https://orcid.org/0000-0003-1397-3138
Figures
Abstract
Objective
This study aimed to assess the quality of randomized controlled trials (RCTs) that have reported the use of acupuncture for the treatment of post-stroke aphasia (PSA).
Methods
We systematically searched PubMed, Embase, Cochrane Library, Web of Science, Chinese National Knowledge Infrastructure (CNKI), Wanfang data Information Site, and China Science and Technology Journal Database from January 2013 to June 2023. RCTs utilizing acupuncture as an intervention for the treatment of post-stroke aphasia were included in this study. The overall quality score (OQS) of RCTs was independently evaluated by two researchers using the Consolidated Standards for Reporting Trials (CONSORT) and the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) guidelines, with the agreement between researchers calculated using Cohen’s kappa statistics.
Results
In conclusion, we included 38 RCTs in this study. The median OQS of the 38 RCTs was 13 (minimum 8, maximum 20) based on the CONSORT statement. Out of all CONSORT items, 10 (27%) had a positive rate of greater than 80%, while 17 (46%) had a positive rate of less than 10%. The median OQS of the 38 RCTs was 12 (minimum 6, maximum 14) based on the STRICTA guideline. Within the STRICTA guideline, 6 items (35%) had a positive rate of greater than 80%, and 3 items (18%) had a positive rate of less than 10%. Most items based on the CONSORT and STRICTA guidelines were observed to have a perfect or good degree of agreement.
Conclusions
The overall reporting quality of RCTs for acupuncture treatment of PSA was found to be suboptimal. Notably, the reporting quality of the STRICTA guideline is higher compared to the CONSORT statement. Therefore, strict adherence to both the CONSORT and STRICTA statements is recommended to enhance the quality of RCT reports on acupuncture treatment for post-stroke aphasia.
Citation: Qin C, Deng S, Li B, Zhu W, Liu C, Jiang H, et al. (2024) How is the quality of randomized controlled trials (RCTs) for acupuncture treatment of post-stroke aphasia? A report quality assessment. PLoS ONE 19(10): e0308704. https://doi.org/10.1371/journal.pone.0308704
Editor: Yuzhen Xu, The Second Affiliated Hospital of Shandong First Medical University, CHINA
Received: March 26, 2024; Accepted: July 26, 2024; Published: October 25, 2024
Copyright: © 2024 Qin et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Data Availability: All relevant data are within the manuscript and its Supporting information file.
Funding: This work has been funded by the Ministry of Science and Technology of the People's Republic of China, National Key Research and Development Program (2018YFC1706001) and by Tianjin Education Commission scientific research project (2022KJ170). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing interests: The authors have declared that no competing interests exist.
Introduction
Stroke has emerged as a critical global health issue, ranking as the second leading cause of death and the foremost cause of disability worldwide [1, 2]. Generally speaking, a variety of functional impairments following stroke will occur, like motor and sensory disorders, language deficits, dysphagia, and so on [3]. Approximately one third of stroke survivors experience aphasia [4], which severely affects patients’ social interactions, mental health and quality of life. Aphasia, characterized by a collection of acquired receptive and expressive language impairments [5], is one of the most devastating clinical entities after stroke, resulting in a disorder in spontaneous speech, comprehending spoken words, reading, writing, and others [6]. In addition, post-stroke aphasia (PSA) patients were equally related to higher costs of stroke care. A study has demonstrated that PSA patients increased hospitalization costs by $971.35 and length of stay by 0.66 days as compared to non-aphasia patients [7]. Similarly, another study has shown that the rehabilitation costs of PSA patients were about $1,700 higher than that of non-aphasia patients [8]. This undoubtedly severely aggravated the difficulty of clinical rehabilitation and the economic burden of medical and health care. Therefore, there is an urgent need for an effective and easily applicable clinical intervention to treat PSA, aiming to enhance the quality of life for PSA patients and alleviate the societal healthcare burden.
A review of clinical trials on PSA found that interventions for PSA include stimulation therapy, speech and language therapy (SLT), pharmacological therapy and others [9]. Nevertheless, there is inadequate evidence to support the long-term efficacy caused by stimulation therapy for PSA [10]; receiving face-to-face SLT with a therapist can be burdensome for patients, as many PSA patients may face severe communication barriers [11]; there is no high-level evidence that pharmacological therapy gains a significant improvement in language for PSA [12].
Acupuncture originates from Traditional Chinese Medicine, which is widely used against a variety of diseases [13]. Similarly, due to its safety and efficacy, acupuncture is widely used as a complementary and alternative therapy for the rehabilitation of post-stroke aphasia in China. In recent years, the number of clinical trials of acupuncture for PSA has increased. A meta-analysis of randomized controlled trials reported that acupuncture is effective on improvement in language function of PSA [14]. Randomized controlled trials (RCTs) have been viewed as the gold standard of clinical trial design, and it is considered the highest level of evidence in a clinical study [15]. However, incomplete and inadequate RCTs represent a waste that reduces the usefulness of research and failed to benefit clinical practice [16] and it might mislead clinical interventions, ultimately affecting therapeutic effects. As a consequence, it is valuable to evaluate the quality of RCTs of acupuncture for PSA.
