Infrared laser moxibustion for cancer-related fatigue in breast cancer survivors: a randomized controlled trial.

BACKGROUND: Cancer-related fatigue (CRF) is a pervasive, persistent, and distressing symptom experienced by cancer patients, for which few treatments are available. We investigated the efficacy and safety of infrared laser moxibustion (ILM) for improving fatigue in breast cancer survivors. METHODS: A three-arm, randomized, sham-controlled clinical trial (6-week intervention plus 12-week observational follow-up) was conducted at a tertiary hospital in Shanghai, China. The female breast cancer survivors with moderate to severe fatigue were randomized 2:2:1 to ILM (n = 56) sham ILM (n = 56), and Waitlist control (WLC)(n = 28) groups. Patients in the ILM and sham ILM (SILM) groups received real or sham ILM treatment, 2 sessions per week for 6 weeks, for a total of 12 sessions. The primary outcome was change in the Brief Fatigue Inventory (BFI) score from baseline to week 6 with follow-up until week 18 assessed in the intention-to-treat population. RESULTS: Between June 2018 and July 2021, 273 patients were assessed for eligibility, and 140 patients were finally enrolled and included in the intention-to-treat analysis. Compared with WLC, ILM reduced the average BFI score by 0.9 points (95% CI, 0.3 to 1.6, P = .007) from baseline to week 6, with a difference between the groups of 1.1 points (95% CI, 0.4 to 1.8, P = .002) at week 18. Compared with SILM, ILM treatment resulted in a non-significant reduction in the BFI score (0.4; 95% CI, -0.2 to 0.9, P = .206) from baseline to week 6, while the between-group difference was significant at week 18 (0.7; 95% CI, 0.2 to 1.3, P = .014). No serious adverse events were reported. CONCLUSION: While ILM was found to be safe and to significantly reduce fatigue compared with WLC, its promising efficacy against the sham control needs to be verified in future adequately powered trials. TRIAL REGISTRATION: Clinicaltrials.gov: NCT04144309. Registered 12 June 2018.

Comparison efficacy and safety of acupuncture and moxibustion therapies in breast cancer-related lymphedema: A systematic review and network meta-analysis.

OBJECTIVE: Although several acupuncture and moxibustion therapies have been tested in managing breast cancer-related lymphedema (BCRL), there is little consensus regarding the best options for treating this condition. This systematic review and network meta-analysis compared the efficacy of various acupuncture and/or moxibustion therapies for BCRL. METHODS: Seven databases and two clinical registration centers were searched from their inception to December 1st, 2023. The Cochrane Collaboration risk-of-bias assessment tool evaluated the quality of included RCTs. A pairwise meta-analysis was performed in STATA 16.0, while a network meta-analysis was performed in R 4.2.2. RESULTS: 18 studies were included in this analysis. Our results showed that acupuncture and moxibustion methods had great advantages in improving BCRL of patients with breast cancer. In particular, needle-warming moxibustion (NWM) could be the optimal acupuncture and moxibustion method for improving clinical effectiveness and reducing the degree of swelling of affected limbs. CONCLUSION: Our findings suggest that NWM has great potential in treating BCRL. It may reduce arm circumference, lower swelling levels, and improve clinical effectiveness. Nevertheless, more multi-center, high-quality, and large sample RCTs will be needed in the future.

Efficacy and safety of moxibustion for ulcerative colitis: protocol for a systematic review and meta-analysis.

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 I2 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.

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.

Moxibustion for the Treatment of Cancer and its Complications: Efficacies and Mechanisms.

Cancer treatment remains a significant challenge for the medical community, and improved therapies are necessary to treat cancer and its associated complications. Current anticancer therapies often have significant side effects, underscoring the need for new treatment options. Moxibustion is a representative external therapy used in traditional Chinese medicine. This review examines clinical studies demonstrating moxibustion's ability to improve the efficacy of radiotherapy and chemotherapy and control tumor progression. Moxibustion can prevent and treat various complications of cancer, including cancer-related or therapy-induced gastrointestinal symptoms, myelosuppression, fatigue, pain, and postoperative lymphedema. has also been shown to enhance the quality of life for cancer patients. However, very few studies have investigated the underlying mechanisms for these effects, a topic that requires systematic elucidation. Evidence has shown that moxibustion alone or combined with chemotherapy can improve survival and inhibit tumor growth in cancer-bearing animal models. The anticancer effect of moxibustion is associated with alleviating the tumor immunosuppressive and vascular microenvironments. Additionally, the therapeutic effects of moxibustion may originate from the heat and radiation produced during the combustion process on acupoints or lesions. This evidence provides a scientific basis for the clinical application of moxibustion in anticancer treatment and reducing the side effects of cancer therapies and helps promote the precise application of moxibustion in cancer treatment.

