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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.

Aging and age-related declines lead to varying degrees of decreased cardiorespiratory fitness (CRF) in apparently healthy older adults. Exercise training, the primary approach for enhancing CRF, encounters several constraints when used with elderly individuals. Existing evidence implies that moxibustion might enhance the CRF of older adults. However, clinical research in this area still needs to be improved. This study will employ a randomized, assessor-blinded, controlled trial design involving 126 eligible participants. These participants will be stratified and randomly assigned to one moxibustion group, one sham moxibustion group, and one blank control group. Acupoints of bilateral Zusanli (ST36), Shenque (CV8), and Guanyuan (CV4) are selected for both real and sham moxibustion groups. The treatment will last 60 min per session, 5 sessions a week for 12 weeks. The blank control group will not receive any intervention for CRF improvement. Primary outcomes will be the mean change in peak oxygen uptake (VO2peak), anaerobic threshold (AT), and serum central carbon metabolites (CCB) from the baseline to observation points. Secondary outcome measures involve the six-minute walk distance (6MWD), the Short Form 36 Health Survey (SF-36), and the Qi and Blood Status Questionnaire (QBSQ). Outcome assessments will be conducted at weeks 4, 8, 12, and 24 as part of the follow-up. Adverse events will be assessed at each visit. This trial can potentially ascertain moxibustion's effectiveness and safety in enhancing CRF among apparently healthy older adults. ChiCTR, ChiCTR2300070303. Registered on April 08, 2023.

Though moxibustion is frequently used to treat primary dysmenorrhea in China, relevant evidence supporting its effectiveness is still scanty. This study was a pragmatic randomized, conventional drug controlled, open-labeled clinical trial. After initial screen, 152 eligible participants were averagely randomized to receive two different treatment strategies: Moxibustion and conventional drugs. Participants and practitioners were not blinded in this study. The duration of each treatment was 3 months. The primary outcome was pain relief measured by the Visual Analogue Scale. The menstrual pain severity was recorded in a menstrual pain diary. 152 eligible patients were included but only 133 of them eventually completed the whole treatment course. The results showed that the menstrual pain intensity in experimental group and control group was reduced from 6.38±1.28 and 6.41±1.29, respectively, at baseline, to 2.54±1.41 and 2.47±1.29 after treatment. The pain reduction was not significantly different between these two groups (P = 0.76), however; the pain intensity was significantly reduced relative to baseline for each group (P<0.01). Three months after treatment, the effectiveness of moxibustion sustained and started to be superior to the drug's effect (-0.87, 95%CI -1.32 to -0.42, P<0.01). Secondary outcome analyses showed that moxibustion was as effective as drugs in alleviating menstrual pain-related symptoms. The serum levels of pain mediators, such as PGF2α, OT, vWF, β-EP, PGE2, were significantly improved after treatment in both groups (P<0.05). No adverse events were reported in this trial. Both moxibustion and conventional drug showed desirable merits in managing menstrual pain, given their treatment effects and economic costs. This study as a pragmatic trial only demonstrates the effectiveness, not the efficacy, of moxibustion for menstrual pain. It can't rule out the effect of psychological factors during treatment process, because no blind procedure or sham control was used due to availability. In clinical practice, moxibustion should be used at the discretion of patients and their physicians. ClinialTrials.gov NCT01972906.

