The management of patients with chronic bacterial prostatitis (CBP) is associated with a number of challenges. In particular, even in case of pathogen identification, targeted antimicrobial therapy does not reliably control the activity of the inflammatory process and pain syndrome. In addition to the pain syndrome, the clinical picture is aggravated by disorders of urination, sexual function and psycho-emotional sphere, which requires the inclusion of appropriate means of correction in the treatment program. In addition, as result of the chronic course of the disease, repeated and long courses of treatment should be carried out, putting forward additional requirements for the safety of the drugs used. Thus, the development of effective and safe protocols for the management of patients with CBP is an actual scientific task. Given the wide range of biological effects, plant and animal extracts have the potential to enhance the effectiveness of standard CBP treatment.
The objective: to compare the efficacy and safety of adding to the standard therapy (ST) CBP, regulated by the protocol of medical care of the Ministry of Health of Ukraine, biologically active plant substances (dwarf palm, stinging nettle, ginkgo biloba, Japanese bitterness, lovage, calendula officinalis) and animal (peptides isolated from the prostate of sexually mature gobies) origin in the form of capsules and suppositories.
Materials and methods. The study included 105 patients with CBP, aged from 26 to 39 years and duration of the disease from 6 months to 5 years. Depending on the treatment program, patients were randomized into three groups of equal size (n=35): group I – ST + 1 capsule and 1 rectal suppository per day with plant extracts (PE), group II – ST + 1 rectal suppository with PE per day, ІІІ group – ST + 1 rectal suppository with animal extract (AE). Composition of 1 capsule with PE: dwarf palm berry extract – 160 mg; stinging nettle extract – 100 mg; ginkgo biloba extract – 20 mg; Japanese knotweed extract – 20 mg; selenium methionine – 15 mg. Composition of 1 suppository with PE: extract of dwarf palm berries – 150 mg, extract of lovage roots – 50 mg, extract of calendula flowers – 50 mg. Composition of 1 suppository with AE: prostate extract of sexually mature bulls – 30 mg. The therapy lasted 30 days. At the end of therapy, the groups were compared with each other in terms of changes in pain syndrome (NIH CPSI), results of digital rectal examination, intensiveness of lower urinary tract symptoms (IPSS/QoL), sexual function (IIEF), activity of the inflammatory reaction of metabolism in the prostate (leukocyte count, lecithin grains in the field of view during light microscopy of prostatic secretion), the size of the prostate, the frequency of detection of sonographic artifacts (ultrasound examination), the maximum flow rate – Qmax, urination time – Tu (uroflowmetry), the frequency and nature of undesirable phenomena. To assess the significance of differences, the Student and Fisher tests were used. Significance level – 0.05.
Results. Initially, the following disorders were recorded in groups I, II and III: pain syndrome – in 45.7%, 37.1% and 40% of patients, respectively, dysuria – in 62.9%, 51.4% and 54.3%, premature ejaculation (PEj) – in 31.9%, 34.3%, 40%, erectile dysfunction (ED) – in 20%, 14.3%, 20%, calcifications in the prostate – in 45.7%, 40%, 34.3%, diffuse changes in the pancreas. The most common pathogen in all groups was Escherichia coli: it was identified in 42.9%, 54.3% and 60% of patients, respectively. The second and third places in the frequency of detection were taken by Streptococcus faecalis (38.1%) and Staphylococcus aureus (16.2%). At the end of therapy, a decrease in the intensity of pain sensations was recorded in all groups, but the most pronounced – in group I. Thus, in group I, the rate of decrease in the indicator was 15.8 times, in contrast to 4.3 times in group II, and 2.9 times in group III (p<0.001). Pain on palpation of the pancreas was arrested in 100% of patients in group I, in 91.4% in group II, in 88.6% in group III (p<0.001). The decrease in the intensity of dysuria was also more significant in group I. The addition of a combination of PE in the form of capsules and suppositories to ST was associated with a more pronounced decrease in the proportion of patients with PEj and ED. In group I, their share decreased by 3.7 and 3.5 times, respectively, while in group II – by 2 and 2.5 times, and in group III – by 2 and 2.3 times (p<0.001). All three modes of therapy effectively reduced the activity of the inflammatory reaction (a decrease in the number of leukocytes in the pancreas secretion in the field of view), but did not differ in the severity of this effect (p>0.05). Only in group I statistically significant changes in the frequency of daytime and nighttime urination were recorded, which decreased by 21% and 50%, respectively. Although IPSS and QoL improved in all groups, the groups, where PE were used, did not differ in the magnitude of changes in these parameters (p>0.05). The frequency of detecting diffuse and focal changes in the echostructure of the prostate also decreased in all three groups. All three treatment regimens significantly increased Qmax (on average by 1.7 times) and reduced Tu (on average by 1.66 times), but these effects did not differ statistically significantly. Also, there were no significant intergroup differences in the change in the integral indicator of the NIH CPSI scale and the effectiveness of pathogen eradication. In particular, in group I it decreased from 39.3±2.2 to 18.3±1.8 points (p<0.01); in group II – from 37.4±2.7 to 21.3±0.19 points (p<0.01); in group III – from 37.9±2.4 to 22.3±1.9 points (p<0.01). Eradication of the pathogen was achieved in 97.1%, 91.4% and 85.7%, respectively. All three therapeutic regimens were characterized by a satisfactory safety profile: adverse events in the form of a transient skin rash occurred in 1 (2.9%) patient from group I, in 2 (5.7%) patients from group II, and in 2 (5, 7%) of patients from group III. When comparing the groups in accordance with the integral assessment of treatment results, it was found that the proportion of patients assessing the effect as “high” was significantly higher in group I – 57.1% in contrast to 48.6% and 37.1% in II and III groups, respectively.
Conclusion. The multisyndromic nature of CBP makes it possible to include in the therapy program extracts of plant and animal origin, which have a wide range of biological effects. Adding of the PE in the form of capsules and rectal suppositories to standard treatment of CBP is scientifically approved, since it is statistically significantly more effective. than PE in the form of capsules and AE in the form of suppositories in correction of pain syndrome, sexual disorders, dysuria, day and night pollakiuria, and is characterized by a higher integral assessment of the effect. The effect of ST with the inclusion of PE in the form of capsules and rectal suppositories on the activity of inflammation, urination parameters, and pathogen eradication can be compared with that of ST + PE in the form of capsules and ST + AE in the form of suppositories. The addition of the plant and animal extracts to ST is safe. Long-term studies are required to evaluate the possibility of ST + PE in the form of capsules and rectal suppositories to influence the size of the prostate.
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