Prebiotic effect of two grams of lactulose in healthy Japanese women: a randomised, double-blind, placebo-controlled crossover trial

2019 ◽  
Vol 10 (6) ◽  
pp. 629-639 ◽  
Author(s):  
Y. Sakai ◽  
N. Seki ◽  
K. Hamano ◽  
H. Ochi ◽  
F. Abe ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Crossover Trial ◽  
Random Order ◽  
Japanese Women ◽  
Double Blind ◽  
Colony Forming Units ◽  
Significant Difference ◽  
Faecal Consistency ◽  
Bristol Stool Scale ◽  
Trial Participants

Sixty healthy Japanese women with a defaecation frequency of 2-4 times/week participated in this randomised, double-blind crossover trial. Participants received 2 g/day lactulose for 2 weeks and placebo in a random order, separated by a washout period of 3 weeks. Eight participants were excluded who did not satisfy the conditions, and therefore data from 52 were analysed. The primary outcome was defaecation frequency and the secondary outcomes were the number of defaecation days, faecal consistency, faecal volume, and the number and percentage of Bifidobacterium in faeces. The defaecation frequency (times/week) was significantly higher during lactulose (4.28±0.23) than placebo (3.83±0.23) treatment (delta (Δ) 0.45 [95% confidence interval (CI) 0.10-0.80], P=0.013). The defaecation days (days/week) was significantly higher during lactulose (3.77±0.17) than placebo (3.47±0.17) treatment (Δ0.30 [95% CI 0.04-0.56], P=0.024). Faecal consistency using the Bristol Stool Scale (/defaecation) was significantly higher during lactulose (3.84±0.10) than placebo (3.68±0.10) treatment (Δ0.16 [95% CI 0.00-0.31], P=0.044). Faecal volume (/week) was significantly higher during lactulose (21.73±3.07) than placebo (17.65±3.07) treatment (Δ4.08 [95% CI 0.57-7.60], P=0.024). The number of Bifidobacterium in faeces (log colony forming units/g faeces) was significantly higher during lactulose (9.53±0.06) than placebo (9.16±0.06) treatment (Δ0.37 [95% CI 0.23-0.49], P<0.0001). The percentage of Bifidobacterium in faeces was also significantly higher during lactulose (25.3±1.4) than placebo (18.2±1.4) treatment (Δ7.1 [95% CI 2.9-11.4], P=0.0014). Finally, straining at defaecation (/defaecation) during lactulose (3.62±0.24) treatment was significantly lower than during placebo (3.97±0.24) treatment (Δ0.35 [95% CI -0.69 – -0.02], P=0.037). No significant difference was observed between lactulose and placebo with regard to flatulence. Severe adverse effects did not occur. Thus, oral ingestion of 2 g/day lactulose had a prebiotic effect, increasing the number and percentage of bifidobacteria in faeces, softening the faeces, and increasing defaecation frequency, but without increasing flatulence.

scholarly journals A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Effects of Kamishoyosan, a Traditional Japanese Medicine, on Menopausal Symptoms: The KOSMOS Study

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Kiyoshi Takamatsu ◽  
Mariko Ogawa ◽  
Satoshi Obayashi ◽  
Takashi Takeda ◽  
Masakazu Terauchi ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Premenopausal Women ◽  
Japanese Women ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Traditional Japanese Medicine ◽  
Significant Difference ◽  
High Level

Objective. The KOSMOS study, a multicenter, randomized, double-blind, placebo-controlled trial, investigated the effects and safety of kamishoyosan (TJ-24), a traditional Japanese medicine, in the treatment of climacteric disorder. Methods. Japanese women with climacteric disorder were administered a placebo during a 4-week run-in period, after which they were classified as placebo responders (R group) if their score on the modified Questionnaire for the Assessment of Climacteric Symptoms in Japanese Women (m-QACS) with excitability and irritability as the primary outcome improved by ≥ 3 points and as placebo nonresponders (NR group) otherwise. Members of the NR group were randomly allocated to receive either TJ-24 or placebo. After 12 weeks, their m-QACS scores, anxiety and depression, sleep, and overall quality of life (QOL) were compared. Results. The TJ-24 and placebo arms in the NR group included 20 patients each. The change in the m-QACS scores of members of the NR group for excitability and irritability at 12 weeks versus baseline was –3.1 ± 1.7 in the TJ-24 arm, a significant decrease, but compared with –2.7 ± 2.2 in the placebo arm, no significant difference was between two arms. However, the proportion of participants whose score improved by ≥3 points was significantly higher in the TJ-24 arm. In the subgroup analysis of premenopausal women, the changes in the score for excitability and irritability were significantly larger in the TJ-24 arm. The incidence of adverse drug reactions or adverse events did not differ between the two arms, and no serious events were reported. Conclusion. Although no significant difference was identified for the primary outcome, a significantly higher proportion of patients who received TJ-24 displayed improvement. Its high level of safety and effects on excitability and irritability in premenopausal women suggest that TJ-24 may be a useful treatment.

