Marie-Christine Perault-Pochat

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

AimPhloroglucinol 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.MethodsA 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.ResultsThree 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.DiscussionThere is insufficient data to justify the wide-spread prescription of phloroglucinol for alleviating abdominal pain.

Detection of adverse drug reactions: evaluation of an automatic data processing applied in oncology performed in the French Diagnosis Related Groups database

The aim of this study was to assess an automated detection method of serious adverse reactions induced by oral targeted therapy (OTT) in patients with cancer, performed in the French Diagnosis Related Groups (DRG) database. Patients with cancer of the Poitiers hospital who started an OTT between 2014 and 2015 were included. This study focused on adverse drug reaction which required inpatient hospitalization (ADRh). All diagnoses coded in the DRG database for hospital stays that occurred within 3 months after OTT initiation were collected (potential ADRh). Filters (exclusion criteria) were automatically applied on potential ADRh to exclude diagnoses that were not adverse drug reactions (false positives). A pharmacovigilance review was carried out to identify ADRh in the medical records (reported ADRh). The sensitivity and specificity of the detection method were estimated for each filter combinations by comparison between potential and reported ADRh. This study included 129 patients. The medical records review led to identify 19 ADRh (all coded in the DRG database) in 14 patients. To maintain a 100% sensitivity of the method detection, the best specificity obtained was 58.3% (95% IC: [55.2–61.4]).The use of restrictive filters (‘drug’ in the diagnostic label, specific diagnosis code for adverse cancer drug reaction) resulted in a 97.8% specificity (95% IC: [96.6–98.5]) with a 38.2% sensitivity (95% IC: [23.9–55.0]). Our method has detected the third of ADRh with an excellent specificity. Complementary experimentations in pharmacovigilance centers are necessary to evaluate the interest of this tool in routine in addition to spontaneous reporting.