[Evaluation of the reporting quality of randomized controlled trials of acupuncture for depression based on CONSORT statement, STRICTA criteria and SHARE checklist].

OBJECTIVE: To evaluate the reporting quality of randomized controlled trials (RCTs) of acupuncture for depression. METHODS: Systematic searches were performed in PubMed, the Cochrane Library, EMbase, CNKI, Wanfang, SinoMed and VIP Database for RCTs of acupuncture in treatment of depression. The search time was from the establishment of database to December 1, 2023, and the language restriction was Chinese and English. The reporting quality of RCTs of acupuncture for depression was evaluated using the CONSORT statement, the international standardization for trial reporting, STRICTA, the international standard for clinical trial interventions of acupuncture, and SHARE, the guideline and checklist for reporting sham acupuncture controls. RESULTS: According to the CONSORT statement items, the items with the reporting rate less than 50% was accounted for 54.05% of all of the items for Chinese articles, and there were 8 and 1 items with a reporting rate of 0% and 100%, respectively. For the English articles, the items with the reporting rate less than 50% was accounted for 35.14% of all of the items, and there were 3 and 7 items with a reporting rate of 0% and 100%, respectively. The reporting rate of 15 items in Chinese and English articles was greater than 50%, e.g. structured abstract, background and purpose. Based on STRICTA criteria, the reporting rate of either Chinese or English articles was relatively high. The items for Chinese articles with the reporting rate less than 50% was accounted for 23.53% of all of the items, and there were 1 and 4 items with a reporting rate of 0% and 100%, respectively. For English articles, the items with the reporting rate less than 50% was accounted for 11.76% of all of the items, and there was 1 item with a reporting rate of either 0% or 100%. In compliance with SHARE checklist, the reporting rate was low for either Chinese or English articles. The items with the reporting rate less than 50% was accounted for 57.89% of all of the items for Chinese articles, and there were 2 and 0 items with a reporting rate of 0% and 100%, respectively. For English articles, the items with the reporting rate less than 50% was accounted for 52.63% of all of the items, and there was 1 item with a reporting rate of 0% and 100%, respectively. CONCLUSION: The overall reporting quality of RCTs of acupuncture for depression is low currently. It is urgent to enhance the reporting of the details on sham acupuncture control especially. It is suggested that RCTs should be reported strictly in compliance with the CONSORT statement, STRICTA criteria, and SHARE checklist in the future.

Key issues in the STRICTA checklist. / 对STRICTAæ¸ å•å‡ ä¸ªå ³é”®é—®é¢˜çš„æ¢³ç†.

The STRICTA checklist is the guideline for reporting clinical trials undertaken using acupuncture intervention. As an extension of the CONSORT checklist, the STRICTA checklist facilitates the reporting quality of acupuncture clinical trials. The clinical research paradigm changes along with the development of science and technology. It is crucial to ensure whether or not the existing STRICTA checklist guides the reporting clinical trials of acupuncture now and in the future as well. This paper introduces the development and the updating procedure of the STRICTA checklist, analyzes the characteristics of utility and the limitation, and proposes several suggestions on the difficulties and challenges encountered in the implementation of the STRICTA checklist of current version so as to advance the further update and improvement.

[Considerations of methods for developing patient versions of guidelines and their application for acupuncture].

Currently, there is no international standard for the methodology of patient versions of guideline development. In China, the development of patient versions of guidelines is still in its infancy, and there are no registered or published patient versions of guidelines in the field of acupuncture. This paper introduces two methods of developing patient versions of guidelines: directly converting clinical practice guidelines into patient versions guidelines and developing patient versions of guidelines independently. The relationship and differences between patient guidelines and clinical practice versions of guidelines are compared. By integrating the unique characteristics of acupuncture, this paper analyzes and discusses the significance, problems, and challenges of developing patient versions of guidelines in the field of acupuncture, aiming to provide methodological references for the future development of acupuncture patient versions of guidelines.

Efficacy of Laser Acupuncture for Treatment of Chronic Low Back Pain: A Systematic Review and Meta-Analysis.

