scholarly journals Safety and Efficacy of an Intravaginal Prebiotic Gel in the Prevention of Recurrent Bacterial Vaginosis: A Randomized Double-Blind Study

2012 ◽  
Vol 2012 ◽  
pp. 1-7 ◽  
Author(s):  
Isabelle Coste ◽  
Philippe Judlin ◽  
Jean-Pierre Lepargneur ◽  
Sami Bou-Antoun
Keyword(s):  
Placebo Group ◽  
Bacterial Vaginosis ◽  
Vaginal Flora ◽  
Double Blind Study ◽  
Normal Flora ◽  
Double Blind ◽  
Nugent Score ◽  
Ph Values ◽  
Gel Treatment ◽  
Previously Treated

Objective. This study was performed to evaluate the efficacy and safety of a prebiotic treatment in the balance recovery of the vaginal flora in subjects previously treated for bacterial vaginosis (BV).Study Design. A randomized trial was carried out on 42 subjects with an active prebiotic group compared to a placebo group. The main evaluation criterion was the quantification of the vaginal flora measured by the Nugent score. Secondary criteria included vaginal pH and BV recurrence.Results. After 8 days of treatment, all subjects who received the prebiotic had a normal Nugent score, whereas 33% of the subjects treated with placebo had an intermediate or positive Nugent score. After 16 days of application, a normal Nugent score was maintained in all subjects treated with the prebiotic, whereas in the placebo group 24% of the subjects still had an elevated Nugent score. Moreover, the maintenance of (or reversion to) a normal flora was associated with the maintenance of (or reversion to) physiological pH values.Conclusions. The intravaginal gel treatment improves the recovery of a normal vaginal flora after the treatment of a BV episode, which should warrant a reduction in the risk of further recurrences.

scholarly journals The Efficacy of Lactobacillus plantarum as Adjunctive Therapy of Bacterial Vaginosis: A Double-blind, Randomized, Placebo-controlled Trial

2020 ◽  
Vol 32 (3) ◽  
pp. 214
Author(s):  
Ridha Ramadina Widiatma ◽  
Muhammad Yulianto Listiawan ◽  
Dwi Murtiastutik ◽  
Cita Rosita Sigit Prakoeswa ◽  
Sawitri Sawitri ◽  
...  
Keyword(s):  
Placebo Group ◽  
Bacterial Vaginosis ◽  
Lactobacillus Plantarum ◽  
Adjunctive Therapy ◽  
Controlled Trial ◽  
Vaginal Flora ◽  
Control Group ◽  
Therapeutic Effects ◽  
Cure Rate ◽  
Double Blind

Background: Bacterial vaginosis (BV) is a clinical syndrome caused by the changing of Lactobacillus spp., a producer of hydrogen peroxide, in the normal vagina with a high concentration of anaerobic bacteria, Gardnerella vaginalis and Mycoplasma hominis. This study reports a resistance of BV therapy regimens, high recurrence rates, and side effects of an antibiotic. Therefore, adjunctive therapy for BV management is needed. Research has reported the therapeutic effects of probiotic in BV; however, the results are inconsistent. Purpose: To evaluate the efficacy of standard therapy using metronidazole and Lactobacillus plantarum for BV measured by the cure rate and vaginal flora balance. Methods: A randomized, double-blind, placebo-controlled trial, 30 subjects were randomized to take metronidazole 500 mg twice a day for seven days with weekly evaluation. The Lactobacillus plantarum or placebo group was evaluated every 4 weeks. The cure rate and vaginal flora balance were evaluated using the Amsel criteria and Nugent score before and after the intervention. Result: A total of 30 subjects returned for 28-day follow-up, of which 60% subjects of the antibiotic/probiotic group were cured compared to 40% in the antibiotic/placebo group (p>0.05). Conclusion: There was no difference in the increase of cure rate and vaginal flora balance between the treatment group and significant control group.

