Vitamin E in the neuroprotection of cisplatin induced peripheral neurotoxicity and ototoxicity

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9114-9114 ◽  
Author(s):  
A. Pace ◽  
S. Carpano ◽  
E. Galiè ◽  
A. Savarese ◽  
M. Della Giulia ◽  
...  
Keyword(s):  
Placebo Group ◽  
Vitamin E ◽  
Peripheral Neurotoxicity ◽  
Double Blind ◽  
Multicentric Study ◽  
Phase Ii Studies ◽  
Significant Difference ◽  
Before And After ◽  
Vitamin E Supplementation

9114 Background: Peripheral neurotoxicity is a well recognized effect of cisplatin chemotherapy that can result in severe disability and represents a major dose-limiting factor. Several phase II studies have recently investigated the role of vitamin E as neuroprotectant in the prevention of cisplatin induced peripheral neurotoxicity and ototoxicity. Methods: An Italian randomized, placebo controlled, double blind multicentric study is ongoing to confirm the role of vitamin E supplementation in the prevention of neurotoxicity and ototoxicity induced by cisplatin Patients candidates to cisplatin chemotherapy were randomised to either vitamin E supplementation (a-tocopherol 400 mg/day) or to placebo. Patients were evaluated with neurological and neurophysiological examination before and after treatment. Neurotoxicity was measured using the comprehensive clinical and neurophysiological Total Neuropathy Score (TNS). Ototoxicity was evaluated with audiometric test and acoustic evoked potential before and after treatment. Results: 81 patients have been enrolled in 3 italian oncologic centers. An interim analysis on the first 50 patients was carried out. 25 patients (11 in the vit E group and 14 in the placebo group) received a cumulative dose higher than 300 mg/mq and were evaluable for neurotoxicity. Statistical analysis showed a significant difference (p < 0.05) in median neurotoxicity score observed in vit E group (TNS=1) respect to the placebo group (TNS=5). Conclusions: This is the first randomised, placebo controlled, double blind trial exploring the efficacy of vitamin E in the neuroprotection of cisplatin neurotoxicity. The results of this study confirm the neuroprotective effect of vitamin E supplementation against cisplatin-induced neurotoxicity. No significant financial relationships to disclose.

scholarly journals Role of Anti-oxidants in the Treatment of Vitiligo

2019 ◽  
Vol 17 (1) ◽  
pp. 49-57
Author(s):  
Amit Kumar ◽  
Sudha Agrawal ◽  
Tapan Kumar Dhali ◽  
Shankar Kumr Majhi
Keyword(s):  
Oxidative Stress ◽  
Placebo Group ◽  
Vitamin E ◽  
Primary Outcome ◽  
Antioxidant Supplementation ◽  
Significant Difference ◽  
Anti Oxidant ◽  
And Oxidative Stress

Introduction: The role of free radicals and oxidative damage in the pathophysiology of vitiligo has been documented in recent studies. Antioxidant supplementation has been reported to be useful in the treatment of vitiligo. Objective: To evaluate the role of oral antioxidants supplementation therapy in the treatment of vitiligo by assessing the onset of repigmentation and oxidative stress. Materials and Methods: A total of 80 cases of vitiligo randomized into two groups: antioxidant and placebo comprising 40 patients each and were followed up for 8 weeks for the assessment of onset of repigmentation of vitiliginous lesions as primary outcome.  The activities of Malondialdehyde (MDA), Vitamin C, and Vitamin E in serum and of Catalase (CAT) in erythrocytes of patients at baseline and at end of eight weeks were also assessed by using the spectrophotometric assay. Results: The onset of repigmentation was noted significantly earlier among the anti-oxidant group as compared to the placebo group (p=0.015). At the baseline, between the two groups, no significant difference was found in the different biochemical parameters. However, at the end of 2 months the level of MDA (p<0.001) was found to be significantly lower and that of Vitamin E (p<0.001) and CAT (p=0.005) was significantly higher among the anti-oxidants group as compared to the placebo group. Conclusion: Antioxidant supplementation carried a better response in terms of early onset of repigmentation and significant decrease in the oxidative stress, in the short follow up of two months.

scholarly journals Comparing the Efficacy of Topical Metformin and Placebo in the Treatment of Melasma: A Randomized, Double-blind, Clinical Trial

