Chinese pediatric Tuina on children with acute diarrhea: a randomized sham-controlled trial

Abstract Background Pediatric Tuina has been widely used in children with acute diarrhea in China. However, due to the lack of high-quality clinical evidence, the benefit of Tuina as a therapy is not clear. We aimed to assess the effect of pediatric Tuina compared with sham Tuina as an add-on therapy in addition to usual care for 0–6-year-old children with acute diarrhea. Methods Eighty-six participants aged 0–6 years with acute diarrhea were randomized to receive pediatric Tuina plus usual care (n = 43) or sham Tuina plus usual care (n = 43). The primary outcomes were days of diarrhea from baseline and times of diarrhea on day 3. Secondary outcomes included a global change rating (GCR) and the number of days when the stool characteristics returned to normal. Adverse events were assessed. Results Pediatric Tuina was associated with a reduction in times of diarrhea on day 3 compared with sham Tuina in both ITT (crude RR, 0.73 [95% CI, 0.59–0.91]) and PP analyses (crude RR, 0.66 [95% CI, 0.53–0.83]). However, the results were not significant when we adjusted for social demographic and clinical characteristics. No significant difference was found between groups in days of diarrhea, global change rating, or number of days when the stool characteristics returned to normal. Conclusions In children aged 0–6 years with acute diarrhea, pediatric Tuina showed significant effects in terms of reducing times of diarrhea compared with sham Tuina. Studies with larger sample sizes and adjusted trial designs are warranted to further evaluate the effect of pediatric Tuina therapy. Trial registration Clinicaltrials.gov, Identifier: NCT03005821, Data of registration: 2016-12-29.

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A double-blind placebo-controlled trial of perioperative prophylactic antibiotics for elective neurosurgery

Journal of Neurosurgery ◽

10.3171/jns.1988.69.5.0687 ◽

1988 ◽

Vol 69 (5) ◽

pp. 687-691 ◽

Cited By ~ 73

Author(s):

Ross Bullock ◽

James R. van Dellen ◽

William Ketelbey ◽

S. Gustav Reinach

Keyword(s):

Controlled Trial ◽

Prophylactic Antibiotics ◽

Risk Of Infection ◽

Broad Spectrum Antibiotic ◽

Wound Sepsis ◽

Double Blind ◽

Content Type ◽

Exact Test ◽

Significant Difference ◽

To Receive

✓ In this study, 417 patients undergoing “clean” elective neurosurgical operative procedures were randomized to receive a broad-spectrum antibiotic (piperacillin) or placebo given as three perioperative doses, each 6 hours apart. Randomization was carried out by hospital pharmacists, and the investigators remained blinded until the end of the study. Twenty cases were excluded from analysis because either an unforeseen second operation was performed or antibiotic therapy was initiated within 30 days after surgery to treat infection or the risk of infection. Twelve of the 205 patients treated with placebo developed postoperative wound sepsis, and four of the 192 piperacillin-treated patients developed wound sepsis — a statistically significant difference (p < 0.05, Fisher's exact test). Piperacillin thus appeared to reduce the incidence of neurosurgical wound infection in this study.

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Aspirin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

10.1101/2021.06.08.21258132 ◽

2021 ◽

Author(s):

Peter W Horby ◽

Guilherme Pessoa-Amorim ◽

Natalie Staplin ◽

Jonathan R Emberson ◽

Enti Spata ◽

...

Keyword(s):

