OBJECTIVES: To assess the validity of our observational experience that a short course of oral prednisolone therapy might be of value in the management of symptoms of chronic pelvic pain syndrome (CPPS) in men. PATIENTS AND METHODS: Twenty-one men with CPPS (inflammatory or non-inflammatory) for > or =6 months, and who had failed to improve with standard antibiotic therapy, were randomized to receive either a 1-month reducing course of oral prednisolone (nine) or an equivalent placebo regimen (12 men). The outcome measures used were the McGill Pain Questionnaire, the Hospital Anxiety and Depression Scale (HADS), General Health Questionnaire-30 (GHQ-30) and the National Institute of Health Chronic Prostatitis Symptom Index (NIH-CPSI), which were completed at baseline and 3 months. RESULTS: Outcomes were analysed for the 18 patients (six treated, 12placebo) who completed the 3 months of follow-up. At both baseline and 3 months, respectively, there was no statistically significant difference between the groups in the NIH-CPSI total score (P = 0.48 and 0.62; Mann-Whitney U-test), or in the HADS (anxiety, P = 0.85 and 0.67; depression P = 0.96 and 0.74), and there was no significant improvement or deterioration over time. Although not statistically significant, there was a trend to improvement in the depression score for the active group (P = 0.13). However, the clinical significance is doubtful, as both baseline and follow-up depression scores were within the normal range. No patient had clinically negative changes in depression. A 3-month follow-up analysis was not possible for the McGill Pain Questionnaire or GHQ-30 as not all patients completed the questionnaire. CONCLUSIONS: Whilst the study showed no clinical benefit of using corticosteroids in the management of CPPS, the few patients recruited limited the validity of firm conclusions from the data. There was a trend towards an improvement of depression levels amongst subjects. The study highlights the difficulties of recruitment and illustrates the complex psychological profiles of patients with CPPS.
RCT Entities:
OBJECTIVES: To assess the validity of our observational experience that a short course of oral prednisolone therapy might be of value in the management of symptoms of chronic pelvic pain syndrome (CPPS) in men. PATIENTS AND METHODS: Twenty-one men with CPPS (inflammatory or non-inflammatory) for > or =6 months, and who had failed to improve with standard antibiotic therapy, were randomized to receive either a 1-month reducing course of oral prednisolone (nine) or an equivalent placebo regimen (12 men). The outcome measures used were the McGill Pain Questionnaire, the Hospital Anxiety and Depression Scale (HADS), General Health Questionnaire-30 (GHQ-30) and the National Institute of Health Chronic Prostatitis Symptom Index (NIH-CPSI), which were completed at baseline and 3 months. RESULTS: Outcomes were analysed for the 18 patients (six treated, 12 placebo) who completed the 3 months of follow-up. At both baseline and 3 months, respectively, there was no statistically significant difference between the groups in the NIH-CPSI total score (P = 0.48 and 0.62; Mann-Whitney U-test), or in the HADS (anxiety, P = 0.85 and 0.67; depression P = 0.96 and 0.74), and there was no significant improvement or deterioration over time. Although not statistically significant, there was a trend to improvement in the depression score for the active group (P = 0.13). However, the clinical significance is doubtful, as both baseline and follow-up depression scores were within the normal range. No patient had clinically negative changes in depression. A 3-month follow-up analysis was not possible for the McGill Pain Questionnaire or GHQ-30 as not all patients completed the questionnaire. CONCLUSIONS: Whilst the study showed no clinical benefit of using corticosteroids in the management of CPPS, the few patients recruited limited the validity of firm conclusions from the data. There was a trend towards an improvement of depression levels amongst subjects. The study highlights the difficulties of recruitment and illustrates the complex psychological profiles of patients with CPPS.
Authors: Dominik S Schoeb; Daniel Schlager; Martin Boeker; Ulrich Wetterauer; Martin Schoenthaler; Thomas R W Herrmann; Arkadiusz Miernik Journal: World J Urol Date: 2017-06-13 Impact factor: 4.226