2019 ◽  
pp. 1-8
Author(s):  
Mohammad Ali Mapar ◽  
Ali Asghar Hemmati ◽  
Ghazal Namdari
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Double Blind ◽  
Laboratory Findings ◽  
Double Blind Clinical Trial ◽  
Metformin Group ◽  
Significant Difference ◽  
Before And After ◽  
P 16 ◽  
The Mean

Introduction: Generally affecting women, melasma is the acquired disorder of hyperpigmentation, and researches are still ongoing to find an effective, fast, and low-side-effect drug treating this disease. The present study is aimed at comparing the efficacy of topical metformin and placebo in the treatment of melasma. Methods: Sixty patients with melasma were treated in placebo and topical metformin recipient groups in a double-blind clinical trial. In addition to the demographic and laboratory findings of patients before and after the intervention, the MASI Score of patients in weeks 0, 4, 8, and 12 of the study and then one month after the study were analyzed using SPSS version 20 software. Results: The mean age of the studied patients was 35.25 ± 7.11 years. No significant difference was observed between the phenotypes (P= .49) and the type of melasma (P= .63) in the two groups. The mean MASI score of patients at the time of being included in the study in the placebo group was 10.47 ± 3.08; and in the metformin group, it was 11.93 ± 4.64 (P = .16). Compared to the beginning of the study, the MASI scores were significantly decreased in both groups of placebo (P = .00) and metformin (P = .00) one month after the end of the study; nevertheless, no statistically significant difference was observed between the MASI Scores of two groups in any of the study periods (P > .05). Conclusion: The results of the present study showed that metformin cream significantly declines the patients’ MASI score and does not have any effect on patients’ laboratory markers. Of course, no significant difference was observed between the MASI scores of the patients receiving metformin and the placebo group; however, the MASI score decrease trend continued until the 12th week; while in the placebo group, no significant decrease was seen after eight weeks.

SUBLINGUAL VITAMIN D3 DRUG THERAPY IN VITAMIN D DEFICIENCY PATIENTS AT PRAVARA RURAL HOSPITAL

2019 ◽  
pp. 18-20
Author(s):  
Sanjeeva Kumar Goud T ◽  
Rahul Kunkulol
Keyword(s):  
Vitamin D ◽  
Vitamin D Deficiency ◽  
Vitamin D3 ◽  
Serum Vitamin ◽  
Cross Sectional ◽  
Serum Vitamin D ◽  
Significant Difference ◽  
Before And After

The present study was aimed to study the effect of Sublingual Vitamin D3 on Serum Vitamin D level in Vitamin D deficiency patients. This was a cross-sectional and interventional study. All the Vitamin D deficiency patients of age 18-60years and either gender, willing to participate in the study were included. Patients who had greater than 20 ng/ml were excluded from the study. The total number of participants in our study was 200, out of these 111 males and 89 females, the mean age in our study was 51.07 ± 7.39Yrs. All volunteers were given sublingual vitamin D3 (60,000IU) in six doses every fifteen days of follow up for 3 months. The subject’s serum 25(OH)D levels were estimated before and after the treatment of sublingual vitamin D3. There was a statistically significant difference in serum vitamin D3 level before 16.61±6.71 ng/ml and after 35.80±7.80 ng/ml after treatment with Sublingual Vitamin D3. Six doses of 60,000IU of Vitamin D3 sublingual route having improved the role of serum 25(OH)D levels in the treatment of Vitamin D3 deficiency patients.Keywords: Vitamin D3; Sublingual route

scholarly journals Effects of Fermented Milk Containing Lacticaseibacillus paracasei Strain Shirota on Constipation in Patients with Depression: A Randomized, Double-Blind, Placebo-Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 2238
Author(s):  
Xiaomei Zhang ◽  
Shanbin Chen ◽  
Ming Zhang ◽  
Fazheng Ren ◽  
Yimei Ren ◽  
...  
Keyword(s):  
Mental Illness ◽  
Placebo Group ◽  
Rating Scale ◽  
Controlled Trial ◽  
Fermented Milk ◽  
Daily Consumption ◽  
Double Blind ◽  
Tnf Α ◽  
Significant Difference ◽  
Factor Α

