中国组织工程研究 ›› 2025, Vol. 29 ›› Issue (30): 6566-6573.doi: 10.12307/2025.930
• 组织构建循证医学 evidence-based medicine in tissue construction • 上一篇 下一篇
基于CONSORT声明和STRICTA清单评价针灸推拿治疗枕大神经痛的随机对照试验报告质量
刘利国1，丘明旺2，黄艳玲2，范志勇2，吴 山2，郭汝松2
- 1 广州中医药大学第二临床医学院，广东省广州市 510405；2广州中医药大学第二附属医院，广东省广州市 510120
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收稿日期:2024-10-11接受日期:2024-10-23出版日期:2025-10-28发布日期:2025-03-29 -
通讯作者:吴山，博士，主任医师，博士生导师，博士后合作导师，广州中医药大学第二附属医院，广东省广州市 510120 通讯作者：郭汝松，男，硕士，副主任医师，硕士生导师，广州中医药大学第二附属医院，广东省广州市 510120 -
作者简介:刘利国，男，1996年，广东省东莞市人，汉族，广州中医药大学第二临床医学院在读博士，主要从事岭南林氏正骨推拿的临床研究。 -
基金资助:国家自然科学基金(81874511)，项目负责人：吴山；广东省名中医传承工作室建设项目(102018007)，项目负责人：范志勇；广东省第四批名中医师承项目(102018105)，项目负责人：吴山
Reporting quality of randomized controlled trials on acupuncture and manipulation for greater occipital neuralgia evaluated using the CONSORT statement and STRICTA checklist
Liu Liguo1, Qiu Mingwang2, Huang Yanling2, Fan Zhiyong2, Wu Shan2, Guo Rusong2
- 1Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou 510405, Guangdong Province, China; 2Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510120, Guangdong Province, China
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Received:2024-10-11Accepted:2024-10-23Online:2025-10-28Published:2025-03-29 -
Contact:Wu Shan, MD, Chief physician, Doctoral supervisor, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510120, Guangdong Province, China Corresponding author: Guo Rusong, MS, Associate chief physician, Master’s supervisor, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510120, Guangdong Province, China -
About author:Liu Liguo, Doctoral candidate, Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou 510405, Guangdong Province, China -
Supported by:National Natural Science Foundation of China, No. 81874511 (to WS); Guangdong Province Famous Chinese Medicine Inheritance Studio Construction Project, No. 102018007 (to FZY); Guangdong Province Fourth Batch of Famous Chinese Medicine Apprenticeship Project, No. 102018105 (to WS)
摘要：
文题释义：
CONSORT声明：是一个旨在提高随机对照试验报告质量的国际性倡议，它提供了一套详细的指南，用于指导临床试验作者在撰写研究报告时应该包含哪些关键信息，包括标题和摘要、引言、方法、结果、讨论以及其他信息，并细化为多个具体项和子项。
STRICTA清单：是专门针对针灸的临床试验报告规范。STRICTA清单包括6个主要部分：针灸治疗的合理性、针刺的详细信息、治疗方案、其他干预措施、治疗师背景和对照或比较干预措施。
目的：近年来，针灸推拿疗法治疗枕大神经痛的临床研究报告逐渐增多，但质量参差不齐。目前尚未有文献对已发表报告进行质量评价，这不利于这些疗法的临床使用推广。为此，文章评价了针灸和推拿疗法治疗枕大神经痛随机对照试验的报告质量。
方法：计算机检索Cochrane Library、PubMed、Web of Science、Embase、中国知网、维普、万方和中国生物医学文献数据库，检索时间从各数据库建库至 2024-05-20，由2名研究者使用 CONSORT 声明、STRICTA 清单和 Cochrane 风险偏倚评估工具独立评估纳入随机对照试验的报告质量，由第三位研究者负责解决过程中产生的分歧。
结果：共纳入62篇文献。在 CONSORT 声明的评估中，报告率< 50%的条目占全部条目的59.46%(22/37)，主要包括“文题能识别是随机临床试验(1/62，1.61%)”“如何确定样本量(7/62，11.29%)”“随机的实施(1/62，1.61%)”“盲法(1/62，1.61%)” 和“资金来源(4/62，6.45%)”等项目。在 STRICTA 清单的评估中，报告率< 50%的条目占全部条目的29.41%(5/17)，主要包括“针刺细节(7/58，12.07%)”“治疗的环境和背景(0/58，0%)”和“针灸师的相关描述(0/58，0%)”等项目。
结论：针灸和手法治疗枕大神经痛的随机对照试验报告质量偏低，提示未来的研究人员需要在试验设计、实施和报告过程中严格遵守CONSORT声明及STRICTA清单的要求，这将促进该领域研究的规范化和标准化，增强研究结果的可靠性和可重复性。
https://orcid.org/0000-0003-2314-101X (Liu Liguo); https://orcid.org/0000-0002-7155-9464 (Wu Shan); https://orcid.org/0009-0001-0820-2382 (Guo Rusong)
中国组织工程研究杂志出版内容重点：组织构建；骨细胞；软骨细胞；细胞培养；成纤维细胞；血管内皮细胞；骨质疏松；组织工程
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引用本文
刘利国, 丘明旺, 黄艳玲, 范志勇, 吴 山, 郭汝松. 基于CONSORT声明和STRICTA清单评价针灸推拿治疗枕大神经痛的随机对照试验报告质量[J]. 中国组织工程研究, 2025, 29(30): 6566-6573.
