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

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.

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Daily intake of heat-killed Lactobacillus plantarum L-137 improves inflammation and lipid metabolism in overweight healthy adults: a randomized-controlled trial

European Journal of Nutrition ◽

10.1007/s00394-019-02112-3 ◽

2019 ◽

Vol 59 (6) ◽

pp. 2641-2649 ◽

Cited By ~ 3

Author(s):

Yusuke Tanaka ◽

Yoshitaka Hirose ◽

Yoshihiro Yamamoto ◽

Yasunobu Yoshikai ◽

Shinji Murosaki

Keyword(s):

Lipid Metabolism ◽

Lactobacillus Plantarum ◽

Mononuclear Cells ◽

Controlled Trial ◽

Low Density Lipoprotein ◽

Daily Intake ◽

Density Lipoprotein ◽

Control Group ◽

Double Blind ◽

Peripheral Blood Mononuclear

Abstract Purpose The effects of heat-killed Lactobacillus plantarum L-137 (HK L-137) on inflammation and lipid metabolism were investigated in overweight volunteers. Methods One hundred healthy subjects with a body mass index from 23.0 to 29.9 (51 men and 49 women; mean age: 41.4 years) were enrolled in this randomized, double-blind, placebo-controlled, parallel group study. Subjects were randomly assigned to daily administration of a tablet containing HK L-137 (10 mg) or a placebo tablet for 12 weeks. Blood samples were collected every 4 weeks to measure biomarkers of lipid metabolism and inflammatory mediators. Results The percent change of concanavalin A-induced proliferation of peripheral blood mononuclear cells was significantly larger in the HK L-137 group than in the control group, similar to previous studies. The decreases of aspartate aminotransferase and alanine aminotransferase over time were significantly larger in the HK L-137 group than in the control group, as were the decreases of total cholesterol, low-density lipoprotein cholesterol, and the leukocyte count at one time point. These effects of HK L-137 were stronger in the subjects with higher C-reactive protein levels. Conclusions These findings suggest that daily intake of HK L-137 can improve inflammation and lipid metabolism in subjects at risk of inflammation.

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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

Canadian Journal of Microbiology ◽

10.1139/w08-102 ◽

2009 ◽

Vol 55 (2) ◽

pp. 133-138 ◽

Cited By ~ 92

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.

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Effects of the Preoperative Administration of Dexketoprofen Trometamol on Pain and Swelling After Implant Surgery: A Randomized, Double-Blind Controlled Trial

Journal of Oral Implantology ◽

10.1563/aaid-joi-d-17-00185 ◽

2018 ◽

Vol 44 (2) ◽

pp. 122-129

Author(s):

Arturo Sánchez-Pérez ◽

Jesús Muñoz-Peñalver ◽

María José Moya-Villaescusa ◽

Carmen Sánchez-Matás

Keyword(s):

Placebo Group ◽

Postoperative Pain ◽

Controlled Trial ◽

Test Group ◽

Control Group ◽

Double Blind ◽

Implant Surgery ◽

Lower Pain ◽

Dexketoprofen Trometamol ◽

Group A

The fear of postoperative pain is often mentioned by patients as one of the factors that is most frequently associated with dental implants. To reduce this factor, a single oral dose of 25 mg dexketoprofen trometamol (DKT) or placebo was administered 15 minutes before implant surgery. One hundred patients who required single-implant treatments were randomly assigned to 1 of 2 blinded groups. The patients in the test group were given 25 mg DKT (DKT group), and those in the control group were given 500 mg vitamin C as a placebo (PLACEBO group). A subjective visual analogue scale of 100 mm in length was used to evaluate pain. Inflammation and complications were assessed using a 5-point Likert scale. An analysis of variance, t-tests, and a Mann-Whitney U test were performed. Among the 100 patients, 83 completed the study (there were 8 dropouts in the PLACEBO group and 9 in the DKT group). The patients who received DKT reported a lower pain intensity during the immediate postoperative period. The inflammatory response was weaker in the DKT group than the control group at 48 hours, but bleeding was greater. There were no other complications in either of the groups. In conclusion, the preemptive use of 25 mg soluble DKT administered orally 15 minutes before implant surgery can reduce the severity of immediate postoperative pain.