The Effect of Warfarin Sodium on the Duration of Platelet Aggregation

1967 ◽  
Vol 18 (03/04) ◽  
pp. 766-778 ◽  
Author(s):  
H. J Knieriem ◽  
A. B Chandler
Keyword(s):  
Platelet Count ◽  
Placebo Group ◽  
Platelet Aggregation ◽  
Prothrombin Time ◽  
Platelet Rich Plasma ◽  
Healthy Adults ◽  
Double Blind Study ◽  
Double Blind ◽  
Warfarin Sodium

SummaryThe effect of the administration of warfarin sodium (Coumadin®) on the duration of platelet aggregation in vitro was studied. Coumadin was given for 4 consecutive days to 10 healthy adults who were followed over a period of 9 days. The duration of adenosine diphosphate-induced platelet aggregation in platelet-rich plasma, the prothrombin time, and the platelet count of platelet-rich plasma were measured. Four other healthy adults received placebos and participated in a double-blind study with those receiving Coumadin.Although administration of Coumadin caused a prolongation of the prothrombin time to 2 or 21/2 times the normal value, a decrease in the duration of platelet aggregation was not observed. In most individuals who received Coumadin an increase in the duration of platelet aggregation occurred. The effect of Coumadin on platelet aggregation was not consistently related to the prothrombin time or to the platelet count. In the placebo group there was a distinct relation between the duration of platelet aggregation and the platelet count in platelet-rich plasma.The mean increase in the duration of platelet aggregation when compared to the control value before medication with Coumadin was 37.7%. In the placebo group there was a mean increase of 8.4%. The difference between the two groups is significant (p <0.001). Increased duration of platelet aggregation also occurred in two individuals who received Coumadin over a period of 10 and 16 days respectively.

scholarly journals Efficacy of Calcipotriol 0.005% Ointment for Uremic Xerosis with Pruritus in Chronic Kidney Diseases Undergoing Hemodialysis Patients: Randomized Double Blind Clinical Trial

2021 ◽  
Vol 5 (6) ◽  
pp. 531-539
Author(s):  
Widyastuti ◽  
Yulia Farida Yahya ◽  
Suroso Adi Nugroho ◽  
Soenarto Kartowigno ◽  
M. Izazi Hari Purwoko ◽  
...  
Keyword(s):  
Adverse Effect ◽  
Placebo Group ◽  
Visual Analog Scale ◽  
Kidney Diseases ◽  
Double Blind Study ◽  
Surface Lipid ◽  
Dry Skin ◽  
Analog Scale ◽  
Double Blind ◽  
Skin Score

Introduction: Uremic xerosis with pruritus (UXP) is a chronic cutaneous complication among patients undergoing maintenance renal dialysis. Uremic xerosis level is directly related with pruritus severity or vice versa. Uremic xerosis with pruritus may lead to discomfort and negative psychological effect. The ethiopathogenesis still unknown, Most of treatments are empirical, and there is no effective and safe therapy. Emollient has not been effective enough to improve quality of life. There is some report about efficacy of topical vitamin D in xerosis and chronic pruritus. Objective: We evaluate the efficacy of calcipotriol 0.005% ointment for uremic xerosis and uremic pruritus in chronic kidney disease patients undergoing hemodialysis. Material & methode: Sixty two patients with UXP were enrolled, randomized double blind study. Patients were divided to two group, calcipotriol 0.005% ointment group or placebo. In baseline, patients were instructed to apply twice daily for four weeks. We assesesment the efficacy and safety of calcipotriol 0.005% ointment and placebo after 2nd and 4th weeks treatment using overall dry skin score (ODSS), visual analog scale (VAS), corneometer and sebumeter. We also assessed adverse effect and tolerance this drugs using visual assessment scale. Results: Overall dry skin score (ODSS) and visual analog scale (VAS) significantly decreased in calcipotriol 0.005% ointment group than in placebo group (p <0.05). Skin hydration level based on Corneometer score and skin surface lipid based on Sebumeter score was significantly increased in calcipotriol 0.005% ointment group than in placebo group (p <0.05). Cure rate and clinical improvement for calcipotriol 0.005% ointment group was significantly higher than placebo group. There was no adverse effect between two groups after treatment. Conclusion: calcipotriol 0.005% ointment is effective than placebo and can be used as alternative or adjuctive treatment and safe and tolerance for UXP.

