days. Resolution rates were estimated using Kaplan-Meier analysis, and resolution profiles were compared between groups using the log-rank test. The mean percentage change in total symptom severity scores at days 4 and 8 from baseline were compared between the two groups by one-way analysis of variance (ANOVA). RESULTS: The median (interquartile range) time to resolution of all symptoms was 8 (5-9) days in the placebo group and 4 (3-6) days in the Immumax group. The results of the log-rank test indicate that symptoms resolved significantly faster in the Immumax group than in the placebo group (P < 0.001). The mean percentage reduction in total symptom severity scores from baseline at days 4 and 8 was significantly greater in the Immumax group than in the placebo group by one-way ANOVA (P < 0.01). CONCLUSION: We can conclude from our study that Immumax is helpful in reducing the duration and severity of common cold symptoms.
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BACKGROUND: Lady 4 is a combination of 4 natural components (evening primrose oil, damiana, ginseng, royal jelly) with a known history of traditional use for menopausal symptoms. OBJECTIVE: To study efficacy and safety of Lady 4 in women suffering from menopausal syndrome. METHODS: 120 women with menopausal symptoms were randomised into an experimental group treated with 2 capsules of Lady 4 daily and a control group treated with placebo. The outcome was measured by the Menopause Rating Scale II (MRS-II). RESULTS: There was a statistically significant improvement in the MRS-II score in both groups after 2 and 4 weeks of treatment, but the improvement was significantly better in the Lady 4 group (p < 0.001). 86.7% in the Lady 4 group and 56.7% in the placebo group rated the therapy success as 'much improved' or 'very much improved'. CONCLUSION: Lady 4 may be beneficial in the treatment of menopausal syndrome and can be used as a safe natural promoter of health and well-being in women during the menopausal transition.
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Menopausa , Fitoterapia/normas , Extratos Vegetais/uso terapêutico , Adulto , Feminino , Humanos , Pessoa de Meia-Idade , Síndrome , Resultado do TratamentoRESUMO
BACKGROUND: Acute exacerbations of chronic bronchitis (AECB) are defined as recurrent attacks of worsening bronchial inflammation that are marked by an increase in the volume of daily sputum produced, a change in color of the expectorated sputum, and worsening dyspnea. Farcosolvin (Pharco Pharmaceuticals, Alexandria, Egypt) is a mixture of ambroxol (15 mg); theophylline (50 mg); and guaiphenesin (30 mg), per 5 mL syrup. OBJECTIVE: To test the clinical efficacy of Farcosolvin in the treatment of AECB in a randomized, single-blinded, controlled study design. PATIENTS AND METHODS: One hundred patients with AECB were randomized to either Farcosolvin or guaiphenesin treatment groups, in addition to the standard medical treatment for their cases. Baseline clinical symptomatolgy of breathlessness, cough, and sputum severity scoring were compared before and after 3 and 7 days of treatment in both groups and the differences compared between groups. Changes in perceived improvement were also compared between groups using the Clinical Global Impression of Improvement or Change Scale (CGIC). RESULTS: There were statistically significant improvements in breathlessness and cough scores in both groups (pretreatment versus posttreatment at day 3 and at day 7; P < 0.05). There were highly statistically significant differences between groups in improvement in breathlessness and cough scores, after 3 and 7 days treatment, in favor of the Farcosolvin treatment group (P < 0.001). Out of 50 patients, 48 (96%) in the Farcosolvin-treated group rated their improvement on the CGIC scale as "much" and "very much" improved, while only 41 patients (82%) reported such a degree of improvement in the control group. The difference was statistically significant (P < 0.05). CONCLUSION: We concluded from our study that Farcosolvin syrup might be safe and effective in improving symptoms in cases of acute exacerbation of chronic bronchitis.