Mechanical Ventilation ◽

Usual Care ◽

Rate Ratio ◽

Invasive Mechanical Ventilation ◽

Standard Of Care ◽

Open Label ◽

Absolute Increase ◽

Significant Difference ◽

Randomised Controlled ◽

To Receive

Background: Aspirin has been proposed as a treatment for COVID-19 on the basis of its antithrombotic properties. Methods: In this randomised, controlled, open-label trial, several possible treatments were compared with usual care in patients hospitalised with COVID-19. Eligible and consenting adults were randomly allocated in a 1:1 ratio to either usual standard of care alone or usual standard of care plus 150mg aspirin once daily until discharge using web-based simple (unstratified) randomisation with allocation concealment. The primary outcome was 28-day mortality. The trial is registered with ISRCTN (50189673) and clinicaltrials.gov (NCT04381936). Findings: Between 01 November 2020 and 21 March 2021, 7351 patients were randomly allocated to receive aspirin and 7541 patients to receive usual care alone. Overall, 1222 (17%) patients allocated to aspirin and 1299 (17%) patients allocated to usual care died within 28 days (rate ratio 0.96; 95% confidence interval [CI] 0.89-1.04; p=0.35). Consistent results were seen in all pre-specified subgroups of patients. Patients allocated to aspirin had a slightly shorter duration of hospitalisation (median 8 days vs. 9 days) and a higher proportion were discharged from hospital alive within 28 days (75% vs. 74%; rate ratio 1.06; 95% CI 1.02-1.10; p=0.0062). Among those not on invasive mechanical ventilation at baseline, there was no significant difference in the proportion meeting the composite endpoint of invasive mechanical ventilation or death (21% vs. 22%; risk ratio 0.96; 95% CI 0.90-1.03; p=0.23). Aspirin use was associated with an absolute reduction in thrombotic events of 0.6% (SE 0.4%) and an absolute increase in clinically significant bleeding of 0.6% (SE 0.2%). Interpretation: In patients hospitalised with COVID-19, aspirin was not associated with reductions in 28-day mortality or in the risk of progressing to invasive mechanical ventilation or death but was associated with a small increase in the rate of being discharged alive.

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Problem-solving therapy for people who present to hospital with self-harm: Zelen randomised controlled trial

The British Journal of Psychiatry ◽

10.1192/bjp.bp.110.090126 ◽

2011 ◽

Vol 199 (4) ◽

pp. 310-316 ◽

Cited By ~ 35

Author(s):

Simon Hatcher ◽

Cynthia Sharon ◽

Varsha Parag ◽

Nicola Collins

Keyword(s):

Problem Solving ◽

Randomised Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Effective Intervention ◽

Number Needed To Treat ◽

Problem Solving Therapy ◽

Significant Difference ◽

Self Harm ◽

Randomised Controlled

BackgroundPresentations to hospital with self-harm are common, associated with suicide and have an increased mortality, yet there is no accepted effective intervention.AimsTo investigate whether problem-solving therapy would improve outcomes in adults presenting to hospital with self-harm, compared with usual care.MethodA Zelen randomised controlled trial was conducted in four district health boards in New Zealand. A second hospital presentation with self-harm at 1 year for all episodes, plus separate comparisons of first-time and repeat presentations at the index episode, were the a priori primary outcomes. The trial registration number was ACTRN12605000337673.ResultsIn an intention-to-treat analysis of all randomised patients (n = 1094) there was no significant difference at 12 months in the proportion of people who had presented again with self-harm when comparing all episodes (intervention 13.4%, usual care 14.1%; relative risk reduction RR = 0.05, 95% CI −0.28 to 0.30, P = 0.79) or where the index episode was the first episode (intervention 13.4%, usual care 9.4%, RR =–0.42, 95% CI −1.17 to 0.08, P = 0.37). Where the index episode was repeated self-harm, those who received therapy were less likely to present again with self-harm (intervention 13.5%, usual care 22.1%, RR = 0.39, 95% CI 0.07 to 0.60, number needed to treat 12, P = 0.03).ConclusionsProblem-solving therapy is not recommended for everyone who presents to hospital with self-harm. Among adults with a history of self-harm it may be an effective intervention.

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EMDR Individual Protocol for Paraprofessional Use: A Randomized Controlled Trial With First Responders

Journal of EMDR Practice and Research ◽

10.1891/1933-3196.7.2.55 ◽

2013 ◽

Vol 7 (2) ◽

pp. 55-64 ◽

Cited By ~ 16

Author(s):

Ignacio Jarero ◽

Carolina Amaya ◽

Martha Givaudan ◽

Alaide Miranda

Keyword(s):

Controlled Trial ◽

First Responders ◽

Global Improvement ◽

Randomized Controlled ◽

Posttraumatic Symptoms ◽

Significant Difference ◽

To Receive ◽

Nonsignificant Decrease ◽

Supportive Counseling

The eye movement desensitization and reprocessing (EMDR) individual protocol for paraprofessional use in acute trauma situations (EMDR-PROPARA) is part of a project developed at the initiative of Dr. Francine Shapiro. This randomized clinical trial examined the effectiveness of the protocol administered by experienced EMDR therapists. There were 39 traumatized first responders on active duty randomly assigned to receive two 90-min sessions of either EMDR-PROPARA or of supportive counseling. Participants in the EMDR-PROPARA group showed benefits immediately after treatment, with their scores on the Short PTSD Rating Interview (SPRINT) showing further decreases at 3-month follow-up. In comparison, supportive counseling participants experienced a nonsignificant decrease after treatment and an increase in the SPRINT scores at the second follow-up. The significant difference between the two treatments provides preliminary support for EMDR-PROPARA’s effectiveness in reducing severity of posttraumatic symptoms and subjective global improvement. More controlled research is recommended to evaluate further the efficacy of this intervention.