OBJECTIVE: To summarize and systematically analyze the efficacy of laser acupuncture (LA) interventions in reducing pain scores in patients suffering from chronic low back pain (LBP). METHODS: PubMed, EMBASE, and Scopus databases were searched for randomized controlled trials, published in peer-reviewed journals, and reporting LA interventions in patients with chronic LBP. All included studies had a comparison group of patients, receiving placebo treatment, sham intervention, conventional therapy, or no treatment. The outcome of interest was the pain intensity score. Pooled effect estimates were calculated using random-effects models and reported as weighted mean difference (WMD) with 95% confidence intervals (CI). RESULTS: A total of 20 studies were included. Compared to the control group, patients who underwent LA experienced a significant reduction in reported pain scores immediately after completing the treatment (WMD -1.14, 95% CI: -1.68 to -0.61). High dose of LA was associated with a more significant decrease in the pain scores (WMD -1.40, 95% CI: -1.94 to -0.85; N = 15, I2 = 81.0%). However, reported pain scores of patients who received LA were statistically similar to those of the control group at short-term (4-8 weeks after the treatment) and long-term (12 months) follow-ups. CONCLUSIONS: In patients with chronic LBP, LA may help in alleviating pain immediately after the treatment. However, this effect does not appear to be sustained on later follow-up assessments. Consequently, patients should be informed about the potential limitations of the treatment in providing lasting pain relief.

Analysis on the location of scalp acupuncture lines based on the 2021 version of Standardized Manipulations of Acupuncture and Moxibustion--Part 2： Scalp Acupuncture. / 2021版《针灸技术操作规范（第2部分）：头针》头穴线定位疑析.

In order to better promote the popularization and application of the national standard of Standardized Manipulations of Acupuncture and Moxibustion--Part 2： Scalp Acupuncture (GB/T 21709.2-2021), and to provide reference for the improvement and formulation of the next version, in the present paper, the differences about the position descriptions of two scalp acupuncture lines Dingnie Qianxiexian (anterior oblique line of vertex-temporal, MS6) and Dingpangxian 1 (lateral line 1 of vertex, MS8) between the new (GB/T 21709.2-2021) and old (GB/T 21709.2-2008) versions of the national standards as well as the International Standard Proposal of Scalp Acupuncture Point were compared, and the disputes still existing in the 2021 version were discussed. Although the 2021 version has made relevant amendments in some controversial or non-standard contents in the 2008 version, there are still some inappropriate contents. Firstly, only the relevant revision in the attached figure 3 was mentioned in the preface, without mention of the word revision about MS6 in both English and Chinese, but actually "Chengguang" (BL6) has been changed to "Tongtian" (BL7). Secondly, The attached figure does not match the word description. There is a revision in the attached figure and text at the same time, in which the text description of Qianding (GV21) of the MS6 has not been revised, but the front Shencong (EX-HN1) in the attached figure has been changed to GV21, which is obviously inconsistent with the positioning of the MS6 according to the WHO international standard, and the basis for the revision is not known. These revisions of the 2021 version of national standard on the position of the two scalp acupoint lines in the 2008 version are inconsistent, which may make many colleagues in the acupuncture field confused. Thus, further revision is necessary.

Practice recommendations for physiotherapists in Canada managing adverse events associated with acupuncture.

In Canada, acupuncture is a regulated medical practice that involves inserting thin needles at specific points on the body to alleviate pain and other health conditions. Acupuncture is a controlled act in physiotherapy practice. Therefore, physiotherapists who incorporate acupuncture into their practice should have the necessary education and roster this controlled act with the regulatory college in their province. Although acupuncture can be helpful, potential complications can arise, ranging from minor bruising to life-threatening conditions such as pneumothorax and cardiac tamponade. This article provides information on the potential adverse effects of acupuncture and provides recommendations for physiotherapists regarding prevention and management of any incidents that may arise during treatment.

Investigation of combined treatment of acupuncture and neurofeedback for improving cognitive function in mild neurocognitive disorder: A randomized, assessor-blind, pilot study.

