scholarly journals Prune intake ameliorates chronic constipation symptoms and causes little discomfort from diarrhea and loose stools: A randomized placebo-controlled trial

2022 ◽  
Author(s):  
Taishi Koyama ◽  
Naoyoshi Nagata ◽  
Kengo Nishiura ◽  
Naoki Miura ◽  
Takashi Kawai ◽  
...  
Keyword(s):  
Chronic Constipation ◽  
Rating Scale ◽  
Controlled Trial ◽  
Double Blind ◽  
Gastrointestinal Symptom Rating Scale ◽  
Long Time ◽  
Stool Form ◽  
Natural Foods ◽  
Symptom Rating

Aim: Little data is available regarding the effectiveness of natural foods in treating chronic constipation. We aimed to identify whether prune ameliorates chronic constipation and can be used safely for a relatively long time. Methods: In this double-blind, randomized, placebo-controlled trial, 84 subjects with chronic constipation, presenting more than 6 months before and persisting for more than 3 months, were randomized to prune (n=42) or placebo (n=42) intake for 8 weeks. We assessed daily Bristol stool form scale (BSFS) scores and stool frequencies and administered the gastrointestinal symptom rating scale (GSRS) questionnaire, as primary outcomes for constipation improvement. Results: The prune group showed significantly decreased rates of hard stool (BSFS1 or 2) and increased rates of normal stool (BSFS 3 or 4) after 1 week, which were more evident after 7 weeks between the two groups. Prune significantly increased stool frequency immediately after 1 week. Furthermore, GSRS of hard stools, flatulence, and incomplete evacuation significantly improved after 4-8 weeks of prune intake, of which constipation and hard stools were significantly reduced compared to the placebo group. In contrast, prune intake did not cause diarrhea, loose stools, or urgent need for defecation during 8 weeks evaluated by GSRS score. We found no abnormal laboratory tests of liver function, renal function, inflammation, or urinalysis after prune intake. Conclusions: Daily prune intake ameliorates chronic constipation, improving quality of life, and causes few diarrhea-related symptoms or side effects. Our results emphasize a new, useful, and easy strategy for chronic constipation. (UMIN ID:000041384)

scholarly journals Effect of probiotics on nasal and intestinal microbiota in people with high exposure to particulate matter ≤ 2.5 μm (PM2.5): a randomized, double-blind, placebo-controlled clinical study

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Yongcan Wu ◽  
Caixia Pei ◽  
Xiaomin Wang ◽  
Mingjie Wang ◽  
Demei Huang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Intestinal Microbiota ◽  
Rating Scale ◽  
Short Form ◽  
Controlled Trial ◽  
High Exposure ◽  
Gastrointestinal Symptom Rating Scale ◽  
Probiotic Treatment ◽  
High Concentrations

Abstract Background Extended exposure to high concentrations of PM2.5 changes the human microbiota profile, which in turn may increase morbidity and mortality due to respiratory system damage. A balanced microecosystem is crucial to human health, and certain health-related problems may be addressed by effective microecosystem regulation. Recent studies have confirmed that probiotics may reduce the incidence of respiratory diseases. However, few studies have investigated probiotic treatment outcomes in subjects exposed to high concentrations of PM2.5. Methods This study is designed as a prospective, randomized, participants- and assessor-blinded, placebo-controlled trial. One hundred and twenty eligible volunteers recruited from October 2019 to July 2020 in downtown Chengdu, China, will be treated with either probiotics or placebo over 4 consecutive weeks. The primary outcome will be 16SrRNA sequencing assay data from nasal and intestinal secretions. Secondary outcomes will be pulmonary function, score on a gastrointestinal symptom rating scale, COOP/WONCA charts, and the Short-Form Health Survey 36 for quality of life. Results will be analyzed to assess differences in clinical efficacy between groups. Six-month follow-up examinations will evaluate the long-term value of probiotics on cardiovascular and respiratory disease end-point events. Discussion We will explore the characteristics of nasal and intestinal microbiota in a population with high exposure to PM2.5. Probiotics and placebo interventions will be tested for efficacy in microbial balance regulation, effects on lung and physical functions, and quality of life improvement. This study is expected to provide reliable evidence to support the widespread promotion of probiotics in clinical practice for the protection of individuals with high exposure to PM2.5. Trial registration Chinese Clinical Trial Registry ChiCTR1900025469. Registered on 27 August 2019.

