Microbiological alterations in the conjunctiva of hot tub-soaking ophthalmologists (MACHO): a randomized double-blind clinical trial

Background: To determine if there is a difference in the quantity of microbial flora of the conjunctiva in individuals practicing head submersion (“dunk”) versus no head submersion (“no-dunk”) during hot tub use. Methods: In this double-blind randomized clinical trial, healthy volunteers aged ≥ 18 years were recruited. Participants were randomized to head submersion versus no head submersion during a 15-minute hot tub soak. Study personnel, masked to the dunk or no-dunk group assignment, obtained conjunctival cultures before and immediately after hot tub use. De-identified specimens were submitted to the clinical microbiology laboratory for culture and analysis. The main outcome measure was the difference in the quantity of organisms cultured from the conjunctiva before and after hot tub exposure, as determined using a defined ordinal scale. A two-tailed Student’s t-test was performed to compare the total microbial colony counts between the two arms. Simpson’s diversity was used to measure the changes in organism diversity between the arms. Results: Of 36 enrolled subjects, 19 were randomly assigned to the dunk and 17 were assigned to the no-dunk groups. Water samples obtained from all hot tubs were culture negative. Eleven of 19 eyes (58%) from the dunk group and eight of 17 eyes (47%) from the no-dunk group had negative conjunctival bacterial cultures before and after hot tub exposure. However, six of 19 eyes (32%) and four of 17 eyes (24%) of the dunk and no-dunk groups, respectively, were culture-positive after, but not before hot tub exposure. The quantity of organisms before and after hot tub exposure was not significantly different between the two arms (P = 0.12). However, the dunk group only showed a small increase in the quantity of organisms after as compared to before hot tub use (P = 0.03). None of the samples from subjects or hot tubs were culture-positive for Acanthamoeba. Conclusion: Head submersion in a public hot tubs during a 15-minute soak does not appear to change conjunctival flora, as determined by culture plate yield.

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PREEMPTIVE ANALGESIA WITH AMITRIPTYLINE IN WOMEN UNDERGOING ABDOMINAL HYSTERECTOMY: A RANDOMIZED CLINICAL TRIAL

10.36106/gjra/4508238 ◽

2020 ◽

pp. 2-5

Author(s):

Antônio Henriques De França Neto ◽

Alexandre Magno Nóbrega Marinho ◽

Eveline Pereira De Arruda Agra ◽

Priscilla Guimarães Alves ◽

Josikwylkson Costa Brito ◽

...

Keyword(s):

Clinical Trial ◽

Postoperative Pain ◽

Pressure Pain Threshold ◽

Abdominal Hysterectomy ◽

Tricyclic Antidepressant ◽

Preemptive Analgesia ◽

Chi Square ◽

Double Blind ◽

Exact Test ◽

Student’S T

The concept of preemptive analgesia, albeit long-standing, has reemerged. Consequently, recent research has focused on testing a variety of drugs preoperatively to prevent the occurrence of postoperative pain, a major factor of morbidity. Amitriptyline is a tricyclic antidepressant used to treat chronic pain. Because amitriptyline acts on pain transmission pathways, it could theoretically be used as an agent for the prevention of postoperative pain. This study evaluated the effectiveness of amitriptyline in preventing pain in patients submitted to hysterectomy, the most commonly performed gynecological surgery. A randomized, double-blind clinical trial was conducted with 145 patients, 72 of these receiving amitriptyline and 73 placebo. All patients were evaluated at 6, 12, 24 and 48 hours after surgery using a visual analog scale (VAS) for pain and algometry to determine the pressure-pain threshold. Statistical analysis was conducted using the chi-square test of association, Student's t-test, and the Mann-Whitney test, with Fisher's exact test being used whenever appropriate. No statistically signicant difference was found between the two groups with respect to pain at any of the time points evaluated, leading to the conclusion that at a dose of 25 mg, amitriptyline is ineffective in preventing postoperative pain in patients submitted to abdominal hysterectomy

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Effectiveness of paranasal air suction on acute migraine using portable air sucker – a randomized, double blind study

BMC Neurology ◽

10.1186/s12883-021-02203-x ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

S. M. R. Bandara ◽

S. Samita ◽

A. M. Kiridana ◽

H. M. M. T. B. Herath

Keyword(s):