BACKGROUND: Mild neurocognitive disorder (MND) is an intermediate state that can progress to dementia, and the cognitive reserve of MND is an important task in preventing dementia. Acupuncture and neurofeedback (NF) training have been used to improve cognitive function and treat MND or dementia, but their effectiveness remains controversial. In this trial, we will evaluate the efficacy and safety of combined NF-acupuncture treatment in comparison with single acupuncture treatment. METHODS AND DESIGN: This study is a randomized, assessor-blind, pilot trial. It is designed in accordance with the Standards for Reporting Interventions in Controlled Trials of Acupuncture. A total of 44 MND participants who meet the inclusion and exclusion criteria will be enrolled, and each will be randomly assigned to 1 of 2 groups of 22 subjects. Each subject will visit 24 times over 12 weeks and receive either acupuncture or NF-acupuncture combined treatment. At visit 25 (week 13), a follow-up evaluation will be performed, and then the investigator will analyze the results. The primary outcome is defined by the Korean version of the Montreal Cognitive Assessment score from screening to visit 25. The secondary outcome includes the following: change in Alzheimer Disease Assessment Scale-Cognitive, the Korean version of the Beck Depression Inventory, Body Awareness Questionnaire, delayed matching to sample task scores, and functional near-infrared spectroscopy values, from visit 1 to visit 25; heart rate variability values from visit 1 to visit 5, visit 9, visit 13, visit 21, visit 25; breath per minute values from visit 1 to visit 1 to 25. DISCUSSION: We will evaluate the effectiveness and safety of combined NF-acupuncture therapy, and expect that it will serve as the basis for the use of NF together with acupuncture in the clinical setting. TRIAL REGISTRATION NUMBER: KCT0004972 (registered in Clinical Research Information Service of the Republic of Korea, https://cris.nih.go.kr/cris/search/detailSearch.do/16239).

Acupuncture treatment of glaucoma based on radar plots: A protocol for an overview of systematic reviews.

BACKGROUND: Glaucoma is the second most blinding eye disease in the world. Currently, lowering the intraocular pressure through various methods is the main treatment of glaucoma. Acupuncture has been effectively and safely used in the treatment of glaucoma. However, the evidence for the efficacy of acupuncture in the treatment of glaucoma is controversial, leading to inconsistent findings from systematic evaluations at abroad and home. Therefore, this protocol aims to provide a multivariate evaluation on the quality of evidences from current systematic reviews (SRs) and/or meta-analyzes (MAs) of acupuncture in the treatment of glaucoma, and literature quality, thus providing an intuitive and reliable evidence synthesis and basis for clinical decision making. METHODS: MAs/SRs about the acupuncture treatment of glaucoma will be searched online, including Chinese Biomedical Literature Database (CBM), China Science and Technology Journal Database (VIP), China National Knowledge Infrastructure (CNKI), WanFang Database (WF), Web of Science, Embase, PubMed, and Cochrane Library. Two investigators will independently screen literatures according to inclusion and exclusion criteria and extract data. A multivariate evaluation of the included literature will be performed by depicting radar plots in 6 aspects as follows: Year of publication, study type, SRs assessment through the Assessment of Multiple Systematic Reviews 2 (AMSTAR 2), literature quality assessment through the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA), homogeneity, and publication bias. The Grading of Recommendations Assessment, Development, and Evaluation evidence quality assessment tool will be used to grade and evaluate the quality of outcome indicators of the included literatures. RESULTS: This study will be submitted for publication in a peer-reviewed journal. CONCLUSION: We would like to provide a visual and scientific approach for clinical decision making of acupuncture treatment of glaucoma through a accessible and useful assessment of systematic reviews.

Comparison of therapeutic effects of different acupuncture and moxibustion therapies on irritable bowel syndrome: A protocol for systematic review and network meta-analysis.

BACKGROUND: Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder with recurrent abdominal pain and changes in bowel habits. Many pieces of evidence show that acupuncture and moxibustion therapy has advantages in the treatment of IBS, but there are many acupuncture and moxibustion therapy options, each of which has different therapeutic effects. This study will evaluate the clinical efficacy of different acupuncture and moxibustion therapies in the treatment of IBS by means of a network meta-analysis. METHODS: According to the retrieval strategy, we retrieved the randomized controlled trials of acupuncture and moxibustion treatment of IBS from China National Knowledge Infrastructure, Wanfang, VIP, Chinese biomedical databases, PubMed, Embase, Web of Science, and the Cochrane Library databases from the database establishment to July 2021. We assessed the quality of the studies using the Cochrane Risk Bias Assessment Tool and assessed the strength of the evidence using the Grading of Recommendation Assessment, Development, and Evaluation methodology. All data analyses were performed by RevMan5.3, Gemtc 0.14.3, and Stata 14.0. RESULTS: This study evaluated the efficacy of different acupuncture and moxibustion therapies in the treatment of IBS by evaluating the clinical efficacy rate, symptom scores, quality of life scores, adverse reactions, etc, and further explore the mechanism of action of each therapy. CONCLUSION: This study will provide a reliable evidence-based basis for selecting the best acupuncture and moxibustion therapy for IBS. ETHICS AND DISSEMINATION: Private information from individuals will not be published. This systematic review also does not involve endangering participant rights. Ethical approval will not be required. The results may be published in a peer-reviewed journal or disseminated at relevant conferences. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/3278Y.

