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Introduction: This study tested the effectiveness of moxibustion on pain and function in chronic knee osteoarthritis (KOA) and evaluated safety., Methods: A multi-centre, non-blinded, parallel-group, randomised controlled trial compared moxibustion with usual care (UC) in KOA. 212 South Korean patients aged 40-70 were recruited from 2011-12, stratified by mild (Kellgren/Lawrence scale grades 0/1) and moderate-severe KOA (grades 2/3/4), and randomly allocated to moxibustion or UC for four weeks. Moxibustion involved burning mugwort devices over acupuncture and Ashi points in affected knee(s). UC was allowed. Korean Western Ontario and McMaster Universities Questionnaire (K-WOMAC), Short Form 36 Health Survey (SF-36v2), Beck Depression Inventory (BDI), physical performance test, pain numeric rating scale (NRS) and adverse events were evaluated at 5 and 13 weeks. K-WOMAC global score at 5 weeks was the primary outcome., Results: 102 patients (73 mild, 29 moderate-severe) were allocated to moxibustion, 110 (77 mild, 33 moderate-severe) to UC. K-WOMAC global score (moxibustion 25.42+/-SD 19.26, UC 33.60+/-17.91, p<0.01, effect size = 0.0477), NRS (moxibustion 44.77+/-22.73, UC 56.23+/-17.71, p<0.01, effect size = 0.0073) and timed-stand test (moxibustion 24.79+/-9.76, UC 25.24+/-8.84, p = 0.0486, effect size  = 0.0021) were improved by moxibustion at 5 weeks. The primary outcome improved for mild but not moderate-severe KOA. At 13 weeks, moxibustion significantly improved the K-WOMAC global score and NRS. Moxibustion improved SF-36 physical component summary (p = 0.0299), bodily pain (p = 0.0003), physical functioning (p = 0.0025) and social functioning (p = 0.0418) at 5 weeks, with no difference in mental component summary at 5 and 13 weeks. BDI showed no difference (p = 0.34) at 5 weeks. After 1158 moxibustion treatments, 121 adverse events included first (n = 6) and second degree (n = 113) burns, pruritus and fatigue (n = 2)., Conclusions: Moxibustion may improve pain, function and quality of life in KOA patients, but adverse events are common. Limitations included no sham control or blinding., Trial Registration: Clinical Research Information Service (CRIS) KCT0000130.

Background: The treatment of knee osteoarthritis, which is a major cause of disability among the elderly, is typically selected from multidisciplinary options, including complementary and alternative medicine. Moxibustion has been used in the treatment of knee osteoarthritis in Korea to reduce pain and improve physical activity. However, there is no sufficient evidence of its effectiveness, and it cannot therefore be widely recommended for treating knee osteoarthritis. We designed a randomised controlled clinical trial to evaluate the effectiveness, safety, cost-effectiveness, and qualitative characteristics of moxibustion treatment of knee osteoarthritis compared to usual care., Methods/designs: This is a protocol for a multicentre, pragmatic, randomised, assessor-blinded, controlled, parallel-group study. A total of 212 participants will be assigned to the moxibustion group (n = 106) and the usual care group (n = 106) at 4 clinical research centres. The participants assigned to the moxibustion group will receive moxibustion treatment of the affected knee(s) at 6 standard acupuncture points (ST36, ST35, ST34, SP9, Ex-LE04, and SP10) 3 times per week for 4 weeks (a total of 12 sessions). Participants in the usual care group will not receive moxibustion treatment during the study period. Follow-up will be performed on the 5th and 13th weeks after random allocation. Both groups will be allowed to use any type of treatment, including surgery, conventional medication, physical treatment, acupuncture, herbal medicine, over-the-counter drugs, and other active treatments. Educational material that explains knee osteoarthritis, the current management options, and self-exercise will be provided to each group. The global scale of the Korean Western Ontario and McMaster Osteoarthritis Index (K-WOMAC) will be the primary outcome measurement used in this study. Other subscales (pain, stiffness, and function) of the K-WOMAC, the Short-Form 36v2 Health Survey, the Beck Depression Inventory, the Physical Function test, Patient Global Assessment, and the Pain Numerical Rating Scale will be used as outcome variables to evaluate the effectiveness of moxibustion. Safety will be assessed at every visit. In addition, an economic evaluation and a qualitative study will be conducted as a mixed-methods approach., Discussion: This trial may contribute to developing evidence for the effectiveness and safety of moxibustion for treating knee osteoarthritis., Trial Registration Number: KCT0000130.

