No evidence of clinical efficacy of oxomemazine in cough, according to a systematic review.

PURPOSE: Cough is a prevalent symptom driving patients to seek medical attention in general practice. Despite its widespread use, the clinical efficacy of oxomemazine, the second most reimbursed molecule in France for symptomatic cough treatment, remains uncertain. This study aims to systematically evaluate the clinical efficacy of oxomemazine in cough. METHODS: A systematic literature review with meta-analysis of randomized controlled trials (RCTs) was conducted according to the Rebuild the Evidence Base (REB) protocol. Clinical trials comparing the efficacy of oxomemazine versus placebo or active comparator in cough were searched for. Trials with insufficient data were excluded. Searches were conducted across major databases (Medline, Cochrane Central Register of Controlled Trials, and Embase) and trial registries (World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov). RCTs comparing oxomemazine versus placebo or active comparators in cough were sought. Risk of bias was assessed using the Cochrane Collaboration's RoB2 tool. The protocol was preregistered on PROSPERO under the number CRD42022345496 (15). This study received no funding. RESULTS: No RCTs were at low risk of bias. Therefore, no meta-analysis was conducted, in accordance to the pre-specified protocol. CONCLUSIONS: This systematic review highlights the lack of evidence regarding the efficacy of oxomemazine in cough treatment and underscores the need for further well-designed clinical trials to inform its clinical utility in primary care settings.

A Rebuild the Evidence-Base-reading of cholinesterase inhibitors' effect on all-cause mortality in patients with dementia.

We propose a new reading of the results of a solid systematic review published in 2022 in Neurology by Truong et al. comparing cholinesterase inhibitors (ChEIs) treatment to placebo or no treatment on all-cause mortality in patients with any type of dementia. Leaving ethical considerations aside, we tested if another method of interpretation of the results of the systematic review would yield different results. We applied the "Rebuild the Evidence Base" method to the data extracted from the meta-analysis and found that the positive result of the meta-analysis (P = .01) and the lack of heterogeneity did not weigh enough in the balance against the strictly exploratory nature of all the results of the individual randomized controlled trials included and the suspected publication bias. There was a lack of evidence of effect of ChEI treatment on overall mortality in patients with dementia.

Project rebuild the evidence base (REB): A method to interpret randomised clinical trials and their meta-analysis to present solid benefit-risk assessments to patients.

Evidence-based medicine is the cornerstone of shared-decision making in healthcare today. The public deserves clear, transparent and trust-worthy information on drug efficacy. Yet today, many drugs are prescribed and used without solid evidence of efficacy. Clinical trials and randomised clinical trials (RCTs) are the best method to evaluate drug efficacy and side effects. In a shared medical decision-making approach, general practitioners need drug assessment based on patient-important outcomes. The aim of project rebuild the evidence base (REB) is to bridge the gap between the data needed in clinical practice and the data available from clinical research. The drugs will be assessed on clinical patient important outcomes and for a population. Using the Cochrane tools, we propose to analyse for each population and outcome: 1) a meta-analysis based on RCTs with a low risk of bias overall; 2) an evaluation of results of confirmatory RCTs; 3) a statistical analysis of heterrogeneity between RCTs and 4) an analysis of publication bias. Depending on the results of these analyses, the evidence will be categorized in 4 different levels: firm evidence, evidence (to be confirmed), signal or absence of evidence. Project REB proposes a method for reading and interpreting RCTs and their meta-analysis to produce quality data for general practitioners to focus on risk-benefit assessment in the interest of patients. If this data does not exist, it could enable clinical research to better its aim.

Familial colonoscopic screening: how do French general practitioners deal with patients and their high-risk relatives. A qualitative study.

BACKGROUND: Screening of colorectal cancer (CRC) can reduce incidence and mortality. First-degree relatives (FDRs) of patients with CRC or advanced adenoma before the age of 65 (index patients) are at increased risk of CRC; however, the guidelines for screening of FDRs by colonoscopy are poorly followed. OBJECTIVES: The present study, conducted in the context of the COLOR3 interventional study project, aimed to explore the positioning of general practitioners (GPs) in familial CRC screening in France. METHODS: From February 2020 to April 2021, 35 semi-structured interviews with GPs of index patients and/or their FDRs were conducted by telephone. The full-data transcribed corpus was subjected to horizontal thematic analysis. RESULTS: Knowledge and compliance with the guidelines vary greatly between GPs. Although initiating the diagnostic process, GPs do not consider themselves as actors in the flow of information concerning familial risk. Their accompaniment of index patients in this role varies. GPs should overcome barriers to implementing colonoscopic screening for FDRs. They underline the importance of exploring family history, but they lack the time and doubt the reliability of the information given by FDRs. CONCLUSION: Challenges include circumventing gaps in knowledge, adherence to guidelines and improving family history updates. The GPs interviewed suggested personalised guidelines in specialists' reports to initiate information campaigns raising awareness of familial risk, and to enhance coordination between organised screening and familial screening.

