Background
It is a common practice to control efficacy of pharmacological treatment with a placebo group. However, placebo itself may affect subjective and even objective results. The purpose of this study was to evaluate the placebo effect on symptoms of CP/CPPS to improve future clinical trials.
Methods
A search at three databases (Scopus, MEDLINE, and Web of Science) was conducted to identify double‐blind placebo‐controlled clinical trials on the treatment of CP/CPPS published until April 2021. The primary outcome – National Institutes of Health Chronic Prostatitis Symptom Index (NIH‐CPSI) score. Secondary outcomes: Qmax, PVR, IPSS, and prostate volume.
Results
A total of 3502 studies were identified. Placebo arms of 42 articles (5512 patients, median 31 patients) were included in the systematic review. Systematic review identified positive changes in the primary endpoint, meta‐analysis of 10 articles found that NIH‐CPSI total score results were significantly influenced by placebo, mean difference −4.2 (95% confidence interval [CI]: −6.31, −2.09). Mean difference of NIH‐CPSI pain domain was −2.31 (95% CI: −3.4, −1.21), urinary domain −1.12 (95% CI: −1.62, −0.62), quality of life domain −1.67 (95% CI: −2.38, −0.96); p < 0.001 for all. In case of the objective indicator – Qmax, there were three articles included in the meta‐analysis. Qmax mean change from baseline was 0.68 (95% CI: −0.85, 2.22, p = 0.38). Systematic review showed no significant changes in pain, measured by VAS or other scores, IPSS and PVR.
Conclusions
Placebo significantly affected the subjective parameters (NIH‐CPSI) and limitedly affected various other measurements of pain (visual analog scale, McGill pain questionnaire). There was no long‐term effect on IPSS and objective measurements (Qmax, PVR). This study can be used in further clinical trials to develop general rules of CPPS treatment assessment.
The purpose of the review is to summarize the recent data on circulating tumor cells (CTC) use in clinical practice. We performed a systematic literature search using two databases (Medline and Scopus) over the past five years and the following terms: (CTC OR “circulating tumor cells” OR “liquid biopsy”) AND prostate. The primary outcome was CTC predictive value for prostate cancer (PC) progression and survival. The secondary outcomes were the CTC predictive value for therapy response and the results of CTC detection depending on the assessment method. In metastatic PC, the CTC count showed itself to be a prognostic marker in terms of clinically important features, namely survival rates and response to treatment. CTC concentration was significantly associated with the overall survival and progression-free survival rates. A strong association between the overall survival or progression-free survival rate and CTC concentration could be observed. Variant-7 androgen receptors-positive (AR-V7-positive) patients showed a poor response to androgen receptor signaling (ARS) inhibitors, but this did not compromise their response to taxanes. In localized PC, only positive Cluster of Differentiantion 82 protein (CD82+) correlated with a higher survival rate. CTC count and AR-V7 expression showed itself to be a valuable biomarker for survival in metastatic PC and response to ARS-inhibitors. CTC diagnostic performance for localized PC or for screening and early detection is not high enough to show additional value over the other biomarkers.
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