Background: Hypertension is a risk factor for cardiovascular disease, and the prevalence of hypertension tends to increase with age. Current treatments for hypertension have adverse side effects and poor adherence. The purpose of this study is to evaluate the effects of moxibustion on blood pressure in individuals with pre- or stage I hypertension., Methods/design: Forty-five subjects with pre- or stage I hypertension will be randomized into three groups: treatment group A (2 times/week), treatment group B (3 times/week), and the control group (non-treated group). The inclusion criteria will be as follows: (1) aged between 19 and 65 years; (2) prehypertension or stage I hypertension (JNC 7, Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure); (3) the participants are volunteers and written consent obtained.The participants in the treatment group A will undergo indirect moxibustion 2 times per week for 4 weeks, and the participants in the treatment group B will undergo indirect moxibustion 3 times per week for 4 weeks. The participants in the control group (non-treated group) will maintain their current lifestyle, including diet and exercise. The use of antihypertensive medication is not permitted. The primary endpoint will be a change in patient blood pressure. The secondary endpoints will be the body mass index, lipid profile, EuroQol and Heart Rate Variability. The data will be analyzed with the Student's t-test and analysis of variance (ANOVA) (p < 0.05)., Discussion: The results of this study will help to establish the optimal approach for the care of adults with pre- or stage I hypertension., Trial Registration: Clinical Research Information Service KCT0000469.

Background: Moxibustion is an ancient traditional medicine using burning mugworts to stimulate acupuncture points. The aim of this study was to investigate the safety and efficacy of moxibustion for the treatment of constipation using a randomized, sham-controlled, participant-blinded, pilot trial., Methods: Twenty-six participants (identified with either qi (vital energy) deficiency or qi excess syndrome) were randomly divided into either a moxibustion or sham group. Participants were treated with real or sham moxibustion at 4 acupuncture points, ST23 and ST27, bilaterally, 3 times per week for four weeks. The primary outcome was the frequency of defecations; secondary outcomes were the Bristol stool form scale (BSS) and the constipation assessment scale (CAS)., Results: Of the 26 participants that were randomized, 24 completed the study. Defecation frequency, BSS, and CAS showed no difference between the moxibustion and sham groups. The differences were -0.25 (95% CI: -2.08, 1.58, p = 0.78), -1.22 (95% CI: -2.7, 0.26, p = 0.1), 0.91 (95% CI: -1.46, 3.28, p = 0.44) in defecation frequency, BSS, CAS, respectively. The defecation frequency increased from an average of 3.3 to 4.6 times per week in the moxibustion group (1.5[-0.5, 2], p = 0.06) and from 2.7 to 3.7 stools per week in the sham group (1[-1, 2], p = 0.15) after four weeks of treatment. The difference between participants with a deficiency or an excess syndrome, determined based on assessment of sweat, facial features, pain, body energy, and pulse type, was significant in only defecation frequency. The difference was 3.3 (95% CI: 0.41, 6.19, p = 0.03)., Conclusion: Moxibustion treatment appears safe, but showed no positive effect on constipation. The effectiveness of moxibustion treatment may depend on the syndrome pattern, and further long-term studies with a larger number of subjects are warranted., Trial Registration: Clinical Research Information Service, KCT0000168., (© 2011 Park et al; licensee BioMed Central Ltd.)