How do they add up? The interaction between the placebo and treatment effect: A systematic review.

AIM: The placebo effect and the specific effect are often thought to add up (additive model). Whether additivity holds can dramatically influence the external validity of a trial. This assumption of additivity was tested by Kleijnen et al in 1994 but the data produced since then have not been synthetized. In this review, we aimed to systematically review the literature to determine whether additivity held. METHODS: We searched Medline and PsychInfo up to 10 January 2019. Studies using the balanced placebo design (BPD), testing two different strengths of placebos, were included. The presence of interaction was evaluated by comparing each group in the BPD with analysis of variance or covariance. RESULTS: Thirty studies were included and the overall risk of bias was high: four found evidence of additivity and 16 studies found evidence of interaction (seven had evidence of positive additivity). CONCLUSION: Evidence of additivity between placebo and specific features of treatments was rare in included studies. We suggest interventions for placebo-sensitive ailments should be tested in trials designed to take interactions seriously once an exploratory RCTs has proven their efficacy with sufficient internal validity.

Correction to: Efficacy of phloroglucinol for the treatment of pain of gynaecologic or obstetrical origin: a systematic review of literature of randomised controlled trials.

The correct presentation of the Author names are shown in this paper.

Efficacy of acetylleucine in vertigo and dizziness: a systematic review of randomised controlled trials.

PURPOSE: To assess the efficacy of acetylleucine to improve or stop an attack of vertigo and dizziness (vertigo/dizziness). METHODS: Systematic review by 2 independent reviewers. Consultation of the Medline, Cochrane and ClinicalTrials.gov databases until September 2018. Keywords used: Acetylleucine, Tanganil®, Acetyl-DL-leucine, Acetyl-leucine. Trial selection: randomised controlled trials (RCTs) comparing acetylleucine against placebo. RESULTS: Up until 2018, no RCTs have been published on the efficacy of acetylleucine in vertigo/dizziness. CONCLUSION: There is no solid evidence of the efficacy of acetylleucine in vertigo/dizziness. Given its frequent prescription and the cost generated for the French social security system, high-quality randomised trials should be carried out to assess its efficacy.

Are patients' pejorative representations of buprenorphine associated with their level of addiction and of misuse?

BACKGROUND: In France, buprenorphine is at once the most widely prescribed and the most commonly misused opioid maintenance treatment (OMT). Unlike other medicines, it is seldom prescribed as a generic drug. Several studies have underlined the influence of the patient's representations when choosing brand-name rather than generic forms. We aim to prove a link between these pejorative representations and misuse, a higher degree of addiction and a preference for brand-name products. METHODS: An observational study carried out at 11 sites in France using self-assessment questionnaires filled out in dispensing pharmacies by patients having come to them for buprenorphine delivery. RESULTS: Analysis was based on 806 usable questionnaires. There indeed exists a significant correlation between pejorative representations of OMT by means of buprenorphine, and a higher degree of addiction and misuse (p < .0001 for each). Preference for the brand-name product is correlated with the representation of OMT as a "trap" (p = .020). CONCLUSION: Our results underscore the existence of a link between patients' negative representations of their OMT and their drug-taking behavior. Prescribing physicians should consequently take these representations into account to more precisely identify the relevant behaviors and help their patients to evolve positively.

Efficacy of phloroglucinol for treatment of abdominal pain: a systematic review of literature and meta-analysis of randomised controlled trials versus placebo.

AIM: Phloroglucinol is a musculotropic anti-spasmodic drug. It is frequently prescribed in many European countries with a considerable cost for health services. The purpose of this study was to review the existing randomised controlled trials (RCT) comparing the efficacy of phloroglucinol treating abdominal pain versus placebo. METHODS: A literature search was carried out up to May 2017 to select RCT comparing the effect of phloroglucinol versus placebo with intensity of abdominal pain as an endpoint. Studies concerning obstetric or gynaecologic-related pain were not included. RESULTS: Three RCT were included and then analysed for risk of bias and meta-analysed. Only one RCT found that phloroglucinol was superior to placebo, although with a high risk of bias. The meta-analysis found a risk ratio of 1.10 (95% CI 0.95, 1.27) with no statistical significance. DISCUSSION: There is insufficient data to justify the wide-spread prescription of phloroglucinol for alleviating abdominal pain.