Diclofenac Sodium in Ureteral Colic: A Double-Blind Comparison Trial with Placebo

1983 ◽  
Vol 11 (5) ◽  
pp. 303-307 ◽  
Author(s):  
A Vignoni ◽  
A Fierro ◽  
G Moreschini ◽  
M Cau ◽  
A Agostino ◽  
...  
Keyword(s):  
Placebo Group ◽  
Saline Solution ◽  
Diclofenac Sodium ◽  
Complete Relief ◽  
Double Blind Study ◽  
Prostaglandin Synthetase ◽  
Double Blind ◽  
Ureteral Colic ◽  
Comparison Trial ◽  
Blind Comparison

A randomized prospective double-blind study of the analgesic effect of 75 mg intramuscular diclofenac sodium (Voltaren®), a potent prostaglandin synthetase inhibitor, versus placebo (saline solution) was carried out in 131 consecutive patients with acute ureteral colic. Diclofenac provided complete relief of pain 25 minutes after the injection in 59% of the cases, while placebo provided relief in 29% (p < 0·01). Forty patients in the placebo group and seventeen patients in the diclofenac group needed an open injection of 75 mg diclofenac intramuscularly after 25 minutes due to persistent pain. Fifty-four of the fifty-seven patients treated with an open injection of diclofenac achieved complete relief of pain after 30 minutes. There were no side-effects of the treatment.

scholarly journals Comparisons of vaginal flora patterns among sexual behaviour groups of women: implications for the pathogenesis of bacterial vaginosis

Sexual Health ◽  
2018 ◽  
Vol 15 (1) ◽  
pp. 61 ◽  
Author(s):  
Kristin M. Olson ◽  
Louis J. Boohaker ◽  
Jane R. Schwebke ◽  
Stella Aslibekyan ◽  
Christina A. Muzny
Keyword(s):  
African American ◽  
Bacterial Vaginosis ◽  
African American Women ◽  
Sexual Behaviour ◽  
Laboratory Data ◽  
Vaginal Flora ◽  
Sexual Practices ◽  
Nugent Score ◽  
Matched Group ◽  
Significant Difference

Background Bacterial vaginosis (BV) is the most common cause of vaginal discharge. The objective was to compare the prevalence of BV by Nugent score among African-American women who have sex with women (WSW) and women who have sex with women and men (WSWM) compared with an age-matched group of women who have sex with men (WSM). Secondary objectives were to correlate low versus high Nugent scores with vaginal symptoms among women with BV and to correlate BV diagnosis with sexual practices. Methods: A secondary analysis of clinical and laboratory data from African-American WSW (n = 73) and WSWM (n = 68) participating in the Women’s Sexual Health Project (August 2011–October 2013) and a 3 : 1 age-matched group of African-American WSM participating in the Longitudinal Study of Vaginal Flora (August 1999–February 2002) at a sexually transmissible infection clinic (n = 423) was performed. Results:Compared with WSM, WSW and WSWM were significantly more likely to have BV based on the Nugent score (OR 2.63; 95% CI 1.55–4.48; P < 0.01 and OR 3.67; 95% CI 2.17–6.21; P < 0.01 respectively). WSW and WSWM with BV were not significantly more likely to have higher Nugent scores than WSM with BV. Among women with BV reporting symptoms, there was no significant difference in the proportion of women with low-positive versus high-positive Nugent scores. Women who participated in receptive vaginal sex (penile or digital) within the 30 days preceding study enrolment were significantly more likely to have BV (OR 2.50; 95% CI 1.57–3.63; P < 0.01). Conclusions: WSW and WSWM were significantly more likely to have BV than WSM. Further analysis of sexual practices among sexual behaviour groups of women is needed to determine their potential impact on BV rates.

