Are Most of the Published Clinical Trial Results in Restorative Dentistry Invalid? An Empirical Investigation

2020 ◽  
Vol 15 (2) ◽  
pp. 122-130
Author(s):  
Steffen Mickenautsch
Keyword(s):  
Clinical Trial ◽  
Treatment Group ◽  
Sample Size ◽  
Controlled Clinical Trial ◽  
Restorative Dentistry ◽  
Trial Methodology ◽  
Trial Report ◽  
Hand Search ◽  
Inadequate Sample Size ◽  
Clinical Trial Results

Background: To establish the number of invalid clinical trial reports in restorative dentistry, due to lack of effective randomisation and/or inadequate sample size and whether this number changed, during the 1990-2019 period. Methods: Databases were searched up to 14 July 2019 without limitations regarding publication language. A Journal hand search and reference check were conducted for trial reports. Selection criteria were: reporting on a prospective, controlled clinical trial; relevance to placing direct tooth restorations in human vital teeth; direct comparison between restorative materials concerning tooth restoration longevity; trial report published from 1990. Randomisation reported (Yes/No) and treatment group sample size ≥ 200 were applied as criteria, using the deductive falsification approach for trial report appraisal. Results: 683 trial reports were appraised. 660 lacked effective randomisation. Of the remaining 23 reports, only 2 included a sample size of more than 200 restored teeth (mean number per treatment group 87; Standard deviation = 108.51). 92.5% of all treatment groups had a sample size of < 200. Randomisation reporting increased and sample size remained essentially unchanged between 1990 and 2019. Conclusion: Most of the published clinical trial results in restorative dentistry were judged invalid, due to lack of effective randomisation and adequate sample size. These results are in line with previous findings. Evidence-based recommendations on how to improve trial methodology are available in the dental/medical literature.

scholarly journals Assessment of boron-containing compounds and oleoylethanolamide supplementation on the recovery trend in patients with COVID-19: A structured summary of a study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Helda Tutunchi ◽  
Majid Mobasseri ◽  
Samira Pourmoradian ◽  
Hamid Soleimanzadeh ◽  
Behnam Kafil ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sample Size ◽  
Complete Blood Count ◽  
Controlled Clinical Trial ◽  
Medical Sciences ◽  
Boron Compounds ◽  
Double Blind ◽  
Link Type ◽  
Nutrition Research ◽  
Full Protocol

Abstract Objectives In this study, we investigate the effect of boron-containing compounds and oleoylethanolamide supplementation on the recovery trend in patients with COVID-19. Trial design The current study is a single-center, randomized, double-blind, placebo-controlled clinical trial with parallel groups. Participants The inclusion criteria include male and female patients≥18 years of age, with a confirmed diagnosis of SARS-CoV-2 infection via polymerase chain reaction (PCR) and/or antibody test and with written informed consent to participate in this trial. The exclusion criteria include regular use of any other supplement, severe and critical COVID-19 pneumonia, pregnancy and breastfeeding. This study is being conducted at Imam Reza Hospital, Tabriz University of Medical Sciences, Tabriz, Iran. Intervention and comparator Patients are randomly assigned to four groups. The first group (A) will take one capsule containing 5 mg of boron compounds twice a day for two weeks. The second group (B) will take one capsule containing 200 mg oleoylethanolamide twice a day for two weeks. The third group (C) will take one capsule containing 5 mg boron compounds with 200 mg oleoylethanolamide twice a day for two weeks, and the fourth group (D) does not receive any additional treatment other than routine treatments. Boron-containing compounds and oleoylethanolamide capsules will be synthesized at Nutrition Research Center of Tabriz University of Medical Sciences. Main outcomes The primary end point of this study is to investigate the recovery rate of clinical symptoms, including fever, dry cough, and fatigue, as well as preclinical features, including complete blood count (CBC), the erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) profiles within two weeks of randomization. Randomisation Patients are randomized into four equal groups in a parallel design (allocation ratio 1:1). A randomized block procedure is used to divide subjects into one of four treatment blocks (A, B, C, and D) by a computer-generated allocation schedule. Blinding (masking) The participants and investigators (enrolling, assessing, and analyzing) are blinded to the intervention assignments until the end of the study and data analysis. Numbers to be randomised (sample size) The calculated total sample size is 40 patients, with 10 patients in each group. Trial Status The protocol is Version 1.0, May 17, 2020. Recruitment began May 19, 2020, and is anticipated to be completed by October 19, 2020. Trial registration This clinical trial has been registered by the title of “Assessment of boron-containing compounds and oleoylethanolamide supplementation on the recovery trend in Patients with COVID-19: A double-blind randomized placebo-controlled clinical trial” in the Iranian Registry of Clinical Trials (IRCT). The registration number is “IRCT20090609002017N35”, https://www.irct.ir/trial/48058. The registration date is 17 May 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Effect of Acupuncture in the Treatment of Seasonal Allergic Rhinitis: A Randomized Controlled Clinical Trial