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Breast Microecology Improvement Using Probiotics Following Needle Aspiration in Patients With Lactational Breast Abscess: a Multi-center Randomized Double-blind Controlled Trial

10.21203/rs.3.rs-280421/v1 ◽

2021 ◽

Author(s):

Yi Zhang ◽

Yajun Gao ◽

Jing Qin ◽

Xiaoting Li ◽

Fei Jiang ◽

...

Keyword(s):

Controlled Trial ◽

Reaction Rates ◽

Needle Aspiration ◽

Healing Time ◽

Control Group ◽

Cure Rate ◽

Control Groups ◽

Clinical Trial Registry ◽

Double Blind ◽

And Control

Abstract Background: Studies show that oral probiotics can improve the breast microecology and thus alleviate the inflammatory response; however, there is a lack of experimental data corresponding to cases with existing abscesses. We aimed to investigate the effect of Lactobacillus fermentum CECT5716 during needle aspiration in patients with lactational breast abscesses.Methods: Patients (aged 20–41 years) with lactational single-cavity breast abscesses (diameter 3–6 cm) from 12 hospitals were randomly assigned to the experimental (n=51) and control groups (n=50). Outcome measures included the abscess cure rate on day-5 of treatment, delactation rate, relieving pain rate, and the number of needle aspirations until day-28.Results: The experimental group’s 5-day cure rate (43.1%, 22/51) was significantly higher (p<0.05). The breastfeeding continuation on day-5 did not differ significantly (experimental group: 88.2%, 45/51; control group: 96.0%, 48/50; p=0.269). In the experimental and control groups, 19.6% and 14.0% of patients experienced moderate to severe pain on day-5, respectively, with no statistically significant differences (p=0.451). The median number of needle aspirations up to day-28 was two in the experimental (1–3 times) and control (1–4 times) groups, with no statistically significant differences (Mann–Whitney U test, p=0.322). Four patients in each group developed diarrhea, with adverse reaction rates of 7.84% (4/51) and 8.0% (4/50), respectively. No adverse reactions were reported in the infants.Conclusion: L. fermentum can shorten the healing time in patients with lactational breast abscesses.Trial registration: This study was registered in the Chinese Clinical Trial Registry (http://www.chictr.org.cn), registration number: ChiCTR2000032682, registration date: May 6, 2020.

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Effects of synbiotic supplementation and lifestyle modifications on women with polycystic ovary syndrome

The Journal of Clinical Endocrinology & Metabolism ◽

10.1210/clinem/dgab369 ◽

2021 ◽

Author(s):

Izabela Chudzicka-Strugała ◽

Anna Kubiak ◽

Beata Banaszewska ◽

Barbara Zwozdziak ◽

Martyna Siakowska ◽

...

Keyword(s):

Placebo Group ◽

Polycystic Ovary Syndrome ◽

Polycystic Ovary ◽

Controlled Trial ◽

Reproductive Age ◽

Control Group ◽

Lifestyle Modifications ◽

Ovary Syndrome ◽

Double Blind ◽

Synbiotic Supplementation

Abstract Context Polycystic ovary syndrome (PCOS) is the most common endocrinopathy affecting women of reproductive age. Objective This study was designed to evaluate effects of lifestyle modifications and synbiotic supplementation on PCOS. Design A randomized (1:1) double-blind, placebo-controlled trial. Setting Academic hospital. Patients or Other Participants Overweight and obese women with PCOS were identified according to the Rotterdam criteria. Evaluations were performed at baseline and repeated after 3 months of treatment. Intervention Lifestyle modifications in combination with synbiotic supplementation or placebo. Main Outcome Measures Change in BMI and testosterone level. Results In the Placebo Group, a 5% decrease in BMI was accompanied by significant decreases of the waist, hip, and thigh circumferences. The Synbiotic Group experienced an 8% decrease in BMI, which was significantly greater than that in the Control Group (P=0.03) and was accompanied by decreases in the waist, hip, and thigh circumferences. Testosterone did not decrease significantly in the Placebo Group (decrease of 6%), while in the Synbiotic Group it decreased by 32% (P<0.0001). The decrease of testosterone was significantly greater in the Synbiotic Group than in the Placebo Group (P=0.016). Conclusions Synbiotic supplementation potentiated effects of lifestyle modifications on weight loss and led to significant reduction of serum testosterone.

