Jun Xiong

The design and protocol of heat-sensitive moxibustion for knee osteoarthritis: a multicenter randomized controlled trial on the rules of selecting moxibustion location

BackgroundKnee osteoarthritis is a major cause of pain and functional limitation. Complementary and alternative medical approaches have been employed to relieve symptoms and to avoid the side effects of conventional medication. Moxibustion has been widely used to treat patients with knee osteoarthritis. Our past researches suggested heat-sensitive moxibustion might be superior to the conventional moxibustion. Our objective is to investigate the effectiveness of heat-sensitive moxibustion compared with conventional moxibustion or conventional drug treatment.MethodsThis study consists of a multi-centre (four centers in China), randomised, controlled trial with three parallel arms (A: heat-sensitive moxibustion; B: conventional moxibustion; C: conventional drug group). The moxibustion locations are different from A and B. Group A selects heat-sensitization acupoint from the region consisting of Yin Lingquan(SP9), Yang Lingquan(GB34), Liang Qiu(ST34), and Xue Hai (SP10). Meanwhile, fixed acupoints are used in group B, that is Xi Yan (EX-LE5) and He Ding (EX-LE2). The conventional drug group treats with intra-articular Sodium Hyaluronate injection. The outcome measures above will be assessed before the treatment, the 30 days of the last moxibustion session and 6 months after the last moxibustion session.DiscussionThis trial will utilize high quality trial methodologies in accordance with CONSORT guidelines. It will provide evidence for the effectiveness of moxibustion as a treatment for moderate and severe knee osteoarthritis. Moreover, the result will clarify the rules of heat-sensitive moxibustion location to improve the therapeutic effect with suspended moxibustion, and propose a new concept and a new theory of moxibustion to guide clinical practices.Trial RegistrationThe trial is registered at Controlled Clinical Trials: ChiCTR-TRC-00000600.

Comparison of heat-sensitive moxibustion versus fluticasone/salmeterol (seretide) combination in the treatment of chronic persistent asthma: design of a multicenter randomized controlled trial

BackgroundAsthma is a major health problem and has significant mortality around the world. Although the symptoms can be controlled by drug treatment in most patients, effective low-risk, non-drug strategies could constitute a significant advance in asthma management. An increasing number of patients with asthma are attracted by acupuncture and moxibustion. Therefore, it is of importance that scientific evidence about the efficacy of this type of therapy is regarded. Our past researches suggested heat-sensitive moxibustion might be effective in treatment of asthma. Our objective is to investigate the effectiveness of heat-sensitive moxibustion compared with conventional drug treatment.Methods/DesignThis study is comprised of a multi-centre (12 centers in China), randomized, controlled trial with two parallel arms (A: heat-sensitive moxibustion; B: conventional drug). Group A selects heat- sensitive acupoints from the rectangle region which consist of two outer lateral lines of dorsal Bladder Meridian of Foot-Taiyang, and two horizontal lines of BL13(Fei Shu) and BL17 (Ge Shu);6 inch outer the first and second rib gap of anterior chest. Group B treats with fluticasone/salmeterol (seretide). The outcome measures will be assessed over a 3-month period before each clinic visit at days 15, 30, 60, and 90. Follow-up visit will be at 3, 6 months after the last treatment session. Adverse event information will be collected at each clinic visit.DiscussionThis trial will utilize high quality trial methodologies in accordance with CONSORT guidelines. It may provide evidence for the effectiveness of heat-sensitive moxibustion as a treatment for chronic moderate persistent asthma. Moreover, the result may propose a new type moxibustion to control asthma.Trial RegistrationThe trial is registered at Chinese Clinical Trials Registry: ChiCTR-TRC-09000599

Heat-sensitive moxibustion for lumbar disc herniation: a meta-analysis of randomized controlled trials

OBJECTIVE To assess the efficacy and safety of heat-sensitive moxibustion in the treatment of lumbar disc herniation (LDH). METHODS Randomized controlled trials (RCTs) involving heat-sensitive moxibustion in the treatment of LDH were retrieved from the Chinese Biological Medical Literature database (1978-20011), Weipu database (1989-2011), Wanfang digital journal (1998-2011), China National Knowledge Internet (1979-2011), PubMed (1966-2011), EMBASE (1980-2011), and Cochrane Library (Issue 1,2011). Hand-search of the relevant journals from the Library of Jiangxi University of Traditional Chinese Medicine was also adopted for the collection of data. Data were extracted and evaluated by two reviewers independently with a specially designed extraction form. The Cochrane Collaborations RevMan 5.0.20 software was used for data analyses. RESULTS A total of 6 trials involving 580 patients were included. Meta-analysis showed that the total effectiveness rate in the heat-sensitive moxibustion group was significantly different when compared with conventional moxibustion [RR=1.19, 95% CI [1.06, 1.33)] and diclofenac sodium [RR=1.47, 95% CI [1.17, 1.85)], but similar to that of acupuncture. The cure rate in the heat-sensitive moxibustion group was significantly different when compared with conventional moxibustion [RR=1.58, 95% CI (1.04, 2.40)] and diclofenac sodium [RR-1.91, 95% CI (1.01, 3.60)], but similar with that of acupuncture. In terms of the Japanese Orthopaedic Association scores, significant differences were noted in subjective indices, objective indices, and daily life subscales. Two trials reported that there were no adverse events over the duration of treatment. CONCLUSION Compared with conventional moxibustion, acupuncture, and diclofenac sodium, heat-sensitive moxibustion in the treatment of LDH is superior in efficacy. Further large-scale trials are required to define the role of heat-sensitive moxibustion in the treatment of this disease.

