Effectiveness and safety of traditional Chinese medicine in the treatment of senile hypotension: A protocol for systematic review and meta-analysis.

BACKGROUND: Senile hypotension refers to those whose blood pressure (BP) is lower than 90/60 mm Hg. The consequences can not only cause insufficient cardio-cerebral perfusion, but severe cases may also cause angina pectoris and stroke. At present, Western medicine has no ideal therapeutic drugs for senile hypotension. The aim of this systematic review is to assess the effectiveness and safety of traditional Chinese medicine (TCM) therapy for senile hypotension. METHODS: Two reviewers will electronically search the following databases: the Cochrane Central Register of Controlled Trials; PubMed; EMBASE; China National Knowledge Infrastructure; Chinese Biomedical Literature Database; Chinese Scientific Journal Database (VIP database); and Wan-Fang Database from the inception, without restriction of publication status and languages. Additional searching including researches in progress, the reference lists and the citation lists of identified publications. Study selection, data extraction, and assessment of study quality will be performed independently by 2 reviewers. If it is appropriate for a meta-analysis, RevMan 5.4 statistical software will be used; otherwise, a descriptive analysis will be conducted. Data will be synthesized by either the fixed-effects or random-effects model according to a heterogeneity test. The results will be presented as risk ratio (RR) with 95% confidence intervals (CIs) for dichotomous data and weight mean difference (WMD) or standard mean difference 95% CIs for continuous data. RESULTS: This study will provide a comprehensive review of the available evidence for the treatment of TCM with senile hypotension. CONCLUSIONS: The conclusions of our study will provide an evidence to judge whether TCM is an effective and safe intervention for patients with senile hypotension. ETHICS AND DISSEMINATION: This systematic review will be disseminated in a peer-reviewed journal or presented at relevant conferences. It is not necessary for a formal ethical approval because the data are not individualized. TRIAL REGISTRATION NUMBER: INPLASY2020110091.

The efficacy of moxibustion and acupuncture therapy for ankylosing spondylitis: A protocol for an overview of systematic reviews and meta-analysis.

BACKGROUND: Ankylosing spondylitis is a complex and progressive autoimmune inflammatory disease with a worldwide prevalence ranging up to 0.9%. Several systematic reviews and meta-analyses of traditional Chinese medicine alternative therapies, such as acupuncture or moxibustion, have demonstrated the effectiveness of moxibustion and acupuncture in the treatment of ankylosing spondylitis. However, there is no relevant literature to comprehensively evaluate the evidence. The purpose of this overview is to synthesize and evaluate the reliability of evidence generated in the systematic review (SR) and meta-analysis of moxibustion and acupuncture as a primary or complementary therapy for patients with ankylosing spondylitis. METHODS: PubMed, EMBASE, the Cochrane Central Register of Controlled Trials, Chinese National Knowledge Infrastructure, Chinese VIP Information, Wanfang Database, and Chinese Biomedical Literature Database were searched for systematic reviews and meta-analysis that review the efficacy of acupuncture or moxibustion as the primary treatment for patients with Ankylosing Spondylitis. The literature published before August 2020 will be selected. Additionally, the relevant SRs and meta-analyses that unpublished or ongoing will be searched in PROSPERO and INPLASY. The methodological guidelines for overviews will be used to review and extract data by 2 reviewers, and their will do it independently. Methodology quality will be analyzed by the assessment of multiple systematic reviews-2and the risk of bias by POBIS. For the included studies, we will adopt the following results as primary evaluation indicators: effective rate, visual analogue scale and bath AS disease activity index. Reviewers will assess the certainty of evidence by Grading of Recommendations Assessment, Development and Evaluation. RESULTS: The results will be published in a peer-reviewed journal. CONCLUSION: This overview will provide comprehensive evidence of moxibustion and acupuncture for patients with Ankylosing Spondylitis.

Efficacy and safety of thunder-fire moxibustion for patients with knee osteoarthritis: A protocol for systematic review and meta-analysis.