Liu Liguo, Qiu Mingwang, Huang Yanling, Fan Zhiyong, Wu Shan, Guo Rusong. Reporting quality of randomized controlled trials on acupuncture and manipulation for greater occipital neuralgia evaluated using the CONSORT statement and STRICTA checklist[J]. Chinese Journal of Tissue Engineering Research, 2025, 29(30): 6566-6573.
Search results
The initial search yielded 1 020 studies, which were reduced to 479 after removing duplicates. Through preliminary screening of titles and abstracts, 128 relevant studies were selected. After further full-text screening, a total of 62 studies were ultimately included[15-76]. Among them, 60 reports were written in Chinese, and two reports were written in English; however, all reports were published by Chinese researchers. The flow diagram of literature selection is shown in Figure 1.
Information on published papers per year
All the studies were published between 2007 and 2024, with an overall increasing trend in the number of publications. The peak was reached in 2019, with a total of 8 articles published. Details can be found in Figure 2.
Quality of the studies
Risk of bias
The quality of the included literature was evaluated using the Cochrane Collaboration’s tool for assessing the risk of bias. The results indicated that most items were classified as “low risk of bias,” while the proportion of “high risk of bias” items was the lowest, primarily concentrated in the “Random sequence generation” and “Binding of participants and personnel” sections. Specifically, some studies mentioned randomization but did not describe the method used to generate the randomization results, thus being rated as “high risk of bias.” Moreover, although some studies reported the implementation of single blinding in their respective articles, blinding of participants and personnel was deemed impractical considering the designs of the included studies, thereby increasing the potential for performance bias. Low-quality RCTs will produce evidence and results that lack credibility and may even mislead readers and affect the implementation of clinical decision-making. A
CONSORT statement
We conducted a quality report on the 62 included studies according to the CONSORT statement (Table 2). Among the 37 items encompassed within the eight criteria, 15 items had a reporting rate exceeding 50%, with 1 item achieving a 100% reporting rate. Meanwhile, nine items had a reporting rate of 0%, but it is important to note that most of these items are only required to be reported when necessary and are not mandatory. Therefore, their low reporting rates do not necessarily reflect the quality of reporting. Additionally, items with a reporting rate below 50% were mainly concentrated in the following aspects: “Identification as a randomized trial in the title” (1/62, 1.61%), “How sample size was determined” (7/62, 11.29%), “Implementation” (1/62, 1.61%), “Blinding” (1/62, 1.61%) (2/62, 3.23%), “Losses and exclusions after randomization” (19/62, 30.65%), “A table showing baseline data” (21/62, 33.87%), “Reports of Harms” (16/62, 25.81%), “Reports of limitations” (20/62, 32.26%), and “Reports of funding” (4/62, 6.45%). It remains unclear what factors may reduce the credibility of the research results or even lead to misleading conclusions. In the evaluation of the 37 items by two reviewers, 31 items had kappa values greater than 0.8, and the kappa values of the remaining six items were all within the range of 0.6 to 0.8, indicating good overall consistency.
STRICTA checklist
Using the STRICTA checklist, a quality assessment was conducted on the 58 included studies related to acupuncture, as shown in Table 3. Among the 17 items encompassed by the 6 Criteria, 12 items had a reporting rate exceeding 50%, with two items achieving a 100% reporting rate. There were five items with a reporting rate below 50%, among which two items had a 0% reporting rate, precisely “Needle type” (22/58, 37.93%), “Details of other interventions” (7/58, 12.07%), “Setting and context of treatment” (0/58, 0%), “Description of participating acupuncturists” (0/58, 0%), and “Rationale for the control or comparator” (21/58, 36.21%). It remains unknown what factors reduce the reproducibility and authenticity of the research. In the assessment of the 17 detailed items by two evaluators, 14 items had kappa values greater than 0.8, and 3 items ranged from 0.6 to 0.8, indicating good overall consistency.
The initial search yielded 1 020 studies, which were reduced to 479 after removing duplicates. Through preliminary screening of titles and abstracts, 128 relevant studies were selected. After further full-text screening, a total of 62 studies were ultimately included[15-76]. Among them, 60 reports were written in Chinese, and two reports were written in English; however, all reports were published by Chinese researchers. The flow diagram of literature selection is shown in Figure 1.
Information on published papers per year
All the studies were published between 2007 and 2024, with an overall increasing trend in the number of publications. The peak was reached in 2019, with a total of 8 articles published. Details can be found in Figure 2.