Objectives: The aim of this review was to identify adverse events of moxibustion as reported in the medical literature., Methods: Computerised literature searches were carried out in 14 databases. All articles reporting adverse effects of any type from moxibustion in humans were included, regardless of study design and publication language. The related journals and references in all located articles were manually searched for further relevant articles. Data were extracted and evaluated according to predefined criteria by three independent reviewers., Results: Adverse events related to moxibustion treatment were reported in 4 randomised clinical trials, 1 controlled clinical trial, 2 uncontrolled observational studies, 13 case reports, and 1 prospective study. The most common effects identified in this review were allergic reactions, burns, and infections such as cellulitis and hepatitis C. Allergic reactions were reported in six case reports (four case reports related to infections and two related to burns). The other articles were case reports of xerophthalmia, xeroderma, hyperpigmented macules, ptosis and eversion of the eyelids. In clinical trials, various adverse events such as rubefaction, blistering, itching sensations, discomfort due to smoke, general fatigue, stomach upsets, flare-ups, headaches, and burns were reported. Tenderness and pressure in the epigastric region or in one of the hypochondriac regions, unpleasant odour with or without nausea and throat problems, abdominal pain, premature birth, premature rupture of the membrane and bleeding due to excess pressure on the anterior placenta were reported in pregnant women., Conclusion: Moxibustion is not entirely risk free, as it has several kinds of potential adverse events such as allergy, burn and infection. Currently, the incidence of such events is not known. In the interest of patient safety, sufficiently large prospective studies should be considered to clarify this issue., (Copyright © 2010 Elsevier Ltd. All rights reserved.)

Background: Complementary and alternative medicine (CAM) is increasingly used for treatment of inflammatory bowel disease (IBD). Acupuncture-type treatments are among the most popular options. Several studies have reported that moxibustion is effective in ulcerative colitis (UC). The objective of this review was to assess the clinical evidence for or against moxibustion as a treatment for UC., Methods: We searched the literature using 18 databases from their inception to February 10, 2010, without language restrictions. We included randomized clinical trials (RCTs), in which human patients with UC were treated with moxibustion. Studies were included if they were placebo-controlled or controlled against a drug therapy or no treatment group. The methodological quality of all RCTs was assessed using the Cochrane risk of bias., Results: In total, five RCTs were included. All were of low methodological quality. They compared the effects of moxibustion with conventional drug therapy. Three tested moxibustion against sulfasalazine and two against sulfasalazine plus other drugs. A meta-analysis of five RCTs showed favorable effects of moxibustion on the response rate compared to conventional drug therapy (n = 407; risk ratio = 1.24, 95% CI = 1.11 to 1.38; P < 0.0001; heterogeneity: I2 = 16%)., Conclusions: Current evidence is insufficient to show that moxibustion is an effective treatment of UC. Most of included trials had high risk of bias. More rigorous studies seem warranted.

Objective: A hot flash is a general postmenopausal symptom experienced by approximately 75% of climacteric women. Women often turn to complementary and alternative medicines to relieve hot flashes. Moxibustion is one such medication. The aim of this study was to evaluate the effect of moxibustion on hot flashes in perimenopausal and postmenopausal women., Methods: Fifty-one participants were randomly assigned into three groups, namely, moxibustion 1, moxibustion 2, and waiting list (control). The moxibustion groups received 14 sessions of moxibustion treatment for 4 weeks at acupuncture points. Our protocol was supported by evidence from clinical experts (Moxa 1) or published literature (Moxa 2), and we followed all participants for an additional 2 weeks after the end of the study. Our primary outcome measures were frequency and severity of hot flashes. Secondary outcome parameters included quality of life (Menopausal-Specific Quality of Life Scale) and Menopause Rating Scale., Results: Fifty-one women participated in our study. By week 4, the difference in severity and frequency of hot flashes had become statistically significant between the treatment groups and the control participants. In addition, there was a statistically significant difference in Menopausal-Specific Quality of Life Scale scores between treatment group 2 and the other groups., Conclusions: Our results suggest that moxibustion reduces both the frequency and severity of menopausal hot flashes as compared with those in control participants. We would recommend further studies with larger samples and possibly including placebo controls.

An abstract of the study "A Survey on Motivation and Satisfaction of Subjects in Acupuncture & Moxibustion Clinical Trial" by Hee-Jung Jung and colleagues is presented.