BACKGROUND: Knee osteoarthritis (KOA) is a major public health issue because it causes pain and functional limitation in patients. Many studies have reported that moxibustion, a treatment in traditional Chinese medicine, is effective in treating KOA. The aim of this protocol is to develop a standard in advance for synthesize and assess the efficacy and safety of thunder-fire moxibustion for KOA from these randomized controlled trial. METHODS: The 2 commentators will screen 7 databases (PubMed, EMBASE, the Cochrane Library, Chinese National Knowledge Infrastructure, Chinese VIP Information, Wanfang Database, and Chinese Biomedical Literature Database) for randomized controlled trials that can be included from the time the database is built up until publication in December 2020. The original study that randomized control trials of thunder-fire moxibustion for patients with KOA will be selected and is not limited by country or language. In addition, researches in progress, the reference lists, and the citation lists of identified publications will be retrieved similarly. Study selection, data extraction, and assessment of the quality will be performed independently by 2 reviewers who have been trained before data extraction. A meta-analysis will be conduct if the quantity and quality of the original studies included are satisfactory; otherwise, a descriptive analysis will be conducted. Review Manager 5.4 software (The Nordic Cochrane Centre, The Cochrane Collaboration, Copenhagen, Denmark) will be using for data synthesis and assessment the risk of bias according to Cochrane Handbook. RESULT: This study will provide a comprehensive review of current evidence for the treatment of thunder-fire moxibustion on KOA. CONCLUSION: The conclusion of this study will provide a judging basis that whether the treatment of KOA with thunder-fire moxibustion is effective. REGISTRATION NUMBER: INPLASY2020100012.

Acupuncture for drooling in children with cerebral palsy: A protocol for systematic review.

BACKGROUND: The aim of this study is to provide the methods used to evaluate the effectiveness and safety of acupuncture therapy for treating drooling in children with cerebral palsy. METHODS AND ANALYSIS: A comprehensive search of Pubmed, Embase, Cochrane Central Register of Controlled Trials, Web of Science, 4 Chinese databases (China National Knowledge Infrastructure, Chinese Biomedical Literatures database, Wan-Fang Database and Chinese Science and Technology Periodicals will be conducted to identify randomized controlled trials of acupuncture for treating children with cerebral palsy salivation with no restriction on time or language. The primary outcome of this systematic review will be the effective rate. The risk of bias will be implemented according to Cochrane Handbook for Systematic Reviews of Interventions. We will conduct the meta-analysis to synthesize the evidence for each outcome, if possible. The heterogeneity will be evaluated statistically using the χ2 test and the I2 statistic. The random-effect model will be used to provide more conservative results, if significant heterogeneity is identified (I2 > 50% or P < .10). ETHICS/DISSEMINATION: Our findings will be disseminated in a peer-reviewed journal and at conference meetings. It is not necessary for formal ethical approval as no primary data are collected. TRIAL REGISTRATION NUMBER: INPLASY2020110024.

Little needle-scalpel for piriformis syndrome: A protocol for systematic review and meta-analysis.

BACKGROUND: Piriformis syndrome (PS) is a condition in which the sciatic nerve is compressed when passing through the inferior mouth of the piriformis muscle, mainly caused by pain in one hip and leg. In severe cases, patients may experience severe buttock and lower limb pain, discomfort, difficulty walking, and claudication. It is estimated that the annual incidence of low back pain and sciatica is about 40 million cases, and the annual incidence of piriformis syndrome is about 2.4 million cases. The aim of this systematic review is to assess the effectiveness and safety of Little needle-scalpel therapy for Piriformis syndrome. METHODS: Two reviewers will electronically search the following databases: the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; China National Knowledge Infrastructure (CNKI); Chinese Biomedical Literature Database (CBM); Chinese Scientific Journal Database (VIP database); and Wan-Fang Database from the inception, without restriction of publication status and languages. Additional searching including researches in progress, the reference lists, and the citation lists of identified publications. Study selection, data extraction, and assessment of study quality will be performed independently by 2 reviewers. If it is appropriate for a meta-analysis, RevMan 5.4 statistical software will be used; otherwise, a descriptive analysis will be conducted. Data will be synthesized by either the fixed-effects or random-effects model according to a heterogeneity test. The results will be presented as risk ratio (RR) with 95% confidence intervals (CIs) for dichotomous data and weight mean difference (WMD) or standard mean difference (SMD) 95% CIs for continuous data. RESULTS: This study will provide a comprehensive review of the available evidence for the treatment of Little needle-scalpel with piriformis syndrome. CONCLUSIONS: The conclusions of our study will provide an evidence to judge whether Little needle-scalpel is an effective and safe intervention for patients with piriformis syndrome. ETHICS AND DISSEMINATION: This systematic review will be disseminated in a peer-reviewed journal or presented at relevant conferences. It is not necessary for a formal ethical approval because the data are not individualized. TRIAL REGISTRATION NUMBER: INPLASY2020110092.