Efficacy and safety of acupuncture combined with Chinese Herbal Medicine for diabetic nephropathy: A protocol for systematic review and meta-analysis.

BACKGROUND: Diabetic nephropathy (DN) is one of the most serious complications in the development of diabetes mellitus, which has become the main cause of end-stage renal disease and one of the main causes of death in diabetic patients. With the prevalence of diabetes, the number of patients at risk for developing DN is increasing, with 20-40 percent of all patients with diabetes at risk for developing DN. Acupuncture and Chinese herbal medicine treatments are often combined to treat DN; however, there has been no meta-analysis on their synergistic effects. Therefore, we aimed to perform a systematic review and meta-analysis to estimate the effectiveness of acupuncture combined with Chinese herbal medicine for DN treatment. METHODS: Nine electronic databases were retrieved for this study. The English databases mainly retrieved PubMed, Web of Science, Embase, AMED, and the Cochrane Library, while the CNKI, VIP, CBM, and Wanfang databases were used to retrieve the Chinese literature. There is no definite time limit for the retrieval literature, and the languages are limited to Chinese and English. We will consider articles published between database initiation and August 2021. We used Review Manager 5.4, provided by the Cochrane Collaborative Network for statistical analysis. Clinical randomized controlled trials related to acupuncture combined with Chinese herbal medicine for DN were included in this study. Research selection, data extraction, and research quality assessments were independently completed by two researchers. We then assessed the quality and risk of the included studies and observed the outcome measures. RESULTS: This study provides a high-quality synthesis to assess the effectiveness and safety of acupuncture combined with Chinese herbal medicine for treating DN. CONCLUSION: This systematic review will provide evidence to determine whether acupuncture combined with Chinese herbal medicine is an effective and safe intervention for patients with DN. ETHICS AND DISSEMINATION: The protocol of the systematic review does not require ethical approval because it does not involve humans. This article will be published in peer-reviewed journals and presented at relevant conferences. REGISTRATION NUMBER: INPLASY202180018.

Acupuncture and moxibustion combined with cupping for the treatment of post-herpetic neuralgia: A meta-analysis.

BACKGROUND: There are still controversies between the curative effect of acupuncture combined with cupping therapy and western medicine for post-herpetic neuralgia (PHN). Our meta-analysis fully incorporates the research of acupuncture combined with cupping therapy versus Western medicine for PHN, aiming to explore the difference in the efficacy of the 2 therapies, so as to provide guidance for clinical treatment. METHODS: We searched PubMed, Embase, Cochrane Library, CNKI, Wanfang, CQVIP, CBM, from establishment of the database to September, 2020. Include studies that are clearly defined as PHN or herpes zoster, and exclude duplicate publications; studies with no full text, incomplete information, or inability to extract data; the definition of exposure is quite different from most literature; animal experiments. RESULTS: The total effective rate (relative ratio [RR] = 1.21, 95% confidence interval [CI]: 1.12-1.31) and the rate of remarkable effect (RR = 1.46, 95% CI: 1.30-1.63) of acupuncture and moxibustion combined with cupping in the treatment of PHN were significantly higher than that of conventional western medicine. The visual analogue scale score of acupuncture and moxibustion combined with cupping for PHN was significantly lower than that of conventional western medicine treatment (WMD = -1.77, 95% CI [-2.79, -0.75]). In addition, acupuncture and moxibustion combined with cupping therapy significantly reduced the occurrence of PHN compared with conventional western medicine treatment after treatment of acute herpes zoster (RR = 0.30, 95% CI: 0.20-0.45). In order to explore the differences in the efficacy and preventive effects of different types of acupuncture and cupping therapy, we have further conducted a subgroup analysis. CONCLUSION: The effect of acupuncture and moxibustion combined with cupping in the treatment of PHN is significantly higher than that of conventional western medicine, and it can significantly prevent the occurrence of PHN. Chinese medicine should be used more widely in the treatment of PHN.