Effectiveness and safety of electroacupuncture and its cotreatment with electronic moxibustion in the treatment of patients with moderate benign prostatic hyperplasia using alpha blocker: An assessor-blinded, randomized, controlled pilot study.

BACKGROUND: Benign prostatic hyperplasia (BPH) is a disease that affects the quality of life by causing lower urinary tract symptoms (LUTS) in men. Electroacupuncture (EA) and moxibustion therapy have been suggested as an adjunct therapy for improving LUTS in patients with BPH, but clinical studies evaluating the effectiveness of EA and its cotreatment with electronic moxibustion (EM) in patients who have been prescribed alpha blockers have yet to be reported. Therefore, this study aimed to evaluate the effectiveness and safety of EA and EM. METHODS: Twenty-eight patients diagnosed with BPH were randomized to treatment group (TG, n = 14) or control group (CG, n = 14). The TG continued to use the previously prescribed alpha blocker and received the cotreatment of EA and EM 3 times a week for 6 weeks. The CG continued to use the previously prescribed alpha blocker alone for 6 weeks. The primary outcome was the mean change in the international prostate symptom score (IPSS) from baseline to week 6. The secondary outcomes were IPSS at week 3 and 12, clinical relevance, IPSS life satisfaction, EuroQol-Five dimensions, average urinary flow rate, maximum urinary flow rate, and prostate volume. RESULTS: The IPSS decreased at all time points with a statistically significant difference between the 2 groups (3W: P = .0313; 6W: P = .0010; 12W: P = .0304). Based on the minimal clinically important difference (MCID, 3 points), there were significant differences between the TG and the CG at week 3, 6, and 12 (3W: P = .0461; 6W: P = .0123; 12W: P = .0216). Significant group × week interaction effects were found for the IPSS score (P = .0018), as determined from analyses using repeated measures analysis of variance. There were no significant differences between the 2 groups in IPSS life satisfaction, EuroQol-Five dimensions, average urinary flow rate, maximum urinary flow rate, and prostate volume. CONCLUSION: EA and its cotreatment with EM might have a beneficial effect as an adjunct therapy in improving LUTS in patients with BPH. Large-scale randomized controlled trials are warranted to confirm the effectiveness and safety of EA and its cotreatment with EM.

[Prevention from PICC-related venous thrombosis in the upper limbs of malignant tumor patients with moxibustion combined with plucking at Jiquan (HT 1): a randomized controlled trial].

