Acupoint catgut embedding therapy for functional constipation: A protocol for systematic review and meta-analysis

Background:This review will assess current evidence related to the effectiveness and safety of acupoint catgut embedding therapy for functional constipation (FC) and provide efficacy assessments for clinical applications.Methods:We will search the following databases for relevant trials: PubMed, EMBASE OVID, Cumulative Index of Nursing and Allied Health Literature, OVID MEDLINE, Web of Science, the Cochrane Central Register of Controlled Trials, Cochrane library, and Scopus. We will also search the following Chinese databases for trials published in the Chinese literature: China National Knowledge Infrastructure Database (CNKI), Chinese Scientific Journals Database, Wan Fang Database, Chinese Biomedicine and other resources from inception to December 2020. Only randomized controlled trials comparing acupoint catgut embedding versus acupuncture or sham acupuncture or placebo or other therapies will be included. The outcomes involved mean spontaneous bowel movements, complete spontaneous bowel movements, the Bristol Stool Form Scale, the Cleveland Clinic Score, Patient Assessment of Constipation symptom and so on. The risk of bias assessment and quality of evidence for outcomes will be appraised using the Cochrane Risk of Bias Tool and the Grading of Recommendations, Assessment, Development and Evaluation guidelines. RevMan 5.3 software will be employed for the meta-analysis.Results:This work will compare and arrange the comparative efficacy of acupoint catgut embedding with different treatments for FC by summarizing the current evidences.Conclusion:The results of this meta-analysis may help doctors determine the best treatments for patients to manage FC.Ethics and dissemination:This is a protocol with no patient recruitment and personal information collection, approval by the ethics committee is not required.OSF Registration number:DOI 10.17605/OSF.IO/XTKE2.     

Therapeutic effect and safety of Tuina on sciatica: A protocol for systematic review and meta-analysis∗

Background:Sciatica is one of the common pain symptoms in the human body, also known as radiating leg pain. Sciatica is increasingly occurring due to poor posture and lack of physical exercise all over the world. At present, many studies have indicated that Tuina can improve the clinical symptoms and functional status of sciatica. However, there is currently no relevant systematic review to evaluate and report this clinical scientific issue. Consequently, this study will conduct a meta-analysis on the effectiveness and safety of Tuina therapy for sciatica.Methods and analysis:Randomized controlled trials (RCTs) related to Tuina treatment of sciatica will be retrieved from the Chinese and English databases and Clinical Trial Register. These databases include China National Knowledge Infrastructure, Wan Fang Database, Chinese Biomedical Literature Database, VIP Database for Chinese Technical Periodicals, PubMed, Embase, Web of Science, Cochrane Library, and Medline, etc. We will consider articles published in English or Chinese between database initiation and October 2021. Our team will use Review Manager Software 5.3 software provided by the Cochrane Collaborative Network to conduct this systematic review and meta-analysis.Results:This study provides a comprehensive evaluation of the effectiveness and safety of Tuina therapy for sciatica.Conclusion:The conclusion of our study will provide scientific evidence and reference to determine whether Tuina is an effective and safe intervention for patients with sciatica.Registration number:INPLASY2021100034.     

Moxibustion therapy for treating psoriasis vulgaris: A protocol for systematic review and meta-analysis

Background:Psoriasis vulgaris (PV) is an immune-mediated skin disease, which has seriously affected the quality of life of patients. At present, moxibustion therapy has been widely used in the treatment of PV. The purpose of this study is to provide high-quality evidence-based medicine to evaluate the effectiveness and safety of moxibustion for PV.Methods:We will search the following Electronic databases from their inceptions to February 2021 without any language limitation: PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure, WangFang Database, Chinese Science Journal Database, Chinese Biomedical Literature Database. What''s more, the grey literature and the references of all included literature will also be retrieved manually. Any clinical randomized controlled trials (RCTs) related to moxibustion therapy for PV will be taken into. In order to complete data synthesis and assess the risk of bias, we will use the RevMan V.5.3 software.Results:This systematic review will provide an assessment of the current state of moxibustion for PV, aiming to assess the efficacy and safety of moxibustion for patients with PV.Conclusion:This systematic review will establish convincing evidence to prove the effectiveness and safety of moxibustion for PV.INPLASY registration number:INPLASY202120008.     

