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Trials Apr 2017Conventional moxibustion is a representative non-drug intervention in traditional Chinese medicine, and it has been reported to produce encouraging results and benefits... (Comparative Study)
Comparative Study Randomized Controlled Trial
BACKGROUND
Conventional moxibustion is a representative non-drug intervention in traditional Chinese medicine, and it has been reported to produce encouraging results and benefits in relieving symptoms and improving the quality of life for patients with knee osteoarthritis (KOA) in previous clinical trials and systematic reviews. Given that increasing concerns on the safety of generated smoke from conventional moxibustion have received much attention, smoke-free moxibustion is regarded as a potential alternative. However, whether smoke-free moxibustion would display a similar efficacy to that of conventional moxibustion still remains unclear. Therefore, this randomized controlled trial attempts to investigate the difference of efficacy between conventional moxibustion and smoke-free moxibustion in patients with KOA.
METHODS/DESIGN
This is a multicenter, randomized, single-blinded, parallel-group clinical trial. A total of 138 eligible participants with KOA will be randomly allocated to two groups (conventional moxibustion group and smoke-free moxibustion group) in seven hospitals in China. Participants will receive 12 sessions of moxibustion treatment at three acupoints (EX-LE4, ST35, and ST36) over a period of 4 weeks (3 sessions per week). A smoke-removing device is placed at the top of the moxibustion device for the smoke-free moxibustion group (n = 69), while the conventional moxibustion group (n = 69) is treated with traditional moxibustion. The primary outcome measure will be the change of the global scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) from the baseline to 4 weeks. Secondary outcomes include the visual analog scale VASand Patient Global Assessment scores. Follow-up measurements will be performed on the 8th and 12th weeks after random allocation.
DISCUSSION
This study will contribute to providing a solid foundation for the selection of moxibustion in clinical application as well as future research in moxibustion therapy.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT02772055 . Registered on 12 May 2016.
Topics: Acupuncture Points; Adult; Aged; Biomechanical Phenomena; China; Clinical Protocols; Comparative Effectiveness Research; Disability Evaluation; Female; Humans; Knee Joint; Male; Middle Aged; Moxibustion; Osteoarthritis, Knee; Recovery of Function; Research Design; Single-Blind Method; Time Factors; Treatment Outcome
PubMed: 28438185
DOI: 10.1186/s13063-017-1846-2 -
Medicine Mar 2022Cancer-related psychological disorders (CRPD) with high incidence are often underdiagnosed and undertreated. Although, some studies suggested that acupuncture and... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
Cancer-related psychological disorders (CRPD) with high incidence are often underdiagnosed and undertreated. Although, some studies suggested that acupuncture and moxibustion (AM) are effective and safe for CRPD, lacking strong evidence, for instance, the relevant systematic review, meta-analysis, and randomized control trial (RCT) of a large sample, multicenter, makes the effects and safety remain uncertain. The aim of protocol is to evaluating the RCTs of AM for CRPD to verify the association of AM with the improvement of CRPD.
METHODS AND ANALYSIS
Eight electric databases (4 English databases and 4 Chinese databases) will be searched from inception to Mar. 2022. There will be no restrictions on the category of the language. The RCTs of AM for CRPD unlimited to any type of cancer will be included. Depression and anxiety scores will be the primary outcome indicators. Two researchers will independently complete study selection, evaluate the risk of bias, and extract the data. The RevMan 5.2 software will be used to conduct data synthesis using the random-effects model. The weighted mean differences or standardized mean differences with 95% CIs will be used to present the results of measurement data, and the risk ratios with 95% CIs will be used to express the counting data. Additionally, we will use the Grading of Recommendations Assessment, Development, and Evaluation to assess evidence quality.
MAIN RESULTS
The results of the meta-analysis will be presented with tables and figures.
ETHICS AND DISSEMINATION
The results of this meta-analysis and meta-regression will be disseminated via publication in peer-reviewed journals and will be published at relevant conferences. The data to be used will not contain individual patient data; therefore, there is no need to worry about patient privacy.
PROSPERO REGISTRATION NUMBER
CRD42020177219.
Topics: Acupuncture Therapy; Humans; Meta-Analysis as Topic; Moxibustion; Multicenter Studies as Topic; Neoplasms; Research Design; Systematic Reviews as Topic
PubMed: 35451378
DOI: 10.1097/MD.0000000000028860 -
Wound Management & Prevention Aug 2022Evidence about moxibustion and abdominal massage for treating constipation in older hospitalized patients is limited.