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Chinese pediatric Tuina on children with acute diarrhea: study protocol for a randomized sham-controlled trial

Trials ◽

10.1186/s13063-019-3818-1 ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 1

Author(s):

Taoying Lu ◽

Huiyan Zhang ◽

Lingjia Yin ◽

Jianxiong Cai ◽

Meiling Li ◽

...

Keyword(s):

Outcome Measures ◽

Acute Diarrhea ◽

Controlled Trial ◽

Secondary Outcome ◽

Control Group ◽

Double Blind ◽

Pediatric Tuina ◽

Therapeutic Benefits ◽

Appropriate Treatment ◽

Traditional Chinese Medicine Therapy

Abstract Background Acute pediatric diarrhea is one of the most common causes of morbidity and mortality worldwide and seriously affects the health of children. Previous studies have shown that pediatric Tuina, a traditional Chinese medicine therapy, has potential therapeutic benefits for acute pediatric diarrhea. However, the evidence for its effectiveness is insufficient due to the lack of high-quality clinical studies. Our aim is to evaluate the efficacy of Chinese pediatric Tuina for children aged 0–6 years with acute diarrhea. Methods/design This study is a randomized, double-blind, sham-controlled trial. We will include 122 children with acute diarrhea from Dongguan Kanghua Hospital in Guangdong province, China. The patients will be allocated into either the pediatric Tuina group or the sham Tuina group in a 1:1 ratio. The treatment will last for 3 days followed by an 11-day follow-up period. Both groups will receive usual care. In addition, the experimental group will receive 15–25 min of Chinese pediatric Tuina, while the control group will receive 15–25 min of sham pediatric Tuina. Both groups will receive treatments once per day, for 3 consecutive days. Primary outcome measures are diarrhea days from baseline and diarrhea times on the third day. Secondary outcome measures are the global change rating and period of days when the stool character changes to normal. Safety assessments will be monitored during each visit. Discussion This clinical trial is designed to evaluate the efficacy of pediatric Tuina for children with acute diarrhea. We expect results to provide solid evidence and support for pediatric Tuina as an appropriate treatment for children with acute diarrhea. Trial registration ClinicalTrials.gov, NCT03005821. Registered on 29 December 2016.

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Post-tonsillectomy analgesia: The use of benzocaine lozenges

The Journal of Laryngology & Otology ◽

10.1017/s002221510010653x ◽

1988 ◽

Vol 102 (9) ◽

pp. 813-814 ◽

Cited By ~ 21

Author(s):

J. H. Dempster

Keyword(s):

Clinical Trials ◽

Analogue Scale ◽

Controlled Trial ◽

Adult Population ◽

Significant Degree ◽

Conventional Management ◽

Post Operative Pain ◽

Significant Difference ◽

To Receive ◽

Oral Analgesia

AbstractTonsillectomy frequently results in a significant degree of post-operative pain. Conventional management consists of the administration of intra-muscular opiates prior to the commencement of oral analgesia and is often inadequate, producing variable levels of pain relief.One of the recommended uses of benzocaine lozenges is the relief of throat discomfort following tonsillectomy, but there are no clinical trials to support this claim. Therefore, a prospective placebo controlled trial was undertaken to compare the efficacy of benzocaine lozenges (10 mg.) with standard oral analgesia in the management of post-operative pain following tonsillectomy in an adult population.Consecutive patients undergoing elective tonsillectomy were randomised to receive either benzocaine lozenges (10 mg.) or placebo. Intake of supplementary oral analgesia was recorded, and the level of postoperative pain was assessed by use of a visual linear analogue scale. There was no significant difference in analgesic intake or pain severity as measured by linear analogue between the two groups.These results suggest that there is no benefit in administering benzocaine lozenges for the relief of post-tonsillectomy pain, and its use in this situation cannot be recommended.

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Colchicine in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

10.1101/2021.05.18.21257267 ◽

2021 ◽

Author(s):

Peter W Horby ◽

Mark Campbell ◽

Enti Spata ◽

Jonathan R Emberson ◽

Natalie Staplin ◽

...

