4.1 Literature quality evaluation analysis based on the CONSORT statement
According to the CONSORT statement, this study evaluated the literature of RCTs on the treatment of CP/CPPS. The results illustrated that the quality of the studies in this field needs to be improved regarding several aspects.
4.1.1 Title and abstract
Among the included 77 RCTs, 67 (87.01%) articles mentioned “random” and “control” in the title and abstract, and the other 10 (12.99%) articles did not indicate the research type in the title and abstract. Irregular expression of the title and abstract will affect the reader’s judgment on the document and influence whether it can be recognized by the searcher. The author should clearly mark “random” and “control” in the title and abstract to indicate that the research is an RCT.
4.1.2 Sample size
Only 12 (15.58%) of the studies described the process and method of sample size estimation. Appropriate sample size estimation is an important part of clinical trials(12). The sample size must be sufficient to reliably answer the relevant questions raised by the research hypothesis and meet the accuracy and reliability of statistics; at the same time, the sample size should not be excessive to avoid waste. Estimation of the sample size is the basis for the credibility of the research results. Therefore, future clinical studies of CP/CPPS should pay attention to the estimation of sample size.
4.1.3 Randomization, blinding, and allocation hiding
Although the 77 included RCTs mentioned “random,” only 26 (33.77%) papers mentioned the specific randomization methods. Among them, 17 (33.77%) papers generated random assignment sequences by computer, and 9 (11.69%) papers used the order of patient visits as the grouping method. Only 26 (33.77%) articles mentioned the “blind method,” but they did not explain how the method was implemented. 6 (7.79%) studies mentioned allocation hiding. Although the included RCTs all mentioned the word “random,” most studies did not clearly indicate that the randomized control method or randomized method was appropriate, and they can only be called quasi-RCTs. Whether the random sequence is reasonable directly affects the feasibility and credibility of clinical RCTs. Blinding is one of the important measures for controlling bias in RCTs. Implementation of a blinding method can effectively control the bias caused by human-made differences between groups(13). Adopting correct method design (such as the random method, blind method, and allocation concealment) is an important measure for reducing the bias of clinical research. An incorrect design may exaggerate research results.
4.1.4 Subjects and test procedures
36 (46.75%) articles mentioned the recruitment of subjects and the baseline situation of subjects. Conversely, only 6 (7.79%) articles used graphs to present the baseline data. Only 34 articles (44.16%) recorded the number of patients who withdrew from each group after random grouping. 16 (20.78%) articles used flowcharts to record the test process. A flow chart can intuitively record the collection of cases, the status of the test, and the number of withdrawals, but most researchers do not pay sufficient attention to the test process.
4.1.5 Adverse reactions
Of the 77 included RCTs, 67 (87.01%) studies reported whether adverse events occurred during the study, and none of the remaining literature stated whether adverse events occurred before or after the trial. Adverse event reporting is an important part of RCTs. Data on adverse reactions help readers to judge the safety of various therapies, and they can have a major impact on judging the acceptability and practicality of interventions.
4.1.6 Statistical methods
Among the 77 included RCTs, all articles specifically described the statistical methods used to compare the primary and secondary outcome indicators of each group, and 15 (19.48%) articles described the methods of additional analysis. This illustrated that researchers do not pay sufficient attention to data statistics. Statistics, as the foundation of scientific research, is an important tool for medical scientific research(14). The correct application of statistical methods directly affects the quality of medical scientific research and the level of scientific research papers.
4.1.7 Clinical registration, plan announcement, and funding description
Among the included studies, only 16 (20.78%) documents stated that they were registered on various registration platforms, and only 3 (3.90%) mentioned the relevant trial schemes and 6 (7.79%) mentioned funding status. This is not conducive for readers to judge the transparency and reliability of CP/CPPS clinical research. This also illustrates that researchers’ awareness of clinical research registration is relatively weak at this stage. Clinical trial registration is a basic requirement for high-level journals to publish articles. The articles in the clinical registry are only available in the last few years. Future CP/CPPS clinical research should ensure that studies are appropriately registered.
4.1.8 Interpretation of results
Among the 77 included RCTs, 57 (74.03%) studies described the limitations and reasons of the trial in the discussion section. And 57 (74.03%) studies provided explanations that are consistent with the experimental results. Meanwhile, 61 (79.22%) articles provided negative results. Inadequate discussion of study findings may lead to publication bias, thereby exaggerating the effects of interventions. These studies are relatively well done in the process of discussion.
4.2 Literature quality evaluation and analysis based on the Jadad scale
Among all 77 articles evaluated by the improved Jadad scale, only 19 (24.68%) had a score of ≥4. Meanwhile, 58 (75.32%) were low quality studies (score ≤ 3), and little of them mentioned random hiding and execution. Thus, the reader cannot judge whether these tests can be performed correctly. The generally low scores cast doubt on the authenticity of the current RCTs for CP/CPPS.
The results of this study indicate that the quality of RCTs on the treatment of CP/CPPS is generally low, and care should be taken when accepting and using the results. These inadequacies included a lack of information on the nature of the experiment in the title, the estimated sample size, the absence of random grouping or unreasonable methods, a lack of blinding, the absence of graphs to represent the baseline data of subjects, no records on patient withdrawal and elimination, a lack of details about adverse events, and the absence of clinical registration. This missing information may cause readers to question the correctness and rationality of the relevant research design, making it difficult to promote the clinical application of treatments for CP/CPPS. When conducting future research, researchers should follow the internationally recognized CONSORT statement and use the improved Jadad scale to standardize the design and implementation of RCTs; correctly select randomization, blinding, and statistical methods; and pay attention to adverse reaction reports and clinical registration instructions. This strategy to improve the quality of RCTS will provide a more reliable basis for the promotion of clinical applications for the treatment of CP/CPPS.