Evaluation of the effectiveness and safety of cupping therapy in the treatment of asthma: A protocol for systematic review and meta-analysis

Background:Asthma is one of the most common chronic airway diseases and is characterized by wheezing, dyspnea, chest tightness, and coughing. These symptoms reduce the patient''s quality of life and limit physical activity in daily life. However, there is no systematic review of the efficacy of cupping therapy in the treatment of asthma. To evaluate the efficacy and safety of cupping in the treatment of asthma, we conducted a systematic review and meta-analysis of published randomized clinical trials of cupping in the treatment of asthma.Methods:We will search the following Chinese and English databases: China National Knowledge Infrastructure, China Science and Periodical Database, Wanfang Database, China Biomedical Literature Database, PubMed, Embase, Cochrane Library. All of the above electronic databases will be searched from inception to August 22, 2021. In addition, we will manually search for conference papers, ongoing experiments, and internal reports to supplement the studies retrieved via electronic search. We will use the Review Manager 5.4 provided by Cochrane Collaboration Network for statistical analysis.Results:The study will prove the effectiveness and safety of cupping in the treatment of asthma.Conclusion:We plan to submit this systematic review to a peer-reviewed journal.INPLASY registration number:INPLASY202180104.     

Effects of acupoint injection for stroke patients with hemiplegia: A protocol for systematic review and meta-analysis of randomized controlled trials

Background:Acupoint injection has currently received increasing attention as a treatment for hemiplegia. A number of studies have reported that acupoint injection have some advantages in treatment of hemiplegia. However, currently no article has summarized the existing evidence. Our study will evaluate the efficacy and safety of acupoint injection as a clinical treatment for hemiplegia, so that it can provide an important reference for clinical decision-making.Methods:Randomized controlled trials and case control studies of acupoint injection for hemiplegia according to the included and excluded standard were identified in searches of 6 databases from their inception to February 2021. All data were assessed and extracted by 2 authors independently. The risk of bias assessment recommended by the Cochrane Collaboration was used to assess the quality of the selected studies. Review Manager 5.4 (Cochrane Collaboration) was used to conduct meta-analysis for the efficacy and safety of acupoint injection.Result:The results of this systemic review and meta-analysis will be submitted to a recognized journal for publication.Conclusion:This systemic review and meta-analysis will evaluate the efficacy and safety of acupoint injection as a clinical treatment for hemiplegia. We hope this study can make a definitive conclusion for acupoint injection in the treatment of hemiplegia.Registration:PROSPERO (registration number CRD42021234453).     

Effectiveness and safety of Yufeng Ningxin for the treatment of essential hypertension: A protocol for systematic review and meta-analysis

Background:Essential hypertension is the primary cause of death and disability and it has become a major public health problem globally. Yufeng Ningxin (YFNX) is a commonly used Chinese patent medicine in treating essential hypertension. The objective of this protocol is to evaluate the effectiveness and safety of YFNX for the treatment of essential hypertension.Methods:Randomized controlled trials (RCTs) in relation to the effectiveness and safety of YFNX in the treatment of essential hypertension will be systematically searched and collected from the following databases: PubMed, EMBASE, Cochrane Library, Chinese National Knowledge Infrastructure, Wanfang Database, Chinese Biomedical Literature Database, and Chinese Scientific Journal Database from the database inception to January 1, 2021. The data screening and extraction will be carried out by 2 different reviewers. The quality of randomized controlled trials will be assessed based on the version 2 of the risk-of-bias tool for randomized trials (RoB 2) in the Cochrane Handbook. The reduction of systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be served as the primary outcome. The secondary outcomes will include average SBP and average DBP during the day and the night measured by 24 hours ambulatory blood pressure monitoring, the clinical effectiveness rate, scores of traditional Chinese medicine syndrome, clinical symptoms, the quality of life and adverse events. Statistical analysis will be conducted with Review Manager 5.3 and STATA 14.0 software.Conclusion:This systematic review will provide strong evidence to assess the effectiveness and safety of YFNX in the treatment of essential hypertension.Trial registration number:INPLASY202110059.     

