scholarly journals Acupuncture to Reduce HIV-Associated Inflammation

2015 ◽  
Vol 2015 ◽  
pp. 1-6
Author(s):  
Barbara Swanson ◽  
Joyce K. Keithley ◽  
Angela Johnson ◽  
Louis Fogg ◽  
Oluwatoyin Adeyemi ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Plasma Concentrations ◽  
High Sensitivity ◽  
Neural Mechanism ◽  
Sham Acupuncture ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Inflammatory Conditions ◽  
Anti Inflammatory

Background. HIV infection is associated with systemic inflammation that can increase risk for cardiovascular events. Acupuncture has been shown to have immunomodulatory effects and to improve symptoms in persons with inflammatory conditions.Objective. To test the anti-inflammatory effects of an acupuncture protocol that targets the cholinergic anti-inflammatory pathway (CAIP), a neural mechanism whose activation has been shown to reduce the release of proinflammatory cytokines, in persons with HIV-associated inflammation.Design, Setting, Participants, and Interventions. Double-blind, placebo-controlled clinical trial conducted in an outpatient clinic located in a medically underserved urban neighborhood. Twenty-five clinically-stable HIV-infected persons on antiretroviral therapy were randomized to receive once weekly CAIP-based acupuncture or sham acupuncture.Main Outcome Measures. Outcomes included plasma concentrations of high sensitivity C-reactive protein and D-dimer and fasting lipids.Results. Twenty-five participants completed the protocol (treatment groupn=12, control groupn=13). No adverse events related to the acupuncture protocol were observed. Compared to baseline values, the two groups did not significantly differ in any outcome measures at the end of the acupuncture protocol.Conclusions. CAIP-based acupuncture did not favorably modulate inflammatory or lipid parameters. Additional studies are warranted of CAIP-based protocols of different frequencies/durations.

Antioxidant and anti-inflammatory response to curcumin supplementation in hemodialysis patients: a randomized, double-blind, placebo-controlled clinical trial

2021 ◽  
Author(s):  
Hellen Christina Neves Rodrigues ◽  
Tatiane Fagundes Pereira Martins ◽  
Nayara Cristina Freitas e Silva Santana ◽  
Clarice Carneiro Braga ◽  
Marina Alves Coelho Silva ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Inflammatory Response ◽  
Hemodialysis Patients ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Anti Inflammatory

scholarly journals Efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia: a protocol for randomised double-blind controlled clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e041958
Author(s):  
Nirmani Yasara ◽  
Nethmi Wickramarathne ◽  
Chamila Mettananda ◽  
Aresha Manamperi ◽  
Anuja Premawardhena ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sri Lanka ◽  
Intervention Group ◽  
Primary Outcome Measure ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Scientific Publications ◽  
Double Blind ◽  
Fetal Haemoglobin

IntroductionDespite being one of the first diseases to be genetically characterised, β-thalassaemia remains a disorder without a cure in a majority of patients. Most patients with β-thalassaemia receive only supportive treatment and therefore have a poor quality of life and shorter life spans. Hydroxyurea, which has shown to induce fetal haemoglobin synthesis in human erythroid cells, is currently recommended for the treatment of sickle cell disease. However, its clinical usefulness in transfusion-dependent β-thalassaemia is unclear. Here, we present a protocol for a randomised double-blind controlled clinical trial to evaluate the efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia.Methods and analysisThis single-centre randomised double-blind placebo-controlled clinical trial is conducted at the Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Adult and adolescent patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into the intervention or control group. The intervention group receives oral hydroxyurea 10–20 mg/kg daily for 6 months, while the control group receives a placebo which is identical in size, shape and colour to hydroxyurea without its active ingredient. Transfused blood volume, pretransfusion haemoglobin level, fetal haemoglobin percentage and adverse effects of treatment are monitored during treatment and 6 months post-treatment. Cessation or reduction of blood transfusions during the treatment period will be the primary outcome measure. The statistical analysis will be based on intention to treat.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Faculty of Medicine, University of Kelaniya (P/116/05/2018) and the trial is approved by the National Medicinal Regulatory Authority of Sri Lanka. Results of the trial will be disseminated in scientific publications in reputed journals.Trial registration numberSLCTR/2018/024; Pre-results.

scholarly journals Curcumin nanomicelle versus curcumin improves lipid profile, stress oxidative factors and inflammatory markers in patients undergoing coronary elective angioplasty; A Randomized Clinical Trial