OBJECTIVE: To observe the clinical effect of moxibustion combined with plucking technique at Jiquan (HT 1) for preventing peripherally inserted central catheter (PICC)-related venous thrombosis in the upper limbs of malignant tumor patients. METHODS: A total of 80 malignant tumor patients undergoing PICC were randomized into an observation group and a control group, 40 cases in each one. In the control group, the routine care for PICC was exerted. In the observation group, besides the routine care, moxibustion combined with plucking technique at Jiquan (HT 1) was added. Mild moxibustion was exerted along the venous distribution of PICC (avoiding the entry site) for 10 to 15 min, and then, the circling moxibustion was applied to Quchi (LI 11), Xuehai (SP 10) and Tianfu (LU 3), 3 to 5 min at each acupoint. Finally, plucking technique was given at Jiquan (HT 1) for 5 to 10 min. This combined therapy was intervened since the 2nd day of PICC placement, once daily, 5 times a week, for 3 weeks totally. The incidence of the PICC-related venous thrombosis in the upper limbs was compared between the two groups on day 42 of placement. On day 2, 7, 14, 21, 28, 35 and 42 of PICC placement, the peak systolic velocity (PSV) and the end-diastolic velocity (EDV) of the subclavicular vein on the placement side were observed separately in the two groups. RESULTS: The incidence of the PICC-related venous thrombosis in the upper limbs in the observation group was lower than that in the control group (2.5% [1/40] vs 17.5% [7/40], P<0.05). From day 7 to 35 of PICC placement, PSV of the subclavicular vein on the placement side was higher than that on the day 2 of PICC placement in the observation group (P<0.05). On day 28 and 42 of PICC placement, PSV of the subclavicular vein on the placement side was lower than that on the day 2 of PICC placement in the control group (P<0.05). In the observation group, EDV of the subclavicular vein on the placement side was higher than that on the day 2 of PICC placement from day 7 to 28 of PICC placement (P<0.05). In the control group, EDV of the subclavicular vein on the placement side from day 28 to 42 of PICC placement was lower than that on the day 2 of PICC placement (P<0.05). From day 7 to 42 of PICC placement, PSV and EDV of the subclavicular vein on the placement side in the observation group were all higher than those in the control group (P<0.01, P<0.05). CONCLUSION: The combined treatment of moxibustion with plucking technique at Jiquan (HT 1) can effectively prevent PICC-related venous thrombosis in the upper limbs and improve venous blood flow velocity in malignant tumor patients.

Efficacy of thunder-fire moxibustion in treating ankylosing spondylitis of kidney deficiency and governor meridian cold and its influence on TNF-α and RANKL: study protocol for a prospective, nonblinded, single-center, randomized controlled trial.

BACKGROUND: Ankylosing spondylitis (AS) is a common chronic inflammatory spondyloarthropathy. It is considered in traditional Chinese medicine (TCM) that the pathogenesis of AS is mainly due to Yang deficiency of kidney governor meridian and internal prosperity of cold evil. Thunder-fire moxibustion is a kind of moxibustion that is characterized in abundance in drug composition, high heat radiation, and strong penetration. Thunder-fire moxibustion on the spinal segment of the governor meridian in treating AS seems compatible with the main pathogenesis of kidney deficiency and governor meridian cold. The trial aims to explore the efficacy of thunder-fire moxibustion in patients with AS of kidney deficiency and governor meridian cold and its influence on bone metabolism, through a prospective randomized trial. METHODS: Sixty patients with AS of kidney deficiency and governor meridian cold will be recruited and randomly assigned to the treatment group (thunder-fire moxibustion three times a week plus basic treatment) and the control group (basic treatment) at the Center of TCM of Beijing Luhe Hospital Affiliated to Capital Medical University (Beijing, China). Each patient will be treated for 4 weeks. The primary outcome is the efficacy of TCM syndrome, and the secondary outcome indexes will include the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Short-Form-36 Questionnaire (SF-36), tumor necrosis factor-α (TNF-α), and receptor activator of nuclear factor-κB ligand (RANKL). TNF-α and RANKL with observation will be determined once respectively before and after treatment, while the other indexes will be observed once prior to the treatment, 2 weeks post-treatment, and at the end of the treatment. Side effects will be recorded and analyzed as well. Inter-group comparison and analysis will be performed based on the intention-to-treat set and per-protocol set. DISCUSSION: This prospective randomized trial will help verify the efficacy of thunder-fire moxibustion in treating AS of kidney deficiency and governor meridian cold, discuss preliminarily its mechanism in treating this disease, and provide high-quality evidences for scientific researches on clinical treatment with thunder-fire moxibustion against AS. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2100044227 . Registered on 12 March 2021.

Mild moxibustion for Irritable Bowel Syndrome with Diarrhea (IBS-D): A randomized controlled trial.