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

Obstetrics and Gynecology International ◽

10.1155/2012/147867 ◽

2012 ◽

Vol 2012 ◽

pp. 1-7 ◽

Cited By ~ 18

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.

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Effects and Safety of Gyejibongnyeong-Hwan on Dysmenorrhea Caused by Blood Stagnation: A Randomized Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2013/424730 ◽

2013 ◽

Vol 2013 ◽

pp. 1-6 ◽

Cited By ~ 6

Author(s):

Jeong-Su Park ◽

Sunju Park ◽

Chun-Hoo Cheon ◽

Seong-Cheon Jo ◽

Han Baek Cho ◽

...

Keyword(s):

Placebo Group ◽

Controlled Trial ◽

Control Group ◽

Menstrual Pain ◽

Double Blind ◽

Menstrual Cycles ◽

Intention To Treat ◽

Investigational Drugs ◽

Significant Difference ◽

Vas Scores

Objective. This study was a multicenter, randomized, double-blind, and controlled trial with two parallel arms: the GJBNH group and the placebo group. This trial recruited 100 women aging 18 to 35 years with primary dysmenorrhea caused by blood stagnation. The investigational drugs, GJBNH or placebo, were administered for two menstrual periods (8 weeks) to the participants three times per day. The participants were followed up for two menstrual cycles after the administration.Results. The results were analyzed by the intention-to-treat (ITT) dataset and the per-protocol (PP) dataset. In the ITT dataset, the change of the average menstrual pain VAS score in the GJBNH group was statistically significantly lower than that in the control group. Significant difference was not observed in the SF-MPQ score change between the GJBNH group and the placebo group. No significant difference was observed in the PP analyses. In the follow-up phase, the VAS scores of the average menstrual pain and the maximum menstrual pain continually decreased in the placebo group, but they increased in the GJBNH group.Conclusion. GJBNH treatment for eight weeks improved the pain of the dysmenorrhea caused by blood stagnation, but it should be successively administered for more than two menstrual cycles.Trial Registration. This trial is registered with Current Controlled Trials no.ISRCTN30426947.

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A Controlled Trial of Phenothiazine Withdrawal in Chronic Schizophrenic Patients

The British Journal of Psychiatry ◽

10.1192/bjp.128.5.451 ◽

1976 ◽

Vol 128 (5) ◽

pp. 451-455 ◽

Cited By ~ 39

Author(s):

P. Andrews ◽

J. N. Hall ◽

R. P. Snaith

Keyword(s):

Placebo Group ◽

Controlled Trial ◽

Control Group ◽

Double Blind ◽

Chronic Schizophrenic ◽

Active Medication ◽

Schizophrenic Patients ◽

Weekly Assessment ◽

Phenothiazine Drugs

SummaryPhenothiazine drugs were withdrawn from 17 chronic schizophrenic in-patients, with a control group of 14 patients remaining on active medication. The trial was conducted under double blind conditions over a period of 42 weeks with weekly assessment of the patients by ward nurses. Of the placebo group 35 per cent relapsed, relapse being related to the level of previous active medication.

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Effects of Cinnamon on Anthropometry Status and Headache Disability of Migraine Patients: A Randomized Double-blind Placebo-controlled Trial

10.21203/rs.3.rs-39330/v1 ◽

2020 ◽

Author(s):

Azadeh Zareie ◽

Mohammad Bagherniya ◽

Manoj Sharma ◽

Fariborz Khorvash ◽

Akbar Hasanzadeh ◽

...