Pyridoxine is not effective for the prevention of hand foot syndrome (HFS) associated with capecitabine therapy: Results of a randomized double-blind placebo-controlled study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9007-9007 ◽  
Author(s):  
S. Lee ◽  
S. Lee ◽  
Y. Chun ◽  
M. Kim ◽  
H. Chang ◽  
...  
Keyword(s):  
Placebo Group ◽  
Chemotherapy Regimen ◽  
Controlled Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference ◽  
Hand Foot Syndrome ◽  
Version 2.0 ◽  
The Mean ◽  
To Receive

9007 Introduction: Although pyridoxine has been used empirically for the prevention of HFS associated with capecitabine, its efficacy has not been proven yet. We performed a prospective randomized double-blind study to determine whether pyridoxine can prevent the development of HFS when given concurrently with capecitabine. Method: Chemotherapy-naive patients (pts) with gastrointestinal tract cancers who were going to have capecitabine-containing chemotherapy were randomized to receive either oral pyridoxine (200 mg/day) or placebo daily during chemotherapy after stratified by chemotherapy regimen: 1) capecitabine alone, 2) capecitabine and cisplatin, or 3) docetaxel, capecitabine, and cisplatin. The patients were observed until grade 2 or 3 HFS (by NCI CTC version 2.0) developed or capecitabine containing chemotherapy ended. When grade 2 or 3 HFS developed in pts in placebo group, the pts were randomized again to receive either pyridoxine or placebo for next cycle of chemotherapy in order to determine whether pyridoxine could improve the HFS. Result: From Jun 2004 to Oct 2005, total 389 pts were entered onto the study. But, 29 pts (15 in placebo group and 14 in pyridoxine group) were excluded from the study because of ineligibility or pts’ refusal. Pts’ characteristics were well balanced between the 2 groups. Grade 2 or 3 HFS developed in 55 of 180 (30.6%) pts in placebo group and in 57 of 180 (31.7%) pts in pyridoxine group. (p=0.788) The median cycles of chemotherapy to grade 2 or 3 HFS was 3 in both groups. The mean cumulative dose of capecitabine until occurrence of grade 2 or 3 HFS was not different statistically between the two groups. (221,157.5 mg/m2 vs. 259,808.5 mg/m2, p=0.788). Total 44 of 55 pts in placebo group who had grade 2 or 3 HFS were randomized to receive either placebo or pyridoxine at next cycle. There was no significant difference between the two groups in the proportion of pts with improvement of HFS (43% vs 48%, p=0.94). Conclusion: These results indicated that pyridoxine is not effective for the prevention of HFS associated with capecitabine therapy. No significant financial relationships to disclose.

scholarly journals The use of Arsenicum album 30c to complement conventional treatment of neonatal diarrhoea (‘scours’) in calves

1994 ◽  
Vol 83 (04) ◽  
pp. 202-204 ◽  
Author(s):  
A. Rafferty ◽  
S. Kayne
Keyword(s):  
Placebo Group ◽  
Conventional Treatment ◽  
Treatment Plan ◽  
Blind Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Neonatal Calf ◽  
Neonatal Diarrhoea

AbstractIn a pilot double blind study carried out in Scotland, the effect of supplementing a conventional treatment plan with homoeopathic Arsenicum album was studied. In the management of neonatal calf scour it appeared that more animals recovered after one day in the group that had received active medicine, than in the placebo group. These results are encouraging.

Improved cure of bacterial vaginosis with single dose of tinidazole (2 g),Lactobacillus rhamnosusGR-1, andLactobacillus reuteriRC-14: a randomized, double-blind, placebo-controlled trial

2009 ◽  
Vol 55 (2) ◽  
pp. 133-138 ◽  
Author(s):  
Rafael C. R. Martinez ◽  
Sílvio A. Franceschini ◽  
Maristela C. Patta ◽  
Silvana M. Quintana ◽  
Bruna C. Gomes ◽  
...  
Keyword(s):  
Single Dose ◽  
Placebo Group ◽  
Bacterial Vaginosis ◽  
Lactobacillus Reuteri ◽  
Controlled Trial ◽  
Lactobacillus Rhamnosus ◽  
Antimicrobial Treatment ◽  
Double Blind ◽  
Probiotic Group ◽  
Probiotic Lactobacilli

Bacterial vaginosis (BV) is the most prevalent vaginal infection worldwide and is characterized by depletion of the indigenous lactobacilli. Antimicrobial therapy is often ineffective. We hypothesized that probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 might provide an adjunct to antimicrobial treatment and improve cure rates. Sixty-four Brazilian women diagnosed with BV were randomly assigned to receive a single dose of tinidazole (2 g) supplemented with either 2 placebo capsules or 2 capsules containing L. rhamnosus GR-1 and L. reuteri RC-14 every morning for the following 4 weeks. At the end of treatment (day 28), the probiotic group had a significantly higher cure rate of BV (87.5%) than the placebo group (50.0%) (p = 0.001). In addition, according to the Gram-stain Nugent score, more women were assessed with “normal” vaginal microbiota in the probiotic group (75.0% vs. 34.4% in the placebo group; p = 0.011). This study shows that probiotic lactobacilli can provide benefits to women being treated with antibiotics for an infectious condition.