Probiotics have been shown to benefit patients with constipation and depression, but whether they specifically alleviate constipation in patients with depression remains unclear. The aim of this study was to investigate the effect of Lacticaseibacillus paracasei strain Shirota (LcS), formerly Lactobacillus casei strain Shirota, on constipation in patients with depression with specific etiology and gut microbiota and on depressive regimens. Eighty-two patients with constipation were recruited. The subjects consumed 100 mL of a LcS beverage (108 CFU/mL) or placebo every day for 9 weeks. After ingesting beverages for this period, we observed no significant differences in the total patient constipation-symptom (PAC-SYM) scores in the LcS group when compared with the placebo group. However, symptoms/scores in item 7 (rectal tearing or bleeding after a bowel movement) and items 8–12 (stool symptom subscale) were more alleviated in the LcS group than in the placebo group. The Beck Depression Index (BDI) and Hamilton Depression Rating Scale (HAMD) scores were all significantly decreased, and the degree of depression was significantly improved in both the placebo and LcS groups (p < 0.05), but there was no significant difference between the groups. The LcS intervention increased the beneficial Adlercreutzia, Megasphaera and Veillonella levels and decreased the bacterial levels related to mental illness, such as Rikenellaceae_RC9_gut_group, Sutterella and Oscillibacter. Additionally, the interleukin (IL)-1β, IL-6, and tumor necrosis factor-α (TNF-α) levels were significantly decreased in both the placebo and LcS groups (p < 0.05). In particular, the IL-6 levels were significantly lower in the LcS group than the placebo group after the ingestion period (p < 0.05). In conclusion, the daily consumption of LcS for 9 weeks appeared to relieve constipation and improve the potentially depressive symptoms in patients with depression and significantly decrease the IL-6 levels. In addition, the LcS supplementation also appeared to regulate the intestinal microbiota related to mental illness.

Rehydration with a Caffeinated Beverage during the Nonexercise Periods of 3 Consecutive Days of 2-a-Day Practices

2004 ◽  
Vol 14 (4) ◽  
pp. 419-429 ◽  
Author(s):  
Kelly A. Fiala ◽  
Douglas J. Casa ◽  
Melissa W. Roti
Keyword(s):  
Body Fat ◽  
Hydration Status ◽  
Double Blind ◽  
Psychological Measures ◽  
Mild Heat ◽  
Urine Color ◽  
Significant Difference ◽  
Before And After ◽  
Time Point

The purpose of this study was to assess the influence of rehydration with a caffeinated beverage during non exercise periods on hydration status throughout consecutive practices in the heat. Ten (7 women, 3 men) partially heat-acclimated athletes (age 24 ± ly, body fat 19.2 ± 2%, weight 68.4 ± 4.0 kg, height 170 ± 3 cm) completed 3 successive days of 2-a-day practices (2 h/ practice, 4 h/d) in mild heat (WBGT = 23 °C). The 2 trials (double-blind, random, cross-over design) included; 1) caffeine (CAF) rehydrated with Coca-Cola® and 2) caffeine-free (CF) rehydrated with Caffeine-Free Coca-Cola®. Urine and psychological measures were determined before and after each 2-h practice. A significant difference was found for urine color for the post-AM time point, F = 5.526, P = 0.031. No differences were found among other variables (P > 0.05). In summary, there is little evidence to suggest that the use of beverages containing caffeine during non exercise might hinder hydration status.

scholarly journals Effects of Aroma Massage on Home Blood Pressure, Ambulatory Blood Pressure, and Sleep Quality in Middle-Aged Women with Hypertension

2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Myeong-Sook Ju ◽  
Sahng Lee ◽  
Ikyul Bae ◽  
Myung-Haeng Hur ◽  
Kayeon Seong ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Placebo Group ◽  
Sleep Quality ◽  
Nursing Intervention ◽  
Home Blood Pressure ◽  
Control Group ◽  
Middle Aged ◽  
Significant Difference ◽  
Before And After ◽  
Massage Group