Effects of Helichrysum Psudoplicatum supplementation on pruritus intensity, fatigue, quality of life and anorexia in hemodialysis patients: a randomized, double-blind placebo-controlled trial

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Maryam Mohajeranirad ◽  
Naser Saeidi ◽  
Mohammad Kamali Nejad ◽  
Amir Almasi-Hashiani ◽  
Mehdi Salehi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rating Scale ◽  
Controlled Trial ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Dialysis Patients ◽  
Time Duration ◽  
Double Blind ◽  
Double Blind Placebo

Abstract Objectives Anorexia, fatigue and pruritus are common complications of hemodialysis (HD) patients. Today, the use of medicinal plants is more than synthetic drugs due to their safety. Therefore, we designed a randomized controlled clinical trial to evaluate the effects of Helichrysum psudoplicatum (H. psudoplicatum) supplementation on biochemical parameters, pruritus intensity, fatigue, quality of life and anorexia in HD patients. Methods This randomized, double-blind, placebo-controlled trial was performed on 50 subjects with, aged 55–65 years old. HD patients were randomly divided into two groups. Intervention group received 250 mg/day of H. psudoplicatum supplement capsule for 6 weeks (n=25), and the placebo group was given placebo capsule for the same time duration and dosage (n=25). The serum concentrations of urea, creatinine, albumin and hemoglobin were measured enzymatically methods. Anorexia, pruritus intensity, quality of life the dialysis patients with pruritus and fatigue score was measured using a Simplified Nutritional Appetite Questionnaire (SNAQ), Numerical rating scale (NRS), Fatigue severity scale (FSS) and ItchyQoL questionnaire, respectively. Shapiro–Wilk and independent-samples t-test or Mann–Whitney test were used for the analysis of the data. Results The results showed that the H. psudoplicatum supplementation significantly improved the pruritus intensity, quality of life the dialysis patients with pruritus and fatigue in HD patients, for 6 weeks (p<0.001). However, it did not significantly effect on the anorexia, albumin, hemoglobin, urea, creatinine, arm circumference, and body mass index (p>0.05). Conclusions According to the results of this study, H. psudoplicatum supplementation can be effective as an adjunct therapy to improve pruritus intensity, quality of life, fatigue and relative improvement of anorexia in HD patients.

scholarly journals Characteristics of nasal and intestinal microbiota and effects of probiotics intervention in highly exposed people with PM2.5: a randomized, double-blind, placebo-controlled clinical study

2019 ◽  
Author(s):  
Yongcan Wu ◽  
Caixia Pei ◽  
Xiaomin Wang ◽  
Mingjie Wang ◽  
Demei Huang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Intestinal Microbiota ◽  
Rating Scale ◽  
Short Form ◽  
Controlled Trial ◽  
High Exposure ◽  
Gastrointestinal Symptom Rating Scale ◽  
Probiotic Treatment ◽  
High Concentrations