ETHNOPHARMACOLOGICAL RELEVANCE: Moxibustion therapy is a traditional Chinese medicine external treatment method, which involves crushing dried herb Artemisia argyi H. Lév. & Vanio and rolling it into a long cigarette-like strip, igniting it and using its warmth to stimulate specific acupuncture points for a certain period of time. It is often used in Asia to treat various diseases, especially abdominal pain. Clinical reports suggest that acupuncture and moxibustion are the effective treatment for Irritable Bowel Syndrome with Diarrhea (IBS-D). However, there is no placebo-controlled study to prove its safety and efficacy. OBJECTIVE: To evaluate the effects of mild moxibustion (MM) for the treatment of irritable bowel syndrome with diarrhea (IBS-D) through comparisons with those of placebo moxibustion. PATIENTS AND METHODS: This was a single-site, randomized controlled trial was conducted at Shanghai Research Institute of Acupuncture and Meridian in China and enrolled 76 participants who met the Rome IV diagnostic criteria for IBS-D between May 2017 and December 2019. 76 participants were randomized to either mild moxibustion (MM) or placebo moxibustion group (PM) in a 1:1 ratio. 18 sessions of MM or PM were implemented over the course of 6 weeks (3 times per week). The primary outcome was adequate relief after 6 weeks of treatment. RESULTS: Of 76 patients with IBS-D who were randomized (38 in the MM group and 38 in the PM group) were included in the intention-to-treat (ITT) analysis set. After treatment at week 6, the response rate was significantly higher in the MM group than the PM group (81.58% vs. 36.84%) with an estimated difference of 44.74 (95% CI, 23.46 to 66.02, P < 0.001). No participant reported severe adverse effects. CONCLUSION: The findings suggest that mild moxibustion may be more effective than placebo moxibustion for the treatment of IBS-D, with effects lasting up to 12 weeks. TRIAL REGISTRATION: ChiCTR, ChiCTR2100046852. Registered 29 May 2021 - Retrospectively registered, URL: http://www.chictr.org.cn/showproj.aspx?proj=127000.

10.6-µm infrared laser as adjuvant therapy for diabetic peripheral neuropathy: study protocol for a double-blind, randomized controlled trial.

BACKGROUND: Diabetic peripheral neuropathy (DPN) is the most common chronic neurological complication. It is the main cause of disability in diabetes mellitus (DM) patients and seriously affects the quality of life of patients. Pharmacological treatments always associate with limited efficacy and adverse effects. Moxibustion has been recommended to treat DPN as an adjuvant therapy to conventional medical treatment to accelerate alleviation of the symptoms of DPN. 10.6-µm laser moxibustion (LM), whose wavelength is close to the peak of infrared radiation spectrum of the traditional moxibustion as well as human acupoints, produces the thermal effect similar with moxibustion but with no smoke or smell. The purpose of this sham controlled clinical trial is to determine the effect and safety of 10.6-µm LM as adjuvant therapy in patients with DPN. METHODS: This is a protocol for a randomized, double-blind, sham-controlled trial. One hundred fourteen patients meeting the inclusion and exclusion criteria will be recruited and randomly assigned to the LM group or the sham LM group with a 1:1 allocation ratio. Patients in both groups will receive a basic integrated treatment of Chinese and Western medicine and a total of 12 sessions of true or sham LM treatments over 4 weeks with 3 sessions a week. The primary outcome is nerve conduction velocity (NCV), and the secondary outcomes include Michigan Neuropathy Screening Instrument (MNSI) scores, Diabetes-Specific Quality of Life (DSQL) scores, blood rheology parameters, and assessments of safety and blinding. Outcome measures will be collected at baseline, 2 weeks after treatment, the end of LM treatments (4 weeks), and 4, 8 weeks after the end of LM treatment (8, 12weeks). DISCUSSION: This study will be conducted to compare the efficacy of LM versus sham LM combined with medical treatment. 10.6-µm LM may alleviate symptoms, improve quality of life, and reduce the dosage of drugs as well as avoid causing serious side effects. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2000029329 . Registered on 25 January 2020.

Efficacy and safety of acupuncture and moxibustion combined with the external application of traditional Chinese medicine in the treatment of primary liver cancer: A protocol for systematic review and meta-analysis.