2002 ◽  
Vol 30 (01) ◽  
pp. 1-11 ◽  
Author(s):  
Charlie Changli Xue ◽  
Robert English ◽  
Jerry Jiansheng Zhang ◽  
Cliff Da Costa ◽  
Chun Guang Li
Keyword(s):  
Clinical Trial ◽  
Allergic Rhinitis ◽  
Treatment Group ◽  
Seasonal Allergic Rhinitis ◽  
Acupuncture Treatment ◽  
Sham Acupuncture ◽  
Syndrome Differentiation ◽  
Controlled Clinical Trial ◽  
Safe Alternative ◽  
Real Acupuncture

The clinical efficacy and safety of acupuncture in the treatment of Seasonal Allergic Rhinitis (SAR) was evaluated by employing a two-phase crossover single-blind clinical trial. Thirty subjects were randomly assigned to two groups with 17 and 13 subjects respectively and treated with real or sham acupuncture (three times per week) for four consecutive weeks and then a crossover for treatments for a further four weeks without a washout period. The administration of real acupuncture treatment was guided by a syndrome differentiation according to Chinese Medicine Theory. Subjects were assessed by various criteria before, during and after the treatments. Outcome measures included subjective symptom scores using a five-point scale (FPS), relief medication scores (RMS) and adverse effect records. Twenty-six (26) subjects completed the study. There was a significant improvement in FPS (nasal and non-nasal symptoms) between the two types of acupuncture treatments. No significant differences were shown in RMS between the real acupuncture treatment group and the sham acupuncture treatment group. No side effects were observed for both groups. The results indicate that acupuncture is an effective and safe alternative treatment for the management of SAR.

scholarly journals Bayesian interpretation of p values in clinical trials

2021 ◽  
pp. bmjebm-2020-111603
Author(s):  
John Ferguson
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Sample Size ◽  
Confidence Intervals ◽  
Statistical Significance ◽  
Large Sample Size ◽  
P Values ◽  
Clinical Trial Results ◽  
Sound Treatment ◽  
Counterintuitive Result

Commonly accepted statistical advice dictates that large-sample size and highly powered clinical trials generate more reliable evidence than trials with smaller sample sizes. This advice is generally sound: treatment effect estimates from larger trials tend to be more accurate, as witnessed by tighter confidence intervals in addition to reduced publication biases. Consider then two clinical trials testing the same treatment which result in the same p values, the trials being identical apart from differences in sample size. Assuming statistical significance, one might at first suspect that the larger trial offers stronger evidence that the treatment in question is truly effective. Yet, often precisely the opposite will be true. Here, we illustrate and explain this somewhat counterintuitive result and suggest some ramifications regarding interpretation and analysis of clinical trial results.

scholarly journals Safety and Efficacy of MLC601 in Iranian Patients after Stroke: A Double-Blind, Placebo-Controlled Clinical Trial

2011 ◽  
Vol 2011 ◽  
pp. 1-5 ◽  
Author(s):  
A. A. Harandi ◽  
R. Abolfazli ◽  
A. Hatemian ◽  
K. Ghragozlee ◽  
M. Ghaffar-Pour ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Ischemic Stroke ◽  
Treatment Group ◽  
Repeated Measures ◽  
Motor Recovery ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Stroke Treatment ◽  
Double Blind Placebo

Objective. To investigate the safety and efficacy of MLC601 (NeuroAid) as a traditional Chinese medicine on motor recovery after ischemic stroke.Methods. This study was a double-blind, placebo-controlled clinical trial on 150 patients with a recent (less than 1 month) ischemic stroke. All patients were given either MLC601 (100 patients) or placebo (50 patients), 4 capsules 3 times a day, as an add-on to standard stroke treatment for 3 months.Results. Sex, age, elapsed time from stroke onset, and risk factors in the treatment group were not significantly different from placebo group at baseline (P>.05). Repeated measures analysis showed that Fugl-Meyer assessment was significantly higher in the treatment group during 12 weeks after stroke (P<.001). Good tolerability to treatment was shown, and adverse events were mild and transient.Conclusion. MLC601 showed better motor recovery than placebo and was safe on top of standard ischemic stroke medications especially in the severe and moderate cases.