Quality of the studies
Risk of bias
The quality of the included literature was evaluated using the Cochrane Collaboration’s tool for assessing the risk of bias. The results indicated that most items were classified as “low risk of bias,” while the proportion of “high risk of bias” items was the lowest, primarily concentrated in the “Random sequence generation” and “Binding of participants and personnel” sections. Specifically, some studies mentioned randomization but did not describe the method used to generate the randomization results, thus being rated as “high risk of bias.” Moreover, although some studies reported the implementation of single blinding in their respective articles, blinding of participants and personnel was deemed impractical considering the designs of the included studies, thereby increasing the potential for performance bias. Low-quality RCTs will produce evidence and results that lack credibility and may even mislead readers and affect the implementation of clinical decision-making. A
CONSORT statement
We conducted a quality report on the 62 included studies according to the CONSORT statement (Table 2). Among the 37 items encompassed within the eight criteria, 15 items had a reporting rate exceeding 50%, with 1 item achieving a 100% reporting rate. Meanwhile, nine items had a reporting rate of 0%, but it is important to note that most of these items are only required to be reported when necessary and are not mandatory. Therefore, their low reporting rates do not necessarily reflect the quality of reporting. Additionally, items with a reporting rate below 50% were mainly concentrated in the following aspects: “Identification as a randomized trial in the title” (1/62, 1.61%), “How sample size was determined” (7/62, 11.29%), “Implementation” (1/62, 1.61%), “Blinding” (1/62, 1.61%) (2/62, 3.23%), “Losses and exclusions after randomization” (19/62, 30.65%), “A table showing baseline data” (21/62, 33.87%), “Reports of Harms” (16/62, 25.81%), “Reports of limitations” (20/62, 32.26%), and “Reports of funding” (4/62, 6.45%). It remains unclear what factors may reduce the credibility of the research results or even lead to misleading conclusions. In the evaluation of the 37 items by two reviewers, 31 items had kappa values greater than 0.8, and the kappa values of the remaining six items were all within the range of 0.6 to 0.8, indicating good overall consistency.
STRICTA checklist
Using the STRICTA checklist, a quality assessment was conducted on the 58 included studies related to acupuncture, as shown in Table 3. Among the 17 items encompassed by the 6 Criteria, 12 items had a reporting rate exceeding 50%, with two items achieving a 100% reporting rate. There were five items with a reporting rate below 50%, among which two items had a 0% reporting rate, precisely “Needle type” (22/58, 37.93%), “Details of other interventions” (7/58, 12.07%), “Setting and context of treatment” (0/58, 0%), “Description of participating acupuncturists” (0/58, 0%), and “Rationale for the control or comparator” (21/58, 36.21%). It remains unknown what factors reduce the reproducibility and authenticity of the research. In the assessment of the 17 detailed items by two evaluators, 14 items had kappa values greater than 0.8, and 3 items ranged from 0.6 to 0.8, indicating good overall consistency.
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Clinical observation on the effect of acupuncture in treating occipital neuralgia. Zhenjiu Linchuang Zazhi. 2011;27(7):29-30. [70] CUI YL. Clinical study on acupuncture treatment of occipital neuralgia. Harbin: Heilongjiang Zhongyiyao Daxue. 2011. [71] CHEN GL. Clinical observation on the effect of acupotomy combined with neck and shoulder functional exercise in treating occipital neuralgia. Fuzhou: Fujian Zhongyiyao Daxue. 2019. [72] GONG C, SHI KS, SONG Y, et al. Clinical effect of acupotomy combined with bone-setting therapy on occipital neuralgia. Shanxi Zhongyi. 2017;38(6):798-799. [73] LI M. Clinical study on zheng’s “golden hook fishing” acupuncture technique in treating occipital neuralgia. Lanzhou: Gansu Zhongyiyao Daxue. 2019. [74] LIU YQ, ZHANG WL, ZHAO FG, et al. Clinical observation on the treatment of occipital neuralgia with acupuncture at finger and toe ends combined with local acupuncture in 30 cases. Hebei Zhongyi. 2013;35(6):892-893. [75] WANG N. Clinical observation on the effect of needle-retention therapy in treating occipital neuralgia. Tianjin: Tianjin Zhongyiyao Daxue. 2020. [76] ZHENG SL, SONG FJ, GE JY, et al. Treatment of occipital neuralgia with lifting-thrusting manipulation under needle-retention state: a report of 60 cases. Shandong Zhongyi Zazhi. 2012;31(10):738-739. [77] ZHANG D, ZHOU L, LI JC, et al. Evaluation of the application effect of online sample size calculation tools in randomized controlled trials. Zhongguo Bingan. 2024;25(8):63-68. [78] LIM CY, IN J. Randomization in clinical studies. Korean J Anesthesiol. 2019; 72(3):221-232. [79] NÚÑEZ-NÚÑEZ M, CANO-IBÁÑEZ N, ZAMORA J, et al. Assessing the integrity of clinical trials included in evidence syntheses. Int J Environ Res Public Health. 2023;20(12):6138. [80] LI HZ, LI B, ZHAO GZ. Methods and improvements in randomization during clinical trials of traditional Chinese medicine. Zhongguo Xinyao ZaZhi. 2019;28(11):1348-1354. [81] CHAN AW, HRÓBJARTSSON A, HAAHR MT, et al. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA. 2004;291(20):2457-2465. [82] DECHARTRES A, RAVAUD P, ATAL I, et al. Association between trial registration and treatment effect estimates: a meta-epidemiological study. BMC Med. 2016;14(1):100. [83] JIAO WWi, LIU KW, SHEN W, et al. Analysis of characteristics of real-world studies on traditional Chinese medicine registered in the chinese clinical trial registry. Shijie Zhongyiyao. 