The effectiveness of acupoint herbal patching for constipation after stroke: A protocol for systematic review and meta-analysis

Background:Constipation is one of the common problems in stroke patients, which seriously affects the life quality of patients and even leads to the recurrence of cerebrovascular disease. The clinical trials of acupoint herbal patching (AHP) in the adjuvant treatment of constipation after stroke (CAS) is currently in progress. However, there is no systematic review or meta-analysis to evaluate the effects of AHP on CAS.Methods:We will search articles in 8 electronic databases including the Cochrane Central Register of Controlled Trials, PubMed, Embase, the Web of Science, China National Knowledge Infrastructure, the Chinese Biomedical Literature Database, Wanfang Database, and the Chinese Scientific Journal Database for randomized controlled trials of CAS treated by AHP from their inception to November 1, 2021. The primary outcome measures will be clinical effective rate, defecation frequency, improvement of clinical symptoms including complete spontaneous bowel movements. The data meeting the inclusion criteria were analyzed by RevMan V.5.4 software. Two authors evaluated the study using the Cochrane collaborative risk bias tool. We will use a scoring method to assess the overall quality of evidence supporting the main results.Results:This study will analyze the clinical effective rate, defecation frequency, improvement of clinical symptoms including complete spontaneous bowel movements after stroke.Conclusion:The findings of this systematic review will provide evidence to evaluate the effectiveness and safety of AHP for CAS.INPLASY registration number:INPLASY202210065.     

The effect of acupoint herbal patching on the quality of life of patients recovering from COVID-19: A protocol for systematic review and meta analysis

Background:There is a worldwide outbreak of COVID-19, and as the number of patients increases, an increasing number of patients are recovering. However, no relevant systematic review or meta-analysis has been designed to evaluate the effects of acupoint herbal patching on the life of patients recovering from COVID-19.Methods:The following electronic databases will be searched from the respective dates of database inception to April 20, 2021: The Cochrane Library, Web of Science, EMBASE, MEDLINE, China National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature Database (CBM), Wanfang database, the Chinese Scientific Journal Database (VIP), and other sources. All published randomized controlled trials in English or Chinese related to acupoint herbal patching for COVID-19 will be included. The primary outcome was the timing of the influence of acupoint herbal patching on the quality of life of convalescent patients. Secondary outcomes were accompanying symptoms (such as myalgia, expectoration, stuffiness, runny nose, pharyngalgia, anhelation, chest distress, dyspnea, crackles, headache, nausea, vomiting, anorexia, diarrhea) disappearance rate, negative COVID-19 results rate on two consecutive occasions (not on the same day), average hospitalization time, clinical curative effect, and improved quality of life.Results:The main purpose of this systematic review protocol was to assess the effectiveness and safety of acupoint herbal patching therapy for treating patients recovering from COVID-19.Conclusion:The conclusion of our study will provide evidence to judge whether acupoint herbal patching is an effective intervention for the quality of life in patients recovering.PROSPERO registration number:CRD42021246550     

The effectiveness of Salvianolate injection for in-stent restenosis after percutaneous coronary intervention: A protocol for systematic review and meta-analysis