BACKGROUND: Primary liver cancer (PLC) is one of the most common malignant tumors in the world, and its incidence and fatality rate are increasing year by year. Due to the large population base in China, the aging population is severely affected by environmental pollution, eating habits, and unhealthy lifestyles. And many other influences have caused the number of new PLC cases and deaths in China to rank first in the world. Acupuncture combined with external application of Chinese medicine to treat PLC is currently one of the commonly used treatments in China. However, this combined treatment still lacks evidence-based medicine support. Therefore, this systematic review and meta-analysis aims to evaluate the efficacy and safety of acupuncture combined with external application of traditional Chinese medicine in the treatment of PLC. METHOD: We will search PubMed, Web of Science, GCBI, Embase, OVID, AMED, Cochrane Library, CNKI, VIP, CBM, and Wanfang databases. As of September 15, 2021, there are no restrictions on search language, publication time, and publication status. We will use the following medical keywords to search, including: "acupuncture", "external application of traditional Chinese medicine", and "primary liver cancer". At the same time, we will manually search all reference lists from relevant systematic reviews to find other eligible studies. We will use the random effects model in REVMAN v5.3 for meta-analysis. The study for acupuncture combined with Chinese herbal medicine in the treatment of PLC was a randomized controlled study. Two researchers will independently review the research selection, data extraction, and research quality assessments. Finally, we will observe the outcome measures. RESULTS: This study will provide evidence-based guidance for the treatment of PLC with acupuncture and the external application of traditional Chinese medicine and offers new ideas and methods for the treatment of PLC.

Moxibustion for treating cancer-related fatigue: A multicenter, assessor-blinded, randomized controlled clinical trial.

Cancer-related fatigue (CRF) is one of the most common chronic symptoms experienced by cancer patients. As moxibustion is a popular traditional therapy for managing fatigue, it can be an alternative strategy to treat CRF as well. Therefore, we rigorously designed a full-scale, multicenter, assessor-blinded, randomized controlled trial to evaluate the efficacy and safety of moxibustion treatment for CRF. Ninety-six subjects suffering from CRF were recruited and randomly assigned to moxibustion group, sham moxibustion group, or usual care group. Both the moxibustion group and the sham group received moxibustion treatment for 8 weeks and the usual care group did not. Brief fatigue inventory (BFI) score and Functional Assessment of Cancer Therapy-Fatigue score were used to assess CRF at baseline and weeks 5, 9, and 13. Questionnaires for the assessment of cognitive impairment, quality of life, and Cold-Heat and Deficiency-Excess patterns were also evaluated. BFI scores significantly decreased in moxibustion group compared to the usual care group (mean difference of -1.92, p < 0.001 at week 9 and mean difference of -2.36, p < 0.001 at week 13). Although the sham group also showed significant improvement during the treatment period, only the moxibustion group showed improvement after 4 weeks of follow-up period (mean difference of -1.06, p < 0.001). There were no serious adverse events. Our findings confirmed the efficacy and safety of moxibustion for CRF compared to usual care. We also found that moxibustion has a prolonged treatment effect during 4 weeks of follow-up period.

The efficacy and safety of moxibustion for chronic fatigue syndrome: A protocol for systematic review and meta-analysis.

BACKGROUND: The pathogenesis of chronic fatigue syndrome (CFS) is not clear. The main purpose of treatment is to improve autoimmune function and relieve fatigue symptoms. Moxibustion is often used to treat diseases caused by low autoimmunity, especially in relieving fatigue symptoms. It is a superior therapy for CFS in traditional Chinese medicine. At present, there is a lack of the high level clinical evidence to support the moxibustion in the treatment of CFS, so this study will systematically review and analyze the currently available randomized controlled trials to evaluate the efficacy and safety of moxibustion in the treatment of CFS. METHODS: We will systematically search PubMed, EMBASE, Cochrane library, Sinomed, CNKI, VIP, and Wanfang Database, ClinicalTrials.gov and Chinese Clinical Trial Registry will also be searched. The time range for the search will be from database activation to March 31, 2021. The randomized controlled trials (RCTs) associated with moxibustion for CFS will be included, regardless of language.We will use the standard proposed in Cochrane Handbook 5.1.0 to assess the bias risk of a single RCT. The main outcome index of the study is Fatigue Assessment Instrument (FAI), secondary outcome indexes will include Fatigue Scale -14 (FS-14), Fatigue Severity Scale (FSS), Pittsburgh sleep quality index (PSQI), natural killer (NK) cells, interleukin- 2 (IL-2), T lymphocyte subsets (CD4+, CD8+), cure rate, total efficiency and adverse reactions. The random effect model meta was used to analyze the effect data of a single RCT. Heterogeneity will be measured by Cochran Q test and I-squared statistics. We will use 2 subgroup analyses to explore the source of heterogeneity. RCTs with high bias risk was excluded and adjustment effect model was used for sensitivity analysis to test the robustness of the meta-analysis results. The publication bias included in RCTs will be assessed by funnel plot and Egger test. RESULTS: This study will objectively and comprehensively evaluate the efficacy and safety of randomized controlled trials of moxibustion in the treatment of chronic fatigue syndrome, and the results will be submitted to peer-reviewed journals for publication. CONCLUSION: This systematic review will provide clinicians with the latest high-quality evidence for the use of moxibustion in the treatment of chronic fatigue syndrome. INPLASY REGISTRATION NUMBER: INPLASY202140063.