2022;18(1):118-126. [84] ZHU YB, XI XM. The impact of current clinical research methodology on the results of randomized controlled trials. Zhonghua Zhongzheng Yixue Dianzi Zazhi. 2020;6(4):365-369. [85] FEI YT, CAO HJ, XIA RY, et al. Methodological challenges in the design and conduct of randomized controlled trials in acupuncture. BMJ. 2022;376: e064345. [86] ZhANG YQ, LU L, XU N, et al. Increasing the usefulness of acupuncture guideline recommendations. BMJ. 2022;376:e070533. [87] PARKER L, RYAN R, YOUNG S, et al. Medications and doctor-patient communication. Aust J Gen Pract. 2021;50(10):709-714. [88] HE Y, LI N, WANG Q, et al. Factors influencing the quality of acupuncture clinical trials: a qualitative interview of stakeholders. BMC Complement Med Ther. 2023;23(1):326. [89] ZHAO H, LIANG F, FANG Y, et al. Application of Grading of Recommendations Assessment, Development, and Evaluation (GRADE) to the guideline development for clinical practice with acupuncture and moxibustion. Front Med. 2017;11(4):590-594. |
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Introduction
OGreater occipital neuralgia (GON) refers to paroxysmal pain within the distribution range of the greater occipital nerve, which can radiate to the vertex, mastoid process, or external ear[1]. This disease is characterized by a high incidence rate and a wide range of affected populations, and in recent years, the onset of the disease has shown a trend of younger age[2]. Modern medical anatomy reveals that the occipital nerve’s long path and extensive distribution render it susceptible to various neck factors, leading to compression and occipital neuralgia due to local damage, scarring, adhesion, or enlarged lymph node compression[3]. Therefore, relieving the compression during the greater occipital nerve is the key to treating occipital neuralgia.
Multiple treatment options exist for GON, including acupuncture, autonomy, manipulation, oral medication, and surgery. While oral medicines offer swift pain relief, it often accompanies significant side effects. Moreover, surgical intervention is invasive and may not be well-received by patients. As traditional Chinese medicine’s comprehension of GON evolves, there is a growing emphasis on incorporating its therapies into clinical practice. Acupuncture, a prevalent clinical treatment for GON, enhances local blood circulation, facilitates inflammation absorption, and alleviates pain, exhibiting notable clinical efficacy[4]. Furthermore, manipulation techniques can rectify misaligned joints, address neck muscle imbalances, relax tense or spasmodic neck muscles and fascia, and ease nerve entrapment symptoms[5].
Randomized controlled trials (RCTs) are widely regarded as the gold standard in clinical research, representing the primary form of interventional study[6]. These trials effectively mitigate selection and confounding bias, which is crucial for conducting high-quality clinical research[7]. The methodologies employed, the quality of reporting, and the chosen outcome indicators in RCTs directly impact the authenticity and validity of systematic evaluation evidence[8]. Previous meta-analyses have shown that the number of clinical research reports on acupuncture and manipulation therapies for the treatment of GON has gradually increased[9]. However, the quality of these reports is inconsistent. What is more, notably, there is a lack of literature dedicated to evaluating the quality of the published reports, which hinders the advancement and adoption of these therapies. To address this gap, our study utilizes the consolidated standards of reporting trials (CONSORT) statement and the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) checklist to evaluate the reporting quality of RCTs involving acupuncture and manipulation for GON[10-11]. We conducted an in-depth analysis and discussion of the results, aiming to improve the integrity of related clinical trials and promote the standardization of clinical research reporting.
中国组织工程研究杂志出版内容重点：组织构建；骨细胞；软骨细胞；细胞培养；成纤维细胞；血管内皮细胞；骨质疏松；组织工程
OGreater occipital neuralgia (GON) refers to paroxysmal pain within the distribution range of the greater occipital nerve, which can radiate to the vertex, mastoid process, or external ear[1]. This disease is characterized by a high incidence rate and a wide range of affected populations, and in recent years, the onset of the disease has shown a trend of younger age[2]. Modern medical anatomy reveals that the occipital nerve’s long path and extensive distribution render it susceptible to various neck factors, leading to compression and occipital neuralgia due to local damage, scarring, adhesion, or enlarged lymph node compression[3]. Therefore, relieving the compression during the greater occipital nerve is the key to treating occipital neuralgia.
Multiple treatment options exist for GON, including acupuncture, autonomy, manipulation, oral medication, and surgery. While oral medicines offer swift pain relief, it often accompanies significant side effects. Moreover, surgical intervention is invasive and may not be well-received by patients. As traditional Chinese medicine’s comprehension of GON evolves, there is a growing emphasis on incorporating its therapies into clinical practice. Acupuncture, a prevalent clinical treatment for GON, enhances local blood circulation, facilitates inflammation absorption, and alleviates pain, exhibiting notable clinical efficacy[4]. Furthermore, manipulation techniques can rectify misaligned joints, address neck muscle imbalances, relax tense or spasmodic neck muscles and fascia, and ease nerve entrapment symptoms[5].