Background:In-stent restenosis (ISR) caused by vascular remodeling after percutaneous coronary intervention limits the long-term efficacy of this method. Salvianolate injection is now widely used in the clinical treatment of ISR. However, there is no systematic review or meta-analysis to evaluate the effects of Salvianolate injection on ISR.Methods:We will search articles in 8 electronic databases, including the Cochrane Central Register of Controlled Trials, PubMed, Embase, the Web of Science, China National Knowledge Infrastructure, the Chinese Biomedical Literature Database, Wanfang Database, and the Chinese Scientific Journal Database for randomized controlled trials of ISR treated by Salvianolate injection from their inception to February 27, 2022. The primary outcome measure will be the restenosis rate. The data meeting the inclusion criteria were analyzed by RevMan V.5.4 software. Two authors evaluated the study using the Cochrane collaborative risk bias tool. We will use a scoring method to assess the overall evidence supporting the main results.Results:This study will analyze the clinical effectiveness of Salvianolate injection in the treatment of ISR.Conclusion:The findings of this systematic review will provide evidence to evaluate the effectiveness of Salvianolate injection for the treatment of ISR.INPLASY registration number:INPLASY202220117.     

Efficacy of acupuncture for persistent and intractable hiccups: A protocol for systematic review and meta-analysis of randomized controlled trials

Background:Persistent and intractable hiccups are a common clinical symptom that cause considerable physical pain to patients and severely damage their quality of lives. An increasing number of studies have demonstrated that acupuncture applied at acupoints dominated by Cuanzhu (BL2) can be used as one of the nonpharmacological therapies for controlling intractable hiccups. However, there is insufficient evidence evaluating the safety and effectiveness of those interventions. Therefore, this study is intended to conduct a systematic review and meta-analysis to provide evidence for a further study investigating alternative treatment options for persistent and intractable hiccups.Methods and Analysis:Randomized controlled trials (RCTs) of adult patients aged >18 years who meet the criteria for intractable hiccup diagnosis will be included, regardless of gender, nationality, and education level. Eight electronic databases will be searched, including 4 Chinese databases (CNKI, SinoMed, Wanfang Database, and Chinese Scientific Journal Database), 4 English databases (Web of Science, Medline, Embase, and Cochrane Library), from their date of establishment to September 2020. Two independent reviewers will evaluate the title summary for each RCT. Disagreements will be discussed with a third commentator. Data integration, heterogeneity analysis, subgroup analysis, and sensitivity analysis, will be performed using R-3.3.2 software. The RevMan 5.3 software will be used for the meta-analysis, and the “risk of bias” assessment will be conducted based on the methodological quality of the included trials recommended by the Cochrane Handbook 5.1. The quality evaluation of this study will be completed by the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE).Results:This study will summarize all the selected trials aimed at estimating the effectiveness, as well as safety, of applying acupuncture at acupoints dominated by Cuanzhu (BL2) to persistent and intractable hiccups.Conclusions:This systematic review will provide evidence to assess the validity and safety of applying acupuncture at acupoints dominated by Cuanzhu (BL2) for persistent and intractable hiccups, which may provide clinicians with more choices in the treatment of this disease.PROSPERO registration number:CRD42020114900.     

