scholarly journals Clinical evaluation of the synbiotic Prodefen Plus® in the prevention of the antibiotic-associated diarrhoea in subjects requiring antibiotic treatment

2020 ◽  
Vol 11 (6) ◽  
pp. 535-545
Author(s):  
C. Barreiro Guridi ◽  
A. Romeo Serena ◽  
S. Gallego Cabrera ◽  
I. Alaman Fernández ◽  
C. Royo Hernández ◽  
...  
Keyword(s):  
Antibiotic Treatment ◽  
Adult Population ◽  
Supportive Therapy ◽  
Food Supplement ◽  
Active Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Group A ◽  
Antibiotic Associated Diarrhoea ◽  
Dietary Food

Prodefen® is a dietary food supplement formulated as a synbiotic that has shown additional benefit to the standard supportive therapy in the management of acute viral diarrhoea in children. There is scarce evidence of this synbiotic in adults. The objective of this randomised double blind placebo-controlled clinical trial was to evaluate the efficacy and safety of Prodefen Plus® in the prevention of antibiotic-associated diarrhoea (AAD) in an adult population requiring either antibiotic treatment for an oral infection or antibiotic prophylaxis for a dental surgical procedure in a dental consultation. 151 subjects were randomised to the active (synbiotic) or control arm (placebo) for 14 days. There was a significantly higher reduction in the AAD incidence, and an improvement in the stool consistency in the active group. A higher reduction in both the frequency and duration of the diarrhoea episodes in the active group was also observed, as it was an improved perception of the diarrhoea severity. Overall, the study medication was well tolerated. In conclusion, results from this study confirm the beneficial effect of the synbiotic administered as adjuvant therapy in preventing the antibiotic-associated diarrhoea.

scholarly journals Prospective Parallel Randomized, Double-Blind, Double-Dummy Controlled Clinical Trial Comparing Clomiphene Citrate and Metformin as the First-Line Treatment for Ovulation Induction in Nonobese Anovulatory Women with Polycystic Ovary Syndrome

2005 ◽  
Vol 90 (7) ◽  
pp. 4068-4074 ◽  
Author(s):  
Stefano Palomba ◽  
Francesco Orio ◽  
Angela Falbo ◽  
Francesco Manguso ◽  
Tiziana Russo ◽  
...  
Keyword(s):  
Polycystic Ovary ◽  
Clomiphene Citrate ◽  
Controlled Clinical Trial ◽  
Line Treatment ◽  
First Line ◽  
Ovary Syndrome ◽  
Double Blind ◽  
Group A ◽  
Group B ◽  
First Line Treatment

Abstract Context: Although metformin has been shown to be effective in the treatment of anovulation in women with polycystic ovary syndrome (PCOS), clomiphene citrate (CC) is still considered to be the first-line drug to induce ovulation in these patients. Objective: The goal of this study was to compare the effectiveness of metformin and CC administration as a first-line treatment in anovulatory women with PCOS. Design: We describe a prospective parallel randomized, double-blind, double-dummy controlled clinical trial. Setting: The study was conducted at the University “Magna Graecia” of Catanzaro, Catanzaro, Italy. Patients: One hundred nonobese primary infertile anovulatory women with PCOS participated. Interventions: We administered metformin cloridrate (850 mg twice daily) plus placebo (group A) or placebo plus CC (150 mg for 5 d from the third day of a progesterone withdrawal bleeding) (group B) for 6 months each. Mean outcome measures: The main outcome measures were ovulation, pregnancy, abortion, and live-birth rates. Results: The subjects of groups A (n = 45) and B (n = 47) were studied for a total of 205 and 221 cycles, respectively. The ovulation rate was not statistically different between either treatment group (62.9 vs. 67.0%, P = 0.38), whereas the pregnancy rate was significantly higher in group A than group B (15.1 vs. 7.2%, P = 0.009). The difference found between groups A and B regarding the abortion rate was significant (9.7 vs. 37.5%, P = 0.045), whereas a positive trend was observed for the live-birth rate (83.9 vs. 56.3%, P = 0.07). The cumulative pregnancy rate was significantly higher in group A than group B (68.9 vs. 34.0%, P < 0.001). Conclusions: Six-month metformin administration is significantly more effective than six-cycle CC treatment in improving fertility in anovulatory nonobese PCOS women.