Clinical Trial ◽

Side Effects ◽

Sri Lanka ◽

Primary Headache ◽

Headache Disorder ◽

Low Pressure ◽

Outcome Variable ◽

Double Blind ◽

Primary Headache Disorder ◽

Before And After

Abstract Background Migraine is a primary headache disorder and is the most common disabling primary headache disorder that occurs in children and adolescents. A recent study showed that paranasal air suction can provide relief to migraine headache. However, in order to get the maximum benefit out of it, an easy to use effective air sucker should be available. Aiming to fulfil the above requirement, a randomized, double blind control clinical trial was conducted to investigate the efficacy of a recently developed low–pressure portable air sucker. Methods Eighty-six Sri Lankan school children of age 16–19 years with migraine were enrolled for the study. They were randomly allocated into two groups, and one group was subjected to six intermittent ten-second paranasal air suctions using the portable air sucker for 120 s. The other group was subjected to placebo air suction (no paranasal air suction). The effect of suction using portable air sucker was the primary objective but side of headache, type of headache, and gender were also studied as source variables. The primary response studied was severity of headache. In addition, left and right supraorbital tenderness, photophobia, phonophobia, numbness over the face and scalp, nausea and generalized tiredness/weakness of the body were studied. The measurements on all those variables were made before and after suction, and the statistical analysis was performed based on before and after differences. As a follow–up, patients were monitored for 24-h period. Results There was a significant reduction in the severity of headache pain (OR = 25.98, P < 0.0001), which was the primary outcome variable, and other migraine symptoms studied, tenderness (left) (OR = 289.69, P < 0.0001), tenderness (right) (OR > 267.17, P < 0.0001), photophobia (OR = 2115.6, P < 0.0001), phonophobia (OR > 12.62, P < 0.0001) nausea (OR > 515.59, P < 0.0001) and weakness (OR = 549.06, P < 0.0001) except for numbness (OR = 0.747, P = 0.67) in the treatment group compared to the control group 2 min after the suction. These symptoms did not recur within 24-h period and there were no significant side effects recorded during the 24-h observation period. Conclusion This pilot study showed that low–pressure portable air sucker is effective in paranasal air suction, and suction for 120 s using the sucker can provide an immediate relief which can last for more than 24-h period without any side effects. Trail registration Clinical Trial Government Identification Number – 1548/2016. Ethical Clearance Granted Institute – Medical Research Institute, Colombo, Sri Lanka (No 38/2016). Sri Lanka Clinical Trial Registration No: SLCTR/2017/018. Date of registration = 29/ 06/2017. Approval Granting Organization to use the device in the clinical trial– National Medicines Regulatory Authority Sri Lanka (16 Jan 2018), The device won award at Geneva international inventers exhibition in 2016 and President award in 2018 in Sri Lanka. It is a patented device in Sri Lanka and patent number was SLKP/1/18295. All methods were carried out in accordance with CONSORT 2010 guidelines.

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A 36-week multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 clinical trial of sodium oligomannate for mild-to-moderate Alzheimer’s dementia

Alzheimer s Research & Therapy ◽

10.1186/s13195-021-00795-7 ◽

2021 ◽

Vol 13 (1) ◽

Author(s):

Shifu Xiao ◽

Piu Chan ◽

Tao Wang ◽

Zhen Hong ◽

Shuzhen Wang ◽

...

Keyword(s):

Alzheimer’S Disease ◽

Alzheimer's Disease ◽

Clinical Trial ◽

Controlled Trial ◽

Drug Effects ◽

Disease Assessment ◽

Phase 3 ◽

Double Blind ◽

Double Blind Placebo ◽

The Difference

Abstract Background New therapies are urgently needed for Alzheimer’s disease (AD). Sodium oligomannate (GV-971) is a marine-derived oligosaccharide with a novel proposed mechanism of action. The first phase 3 clinical trial of GV-971 has been completed in China. Methods We conducted a phase 3, double-blind, placebo-controlled trial in participants with mild-to-moderate AD to assess GV-971 efficacy and safety. Participants were randomized to placebo or GV-971 (900 mg) for 36 weeks. The primary outcome was the drug-placebo difference in change from baseline on the 12-item cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS-cog12). Secondary endpoints were drug-placebo differences on the Clinician’s Interview-Based Impression of Change with caregiver input (CIBIC+), Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale, and Neuropsychiatric Inventory (NPI). Safety and tolerability were monitored. Results A total of 818 participants were randomized: 408 to GV-971 and 410 to placebo. A significant drug-placebo difference on the ADAS-Cog12 favoring GV-971 was present at each measurement time point, measurable at the week 4 visit and continuing throughout the trial. The difference between the groups in change from baseline was − 2.15 points (95% confidence interval, − 3.07 to − 1.23; p < 0.0001; effect size 0.531) after 36 weeks of treatment. Treatment-emergent adverse event incidence was comparable between active treatment and placebo (73.9%, 75.4%). Two deaths determined to be unrelated to drug effects occurred in the GV-971 group. Conclusions GV-971 demonstrated significant efficacy in improving cognition with sustained improvement across all observation periods of a 36-week trial. GV-971 was safe and well-tolerated. Trial registration ClinicalTrials.gov, NCT02293915. Registered on November 19, 2014

