DOI: 10.31038/JCRM.2020314

Introduction

Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a male pelvic floor dysfunction, which usually manifests as urogenital pain, lower urinary tract symptoms, sexual dysfunction and psychological problems [1]. In China, a national survey shows that the prevalence of CP/CPPS in 2009 was 4.5% [2]. The treatment options of CP/CPPS includes antibiotics, α-blockers, anti-inflammatory medications and so on, but we have to admit that patients and doctors are highly dissatisfied with the treatment of this disease [3]. Therefore, it is not surprising that patients often seek other forms of treatment.

In China, it is becoming more and more popular for patients to seek Traditional Chinese Medicine (TCM) treatment. To our knowledge, a systematic review of acupuncture treatment of CP/ CPPS was published in 2016 [4]. A systematic review of the efficacy and safety of moxibustion in the treatment of CP/CPPS was published in 2019[5]. In terms of drug treatment, although phytotherapy such as quercetin [6] and pollen extract [7] are reported to have a certain effect in the treatment of CP/CPPS, Chinese doctors use more compound prescriptions of TCM. There are few reports on oral TCM in the treatment of CP/CPPS, so we focuses on the current treatment of TCM in the treatment of CP/CPPS, as well as our research on the use of GuiHuang prescription in the treatment of CP/CPPS.

Treatment of CP/CPPS with TCM

In an open, multicenter, pre-and post-controlled clinical trial, 240 patients with type III prostatitis who met the diagnostic criteria of the National Institutes of Health (NIH) were treated with Longjin Tonglin capsule, 3 tablets per time, 3 times a day for 12 weeks. Taking NIH chronic prostatitis symptom index (NIH-CPSI) as the main curative effect index, the curative effect was compared before and after treatment. It was found that the total CPSI scores of patients with type III A prostatitis were 23.12 ±6.99(before treatment), after treatment4, 8 and 12 weeks were 18.22 ±6.39,14.12 ±5.88,12.36 ±6.04respectively (P< 0.0l). Before treatment and 4, 8 and 12 weeks after treatment, the total CPSI scores of patients with type III B prostatitis were 23.12 ±6.99,18.22 ±6.39,14.12 ±5.88,12.36 ±6.04 respectively. No abnormal liver and renal function and adverse events were found in the test.

It shows that Longjin Tonglin capsule is safe and effective in the treatment of type III prostatitis [8].

A systematic review on the efficacy and safety of the compound prescription of TCM for clearing away heat and promoting diuresis in the treatment of chronic prostatitis.Meta analysis showed that the compound prescription of traditional Chinese medicine for clearing away heat and promoting diuresis was superior to Prostat(RR1.26,95%CI1.13~1.41), and subgroup analysis showed that this compound was superior to Qianliekang(RR1.32,95%CI1.19~1.45) and quinolone antibiotics (RR1.34,95%CI1.15~1.57). There was no significant difference between heat-clearing and diuresis-promoting TCM and quinolone antibiotics alone (P< 0.01), and there was no serious adverse reaction reported [9]. No serious adverse reactions were reported.

A study was conducted to evaluate the safety and efficacy of Qianlie Shule granule in the treatment of chronic prostatitis. 66 patients with chronic prostatitis were enrolled in a multicenter, open, self-controlled clinical study. The patients were treated with Qianlie Shule granule 1 bag per time, 3 times a day for 6 weeks. The efficacy of the treatment was evaluated with the NIH-CPSI as the main evaluation index, TCM syndrome as the secondary efficacy index, urine routine and liver and kidney function indexes before and after treatment to evaluate its safety, and adverse events were recorded. The Results showed that NIH-CPSI before treatment was significantly higher than that after 6 weeks treatment (P<0.05), and the score of TCM syndrome waiting score was 11.15 ±8.54 before treatment and 3.56 ±3.83 after 6 weeks treatment, and the difference was also statistically significant (P<0.05). Qianlie Shule granule can relieve the urinary system related symptoms of patients with chronic prostatitis (kidney and spleen deficiency, qi stagnation and blood stasis syndrome), reduce NIH-CPSI and TCM syndrome score, the clinical effect is significant [10].

Our research

The rich clinical experience handed down by the ancestors of TCM for thousands of years, should also seriously evaluate the curative effect of TCM in accordance with the principle of evidence-based medicine. For this reason, we carried out the clinical study of GuiHuang prescription in the treatment of CP/CPPS. This study was randomly divided into two groups: treatment group (GuiHuang prescription group, n=33) and control group (Tamsulosin group, n=33). The patients were treated for 6 weeks and followed up for 2 weeks according to NIH-CPSI score and TCM symptom score. To observe the safety and efficacy of GuiHuang prescription in the treatment of CP/CPPS with dampness-heat stasis. The project was reviewed by the Medical Ethics Committee of Xiyuan Hospital on June 21, 2019, and obtained the ethical approval (batch number: 2019XLA019-3). The project was registered by the China Clinical trial Center (Registration No.: ChiCTR1900026966) on October 27th, 2019. At present, the project is still recruiting. The composition of GuiHuang prescription includes: Angelica 12g, Phellodendron chinense 12g, honeysuckle 15g, turmeric 10g, frankincense 5g, myrrh 5g, Angelica dahurica 10g, tangerine peel 10g, plantain 15g, Hedyotis diffusa 15g, which has the effect of clearing heat and removing dampness, removing blood stasis and relieving pain.

Comment

The best treatment for CP/CPPS has yet to be determined, and the basic strategy is based on symptom control and anxiety relief. The UPOINT phenotypic system (Urinary symptoms, Psychosocial dysfunction, Organ specific, Infection, Neurologic dysfunction and Tenderness of muscles ) play an important role in guiding the clinic [11]. At the same time, it reflects the individual differences of patients, with different phenotypes of different drugs, which is similar to the syndrome differentiation and treatment of TCM. It appears that a tailored treatment strategy addressing individual patient characteristics is more effective than one single therapy[12].

The use of TCM compound prescription, need syndrome differentiation addition and subtraction, according to the different physique and symptoms of patients, will use different prescriptions, there will be a patient a treatment prescription, which is not conducive to evidence-based research. In order to avoid insufficient, we fixed the composition of GuiHuang prescription, studied the patients in accordance with this prescription (damp-heat stagnation type), and we did not add or subtract the prescription. This can ensure the accuracy of the research results, and we are full of expectations for the results.

The compound prescription of TCM, which has been used clinically, such as Ningmitai capsule[13], which is a commercial formula, has been reported to have a good therapeutic effect and is safe. In clinical practice ,the use of TCM compound alone, or combined with western medicine is our Strategy for the purpose of clinical efficacy. There are also external uses of TCM, such as enema, TCM sitz bath.

The use of TCM compound prescription in the treatment of CP/ CPPS is very common. In our department, the proportion of patients taking oralTCM is more than 80%, but unfortunately, our reports are relatively few. The characteristics of TCM are often the first clinical use, such as GuiHuang prescription, we have used for more than a decade, the clinical effect is accurate, and then we are in clinical observation and research, have obtained a higher level of evidence, and then carry out mechanism research. However, we have some shortcomings, there are 10 herbs in the prescription, and the exact mechanism of the effect is not clear. At present, many studies are published in Chinese, which is not conducive to international promotion, and the recognition of research is affected. More published English-language clinical trials are needed to prove its effectiveness. We believe that TCM can be used as a supplementary treatment option for CP/CPPS.

Acknowledgement

This work was financially supported by Xiyuan Hospital Project, Grant number 2019XYMP–23

References

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