2019 ◽  
Author(s):  
Bijan Helli ◽  
Hadis Gerami ◽  
Maria Kavianpour ◽  
Habib Heybar ◽  
Seyed Kianoosh Hosseini ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Lipid Profile ◽  
Inflammatory Markers ◽  
Interleukin 1 ◽  
Stress Index ◽  
Inflammatory Factors ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Stress Oxidative

Abstract Background: Curcumin exhibited antioxidant and anti-inflammatory effects. The aim of this study, assess and compare curcumin and nano- curcumin effects on lipid profile, oxidative stress index and inflammatory factors of heart patients.Methods: This Randomized, Double-Blind, Placebo-Controlled Clinical Trial conducted on 90 patients undergoing coronary elective angioplasty. Patients were randomly divided into 3 groups. The first group received a 500 mg capsule of curcumin daily. The second group received an 80 mg capsule of nano- curcumin daily. The placebo group also received capsules similar to curcumin for 8 weeks. Lipid profile, stress oxidative factors and inflammatory markers measured in baseline and end of the investigation.Results: At the end of study, statistically significant changes was seen in the total cholesterol (TC), triglyceride (TG) and low density lipoprotein (LDL) in the intervention groups to the control group (p<0.05). These changes in the nano-curcumin group were greater than the curcumin group. Curcumin and nano-curcumin supplementation also caused a statistically significant improvement in plasma levels of total antioxidant capacity (TAC), malondialdehyde (MDA), Superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), high-sensitivity C-reactive protein (hs-CRP), Interleukin 1 beta (IL-1β) and tumor necrosis factor alpha (TNF-α) in comparison to the placebo (p<0.05).Conclusion: Complementary therapy of cardiovascular patients with curcumin and nano-curcumin supplements, could improve lipid profile, stress oxidative index and, inflammatory factors. The effects of curcumin on nano formula may be better for cardiac patients due to high bioavailability. However, further investigation is suggested in this regard.

scholarly journals Efficacy and Safety of Ejiao (Asini Corii Colla) in Women With Blood Deficient Symptoms: A Randomized, Double-Blind, and Placebo-Controlled Clinical Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Li Zhang ◽  
Zhongju Xu ◽  
Tao Jiang ◽  
Jialu Zhang ◽  
Pinxian Huang ◽  
...  
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Blood Cell ◽  
Control Group ◽  
Placebo Control ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Placebo Control Group ◽  
Sf 36

Equus asinus L [Equidae; Asini Corii Colla] (donkey-hide gelatin, Ejiao), a well-known traditional Chinese medicine, has been widely used to nourish the blood, especially for women. The aim of this study was to assess the efficacy and safety of Ejiao in blood-deficient patients. A total of 210 participants were recruited and randomly allocated into the placebo control group and Ejiao-treated group (6 g/day). The primary outcomes on the efficacy of Ejiao included traditional Chinese medicine symptom scores, blood indicators, and SF-36. The secondary outcomes were changes in fireness and safety evaluation. Results showed that Ejiao treatment for 8 weeks had significantly improved dizziness symptoms. Among the tested 24 blood biochemical parameters, the hematocrit and red blood cell numbers decreased in the placebo control group, but decreased significantly less in the Ejiao treatment group. The white blood cell and neutrophil counts increased in the Ejiao group but were within the normal range. In addition, the quality of life improved as the scores in SF-36 domains were significantly higher in the Ejiao group. At the same time, there was no significant change in the fire–heat symptoms score or other safety parameters. Considering all these, our study showed that Ejiao has a promising effect in women suffering from blood deficiency without obvious adverse effects.

scholarly journals THE EFFECTS OF CURCUMIN ADMINISTRATION ON EXPRESSION PATTERNS OF VEGF AND COX-2 IN FERTILE ENDOMETRIUM: A RANDOMISED CLINICAL TRIAL

2019 ◽  
pp. 149-152
Author(s):  
RAJUDDIN RAJUDDIN ◽  
BUDI WIWEKO ◽  
LUTFI NUGROHO
Keyword(s):  
Clinical Trial ◽  
Biological Activities ◽  
Expression Patterns ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Vegf Expression ◽  
Double Blind ◽  
Endometrial Stromal Cells ◽  
Cox 2 ◽  
Fertile Women