Acupoint catgut embedding for obesity: A protocol of systematic review

Background:Obesity is a chronic metabolic disease in which patients are overweight due to the excessive accumulation of fat in the body. As a subtype of acupuncture, catgut embedding at acupoints has increased in clinical application for obesity. The aim of this study is to evaluate the effectiveness and safety of acupoint catgut embedding therapy for simple obesity.Methods and analysis:Electronic searches of the Cochrane Library, PubMed, Springer Medline, EMBASE, Web of Science, China National Knowledge Infrastructure (CNKI), Wan-Fang Data (WANFANG), Chinese Biomedical Literature Database (CBM), and Chinese Scientific Journal Database (VIP databases) will be performed. The Chinese Clinical Trial Registry Center and the ClinicalTrials.gov registry will also be searched for ongoing trials. Databases will be searched from inception to August 2020.Randomized controlled clinical trials (RCTs) will be included if acupoint catgut embedding was evaluated as the sole treatment (diet or exercise therapy as the control group will be allowed) for simple obesity. The primary outcomes will consist of the improvement rate and reduction in body weight (BW). The secondary outcomes will include body mass index (BMI), waist circumference (WC), fat percentage (F %) and adverse effects. Two reviewers will undertake the study selection, data extraction and assessments of study quality. After screening the studies, the quality of the included studies will be assessed according to the quality criteria specified by the Cochrane Handbook for Systematic Reviews of Interventions (version 5.1.0). Meta-analysis will be performed by RevMan 5.3 software.Results:According to the data of improvement rate and reduction in BW, BMI, WC, and F %, this study will provide an evidence-based review of acupoint catgut embedding therapy for simply.Conclusions:This systematic review will present the current evidence for acupoint catgut embedding therapy for obesity.Ethics and dissemination:Ethical approval is not necessary since this protocol is only for systematic review and does not involve privacy data. The findings of this study will be disseminated electronically through a peer-review publication or presented at a relevant conference.Trial registration number:INPLASY2020110045.     

Effectiveness and safety of warm needle acupuncture on lumbar muscles strain: A protocol for systematic review and meta analysis

Background:Lumbar muscle strain (LMS) is the most common orthopedic syndrome, with high incidence globally and lingering disease, which seriously affects patients’ work efficiency and quality of life. Warm needle acupuncture (WNA) is a treatment method combining acupuncture technology with warm and medicinal effect of moxibustion. It has outstanding curative effect and wide range of treatment, especially in the treatment of pain diseases. We aim to collect clinical evidence and demonstrate the efficacy and safety of WNA on LMS.Methods/design:We will search the following database sources for the randomized controlled trials: PubMed, Cochrane Library, Excerpta Medica Database (EMBASE), Web of Science, WHO International Clinical Trials Registry Platform (TCTRP), Chinese Biomedical Literature Database (CBM), Chinese National Knowledge Infrastructure Database (CNKI), Chinese Scientific Journals Database (VIP), and the Wanfang Database.All randomized controlled trials of WNA for lumbar muscle strain (LMS) in the above database will be considered for inclusion, and high-quality articles will be screened for data extraction and analysis, to summarize the therapeutic effect of WNA on LMS patients.Result:This study will provide a rational synthesis of current evidences for warm needle acupuncture on lumbar muscle strain.Conclusion:The conclusion of this study will provide evidence to judge the effectiveness and safety of WNA on LMS.Trial registration:INPLASY2020120100 (DOI number: 10.37766/inplasy2020.12.0100).     

Efficacy and safety of abdominal acupuncture for insomnia: A protocol of systematic review and meta-analysis

Background:Insomnia is characterized by high incidence, easy recurrence, and difficulty in curing. Serious insomnia not only seriously affects the body organ function, but psychological patients also cause great damage. Abdominal acupuncture (AA) has fewer side effects and is increasingly used to treat insomnia. This study aimed to systematically review the effectiveness and safety of abdominal acupuncture in the treatment of insomnia.Methods:Literature on abdominal acupuncture for insomnia in the PubMed, Excerpt Medica Database(Embase), Cochrane Central Register of Controlled Trials, Web of Science, China National Knowledge Infrastructure Database, China Biomedical Literature Database, Chinese Scientific Journal Database, and Wan Fang databases were searched from the creation of these databases to October 3, 2021. In addition, the reference lists of studies meeting the inclusion criteria will also be searched to achieve a comprehensive retrieval of the maximum. All randomized controlled trials of AA for treating insomnia were included. Two reviewers will conduct literature screening, data extraction, and quality evaluation respectively. The main outcome was the Pittsburgh Sleep Quality Index, and the secondary outcomes included clinical efficacy and safety. RevMan 5.4.1 software was used for mate analysis.Results:This study aimed to evaluate the current status of AA treatment for insomnia, with the aim of illustrating the effectiveness and safety of abdominal acupuncture.Conclusion:This study will provide high-quality evidence to evaluate the effectiveness and safety of AA in treating insomnia.Registration: INPLASY2021100088     