The Consolidated Standards for Reporting Trials (CONSORT) [17, 18], established in 1996 and updated in 2010, aims at improving the transparency and rigor of RCTs. The Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) [19, 20], an extension of the CONSORT statement, was published in 2001 and revised in 2010 to help researchers fully report details of clinical studies on acupuncture. As far as we know, there is no study assessing the quality of acupuncture for PSA using CONSORT and STRICTA statements. Consequently, the main goal of this study is to evaluate the reporting quality of RCTs of acupuncture for PSA based on the above two guidelines. This is intended to acquire preliminary data that can aid in advancing clinical trials on acupuncture treatment for PSA and identifying potential issues currently existing in clinical trials, thereby providing a reference for future clinical research.
Materials and methods
Search strategy
The following online databases were searched from January 2013 to June 2023: PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), China Science and Technology Journal Database and Wanfang data Information Site. The main combinations of search terms used in Chinese and English were as follows: (acupuncture OR scalp acupuncture OR tongue acupuncture OR body acupuncture OR manual acupuncture OR acupuncture therapy OR electroacupuncture OR needle OR acupoint) AND (aphasia) AND (stroke OR apoplexy OR cerebral apoplexy OR cerebral infarction OR cerebral hemorrhage) AND (RCT OR randomized OR randomised OR randomized trial OR randomized controlled trials OR RCTs). The details of the search process are displayed in Fig 1.
The entire selection process resulted in a total of 38 studies being included in the analysis.
Included and excluded criteria
Types of studies.
We included RCTs in our assessment to examine the efficacy of acupuncture interventions for PSA. The study excluded reports that met the following criteria: (1) abstract only or full text not available; or (2) non-randomized, reviews, cross-over RCTs, case reports, retrospective studies, conference papers, dissertations, case-control studies and duplicate publications.
Types of participants.
We included subjects who have been clearly diagnosed as PSA by referring to clearly diagnostic criteria, regardless of gender, ethnicity, occupation, and other demographic factors.
Aphasia caused by other diseases is excluded.
Types of intervention.
Different methods of acupuncture for example scalp acupuncture, tongue acupuncture, electroacupuncture and acupoint-sites, were all included.
Included RCTs met the following criteria: (1) in the experimental group acupuncture was implemented alone, and a placebo or conventional treatment or sham acupuncture was used in the control group; or (2) when the intervention in the experimental group was acupuncture combined with other therapies, the intervention in the control group must be same as other therapies of the experimental group.
Excluded RCTs met the following criteria: (1) studies in which the experimental group of patients was served by acupuncture combined with medication; or (2) studies that compared the effectiveness of different acupuncture therapies; or (3) studies with a total effective rate alone as an outcome indicator.
Study selection and data extraction
First, the researcher (C Y Q) used NoteExpress 3.8.0 software to eliminate duplicate studies. Next, two researchers (C Y Q and B X L) independently screened the titles and abstracts of the studies based on inclusion and exclusion criteria. After the initial screening, the researchers reviewed the full texts of all potentially eligible studies to make the final selection. Any reports with contentious eligibility were labeled as ’uncertain,’ and a senior researcher (Z H M) made the ultimate decision regarding their inclusion.
Subsequently, two researchers (C Y Q and B X L) utilized Microsoft Excel 2019 16.0 software to extract general information from the included studies. This information encompassed details such as the author, publication year, number of subjects, intervention methods, treatment duration, and other elements relevant to the assessment based on CONSORT and STRICTA guidelines.
Assessment of reporting quality
Two researchers (C Y Q and B X L) individually assessed the reporting quality of included RCTs based on the CONSORT and STRICTA statements. To evaluate the degree of agreement between the two researchers, Cohen’s κ-statistic was calculated using IBM SPSS Statistics 23.0 software. Agreement was judged as perfect if κ was > 0.8, good if 0.6 < κ ≤ 0.8, moderate if 0.4 < κ ≤ 0.6, fair if 0.2 < κ ≤ 0.4 and poor if κ was ≤ 0.2.
Each of the Thirty-seven items included in the CONSORT 2010 was scored to calculate an overall quality score (OQS). Each of seventeen items in the STRICTA statements was also scored. For scoring the quality of items, one point was given if the item-related information was mentioned in the study, and zero points if it was not mentioned or was unclear (S1 Table).
Results
Search results
Initially, a total of 1209 relevant reports were identified from seven databases. 830 reports remained after the exclusion of duplicates. After reading the titles, abstracts and full text, 38 RCTs were ultimately extracted for further assessment. Fig 1 outlines the whole selection process for this study, and the general characteristics of the 38 included RCTs are indicated in Table 1.