Randomized controlled trials (RCTs) are widely regarded as the gold standard in clinical research, representing the primary form of interventional study[6]. These trials effectively mitigate selection and confounding bias, which is crucial for conducting high-quality clinical research[7]. The methodologies employed, the quality of reporting, and the chosen outcome indicators in RCTs directly impact the authenticity and validity of systematic evaluation evidence[8]. Previous meta-analyses have shown that the number of clinical research reports on acupuncture and manipulation therapies for the treatment of GON has gradually increased[9]. However, the quality of these reports is inconsistent. What is more, notably, there is a lack of literature dedicated to evaluating the quality of the published reports, which hinders the advancement and adoption of these therapies. To address this gap, our study utilizes the consolidated standards of reporting trials (CONSORT) statement and the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) checklist to evaluate the reporting quality of RCTs involving acupuncture and manipulation for GON[10-11]. We conducted an in-depth analysis and discussion of the results, aiming to improve the integrity of related clinical trials and promote the standardization of clinical research reporting.
中国组织工程研究杂志出版内容重点：组织构建；骨细胞；软骨细胞；细胞培养；成纤维细胞；血管内皮细胞；骨质疏松；组织工程
MATERIALS AND METHODS
Search strategy
Study types
Publicly published RCTs, limited to Chinese and English languages.
Databases
China National Knowledge Infrastructure (CNKI), VIP, WanFang Data, China BioMedical Literature Database (CBM), Cochrane Library, PubMed, Web of Science, and Embase.
Search terms
Chinese search terms were “Tuina, bone setting, spinal correction, manipulation, massage, acupuncture, electroacupuncture, greater occipital neuralgia, occipital neuralgia, clinical observation, randomized controlled trial, efficacy.” English search terms were “massage, manipulation, Tuina, acupuncture, electroacupuncture, auricular, moxibustion, greater occipital neuralgia, randomized controlled trial, random.”
Search timeframe
From inception to May 20, 2024.
Strategy
The details of the search strategy (PubMed) can be found in Table 1.
Inclusion and exclusion criteria
Studies considered for inclusion were required to fulfill the following criteria: Publicly published RCTs, limited to Chinese and English languages; the subjects must be over 18 years old, with no restrictions on gender, age, or case source; there is a transparent and standardized diagnostic criterion for GON[12]; the treatment group was treated with acupuncture or manipulation therapy alone or acupuncture, manipulation combined with other interventions, while the control group receives interventions such as traditional Chinese medicine, medicine, acupuncture, and manipulation.
Studies meeting any of the following criteria were excluded: those that were republished, contained data that could not be extracted or lacked access to the full text.
Study selection and data extraction
Two researchers independently gathered and sorted through the literature, utilizing Note Express 3.2 to handle the collected documents. Initially, any duplicate documents were eliminated. Following this, documents that needed to meet the inclusion criteria were excluded upon reviewing their titles and abstracts. Afterward, the remaining documents underwent a comprehensive reading, allowing for selecting those that adhered to the set criteria. Microsoft Excel 2016 was utilized to construct a data table, compiling details like the title, author, publication year, CONSORT statement, and STRICTA checklist. Two researchers first conducted a pre-extraction round to improve the extraction form’s design and unify extraction standards. Then, they extracted the data independently and completed the data entry after cross-checking. The whole methodology employed was systematically outlined using a flowchart.
Assessment of reporting quality
Two researchers evaluated the quality of each RCT using the CONSORT 2010 Statement and the STRICTA checklist. The CONSORT 2010 Statement consists of six sections, including Title and Abstract, Introduction, Methods, Results, Discussion, and Other Information, and is divided into 25 items and 37 sub-items. The STRICTA checklist[10-11], an extended version of the CONSORT Statement, is mainly used to evaluate the reporting norms of intervention measures in acupuncture RCTs. It includes six sections: Rationality of Acupuncture Treatment, Details of Needling, Treatment Regimen, Other Interventions, Therapist Background, and Control or Comparator Interventions, and is further divided into six items and 17 sub-items. Based on whether each item was reported in the article, the two researchers made a judgment of “reported” or “not reported” item by item. After completing the evaluation, the two researchers cross-checked each other’s work. In case of disagreement, a third party could participate in the adjudication. Finally, the number and percentage of reported articles for each item were calculated.
Cohen’s κ-statistic was quantified to evaluate the interrater agreement[13]. Agreement levels were categorized as follows: 0.20 or less was deemed “poor,” greater than 0.20 but less than 0.40 as “low,” values between 0.40 and 0.60 were considered “moderate,” those between 0.60 and 0.80 were labeled as “substantial,” above 0.80 was classed as “good,” and a perfect score of 1 indicated “perfect” agreement. Items with any disagreement were subject to specific examination to facilitate consensus. The calculation of Cohen’s κ-statistic and the determination of the 95% confidence interval (95%CI) for each item were executed using PASW Statistics for Windows, version 18.0 (SPSS Inc., Released 2009, Chicago, IL, USA).