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.

The effectiveness of moxibustion for treating of low back pain: A protocol for systematic review and meta-analysis.

BACKGROUND: Low back pain is a common clinical chronic disease with symptoms of back soreness, numbness, and pain. The incidence of low back pain is high, and gradually increases with age. It is mainly middle-aged and has a high recurrence rate. It is considered to be one of the common diseases with the highest disability rate. The aim of this systematic review is to assess the effectiveness and safety of moxibustion therapy for low back pain. METHODS: Two reviewers will electronically search the following databases: the Cochrane Central Register of Controlled Trials (CENTRAL);PubMed; EMBASE; China National Knowledge Infrastructure (CNKI); Chinese Biomedical Literature Database (CBM); Chinese Scientific Journal Database (VIP database); and Wan-Fang Database from the inception, without restriction of publication status and languages. Additional searching including researches in progress, the reference lists and the citation lists of identified publications. Study selection, data extraction, and assessment of study quality will be performed independently by 2 reviewers. If it is appropriate for a meta-analysis, RevMan 5.4 statistical software will be used; otherwise, a descriptive analysis will be conducted. Data will be synthesized by either the fixed-effects or random-effects model according to a heterogeneity test. The results will be presented as risk ratio (RR) with 95% confidence intervals (CIs) for dichotomous data and weight mean difference (WMD) or standard mean difference (SMD) 95% CIs for continuous data. RESULTS: This study will provide a comprehensive review of the available evidence for the treatment of moxibustion with low back pain. CONCLUSIONS: The conclusions of our study will provide an evidence to judge whether moxibustion is an effective and safe intervention for patients with low back pain. TRIAL REGISTRATION NUMBER: INPLASY202080027.

Efficacy of fire needle on patients of facial spasm: A protocol for systematic review and meta analysis.

BACKGROUND: Facial spasm causes a lot of troubles to patients daily life and seriously affects their mental and physical health. Relevant studies have shown that fire needle therapy has certain benefits for facial spasm, is an integral part of acupuncture therapy. However, there is no unanimous conclusion. The main purpose of our study is to measure whether fire needle therapy is effective for facial spasm. METHODS: The following electronic databases will be searched for the collection of fire-needle related randomized controlled trials (RCTS) for facial spasm, including 4 English databases (Web of Science, the Cochrane Library, EMBASE, Pubmed) and 3 Chinese databases (Chinese National Knowledge Infrastructure [CNKI], Wanfang data, Chinese VIP Information). The cure rate and total effective rate are the main outcomes, while the intensity, frequency, recurrence rate and adverse events are the secondary outcomes. We will use Endnote software X9 for study selection, Review Manager software 5.4 and STATA 13.0 software for analysis and synthesis. RESULTS: We will evaluate the efficacy of fire needles in the treatment of facial spasm in combination with current studies. CONCLUSION: The conclusion of this study will provide evidence for the efficacy of fire needle in the treatment of facial spasm. TRIAL REGISTRATION NUMBER: INPLASY202080036.

Plum-blossom needle plus Chinese herbal medicine for alopecia areata: A protocol for systematic review and meta analysis.