Characteristics of included trials
Out of the 38 studies, 13 (34.2%) were published between 2013 and 2018, while 25 (65.8%) were published from 2019 to the present (see Fig 2). All 38 RCTs were conducted by Chinese researchers. The sample size ranged from 40 to 120 (Median: 80). Only one report (2.6%) used acupuncture alone in the experimental group, while 37 reports (97.3%) utilized acupuncture in combination with other therapies. The acupuncture treatment course varied from 2 weeks to 12 weeks (Median: 4 weeks). Only 9 studies (23.7%) reported their source of funding. The main interventions in the treatment group included scalp acupuncture (23.6%), electroacupuncture (15.7%), tongue acupuncture (7.8%), and body acupuncture (52.6%). There were 5 studies (13.2%) that classified aphasia, while 16 studies (42.1%) did not report the type of aphasia. Additionally, 16 studies (42.1%) included patients with motor aphasia, and 1 study (2.6%) involved patients with thalamic aphasia (see Fig 3 and Table 2).
The blue bars is the number of publications. The red and green bars represent the average scores of OQS based on CONSORT and STRICTA guidelines respectively in each year.
The orange bars represent the types of aphasia, and the blue bars represent the types of interventions.
Quality of the reports
Reporting quality score based on CONSORT items.
Table 2 presents the data regarding the overall quality of reporting based on the CONSORT statement. Among the 38 RCTs, the median OQS was 13, ranging from a minimum of 8 to a maximum of 20. Items such as "structured summary," "scientific background," "eligibility criteria," "interventions," "random allocation sequence," "description of the similarity of interventions," "statistical methods," "recruitment and follow-ups," "outcomes result," and "interpretation" were reported in a sufficiently detailed manner, with positive rates exceeding 80%. These items accounted for 27% of all the checklist items.
Conversely, items related to "title," "changes to methods," "trial design," "changes to outcomes," "sample size," "interim analyses," "type of randomization," "allocation concealment," "implementation," "blinding," "additional analyses," "reasoning for stopping," "absolute and relative effect sizes," "ancillary analyses," "harms," "registration," and "study protocol" were reported less thoroughly, with a positive rate of less than 10%. These items accounted for 46% of all checklist items.
The degree of agreement among the items was generally good or perfect, except for items (Interventions) and 11b (Description of the similarity of interventions), which exhibited a moderate degree of agreement.
Reporting quality score based on STRICTA items.
Table 3 displays the data regarding the overall quality of reporting based on the STRICTA statement. Among the 38 RCTs, the median OQS was 12, with a minimum score of 6 and a maximum of 14. Items such as "style of acupuncture," "names of points," "needle stimulation," "needle retention time," "number of treatment sessions," and "frequency and duration of treatment" were adequately reported, with a positive rate exceeding 80%. These items constituted 35% of all checklist items.
On the other hand, items related to the "number of needle insertions," "setting and context of treatment," and "description of participating acupuncturists" had a positive rate below 10%, accounting for 18% of all items. Most RCTs provided sufficient information regarding the treatment regimen and needling details. Items 1b (reasoning for provided treatment), 1c (Extent to which treatment varied), 4a (details of other interventions), and 6b (a precise description of the control or comparator) demonstrated a moderate degree of agreement, while the remaining items exhibited a good or perfect degree of agreement.
Discussion
In this study, we conducted a systematic search of RCTs on acupuncture for the treatment of PSA published in the last decade. We evaluated the quality of the included reports using the CONSORT and STRICTA guidelines. Unfortunately, the results of reporting quality were found to be unsatisfactory. The overall average reporting rate was 35.6% based on CONSORT and 63.3% based on STRICTA statements, which is consistent with the findings of previous reports [59, 60].
The low reporting quality based on the CONSORT statement was a cause for concern. The median overall quality score (OQS) of the 38 RCTs was 13, which is less than 35% of the total points. Most items of the CONSORT statement were inadequately reported or overlooked, with significant deficiencies observed in the trial methods section, particularly in items related to trial design, sample size, randomization, and blinding.
Notably, none of the included reports indicated in their titles that they were RCTs, which may complicate the identification of RCTs. Additionally, none of the studies explicitly described their trial design, such as randomized, parallel, or factorial design. Clearly defining the trial design can reduce potential misunderstandings in research data and enhance the transparency of the trials [61]. Inappropriate trial design not only leads to considerable resource waste but also affects the reliability of the clinical evidence it generates [62]. According to a study published in Lancet, about 85% of funding is wasted each year due to improper trial design and other reasons [63].
None of the studies reported the item of sample size. Sample size calculation details are required to be reported so that the reader can critically judge whether the sample size calculation was realistic and reproduces it [64]. An inadequate sample size may fail to detect clinical effects, produce confounding factors, and biases. Adequate sample size calculation ensures that financial and medical resources are used efficiently to achieve reliable clinical outcomes based on clinically significant differences [65, 66].