Evaluation of different moxibustion doses for lumbar disc herniation: multicentre randomised controlled trial of heat-sensitive moxibustion therapy

Background There is some evidence for the effectiveness of moxibustion for the treatment of lumbar disc herniation (LDH), but it remains unclear what dose is optimal. Objective To compare the effectiveness of a new technique of individualised ‘sensitivity elimination’ dose versus a standardised 15 min dose in the treatment of LDH. Methods This study was a multicentre (four centres in China), randomised, controlled trial with two parallel arms (group A, individualised sensitivity elimination dose; group B, standardised dose). The most heat-sensitised acupuncture point from the triangle bound by BL25 and GV2 was selected. Both groups received 18 sessions over 2 weeks. The outcome was evaluated by Modified Japanese Orthopaedic Association scale (M-JOA) score before and after treatment and at 6-month follow-up examination. All main analyses were by intention to treat. Results A total of 96 patients were included. A Significant difference of total M-JOA score was noted between the groups at weeks 1 and 2 (p<0.05). Significant differences were also evident during the follow-up period (p<0.01). The mean duration of moxibustion was 42.7±5.4 (range, 22–58) minutes in the experimental group. Conclusions The effectiveness of the individualised sensitivity elimination dose appears superior to the standardised dose in the treatment of LDH. Only 15 min moxibustion in the conventional dose group seemed insufficient to elicit the satisfactory clinical effects obtained by heat-sensitive moxibustion therapy. However, in view of some limitations of this study further research is necessary before this can be stated conclusively. Trial Registration Controlled Clinical Trials: ChiCTR-TRC-09000602.

Heat-sensitive moxibustion in patients with osteoarthritis of the knee: a three-armed multicentre randomised active control trial

Background In China, heat-sensitive moxibustion (HSM) is used for knee osteoarthritis (KOA) to reduce pain and improve physical activity. However, there is little high-quality evidence of its effectiveness. Objective To evaluate the effectiveness of HSM in the treatment of KOA compared with usual care. Methods We performed a multicentre, randomised controlled trial. In total, 432 patients with KOA were randomly assigned to one of three groups (HSM, conventional moxibustion, or conventional injection with sodium hyaluronate). The primary end point was the guiding principle of clinical research on new drugs in the treatment of KOA (GPCRND-KOA). Measurements were obtained at baseline and after 1 and 6 months (month 7) of study. Result For GPCRND-KOA, there were significant differences among the three groups after treatment at months 1 and 7. Pairwise comparisons showed that HSM was more effective than the conventional drug. There was no difference in any measures between conventional moxibustion and the conventional drug. Compared with conventional moxibustion, HSM resulted in greater improvement in all outcomes. Conclusions This trial provided some evidence of the superiority of HSM in patients with KOA, suggesting that the observed differences might be due to superiority effects of a heat-sensitive point, although the effect of expectation cannot be ruled out. Trial Registration Number The trial was registered at Controlled Clinical Trials: ChiCTR-TRC-09000600.

Curative effect of heat-sensitive moxibustion on chronic persistent asthma： a multicenter randomized controlled trial

OBJECTIVE To compare the curative effects of heat-sensitive moxibustion with conventional drugs on chronic persistent asthma and seek a valuable therapy to replace Western Medicine. METHODS The participants in this multi-center, randomized, and controlled study were randomly divided into two groups: group A (n=144), treated with heat-sensitive moxibustion (50 sessions) and group B (n=144), treated with Seretide (salmeterol 50 plg/fluticasone 250 pg, twice a day). The scores of asthma control test (ACT), forced expiratory volume in 1 second (FEV1), peak expiratory flow (PEF), and attack frequency were measured after 15, 30, 60, and 90 days of treatment. Patients followed up 3 and 6 months after treatment. RESULTS There was a significant difference (P= 0.0002) in the ACT score and lung function between the two groups after 3 months of treatment and (P=0.000 03) during the follow-up visits. In addition, heat-sensitive moxibustion reduced attack frequency in the period from inclusion to the 6-month follow-up visit. CONCLUSION This study shows that heat-sensitive moxibustion may have a comparable curative effect to Seretide (salmetero/fluticasone) on asthma.

