scholarly journals Diarrhoea Management using Over-the-counter Nutraceuticals in Daily practice (DIAMOND): a feasibility RCT on alternative therapy to reduce antibiotic use

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Yanhong Jessika Hu ◽  
Xudong Zhou ◽  
Shanjuan Wang ◽  
Merlin Willcox ◽  
Colin Garner ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Alternative Therapy ◽  
Acute Diarrhoea ◽  
Final Analysis ◽  
Daily Practice ◽  
Antibiotic Use ◽  
Symptom Duration ◽  
Structured Interviews ◽  
Double Blind

Abstract Background Although rarely indicated, antibiotics are commonly used for acute diarrhoea in China. We conducted a randomised, double blind exploratory clinical trial of loperamide, berberine and turmeric for treatment of acute diarrhoea. Methods Adults with acute uncomplicated diarrhoea aged 18 to 70 were randomised to 4 groups: (A) loperamide; (B) loperamide and berberine; (C) loperamide and turmeric; (D) loperamide, berberine and turmeric. All participants were given rescue ciprofloxacin for use after 48 h if symptoms worsened or were unimproved. Primary endpoints were feasibility and ciprofloxacin use during the 2-week follow-up period. Semi-structured interviews were conducted following recruitment and were analysed thematically. Recruiting doctors, delivery pharmacists and research assistants were blinded to treatment allocation. Results Only 21.5% (278/1295) of patients screened were deemed eligible, and 49% (136/278) of these consented and were entered into the final analysis. Most participants had mild symptoms, because most patients with moderate or severe symptoms wanted to be given antibiotics. Follow-up was good (94% at 2 weeks). Only three participants used rescue antibiotics compared to 67% of acute diarrhoea patients in the hospital during the recruitment period. The median symptom duration was 14 h in group B (interquartile range (IQR) 10-22), 16 h in group D (IQR 10-22), 18 h in group A (IQR 10-33) and 20 h in group C (IQR 16-54). Re-consultation rates were low. There were no serious treatment-related adverse events. Most interviewed participants said that although they had believed antibiotics to be effective for diarrhoea, they were surprised by their quick recovery without antibiotics in this trial. Conclusion Although recruitment was challenging because of widespread expectations for antibiotics, patients with mild diarrhoea accepted trying an alternative. The three nutraceuticals therapy require further evaluation in a fully powered, randomised controlled trial among a broader sample. Trial registration ChiCTR-IPR-17014107

scholarly journals Diarrhoea Antibiotic Management Using Over-the-Counter Nutraceuticals in Daily Practice (DIAMOND): A Feasibility RCT on Alternative Therapy to Reduce Antibiotic Use

2020 ◽  
Author(s):  
Yanhong Jessika Hu ◽  
Xudong Zhou ◽  
Shanjuan Wang ◽  
Merlin Willcox ◽  
Colin Garner ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Alternative Therapy ◽  
Acute Diarrhoea ◽  
Final Analysis ◽  
Daily Practice ◽  
Antibiotic Use ◽  
Symptom Duration ◽  
Structured Interviews ◽  
Double Blind

Background: Although rarely indicated, antibiotics are commonly used for acute diarrhoea in China. We conducted a randomized, double blind exploratory clinical trial of loperamide, berberine and turmeric for treatment of acute diarrhoea. Methods: Adults with acute uncomplicated diarrhoea were randomized to 4 groups: (A) loperamide; (B) loperamide and berberine; (C) loperamide and turmeric; (D) loperamide, berberine and turmeric. All participants were given rescue ciprofloxacin for use after 48 hours if symptoms worsened or were unimproved. Primary endpoints were feasibility and ciprofloxacin use during the 2 week follow-up period. Semi-structured interviews were conducted following recruitment. Results: Only 21.5% (278/1295) of patients screened were deemed eligible, and 49% (136/278) of these consented and entered into the final analysis. Most participants had mild symptoms, because most patients with moderate or severe symptoms wanted to be given antibiotics. Follow-up was good (94% at 2 weeks). Only two participants used rescue antibiotics compared to 65% of acute diarrhoea patients in the hospital during the recruitment period. The median symptom duration was: 14 hours in group B (IQR 10-22), 16 hours in group D (IQR 10-22), 18 hours in group A (IQR 10-33), 20 hours in group C (IQR 16-54). Re-consultation rates were low. There were no serious treatment-related adverse events. Most interviewed participants said the treatment was effective. Conclusion: Although recruitment was challenging because of widespread expectations for antibiotics, patients with mild diarrhoea accepted to try an alternative. This therapy requires further evaluation in a fully powered, randomised controlled trial among a broader sample.