Risk of bias assessments
The quality of the included literature was evaluated using the Cochrane Collaboration’s tool for assessing the risk of bias[14]. Two researchers independently assessed each item as “low risk,” “unclear risk,” or “high risk” based on criteria such as the random allocation method, allocation concealment, blinding of subjects, blinding in outcome assessment, completeness of outcome data, selective reporting, and other potential sources of bias. In case of any disagreement during the evaluation, a third researcher was consulted to reach a consensus.
Main observational indicators
Quality of the studies.
Search strategy
Study types
Publicly published RCTs, limited to Chinese and English languages.
Databases
China National Knowledge Infrastructure (CNKI), VIP, WanFang Data, China BioMedical Literature Database (CBM), Cochrane Library, PubMed, Web of Science, and Embase.
Search terms
Chinese search terms were “Tuina, bone setting, spinal correction, manipulation, massage, acupuncture, electroacupuncture, greater occipital neuralgia, occipital neuralgia, clinical observation, randomized controlled trial, efficacy.” English search terms were “massage, manipulation, Tuina, acupuncture, electroacupuncture, auricular, moxibustion, greater occipital neuralgia, randomized controlled trial, random.”
Search timeframe
From inception to May 20, 2024.
Strategy
The details of the search strategy (PubMed) can be found in Table 1.
Inclusion and exclusion criteria
Studies considered for inclusion were required to fulfill the following criteria: Publicly published RCTs, limited to Chinese and English languages; the subjects must be over 18 years old, with no restrictions on gender, age, or case source; there is a transparent and standardized diagnostic criterion for GON[12]; the treatment group was treated with acupuncture or manipulation therapy alone or acupuncture, manipulation combined with other interventions, while the control group receives interventions such as traditional Chinese medicine, medicine, acupuncture, and manipulation.
Studies meeting any of the following criteria were excluded: those that were republished, contained data that could not be extracted or lacked access to the full text.
Study selection and data extraction
Two researchers independently gathered and sorted through the literature, utilizing Note Express 3.2 to handle the collected documents. Initially, any duplicate documents were eliminated. Following this, documents that needed to meet the inclusion criteria were excluded upon reviewing their titles and abstracts. Afterward, the remaining documents underwent a comprehensive reading, allowing for selecting those that adhered to the set criteria. Microsoft Excel 2016 was utilized to construct a data table, compiling details like the title, author, publication year, CONSORT statement, and STRICTA checklist. Two researchers first conducted a pre-extraction round to improve the extraction form’s design and unify extraction standards. Then, they extracted the data independently and completed the data entry after cross-checking. The whole methodology employed was systematically outlined using a flowchart.
Assessment of reporting quality
Two researchers evaluated the quality of each RCT using the CONSORT 2010 Statement and the STRICTA checklist. The CONSORT 2010 Statement consists of six sections, including Title and Abstract, Introduction, Methods, Results, Discussion, and Other Information, and is divided into 25 items and 37 sub-items. The STRICTA checklist[10-11], an extended version of the CONSORT Statement, is mainly used to evaluate the reporting norms of intervention measures in acupuncture RCTs. It includes six sections: Rationality of Acupuncture Treatment, Details of Needling, Treatment Regimen, Other Interventions, Therapist Background, and Control or Comparator Interventions, and is further divided into six items and 17 sub-items. Based on whether each item was reported in the article, the two researchers made a judgment of “reported” or “not reported” item by item. After completing the evaluation, the two researchers cross-checked each other’s work. In case of disagreement, a third party could participate in the adjudication. Finally, the number and percentage of reported articles for each item were calculated.
Cohen’s κ-statistic was quantified to evaluate the interrater agreement[13]. Agreement levels were categorized as follows: 0.20 or less was deemed “poor,” greater than 0.20 but less than 0.40 as “low,” values between 0.40 and 0.60 were considered “moderate,” those between 0.60 and 0.80 were labeled as “substantial,” above 0.80 was classed as “good,” and a perfect score of 1 indicated “perfect” agreement. Items with any disagreement were subject to specific examination to facilitate consensus. The calculation of Cohen’s κ-statistic and the determination of the 95% confidence interval (95%CI) for each item were executed using PASW Statistics for Windows, version 18.0 (SPSS Inc., Released 2009, Chicago, IL, USA).
Risk of bias assessments
The quality of the included literature was evaluated using the Cochrane Collaboration’s tool for assessing the risk of bias[14]. Two researchers independently assessed each item as “low risk,” “unclear risk,” or “high risk” based on criteria such as the random allocation method, allocation concealment, blinding of subjects, blinding in outcome assessment, completeness of outcome data, selective reporting, and other potential sources of bias. In case of any disagreement during the evaluation, a third researcher was consulted to reach a consensus.
Main observational indicators
Quality of the studies.
DISCUSSION
Our research findings indicate that the reporting quality of RCTs on GON is mostly low. Many researchers pay inadequate attention to crucial elements such as title writing rules, methods for determining sample size, allocation concealment of interventions, blinding, complete trial reporting, detailed intervention implementation, and trial registration. Addressing these shortcomings, we identify the following reasons: (1) Trial designers and executors lack standardized and unified training in clinical trial fundamentals, leading to inadequate awareness of clinical trial reporting. (2) Human subjects introduce numerous uncontrollable factors into trials. (3) Researchers tend to reference literature with low reporting quality excessively. The abundance of low-quality literature poses significant challenges for researchers in understanding the rationality of study designs. In response, we propose the following recommendations.