Randomization and allocation concealment are key methodologic parts of RCTs. Only one study (3%) reported sequence generation and allocation concealment, despite 87% of the included studies mentioning the randomization method used. The reporting rate of the methodologic items has been low and has not been improved [67, 68]. Moreover, no one study reported who had generated the random allocation sequence. As one of the key methodological parts of RCTs, the implementation of allocation concealment is conducive to reduce selection bias, enhance baseline comparability, and minimize trial result heterogeneity [69]. Likewise, the biases of statistical outcome will occur in trials that use inadequate allocation concealment methods [70]. Thus, it is crucial to pay more attention to randomization and select a good allocation concealment method to improve report quality and prevent various biases.
Furthermore, none of the studies provided details of blinding. Blinding is comprised of single-blinded, double-blinded, and triple-blinded [71]. Blinding can be implemented in a wide range of distinct procedures of trials and correct blinding is vital for improving the validity of outcome assessment and preventing potential biases [72, 73]. Hróbjartsson et al [74] observed that the treatment effect was overestimated in unblinded RCTs. Compared with pharmacologic trials, blinding patients and intervenors simultaneously is more difficult to carry out in trials on acupuncture as its particularity. At present, blinding methods in acupuncture trials consist of nonpenetration acupuncture, shallow puncture, non-acupoints puncture and so on [75–77]. Despite it being difficult in blinding in acupuncture trials, researchers should make every effort to implement blinding methods to improve the scientific rigor and validity of their trials.
Surprisingly, none of the RCTs reported the accessibility of their study protocols and registration numbers. Study protocols serve as the foundation for conducting clinical trials, describing the trial’s purpose, design, methods, and statistical information. Registration of trials and the availability of protocols ensure that clinical trial information is publicly accessible, aligning with the principles of evidence-based medicine [78]. Trial registration and protocols also protect the informed rights and interests of study participants, enhance public trust in clinical trials, and enable tracking of trial outcomes and quality control of trial processes and results [79].
Regarding the quality assessment based on the STRICTA guideline, it was rated as moderate. The median OQS of the 38 RCTs was 12, which was greater than 70% of the total points. While most items of the STRICTA guidelines were reported in more than 70% of trials, indicating relatively complete descriptions of acupuncture interventions, some items, such as "number of needles," "setting and context of treatment," and "qualifications of acupuncturists," were not fully addressed. Only 2 RCTs (5%) reported the number of needle insertions and the qualifications of acupuncturists, and 1 RCT (3%) reported the treatment setting. Notably, a study has shown that the number of needles and sessions are related to the treatment outcomes [80]. Besides, more than half of the RCTs did not report the type of acupuncture, and some only mentioned the length of acupuncture without information like diameter and manufacturer. Neglect of the explanation of acupuncture details not only affects the internal validity of the clinical results but also influences other researchers to replicate the intervention [81]. On top of that, different acupuncturists can make a difference impact on studies because of the characteristics of acupuncture, so the lack of report on the qualification of acupuncturists may affect the generalizability of trial results [82]. Therefore, it is crucial to provide clear descriptions of acupuncture interventions in compliance with STRICTA guidelines.
Generally, there are several common issues observed in the reporting of acupuncture RCTs. A study evaluating the reporting quality of acupuncture RCTs has revealed that the reporting quality of Chinese-language acupuncture RCTs needs significant improvement when compared to English-language acupuncture RCTs. Additionally, the reporting rates of certain items, such as trial methods, differ by over 50% between Chinese and English RCTs [83]. This may be closely linked to the lack of emphasis among Chinese researchers on clinical trial registration, resulting in selective reporting. At the same time, we must acknowledge that positive research outcomes are more likely to be published compared to negative results. Therefore, giving greater importance to clinical trial registration can significantly reduce the likelihood of publication bias. In an assessment of the quality of RCTs for acupuncture treatment of female urinary incontinence, it was noted that funding support can influence CONSORT scores, with funded RCTs more likely to receive higher scores [84]. This can partly explain that funding providers and project supervisors play a crucial role throughout the entire RCT trial. The importance of trial protocols is emphasized in the quality assessment of RCTs for acupuncture treatment of low back pain, as these protocols provide an overview and detailed information about the entire study [68]. The evaluation of the quality of RCTs for acupuncture treatment of acute herpes zoster highlights that a lack of proper sample size estimation can lead to a decrease in test performance, affecting the authenticity and reliability of study results [60]. These challenges mirror the observations made in the evaluation presented in this study.
There are a few limitations to our study. First and foremost, the number of included RCTs was relatively small. We excluded literature that compared different acupuncture methods and studies in which intervention types were inconsistent between the experimental and control groups, which could potentially impact our research results. However, this reduction in heterogeneity among studies was achieved. A more comprehensive assessment would require the inclusion of a larger number of studies for quality evaluation. Second, it is important to note that all the included RCTs were conducted in China. This might be attributed to the fact that the mechanism of acupuncture for PSA is not entirely clear, even though it has been proven effective in treating aphasia. Consequently, there are relatively few relevant international clinical trials. Lastly, we only included RCTs published in the past 10 years. It remains uncertain whether the inclusion of RCTs published before 2013 would alter the composition of our reports or the outcomes. However, recent studies are more likely to identify potential issues in ongoing RCTs, making them relatively more clinically instructive.