BACKGROUND: Alopecia areata (AA) is a common, inflammatory, nonscarring type of hair loss that is characterized by depression, anxiety and social isolation. In recent years, Plum-blossom needle plus Chinese herbal medicine has gradually shown its clinical advantages and been more and more widely used in China. Whereas, there has been no systematic review and meta-analysis. The purpose of this study is to estimate the safety and effectiveness of Plum-blossom needle plus Chinese herbal medicine in AA treatment. METHODS: Seven databases as following: PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), and Chinese Biomedical Literatures Database (CBM) will be searched from their inception to August 2020. Two reviewers (LBL and ZYZ) will respectively regulate research selection, data extraction, and risk of bias assessment. A third reviewer will be settled to consulting, if necessary. Review Manager Software 5.4 will be implemented for this study. RESULTS: The results will be published in a peer-reviewed medical journal. This meta-analysis will provide a synthetic review of the credible evidence for the treatment of Plum-blossom needle plus Chinese herbal medicine with AA. CONCLUSIONS: This systematic review and meta-analysis expects to provide high-quality evidence regarding the synergistic effect of Plum-blossom needle plus Chinese herbal medicine treatment for AA.

Efficacy and safety of fire needle vs conventional acupuncture in the treatment of postherpetic neuralgia: A protocol for systematic review and meta analysis.

BACKGROUND: Fire needle therapy has the double function of acupuncture and moxibustion, which has both the stimulation of needle and the warm stimulation of moxibustion. As an important part of acupuncture and moxibustion, fire needle has been widely used in clinical treatment since ancient times in China. Postherpetic neuralgia (PHN) is a kind of chronic and solid neuropathic pain with persistent and intense pain after the skin lesion of sores has been completely eliminated. The clinical treatment of PHN is mostly integrated therapy. In recent years, many literatures have reported that the curative effect of fire needle on PHN is accurate. The purpose of this protocol is to describe how to accumulate evidence for further understanding of the status quo and reliability of clinical practice in the treatment of PHN with fire needle. METHODS: Seven electronic databases were used to retrieve the literature for the PHN randomized controlled trials, including 3 English databases (PubMed, EMBASE, the Cochrane Central Register of Controlled Trials [Cochrane Library]) and 4 Chinesedatabases (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 fireneedle therapy for PHN. Pain intensity, safety and cost, quality of life, global perceptionare outcomes. 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: Conclusion:This proposed systematic review will provide up-to-date evidence to assess the effect of fire needle for patients with PHN. REGISTRATION: INPLASY202080029.

Effect of fire needle for ganglion cysts: A protocol of systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Ganglion cysts (GCs) are tumor-like lesions that often occur in the soft tissues, which are mostly caused by the degeneration of mucin produced by the joint capsule and tendon sheath on the carpal dorsal joints of extremities. GCs may appear asymptomatic as benign tumors, but some patients also seek treatment because of the pain caused by these fluid-filled cysts. As a kind of complementary and alternative therapy, there have been some studies published in China which have proved that the fire needle has a better therapeutic effect on ganglion cyst. The purpose of this systematic review is to evaluate the efficacy of fire needle in the treatment of GCs. METHODS: PubMed, EMBASE, the Cochrane Library, Chinese National Knowledge Infrastructure, Chinese VIP Information, Wanfang Database, and Chinese Biomedical Literature Database were searched by 2 reviewers from the inception until August 2020. The original study that randomised control trials of fire needle for GCs will be selected and is not limited by country or language. In addition, researches in progress, the reference lists and the citation lists of identified publications will be retrieved similarly. Study selection, data extraction, and assessment of the quality will be performed independently by 2 reviewers who have been trained prior to data extraction. A meta-analysis will be conduct if the quantity and quality of the original studies included are satisfactory; otherwise, a descriptive analysis will be conducted. Review Manager V5.4: (The Nordic Cochrane Centre, The Cochrane Collaboration, Copenhagen, Denmark) software will be using for data synthesis and assessment the risk of bias according by Cochrane Handbook. RESULT: This study will provide a comprehensive review of current evidence for the treatment of fire needle on GCs. CONCLUSION: The conclusion of this study will provide a judging basis that whether the treatment of GCs with fire needle is effective. INPLASY REGISTRATION NUMBER: INPLASY202080032.