Heat sensitisation in suspended moxibustion: features and clinical relevance

We have observed a ‘heat-sensitisation’ phenomenon in a large proportion of patients receiving suspended moxibustion treatment. Patients become thermally sensitised to moxibustion stimulation at certain locations on the body, indicated by sensations of strong warmth or heat penetrating into the body (heat penetration), warmth spreading around the stimulation site (heat expansion), warmth conducting in certain directions and reaching some body regions or even internal organs remote from stimulation sites (heat transmission), or other non-thermal sensations such as aching, heaviness, pressure etc. These heat-sensitised locations are not fixed, but may, during the progression of disease, dynamically change within a certain range centred on acupuncture points. Each condition seems to have its specific set of such sensitised acupuncture points and such phenomena are not commonly observed in other body regions or in healthy subjects. A number of clinical trials have shown that the appearance of heat sensitisation is correlated with better therapeutic effects in various diseases, indicating the clinical significance of such responses. Further investigation is required to elucidate the epidemiological characteristics and biological mechanisms of the heat sensitisation in suspended moxibustion.

Comparative Effectiveness of the Deqi Sensation and Non-Deqi by Moxibustion Stimulation: A Multicenter Prospective Cohort Study in the Treatment of Knee Osteoarthritis

Substantial evidence has supported that moxibustion stimulates a unique phenomenon of Deqi, heat-sensitive moxibustion sensation. This study consisted of a multicenter, prospective cohort study with two parallel arms (A: heat-sensitive moxibustion sensation group; B: nonheat-sensitive moxibustion sensation group). All forms of moxibustion were applied unilaterally on the right leg with a triangle shape of three acupuncture points simultaneously (bilateral Xi Yan (EX-LE5) and He Ding (EX-LE2)). After one month the primary outcome parameter GPCRND-KOA showed significant differences between groups: trial group 5.23 ± 2.65 (adjusted mean ± SE) 95% CI [4.44~6.01] versus control group 7.43 ± 2.80 [6.59~8.26], P = 0.0001. Significant differences were manifested in total M-JOA score during the follow-up period (P = 0.0006). Mean knee circumference indicated significant difference between the groups (P = 0.03; P = 0.007). Overall, this evidence suggested that the effectiveness of the Deqi sensation group might be more superior than the non-Deqi sensation one in the treatment of KOA. This study was aimed at providing scientific evidence on the Deqi sensation of moxibustion and at showing that heat-sensitive moxibustion sensation is essential to achieve the preferable treatment effects of KOA.

Influence of the deqi sensation by suspended moxibustion stimulation in lumbar disc herniation: study for a multicenter prospective two arms cohort study.

Moxibustion stimulates the Deqi (Qi arrival) phenomenon. Many clinical observations have documented that the character of the Deqi was a composite heat-sensitive moxibustion sensation. In this prospective multicentre comparative observational nonrandomized study, 92 patients with moderate to severe LDH were included. This study consisted of two parallel arms (A: heat-sensitive moxibustion sensation group; B: nonheat-sensitive moxibustion sensation group). Moxibustion was applied in the following three acupuncture points simultaneously: Da Changshu (BL25), Wei Zhong (BL40), and A-Shi acupuncture point (tenderness). The adjusted mean total Modified-JOA score showed significant differences between the groups in the first week (10.32 ± 4.27 95% CI [9.23 ~ 11.40] versus control group 12.42 ± 5.02 [11.62 ~ 13.69], P = 0.03). The outcome in the second week also presented significant differences in both groups (7.62 ± 4.80 [6.46 ~ 8.77] versus 10.56 ± 4.75 [9.35 ~ 11.76], P = 0.005). Significant differences were also manifested in the follow-up period (P = 0.007). It can be inferred that the existence of the Deqi (heat-sensitive moxibustion sensation) phenomenon in the process of suspended moxibustion is closely related to the curative effect, and arrival of heat-sensitive moxibustion sensation could improve the clinical curative effect of moxibustion.

Effectiveness of heat-sensitive moxibustion in the treatment of lumbar disc herniation: study protocol for a randomized controlled trial

BackgroundLumbar disc herniation is a common and costly problem. Moxibustion is employed to relieve symptoms and might therefore act as a therapeutic alternative. Many studies have already reported encouraging results in heat-sensitive moxibustion for lumbar disc herniation. Hence, we designed a randomized controlled clinical trial to investigate the effectiveness of heat-sensitive moxibustion compared with conventional moxibustion.MethodsThis trial is a multicenter, prospective, randomized controlled clinical trial. The 316 eligible patients are randomly allocated to two different groups. The experimental group is treated with heat-sensitive moxibustion (n = 158); while the control group (n = 158) is treated with conventional moxibustion. The moxibustion locations are different for the groups. The experimental group selects heat-sensitization acupoints from the region which consists of bilateral Da Changshu (BL25) and Yao Shu (Du2). Meanwhile, fixed acupoints are used in control group; patients in both groups receive 18 sessions in 2 weeks.DiscussionThe study design guarantees a high internal validity for the results. It is one large-scale randomized controlled trial to evaluate the efficacy of heat-sensitive moxibustion compared to conventional moxibustion and may provide evidence for this therapy as a treatment for moderate and severe lumbar disc herniation. Moreover, the result may uncover the inherent laws to improve the therapeutic effect with suspended moxibustion.Trial RegistrationThe trial is registered at Chinese Clinical Trials Registry: ChiCTR-TRC-09000604. The application date was 27 November 2009. The first patient was randomized on the 16 June 2011.