Conclusions
In summary, this study has provided an overview of the reporting characteristics of RCTs on acupuncture for PSA and has highlighted that the overall quality of these reports is suboptimal. It is worth noting that the quality of reports based on the CONSORT statement is relatively lower, while those following the STRICTA checklist tend to be of better quality. RCTs with suboptimal quality may compromise their scientific validity and their ability to provide effective evidence for clinical treatment. Therefore, we recommend that researchers should rigorously adhere to both the CONSORT and STRICTA statements and focus on enhancing the quality of methodological aspects such as randomization, allocation concealment, blinding, and so on in their future reports.
References
- 1. Campbell B, De Silva D A, Macleod M R, et al. Ischaemic stroke[J]. Nat Rev Dis Primers, 2019,5(1):70.
- 2. Global, regional, and national disability-adjusted life-years (DALYs) for 359 diseases and injuries and healthy life expectancy (HALE) for 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017[J]. Lancet, 2018,392(10159):1859–1922.
- 3. Ferro J M, Caeiro L, Figueira M L. Neuropsychiatric sequelae of stroke[J]. Nat Rev Neurol, 2016,12(5):269–280.
- 4. Brady M C, Kelly H, Godwin J, et al. Speech and language therapy for aphasia following stroke[J]. Cochrane Database Syst Rev, 2016,2016(6):CD425.
- 5. Stefaniak J D, Halai A D, Lambon R M. The neural and neurocomputational bases of recovery from post-stroke aphasia[J]. Nat Rev Neurol, 2020,16(1):43–55.
- 6. Mattioli F. The clinical management and rehabilitation of post stroke aphasia in Italy: evidences from the literature and clinical experience[J]. Neurol Sci, 2019,40(7):1329–1334.
- 7. Wu C, Qin Y, Lin Z, et al. Prevalence and Impact of Aphasia among Patients Admitted with Acute Ischemic Stroke[J]. J Stroke Cerebrovasc Dis, 2020,29(5):104764.
- 8. Ellis C, Simpson A N, Bonilha H, et al. The one-year attributable cost of poststroke aphasia[J]. Stroke, 2012,43(5):1429–1431.
- 9. Berube S, Hillis A E. Advances and Innovations in Aphasia Treatment Trials[J]. Stroke, 2019,50(10):2977–2984.
- 10. Turkeltaub P E. Brain Stimulation and the Role of the Right Hemisphere in Aphasia Recovery[J]. Curr Neurol Neurosci Rep, 2015,15(11):72.
- 11. Fridriksson J, Hillis A E. Current Approaches to the Treatment of Post-Stroke Aphasia[J]. J Stroke, 2021,23(2):183–201.
- 12. Saxena S, Hillis A E. An update on medications and noninvasive brain stimulation to augment language rehabilitation in post-stroke aphasia[J]. Expert Rev Neurother, 2017,17(11):1091–1107.
- 13. Liu W H, Chen C, Wang F, et al. Development trend and current situation of acupuncture-moxibustion indications[J]. World Journal of Acupuncture—Moxibustion, 2020,30(4):245–250.
- 14. Tang H Y, Tang W, Yang F, et al. Efficacy of acupuncture in the management of post-apoplectic aphasia: a systematic review and meta-analysis of randomized controlled trials[J]. BMC Complement Altern Med, 2019,19(1):282.
- 15. Zabor E C, Kaizer A M, Hobbs B P. Randomized Controlled Trials[J]. Chest, 2020,158(1S):S79–S87.
- 16. Bothwell L E, Greene J A, Podolsky S H, et al. Assessing the Gold Standard—Lessons from the History of RCTs[J]. N Engl J Med, 2016,374(22):2175–2181.
- 17. Schulz K F, Altman D G, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials[J]. BMJ, 2010,340:c332.
- 18. Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement[J]. JAMA, 1996,276(8):637–639.
- 19. MacPherson H, Altman D G, Hammerschlag R, et al. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement[J]. PLoS Med, 2010,7(6):e1000261.
- 20. MacPherson H, White A, Cummings M, et al. Standards for reporting interventions in controlled trials of acupuncture: the STRICTA recommendations[J]. Complement Ther Med, 2001,9(4):246–249.
- 21. Zhang J W. Observation on Acupuncture Treating Motor Aphasia after Stroke[J]. World Chinese Medicine, 2014,9(10):1349–1351.
- 22. He J F, Xu X H, Mao H X, Wang L D, Chen H, Wang W M. Clinical Observation of Rehabilitation Therapy Combined with Acupuncture in Treatment of Motor Aphasia after Stroke [J]. Chinese Archives of Traditional Chinese, 2015,33(3):763–765.
- 23. Wang N, Li Y. Therapeutic Observation of Cluster Needling at Anterior Oblique Line of Vertex-temporal plus Speech Training for Motor Aphasia after Cerebral Infarction[J]. Shanghai Journal of Acupuncture and Moxibustion, 2015,34(05):412–414.
