Prevention of radiotherapy induced enteropathy by probiotics (PREP): protocol for a double-blind randomized placebo-controlled trial

Abstract Background Radiation induced enteropathy is a common complication of radiotherapy for pelvic tumors and adversely affects patient quality of life. Probiotics are thought to restore bowel microflora to optimal levels and reinforce intestinal barrier capacity. Although probiotics are effective in the treatment of radiation induced enteropathy, less is known about their efficacy to prevent radiation induced enteropathy. Methods This double-blind randomized placebo-controlled study will investigate the efficacy of probiotics to prevent radiation-induced enteropathy in patients with gynecologic or urologic cancer who received pelvic radiotherapy. The study is designed to enroll 248 eligible patients, who will be randomized 1:1 to a probiotic or placebo group. Toxicities will be evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Discussion The primary aim of this study is to provide high level evidence for the ability of probiotics to prevent acute radiation induced enteropathy. The secondary aims are to determine the effects of probiotics on the incidence of chronic radiation induced enteropathy and the safety of probiotics in patients with gynecologic or urologic cancer. Trial registration ClinicalTrials.gov (NCT03978949, Registered on 7 June 2019).

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Efficacy of probiotics in irritable bowel syndrome: A randomized, double blind placebo-controlled study

Bangabandhu Sheikh Mujib Medical University Journal ◽

10.3329/bsmmuj.v6i1.29020 ◽

2016 ◽

Vol 6 (1) ◽

pp. 21 ◽

Cited By ~ 1

Author(s):

Md. Zahidur Rahman ◽

Mohammad Shoaib Chowdhury ◽

Mohammad Asadur Rahman ◽

Shohely Parveen ◽

Rajib Barua ◽

...

Keyword(s):

Irritable Bowel Syndrome ◽

Placebo Group ◽

Intestinal Microbiota ◽

Therapeutic Potential ◽

Intestinal Barrier ◽

Controlled Study ◽

Double Blind ◽

Before And After ◽

Irritable Bowel

Background: Gut flora have important trophic effects on intestinal epithelia and on immune structure and fonction.They also protect colonized host against invasion by alien microbes.Recent research suggests that an imbalance of the intestinal microbiota and a dysfunctional intestinal barrier might trigger irritable bowel syndrome (lBS). As probiotics have been reported to restore the intestinal microbiota and the gut barrier, the therapeutic potential of probiotics within IBS became of strong interest. Objectives: To assess the efficacy of probiotics in lBS. Methods: Patients of 15 to 60 years old and both sexes were included f om the out patient department (OPD) of gastroenterology, Bangabandhu Sheikh Mujib Medical University (BSMMU). A validated lBS-QOL instmment consisted of 34 questions used to assess improvement of quality of Iife before and after treatment. A total of 65 diarrhoea predominant LBS patients were randomised to receive either probiotics(n-33) or placebo(n-32) twice daily frir 6 weeks.Results: At the end of 6 weeks therapy, improvement in various symptoms(abclominal pain, stool frequency, consistency and 11atulence) in probiotics group was statistically significant. Mean QOL score before treatment was 103 in probiotics group and I 06 in placebo group. After 6 weeks of treatment mean QOL score was 82 in probiotics group and I 02.58 in placebo group. No side effects of the therapeutic agents were observed in any patient during the trial. Conclusions: Probiotics effectively alleviates global IBS and improves TBS symptoms simultaneously with an improvement of quality of life.

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The Safety of Mother’s Milk® Tea: Results of a Randomized Double-Blind, Controlled Study in Fully Breastfeeding Mothers and Their Infants

Journal of Human Lactation ◽

10.1177/0890334418787474 ◽

2018 ◽

Vol 35 (2) ◽

pp. 248-260 ◽

Cited By ~ 4

Author(s):

Carol L. Wagner ◽

Andrea D. Boan ◽

Alicia Marzolf ◽

Carolyn W. Finch ◽

Kristen Morella ◽

...

Keyword(s):

Quality Of Life ◽

Adverse Effects ◽

Controlled Trial ◽

Test Group ◽

Psychological State ◽

Controlled Study ◽

Double Blind ◽

Mother's Milk ◽

Mother’S Milk

Background: Various natural products are reported to improve maternal milk supply yet are not necessarily safe for infants. Researchers have not systematically studied galactagogue teas for safety. Research aim: This study evaluates the safety of a galactagogue tea in breastfeeding women and their infants, assessing short- and long-term adverse effects. Methods: Healthy, exclusively/fully breastfeeding women ( N = 60) with no milk insufficiency were randomized into (1) an all-natural tea containing fruits of bitter fennel, anise, and coriander; fenugreek seed; and other herbs (Mother’s Milk® herbal tea; test) group or (2) a lemon verbena leaf (placebo) group. Maternal diaries captured self-reported maternal and infant adverse effects, tea consumed, and perceived infant satisfaction. Maternal quality of life and psychological state were assessed at baseline and 2 and 4 weeks. Poststudy calls assessed adverse effects through the infants’ age of 12 months. Results: No adverse effects attributable to the interventions were reported at any time point. No differences were found between test and placebo groups in sociodemographic characteristics, maternal or infant adverse symptoms, quality of life, breastfeeding self-efficacy, maternal psychological measures, infant growth, and infant satisfaction (all p >.05). Conclusions: This double-blind, randomized controlled trial (RCT) of an herbal galactagogue versus placebo among healthy, exclusively/fully breastfeeding mothers and infants found no adverse events associated with the test tea across the 30-day study or the first year of their infant’s life. This composite tea appears to present no safety risk for mothers or their young babies.