scholarly journals The Effect of 2 Injection Speeds on Local Anesthetic Discomfort During Inferior Alveolar Nerve Blocks

2015 ◽  
Vol 62 (3) ◽  
pp. 106-109 ◽  
Author(s):  
Marcelo Rodrigo de Souza Melo ◽  
Mark Jon Santana Sabey ◽  
Carla Juliane Lima ◽  
Liane Maciel de Almeida Souza ◽  
Francisco Carlos Groppo
Keyword(s):  
Pain Perception ◽  
Crossover Trial ◽  
Healthy Adult ◽  
Inferior Alveolar Nerve ◽  
Needle Insertion ◽  
Test Results ◽  
Nerve Blocks ◽  
Double Blind ◽  
Significant Difference ◽  
Adult Volunteers

Abstract This randomized double-blind crossover trial investigated the discomfort associated with 2 injection speeds, low (60 seconds) and slow (100 seconds), during inferior alveolar nerve block by using 1.8 mL of 2% lidocaine with 1 : 100,000 epinephrine. Three phases were considered: (a) mucosa perforation, (b) needle insertion, and (c) solution injection. Thirty-two healthy adult volunteers needing bilateral inferior alveolar nerve blocks at least 1 week apart were enrolled in the present study. The anesthetic procedure discomfort was recorded by volunteers on a 10-cm visual analog scale in each phase for both injection speeds. Comparison between the 2 anesthesia speeds in each phase was performed by paired t test. Results showed no statistically significant difference between injection speeds regarding perforation (P = .1016), needle placement (P = .0584), or speed injection (P = .1806). The discomfort in all phases was considered low. We concluded that the 2 injection speeds tested did not affect the volunteers' pain perception during inferior alveolar nerve blocks.

scholarly journals Formoterol Thrice Weekly Does Not Result in the Development of Tolerance to Bronchoprotection

2003 ◽  
Vol 10 (1) ◽  
pp. 23-26 ◽  
Author(s):  
Beth E Davis ◽  
John K Reid ◽  
Donald W Cockcroft
Keyword(s):  
Crossover Trial ◽  
Positive Control ◽  
Forced Expiratory Volume ◽  
Weekly Administration ◽  
Double Blind ◽  
Once Daily ◽  
Regular Treatment ◽  
Significant Difference ◽  
Direct Acting ◽  
Development Of Tolerance

BACKGROUND: Loss of bronchoprotection routinely follows regular treatment with beta2-agonists. There are no data on the effects on bronchoprotection for thrice weekly use of a beta2-agonist.METHODS: A double-blind, randomized, placebo controlled crossover trial was conducted to investigate the effects of thrice weekly administration of 12 μg of formoterol versus placebo on bronchoprotection against methacholine. As an expected positive control, formoterol 12 μg once daily was also evaluated.RESULTS: There was no significant difference versus placebo in the bronchoprotective effects of 12 μg of formoterol administered on day 8, following daily treatment for seven days or treatment every other day (analysis of variance P=0.34). However, a nonsignificant trend towards lower concentration of methacholine that caused a 20% fall in forced expiratory volume in 1 s developed only following the daily formoterol dosing.CONCLUSIONS: Thrice weekly dosing does not result in the development of tolerance to bronchoprotection against the direct acting stimulus methacholine.

scholarly journals Low Dose Perioperative Intravenous Tranexamic Acid in Patients Undergoing Total Knee Arthroplasty: A Double-Blind Randomized Placebo Controlled Clinical Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-5 ◽  
Author(s):  
Mahdi Motififard ◽  
Mohammad Ali Tahririan ◽  
Mehdi Saneie ◽  
Sajad Badiei ◽  
Amin Nemati
Keyword(s):  
Tranexamic Acid ◽  
Primary Outcome ◽  
Low Dose ◽  
Study Groups ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Significant Difference ◽  
Duration Of Hospitalization ◽  
Slow Infusion ◽  
The Difference