Double-Blind, Placebo-Controlled Trial of Oral Immunotherapy (OIT) in Peanut (PN) Allergic Children: A Follow-up

2010 ◽  
Vol 125 (2) ◽  
pp. AB58 ◽  
Author(s):  
S.M. Jones ◽  
A.M. Scurlock ◽  
L. Pons ◽  
T.T. Perry ◽  
A.R. Morgan ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Oral Immunotherapy ◽  
Double Blind ◽  
Double Blind Placebo

No Additive Clinical or Physiological Effects of Short-term Anti-inflammatory Treatment to Physical Rehabilitation in the Early Phase of Human Achilles Tendinopathy: A Randomized Controlled Trial

2021 ◽  
pp. 036354652199190
Author(s):  
Nikolaj M. Malmgaard-Clausen ◽  
Oscar H. Jørgensen ◽  
Rikke Høffner ◽  
Peter E.B. Andersen ◽  
Rene B. Svensson ◽  
...  
Keyword(s):  
Early Phase ◽  
Controlled Trial ◽  
Rehabilitation Program ◽  
Achilles Tendinopathy ◽  
Physical Rehabilitation ◽  
Symptom Duration ◽  
Short Term ◽  
Nsaid Treatment ◽  
T2 Mri

Background: Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used in the treatment of Achilles tendinopathy, but whether they have any additive clinical effect on physical rehabilitation in the early phase of tendinopathy remains unknown. Purpose/Hypothesis: To investigate whether an initial short-term NSAID treatment added to a physical rehabilitation program in the early phase of Achilles tendinopathy would have an additive effect. We hypothesized that the combination of NSAID and rehabilitation would be superior to rehabilitation alone. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 69 patients with early phase Achilles tendinopathy (lasting <3 months) were randomly assigned to either a naproxen group (7 days of treatment; 500 mg twice daily; n = 34) or a placebo group (7 days of placebo treatment; n = 35). Both groups received an identical 12-week physical rehabilitation program. The clinical outcome of the study was evaluated using the Victorian Institute of Sports Assessment–Achilles (VISA-A) questionnaire and a numerical rating scale (NRS), and the physiological outcome was evaluated using ultrasonography, magnetic resonance imaging (MRI), and ultra-short time to echo T2* mapping MRI (UTE T2* MRI). Follow-up was performed at 1 week, 3 months, and 1 year. Time effects are presented as mean difference ± SEM. Results: No significant differences were found between the 2 treatment groups for any of the outcome measures at any time point ( P > .05). For the VISA-A score, a significant time effect was observed between baseline and 3-month follow-up (14.9 ± 2.3; P < .0001), and at 1-year follow-up, additional improvements were observed (6.1 ± 2.3; P < .01). Furthermore, the change in VISA-A score between baseline and 3-month follow-up was greater in patients with very short symptom duration (<1 month) at baseline compared with patients who had longer symptom duration (>2 months) (interaction between groups, 11.7 ± 4.2; P < .01). Despite clinical improvements, total weekly physical activity remained lower compared with preinjury levels at 3 months (–2.7 ± 0.5 h/wk; P < .0001) and 1 year (–3.0 ± 0.5 h/wk; P < .0001). At baseline, ultrasonography showed increased thickness (0.12 ± 0.03 cm; P < .0001) and vascularity (0.3 ± 0.1 cm2; P < .005) on the tendinopathic side compared with the contralateral side, but no changes over time were observed for ultrasonography, MRI, or UTE T2* MRI results. Conclusion: Clinical symptoms in early tendinopathy improved with physical rehabilitation, but this improvement was not augmented with the addition of NSAID treatment. Furthermore, this clinical recovery occurred in the absence of any measurable structural alterations. Finally, clinical improvements after a physical rehabilitation program were greater in patients with very short symptom duration compared with patients who had longer symptom duration. Registration: NCT03401177 (ClinicalTrials.gov identifier) and BFH-2016-019 (Danish Data Protection Agency)

The SNAP Trial: 2-Year Results of a Double-Blind Multicenter Randomized Controlled Trial of a Silicon Nitride Versus a PEEK Cage in Patients After Lumbar Fusion Surgery

2021 ◽  
pp. 219256822098547
Author(s):  
R. F. M. R. Kersten ◽  
F. C. Öner ◽  
M. P. Arts ◽  
M. Mitroiu ◽  
K. C. B. Roes ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Silicon Nitride ◽  
Interbody Fusion ◽  
Controlled Trial ◽  
Segmental Motion ◽  
Lumbar Interbody Fusion ◽  
Double Blind ◽  
Randomized Controlled ◽  
Disability Questionnaire

Study Design: Randomized controlled trial. Objectives: Lumbar interbody fusion with cages is performed to provide vertebral stability, restore alignment, and maintain disc and foraminal height. Polyetheretherketone (PEEK) is commonly used. Silicon nitride (Si3N4) is an alternative material with good osteointegrative properties. This study was designed to assess if Si3N4 cages perform similar to PEEK. Methods: A non-inferiority double-blind multicenter RCT was designed. Patients presenting with chronic low-back pain with or without leg pain were included. Single- or double-level instrumented transforaminal lumbar interbody fusion (TLIF) using an oblique PEEK or Si3N4 cage was performed. The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ). The non-inferiority margin for the RMDQ was 2.6 points on a scale of 24. Secondary outcomes included the Oswestry Disability Questionnaire (ODI), Visual Analogue Scales (VAS), SF-36 Physical Function, patient and surgeon Likert scores, radiographic evaluations for subsidence, segmental motion, and fusion. Follow-up was planned at 3, 6, 12, and 24-months. Results: Ninety-two patients were randomized ( i.e. 48 to PEEK and 44 to Si3N4). Both groups showed good clinical improvements on the RMDQ scores of up to 5-8 points during follow-up. No statistically significant differences were observed in clinical and radiographic outcomes. Mean operative time and blood loss were statistically significantly higher for the Si3N4 cohort. Although not statistically significant, there was a higher incidence of complications and revisions associated with the Si3N4 cage. Conclusions: There was insufficient evidence to conclude that Si3N4 was non-inferior to PEEK.