The purpose of this study was to evaluate the effects of aroma massage applied to middle-aged women with hypertension. The research study had a nonequivalent control group, nonsynchronized design to investigate the effect on home blood pressure (BP), ambulatory BP, and sleep. The hypertensive patients were allocated into the aroma massage group (n=28), the placebo group (n=28), and the no-treatment control group (n=27). To evaluate the effects of aroma massage, the experimental group received a massage with essential oils prescribed by an aromatherapist once a week and body cream once a day. The placebo group received a massage using artificial fragrance oil once a week and body cream once a day. BP, pulse rate, sleep conditions, and 24-hour ambulatory BP were monitored before and after the experiment. There was a significant difference in home systolic blood pressure (SBP) (F=6.71,P=0.002) between groups after intervention. There was also a significant difference in SBP (F=13.34,P=0.001) and diastolic blood pressure (DBP) (F=8.46,P=0.005) in the laboratory between aroma massage and placebo groups. In sleep quality, there was a significant difference between groups (F=6.75,P=0.002). In conclusion, aroma massage may help improve patient quality of life and maintain health as a nursing intervention in daily life.

Oral Vitamin E Supplementation for the Prevention of Anemia in Premature Infants: A Controlled Trial

PEDIATRICS ◽  
1987 ◽  
Vol 79 (1) ◽  
pp. 61-68 ◽  
Author(s):  
A. Zipursky ◽  
E. J. Brown ◽  
J. Watts ◽  
R. Milner ◽  
C. Rand ◽  
...  
Keyword(s):  
Vitamin E ◽  
Premature Infants ◽  
Controlled Trial ◽  
Newborn Infants ◽  
Serum Vitamin ◽  
Hemoglobin Concentration ◽  
Erythrocyte Morphology ◽  
Significant Difference ◽  
Vehicle Treatment ◽  
Vitamin E Supplementation

Serum vitamin E levels are reduced in newborn infants. It has been reported that this deficiency is responsible, in part, for the development of anemia in premature infants during the first 6 weeks of life. The efficacy of vitamin E supplementation for the prevention of anemia in premature infants has been studied in a randomized, controlled, and blinded trial. Premature infants whose birth weights were less than 1,500 g were given, by gavage, 25 IU of dl-α-tocopherol or a similar volume of the drug vehicle. Treatment was continued for the first 6 weeks of life. A total of 178 infants were studied. Vitamin E levels were significantly higher in a supplemented group by day 3 and for the remainder of the 6-week period. At 6 weeks of age, there was no significant difference between the supplemented and unsupplemented groups in hemoglobin concentration, reticulocyte and platelet counts, or erythrocyte morphology. It is concluded that there is no evidence to support a policy of administering vitamin E to premature infants to prevent the anemia of prematurity.

The early anaemia of the premature infant: is there a place for vitamin E supplementation?

1986 ◽  
Vol 56 (1) ◽  
pp. 105-114 ◽  
Author(s):  
S. P. Conway ◽  
I Rawson ◽  
P. R. F. Dear ◽  
S. E. Shires ◽  
J. Kelleher
Keyword(s):  
Vitamin E ◽  
Premature Infant ◽  
Premature Baby ◽  
Oral Feeding ◽  
Plasma Vitamin ◽  
Double Blind ◽  
Plasma Vitamin E ◽  
Sufficient Vitamin ◽  
Vitamin E Supplementation

1. The efficacy of oral vitamin E supplementation in preventing the early anaemia of the premature infant was assessed in a 10-week double-blind trial. Forty-two babies received either a placebo or 5 or 15 mg supplementary vitamin E/d with oral feeding. No infant received less than the recommended vitamin E:polyunsaturated fatty acid (E:PUFA) value of 0.6. No iron supplement was given.2. Weekly full blood counts were taken, and plasma vitamin E assay and in vitro haemolysis tests performed on blood sampled on day 1, and also at 6 and 10 weeks of age. All blood withdrawn and transfused and all feeds were documented.3. Thirty-six (86%) of the babies had a plasma vitamin E level at birth below the accepted adult norm, i.e. < 5200 μg/l. At 6 weeks of age thirty-three (79%) and at 10 weeks thirty-five (83%) of the babies had levels within the normal adult range. No baby showed either clinical or haematological evidence of a vitamin E deficiency state during the trial.4. It is concluded that in the absence of Fe supplementation and observing the minimum recommended E:PUFA value, contemporary feeding practices allow for the absorption of sufficient vitamin E by the premature baby to prevent the development of an early haemolytic anaemia.5. No significant relation was found between plasma vitamin E levels and the degree of peroxide haemolysis.