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Vitamin D supplementation in people with IBS has no effect on symptom severity and quality of life: results of a randomised controlled trial

European Journal of Nutrition ◽

10.1007/s00394-021-02633-w ◽

2021 ◽

Author(s):

Claire E. Williams ◽

Elizabeth A. Williams ◽

Bernard M. Corfe

Keyword(s):

Quality Of Life ◽

Vitamin D ◽

Symptom Severity ◽

Controlled Trial ◽

Community Setting ◽

Vitamin D Supplementation ◽

Controlled Study ◽

Double Blind ◽

Vitamin D Levels

Abstract Purpose Several small trials suggest a benefit of vitamin D supplementation in irritable bowel syndrome (IBS). The generalisability of these reports is limited by their design and scale. This study aimed to assess whether vitamin D supplementation improved IBS symptoms in a UK community setting. Methods This was a randomised, double-blind, placebo-controlled study. Participants were recruited from the community in winter months between December 2017 and March 2019. 135 participants received either vitamin D (3,000 IU p.d.) or placebo for 12 weeks. The primary outcome measure was change in IBS symptom severity; secondary outcomes included change in IBS-related quality of life. Results The participants were analysed on an intent-to-treat basis. 60% of participants were vitamin D deficient or insufficient at baseline. Although vitamin D levels increased in the intervention arm relative to placebo (45.1 ± 32.88 nmol/L vs 3.1 ± 26.15 nmol/L; p < 0.001). There was no difference in the change of IBS symptom severity between the active and placebo trial arms (− 62.5 ± 91.57 vs – 75.2 ± 84.35, p = 0.426) over time. Similarly there was no difference between trial arms in τhe change in quality of life (− 7.7 ± 25.36 vs – 11.31 ± 25.02, p = 0.427). Conclusions There is no case for advocating use of vitamin D in the management of IBS symptoms. The prevalence of vitamin D insufficiency suggests routine screening and supplementation should be implemented in this population for general health reasons. This trial was retrospectively registered with ISRCTN (ISRCTN13277340) on 24th April 2018 after recruiting had been initiated.

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

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2021/8856149 ◽

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.

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Faculty Opinions recommendation of OnabotulinumtoxinA 100 U significantly improves all idiopathic overactive bladder symptoms and quality of life in patients with overactive bladder and urinary incontinence: a randomised, double-blind, placebo-controlled trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.718006591.793478312 ◽

2013 ◽

Author(s):

Francisco Cruz

Keyword(s):

Quality Of Life ◽

Urinary Incontinence ◽

Overactive Bladder ◽

Controlled Trial ◽

Double Blind ◽

Double Blind Placebo ◽

Overactive Bladder Symptoms ◽

Bladder Symptoms

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Faculty of 1000 evaluation for Epidural neostigmine and clonidine improves the quality of combined spinal epidural analgesia in labour: A randomised, double-blind controlled trial.

F1000 - Post-publication peer review of the biomedical literature ◽

10.3410/f.718077426.793483746 ◽

2013 ◽

Author(s):

Bernard Wittels

Keyword(s):

Epidural Analgesia ◽

Controlled Trial ◽

Double Blind ◽

Combined Spinal Epidural ◽

Spinal Epidural

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Adjunctive Garcinia mangostana Linn. (Mangosteen) Pericarp for Schizophrenia: A 24-Week Double-blind, Randomized, Placebo Controlled Efficacy Trial: Péricarpe d’appoint Garcinia mangostana Linn (mangoustan) pour la schizophrénie : un essai d’efficacité de 24 semaines, à double insu, randomisé et contrôlé par placebo

The Canadian Journal of Psychiatry ◽

10.1177/0706743720982437 ◽

2020 ◽

pp. 070674372098243

Author(s):

Alyna Turner ◽

Andrea Baker ◽

Olivia M. Dean ◽

Adam J. Walker ◽

Seetal Dodd ◽

...

