scholarly journals Efficacy of dexamethasone in reducing the postembolisation syndrome in men undergoing prostatic artery embolisation for benign prostatic hyperplasia: protocol for a single-centre, randomised, double-blind, placebo-controlled trial—the ‘DEXAPAE’ study

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e047878
Author(s):  
Petra Svarc ◽  
Hein Vincent Stroomberg ◽  
Ruben Juhl Jensen ◽  
Susanne Frevert ◽  
Mats Håkan Lindh ◽  
...  
Keyword(s):  
Benign Prostatic Hyperplasia ◽  
Controlled Trial ◽  
Specific Antigen ◽  
Prostatic Hyperplasia ◽  
Common Side Effect ◽  
Single Centre ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Randomised Controlled ◽  
Prostatic Artery

IntroductionPostembolisation syndrome (PES) is the most common side effect of vascular embolisation of solid organs. Although prophylactic corticosteroids are known to reduce the incidence and severity of PES, no trials investigating their efficacy have been conducted in men undergoing prostatic artery embolisation (PAE). We postulate that steroids can have a similar effect in reducing PES after PAE. This paper describes the rationale and detailed protocol for a randomised controlled trial evaluating the efficacy of dexamethasone (DEXA) in reducing PES after PAE.Methods and analysisIn this single-centre, randomised, double-blind, placebo-controlled trial, we will enrol 60 individuals undergoing PAE for benign prostatic hyperplasia. Participants will be randomised to receive IV DEXA (24 mg) or placebo (saline). The primary outcomes will be postprocedural fever, pain and quality of life. The secondary outcomes will include postprocedural nausea, postprocedural medicine usage, laboratory parameters (C reactive protein, prostate-specific antigen) and early PAE results.Ethics and disseminationEthics approval was obtained from the Danish Committee on Health Research Ethics in the Capital Region (H-20025910). The results from this trial will be disseminated through publication in peer-reviewed journals and national and international presentations.Trial registration numberClinicaltrials.gov identifier: NCT04588857; EudraCT number: 2020-000915-53.

Homoeopathic Treatment of Benign Prostatic Hyperplasia: A Case Series

2018 ◽  
Vol 31 (03) ◽  
pp. 209-219
Author(s):  
Girish Gupta ◽  
Arun Kumar ◽  
Reteka Sexena ◽  
Chaturbhuja Nayak
Keyword(s):  
Benign Prostatic Hyperplasia ◽  
Controlled Trial ◽  
Specific Antigen ◽  
Case Series ◽  
Uttar Pradesh ◽  
Prostatic Hyperplasia ◽  
Post Treatment ◽  
Open Label ◽  
Basic Principles ◽  
Randomised Controlled

Background Benign prostatic hyperplasia (BPH) is one of the most common diseases in age group above 50 years. Symptoms relating to urination are usually frequency, urgency, and hesitancy and vary from case to case. Very few studies are reported on homoeopathic treatment of BPH. Hence, an evidence-based observational study on five patients of BPH was done using homoeopathic medicines. The objective of this case series is to assess the usefulness of individualised homoeopathic medicines in the treatment of cases of BPH. Methodology An open-label observational prospective study was done on patients of BPH at Gaurang Clinic and Centre for Homoeopathic Research, Lucknow, Uttar Pradesh, India, and five patients included in this cases series were treated during 2007–2009. Individualised homoeopathic medicines were prescribed to these patients, after proper case taking, repertorisation and consultation of Materia Medica. Patients were assessed using parameters like International Prostate Symptom Score, uroflowmetry, ultrasonography and prostate-specific antigen. Results Baseline and post-treatment parameters were assessed, which showed significant improvement in post-treatment values along with relief of symptoms in all five patients. Conclusion Results of the study are encouraging and in accordance with the basic principles of homoeopathic prescribing (i.e. classical approach), exhibiting the benefits of constitutional medicines. All the patients showed improvement in their symptoms and laboratory parameters. However, studies with larger sample size and randomised controlled trial study design are suggested.

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