Abstract Background: Extended exposure to high concentrations of PM2.5 changes the human microbiota profile, which in turn may increase morbidity and mortality due to respiratory system damage. A balanced microecosystem is crucial to human health, and certain health-related problems may be addressed by effective microecosystem regulation. Recent studies have confirmed that probiotics may reduce the incidence of respiratory diseases. However, few studies have investigated probiotic treatment outcomes in subjects exposed to high concentrations of PM2.5. Methods: This study is designed as a prospective, 2×2 factorial, randomized, participants- and assessor-blinded, placebo-controlled trial. One hundred and twenty eligible volunteers recruited from October 2019 to July 2020 in downtown Chengdu, China will be treated with either probiotics or placebo over 4 consecutive weeks. The primary outcome will be 16SrRNA sequencing assay data from nasal and intestinal secretions. Secondary outcomes will be pulmonary function, score on a gastrointestinal symptom rating scale, COOP/WONCA charts, and the Short-Form Health Survey 36 for quality of life. Results will be analysed to assess differences in clinical efficacy between groups. Six-month follow-up examinations will evaluate the long-term value of probiotics on cardiovascular and respiratory disease end-point events. Discussion: We will explore the characteristics of nasal and intestinal microbiota in a population with high exposure to PM2.5. Probiotics and placebo interventions will be tested for efficacy in microbial balance regulation, effects on lung and physical functions, and quality of life improvement. This study is expected to provide reliable evidence to support the widespread promotion of probiotics in clinical practice for the protection of individuals with high exposure to PM2.5.

scholarly journals Lansoprazole for recurrent abdominal pain in adolescents

2011 ◽  
Vol 51 (4) ◽  
pp. 234
Author(s):  
Ade Saifan Surya ◽  
Selvi Nafianti ◽  
Melda Deliana ◽  
Supriatmo Supriatmo ◽  
Atan Baas Sinuhaji
Keyword(s):  
Abdominal Pain ◽  
Rating Scale ◽  
Controlled Trial ◽  
Drug Efficacy ◽  
Recurrent Abdominal Pain ◽  
Double Blind ◽  
Before And After ◽  
Pain Frequency ◽  
Physical Examinations

Background Recurrent abdominal pain is common among adolescents. School absenteeism and lower quality of life are associated with severity of symptoms. Lansoprazole has been used to treat recurrent abdominal pain.Objective To investigate the effectiveness of lansoprazole as a treatment for recurrent abdominal pain in adolescents.Methods We conducted a randomized, double-blind, controlled trial from August 2009 to October 2009. Adolescents suffering recurrent abdominal pain were eligible for the study. Simple randomization was done to divide subjects into two groups. Groups received 30 mg of lansoprazole or placebo, once a day for 14 days. Before treatment, we performed laboratory and physical examinations. Pain frequency was measured in number of abdominal pain episodes per month. Duration was measured in minutes and pain intensity was measured by a pain rating scale. Drug efficacy was measured before, during and after intervention. Data was analyzed using Mann-Whitney U-test and t-test.Results One hundred sixteen recurrent abdominal pain patients were randomized into two groups of 58 patients. There were no statistically significant differences in pain frequency before and after treatment for either the lansoprazole group or the placebo group (P=0.083, 95%CI, -0.033 to 0.021 and P=0.096, 95%CI -0.376 to 0.031, respectively). In addition, there were no significant differences in frequency, duration, and degree of abdominal pain at baseline and after 1, 2 and 3 months of treatment between the two groups.Conclusion Lansoprazole was not more effective than the placebo for treatment of recurrent abdominal pain among adolescents.

scholarly journals Prolonged Perioperative Use of Pregabalin and Ketamine to Prevent Persistent Pain after Cardiac Surgery

2019 ◽  
Vol 131 (1) ◽  
pp. 119-131 ◽  
Author(s):  
Sibtain Anwar ◽  
Jackie Cooper ◽  
Junia Rahman ◽  
Chhaya Sharma ◽  
Richard Langford
Keyword(s):  
Quality Of Life ◽  
Cardiac Surgery ◽  
Odds Ratio ◽  
Rating Scale ◽  
Controlled Trial ◽  
Persistent Pain ◽  
Control Group ◽  
Analgesic Requirement ◽  
Double Blind