Keyword(s):

Placebo Group ◽

Corn Starch ◽

Controlled Trial ◽

Intervention Group ◽

Primary Headache ◽

Control Group ◽

Double Blind ◽

Beneficial Effects ◽

The Difference ◽

Headache Disability

Abstract Background: Migraine is a common type of primary headache that is highly disabling and is possibly associated with obesity. Increasing body mass index (BMI) seems to be a risk factor for migraine attacks. Cinnamon has anti-inflammatory, neuroprotective, and anti-obesity effects. Thus, this study aimed to assess the effects of cinnamon on anthropometry status and headache disability of migraine patients.Methods: Fifty patients with migraine were randomized to receive either cinnamon powder, three capsules/day each containing 600 mg of cinnamon or three placebo capsules/day each containing 100 mg of corn starch (control group) for two months. Height, body weight (BW), waist circumference (WC), and hip circumference (HC) were measured at baseline and the end of the study. Furthermore, Minimal or Infrequent Disability (MIDAS) and Headache Daily Result (HDR) Questionnaire were recorded. Results: After follow-up, BW and BMI did not change in the intervention group, however, both of them significantly increased in the placebo group. The differences between the two groups were statistically significant (p=0.001). WC significantly decreased in the cinnamon group and remarkably increased in the control group; the difference between groups was significant (p<0.001). Furthermore, HC and WHR significantly decreased in the intervention group than the placebo group (p=0.001). HDR and the total score of disability in migraine patients were significantly decreased in the intervention versus the control group (p<0.001). Conclusion: Cinnamon seems to have beneficial effects on BW, BMI, WC, and HC and it reduces the headache disability of migraine patients. More randomized controlled trials should be undertaken to confirm these effects.

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A Randomized, Double-Blind, Controlled Trial Evaluating the Efficacy of Nd:YAG 1064 nm Short-Pulse Laser Compared With Placebo in the Treatment of Toenail Onychomycosis

Journal of Cutaneous Medicine and Surgery ◽

10.1177/1203475419861071 ◽

2019 ◽

Vol 23 (5) ◽

pp. 507-512 ◽

Cited By ~ 1

Author(s):

Laura Sabbah ◽

Carolanne Gagnon ◽

Fanny-Emmanuelle Bernier ◽

Catherine Maari

Keyword(s):

Placebo Group ◽

Short Pulse ◽

Controlled Trial ◽

Treatment Options ◽

Treatment Success ◽

Nail Plate ◽

Cure Rate ◽

Double Blind ◽

End Points ◽

Laser Group

Introduction: Laser and light-based therapies have emerged as interesting treatment options with minimal side effects or contraindications to treat onychomycosis. Although increasing reports of successful treatment exist, few randomized, controlled, prospective studies have evaluated their true efficacy. We conducted a prospective, randomized, double-blind, controlled trial to evaluate the cure rate of onychomycosis treated by laser. Methods: Fifty-one patients were randomized to receive 3 treatments (0, 12, 24 weeks) of 1064 Nd:YAG short-pulse (Cutera GenesisPlus) laser or placebo sham laser. The primary efficacy end point is the proportion of patients with a complete cure rate of the target great toenail at week 52. The secondary efficacy end points, at week 52, were treatment success defined as almost clear nail (≤ 10%) and negative mycology, completely or almost clear nail of the great toenail, negative mycology, improvement from one OSI severity class to another of the target toenail, and the difference in proximal nail plate clearance between baseline and week 52. Results: No patient (0%) in the laser group and 2 patients (7.7%) in the placebo group reached the primary outcome. One patient (4.8%) in the laser group reached treatment success vs 2 (7.7%) in the placebo group. Only 6 patients (33%) had negative cultures in the laser group vs 11 (50%) in the placebo group. None of the secondary end points were met. Conclusions: This study demonstrated that 3 treatments of Nd:YAG 1064 nm laser at 3-month intervals were not effective to treat onychomycosis.

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