Effectiveness and safety of acupuncture and moxibustion for peripheral facial paralysis: A protocol for an overview of systematic reviews and meta-analysis.

BACKGROUND: Peripheral facial paralysis (PFP) seriously affects patients' quality of life and work and even causes psychological problems such as anxiety and depression for them. Acupuncture (ACU) and moxibustion have been widely used to treat the disease with satisfactory results. Several systematic reviews and meta-analyses have reported the effectiveness of acupuncture for patients with PFP. However, the evidence has not been systematically synthesized. This overview aims to synthesize and assess the reliability of evidence generated from these systematic reviews (SRs) and meta-analyses of ACU and moxibustion for PFP. METHODS: We will make a comprehensive retrieval in 9 databases as following: (1) Embase; (2) Cochrane Library; (3) Pubmed; (4) Chinese databases SinoMed (previously called the Chinese Biomedical Database); (5) Chinese National Knowledge Infrastructure (CNKI); (6) Chinese Scientific Journals Database (VIP); (7) Wanfang Data (WF). The time is limited from the construction of the library to August 2020. We will use the Assessment of Multiple Systematic Reviews-2 (AMSTAR-2) tool to evaluate methodological quality. Preferred Reporting Items for Systematic Reviews and Meta-analysis Protocols (PRISMA-P) will be used in the report checklist to assess the quality of reports in the study. The Grading of the Classification of Recommendations, Evaluation, Development and Evaluation (GRADE) will be used to evaluate the included SRs and meta-analysis. Our reviewers will conduct systematic reviews, qualification evaluation, data extraction, methodological quality and evidence quality screening in pairs. The outcomes of interest include: the effective rate, the House-Brackmann (H-B) score, cure rate, and side effects. Or any other scale used to assess the level of illness. The evidence will be synthesized where appropriate based on patient subgroups and outcomes. RESULTS: The results will be published in a peer-reviewed journal. CONCLUSION: This overview will provide comprehensive evidence of ACU and moxibustion for patients with PFP. TRIAL REGISTRATION NUMBER: INPLASY202080016.

Acupuncture with or without moxibustion for primary dysmenorrhea: A protocol for a systematic review and meta-analysis.

BACKGROUND: Primary dysmenorrhea (PD) occurs during menstrual cramps, and there is currently no pathological evidence. This disease severely affects the daily lives of young women. Acupuncture (ACU) and moxibustion are an excellent way to relieve the pain of patients with PD. And it has been widely utilizing. However, the effectiveness and safety of ACU and moxibustion in treating patients with PD are not confirmed by a high-quality meta-analysis. This work aims to evaluate ACU's efficacy and safety with or without moxibustion in the management of PD. METHODS: We will make a comprehensive retrieval in 9 databases as following: Embase; Cochrane Library; PubMed; Chinese databases SinoMed (previously called the Chinese Biomedical Database); Chinese National Knowledge Infrastructure; Chinese Scientific Journals Database; Wanfang Data. The time is limited from the construction of the library to August 2020. No restrictions about language and status. Our 2 authors will perform the selection of studies, the extraction of data, and the quality assessment with the risk of bias tool independently. We will use NoteExpressV3.2.0 and Excel2010 software to extract data. The content will be saved in electronic form. We will use the bias risk tool provided by the Cochrane Collaboration to evaluate the quality of the literature using RevMan 5.4 software. The primary outcome is the pain degree evaluation, including visual analog scale, numerical rating scale, Cox retrospective symptom scale, or any other scale used to evaluate the level of pain.Furthermore, the response rate involved an overall reduction in symptoms. The adverse effects and quality of life will be assessed as secondary outcomes. The risk ratio for dichotomous data and mean differences with a 95% confidence interval for continuous data will be adopted to express the effect and safety of ACU with or without moxibustion for PD. RESULTS: The results of our study expect to provide high-quality, evidence-based recommendations on further treatment for clinicians. TRIAL REGISTRATION NUMBER: INPLASY202080006. CONCLUSION: This study will provide scientific evidence of PD Systematic review.