Keyword(s):

Mechanical Ventilation ◽

Usual Care ◽

Rate Ratio ◽

Invasive Mechanical Ventilation ◽

Composite Endpoint ◽

Standard Of Care ◽

Open Label ◽

Significant Difference ◽

Randomised Controlled ◽

To Receive

Background: Colchicine has been proposed as a treatment for COVID-19 on the basis of its anti-inflammatory actions. Methods: In this randomised, controlled, open-label trial, several possible treatments were compared with usual care in patients hospitalised with COVID-19. Eligible and consenting adults were randomly allocated in a 1:1 ratio to either usual standard of care alone or usual standard of care plus colchicine twice daily for 10 days or until discharge (or one of the other treatment arms) using web-based simple (unstratified) randomisation with allocation concealment. The primary outcome was 28-day mortality. The trial is registered with ISRCTN (50189673) and clinicaltrials.gov (NCT04381936). Findings: Between 27 November 2020 and 4 March 2021, 5610 patients were randomly allocated to receive colchicine and 5730 patients to receive usual care alone. Overall, 1173 (21%) patients allocated to colchicine and 1190 (21%) patients allocated to usual care died within 28 days (rate ratio 1.01; 95% confidence interval [CI] 0.93-1.10; p=0.77). Consistent results were seen in all pre-specified subgroups of patients. There was no significant difference in duration of hospitalisation (median 10 days vs. 10 days) or the proportion of patients discharged from hospital alive within 28 days (70% vs. 70%; rate ratio 0.98; 95% CI 0.94-1.03; p=0.44). Among those not on invasive mechanical ventilation at baseline, there was no significant difference in the proportion meeting the composite endpoint of invasive mechanical ventilation or death (25% vs. 25%; risk ratio 1.02; 95% CI 0.96-1.09; p=0.47). Interpretation: In adults hospitalised with COVID-19, colchicine was not associated with reductions in 28-day mortality, duration of hospital stay, or risk of progressing to invasive mechanical ventilation or death.

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The short-term impact of 3 smoked cannabis preparations versus placebo on PTSD symptoms: A randomized cross-over clinical trial

PLoS ONE ◽

10.1371/journal.pone.0246990 ◽

2021 ◽

Vol 16 (3) ◽

pp. e0246990

Author(s):

Marcel O. Bonn-Miller ◽

Sue Sisley ◽

Paula Riggs ◽

Berra Yazar-Klosinski ◽

Julie B. Wang ◽

...

Keyword(s):

Active Treatment ◽

Symptom Severity ◽

Ptsd Symptom ◽

Controlled Trial ◽

Military Veterans ◽

Ptsd Symptoms ◽

Significant Difference ◽

Ptsd Symptom Severity ◽

Stage 1 ◽

To Receive

Importance There is a pressing need for development of novel pharmacology for the treatment of Posttraumatic Stress Disorder (PTSD). Given increasing use of medical cannabis among US military veterans to self-treat PTSD, there is strong public interest in whether cannabis may be a safe and effective treatment for PTSD. Objective The aim of the present study was to collect preliminary data on the safety and potential efficacy of three active concentrations of smoked cannabis (i.e., High THC = approximately 12% THC and < 0.05% CBD; High CBD = 11% CBD and 0.50% THC; THC+CBD = approximately 7.9% THC and 8.1% CBD, and placebo = < 0.03% THC and < 0.01% CBD) compared to placebo in the treatment of PTSD among military veterans. Methods The study used a double-blind, cross-over design, where participants were randomly assigned to receive three weeks of either active treatment or placebo in Stage 1 (N = 80), and then were re-randomized after a 2-week washout period to receive one of the other three active treatments in Stage 2 (N = 74). The primary outcome measure was change in PTSD symptom severity from baseline to end of treatment in Stage 1. Results The study did not find a significant difference in change in PTSD symptom severity between the active cannabis concentrations and placebo by the end of Stage 1. All three active concentrations of smoked cannabis were generally well tolerated. Conclusions and relevance The present study is the first randomized placebo-controlled trial of smoked cannabis for PTSD. All treatment groups, including placebo, showed good tolerability and significant improvements in PTSD symptoms during three weeks of treatment, but no active treatment statistically outperformed placebo in this brief, preliminary trial. Additional well-controlled and adequately powered studies with cannabis suitable for FDA drug development are needed to determine whether smoked cannabis improves symptoms of PTSD. Trial registration Identifier: NCT02759185; ClinicalTrials.gov.