- 24. Xiong J, Zhang M, Guo W L, Fan S H, Zhang Y L. Clinical Research on Xingnao Kaiqiao Acupuncture Method Combined with Language Rehabilitation Training in Patients with Cerebral Infarction Motor Aphasia [J]. Acta Chinese Medicine, 2016,31(10):1609–1613.
- 25. Tong X N. Clinical Outcomes of the Application of Temporal Three Needling and Tongue Three Needling Combined with Language Rehabilitation Training in Treating Aphasia after Stroke[J]. Chinese Scientific Journal of Hearing and Speech Rehabilitation, 2017,15(2):107–110.
- 26. Liu Y. Clinical Study on Verbal Training Combined with Xingnao Kaiqiao Acupuncture in Treating Aphasia after Stroke[J]. Guangming Journal of Chinese Medicine, 2017,32(20):2979–2981.
- 27. Xing J, Wang Y, Zhang Y, Guo Y. Clinical Observation on Tongdu Kaiqiao Acupuncture Method Combined with Language Training in Patients with Cerebral Infarction Aphasia[J]. Guiding Journal of Traditional Chinese Medicine and Pharmacy, 2017,23(10):103–105.
- 28. Yang L, Guo Y G. Clinical study of scalp electroacupuncture combined with language training on post-stroke aphasia patients[J]. Chinese Journal of Rehabilitation Medicine, 2017,32(3):305–308.
- 29. Teng Y Y, Yi H J. Clinical observation of scalp acupuncture plus speech rehabilitation for Broca’s aphasia after cerebral stroke[J]. Journal of Acupuncture and Tuina Science, 2017,15(2):104–108.
- 30. Chen X F, Cheng X, Lai J H, Wang Z F, Lu J H, Gao Y L, et al. Effect of speech training with needle on motor aphasia after stroke[J]. Asia-Pacific Traditional Medicine, 2018,14(8).
- 31. Zheng Y B, Lin S F. A Clinical Study of Electro-acupuncture at Lianquan (CV23) and Shuaigu (G8) in the Treatment of Motor Aphasia Patients after Stroke[J]. Chinese Medicine Modern Distance Education of China, 2018,16(9):122–124.
- 32. Wang Q, Xu Z J. Clinical Observation of Modified Tongue Acupuncture Combined with Schuell Stimulation Therapy for Mild to Moderate Post-stroke Aphasia[J]. Hebei Journal of Traditional Chinese Medicine, 2018,40(4):589–592.
- 33. Yu Q P, He S S. Evaluation of Acupuncture Therapy Combined with Schuell Stimulation Therapy Based on the the origin and terminal Theory for Thalamic Aphasia After Stroke[J]. Hebei Journal of Traditional Chinese Medicine, 2018,40(4):608–611.
- 34. Weng P X, Zheng J L, Chen J B. Clinical efficacy of acupuncture plus language rehabilitation training on aphasia after stroke[J]. Clinical Journal of Chinese Medicine, 2019,11(8):87–89.
- 35. Xiao Y K, Li D Y, Li H F. The Effect of Scalp Acupuncture Combined with Language Rehabilitation on Aphasia After Stroke[J]. Neural Injury and Functional Reconstruction, 2019,14(11):581–582.
- 36. Yin X J. Evaluation of Acupuncture Combined with Language Training for Treatment of Post-Stroke Aphasia[J]. China Health Care & Nutrition, 2019,29(18).
- 37. Li Z G, Sun S B. Clinical Observation of Tongue Three-needle Combined with LanguageRehabilitation Training in the Treatment of Stroke Aphasia[J]. Journal of Liaoning University of Traditional Chinese Medicine, 2019,21(03):167–170.
- 38. Ye J S, Peng Z C. Clinical Observation of Scalp Acupuncture Combined with Repetitive Transcranial Magnetic Stimulation for Post-Stroke Motor Aphasia[J]. China’s Naturopathy, 2019,27(21):23–25.
- 39. Lin M, Lin M J. Effect of scalp electroacupuncture combined with speech training in the treatment of aphasia after stroke[J]. China Modern Medicine, 2019,26(19):62–65.
- 40. Liu G, Sun J J, Yang J, Zhang Q P. "Xingnao Kaiyin acupuncture" combined with speech training for post-stroke aphasia[J]. Chinese Acupuncture & Moxibustion, 2019,39(04):355–358.
- 41. Yuan X L, Shi D M, Zhou Z H, Jia K. Effects of Acupuncture and Moxibustion Combined with Hyperbaric Oxygen on Functional Recovery and Quality of Life in Patients with Aphasia after Stroke[J]. Journal of Rare and Uncommon Diseases, 2020,27(5).
- 42. Qiu L F, Yu Y J, Lu J H, Lin W Q, Chen L L, Liao Y T. Effects of acupuncture combined with response elaboration training on language efficacy of patients with chronic aphasia after stroke[J]. China Medicine and Pharmacy, 2020,10(15).