scholarly journals Efficacy of microcurrent therapy for treatment of acute knee pain: A randomized double-blinded controlled clinical trial

2020 ◽  
pp. 026921552096532
Author(s):  
Daryl Lawson ◽  
Kevin H Lee ◽  
Hyun Bin Kang ◽  
Nan Yang ◽  
Tracy Llewellyn ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Treatment Group ◽  
Knee Pain ◽  
Rating Scale ◽  
Short Form ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Physical Function Score ◽  
Double Blinded ◽  
Acute Knee

Objective: We would like to determine whether electrotherapy, specifically microcurrent therapy, increases function and decreases pain in people who have acute knee pain. Design: Randomized, double-blinded, placebo-controlled clinical trial. Setting: University laboratory and patient home. Subjects: A total of 52 subjects (35 females and 17 males) with acute knee pain. Intervention: Treatment group ( n = 26) wore the active microcurrent therapy device at home for 3 hours per day for 4 weeks and the control group ( n = 26) wore the placebo for 3 hours per day for 4 weeks. Main Measures: Numeric Pain Rating Scale (NPRS) and Short Form 12 (SF-12) health scale were used to measure the pain level and the functionality of the participants. Secondary assessments included musculoskeletal ultrasound imaging (MSK US) and Lower Extremity Functional Scale (LEFS). Results: A total of 52 subjects completed the study; 26 in the treatment group and 26 in the control group. Microcurrent therapy significantly reduced pain over 4 weeks. Especially week three was significant ( P < 0.01) after adjusting for the family-wise error rate. The analysis on SF-12 revealed those with microcurrent therapy showed an increasing trend in the improvement of physical function score until week three. Conclusion: An active microcurrent therapy device decreased knee pain and increased function. Microcurrent therapy may be an alternative or used with a pharmacological approach for people with acute knee pain.

scholarly journals Effectivity of Esomeprazole Compared with Lansoprazole in the Treatment of Pediatric with Gastritis

2021 ◽  
Vol 9 (B) ◽  
pp. 1424-1427
Author(s):  
Fini Kollins ◽  
Supriatmo Supriatmo ◽  
Rina Saragih ◽  
Ilhamd Ilhamd
Keyword(s):  
Clinical Trial ◽  
Abdominal Pain ◽  
Treatment Group ◽  
Pediatric Patients ◽  
Controlled Clinical Trial ◽  
P Value ◽  
Test Results ◽  
Initial Symptoms ◽  
Significant Difference ◽  
Single Blind

BACKGROUND: The administration of proton pump inhibitor (PPI) therapy in pediatric patients has also increased dramatically during the last three decades. Clinical trials comparison of esomeprazole and lansoprazole for pediatric were limited. AIM: This study focused on comparing the effectivity of Esomeprazole with lansoprazole for healing gastritis symptoms in pediatric patients. METHODS: A randomized and single blind (assessors) controlled clinical trial was done at H. Adam Malik hospital at Medan. Patients that complied with study’s criteria and signed informed consent were collected information about the symptoms. Confirmation diagnosis of g astritis by gastroscopy, then randomized into lansoprazole treatment group (15 mg if < 30 kg and 30 mg if > 30 kg) or esomeprazole treatment group (0,4–0,8 mg per Kg body weight). Medication for both groups will be given orally for 14 day s, then evaluated for the initial symptoms. p -value of this study was calculated with the χ2 test. RESULTS: Fifty two patients confirmed gastritis were enrolled in this study; 27 patients received lansoprazole and 25 patients received esomeprazole. There was no difference of effectivity between the two groups for vomiting, hematemesis, and nausea. Lansoprazole treatment for 14 days has a significant difference for abdominal pain recovery from esomeprazole treatment. The lansoprazole groups have 92% free of abdominal pain compared to the esomeprazole group for only 66% free of abdominal pain. CONCLUSION: There was no significant difference between lansoprazole and esomeprazole therapy.

scholarly journals Efficacy and Safety of Ayurveda Intervention AYUSH 64 as add-on therapy for patients with COVID 19 infections: An open labelled, Parallel Group, Randomized controlled clinical trial