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Comparison of azithromycin vs doxycycline prophylaxis in leptospirosis, A randomized double blind placebo-controlled trial

The Journal of Infection in Developing Countries ◽

10.3855/jidc.10126 ◽

2018 ◽

Vol 12 (11) ◽

pp. 991-995

Author(s):

Ahmad Alikhani ◽

Ebrahim Salehifar ◽

Fatemeh Zameni ◽

Alireza Rafiei ◽

Jamshid Yazdani-charati ◽

...

Keyword(s):

Paddy Field ◽

Controlled Trial ◽

Fisher Exact Test ◽

Mazandaran Province ◽

Double Blind ◽

Double Blind Placebo ◽

Informed Consent Form ◽

Significant Difference ◽

Field Workers ◽

To Receive

Introduction: Leptospirosis is an important zoonotic disease in paddy field with 29.5% prevalence rate in Mazandaran province and 4% to 52% mortality rate among hospitalized patients. Prevention is an important strategy for the control of this disease. This study aimed to compare the prophylactic effect of azithromycin versus doxycycline against leptospirosis in an endemic area in north of Iran. Methodology: In this randomized double-blind placebo-controlled trial, paddy field workers (n = 187) were randomized to receive azithromycin (500mg weekly), doxycycline (200 mg weekly) or placebo starting one week before exposure to paddy field, during and to four weeks after. Paddy field workers aged 18- 65 years who signed the informed consent form were assessed for signs and symptoms of leptospirosis in addition to serologic evidence of the disease 6th and 12th week. Data were analyzed with SPSS version 13 using Chi-square and Fisher exact test and ANOVA. Results: From June to September 2016, 187 participants were entered the study to receive azithromycin (n = 66), doxycycline (n = 71) or placebo (n = 50). In terms of preventing against clinical leptospirosis, there was not any significant difference between three arms, though there was statistically significant difference of seropositivity after 6 and 12 weeks in comparison to baseline among all three groups (P = 0.029) and between active treatment (eg. azithromycin and doxycycline) groups and placebo group (P = 0.01). Conclusion: Azithromycin like doxycycline decreased seropositivity without significant effect on clinical leptospirosis.

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The Effect of Multimedia Message Reminders on Oral Hygiene Promotion during Removable Orthodontic Treatment

10.21203/rs.3.rs-45868/v1 ◽

2020 ◽

Author(s):

Tahereh Baherimoghadam ◽

Navid Naseri ◽

Maliheh Mokhtar ◽

Shahram Hamedani

Keyword(s):

Oral Hygiene ◽

Orthodontic Treatment ◽

Controlled Trial ◽

Control Group ◽

Orthodontic Appliances ◽

Significant Difference ◽

Tooth Surfaces ◽

Age Range ◽

To Receive ◽

Trial Participants

Abstract Background Orthodontic appliances complicate daily oral hygiene maintenance and enhance the formation of microbial biofilm on tooth surfaces and orthodontic appliances. Any tool that enhances the oral hygiene of patients during orthodontic treatment would be of imperative beneficial. This trial was conducted to assess the effect of message reminders on oral hygiene of patients during removable orthodontic treatment.Methods In this 2-arm parallel randomized controlled trial, participants were randomly allocated to two groups; one receiving messages reminder and one as the control group. The patients in the messaging group received one or two message reminders and educational videos weekly during the course of treatment. The patients with removable maxillary appliance who were in the age range of 8 to 12 years old and had daily access to Internet to receive message reminders were recruited in this study. A single blinded examiner measured the plaque index (PI), gingival index (GI) and dental caries index of patients in both groups at baseline (T0) and one (T1), three (T2) and six (T3) months after the first day of treatment to assess their oral hygiene status during the course of treatment in both groups.Results A total of 50 patients were enrolled and randomized to two even groups (n = 25) but only 46 patients completed the study; 22 in control group, and 24 in message reminder group. The PI and GI scores were increased neither in control group nor in message reminder group during T0 and T1, significantly. The PI and GI scores in message reminder group were significantly lower than those in the control group at T2 (PI: P = 0.003, GI: P = 0.001) and T3 (PI: P = 0.044, GI: P = 0.012). However, slight significant increasing in the PI and GI score were found during T2 and T3 during in message reminder group. Caries index showed no significant difference between two group during study.Conclusion It seems that message reminders can efficiently promote oral hygiene of patients undergoing removable orthodontic treatment. Although, this promotion wasn’t progressive.Trial registration: Iranian Registry of Clinical Trials (IRCT), IRCT20180923041092N2. Registered 25 July 2020 - Retrospectively registered, https://www.irct.ir/user/trial/47612.

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