BACKGROUND
Evidence about moxibustion and abdominal massage for treating constipation in older hospitalized patients is limited.
PURPOSE
To investigate the safety and effectiveness of moxibustion and abdominal massage in hospitalized older patients with constipation.
METHODS
Hospitalized older patients (age ≥60 years) with constipation were retrospectively categorized as 2 cohorts according to whether the patients received moxibustion and abdominal massage in addition to routine nursing care. Gastrointestinal symptoms, Constipation Assessment Scale (CAS) scores, and Geriatric Depression Scale (GDS) scores were compared before and after treatment between cohorts.
RESULTS
The 2 cohorts (n = 100 for each) had similar baseline characteristics and gastrointestinal symptoms; the control cohort and the additional intervention cohort also had similar CAS scores (7.14 ± 3.67 vs 7.48 ± 2.96, respectively), and GDS scores (>17: 31% vs 29%, respectively). Improvement in the 2 scores from baseline was observed after 2 weeks in both the control cohort and the additional intervention cohort (CAS, 5.37 ± 5.34 and 3.80 ± 4.47, respectively; GDS, >17: 28% and 15%, respectively). The cohort with additional interventions had a lower ineffective rate (defined as persistent symptoms or absence of decrease in CAS, 49% vs 32%; P = .028) but had more diarrhea (9% vs 21%; P = .017).
CONCLUSION
Moxibustion and abdominal massage may help relieve constipation in hospitalized elderly patients, but attention should be paid to the increased occurrence of diarrhea. More study is needed.
Topics: Aged; Constipation; Diarrhea; Humans; Massage; Middle Aged; Moxibustion; Retrospective Studies
PubMed: 35926145
DOI: No ID Found -
Medicine Apr 2021Ankylosing spondylitis is a complex and progressive autoimmune inflammatory disease with a worldwide prevalence ranging up to 0.9%. Several systematic reviews and... (Review)
Review
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.
Topics: Acupuncture Therapy; Humans; Meta-Analysis as Topic; Moxibustion; Pain Measurement; Research Design; Spondylitis, Ankylosing; Systematic Reviews as Topic
PubMed: 33847616
DOI: 10.1097/MD.0000000000025179 -
Medicine Dec 2021Benign prostatic hyperplasia (BPH) is a non-malignant enlargement of the prostate gland that is common in older men. The clinical manifestations of BPH are frequent...
BACKGROUND
Benign prostatic hyperplasia (BPH) is a non-malignant enlargement of the prostate gland that is common in older men. The clinical manifestations of BPH are frequent urination, urgency, incomplete dribbling of urine, and urinary retention. Moxibustion, as a convenient, safe and effective method, has been widely applied in the clinical treatment of BPH. The study aim to assess the efficacy and safety of moxibustion for BPH.
METHODS
The following electronic databases will be searched regardless of language and publication status: Pubmed, MEDLINE, EMBASE, China Biomedical Database, China National Knowledge Infrastructure, VIP Database, and Wanfang Database, to select studies that meet the requirements. The study will consist of a prospective randomised controlled clinical trials (RCTs) of moxibustion in the treatment of BPH, language of publication does not have barrier of blinding or restrictions, adverse events will be assessed and reported for safety assessment. Two reviewers will independently conduct and screen all included studies and the meta-analysis will be performed with RevMan V5.3.
RESULTS
The study will provide a high-quality convincing assessment of efficacy and safety of moxibustion for BPH.
CONCLUSION
The conclusion of this study will provide the latest evidence for judging whether moxibustion is effective and safe in the treatment of BPH.
TRIAL REGISTRATION NUMBER
INPLASY2021120021.
Topics: Acupuncture Points; Aged; Humans; Male; Meta-Analysis as Topic; Moxibustion; Prospective Studies; Prostatic Hyperplasia; Randomized Controlled Trials as Topic; Research Design; Systematic Reviews as Topic; Treatment Outcome
PubMed: 34941196
DOI: 10.1097/MD.0000000000028437 -
BMJ Open Mar 2024Ulcerative colitis (UC) is a global chronic inflammatory bowel disease, and the poor efficacy of currently available pharmacological regimens makes the management of UC...
INTRODUCTION
Ulcerative colitis (UC) is a global chronic inflammatory bowel disease, and the poor efficacy of currently available pharmacological regimens makes the management of UC a great challenge. Moxibustion has shown great potential in the management of UC. However, its effectiveness and safety are still controversial. The purpose of this study is to synthesise the latest evidence regarding the clinical efficacy and safety of moxibustion for UC.