- 43. Wang Y, Wang J, Chen S F. Clinical Study of Electroacupuncture Combined with Schuell Stimulation Method for Post-Stroke Aphasia[J]. Journal of Hunan University of Chinese Medicine, 2020,40(4):465–468.
- 44. Fan Q Y, Meng C X, Yan W H, You D Z, Zhang C. Observation on the Effect of Acupuncture Combined with Rehabilitation Training on Aphasia after Stroke[J]. Reflexology and Rehabilitation Medicine, 2020(20):13–15.
- 45. Ma Y P, Yang K. Therapeutic effect of scalp electro acupuncture combined with language training on stroke motor aphasia[J]. Traditional Chinese Medicine Rehabilitation, 2020,11(11):62–64.
- 46. Liu W, Zhu W Z, Song F J, Jin Y X, Liu F W, Song C C, et al. Clinical Study on Scalp Acupuncture Combined with Speech Function Training for Motor Aphasia after Stroke[J]. New Chinese Medicine, 2020,52(6):132–134.
- 47. Zhang R M, Sun S B. Treatment of motor aphasia after stroke with scalp acupuncture and speech rehabilitation[J]. Journal of Changchun University of Chinese Medicine, 2020,36(2):339–342.
- 48. Ren C Z, Lyu X Y, Zhang X J, Zhang X H, Zhang H T. Acupuncture technique of Jingou Diaoyu combined with speech rehabilitation training for post-stroke motor aphasia[J]. Chinese Acupuncture & Moxibustion, 2020,40(10):1037–1041.
- 49. Wang C H, Pang Q M. Clinical Observation of Acupuncture Combined with Language Training for Post-Stroke Language Disorders[J]. Journal of Practical Traditional Chinese Medicine, 2021,37(5).
- 50. He J L. Efficacy Analysis of "Xingshen Kaiyin" Acupuncture Combined with Schuell Stimulation Therapy for Speech Training in Post-Stroke Aphasia [J]. Journal of Practical Traditional Chinese Medicine, 2021,37(12):2103–2105.
- 51. Wang L P, Ma N, Feng N. Efficacy of acupuncture at tongue root acupoint combined with electrical stimulation on post-stroke motor aphasia[J]. Hainan Medical Journal, 2021,32(23).
- 52. Wang S Q, Yuan X, Li M, Xu S Y, Luo R H. Clinical Study of Applying Low Prequency rTMS Associated with Electroacupuncture at Fengfu and Yamen Acupoints in the Treatment of Broca Aphasia after Stroke[J]. Journal of Sichuan of Traditional Chinese Medicine, 2021,39(1):194–197.
- 53. Jia Z Y, Hai Y, Shan X J, Yang G F. Clinical Observation of Tongyang Kaiqiao Acupuncture in the Treatment of Ischemic Stroks[J]. Journal of Practical Traditional Chinese Medicine, 2021,35(06):80–82.
- 54. Wei J H, Jiang T B, Xu M, Li J M, Hong J. Effects of acupuncture plus language training on language function and cerebral blood flow in patients with motor aphasia after ischemic stroke[J]. Journal of Acupuncture and Tuina Science, 2021,19(5).
- 55. Chen X Y, Wang Y L, Wang G Y, Huang Y T. Efficacy Observation of "Xingshen Kaiyin" Acupuncture Combined with Language Training for Stroke Aphasia[J]. Chinese Journal of Integrative Medicine on Cardio-Cerebrovascular Disease, 2021,19(7).
- 56. Wang Y L. Discussion on the Effect of Scalp Acupuncture Combined with Language Rehabilitation in Patients with Post-Stroke Motor Aphasia[J]. World Latest Medicine Information, 2021,21(19).
- 57. Wu L L. Impact of Acupuncture Combined with Language Rehabilitation Training on Patients with Post-Stroke Aphasia[J]. Practical Clinical Journal of Integrated Traditional Chinese and Western Medicine, 2022,22(02):117–119.
- 58. Sun J B, Yan H X, Wang G F, Chen L L, Wu X Q, Song B L. Clinical effect of Kaiqiao Xinshen Acupuncture Method in the treatment of post-stroke motor aphasia[J]. China Medical Herald, 2023,20(13).
- 59. Liu K, Zeng J, Pei W, et al. Assessing the reporting quality in randomized controlled trials of acupuncture for postherpetic neuralgia using the CONSORT statement and STRICTA guidelines[J]. Journal of Pain Research, 2019,12:2359–2370.
- 60. Qian G, Zeng J, Lu L, et al. Evaluation of Reporting Quality in Randomised Controlled Trials of Acupuncture for Acute Herpes Zoster by the CONSORT Statement and STRICTA Guidelines[J]. Evidence-based Complementary and Alternative Medicine, 2020,2020:4308380.
- 61. Calvert M, Blazeby J, Altman D G, et al. Reporting of Patient-Reported Outcomes in Randomized Trials[J]. JAMA, 2013,309(8):814.