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Evaluation of the effectiveness of self-massage in dysmenorrhea/ Ocena efektywności automasażu w redukcji bólu menstruacyjnego kobiet

HIGHER SCHOOL’S PULSE ◽

10.5604/01.3001.0010.5035 ◽

2017 ◽

Vol 11 (3) ◽

pp. 26-32

Author(s):

Anna Dobrzycka ◽

Iwona Wilk

Keyword(s):

Muscle Tension ◽

Pain Scale ◽

Quality Of Sleep ◽

Menstrual Pain ◽

Before And After ◽

Average Pain ◽

The Difference ◽

Student’S T ◽

Experimental Group

Background: Primary menstrual pain affects approximately 45-95% of women between 20-25 years of age. A non-invasive method in reducing menstrual pain by relaxing muscle tension is a massage. It brings the structural tension to normal levels and restores correct blood flow in the pelvic region. Aim of the study: The aim of this study was to test the usefulness of a self-massage in reducing the primary menstrual pain. Materials and methods: Out of 180 female students, 34 women aged 19-30 were qualified for the study with the use of a survey. Pittsburgh Sleep Quality Index questionnaire and visual analog pain scale (VAS) were used for the assessment before and after the therapy. Women in the experimental group performed tensegrity selfmassage a few days before the onset of bleeding for two menstrual cycles. Results were analyzed using Student’s t test and one-way analysis of variance (ANOVA). Results: Applying the self-massage statistically proved to significantly reduce the perception of pain (p=0.001) and the number of days with pain (p=0.007) in the experimental group. Within this group, the difference was noted in all participants except one. In addition, a third measurement was taken in order to assess the duration of the effect. The result of the average pain and number of days of pain after the extension was higher than in the second evaluation, but significantly lower than before the experiment. The significance was in accordance with the evaluation of pain, p=0.002 and number of days p=0.03. Evaluation of the quality of sleep in the experimental group was significantly better (p = 0.04) than before treatment. Conclusions: Self-massage reduces primary menstrual pain in women and can be used as an assisted form of self-therapy. It improves the quality of sleep.

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The Effect of Extract Supplements of Moringa Oleifera Leaves Plus Royal Jelly on Hemoglobin (Hb) Levels of Anemia Pregnant Mother in Takalar Regency

International Journal Papier Advance and Scientific Review ◽

10.47667/ijpasr.v1i2.31 ◽

2020 ◽

Vol 1 (2) ◽

pp. 22-29

Author(s):

Yulni Yulni ◽

Veni Hadju ◽

Burhanuddin Bahar ◽

Citrakesumasari Citrakesumasari ◽

Rahayu Indriasari ◽

...

Keyword(s):

Pregnant Women ◽

Leaf Extract ◽

Moringa Oleifera ◽

Royal Jelly ◽

P Value ◽

Double Blind ◽

Significant Difference ◽

Before And After ◽

The Difference ◽

Double Blind Design

The aim of this study was to determine the effect of Moringa oleifera leaf extract supplements, Moringa oleifera leaf extract plus royal jelly and placebo on hemoglobin levels in anemic pregnant women. This research is a randomized controlled double blind design study which was conducted in Polombangkeng Utara District, Takalar Regency for 2 months. The subjects of this study were pregnant women with anemia, the majority of which were 20-35 years old, primigravida parity, income less than UMR, unemployment, higher education, pregnancy distance of more than 2 years with p value> 0.05. Then divided into three groups, namely Moringa capsules plus royal jelly (KRJ) (n = 24), Moringa capsules (KTR) (n = 24) and placeco (PLC) (n = 21). Before and after the intervention, measurements of hemoglobin levels were carried out using the Hemocue tool and interviewing the characteristics of the respondents. The results showed that the average Hb level increased from each group (mean SD): KRJ 10.06 ± 0.75 to 11.42 ± 1.23, P = 0.001, KTR 10.40 ± 0.46 to 11.15 ± 0 , 90 P = 0.001 and PLC 10.43 ± 0.42 becomes 11.14 ± 0.88 P = 0.002. but there was no significant difference from the difference in the average increase in Hb levels in the three groups, but there was a tendency that KRJ was superior to the KTR and PLC groups with an increase of 1.36 gr / dl, KTR 0.75 gr / dl and PLC 0.71 gr / dl. So it can be concluded that KRJ is better than KTR and PLC in increasing Hb levels in anemic pregnant women in Takalar Regency.