Abstract Editor’s Perspective What We Already Know about This Topic What This Article Tells Us That Is New Background Persistent postsurgical pain is common and affects quality of life. The hypothesis was that use of pregabalin and ketamine would prevent persistent pain after cardiac surgery. Methods This randomized, double-blind, placebo-controlled trial was undertaken at two cardiac surgery centers in the United Kingdom. Adults without chronic pain and undergoing any elective cardiac surgery patients via sternotomy were randomly assigned to receive either usual care, pregabalin (150 mg preoperatively and twice daily for 14 postoperative days) alone, or pregabalin in combination with a 48-h postoperative infusion of intravenous ketamine at 0.1 mg · kg−1 · h−1. The primary endpoints were prevalence of clinically significant pain at 3 and 6 months after surgery, defined as a pain score on the numeric rating scale of 4 or higher (out of 10) after a functional assessment of three maximal coughs. The secondary outcomes included acute pain, opioid use, and safety measures, as well as long-term neuropathic pain, analgesic requirement, and quality of life. Results In total, 150 patients were randomized, with 17 withdrawals from treatment and 2 losses to follow-up but with data analyzed for all participants on an intention-to-treat basis. The prevalence of pain was lower at 3 postoperative months for pregabalin alone (6% [3 of 50]) and in combination with ketamine (2% [1 of 50]) compared to the control group (34% [17 of 50]; odds ratio = 0.126 [0.022 to 0.5], P = 0.0008; and 0.041 [0.0009 to 0.28], P &lt; 0.0001, respectively) and at 6 months for pregabalin alone (6% [3 of 50]) and in combination with ketamine 0% (0 of 5) compared to the control group (28% [14 of 50]; odds ratio = 0.167 [0.029 to 0.7], P = 0.006; and 0.000 [0 to 0.24], P &lt; 0.0001). Diplopia was more common in both active arms. Conclusions Preoperative administration of 150 mg of pregabalin and postoperative continuation twice daily for 14 days significantly lowered the prevalence of persistent pain after cardiac surgery.

Assessment of a Korean Gastrointestinal Symptom Rating Scale (KGSRS) for Measuring Quality of Life in Patients with GERD

2005 ◽  
Vol 61 (5) ◽  
pp. AB152
Author(s):  
Hye-kyung Jung ◽  
Ki-Nam Shim ◽  
Tae Hun Kim ◽  
Sung-Ae Jung ◽  
Sun Young Yi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Gastrointestinal Symptom ◽  
Rating Scale ◽  
Gastrointestinal Symptom Rating Scale ◽  
Symptom Rating

Evaluation of Bacillus subtilis R0179 on gastrointestinal viability and general wellness: a randomised, double-blind, placebo-controlled trial in healthy adults

2015 ◽  
Vol 6 (1) ◽  
pp. 19-27 ◽  
Author(s):  
A. Hanifi ◽  
T. Culpepper ◽  
V. Mai ◽  
A. Anand ◽  
A.L. Ford ◽  
...  
Keyword(s):  
Bacillus Subtilis ◽  
Dose Response ◽  
Rating Scale ◽  
Controlled Trial ◽  
Probiotic Strain ◽  
Healthy Adults ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Gastrointestinal Symptom Rating Scale ◽  
Gi Symptoms