METHODS AND ANALYSIS
The Cochrane Library, PubMed, EMBASE, CNKI, Wanfang, VIP and SinoMed databases will be searched from inception to July 2023, to identify all randomised controlled trials with moxibustion for UC. The primary outcome will be clinical efficacy, as measured by validated scales. The serum inflammatory factor, colonoscopy results, quality of life, recurrence rate and adverse events will be the secondary outcomes. The Cochrane Risk of Bias 2.0 tool will be used to assess the methodological quality of each included trial. All data extraction will be carried out independently by two investigators. RevMan V.5.4 software will be used for data analysis and Cochran's Q statistic and I test will be used to assess heterogeneity between studies. In addition, we will perform subgroup analyses, sensitivity analyses and publication bias if the available data are sufficient. The strength of evidence will be graded using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system.
ETHICS AND DISSEMINATION
Ethics approval is not required for this review. Our findings will be published in a peer-reviewed journal.
PROSPERO REGISTRATION NUMBER
CRD42023425481.
Topics: Humans; Moxibustion; Colitis, Ulcerative; Quality of Life; Systematic Reviews as Topic; Meta-Analysis as Topic; Research Design; Review Literature as Topic
PubMed: 38503422
DOI: 10.1136/bmjopen-2023-078878 -
Medicine Apr 2021Infantile Diarrhea is a common and frequent digestive tract disease in children. The causes of this disease are relatively complex and the onset time is relatively long....
BACKGROUND
Infantile Diarrhea is a common and frequent digestive tract disease in children. The causes of this disease are relatively complex and the onset time is relatively long. At present, there is no specific treatment method in Western medicine. Moxibustion is a simple and painless external treatment. However, due to the lack of high-quality evidence to support the effectiveness and safety of moxibustion therapy for pediatric diarrhea. Therefore, the purpose of this study is to verify the effectiveness and safety of moxibustion in the treatment of pediatric diarrhea.
METHODS
We will use PubMed, Cochrane Library, Wan Fang Database, Web of Science, China National Knowledge Infrastructure Database, Chinese Science Journal Database, China Biomedical Literature Database to carry out a progressive search of diseases. The study will be screened according to eligibility criteria, and quality of the study will be assessed by using the Cochrane Risk of Bias Tool.
RESULTS
Through this study, we will systematically evaluate the effectiveness and safety of moxibustion in the treatment of pediatric diarrhea.
CONCLUSION
The results of this study will provide reliable evidence of the safety and effectiveness of moxibustion in the treatment of infantile diarrhea, and provide a therapeutic basis for the future clinical application.
ETHICS AND DISSEMINATION
Since this paper does not involve ethical issues, it does not need to pass the review of the ethics committee. It can only collect relevant literature and study.
INPLASY REGISTRATION NUMBER
INPLASY202130091.
Topics: Diarrhea, Infantile; Humans; Infant; Meta-Analysis as Topic; Moxibustion; Research Design; Systematic Reviews as Topic; Treatment Outcome
PubMed: 33907156
DOI: 10.1097/MD.0000000000025712 -
Medicine May 2024Myasthenia gravis (MG) is a common autoimmune disease that often involves the skeletal muscle of the whole body and seriously affects patients' quality of life.... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Myasthenia gravis (MG) is a common autoimmune disease that often involves the skeletal muscle of the whole body and seriously affects patients' quality of life. Acupuncture and moxibustion treatment of MG has unique advantages, the aim is to evaluate the clinical effect of acupuncture and moxibustion on MG.
METHODS
The literature on acupuncture and moxibustion treating MG in PubMed, CochraneLibrary, EMBASE, SCI, China Academic Journals full-text database, China Biology Medicine disc, VIP and Wanfang database were searched through computers from the establishment of the database to December 2022.
RESULTS
A total of 11 studies were included, involving 658 patients, where 330 in the treatment group and 328 in the control group. The results of the meta-analysis showed that the treatment group performed better than the control group in improving the total clinical response rate (OR = 3.26, 95%[2.04,5.21], P < .01). Additionally, the treatment group outperformed the control group in raising the absolute clinical score (MD = -3.48, 95%CI[-5.17, -1.78], P < .01). However, there was no significant difference between the treatment group and the control group in improving the level of serum interleukin-6 receptor (MD = -1.45,95%CI[-6.85,3.95], P > .05) and OMG quantitative score (MD = -2.16,95%CI[-4.85,0.52], P > .05). The total clinical effective rate was tested for publication bias, which showed that the 2 sides of the funnel plot were asymmetrical, suggesting the possible existence of publication bias.