Before initiating trials, clinical trial executors should undergo standardized training in fundamental clinical trial knowledge. The title format should be standardized, incorporating terms like “randomized” to avoid misdetections or misleading information that could impair readers’ interpretation and utilization of research results. Emphasis should be placed on sample size calculation to prevent credibility reduction due to insufficient sample sizes or unnecessary waste from excessive inclusion[77]. Accurate and comprehensive recording of all trial data, including patient conditions, intervention details, adverse reactions during the trial, and follow-up situations, enhances the reliability of trial results and enables readers to evaluate them more objectively.
The principles of randomization and blinding are the cornerstones of clinical trials, capable of eliminating chance bias to a great extent and crucial for ensuring the credibility of intervention outcomes[78-79]. However, most of the RCTs in this study needed more rigor in their execution and provided inadequate reporting on the randomization and blinding components required by the CONSORT statement. Some studies merely mentioned the terms “Randomization” and “Binding” without describing the specific randomization methods and the success of blinding implementation in detail. Studies have shown that different randomization methods and their strict implementation processes significantly impact trial results, and a lack of sufficient allocation concealment may lead to an exaggeration of intervention effects by 30%–40%[80]. We recommend adopting random schemes such as computer-generated random number tables and random lot drawings for randomization in future RCTs. For blinding implementation, acupuncture trials should include a sham acupuncture group for blinded control, using specially designed needles to conceal the specific intervention from both operators and patients. While blinding implementation in massage-related clinical trials is challenging, efforts should still be made, as partial implementation is preferable to none.
Trial registration should be prioritized to enhance research transparency and help reduce publication bias and overestimating effect sizes[81-82]. Despite the increasing number of clinical trials in China in recent years, the attention given to trial registration among clinical trial researchers remains low[83]. In this study, none of the included studies reported the name or registration number of the clinical registration authority. This lack of information prevents readers from tracing the trial process and results, making it difficult to assess whether incomplete or selective reporting exists[84]. We recommend that researchers register their trials with the Chinese Clinical Trial Registry and that research institutions strengthen the supervision of trial registration and encourage researchers to register their trials.
The details of acupuncture interventions should be reported more thoroughly. According to the evaluation results of the STRICTA checklist, the included literature is lacking in reports on aspects such as “Needle type,” “Details of other interventions,” “Setting and context of treatment,” “Description of participating acupuncturists,” and “Rationale for the control or comparator,” which is consistent with some current research findings[85]. Given the specificity of different acupuncture points due to their locations, the selected needles and manipulation methods also vary, and these details need to be reported in detail. Otherwise, it will be unfavorable for trial reproducibility and limit the ability of clinicians to implement acupuncture treatments recommended in research reports[86]. Additionally, the years of practice experience of participating acupuncturists significantly impact treatment outcomes. Research indicates that differences in clinical experience among acupuncturists may influence treatment effects, and doctors with more experience and training are positively correlated with better treatment outcomes[87]. What is more, during the diagnosis and treatment process, communication between doctors and patients, as well as the environment provided for treatment, can enhance or reduce the overall effectiveness of the intervention[88], and the rationality of control measures is also related to the value that trial results can demonstrate[89]. Therefore, these details should all be reported in detail.
Finally, journals should also undertake the task of reviewing paper reporting quality. As a crucial step in paper acceptance and publication, journals should strive to minimize the acceptance of poorly reported papers. One specific measure could be to require authors to provide a CONSORT evaluation report of their articles during submission.
This study has its own deficiencies. (1) This study did not include clinical studies conducted abroad, indicating a possible problem of insufficient representation of foreign literature. (2) RCTs were only searched in Chinese and English databases, so RCTs in other languages may be missed.
Based on our assessment, while there are numerous RCTs on acupuncture and manipulation for GON, their reporting quality remains low, falling short of relevant regulatory requirements. This significantly hinders the development of acupuncture and manipulation for GON. Future researchers need to make greater efforts to strictly adhere to the CONSORT statement and STRICTA checklist during trial design, implementation, and reporting. By doing so, we can achieve high-quality reporting of randomized controlled trials and provide more reliable evidence for clinical decision-making.
中国组织工程研究杂志出版内容重点：组织构建；骨细胞；软骨细胞；细胞培养；成纤维细胞；血管内皮细胞；骨质疏松；组织工程
Our research findings indicate that the reporting quality of RCTs on GON is mostly low. Many researchers pay inadequate attention to crucial elements such as title writing rules, methods for determining sample size, allocation concealment of interventions, blinding, complete trial reporting, detailed intervention implementation, and trial registration. Addressing these shortcomings, we identify the following reasons: (1) Trial designers and executors lack standardized and unified training in clinical trial fundamentals, leading to inadequate awareness of clinical trial reporting. (2) Human subjects introduce numerous uncontrollable factors into trials. (3) Researchers tend to reference literature with low reporting quality excessively. The abundance of low-quality literature poses significant challenges for researchers in understanding the rationality of study designs. In response, we propose the following recommendations.