scholarly journals Randomised Double-Blind Trial of Combination Antibiotic Therapy in Rheumatoid Arthritis

2011 ◽  
Vol 2011 ◽  
pp. 1-6 ◽  
Author(s):  
Angela Smith ◽  
Caroline Doré ◽  
Peter Charles ◽  
Alena Vallance ◽  
Tara Potier ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Placebo Group ◽  
Active Treatment ◽  
Active Rheumatoid Arthritis ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Good Evidence ◽  
Double Blind ◽  
Acr20 Response ◽  
Significant Difference

Objective. A combination of intravenous clindamycin and oral tetracycline has been used for many years as a treatment for active rheumatoid arthritis (RA), despite the absence of good evidence for its efficacy. A single-blind pilot study of this therapy suggested that a double-blind placebo-controlled trial was warranted.Methods. Patients with active RA were randomised in a 2 : 1 ratio to receive active treatment or placebo for 25 weeks. The active treatment consisted of intravenous clindamycin in a reducing regime, and oral tetracycline twice daily three times a week. 50 patients were to be recruited. The primary outcome measure was the proportion of patients achieving an ACR20 response.Results. An interim statistical analysis was performed after 20 patients had completed the study. Two patients in the active group achieved an ACR20 response, with none in the placebo group (NS). There was a better ESR20 response in the placebo group (P=.02). There were no other significant differences between the groups. The results indicated that it was unlikely that a significant difference in ACR20 response would emerge if the remaining 30 patients were recruited. The trial was therefore halted.Conclusion. This antibiotic regime is unlikely to be a valuable therapy for active rheumatoid arthritis.

scholarly journals The Effects of Propolis Extract Administration on HIV Patients Receiving ARV

2021 ◽  
Vol 13 (1) ◽  
pp. 75-83
Author(s):  
Erwin Astha Triyono ◽  
Sarah Firdausa ◽  
Heru Prasetyo ◽  
Joni Susanto ◽  
James Hutagalung ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Placebo Group ◽  
Clinical Symptoms ◽  
Cd4 Count ◽  
Controlled Clinical Trial ◽  
Human Immune System ◽  
Hiv Patients ◽  
Double Blind ◽  
Significant Difference

BACKGROUND: Human immunodeficiency virus (HIV) is an infectious disease that targets the human immune system by attacking cluster of differentiation (CD)4 cells. The use of propolis in HIV patients is expected to be safe and beneficial in terms of increasing endurance and immunity by its role in increasing CD4 level. This study aimed to analyze the influence of propolis supplementation in increasing the CD4 level in anti-retroviral (ARV)-treated HIV patients.METHODS: Double-blind randomized controlled clinical trial was conducted in 50 HIV patients who took regular ARV therapy. The subjects were divided into two groups, one group was treated with ARV and propolis, while another one was given ARV and placebo. The CD4 cell count was measured during pre-treatment, in the 3rd month, in the 6th month after treatment. The level of hemoglobin, leukocyte, and platelets were also measured. The SF-12 questionnaire was used to evaluate quality of life of the subject.RESULTS: Out of 50 subjects, 43 subjects completed the study, which were 19 subjects from the propolis group and 24 subjects from the placebo group. After 3-month of treatment, there was a statistically significant difference in the incrwase of CD 44 level in propolis group, while the increment was not significant in the placebo group. After 6-month treatment, the increase of CD4 level was occurred in both groups, propolis and placebo, however the increment was not statistically significant. The levels of hemoglobin, leukocyte, and platelets were not altered by the treatment and remained normal throughout the study. The quality of life was improved during the study; however, it was also not statistically significant. Mild adverse events occurred in 3 subjects which were relieved after the treatment stopped.CONCLUSION: Based on the result of this study, the administration of propolis on HIV patients receiving ARV bring significant difference in the increase of CD4 in propolis group from baseline to 3 month after the treatment. While in placebo group, this increment was not significant. At the end of study, CD4 count continued to rise up, however the increase was not statistically significant. There are no hemoglobin, leukocyte, platelets, and quality of life abnormalities. Therefore, it is necesary to do further research with a spesific CD4 count. However, it may be beneficial in relieving the clinical symptoms and quality of life of patient living with HIV.KEYWORDS: CD4, ARV, HIV, propolis

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