Umbilical acupuncture for insomnia: A protocol for systematic review and meta-analysis

Background:Insomnia is characterized by high incidence, easy recurrence, and difficulty in curing. Serious insomnia not only seriously affects the body organ function but also causes great damage psychological.Umbilical acupuncture (UA) has fewer side effects and is increasingly used to treat insomnia. This study aimed to systematically review the effectiveness and safety of UA in the treatment of insomnia.Methods:Literature on UA for insomnia in PubMed, Excerpt Medica Database, the Cochrane Central Register of Controlled Trials, Web of Science, China National Knowledge Infrastructure Database, China Biomedical Literature Database, Chinese Scientific Journal Database, and Wan Fang Database were searched from the creation of these databases to October 3, 2021. In addition, the reference lists of studies meeting the inclusion criteria will also be searched to achieve a comprehensive retrieval of the maximum. All randomized controlled trials of UA for treating insomnia were included. Two reviewers will conduct literature screening, data extraction, and quality evaluation respectively. The main outcome was the Pittsburgh Sleep Quality Index, and the secondary outcomes included clinical efficacy, and safety. RevMan 5.4.1 software was used for mate analysis.Results:This study aimed to evaluate the current status of UA treatment for insomnia, with the aim of illustrating the effectiveness and safety of UA.Conclusion:This study will provides a high-quality evidence to evaluate the effectiveness and safety of UA in treating insomnia.Registration:PROSPERO CRD42021283036.     

Effect of Chinese herbal medicine for patients with benign thyroid nodules in adults: A protocol for systematic review and meta-analysis

Background:Thyroid nodules (TN) are discrete lesions within the thyroid gland and are a common clinical problem detected in 19% to 68% of people. TN are more common as age increases and occur more frequently in women. TN can cause pressure symptoms, cosmetic complaints, and thyroid dysfunction. Treatment for benign thyroid nodules includes thyroid hormone therapy, surgery, radioiodine treatment, percutaneous ethanol injection therapy, and laser or radiofrequency treatment to shrink nodules. In China and many other countries, doctors use Chinese herbal medicines (CHM) to treat TN. However, systematic review and meta-analysis has not been found to assess the effects and safety of CHM in curing TN at present. Hence, the systematic review is conducted to scientifically and methodically evaluate the value of its effectiveness and safety of CHM on TN.Methods:Literatures related to CHM for TN from the establishment of the database to November 2020 will be retrieved from the following databases: PubMed, Excerpta Medica Database (EMBASE), MEDLINE, Web of Science, Cochrane Library, SpringerLink, WHO International Clinical Trials Registry Platform (ICTRP), Wanfang Database, China National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature Database (CBM), and Chinese Scientific Journal Database (VIP). There are no language restrictions for retrieving literatures. Case reports, animal studies, editorials, expert opinions, reviews without original data, and studies on pediatric population were excluded. Eligible randomized clinical trials (RCTs) evaluating the effectiveness and safety of CHM in TN patients will be put in the study including nodule volume reduction ≥50%, pressure symptoms, cosmetic complaints, quality of life, and adverse events. By scanning the titles, abstracts and full texts, 2 reviewers will independently select studies, extract data, and assess the quality of study. Meta-analysis of RCTs will be conducted using Review Manager 5.1 software. The results will be presented as risk ratio for dichotomous data, and standardized or weighted mean difference for continuous data.Result:This study will provide high-quality available evidence for the treatment of TN with CHM based on nodule volume reduction ≥50%, pressure symptoms, cosmetic complaints, quality of life, and adverse events.Conclusion:The systematic review will to evaluate the efficacy of CHM in treating benign thyroid nodules in adults and provide evidence for clinicians.INPLASY registration number:INPLASY2020120093.     