CONCLUSION
Acupuncture and moxibustion has a good effect on MG, which is better than conventional Western medicine in improving the total clinical effective rate and absolute clinical score.
Topics: Moxibustion; Humans; Myasthenia Gravis; Acupuncture Therapy; Treatment Outcome; Quality of Life
PubMed: 38701271
DOI: 10.1097/MD.0000000000037961 -
Journal of Orthopaedic Surgery and... Dec 2023Knee osteoarthritis (KOA) is the most common chronic degenerative joint disease and places a substantial burden on the public health resources in China. The purpose of...
Efficacy and safety comparison of infrared laser moxibustion and traditional moxibustion in knee osteoarthritis: study protocol for a Zelen-design randomized controlled non-inferiority clinical trial.
BACKGROUND
Knee osteoarthritis (KOA) is the most common chronic degenerative joint disease and places a substantial burden on the public health resources in China. The purpose of this study is to preliminarily evaluate whether infrared laser moxibustion (ILM) is non-inferior to traditional moxibustion (TM) in the treatment of KOA.
MATERIALS AND METHODS
In the designed Zelen-design randomized controlled non-inferiority clinical trial, a total of 74 patients with KOA will be randomly allocated to one of two interventions: ILM treatment or TM treatment. All participants will receive a 6-week treatment and a follow-up 4 weeks after treatment. The primary outcomes will be the mean change in pain scores on the numeric rating scale (NRS) measured at baseline and the end of last treatment at week 6. The secondary outcomes will be the pain scores on the NRS from weeks 1 to 5 after the start of treatment and the changes from baseline to endpoints (weeks 6 and 10) in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), SF-36, knee circumference, and 6-min walking test. In addition, safety assessment will be performed throughout the trial.
CONCLUSION
The results of our study will help determine whether a 6-week treatment with ILM is non-inferior to TM in patients with KOA, therefore providing evidence to verify if ILM can become a safer alternative for TM in clinical applications in the future.
TRIAL REGISTRATION
Clinical Trial Registration Platform (ChiCTR2200065264); Pre-results. Registered on 1 November 2022.
Topics: Humans; Osteoarthritis, Knee; Moxibustion; Knee Joint; Pain; Lasers; Treatment Outcome; Randomized Controlled Trials as Topic
PubMed: 38042770
DOI: 10.1186/s13018-023-04408-x -
Complementary Therapies in Medicine Dec 2022Acupuncture and moxibustion have promising effects in managing primary dysmenorrhea. However, some evidence from clinical trials remains controversial due to... (Review)
Review
BACKGROUND
Acupuncture and moxibustion have promising effects in managing primary dysmenorrhea. However, some evidence from clinical trials remains controversial due to methodological flaws in study designs that involve acupuncture and its related modalities and require urgent attention and dialogue.
METHODS
Allied and Complementary Medicine Database (AMED), Cochrane Library, Excerpta Medica database (EMBASE), PubMed, Web of Sciences, Chinese Biological Medicine (CBM), China National Knowledge Infrastructure (CNKI), VIP Database for Chinese Technical Periodicals (VIP), and Wanfang database were searched from their inception to July 2021. Data were extracted based on the types of study design, primary outcome measures, adverse events (AEs), and participants' subjective views.
RESULTS
Most studies (n = 282, 93 %) were published in Chinese and 21 (7 %) in English. Among these, there were 209 (69 %) randomized controlled trials (RCTs), 39 (13 %) non-randomized controlled trials (nRCTs), 30 (10 %) case-series reports, 15 (5 %) cohort studies, and 10 (3 %) case reports. The most frequent reported outcome was pain, followed by emotion, sleeping quality, quality of life, skin temperature, changes in brain function, uterine and ovarian blood flow, and reproductive endocrine level. AEs were reported in 37 studies with mild events, and all recovered without actions taken; 31 trials reported no AEs; 235 failed to report any AEs. One RCT found that the satisfaction rate of the intervention group was statistically significantly higher than the control group.
CONCLUSION
Clinical studies on acupuncture and its related modalities face methodological challenges and require urgent attention. RCT with blinding and sham control might be the gold standard trial design. However, it may not be the most suitable research method for these modalities. We recommend using pragmatic RCTs in this field, where trial protocol registration on the trial registry platforms and detailed safety reporting should be mandatory.
Topics: Female; Humans; Research Design; Moxibustion; Acupuncture Therapy; Quality of Life; China; Dysmenorrhea
PubMed: 35998757
DOI: 10.1016/j.ctim.2022.102874