scholarly journals Effect of Metformin on Cigarette Withdrawal Syndrome and Abstinence in Lung Cancer Patients; A Double-blind Placebo-controlled Trial

2021 ◽  
Vol 14 (5) ◽  
Author(s):  
Bijan Pirnia ◽  
Raheleh Masoudi ◽  
Melika Sefidrood ◽  
Elham Zarghami ◽  
Kambiz Pirnia ◽  
...  
Keyword(s):  
Withdrawal Syndrome ◽  
Controlled Trial ◽  
Nicotine Withdrawal ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Urinary Cotinine ◽  
Metformin Group ◽  
Secondary Outcomes ◽  
Cigarette Withdrawal

Background: Lung cancer (LC) is a leading cause of cancer morbidity and mortality worldwide. One of the predisposing factors for LC is smoking. Metformin is the first line for diabetes treatment and is shown that it can be used for nicotine withdrawal syndrome reduction. Objectives: This study was conducted to evaluate the effects of metformin on reducing the nicotine withdrawal syndrome and increasing nicotine abstinence in patients with LC. Methods: In a randomized double-blind placebo-controlled trial from February 2018 to May 2019, 53 patients with LC were selected by respondent-driven sampling (RDS), and were assigned into two experimental and wait-list control (WLC) group through block randomization (BR). After 3 weeks of baseline assessment, metformin or placebo was prescribed in the form of escalating doses. Cigarette Withdrawal Scale (CWS-21), urinary cotinine levels, and exhaled carbon monoxide (eCO) levels were evaluated in 16 steps by the repeated measures. The primary outcomes include metformin efficacy on cigarette withdrawal syndrome and secondary outcomes include urinary cotinine levels and eCO level. The data were analyzed by generalized estimation equation (GEE), chi-square, and Atlas-Ti5. Results: The primary outcomes showed that the metformin group had significant effects on the improvement of depression, anxiety, craving, irritability, and appetite, difficulty in concentrating, appetite-weight, and insomnia during the 12-weeks treatment period (all P's < 0.05). In addition, only cravings scores remained constant until the 6-month follow-up (P < 0.05). Secondary outcomes demonstrated that urinary cotinine levels and eCO level significantly decreased in the metformin group (all P's < 0.05). However, this decrease did not remain constant at both levels until the 6-month follow-up (P > 0.05). Conclusions: Metformin had a clinical potential for reducing nicotine withdrawal. However, more studies are needed.

scholarly journals How feasible are lifestyle modification programs for disease prevention in general practice?

2012 ◽  
Vol 18 (2) ◽  
pp. 129 ◽  
Author(s):  
Heike Schütze ◽  
Elizabeth F. Rix ◽  
Rachel A. Laws ◽  
Megan Passey ◽  
Mahnaz Fanaian ◽  
...  
Keyword(s):  
General Practice ◽  
Vascular Disease ◽  
Lifestyle Modification ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Lifestyle Changes ◽  
Health Providers ◽  
Structured Interviews ◽  
Lifestyle Modification Program

Vascular disease is a leading cause of death and disability. While it is preventable, little is known about the feasibility or acceptability of implementing interventions to prevent vascular disease in Australian primary health care. We conducted a cluster randomised controlled trial assessing prevention of vascular disease in patients aged 40–65 by providing a lifestyle modification program in general practice. Interviews with 13 general practices in the intervention arm of this trial examined their views on implementing the lifestyle modification program in general practice settings. Qualitative study, involving thematic analysis of semi-structured interviews with 11 general practitioners, four practice nurses and five allied health providers between October 2009 and April 2010. Providing brief lifestyle intervention fitted well with routine health-check consultations; however, acceptance and referral to the program was dependent on the level of facilitation provided by program coordinators. Respondents reported that patients engaged with the advice and strategies provided in the program, which helped them make lifestyle changes. Practice nurse involvement was important to sustaining implementation in general practice, while the lack of referral services for people at risk of developing vascular disease threatens maintenance of lifestyle changes as few respondents thought patients would continue lifestyle changes without long-term follow up. Lifestyle modification programs to prevent vascular disease are feasible in general practice but must be provided in a flexible format, such as being offered out of hours to facilitate uptake, with ongoing support and follow up to assist maintenance. The newly formed Medicare Locals may have an important role in facilitating lifestyle modification programs for this target group.

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