Before initiating trials, clinical trial executors should undergo standardized training in fundamental clinical trial knowledge. The title format should be standardized, incorporating terms like “randomized” to avoid misdetections or misleading information that could impair readers’ interpretation and utilization of research results. Emphasis should be placed on sample size calculation to prevent credibility reduction due to insufficient sample sizes or unnecessary waste from excessive inclusion[77]. Accurate and comprehensive recording of all trial data, including patient conditions, intervention details, adverse reactions during the trial, and follow-up situations, enhances the reliability of trial results and enables readers to evaluate them more objectively.
The principles of randomization and blinding are the cornerstones of clinical trials, capable of eliminating chance bias to a great extent and crucial for ensuring the credibility of intervention outcomes[78-79]. However, most of the RCTs in this study needed more rigor in their execution and provided inadequate reporting on the randomization and blinding components required by the CONSORT statement. Some studies merely mentioned the terms “Randomization” and “Binding” without describing the specific randomization methods and the success of blinding implementation in detail. Studies have shown that different randomization methods and their strict implementation processes significantly impact trial results, and a lack of sufficient allocation concealment may lead to an exaggeration of intervention effects by 30%–40%[80]. We recommend adopting random schemes such as computer-generated random number tables and random lot drawings for randomization in future RCTs. For blinding implementation, acupuncture trials should include a sham acupuncture group for blinded control, using specially designed needles to conceal the specific intervention from both operators and patients. While blinding implementation in massage-related clinical trials is challenging, efforts should still be made, as partial implementation is preferable to none.
Trial registration should be prioritized to enhance research transparency and help reduce publication bias and overestimating effect sizes[81-82]. Despite the increasing number of clinical trials in China in recent years, the attention given to trial registration among clinical trial researchers remains low[83]. In this study, none of the included studies reported the name or registration number of the clinical registration authority. This lack of information prevents readers from tracing the trial process and results, making it difficult to assess whether incomplete or selective reporting exists[84]. We recommend that researchers register their trials with the Chinese Clinical Trial Registry and that research institutions strengthen the supervision of trial registration and encourage researchers to register their trials.
The details of acupuncture interventions should be reported more thoroughly. According to the evaluation results of the STRICTA checklist, the included literature is lacking in reports on aspects such as “Needle type,” “Details of other interventions,” “Setting and context of treatment,” “Description of participating acupuncturists,” and “Rationale for the control or comparator,” which is consistent with some current research findings[85]. Given the specificity of different acupuncture points due to their locations, the selected needles and manipulation methods also vary, and these details need to be reported in detail. Otherwise, it will be unfavorable for trial reproducibility and limit the ability of clinicians to implement acupuncture treatments recommended in research reports[86]. Additionally, the years of practice experience of participating acupuncturists significantly impact treatment outcomes. Research indicates that differences in clinical experience among acupuncturists may influence treatment effects, and doctors with more experience and training are positively correlated with better treatment outcomes[87]. What is more, during the diagnosis and treatment process, communication between doctors and patients, as well as the environment provided for treatment, can enhance or reduce the overall effectiveness of the intervention[88], and the rationality of control measures is also related to the value that trial results can demonstrate[89]. Therefore, these details should all be reported in detail.
Finally, journals should also undertake the task of reviewing paper reporting quality. As a crucial step in paper acceptance and publication, journals should strive to minimize the acceptance of poorly reported papers. One specific measure could be to require authors to provide a CONSORT evaluation report of their articles during submission.
This study has its own deficiencies. (1) This study did not include clinical studies conducted abroad, indicating a possible problem of insufficient representation of foreign literature. (2) RCTs were only searched in Chinese and English databases, so RCTs in other languages may be missed.
Based on our assessment, while there are numerous RCTs on acupuncture and manipulation for GON, their reporting quality remains low, falling short of relevant regulatory requirements. This significantly hinders the development of acupuncture and manipulation for GON. Future researchers need to make greater efforts to strictly adhere to the CONSORT statement and STRICTA checklist during trial design, implementation, and reporting. By doing so, we can achieve high-quality reporting of randomized controlled trials and provide more reliable evidence for clinical decision-making.
中国组织工程研究杂志出版内容重点：组织构建；骨细胞；软骨细胞；细胞培养；成纤维细胞；血管内皮细胞；骨质疏松；组织工程
文章系统回顾并评估了针灸与推拿治疗枕大神经痛的随机对照试验报告质量，通过搜索8大中英文数据库，纳入了62项研究进行综合分析。研究采用了CONSORT声明、STRICTA清单以及 Cochrane 偏倚风险评估工具等国际公认的报告标准，对纳入的文献进行了全面、细致的质量评价，为针灸与推拿治疗枕大神经痛的疗效和安全性提供了有力的证据支持。此外，文章还指出了当前研究的不足，旨在提高相关临床试验的完整性，促进临床研究报告的标准化。#br#
中国组织工程研究杂志出版内容重点：组织构建；骨细胞；软骨细胞；细胞培养；成纤维细胞；血管内皮细胞；骨质疏松；组织工程#br#
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