Efficacy and safety of heat-sensitive moxibustion in the treatment of ulcerative colitis: A protocol for a systematic review and meta-analysis.

BACKGROUND: Ulcerative colitis (UC) is a chronic nonspecific intestinal inflammatory disease with unclear etiology occurring in the colonic mucosa. Its clinical manifestations are characterized by recurrent abdominal pain, diarrhea, mucous pus, and blood stool. The severity of the disease varies, and itis characterized by a high recurrence rate. Because of its long course of disease, easy to relapse, protracted and difficult to recover, seriously affect the quality of life, increase the economic burden of patients and society, and even the risk of developing cancer, it has become one of the hot issues of general concern in the medical field. Heat-sensitive moxibustion therapy has shown strong advantages in the treatment of UC, and the curative effect is accurate. therefore, this paper will carry out a systematic evaluation and meta analysis of the efficacy and safety of heat-sensitive moxibustion in the treatment of UC. METHODS: We will be searching 8 electronic databases, including PubMed, Embase, Web of Science, Cochrane Library, the China National Knowledge Infrastructure, Chinese Science and Technology Periodical Database, Wanfang Database, and Chinese Biomedical Literature Database. We will search above electronic databases from the beginning to December 2020, without any language restriction. Clinical efficacy, including total effective rate or cure rate, clinical symptom integral (abdominal pain, diarrhea, purulent stool), and recurrence rate will be accepted as the primary outcomes. The changes of cytokine Hs-CRP, IL-6, TNF-αlevels in serum, and improvement of colorectal mucosa will be used as secondary outcomes. RevMan 5.3 software will be used for statistical analysis. The result about the curative effect and safety of heat-sensitive moxibustion for UC will be presented as risk ratio for dichotomous data and mean differences with a 95% confidence interval for continuous data. RESULTS: When this research program is completed, the relevant results can be obtained. CONCLUSIONS: The results of this study will provide reliable evidence for the efficacy and safety of heat-sensitive moxibustion in the treatment of UC. INPLASY REGISTRATION NUMBER: INPLASY20201101034.

Effectiveness and safety of electroacupuncture and its cotreatment with electronic moxibustion in the treatment of patients with moderate benign prostatic hyperplasia using alpha blocker: Study protocol for an assessor-blinded, randomized controlled clinical trial.

BACKGROUND: Benign prostatic hyperplasia (BPH) is a medical condition that affects the quality of life by causing lower urinary tract symptoms (LUTS) in 40% to 70% of men aged ≥60 years. Medication treatment is primarily recommended for patients with BPH if their symptom score based on the International Prostate Symptom score (IPSS) is above the moderate level. However, electroacupuncture (EA) and electronic moxibustion (EM), one of the most recent complementary and alternative treatments, are suggested as adjuvant treatments in the improvement of LUTS caused by BPH with respect to the limitations of medication treatments, such as side effects or no improvement in LUTS despite treatment. Therefore, this study aimed to evaluate the effectiveness and safety of EA and its cotreatment with EM for the improvement of LUTS in patients diagnosed with BPH using an alpha blocker but with moderate symptoms on the basis of IPSS. METHODS/DESIGN: This protocol is a 2-arm parallel-design, randomized, controlled assessor-blinded clinical trial. Seventy-eight patients diagnosed with BPH are randomized to one of the following groups: [EA and its cotreatment with EM + alpha blocker group] and [alpha blocker group]. [EA and its cotreatment with EM + alpha blocker group] continues to use the previously prescribed alpha blocker and visits the study institution 3 times a week for 6 weeks to receive the cotreatment of EA and EM. [Alpha blocker group] continues to use the previously prescribed alpha blocker for 6 weeks. To evaluate the effectiveness of the EA and its cotreatment with EM, the followings are measured: total score of the IPSS, IPSS quality of life assessment, EuroQol-Five dimension, maximum and average urinary flow rate (Qmax and Qave), and prostate size at the baseline, 3rd, 6th, and 12th weeks. The primary effectiveness endpoint measures the average change in the total score of the IPSS at the 6th week. Side effects are recorded at each visit. DISCUSSION: The results of this study are expected to provide useful information on the effectiveness and safety of the EA and its cotreatment with EM for patients with BPH with regard to the improvements in LUTS. TRIAL REGISTRATION: Clinical Research Information Service of Republic of Korea (CRIS-KCT0004411), October 31, 2019.