Objective: Curcumin (diferuloylmethane) is a a compound isolated from turmeric with biological activities, including antifertility. Curcumin inhibits COX-2 expression in granulosa cells of ovarian follicles and disrupts vascular endothelial growth factor (VEGF) derived angiogenesis in the endometrium, reducing endometrial receptivity. The purpose of this study was to examine the effects of curcumin on COX-2 and VEGF expression in endometrium of fertile women. Methods: A prospective double-blind placebo-controlled clinical trial was conducted in a group of fertile women with regular menstrual cycles, aged between 20-30 y, married, and with children. Subjects were divided into a group receiving daily 800 mg encapsulated curcumin. Curcumin orally for ten days, starting on the third day of the first menstrual day, and a control group. Endometrial biopsy was performed using a microcuret and immunohistochemistry was used to assess VEGF and COX-2 expression. The results were analysed using an independent sample t-test. Results: In the curcumin-treated group, VEGF expression was significantly lower than the control group (p<0.05), and COX-2 expression was higher but not significantly so (p>0.05). Conclusion: The curcumin causes VEGF expression in endometrium is lower and negatively affects the growth of endometrial stromal cells.

scholarly journals Comparison of pharmacokinetics of omega-3 fatty acid supplements in monoacylglycerol or ethyl ester in humans: a randomized controlled trial

2020 ◽  
Author(s):  
Laurie Chevalier ◽  
Mélanie Plourde
Keyword(s):  
Plasma Concentration ◽  
Ethyl Ester ◽  
Controlled Trial ◽  
Plasma Concentrations ◽  
Controlled Clinical Trial ◽  
Omega 3 Fatty Acids ◽  
Omega 3 ◽  
Post Dose ◽  
Double Blind ◽  
Omega 3 Fatty Acid

Abstract Background A diet low in omega-3 fatty acids (n-3 FA) results in low plasma concentrations of docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), the two main long chain n-3 FA. n-3 FA supplements on the market are esterified in triglycerides (TG) or ethyl ester (EE); the latter is absorbed less than other esterification forms. The objective of this study was to test and compare the pharmacokinetics of n-3 FA esterified in monoacylglycerides (MAG), a predigested form, with the EE form. Methods This study was a randomized, double-blind, crossover, controlled, clinical trial. Ten men and ten women between 18 and 60 years old were recruited. Participants received a single oral dose of 3 g of n-3 FA esterified in EE or MAG. Eleven blood samples were collected over 24 h post-dose. Plasma total lipids were extracted, methylated, and analyzed using gas chromatography. Results After receiving the MAG form, plasma EPA and DHA peaked at a concentration 3 and 2.5 times higher, respectively, than with the EE form. When provided in MAG form, n-3 FA plasma concentration during the absorption phase was on average 3–5 times higher than in EE form. When n-3 FAs were provided esterified in MAG, their concentration 24 h post-dose was higher than in EE. Males had a lower n-3 FA plasma concentration than females when n-3 FAs were provided in EE but there was no sexe difference when provided in MAG. Conclusions Plasma concentration of DHA and EPA was higher when provided in MAG than EE form.

The efficacy of multidisciplinary rehabilitation in stable multiple sclerosis patients

2006 ◽  
Vol 12 (2) ◽  
pp. 235-242 ◽  
Author(s):  
L K Storr ◽  
P S Sørensen ◽  
M Ravnborg
Keyword(s):  
Multiple Sclerosis ◽  
Outcome Measures ◽  
Bodily Pain ◽  
Intervention Group ◽  
Inpatient Rehabilitation ◽  
Control Group ◽  
Double Blind ◽  
Multidisciplinary Rehabilitation ◽  
Upper Limb Function ◽  
Multiple Sclerosis Patients

Objective To evaluate the short-term efficacy of multidisciplinary, inpatient rehabilitation of multiple sclerosis (MS) patients. Methods A double-blind, randomized, parallel group design was used. The intervention group were offered comprehensive, multidisciplinary inpatient rehabilitation at the Haslev MS Hospital for an average of 35.5 days, while the control group received no treatment related to the study. All patients were examined in their homes twice with a 10-week interval. The rehabilitation of the intervention group started 2-3 weeks after the first examination and ended 2-3 weeks before the second examination. Impairment was assessed by the Multiple Sclerosis Impairment Scale and the Expanded Disability Status Scale. Disability was assessed by means of Guy’s Neurological Disability Scale. Two specific scales were used to assess upper limb function and ambulation: The Nine-Hole Peg Test and timed 10-metre walking. Patients’ own perception of bodily pain, bladder symptoms, spasticity, fatigue, impaired walking and transfers were recorded using visual analogue scales. Finally, quality of life was assessed using the Life Appreciation and Satisfaction Questionnaire and the Functional Assessment in Multiple Sclerosis. Patients Two hundred and thirty-three patients were screened and of those 38 were included for treatment and 52 as controls. Results We found no statistically significant differences between the two groups in any of the outcome measures. Conclusion Although the study was underpowered, the negative outcome exposes the difficulties in quantitative analyses of the efficacy of multidisciplinary rehabilitation, which is liable to confounding factors such as variation in the indication for treatment, in the placebo effect, and in the reliability and responsiveness of the outcome measures.