Background and Objectives. The null hypothesis of this study was that TA has no effect on postsurgical bleeding in patients undergoing TKA. Methods. This study was a double-blind randomized trial. In the first group (T) patients received 500 mg of intravenous Tranexamic acid (TA) twice (once preoperatively and once 3 hours postoperatively) and in the second group (P) they received slow infusion of normal saline as placebo. The primary outcome of the study was the level of Hb 48 hours after surgery. Results. Hb levels 48 hours after surgery as the primary outcome were 10.92±0.97 and 10.23±0.98 (g/dL) in groups T and P, respectively, and the difference was statistically significant (P=0.001). Statistically significant differences were also observed in Hb levels 6 and 24 hours after surgery, the drain output 48 hours after surgery, and the number of units of packed cells transfused between study groups (P<0.05). There was no significant difference in duration of hospitalization between the study groups (P = n.s.). Conclusions. The low dose perioperative intravenous TA significantly reduces blood loss, requirement for blood transfusion, and drain output in patients undergoing TKA. However, duration of hospitalization did not change significantly.

scholarly journals Impact of hand dominance on effectiveness of chest compressions in a simulated setting: a randomised, crossover trial

2019 ◽  
Vol 16 ◽  
Author(s):  
Jamie Cross ◽  
Tommy Lam ◽  
Joel Arndell ◽  
John Quach ◽  
Buck Reed ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Crossover Trial ◽  
Recovery Period ◽  
Outcome Data ◽  
Dominant Hand ◽  
Hand Dominance ◽  
Modest Improvement ◽  
Significant Difference ◽  
Secondary Outcomes ◽  
The Impact

Aim External cardiac compressions (ECC) are a critical component in determining the effectiveness of cardiopulmonary resuscitation (CPR). Guidelines prior to the 2010 International Liaison Committee on Resuscitation directed rescuers to place the heel of the dominant hand directly on the chest when performing ECC, however current guidelines are silent on this issue. Existing research is inconsistent in findings, and heterogeneous in design and participants. The aims of this pilot study were to: 1) investigate the impact of hand dominance on effectiveness of ECC; and 2) generate outcome data to inform sample size calculations for a larger future study.Methods This study utilised a single blinded, prospective randomised crossover trial design. Each participant was allocated to a ‘dominant hand on chest’ (DHOC) or ‘non-dominant hand on chest’ (NDHOC) group. On a simulation manikin, participants in the DHOC group performed 3 minutes of ECC with dominant hand on the chest and non-dominant hand supporting, followed by a ‘rest and recovery’ period and then a second 3-minute period of ECC with the hand reversed such that the non-dominant hand was on the chest. The NDHOC group performed the same series of compressions but in reverse order. The primary outcome measure was effectiveness of ECC, determined by a percentage-based ‘CPR score’ (‘CS’). Secondary outcomes were compression depth, rate and release. The Wilcoxon rank-sum (Mann-Whitney) test was used due to the non-normal distribution of the data. Due to the crossover design, hierarchical linear regression was used to assess for a period or cross over effect. Results For the primary outcome of this study, we have found no significant difference in CS between DHOC and NDHOC (69.9% (SD=29.9) vs. 69.1% (SD=34.1); p=0.92), respectively. There were no differences in the secondary outcomes of compression rate and depth, though compression release was improved in the DHOC group (53% vs. 42%; p=0.02).ConclusionIn this randomised crossover study conducted in a simulation context there was no difference in ECC effectiveness measured by an overall effectiveness outcome according to placement of the dominant or non-dominant hand on the chest during compressions. A modest improvement in ECC release was seen in the dominant hand on chest group. While the study was underpowered, the results support an approach involving rescuers placing whichever hand they are most comfortable with on the chest irrespective of handedness.

scholarly journals Gyejigachulbutang (Gui-Zhi-Jia-Shu-Fu-Tang, Keishikajutsubuto, TJ-18) in Degenerative Knee Osteoarthritis Patients: Lessons and Responders from a Multicenter Randomized Placebo-Controlled Double-Blind Clinical Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-11
Author(s):  
Myung Kwan Kim ◽  
Jungtae Leem ◽  
Young Il Kim ◽  
Eunseok Kim ◽  
Yang Chun Park ◽  
...  
Keyword(s):  
Placebo Group ◽  
Knee Osteoarthritis ◽  
Subgroup Analysis ◽  
Primary Outcome ◽  
Pain Medication ◽  
Outcome Analysis ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Vas Score ◽  
Significant Difference