Domiodol Treatment for Bronchopulmonary Diseases in the Paediatric Age Group: A Double-Blind Controlled Clinical Trial versus Placebo

1988 ◽  
Vol 16 (1) ◽  
pp. 31-38 ◽  
Author(s):  
A. Fiocchi ◽  
U. Grasso ◽  
G. Zuccotti ◽  
R. Arancio ◽  
E. Riva ◽  
...  
Keyword(s):  
Vital Capacity ◽  
Forced Expiratory Volume ◽  
Thyroid Stimulating Hormone ◽  
Controlled Clinical Trial ◽  
Age Group ◽  
Double Blind ◽  
Bronchopulmonary Diseases ◽  
Paediatric Age ◽  
Group A ◽  
Expiratory Flow

Thirty children (25 males, five females), mean age 9.33 ± 2.57 years, with acute infectious pulmonary diseases or acute flare-ups of chronic bronchitis, were randomly treated with either domiodol or placebo. The study was conducted between November 1986 and February 1987. Domiodol was administered orally for 14 days in doses of 0.5 mg/kg three times daily. Subjective symptoms (cough, sputum viscosity, difficulty in raising sputum and sputum characteristics) were assessed semi-quantitatively. They were all reduced significantly in the group treated with domiodol compared to those given placebo. Spirometric measures of vital capacity and peak expiratory flow rate were also improved in patients given domiodol compared with placebo. Conversely, no differences were noted in forced expiratory volume in 1 s, Tiffenau index, or mid-expiratory flow. There were no clinical side-effects and no changes in any other parameters measured; in particular, levels of thyroid hormone and thyroid stimulating hormone were unchanged. Thus, domiodol proved effective in reducing the symptoms of infection of the lower respiratory tract and in improving the consistency of mucus in children.

scholarly journals Impact of vitamin A supplementation in anaemia during pregnancy: a randomized double blind controlled clinical trial

2018 ◽  
Vol 7 (6) ◽  
pp. 2262
Author(s):  
Shakun Singh ◽  
Rachna Chaudhary ◽  
Vandana Dhama ◽  
Anu Singh ◽  
Urmila Karya
Keyword(s):  
Clinical Trial ◽  
Vitamin A ◽  
Pregnant Women ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Vitamin A Supplementation ◽  
Elemental Iron ◽  
Group A ◽  
Group B ◽  
The Impact

Background: To study the impact of Vitamin A supplementation in anaemia during Pregnancy and thus improving maternal and fetal outcome a Randomized double blind controlled clinical trial was conducted in Department of Obstetrics and Gynaecology, L.L.R.M. Medical college Meerut involving 250 pregnant women in late pregnancy 18-28 weeks with haemoglobin levels <11 g% (7-11 g%)..Methods: The study subjects were divided into two groups: Group A (n=125): Received daily supplement containing Iron (60 mg elemental iron) + Folate (500 mcg) + Vitamin A 20,000 IU weekly for a minimum of 12 weeks. Group B (n=125): Received daily supplement containing iron (60 mg elemental iron) + Folate (500 mcg) for a minimum of 12 weeks.Results: Maximum patients were uneducated belonging to low socioeconomic status. The mean haemoglobin values in Group A and Group B increased from 9.674±1.05 and 9.53±1.04 to 12.2±0.89 and 10.82±1.06 respectively after supplementation. Similarily Serum Ferritin levels increased from 15.96±2.94 and 15.70±2.83 to 78.40±17.82 and 58.64±11.93. Mean corpuscular volume, packed cell volume and red blood cell counts also increased significantly. Maximum haemoglobin levels were achieved with both vitamin A and iron supplementation. The proportion of women who became non anaemic was 97.17% in Group A vs 68.69% in Group B.Conclusions: Vitamin A supplementation improves anaemia and also dramatically improves iron stores in anaemic pregnant women.

scholarly journals Probiotic VSL#3 prevents antibiotic-associated diarrhoea in a double-blind, randomized, placebo-controlled clinical trial

2013 ◽  
Vol 84 (2) ◽  
pp. 159-165 ◽  
Author(s):  
C.P. Selinger ◽  
A. Bell ◽  
A. Cairns ◽  
M. Lockett ◽  
S. Sebastian ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Antibiotic Associated Diarrhoea

scholarly journals Does additional antimicrobial treatment have a better effect on URTI cough resolution than homeopathic symptomatic therapy alone? A real-life preliminary observational study in a pediatric population

