INTRODUCTION:For the treatment of LUTS/BPH is used a wide range of drugs that patients have to take for a long time. Therefore, it is important to develop methods for predicting long-term results of therapy. The purpose of this work is to evaluate the possibility to predict long-term results of drug therapy of LUTS/BPH using mathematical modeling on the example of treatment with Serenoa repens extract (ESR - Permixon).MATERIALS AND METHODS:For prediction using the methods of predictive analytics of the therapeutic ESR effect in the long term, materials from the open study "Clinical and biological long-term tolerance of a lipidosterolic extract of Serenoa repens (Permixon) in patients with symptomatic benign prostatic hypertrophy" (No. P0048 95 GP 401) were used. The study took place in 1995-1999 in 3 Moscow medical centers: Research Institute of Urology of the Ministry of Health of the Russian Federation, Urological Clinic of the Moscow Medical Academy named after Sechenov and the urology department of Moscow Clinical Hospital No 60. The study included 155 patients aged 52 to 87 years (65.3) who received the drug in 320 mg capsules per day for two years. The target indicators of the prognosis identified key clinical parameters: a decrease IPSS of>25% or>3 points and an increase in Qmax>25% at 12 and 24 months of treatment. When evaluating the results, a binary approach was used: improvement achieved (1), not achieved (0).RESULTS:Using the methods of predictive analytics, mathematical models were built to predict the long-term results of treatment according to the most significant 7 initial criterias (predictors): IPSS; Qmax; average urine flow rate; urination volume, urination time, residual urine volume, prostate volume. For each target field and time interval, mathematical models were built using ensembles from 7 selected machine learning algorithms with the best predictive qualities: BNet; C5.0; SVM; KNN; NNet; CHAID; C&RT. Verification of models on internal randomized samples showed their high prognostic properties: sensitivity 82.4-99.0; specificity 75.0-96.1; AUC 0,864-0,965.CONCLUSION:The potential for effective prediction by the methods of predictive analytics and data mining of the separated results of drug therapy of LUTS / BPH according to the main clinical criteria was demonstrated. It is necessary to continue training and testing the model with the inclusion of new clinical observations in the data set. This approach is applicable to the creation of similar models for predicting the effect of other drugs.

The efficacy and tolerability of a fixed combination of 160 mg sabal fruit extract WS 1473 and 120 mg urtica root extract WS 1031 per capsule (PRO 160/120) was investigated in elderly, male patients suffering from lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia in a prospective multicenter trial. A total of 257 patients (129 and 128, respectively) were randomized to treatment with PRO 160/120 or placebo (127 and 126 were evaluable for efficacy). Following a single-blind placebo run-in phase of 2 weeks, the patients received 2x1 capsule/day of the study medication under double-blind conditions over a period of 24 weeks. Double-blind treatment was followed by an open control period of 24 weeks during which all patients were administered PRO 160/120. Outcome measures for treatment efficacy included the assessment of the patients' LUTS by means of the I-PSS self-rating questionnaire and a quality of life index as well as uroflow and sonographic parameters. Using the International Prostate Symptom Score (I-PSS), patients treated with PRO 160/120 exhibited a substantially higher total score reduction after 24 weeks of double-blind treatment than patients of the placebo group (6 points vs 4 points; P=0.003, one tailed) with a tendency in the same direction after 16 weeks. This applied to obstructive as well as to irritative symptoms, and to patients with moderate or severe symptoms at baseline. Patients randomized to placebo showed a marked improvement in LUTS (as measured by the I-PSS) after being switched to PRO 160/120 during the control period (P=0.01, one tailed, in comparison to those who had been treated with PRO 160/120 in the double-blind phase). The tolerability of PRO 160/120 was comparable to the placebo. In conclusion, PRO 160/120 was clearly superior to the placebo for the amelioration of LUTS as measured by the I-PSS. PRO 160/120 is advantageous in obstructive and irritative urinary symptoms and in patients with moderate and severe symptoms. The tolerability of the herbal extract was excellent.