scholarly journals Effects of Heat-Killed Lactococcus lactis Strain Plasma on Skin Homeostasis-Related Genes and the Skin Microbiome among Healthy Adults: A Randomized Controlled Double-Blind Study

2021 ◽  
Vol 9 (10) ◽  
pp. 2029
Author(s):  
Toshio Fujii ◽  
Takashi Fujitomo ◽  
Ryohei Tsuji ◽  
Ryuichi Kubo ◽  
Yukiko Kato ◽  
...  
Keyword(s):  
Placebo Group ◽  
Oral Administration ◽  
Healthy Volunteers ◽  
Lactococcus Lactis ◽  
Test Period ◽  
Pcr Analysis ◽  
Double Blind Study ◽  
Skin Microbiome ◽  
Double Blind ◽  
Lactis Strain

Lactococcus lactis subsp. lactis strain plasma (LC-plasma) is a bacterial strain that activates plasmacytoid dendritic cells and induces viral resistance genes via the TLR9/MyD88 pathway. We recently showed that oral administration of LC-plasma prevents skin infection by Staphylococcus aureus, possibly by activating skin immunity. In this study, we conducted a double-blind clinical trial to investigate the effect of oral administration of heat-killed LC-plasma on the skin microbiome, gene expression in the skin, and the skin condition of healthy volunteers. Seventy healthy volunteers were randomly assigned to receive either heat-killed LC-plasma or a placebo for eight weeks. Analysis of the skin microbiome by next-generation sequencing suggested that the alpha-diversity of the skin microbiome did not change during the test period in either group. However, the proportion of species that changed significantly during the test period was 10-fold smaller in the LC-plasma group than in the placebo group, suggesting that LC-plasma may maintain the skin microbiome. Quantitative PCR analysis indicated that tight-junction genes, such as CLDN1 and CLDN12, and the antimicrobial peptide gene BD3 were significantly up-regulated in the LC-plasma group but not in the placebo group. Our results suggest that administration of LC-plasma helps to maintain the skin microbiome and that it affects homeostasis-related genes.

scholarly journals Bacterial vaginosis, alterations in vaginal flora and HIV genital shedding among HIV-1-infected women in Mozambique

2011 ◽  
Vol 12 (2) ◽  
pp. 22-24
Author(s):  
Robert D Kirkcaldy ◽  
Jennifer Mika ◽  
Lori M Newman ◽  
Judite Langa ◽  
Linhui Tian ◽  
...  
Keyword(s):  
Bacterial Vaginosis ◽  
Odds Ratio ◽  
Vaginal Flora ◽  
Hiv Care ◽  
Normal Flora ◽  
Hiv Viral Load ◽  
Hiv Rna ◽  
Genital Shedding ◽  
Hiv 1 ◽  
Abnormal Vaginal Flora

Objectives. We investigated whether abnormal vaginal flora, including bacterial vaginosis (BV), are associated with detection of cervical HIV-1 RNA among HIV-infected women in Mozambique. Methods. We obtained clinical data and vaginal specimens from HIV-infected women registering for their first visit at one of two HIV care clinics in Mozambique. We compared women with detectable cervical HIV viral load (≥40 copies/ml) with women with undetectable cervical HIV. Results. We enrolled 106 women. Women with abnormal vaginal flora (intermediate Nugent scores, 4 - 6) were more likely to have detectable cervical HIV RNA then women with normal vaginal flora (adjusted odds ratio 7.2 (95% confidence interval 1.8 - 29.1), adjusted for CD4 count). Women with BV had a non-significantly higher likelihood of detectable cervical HIV than women with normal flora. Conclusions. Abnormal vaginal flora were significantly associated with cervical HIV expression. Further research is needed to confirm this relationship.

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