- 62. Schultz A, Saville B R, Marsh J A, et al. An introduction to clinical trial design[J]. Paediatr Respir Rev, 2019,32:30–35.
- 63. Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence[J]. Lancet, 2009,374(9683):86–89.
- 64. Speich B. Adequate reporting of the sample size calculation in surgical randomized controlled trials[J]. Surgery, 2020,167(5):812–814.
- 65. In J, Kang H, Kim J H, et al. Tips for troublesome sample-size calculation[J]. Korean J Anesthesiol, 2020,73(2):114–120.
- 66. Wang X, Ji X. Sample Size Estimation in Clinical Research: From Randomized Controlled Trials to Observational Studies[J]. Chest, 2020,158(1S):S12–S20.
- 67. You Y N, Cho M R, Park J H, et al. Assessing the quality of reports about randomized controlled trials of scalp acupuncture treatment for vascular dementia[J]. Trials, 2017,18(1):205.
- 68. Liu X, Xu Z, Wang Y, et al. Evaluating the Quality of Reports About Randomized Controlled Trials of Acupuncture for Low Back Pain[J]. J Pain Res, 2021,14:1141–1151.
- 69. Armijo-Olivo S, Saltaji H, Da C B, et al. What is the influence of randomisation sequence generation and allocation concealment on treatment effects of physical therapy trials? A meta-epidemiological study[J]. BMJ Open, 2015,5(9):e8562.
- 70. Mitchell A, Moe-Byrne T, Cunningham-Burley R, et al. Poor allocation concealment methods are associated with heterogeneity in age and statistical significance of the primary outcome: Review of recent trials published in four general medical journals[J]. J Eval Clin Pract, 2020,26(4):1316–1319.
- 71. Page S J, Persch A C. Recruitment, retention, and blinding in clinical trials[J]. Am J Occup Ther, 2013,67(2):154–161.
- 72. Arroyo-Fernández R, Avendaño-Coy J, Velasco-Velasco R, et al. A New Approach to Assess Blinding for Transcranial Direct Current Stimulation Treatment in Patients with Fibromyalgia. A Randomized Clinical Trial[J]. Brain Sci, 2021,11(10).
- 73. Hróbjartsson A, Boutron I. Blinding in randomized clinical trials: imposed impartiality[J]. Clin Pharmacol Ther, 2011,90(5):732–736.
- 74. Hróbjartsson A, Emanuelsson F, Skou T A, et al. Bias due to lack of patient blinding in clinical trials. A systematic review of trials randomizing patients to blind and nonblind sub-studies[J]. Int J Epidemiol, 2014,43(4):1272–1283.
- 75. Tu J F, Yang J W, Shi G X, et al. Efficacy of Intensive Acupuncture Versus Sham Acupuncture in Knee Osteoarthritis: A Randomized Controlled Trial[J]. Arthritis Rheumatol, 2021,73(3):448–458.
- 76. Zhao L, Li D, Zheng H, et al. Acupuncture as Adjunctive Therapy for Chronic Stable Angina: A Randomized Clinical Trial[J]. JAMA Intern Med, 2019,179(10):1388–1397.
- 77. Zhou J Y, Zhu L L, Luo L. Design of Placebo − control Methods in Clinical Trial of Acupuncture and Moxibustion[J]. Chinese Archives of Traditional Chinese Medicine, 2017,35(04):1034–1037.
- 78. Laine C, Horton R, DeAngelis C D, et al. Clinical trial registration—looking back and moving ahead[J]. N Engl J Med, 2007,356(26):2734–2736.
- 79. Fan Y, Gu L B, Shen C. Introduction to clinical trial registration in China[J]. Practical Geriatrics, 2021,35(07):665–667.
- 80. MacPherson H, Maschino A C, Lewith G, et al. Characteristics of acupuncture treatment associated with outcome: an individual patient meta-analysis of 17,922 patients with chronic pain in randomised controlled trials[J]. PLoS One, 2013,8(10):e77438.
- 81. Zeng J, Lin G, Li L, et al. Assessment of reporting quality in randomised controlled trials of acupuncture for post-stroke rehabilitation using the CONSORT statement and STRICTA guidelines[J]. Acupunct Med, 2017,35(2):100–106.
- 82. Yang J, Yu F, Lin K, et al. Assessment of Reporting Quality in Randomized Controlled Trials of Acupuncture for Primary Insomnia with CONSORT Statement and STRICTA Guidelines[J]. Evid Based Complement Alternat Med, 2022,2022:5157870.
- 83. Xiu W C, Meng X, Hu X Y, Shi L J, Gang W J, Jing X H. Evaluation of the report quality of Chinese and English randomized controlled trials of acupuncture based on CONSORT statement and STRICTA checklist[J]. Chinese Acupuncture & Moxibustion, 2023,43(03):355–361.
- 84. Yang X, Qin C, Li M, et al. How about the RCTs’ quality of acupuncture treatment for female urinary incontinence in recent 20 years? A report quality assessment[J]. World J Urol, 2023,41(1):197–204.