2015 ◽  
Vol 10 ◽  
Author(s):  
Alessandro Zanasi ◽  
Salvatore Cazzato ◽  
Massimiliano Mazzolini ◽  
Carla Maria Sofia Ierna ◽  
Marianna Mastroroberto ◽  
...  
Keyword(s):  
Observational Study ◽  
Antibiotic Treatment ◽  
Pediatric Population ◽  
Adult Population ◽  
Randomized Study ◽  
Real Life ◽  
Symptomatic Therapy ◽  
Oral Antibiotic ◽  
Acute Cough ◽  
Double Blind

Background. The effectiveness of a homeopathic syrup on cough has been demonstrated in an adult population in a previous double-blind randomized study. The present prospective observational study investigated children affected by wet acute cough caused by non-complicated URTIs, comparing those who received the homeopathic syrup versus those treated with the homeopathic syrup plus antibiotic. Objectives. The aims were: 1) to assess whether the addition of antibiotics to a symptomatic treatment had a role in reducing the severity and duration of acute cough in a pediatric population, as well as in improving cough resolution; 2) to verify the safety of the two treatments. Methods. Eighty-five children were enrolled in an open study: 46 children received homeopathic syrup alone for 10 days and 39 children received homeopathic syrup for 10 days plus oral antibiotic treatment (amoxicillin/clavulanate, clarithromycin, and erythromycin) for 7 days. To assess cough severity we used a subjective verbal category-descriptive (VCD) scale. Results. Cough VCD score was significantly (P < 0.001) reduced in both groups starting from the second day of treatment (−0.52 ± 0.66 in the homeopathic syrup group and −0.56 ± 0.55 in children receiving homeopathic syrup plus oral antibiotic treatment). No significant differences in cough severity or resolution were found between the two groups of children in any of the 28 days of the study. After the first week (day 8) cough was completely resolved in more than one-half of patients in both groups. Two children (4.3 %) reported adverse effects in the group treated with the homeopathic syrup alone, versus 9 children (23.1 %) in the group treated with the homeopathic syrup plus antibiotics (P = 0.020). Conclusions. Our data confirm that the homeopathic treatment in question has potential benefits for cough in children as well, and highlight the strong safety profile of this treatment. Additional antibiotic prescription was not associated with a greater cough reduction, and presented more adverse events than the homeopathic syrup alone.

scholarly journals Comparative study of magnesium, sodium valproate, and concurrent magnesium-sodium valproate therapy in the prevention of migraine headaches: a randomized controlled double-blind trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Samira Khani ◽  
Seyed Amir Hejazi ◽  
Mehdi Yaghoubi ◽  
Ehsan Sharifipour
Keyword(s):  
Sodium Valproate ◽  
Migraine Prophylaxis ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
The Third ◽  
Migraine Headaches ◽  
Parallel Group ◽  
Significant Difference ◽  
Group A ◽  
Group B

Abstract Objective This study aimed to assess the efficacy of concurrent magnesium-sodium valproate therapy and compare it with either magnesium or sodium valproate alone in migraine prophylaxis. Materials and methods This randomized single-center double-blind parallel-group controlled clinical trial study was conducted on migraine patients within the age range of 18–65 years. The subjects with at least four monthly attacks were randomly assigned to group A (n = 82) sodium valproate, group B (n = 70) magnesium with sodium valproate, and group C (n = 70) magnesium. The patients passed a one-month baseline without prophylactic therapy and then received a 3-month treatment. The characteristics of migraine, including frequency, severity, duration of the attacks, and the number of painkillers taken per month, were monthly recorded in each visit. The Migraine Disability Assessment (MIDAS) and Headache Impact Test-6 (HIT-6) scores were recorded at the baseline and after 3 months of treatment in each group. Within- and between-group analyses were performed in this study. Results The obtained results revealed a significant reduction in all migraine characteristics in all groups compared to those reported for the baseline (P <  0.001). Intragroup data analysis indicated that there was no statistically significant difference in headache frequency between groups A and B in the third month (P = 0.525); nevertheless, three other parameters showed a significant reduction in group B, compared to those reported for group A in the third month (P <  0.05). On the other hand, group C could not effectively reduce measured parameters in the patients, compared to groups A and B after 3 months (P <  0.001). Furthermore, the MIDAS and HIT-6 scores significantly diminished in groups A, B, and C compared to those reported at the baseline (P <  0.001), and these changes were more significant in groups A and B than in group C (P <  0.001). Conclusion The obtained results of this study revealed that magnesium could enhance the antimigraine properties of sodium valproate in combination therapy and reduce the required valproate dose for migraine prophylaxis.

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