It is expected that the result of the proposed trial will provide objective evidence that acupuncture along with moxibustion is as effective as or superior or inferior to conventional medicinal therapy in alleviating symptoms of benign prostatic hyperplasia by performing the procedure on selected acupoints.
Acupuncture is a traditional therapeutic method for a large variety of medical issues. For thousands of years, it has been widely used for many chronic illnesses. But the effect depends on the selection of the right acupoints and right way of performing acupuncture. Though electroacupuncture is very popular due to the ease in implementation and its consistent effect, manually performing it is still necessary. First of all, the location of acupoints varies between subjects and the feeling of “Teh Qi” is indispensable for the confirmation of selecting the right position and subsequently ensuring its therapeutic effect. Secondly, different manoeuvers result in different outcomes depending on whether they are depleting or replenishing “Qi”.
Based on the TCM theory that benign prostatic hyperplasia is the result of weakened “Qi” of the kidney, therapies aim to increase “Qi” after performing acupuncture. On the back, both “shenshu” and “pangguangshu” are important for increasing “Qi” of the kidney. In the front of the body, “qihai” and “zhongji” are well known acupoints for increasing “Qi” of the kidney. “Shuidao” literally means a conduit of water. In TCM, it refers to the facilitation of expelling of the urine. Therefore, acupuncture of these points will synergistically improve the symptoms of benign prostatic hyperplasia.
Moxibustion is another way of increasing “Qi” and “Yang” due to its nature of providing energy to the body. When acupoints absorb energy from the burning moxa, it promotes the function of the meridian which the acupoints belong to. In the same way, it will synergistically increase “Qi” of the kidney when stimulated by both acupuncture and moxibustion. Based on results of previous small scaled studies on both acupuncture and moxibustion on different acupoints from ours [28–32], it is expected that the proposed combination therapy will be as effective as conventional medical therapies if not superior to them in ameliorating prostatic hyperplasia symptoms.
So far, there are a number of clinical trials completed to compare the efficacy of different herbal decoctions to conventional medicinal therapies in managing benign prostatic hyperplasia, significant improvement of symptoms was observed in patients managed with herbal decoctions [33–35]. However, it is impossible to prescribe the same herbs to all patients with benign prostatic hyperplasia due to slight difference in the nature of their conditions. The composition of the decoctions is nearly the same except a couple or a few herbs that target the conditions which are not the same between patients. Therefore, it is hard to run a randomized clinical trial with the same herbal recipe. Acupuncture, on the contrary, is relatively easy to prescribe the same combinations of acupoints. This poses our study design more compliant with randomized controlled clinical trials.
The present study also has its own limitations. First of all, all patients are recruited from the same hospital. There might be certain bias in patient selection. In the present study, only moderate to severe patients are recruited. Secondly, due to the relatively small size of participants (less than 100 in each group based on the significant superiority of the combined therapy to conventional medicines), blinding is not performed using a centralized computer and patients in the acupuncture group actually know that they are managed with acupuncture and moxibustion. Thirdly, patients have been managed with conventional medicines before starting acupuncture. The therapeutic effect of these medicines might last for a short period in the combined therapy group. However, this will be minimal after 10 weeks management with acupuncture and moxibustion.
In conclusion, the present study is expected to show evidence that acupuncture and moxibustion are as effective as or superior to conventional medicines in managing benign prostatic hyperplasia with few side effects.
This trial will start recruiting participants from 1st April 2020 and is estimated to complete by 1st March 2022. The current version of the protocol is V1.1 as on 5th March 2020 when the study was registered.