Acupuntura en la recuperación de la anestesia general en pacientes intervenidas quirúrgicamente de nódulo de mama / Acupuncture in the recovery from general anesthesia in patients who underwent a breast nodule surgery

RESUMEN Introducción: en el período de recuperación de la anestesia general se deben metabolizar los medicamentos empleados y restablecer las alteraciones fisiológicas. La acupuntura es un método de tratamiento que ha sido estudiado en el período perioperatorio con diferentes fines; sin embargo, es menos conocido su efecto en la recuperación de la anestesia general. Objetivo: describir el efecto de la estimulación con Acupuntura en la recuperación de la anestesia general balanceada en pacientes intervenidas quirúrgicamente por nódulo de mama. Materiales y métodos: se realizó un estudio observacional prospectivo, en 60 pacientes intervenidas quirúrgicamente de nódulo de mama con anestesia general endotraqueal balanceada, de enero de 2014 a enero de 2016, en el Hospital Provincial Docente José Ramón López Tabrane, de Matanzas. Se conformaron dos grupos: grupo I, al que al finalizar la cirugía se le colocaron agujas de acupuntura en los puntos R1, Du26 y P9; y grupo II, al que no se le realizó acupuntura. El efecto de la acupuntura en la recuperación anestésica se midió a través de la Escala de Aldrete. Resultados: la edad de mayor incidencia fue de 40 a 49 años. El estado físico de las pacientes, según la Sociedad Americana de Anestesiología, es I. Prevaleció un tiempo anestésico de 61 a 90 minutos. Más del 75 % de las féminas tuvieron un tiempo de recuperación anestésica entre 31 y 60 minutos. Se presentaron dos complicaciones leves atribuibles a la acupuntura. Conclusiones: la aplicación de la acupuntura acortó el tiempo de recuperación anestésica en las pacientes estudiadas (AU).

ABSTRACT Introduction: in the recovery period from general anesthesia the used drugs should be metabolized and the physiological alterations restored. Acupuncture is a treatment method that has been studied in the perioperative period with different aims; nevertheless its effect on the recovery from general anesthesia is less well known. Objective: to describe the acupuncture stimulation effect on the recovery from general balanced anesthesia in patients who underwent a breast nodule surgery. Materials and methods: a prospective, observational study was performed in 60 patients who underwent a surgery of breast nodule with balanced endotracheal general anesthesia, from January 2014 to January 2016, at the Provincial Teaching Hospital "Jose Ramon Lopez Tabrane" of Matanzas. Two groups were formed: group I included patients to whom acupuncture needles were placed in R1, Du 26 and P9 acupoints after surgery, and Group II patients to whom acupuncture was not performed. The acupuncture effect on anesthetic recovery was assessed using the Aldrete Scale. Two groups were formed: group I, whose members at the end of the surgery were placed acupuncture needles to in the points R1, Du26 and P9; and group II, whose members did not receive acupuncture. The effect of acupuncture on anesthetic recovery was measured through the Aldrete Scale. Results: the highest incidence age was 40 to 49 years. The physical condition of the patients, according to the American Society of Anesthesiology, was I. An anesthetic time of 61 to 90 minutes prevailed. More than 75% of the women had an anesthetic recovery time between 31 and 60 minutes. There were two minor complications attributable to acupuncture. Conclusions: acupuncture application shortened the anesthetic recovery time in the studied patients (AU).

RIGHT for acupuncture: An extension of the RIGHT statement for clinical practice guidelines on acupuncture.

OBJECTIVE: In 2017, the International Standard for Reporting Items for practice Guideline in HealThcare (RIGHT) published reporting guidelines to enhance transparency and clarity in the process of developing clinical practice guidelines (CPGs). Given the original tool was developed in 2017 and demanded in developing and reporting high quality of acupuncture CPGs, an extension with a focus on a specific reporting checklist was warranted. STUDY DESIGN AND SETTING: The study was designed based on the methodology recommended by the Enhancing the Quality and Transparency Of Health Research (EQUATOR) Network with modification accordingly. A reporting checklist and its elaboration and explanations for users were developed. RESULTS: A checklist of seven sections (Basic information, Background, Evidence, Recommendations, Funding, Declaration and management of interest, Other information), twenty-three first level items and forty-three second level items was developed. We clarified the rationales of the items and provided explanations and examples of each item for additional guidance. CONCLUSION: The RIGHT for Acupuncture checklist identifies a set of items to be reported when reviewing clinical practice guidelines on acupuncture. This extension can be expected to improve the reporting quality of CPGs on acupuncture.

Efficacy and safety of acupuncture combined with analgesics on lung cancer pain: A protocol for systematic review and meta-analysis.