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A Comparative Trial of Opipramol and Chlordiazepoxide in the Treatment of Anxiety

Journal of International Medical Research ◽

10.1177/030006057300100301 ◽

1973 ◽

Vol 1 (3) ◽

pp. 145-150 ◽

Cited By ~ 6

Author(s):

K Jepson ◽

G Beaumont

Keyword(s):

Clinical Trial ◽

General Practice ◽

Side Effects ◽

Rating Scale ◽

Comparative Trial ◽

Anxiety Score ◽

Double Blind ◽

Somatic Anxiety ◽

Daily Dose ◽

The Difference

A daily dose of 200 mg of opipramol (Insidon, Geigy) and 30 mg of chlordiazepoxide (Librium, Roche) were compared in a clinical trial in general practice. The trial was double blind and a stratified randomisation technique was employed. Twenty four patients received opipramol and twenty six chlordiazepoxide for four weeks. A total anxiety score and separate ‘psychic’ anxiety and ‘somatic’ anxiety scores were recorded, using a rating scale initially and after two and four weeks treatment. No overall difference in efficacy was found between the two drugs—opipramol producing a 76% improvement and chlordiazepoxide 64% by the end of the study. There was no difference in the relief of psychic anxiety. Although opipramol appeared to give more relief of somatic anxiety, the difference was not statistically significant. Again although opipramol relieved more individual symptoms than chlordiazepoxide, none of the differences were significant. 70% of patients on opipramol and 74% of those on chlordiazepoxide were classified ‘better’ globally by both doctor and patient by the end of the trial. The total number of side effects recorded was similar on both drugs although drowsiness occurred twice as frequently on chlordiazepoxide as it did on opipramol.

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SYMPHYTUM OFFICINALE IN THE TREATMENT OF PLANTAR KERATOSIS IN DIABETIC PATIENTS: DOUBLE BLIND RANDOMIZED CLINICAL TRIAL

10.36106/ijsr/3730706 ◽

2021 ◽

pp. 62-64

Author(s):

Beatriz Bertolaccini Martínez ◽

Elisa Coutinho Moura

Keyword(s):

Clinical Trial ◽

Salicylic Acid ◽

Statistical Analysis ◽

Diabetic Patients ◽

Type 2 Diabetic Patients ◽

Double Blind ◽

Double Blind Clinical Trial ◽

Before And After ◽

Type 2 Diabetic

PURPOSE: To compare the efcacy between SO and salicylic acid SA in the treatment of plantar keratosis of diabetic patients. METHODS: Randomized, double-blind clinical trial, with 47 type 2 diabetic patients, both sexes and with plantar keratosis. Patients were randomized into 2 groups: G1 (n = 48; treated with 15% SO extract) and G2 (n = 46; treated with 10% AS). The feet were photographed before (D0) and after the treatment (D30) and keratosis areas were measured using the Image J software. For each patient, a lesion in each foot was analyzed. The results were expressed by median. In the statistical analysis, the Wilcoxin test was used to compare the lesion areas before and after treatments and the Mann-Whitney test was used to compare the regression of the lesion areas between the two groups. P <0.05 was adopted. RESULTS: G1 (D0 = 2 8.156 vs D30 = 2.226; p <0.0001) and G2 (D0 = 4.835 vs D30 = 2.059; p <0.0001) showed a difference between the areas (cm ) of the keratosis, 2 before and after the treatment. There was a difference in the regression of the areas (cm ) of keratosis, between G1 and G2, respectively (4.540 vs 1.171, p <0.0001). CONCLUSION: Symphytum ofcinale proved to be more effective than Salicylic Acid in the treatment of plantar keratosis in diabetic patients.