Keyword(s):

Quality Of Life ◽

Schizoaffective Disorder ◽

Negative Symptoms ◽

Controlled Trial ◽

Safety Data ◽

Rate Of Change ◽

Adjunctive Treatment ◽

Garcinia Mangostana ◽

Double Blind

Objectives: Garcinia mangostana Linn. (“mangosteen”) pericarp contains bioactive compounds that may target biological pathways implicated in schizophrenia. We conducted a double-blind randomized placebo-controlled trial evaluating the efficacy of adjunctive mangosteen pericarp, compared to placebo, in the treatment of schizophrenia. Methods: People diagnosed with schizophrenia or schizoaffective disorder ( Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition), recruited across 2 sites (Brisbane and Victoria, Australia), were randomized to receive 24 weeks of adjunctive mangosteen pericarp (1,000 mg/day) or matched placebo. The primary outcome measure was the Positive and Negative Symptom Scale total score. Secondary outcomes included positive and negative symptoms, general psychopathology, clinical global severity and improvement, participant reported overall improvement, depressive symptoms, functioning, quality of life, and safety data at 24 and 28 weeks (4 weeks postdiscontinuation). Data were collected from July 2016 to February 2019. Results: Baseline assessments were conducted on 148 people (mangosteen = 74, placebo = 74); data analyses were conducted on 136 (92%) participants with postbaseline data. The treatment group had significantly higher symptom severity compared to placebo, and both groups significantly improved on all symptom, functioning, and quality of life measures over time. No between-group differences were found for the rate of change between baseline and 24 or 28 weeks. Conclusion: Despite promising preclinical and clinical work, our results do not support mangosteen pericarp extract as an adjunctive treatment for schizophrenia or schizoaffective disorder.

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Amelioration of mild and moderate depression through Pranic Healing as adjuvant therapy: randomised double-blind controlled trial

Australasian Psychiatry ◽

10.1177/1039856217726449 ◽

2017 ◽

Vol 26 (1) ◽

pp. 82-87 ◽

Cited By ~ 4

Author(s):

R Rajagopal ◽

Srikanth N Jois ◽

Sumanth Mallikarjuna Majgi ◽

MN Anil Kumar ◽

HB Shashidhar

Keyword(s):

Quality Of Life ◽

Adjuvant Therapy ◽

Mental Disorder ◽

Controlled Trial ◽

Antidepressant Drug ◽

Double Blind ◽

Average Decrease ◽

Moderate Depression ◽

Post Assessment

Objectives: Depression is a mental disorder, affecting the quality of life. Our study explores the efficacy of Pranic Healing (PH), as an adjuvant therapy in treating depression Methods: In this randomised double-blind controlled trial, 52 participants with a mean age of 34.4 years, with mild to moderate depression were assessed using the Hamilton Depression Rating (HAM-D) scale during the 5-week study. Both Medication + PH (MedPH) and Medication + Mock PH (MedMockPH) groups comprising 26 members received Pranic and mock healing lasting 20 minutes per session respectively once a week for 4 weeks, along with the antidepressant drug. Results: The average decrease in HAM-D score in MedPH was median 11 (Interquartile Range (IQR) 7–12) and was significantly higher compared with the MedMockPH group median 6.5 (IQR 3–9). At pre-assessment, both groups had 8 cases of mild and 18 cases of moderate depression. At post-assessment, HAM-D showed that the improvement in depression category was seen in 69.2% of participants in the MedMockPH group and 100% in MedPH group. Conclusions: These results give first the evidence that PH can aid as an adjuvant therapy for depressed people.

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ISA247: Quality of Life Results from a Phase II, Randomized, Placebo-Controlled Study

Journal of Cutaneous Medicine and Surgery ◽

10.2310/7750.2008.07060 ◽

2008 ◽

Vol 12 (6) ◽

pp. 268-275 ◽

Cited By ~ 9

Author(s):

Aditya K. Gupta ◽

Richard G. Langley ◽

Charles Lynde ◽

Kirk Barber ◽

Wayne Gulliver ◽

...

Keyword(s):

Quality Of Life ◽

Phase Ii ◽

Life Quality ◽

Skin Condition ◽

Controlled Study ◽

Double Blind ◽

Plaque Type ◽

Psoriasis Disability Index ◽

Stable Plaque

Background: Psoriasis is a chronic skin condition that can negatively affect a patient's quality of life (QoL), often hindering social functioning. ISA247, a novel psoriatic agent, has shown clinical efficacy in moderate to severe psoriasis sufferers, but its effect on QoL is currently not reported. Objective: The objective of this study was to assess the effect of ISA247 on the QoL in patients with stable, plaque-type psoriasis. Methods: A phase II, randomized, double-blind, placebo-controlled, parallel-group, multicenter study assessed the effects of ISA247 doses of 0.5 mg/kg/d ( n = 77) or 1.5 mg/kg/d ( n = 83) compared with placebo ( n = 41) for 12 weeks. QoL was assessed using the Dermatology Life Quality Index (DLQI) and Psoriasis Disability Index (PDI) scales. Results: ISA247 treatment (pooled groups) significantly improved QoL scores as assessed by both the DLQI and the PDI compared with those receiving placebo ( p < .05). Treatment with the higher dose of 1.5 mg/kg/d demonstrated a significantly greater response to many of the QoL scales compared with the 0.5 mg/kg/d group ( p < .05). Conclusions: ISA247 appears to improve the QoL while also providing effective treatment for chronic, moderate to severe, plaque-type psoriasis.

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