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.
To evaluate the efficacy and safety of compound Decumbent Corydalis Rhizome (DCR) in treating patients with knee osteoarthritis (OA). Totally 79 patients with knee osteoarthritis were selected from out-patient and inpatient departments of West China Hospital and randomly divided into the test group and the control group. The test group (n = 41) was given Compound DCR with the dosage of 1.8 g · d(-1), while the control group (n = 38) was administered with diclofenac sodium with the dosage of 75 mg · d(-1). After 12 weeks of treatment, the total efficacy rates based on patients/physicians evaluation for experimental and control groups were 68.29%, 63.41% and 71.05%, 63.16%, respectively, without significant difference between the two groups. Both of the two groups showed significant improvements in the main efficacy indexes (pain on walking 20 m) and minor indexes (tenderness on palpation, Western Ontario and McMaster Universities OA index (WOMAC) and Short-Form Health Survey (SF-36 ), but without significant difference in efficacy between them. The incidence of related adverse events was 24.39% in the test group and 47.37% in the control group, respectively, with significant differences between the two groups (P < 0.05). In the controlled study, compound DCR is as efficient as diclofenac sodium but more tolerable, with a good clinical application prospect.
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.
INTRODUCTION: Our objective was to compare the effectiveness and safety of traditional Chinese moxibustion to that of sham moxibustion in patients with chronic knee osteoarthritis (KOA) pain.
METHODS: We conducted a randomized placebo-controlled trial involving 110 patients with KOA who met the inclusion criteria. These patients randomly received either active moxibustion (n = 55) or sham moxibustion control (n = 55) at acupoints Dubi (ST 35), extra-point Neixiyan (EX-LE 4), and an Ashi (tender) point three times a week for 6 weeks. Effects were evaluated with Western Ontario and McMaster Universities' Osteoarthritis Index (WOMAC VA 3.1) criteria at the end of the course of treatment and 3, 12, and 24 weeks after the initial treatment.
RESULTS: The WOMAC pain scores showed greater improvement in the active treatment group than in control at weeks 3 (P = 0.012), 6 (P <0.001), 12 (P = 0.002), and 24 (P = 0.002) as did WOMAC physical function scores of the active treatment group at week 3 (P = 0.002), 6 (P = 0.015), and 12 (P <0.001) but not 24 (P = 0.058). Patients and practitioners were blinded successfully, and no significant adverse effects were found during the trial.
CONCLUSIONS: A 6-week course of moxibustion seems to relieve pain effectively and improve function in patients with KOA for up to 18 weeks after the end of treatment. Moxibustion treatment appears to be safe, and the usefulness of the novel moxa device was validated.
TRIAL REGISTRATION: Current controlled trial: ISRCTN68475405. Registered 4 April 2014.
OBJECTIVE: To observe the clinical efficacy of treating middle-aged and aged patients with knee osteoarthritis (KOA) of yang-deficiency induced cold-damp syndrome (YDICDS) by ozone combined Fugui Gutong Granule (FGG).
METHODS: Using a prospective, randomized controlled clinical trial, 200 KOA patients of YDICDS were randomly assigned to four groups. i.e., the control group (Group A), the Chinese medicine treatment group (Group B), the ozone group (Group C), and the Chinese-r medicine treatment plus ozone group (Group D).Patients in Group A took Voltaren Tablet. Those in Group B took FGG. Those in Group C received ozone injection (10 -18 mL) from knee joint cavity at 25 mg/L, once weekly for 4 weeks in total. Those in Group D received injection from knee joint cavity and took FGG. The therapeutic course for all was one month. The efficacy was assessed using visual analogue scale (VAS) and Western Ontario MacMaster University Osteoarthritis index (WOMAC).
RESULTS: The VAS score was obviously lower in Group D than in Group B and Group A at 24 h and 1 week (P <0. 05). After one month of treatment, the VAS score was obviously lower in Group D than in Group A, B, and C (P < 0.05). After treatment the total integral of WOMAC was 25.34 +/- 2.12 in Group D, obviously lower than that in Group A (44.72 +/- 6.57), Group B (40.58 +/- 5.98), and Group C (38.53 +/- 5. 13), showing statistical difference (P <0.05). The pain score, the joint stiffness score, the score for daily activities were lower in Group D than in Group A (P <0.05). The cured and markedly effective rate was 76.0% in Group D, higher than that of Group A (25. 0%), Group B (25. 0%), and Group C (43.8%), respectively (P < 0.05).
CONCLUSION: Ozone combined FGG had advantages in alleviating joint pain, and improving joint stiffness and daily activities of middle-aged and aged patients with KOA of YDICDS.
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.