BACKGROUND: Lung cancer (LC) is the malignant tumor with the highest incidence in the world, and treatment methods include surgery, radiotherapy, chemotherapy, and immunotherapy. Cancer pain is a common symptom in patients with LC, and the clinical treatment is to relieve it with analgesics. Acupuncture can relieve cancer pain. This study aims to systematically study the efficacy and safety of acupuncture combined with analgesics on cancer pain in patients with LC. METHODS: From the beginning to April 2021, search Medline, Embase, Cochrane Central Controlled Trials Register (Central), China National Knowledge Infrastructure (CNKI), Wanfang Database, China Biomedical Literature Database (CBM), and Chinese Science Journal Database (VIP database). Search the international clinical trial registration platform and the Chinese clinical trial registration platform to find ongoing or unpublished trials. The main outcome indicator is the total effective rate of analgesia, and the secondary outcome indicator is pain intensity score and adverse reactions. The RevMan 5.4 software will be used for statistical analysis. RESULTS: This study will provide the latest evidence for acupuncture combined with analgesics to relieve LC pain. CONCLUSION: The conclusion of this study is to evaluate the effectiveness and safety of acupuncture combined with analgesics in alleviating LC pain. INPLASY REGISTRATION NUMBER: INPLASY202150051.

Acupuncture for experimental cerebral ischemia/reperfusion injury: a systematic review of methodology and reporting quality.

OBJECTIVES: Preclinical research is essential to the advancement of science but susceptible to insufficient reporting and methodological shortcomings, which compromise internal validity. We aimed to systematically assess the methodological and reporting quality of studies conducted on acupuncture for experimental cerebral ischemia/reperfusion injury (CIRI). METHODS: A comprehensive search in six databases was performed for animal research concerning acupuncture for CIRI. Two authors independently selected articles, extracted data, and assessed the methodological and reporting quality of identified articles using the Systematic Review Center for Laboratory Animal Experimentation (SYRCLE) tool, and Animal Research: Reporting In Vivo Experiments (ARRIVE) guideline, respectively. RESULTS: A total of 24 studies were identified. Only 1 article (4%) achieved a decent overall rating in using SYRCLE (percentage of items with "low risk" ⩾50%). Of the 22 items on the SYRCLE tool, only 8 items (37%) were rated as "low risk" of bias in more than 50% of the included studies. Of the 39 items of ARRIVE, 20 (51%) items were rated as "low risk" in more than 50% of the included studies. CONCLUSIONS: The methodological and reporting quality of included studies was generally low, which demands further improvement. These findings should inform the development of evidence-based guidelines for future preclinical research assessing the effect of acupuncture on CIRI.

Effectiveness and safety of fire needle for knee osteoarthritis: A protocol of systematic review and meta-analysis.

BACKGROUND: There is a lack of curative medical treatment for patients with knee osteoarthritis (KOA). Acupuncture represents an important alternative therapy. In various forms of acupuncture and moxibustion, the fire needle is an indispensable part. Knee osteoarthritis (KOA) is a series of symptoms and signs of knee joint caused by local injury and inflammation and chronic strain of the knee joint resulting in cartilage degeneration of the articular surface and reactive bone loss of the subchondral bone plate. The results of clinical trial indicated that the fire needle therapy has obvious curative effect in treating KOA. This protocol is intended to describe how to collate and accumulate evidence for the current efficient and safe treatment of KOA with fire needle. METHODS: Seven electronic databases were used to retrieve the literature for the KOA randomized controlled trials, including 3 English databases (PubMed, EMBASE, the Cochrane Central Register of Controlled Trials [Cochrane Library]), and 4 Chinese databases (Chinese National Knowledge Infrastructure, Chinese VIP Information, Wanfang Database, and Chinese Biomedical Literature Database). This systematic review will include all randomized controlled clinical trials using fire needle therapy for KOA. The observation Index is the Change of Western Ontario and McMaster Universities Osteoarthritis Index Total, first proposed by Bellamy in 1988. The selection of the study will be completed independently by 2 reviewers, extract the data, and evaluate the quality of the study before selecting the title, abstract, and full text. Revman 5.4 software will be used to perform meta-analyses of randomized controlled trials, where risk ratios for dichotomous data and standardized or weighted mean differences for continuous data are the results. RESULT: The results will be published in a peer-reviewed journal. CONCLUSION: This systematic review will provide the latest evidence to evaluate the safety and efficacy of fire needle therapy in patients with KOA. TRIAL REGISTRATION NUMBER: INPLASY202080030.