Efficacy and safety of moxibustion in female infertility patients undergoing in vitro fertilization and embryo transfer: A systematic review protocol.

INTRODUCTION: The purpose of this paper is to evaluate the efficacy and safety of moxibustion in infertility females/women undergoing in vitro fertilization and embryo transfer (IVF-ET). METHODS AND ANALYSIS: We will electronically search PubMed, Medline, Embase, Web of Science, the Cochrane Central Register of Controlled Trial, China National Knowledge Infrastructure, China Biomedical Literature Database, China Science Journal Database, and Wan-fang Database from their inception. Also, we will manually retrieve other resources, including reference lists of identified publications, conference articles, and grey literature. The clinical randomized controlled trials or quasi-randomized controlled trials related to moxibustion in female infertility patients undergoing IVF-ET will be included in the study. The language is limited to Chinese and English. Research selection, data extraction, and research quality assessment will be independently completed by 2 researchers. Data were synthesized by using a fixed effect model or random effect model depend on the heterogeneity test. The clinical total effective rate and the clinical pregnancy rate will be the primary outcomes. Ovulation rate, endometrial thickness, hormone level, traditional Chinese medicine (TCM) Syndrome Integral Scale and the adverse event will also be assessed as secondary outcomes. RevMan V.5.3 statistical software will be used for meta-analysis, and the level of evidence will be assessed by Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Continuous data will be expressed in the form of weighted mean difference or standardized mean difference with 95% confidence intervals (CIs), while dichotomous data will be expressed in the form of relative risk with 95% CIs. RESULTS: This study will provide a high-quality comprehensive evaluation of the efficacy and safety of moxibustion in the treatment of female infertility patients undergoing IVF-ET. CONCLUSION: This review will provide evidence to judge for judging whether moxibustion is effective in treating female infertility patients undergoing IVF-ET. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42019135593.

Effectiveness, safety, and economic evaluation of adjuvant moxibustion therapy for aromatase inhibitor-induced arthralgia of postmenopausal breast cancer stage I to III patients: Study protocol for a prospective, randomized, assessor-blind, usual-care controlled, parallel-group, pilot clinical trial.

INTRODUCTION: This study is a prospective, assessor-blinded, parallel-group, randomized controlled pilot trial to explore the effectiveness of 12-week adjuvant moxibustion therapy for arthralgia in menopausal females at stage I to III breast cancer on aromatase inhibitor (AI) administration, compared with those receiving usual care. METHODS/DESIGN: Forty-six menopausal female patients with breast cancer who completed cancer therapy will be randomly allocated to either adjuvant moxibustion or usual care groups with a 1:1 allocation ratio. The intervention group will undergo 24 sessions of adjuvant moxibustion therapy with usual care for 12 weeks, whereas the control group will receive only usual care during the same period. The usual care consists of acetaminophen administration on demand and self-directed exercise education to manage AI-related joint pain. The primary outcome is the mean change of the worst pain level according to the Brief Pain Inventory-Short Form between the initial visit and the endpoint. The mean changes in depression, fatigue, and quality of life will also be compared between groups. Safety and pharmacoeconomic evaluations will also be included. DISCUSSION: Continuous variables will be compared by an independent t test or Wilcoxon rank-sum test between the adjuvant moxibustion and usual care groups. Adverse events will be analyzed using the chi-square or Fisher exact test. The statistical analysis will be performed by a 2-tailed test at a significance level of .05.