Chinese herbal medicine Xianling Gubao capsule for knee osteoarthritis: A protocol for systematic review and meta-analysis

Background:Knee osteoarthritis (KOA) is the most prevalent degenerative joint disease among populations over 60 years old, and is the most common cause of musculoskeletal pain and disability worldwide. Xianling Gubao capsule (XLGBC), a Chinese patent medicine, is widely used for treatment of osteoporosis. Meanwhile, according to the theory of homotherapy for heteropathy, XLGBC is increasingly applied in the clinical practice of KOA. However, no systematic review has found that XLGBC is as effective in treatment of KOA as it is in treatment of osteoporosis. Therefore, we will conduct a systematic review of XLGBC in KOA treatments.Methods:All randomized controlled trials assessing the validity of XLGBC therapy for KOA will be retrieved from the following seven databases, including the Cochrane Library, PubMed, EMBASE, Chinese Biomedical Literature Database, China National Knowledge Infrastructure, Wan Fang Database, and Chinese Scientific Journal Database. The primary outcome measures are the visual analogue scale pain score, and a comprehensive evaluation including the Western Ontario and McMaster Universities Arthritis Index scores, Lysholm scores, and Bristol scores. And the secondary outcome measures include cure rate and adverse events. The procedure such as retrieval and selection of literature, data extraction, evaluation of risk of bias, and assessment of reporting bias will be executed by 2 reviewers independently. The data synthesis for meta-analysis will be conducted by Review Manager 5.4 software.Results:A high-quality evidence of XLGBC for the treatment of KOA will be generated from the aspects of safety and efficacy.Conclusion:This systematic review will provide evidence to help us confirm the clinical efficacy of XLGBC in the treatment of KOA.OSF Registration number:Registration DOI 10.17605/OSF.IO/QD5SY.     

Traditional Chinese medicine fumigation as auxiliary treatment of diabetic peripheral neuropathy: A protocol for systematic review and meta-analysis

Background:Diabetic peripheral neuropathy (DPN) is 1 of the most common clinical complications of diabetes, which seriously affects the quality of life of patients and causes a substantial economic burden on diabetes care. The pathogenesis of DPN is complex. There is no targeted treatment method, and mainstream treatment methods have low efficacy and large side effects. Traditional Chinese medicine has rich clinical experience in the prevention and treatment of diabetic peripheral neuropathy, which has dramatically improved the quality of life of patients. It is clinically proven that traditional Chinese medicine fumigants (TCMF) have apparent effects in treating diabetic peripheral neuropathy. Therefore, we aim to systematically review the effectiveness and safety of TCMF for DPN.Methods:We will search the following databases: PubMed, Embase, Cochrane Library, MEDLINE, the China National Knowledge Infrastructure, the Chinese Biomedical Literature Database, Cqvip Database, and Wanfang Data. Besides, we will also search for clinical trial registrations, potential grey literature, relevant conference abstracts, and reference lists of established studies. The studies published from the inception of the database to November 2020 will be retrieved. The randomized controlled trials on TCMF for DPN will be included. Also, we will search for clinical trial registrations, potential grey literature, relevant conference abstracts, and reference lists of established studies. The main result is clinical efficacy and nerve conduction velocity. Fasting blood glucose, 2 hours postprandial blood glucose, blood lipid, glycosylated hemoglobin, and adverse events are secondary results. We will perform the analyses using RevMan V.5.3 software.Results:This study will provide a high-quality comprehensive evaluation of the efficacy and safety of TCMF in the treatment of DPN.Conclusions:This systematic review will evaluate the effectiveness and safety of TCMF in the treatment of DPN, and provide the latest evidence for clinical application.INPLASY registration number:INPLASY2020110137.