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Beta alanine supplementation effects on metabolic contribution and swimming performance

Journal of the International Society of Sports Nutrition ◽

10.1186/s12970-020-00365-6 ◽

2020 ◽

Vol 17 (1) ◽

Cited By ~ 1

Author(s):

Matheus Silva Norberto ◽

Ricardo Augusto Barbieri ◽

Danilo Rodrigues Bertucci ◽

Ronaldo Bucken Gobbi ◽

Eduardo Zapaterra Campos ◽

...

Keyword(s):

Repeated Measures ◽

Energy Demand ◽

Swimming Performance ◽

Controlled Study ◽

Double Blind ◽

Repeated Measures Anova ◽

Beta Alanine ◽

Before And After ◽

The Difference ◽

And Performance

Abstract Background Investigations of β-alanine supplementation shows effects on metabolic (aerobic and anaerobic) participation and performance on swimming by a possible blood acidosis buffering. Considering this background, the objective of the present study was to analyze the effects of β-alanine supplementation on metabolic contribution and performance during 400-m swim. Methods Thirteen competitive swimmers underwent a 6-week, double-blind placebo-controlled study, ingesting 4.8 g.day− 1 of β-alanine or placebo. Before and after the supplementation period, the total anaerobic contribution (TAn) and 30-s all-out tethered swimming effort (30TS) were assessed. Anaerobic alactic (AnAl) and lactic energy (AnLa) was assumed as the fast component of excess post-exercise oxygen consumption and net blood lactate accumulation during exercise (∆[La−]), respectively. Aerobic contribution (Aer) was determined by the difference between total energy demand and TAn. In addition to conventional statistical analysis (Repeated measures ANOVA; p > 0.05), a Bayesian repeated measures ANOVA was used to evidence the effect probability (BFincl). Results No differences and effects were found between groups, indicating no supplementation effects. Repeated measures ANOVA, with confirmation of effect, was indicate reduce in ∆Lactate (p: 0.001; BFincl: 25.02); absolute AnLa (p: 0.002; BFincl: 12.61), fatigue index (p > 0.001; BFincl: 63.25) and total anaerobic participation (p: 0.008; BFincl: 4.89). Conclusions Thus, the results demonstrated that all changes presented were evidenced as a result of exposure to the training period and β-alanine supplementation doesn’t affect metabolic contribution and performance during 400-m freestyle.

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Effect of Sertraline on Uremic Pruritus Improvement in ESRD Patients

International Journal of Nephrology ◽

10.1155/2012/363901 ◽

2012 ◽

Vol 2012 ◽

pp. 1-5 ◽

Cited By ~ 23

Author(s):

Mansor Shakiba ◽

Hoshang Sanadgol ◽

Hamid Reza Azmoude ◽

Mohamad Ali Mashhadi ◽

Hassan Sharifi

Keyword(s):

Clinical Trial ◽

Rank Test ◽

Uremic Pruritus ◽

Signed Rank ◽

Wilcoxon Signed Rank Test ◽

Before And After ◽

Signed Rank Test ◽

The Difference ◽

Chronic Pruritus ◽

Esrd Patients

Background. Although uremic pruritus is a common and upsetting problem of chronic kidney disease, there is no approved treatment for it. This study was undertaken to find the efficiency of sertraline as a possible treatment for uremic pruritus.Methods. 19 ESRD patients under hemodialysis with severe chronic pruritus were randomly selected to participate in this before-after clinical trial. Before and after starting treatment with sertraline, a detailed pruritus history was obtained and pruritus graded by the 30-item inventory of pruritus that patients based on priorities grade allocated to 3 classes. Subjects were treated with sertraline 50 mg oral daily for four months, with monthly assessments of pruritus symptoms.Results. Before treatment with sertraline, the grade of pruritus in 9 (47.4%) patients was moderate and severe in 10 (52.6%) patients. After treatment, grade of pruritus in 11 (57.8%) patients was weak, 6 (31.5%) have moderate and only 2 (10.7%) patients have severe pruritus. Of 10 patients with severe pruritus, 5 (50%) patients experiencing weak pruritus, and 4 (40%) patients have moderate pruritus after treatment. Based on Wilcoxon signed-rank test, the difference between the grade of pruritus before and after treatment with sertraline was significant (P=0.001).Conclusions. Although no definitive recommendation can be made regarding treatment of uremic pruritus, we found an increased antipruritic effect of sertraline in ESRD patients.

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

Journal of Pharmaceutical Research International ◽

10.9734/jpri/2019/v30i430276 ◽

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.

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