2021 ◽  
Author(s):  
Pankaj Bhardwaj ◽  
Pawan Kumar Godatwar ◽  
Jaykaran Charan ◽  
Sanjeev Sharma ◽  
Shazia Shafi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sample Size ◽  
Standard Treatment ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Randomized Controlled Clinical Trial ◽  
Rt Pcr ◽  
Randomized Controlled ◽  
Parallel Group

COVID-19 pandemic impacted human health and the global economy. There is a huge uncertainty about the management of this disease, many drugs including some older drugs are being tested for efficacy and safety including the medicines from the complementary and alternative system. The Central Council for Research in Ayurvedic Sciences, India's apex body for Ayurvedic research and development under the Ministry of AYUSH, has developed a poly-herbal drug called AYUSH 64 for covid 19 which is considered to be having role in the COVID-19. This study was designed with the aim of assessing the efficacy and safety of AYUSH 64 in mild covid-19 patients as add on therapy with standard treatment. It was an open labelled, comparative, parallel group, Randomized controlled clinical trial. Total 60 stage I (mild) COVID 19 positive subjects were recruited, 30 were assigned to AYUSH 64 as an add on therapy along with the standard treatment and 30 were assigned to standard treatment as per the protocols. RT-PCR test was done as per government guidelines and protocol. Along with the RT-PCR clinical laboratory tests were also performed at screening as well as on the discharge as per the study schedule. Absolute events of negative RT-PCR at day 5 were more in the AYUSH 64 group as compared to control group but it was not statistically significant (70% Vs 54%, p=0.28). There was no significant difference between AYUSH 64 and control group for fever and respiratory symptoms or important lab parameters. No serious adverse event was reported from any group. AYUSH 64 has no significant beneficial effect as compared to control group, this may be because of the less sample size or no actual effect which need to be confirmed by studies with large sample size.

scholarly journals The effect of blue and pink lotus flower extract on acne vulgaris: A randomized double-blind clinical trial

2021 ◽  
Author(s):  
Anna Gordon
Keyword(s):  
Clinical Trial ◽  
Treatment Group ◽  
Side Effect ◽  
Acne Vulgaris ◽  
Treated Group ◽  
Small Sample ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Flower Extract ◽  
Lotus Flower

Background:Acne vulgaris is one of the leading ubiquitous diseases around the world. It is a multifactorial diseasewhich does not threaten life but has serious psychological effects on patients. Patients with moderate tosevere acne have been suggested to have poor body image, poor self-esteem, and social isolation andactivity constraints. Increased levels of anxiety, anger, depression and frustration are also observed inpatients with acne as part of the emotional impact.Research gap:More research on anti-acne treatments is necessary for two reasons. First, the prevalence of acneincidence is high and the effect on the quality of life is profound. Second, there is, according to thenumerous studies, a lack of ant-acne treatments that have less side effect. The use of medicinal plantsand particularly blue and pink lotus flower extract, with its autoinflammatory effect, could bepromising. The blue and pink lotus flower extract is suggested to reduces the activity of sebumoverproduction and helps to balance sebum secretion.Objective:The objective of this study was to examine the medical efficacy of blue and pink lotus flower extract inacne vulgaris.Method:In a randomized double-blind controlled clinical trial, 42 patients (21 patients in treatment and 21 inplacebo group) were randomly received ‘’Nymphaea Caerulea Flower Extract, Nelumbo NuciferaFlower’’ and placebo extract, twice daily for 1 month. We recorded he Investigator's GlobalAssessment (IGA) grading score for each participant. In addition, we evaluated the Acne disabilityindex (ADI) utilizing a standard questionnaire filled out by the participants at the beginning and at theend of the study.Results:The results indicated a 76% mean reduction in the IGA score on the treated group. The mean reductionin the vehicle-treated group, on the other hand, was 4.2%. We also found that the number of comedones,papules, and pustules significantly reduced in the treatment group after 30 days. Additionally, the Acnedisability index (ADI) score decreased by 65.01 percent in treatment group, and only 5.6 percent in theplacebo group. The current study could not discover any significant side effect in both groups.Conclusion:The blue and pink lotus flower extract had significant effects on improving the symptoms of acnevulgaris. The results of this study, because of the small sample size, should however be interpreted withcaution. The future study on the medical efficacy of the mentioned extract should examine with largersamples.

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