Background. Gyejigachulbutang (GUI-ZHI-JIA-SHU-FU-TANG, GCB) is an herbal formula widely prescribed in traditional East Asian medicine practice for arthritis and muscle pain. We evaluated the efficacy and safety of GCB for degenerative knee osteoarthritis (KOA). Methods. Eighty patients with KOA were randomly assigned to the GCB group or the placebo group in a 1 : 1 ratio in two Korean medicine hospitals. Patients took GCB or placebo three times a day for 4 weeks. Primary outcome was the change in the visual analogue scale (VAS) score for knee pain from baseline to 4th week. Secondary outcomes were the change in the VAS score from baseline to 2nd week and 8th week, Korean Western Ontario and McMaster Universities Osteoarthritis Index (K-WOMAC), European Quality of Life Five Dimensions questionnaire (EQ-5D), and safety. Results. There was no significant difference between the compared indicators of the GCB and placebo groups. However, in subgroup analysis, GCB was effective for subjects with a BMI lower than 25 kg/m2. The dose of pain medication was significantly lower in the GCB group than in the placebo group after four weeks ( p = 0.016 ). There were no serious adverse events in the GCB group. Conclusions. GCB was not effective in primary outcome analysis. In exploratory subgroup analysis, GCB might be effective for individuals with BMI lower than 25 kg/m2 for the treatment of degenerative KOA. GCB may also help reduce the consumption of pain medication. Furthermore, research is required for our hypothesis. This trial is registered with KCT0003024.

scholarly journals Effects of thiamine on vasopressor requirements in patients with septic shock: a prospective randomized controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Suttasinee Petsakul ◽  
Sunthiti Morakul ◽  
Viratch Tangsujaritvijit ◽  
Parinya Kunawut ◽  
Pongsasit Singhatas ◽  
...  
Keyword(s):  
Septic Shock ◽  
Sample Size ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Tertiary Hospital ◽  
Double Blind ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial ◽  
Significant Difference ◽  
Dependency Index

Abstract Background Thiamine, an essential vitamin for aerobic metabolism and glutathione cycling, may decrease the effects of critical illnesses. The objective of this study was to determine whether intravenous thiamine administration can reduce vasopressor requirements in patients with septic shock. Methods This study was a prospective randomized double-blind placebo-controlled trial. We included adult patients with septic shock who required a vasopressor within 1–24 h after admission between March 2018 and January 2019 at a tertiary hospital in Thailand. Patients were divided into two groups: those who received 200 mg thiamine or those receiving a placebo every 12 h for 7 days or until hospital discharge. The primary outcome was the number of vasopressor-free days over 7 days. The pre-defined sample size was 31 patients per group, and the study was terminated early due to difficult recruitment. Results Sixty-two patients were screened and 50 patients were finally enrolled in the study, 25 in each group. There was no difference in the primary outcome of vasopressor-free days within the 7-day period between the thiamine and placebo groups (mean: 4.9 days (1.9) vs. 4.0 days (2.7), p = 0.197, mean difference − 0.9, 95% CI (− 2.9 to 0.5)). However, the reductions in lactate (p = 0.024) and in the vasopressor dependency index (p = 0.02) at 24 h were greater among subjects who received thiamine repletion vs. the placebo. No statistically significant difference was observed in SOFA scores within 7 days, vasopressor dependency index within 4 days and 7 days, or 28-day mortality. Conclusions Thiamine was not associated to a significant reduction in vasopressor-free days over 7-days in comparison to placebo in patients with septic shock. Administration of thiamine could be associated with a reduction in vasopressor dependency index and lactate level within 24 h. The study is limited by early stopping and low sample size. Trial registration TCTR, TCTR20180310001. Registered 8 March 2018, http://www.clinicaltrials.in.th/index.php?tp=regtrials&menu=trialsearch&smenu=fulltext&task=search&task2=view1&id=3330.

Fluoxetine (SSRI) treatment of canine atopic dermatitis: a randomized, double-blind, placebo-controlled, crossover trial

2014 ◽  
Vol 17 (2) ◽  
pp. 371-373 ◽  
Author(s):  
M. Fujimura ◽  
H. Ishimaru ◽  
Y. Nakatsuji
Keyword(s):  
Atopic Dermatitis ◽  
Selective Serotonin Reuptake Inhibitors ◽  
Crossover Trial ◽  
Severity Index ◽  
Base Line ◽  
Double Blind ◽  
Canine Atopic Dermatitis ◽  
Double Blind Placebo ◽  
Significant Difference ◽  
Ssri Treatment

Abstract This study investigated effects of a fluoxetine (selective serotonin reuptake inhibitors; SSRI, 1 mg/kg) on pruritus in canine atopic dermatitis (CAD). After 4-weeks of base-line observation, 8 dogs with CAD entered a 2-months randomized, double-blind, placebo-controlled, crossover trial comparing fluoxetine with placebo. Clinical efficacy was evaluated using a Canine Atopic Dermatitis Extent and Severity Index (CADESI-03) and Pruritus Visual Analog Scale (PVAS). Six dogs completed the study [two out of eight dogs (both of them were Shiba Inu) dropped out from the study due to a depression]. CADESI-03 and PVAS between fluoxetine and placebo showed no significant difference statistically (P>0.05 and P>0.05 respectively). Fluoxetine showed no efficacy on pruritus in CAD. Further researches are needed for the treatment on pruritus of CAD