Background The dose–effect relationship of Long-snake-like moxibustion for chronic fatigue syndrome (CFS) remains poorly understood. In order to address this gap, we designed this trial to assess the association between different treatment duration of Long-snake-like moxibustion and its effects on CFS based on the combination measurements of the subjective patient-reported scales with objective medical infrared imaging technology─Thermal Texture Maps (TTM). Methods From December 2020 to January 2022, 60 female CFS patients were recruited and equally allocated to two groups: Group A, receiving 60-min Long-snake-like moxibustion per treatment, and Group B, receiving 30-min Long-snake-like moxibustion per treatment. The treatment was administered 3 times per week for a total of 4 weeks. The primary outcome was defined as the improvement of symptoms measured by the Fatigue scale-14 (FS-14), and secondary outcomes were designated as the improvement in Symptoms Scale of Spleen-Kidney Yang Deficiency, Self-rating depression scale, and Self-rating anxiety scale. TTM scanning was employed twice for CFS patients (before and after 4-week treatment) and once for Healthy control subjects (HCs). Results At week 4, the scores of FS-14 and Symptoms Scale of Spleen-Kidney Yang Deficiency in Group A were significantly lower than those in Group B (physical fatigue: 5.00 vs. 6.00, with 95%CI − 2.00 to 0.00, p  = 0.003; FS-14 total score: 8.00 vs. 9.00, with 95%CI − 3.00 to 0.00, p  = 0.012; total score of Symptoms Scale of Spleen-Kidney Yang Deficiency: 9.80 vs. 13.07, with 95%CI − 5.78 to − 0.76, P  = 0.012). All thermal radiation values of the two groups increased, and statistical differences in ΔTs between Group A and HCs were not obtained. More significant correlations between symptoms improvements and ΔT changes were observed in Group A, and its ΔT changes in Upper Jiao, Shenque (CV8), Zhongwan (CV12), Danzhong (CV17), Zhiyang (GV9), Dazhui (GV14), upper arm, thoracic segments, lumbar segments, renal region, popliteal fossa strongly correlated with the improvement of Spleen-Kidney Yang Deficiency symptoms. Conclusions In the same course of treatment, the positive dose–effect relationship was found between the treatment duration of Long-snake-like moxibustion and CFS effect assessment. 60-min Long-snake-like moxibustion per treatment were associated with optimal clinical response and TTM improvement. Trial registration Chinese Clinical Trail Registry (No. ChiCTR2000041000, date of registration: 16 December 2020), http://www.chictr.org.cn/showproj.aspx?proj=62488

Cancer-related fatigue(CRF) is a prevalent and distressing symptom among cancer patients. This study aimed to assess the initial effectiveness and safety of 3.95 μm infrared moxibustion for CRF. A randomized controlled trial was conducted with 65 CRF-diagnosed cancer patients, where the treatment group received 3.95 μm infrared moxibustion on on the ST36 (bilateral), CV4, and CV6 acupoints, each patient underwent 30-minute sessions, with 8 sessions per course and a total of 24 sessions, while the control group received standard care. The study evaluated fatigue and sleep quality using the Piper Fatigue Score (PFS) and the Pittsburgh Sleep Quality Index (PSQI) after the 2nd and 3rd sessions. After the 2nd session, individual fatigue was significantly lower in the infrared moxibustion treatment group than in the control group (6.39 vs. 5.26, P  = 0.000). After the 3rd session, individuals treated with infrared moxibustion had significantly better fatigue and sleep quality than the control group (6.60 vs. 4.63, P  = 0.000), (9.45 vs. 7.84, P  = 0.041). The safety profile of infrared moxibustion was favorable, with only four cases of skin adverse reactions reported. This study suggests that infrared moxibustion is a safe and effective treatment for CRF in Chinese cancer patients. However, further research involving larger and more diverse populations is necessary to validate these findings.

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. Moxibustion is widely used treatment method for stimulating acupuncture points and has been used for symptom management in cancer patients in East Asia. However, scientific evidence of moxibustion for the treatment of cancer‐related fatigue is still lacking. Through this full‐scale, multicenter, assessor‐blinded, randomized controlled trial, we found that 8 weeks of moxibustion treatment decreased cancer‐related fatigue more effectively than usual care.

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.