A probiotic formulation of Enterococcus faecium R0026 and Bacillus subtilis R0179 has been evaluated in previous clinical trials. However, B. subtilis R0179 has not been evaluated as a single probiotic strain or in combination with other strains at doses higher than 0.1×109 cfu. To establish oral dose-response tolerance and gastrointestinal (GI) viability of B. subtilis R0179, a randomised, double-blind, placebo-controlled trial in healthy adults (n=81; 18-50 years old) was conducted. Participants received B. subtilis R0179 at 0.1, 1.0 or 10×109 cfu/capsule/day or placebo for four weeks. General wellness was assessed using a daily questionnaire evaluating GI, cephalic, ear-nose-throat, behavioural, emetic, and epidermal symptoms. GI symptoms were further evaluated using a weekly gastrointestinal symptom rating scale (GSRS). GI transit viability of B. subtilis R0179 was assessed by plating and microbiota analysis by 16S rRNA at baseline, week 4 of the intervention and washout. General wellness and GI function were not affected by oral consumption of B. subtilis R0179 at any dose. Daily questionnaire syndrome scores were not different from baseline and did not exceed a clinically significant score of 1. GSRS syndrome scores were not different from baseline and ranged from 1.1±0.1 to 1.9±0.2. Faecal viable counts of B. subtilis R0179 demonstrated a dose response: the placebo group (1.1±0.1 log10 cfu/g) differed from 0.1×109 (4.6±0.1 log10 cfu/g), 1×109 (5.6±0.1 log10 cfu/g) and 10×109 (6.4±0.1 log10 cfu/g) (P<0.0001). No significant changes in phyla were observed, but sequence reads binned to multiple operational taxonomic units matching closest to Ruminococci increased during probiotic supplementation. B. subtilis R0179 survives passage through the human GI tract and is well tolerated by healthy adults at intakes from 0.1 to 10×109 cfu/day. The trial has been registered at www.clinicaltrials.gov under NCT01802151.

scholarly journals A Durum Wheat Variety-Based Product Is Effective in Reducing Symptoms in Patients with Non-Celiac Gluten Sensitivity: A Double-Blind Randomized Cross-Over Trial

Nutrients ◽  
2019 ◽  
Vol 11 (4) ◽  
pp. 712 ◽  
Author(s):  
Gianluca Ianiro ◽  
Gianenrico Rizzatti ◽  
Marco Napoli ◽  
Maria Matteo ◽  
Emanuele Rinninella ◽  
...  
Keyword(s):  
Durum Wheat ◽  
Rating Scale ◽  
Wheat Variety ◽  
Gluten Free Diet ◽  
Gluten Sensitivity ◽  
Gluten Free ◽  
Double Blind ◽  
Gastrointestinal Symptom Rating Scale ◽  
Symptom Rating ◽  
Durum Wheat Variety

Patients with non-celiac gluten sensitivity (NCGS) do not have celiac disease, but their symptoms improve after a gluten-free diet (GFD). However, to date, it is uncertain if gluten or other components of wheat are responsible for these symptoms. The aim of this study was to compare the effects of an organic durum wheat variety with those of standard commercial wheat in patients with known NCGS. We performed a double-blind randomized cross-over trial of 42 patients (mean age 45 years, 8 men) with NCGS diagnosed according to the Salerno criteria and adherence to GFD for at least 12 weeks from screening. Enrolled subjects were randomly assigned to one the following groups of treatment: (A) a two-week diet with Senatore Cappelli wheat variety pasta; (B) a two-week diet with standard commercial pasta. Then, after a two-week washout period on gluten-free diet, each patient crossed over to the other treatment group. Symptoms were assessed through a modified version of the Gastrointestinal Symptom Rating Scale (GSRS), tailored on NCGS. Between April 2018 and July 2018, 42 patients with NCGS were enrolled in the study (70.6% females), and 34 patients completed the study. Patients reported lower overall symptoms scores after eating Senatore Cappelli pasta than standard pasta (p = 0.03) and also significantly lower scores in several specific gastrointestinal and extra-intestinal symptoms after eating Senatore Cappelli pasta than standard pasta, specifically, bloating (p = 0.04), abdominal distention (p = 0.004), eructation (p = 0.01), flatus (p = 0.02), feeling of incomplete evacuation (p = 0.001), dermatitis (p = 0.01), and limb numbness (p = 0.03). In our study, patients with NCGS experienced lower gastrointestinal and extra-intestinal symptom scores after eating the Senatore Cappelli wheat variety than a standard commercial wheat. Should our preliminary results be confirmed by further studies, new dietary alternatives may be available to patients with NCGS, with consequent health, economic, and social benefits.

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