Effect of Ibuprofen on Blood Pressure Control by Propranolol and Bendrofluazide

1988 ◽  
Vol 16 (3) ◽  
pp. 173-181 ◽  
Author(s):  
J. G. Davies ◽  
D. C. Rawlins ◽  
M. Busson
Keyword(s):  
Blood Pressure ◽  
Weight Gain ◽  
Crossover Trial ◽  
Antihypertensive Effect ◽  
Pressure Control ◽  
Double Blind ◽  
Randomized Crossover Trial ◽  
Significant Difference ◽  
Change In Mean ◽  
Drug Free

The effect of 1600 mg/day ibuprofen in two groups of patients with hypertension controlled by either propranolol or bendrofluazide was studied in a double-blind, double-placebo, randomized crossover trial. No significant difference in blood pressure was found at the end of the crossover period in either group, suggesting that the routine co-administration of ibuprofen does not attenuate the antihypertensive effect of thiazide diuretics or propranolol. Significant weight gain, attributable to fluid retention, had occurred in the bendrofluazide-treatment group by the end of the drug-free washout period. No significant change in mean weight occurred in the crossover stages in either group, although substantial weight gain was noted during ibuprofen treatment in two patients given bendrofluazide and one given propranolol. Biochemical variables were unaffected by ibuprofen throughout the crossover period. This study suggests that ibuprofen may be administered routinely to patients receiving thiazides or propranolol without loss of control of the anti-hypertensive action of these drugs but it is recommended that individuals are monitored for possible weight gain or an increase in diastolic blood pressure.

scholarly journals Use of proton pump inhibitors to treat persistent throat symptoms: multicentre, double blind, randomised, placebo controlled trial

BMJ ◽  
2021 ◽  
pp. m4903
Author(s):  
James O’Hara ◽  
Deborah D Stocken ◽  
Gillian C Watson ◽  
Tony Fouweather ◽  
Julian McGlashan ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Proton Pump Inhibitors ◽  
Proton Pump ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Randomised Trial ◽  
Secondary Outcome ◽  
Secondary Outcome Measure ◽  
Double Blind ◽  
Significant Difference

Abstract Objective To assess the use of proton pump inhibitors (PPIs) to treat persistent throat symptoms. Design Pragmatic, double blind, placebo controlled, randomised trial. Setting Eight ear, nose, and throat outpatient clinics, United Kingdom. Participants 346 patients aged 18 years or older with persistent throat symptoms who were randomised according to recruiting centre and baseline severity of symptoms (mild or severe): 172 to lansoprazole and 174 to placebo. Intervention Random blinded allocation (1:1) to either 30 mg lansoprazole twice daily or matched placebo twice daily for 16 weeks. Main outcome measures Primary outcome was symptomatic response at 16 weeks measured using the total reflux symptom index (RSI) score. Secondary outcomes included symptom response at 12 months, quality of life, and throat appearances. Results Of 1427 patients initially screened for eligibility, 346 were recruited. The mean age of the study sample was 52.2 (SD 13.7) years, 196 (57%) were women, and 162 (47%) had severe symptoms at presentation; these characteristics were balanced across treatment arms. The primary analysis was performed on 220 patients who completed the primary outcome measure within a window of 14-20 weeks. Mean RSI scores were similar between treatment arms at baseline: lansoprazole 22.0 (95% confidence interval 20.4 to 23.6) and placebo 21.7 (20.5 to 23.0). Improvements (reduction in RSI score) were observed in both groups—score at 16 weeks: lansoprazole 17.4 (15.5 to19.4) and placebo 15.6 (13.8 to 17.3). No statistically significant difference was found between the treatment arms: estimated difference 1.9 points (95% confidence interval −0.3 to 4.2 points; P=0.096) adjusted for site and baseline symptom severity. Lansoprazole showed no benefits over placebo for any secondary outcome measure, including RSI scores at 12 months: lansoprazole 16.0 (13.6 to 18.4) and placebo 13.6 (11.7 to 15.5): estimated difference 2.4 points (−0.6 to 5.4 points). Conclusions No evidence was found of benefit from PPI treatment in patients with persistent throat symptoms. RSI scores were similar between the lansoprazole and placebo groups after 16 weeks of treatment and at the 12 month follow-up. Trial registration ISRCTN Registry ISRCTN38578686 and EudraCT 2013-004249-17.

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