Twelve-week study of moxa smoke: occupational exposure in female rats.

OBJECTIVE: To assess the toxicity of moxa smoke in rats. METHODS: Forty-eight female Wister rats were randomly divided into 4 groups (n = 12/group) to simulate moxa smoke exposure in Chinese medicine clinics (CMCs): the control group, and three moxa-smoke exposed groups of PM10 mass concentrations 3-5, 7-9 and 27-30 mg/m3 , respectively. These concentrations were 1 × , 2-3 × , and 7-9 × fold the concentrations found in CMCs. Exposures continued for 12 weeks (200 min/d, 5 d/week). RESULTS: No deaths were noted. After the exposure, the body weights, ratios of organ weight to body weight, urinary parameters, hematological parameters, clinical chemistry parameters and microscopic examinations revealed no obvious toxicity. CONCLUSION: Moxa smoke did not induce toxic effects in female rats in the study. These findings provide new evidence to the toxicity of moxa smoke.

A Feasibility Study of Moxibustion for Treating Anorexia and Improving Quality of Life in Patients With Metastatic Cancer: A Randomized Sham-Controlled Trial.

OBJECTIVE: The aim of this study was to determine the feasibility, acceptability, and safety of using moxibustion for treating anorexia and improving quality of life in patients with metastatic cancer. METHODS: We conducted a randomized sham-controlled trial of moxibustion. Sixteen patients with metastatic cancer were recruited from Daejeon, South Korea. The patients were randomly placed into a true or a sham moxibustion group and received 10 true or sham moxibustion treatments administered to the abdomen (CV12, CV8, CV4) and legs (ST36) over a 2-week period. Outcome measures included interest in participating in the trial, identification of successful recruitment strategies, the appropriateness of eligibility criteria, and compliance with the treatment plan (ie, attendance at treatment sessions). Clinical outcomes included results of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT), answers on the European Organization for Research and Treatment of Cancer 30-item core quality of life (EORTC QLQ-C30) questionnaires, scores on the visual analogue scale (VAS), and the results from blood tests and a safety evaluation. RESULTS: Moxibustion was an acceptable intervention in patients with metastatic cancer. Compliance with the treatment protocol was high, with 11 patients completing all 10 treatments. No serious adverse events related to moxibustion occurred, but 4 patients in the true moxibustion group reported mild rubefaction, which disappeared in a few hours. CONCLUSION: This study suggests that moxibustion may be safely used to treat anorexia and improve quality of life in patients with metastatic cancer. However, further research is needed to confirm this result.

Human exposure to airborne aldehydes in Chinese medicine clinics during moxibustion therapy and its impact on risks to health.

Many air toxicants, and especially aldehydes, are generated by moxibustion, which means burning Artemisia argyi. Our goal was to investigate indoor-air aldehyde emissions in Chinese medicine clinics (CMCs) during moxibustion to further evaluate the potential health risks, including cancer risk and non-cancer risk, to the medical staff and adult patients. First, the indoor-air-quality in 60 public sites, including 15 CMCs, was investigated. Four CMCs with frequent use of moxibustion were selected from the 15 CMCs to gather the indoor airborne aldehydes in the waiting and therapy rooms. The mean values of formaldehyde and acetaldehyde in the CMCs' indoor air were 654 and 4230 µg m(-3), respectively, in the therapy rooms, and 155 and 850 µg m(-3), respectively, in the waiting rooms. The average lifetime cancer risks (Rs) and non-cancer risks (hazard quotients: HQs) of airborne formaldehyde and acetaldehyde among the CMC medical staff exceeded the acceptable criteria (R < 1.00 × 10(-3) and HQ < 1.00) for occupational workers. The patients' Rs and HQs were also slightly higher than the critical values (R = 1.00 × 10(-6) and HQ = 1.00). Our results indicate that airborne aldehydes pose a significant threat to the health of medical staff, and slightly affected the patients' health, during moxibustion in the CMCs.