Vitamin D Treatment Attenuates Heart Apoptosis After Coronary Artery Bypass Surgery: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial

2020 ◽  
Vol 25 (4) ◽  
pp. 338-345 ◽  
Author(s):  
Erfan Tasdighi ◽  
Manouchehr Hekmat ◽  
Mahmoud Beheshti ◽  
Ramin Baghaei ◽  
Seyed Mohsen Mirhosseini ◽  
...  
Keyword(s):  
Vitamin D ◽  
Coronary Artery ◽  
Coronary Artery Bypass ◽  
Artery Bypass ◽  
Bypass Graft ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Inflammatory Status ◽  
Significant Difference

Background: Vitamin D plays an important role in immune system and in the regulation of inflammatory cytokines. Coronary artery bypass graft (CABG) with cardiopulmonary bypass (CPB) is associated with an extensive inflammatory response. The aim of this study is to examine the effect of vitamin D treatment on the apoptosis and inflammatory changes developed after CABG. Methods: This trial was conducted on 70 patients undergoing CABG with CPB. Patients were randomly administered either in placebo or in the group of orally consuming 150 000 IU vitamin D daily for 3 consecutive days before surgery. The right atrium sample was taken to assess caspases 2, 3, and 7 activity using immunohistochemistry method. The serum level of interleukin-10 (IL-10) and insulin-like growth factor 1 (IGF-1) were compared at intervals. Results: The average number of positive cells for caspases 2 and 3 were less in vitamin D group ( P = .006 and P < .001, respectively). There was an increase in serum levels of IL-10 after 3 days from vitamin D treatment before surgery (vitamin D group = 4.4 ± 4.9 ng/mL and control group = 1 ± 0.5 ng/mL, P = .001). After operation, IL-10 increased in both groups, higher level in vitamin D group ( P < .001). The comparison of serum IGF-1 showed significant difference after 3 days ( P = .006) and remained higher in vitamin D group after CPB ( P < .001). Conclusions: These findings suggest the apoptosis rate after CPB can be reduced by vitamin D. Vitamin D treatment may improve the inflammatory status before and after surgery. Further studies are needed to confirm the antiapoptotic property of vitamin D and clinical implication.

scholarly journals The Efficacy of Once-Daily Dose of Phenobarbital in Children with Generalized Tonic-Clonic Epilepsy

2018 ◽  
Vol 35 (7-8) ◽  
pp. 172-9
Author(s):  
Amril A. Burhany ◽  
Sofyan Ismael ◽  
Hardiono Pusponegoro
Keyword(s):  
Clinical Trial ◽  
Plasma Concentrations ◽  
Serum Levels ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Study Group ◽  
Once Daily ◽  
Daily Dose ◽  
Plasma Measurements ◽  
Better Than

In spite of its long half life, phenobarbital is still given twice-daily in the treatment of generalized tonic-clonic epilepsy. This study aims to determine if daily dose of phenobarbital given once differs to that given twice daily. Subjects of this unblinded controlled clinical trial were generalized tonic-clonic epilepsy patients ranging in age from 1-15 years. There were 40 study cases and 42 controls. We gave phenobarbital 4-6 mg/kg/day once-daily for study group and twice-daily dose for control group. History, physical and EEG examination and phenobarbital plasma measurements were obtained a t the beginning of the study and four weeks later. The ratio of the second to first phenobarbital plasma concentrations in the study group was 0.99 while in the control group it was 1.02. The proportion of seizure-free patients in the study group increased from 70% at the beginning to 85% at the end of study, and in the control group from 64.3% to 83.3%. Hyperactivity and irritability increased in both groups, and there were no significant differences in mean serum levels, seizures control, hyperactivity and irritability in both groups. Drowsiness was found in 50% of cases, but statistically significant decrease were found in study group. The compliance of the study group (92.5%) was significantly better than that of the control group (71.4%).

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