Chronic obstructive pulmonary disease (COPD) is a common chronic respiratory disease. Its high disability rate, high mortality rate, and heavy economic burden have made it a major public health problem. Umbilical moxibustion has been reported to have therapeutic effects on COPD, but there is a lack of high-quality evidence-based studies on this intervention. Therefore, the purpose of this study is to evaluate the efficacy and safety of Wenfei Guyuan (WFGY) umbilical moxibustion in the treatment of COPD. This was a multicenter, open-label, randomized controlled trial (RCT). A total of 220 participants were randomly assigned at a 1:1 ratio to the experimental group (WFGY umbilical moxibustion in combination with conventional drugs) and the control group (conventional drugs). Both groups received 13 weeks of treatment, followed by 26 weeks of follow-up. The primary outcome was the frequency of acute exacerbations, and the secondary outcomes were the 6-minute walk distance (6MWD), modified Medical Research Council dyspnea scale (mMRC) score, clinical symptoms and signs scores, and lung function tests. Statistical analysis was performed using SPSS software (version 25.0). A total of 220 participants were included in the study, and 215 participants completed the trial. There were significant time effects and group effects on the frequency of acute exacerbations (P < 0.001, P = 0.001), but no interaction effects (P = 0.406). Compared with the control group, the frequency of acute exacerbations in the experimental group was significantly reduced at 4 and 13 weeks of treatment and at 13 and 26 weeks of follow-up (P < 0.05). Among the secondary outcomes, there were significant time effects, group effects, and interaction effects on the 6MWD, mMRC scores, and clinical symptoms and signs scores (cough, expectoration, wheezing, chest tightness, shortness of breath, fatigue, cyanosis, and total scores) at different time points between the two groups (P < 0.05). FVC and FEV1 had no time effects, group effects, or interaction effects (P > 0.05). FEV1 % had group effects (P < 0.05) but no time effects or interaction effects (P > 0.05). The overall skin sensitization incidence in the experimental group was 3.74 %, which was slightly higher than the 0 % incidence in the control group, but no statistically significant difference was observed between the two groups (P > 0.05). The experimental group demonstrated superior efficacy to the control group in reducing the frequency of acute exacerbations, enhancing exercise tolerance, reducing dyspnea severity, and improving quality of life. This intervention demonstrated effectiveness and safety in the treatment of stable COPD, providing a foundation for further research. https://www.chictr.org.cn, ChiCTR2100049802. Registered on August 9, 2021. •WFGY umbilical moxibustion reduces exacerbations, enhances exercise tolerance, and improves quality of life in stable COPD.•Outcomes included the frequency of exacerbations, 6MWD, mMRC score, clinical symptoms and signs scores, and lung function.•Umbilical moxibustion has shown a therapeutic effect on COPD, but there is a lack of high-quality evidence-based studies.•WFGY umbilical moxibustion serves as an effective and safe complementary therapy for patients with stable COPD.

Objective To observe the effect of warming needle moxibustion combined with rehabilitation techniques on clinical symptoms and quality of life of patients with anterior disc displacement without reduction (ADDwoR). Methods This randomized controlled trial included 66patients, with ADDwoR, attending the Hangzhou Hospital of Traditional Chinese Medicine. Patients were assigned to the Experimental (12 sessions of warming needle moxibustion combined with rehabilitation manipulation therapy) and Control (rehabilitation therapy only) group ( n  = 33, each). Duration of treatment was 4 weeks, with 3 times a week. Outcomes included VAS pain score, maximum mouth opening (MMO), mandibular function impairment score (MFIQ), oral health impact scale (OHIP-14 scale), and mandibular dysfunction index (Fricton score). Safety assessments during treatment included incidence of fainting, broken needle, bleeding, hematoma and scalding. Results After treatment, the VAS scores, mandibular function impairment scores, oral health impact degree scale, and the scores of Dysfunction index (DI), palpation index (PI) and craniomandibular index (CMI) in the two groups were significantly decreased compared with before. While the maximum mouth opening was increased in both groups, the clinical efficacy evaluation showed the total significant rate of the control group was 59%, and the total significant rate of the experimental group was 83%, demonstrating a significant clinical efficacy difference between the two groups. Conclusion Compared to targeted rehabilitation exercises only, warming needle moxibustion combined with rehabilitation manipulation can not only improve the pain and maximum mouth opening, but also mandibular function impairment, mandibular joint disorder and oral health of patients with ADDwoR. Clinical trial registration http://www.chictr.org.cn/index.aspx , identififier: ChiCTR2200059039.

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