Moxibustion Treatment for Knee Osteoarthritis: A Multi-Centre, Non-Blinded, Randomised Controlled Trial on the Effectiveness and Safety of the Moxibustion Treatment versus Usual Care in Knee Osteoarthritis Patients Clinical observation on cervical spondylopathy vertebroarterial type treated by electro-acupuncture. Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement Acupuncture stimulation improves balance function in stroke patients: a single-blinded controlled, randomized study. Fifty cases of vertebrobasilar ischemic vertigo treated by acupuncture. [Study on clinical therapeutic effect of activating brain and regaining consciousness needling method on poststroke depression and the mechanism]. Local changes in microcirculation and the analgesic effects of acupuncture: a laser Doppler perfusion imaging study.
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 , r and omised 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 grade s 0/1 ) and moderate-severe KOA ( grade s 2/3/4 ) , and r and omly 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 Question naire ( 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-st and 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 ) OBJECTIVE To observe the clinical therapeutic effects of electro-acupuncture in the treatment of cervical spondylopathy of the vertebroarterial type . METHODS According to the consulting order , the patients were r and omly divided into a treatment group ( 29 cases treated with electro-acupuncture ) , and a control group ( 28 cases treated with simple acupuncture ) . 20 treatments were given to patients in both groups . RESULTS The markedly effective rate of the treatment group was 75 % and that of the control group was 61.54 % ( P<0.05 ) . CONCLUSION Electro-acupuncture has a better therapeutic effect than the simple acupuncture in the treatment of cervical spondylopathy of the vertebroarterial type Reporting harms may cause more trouble and discredit than the fame and glory associated with successful reporting of benefits ( 1 ) . The CONSORT ( Consoli date d St and ards of Reporting Trials ) statement , a checklist ( Table 1 ) flow diagram first published in 1996 and revised 5 years later ( 2 , 3 ) , is an effort to st and ardize , and thereby improve , published reports of r and omized , controlled trials ( RCTs ) . One of the additions to the 2001 revision was an item about reporting adverse events . This single item did not do full justice to the importance of harms-related issues . The CONSORT Group met in September 2001 to discuss how to correct this deficiency . We aim ed to provide evidence -based guidance on the reporting of harms in RCTs . First , we search ed MEDLINE , EMBASE , Web of Science , and the Cochrane Library using a wide array of terms related to harms and identified pertinent evidence . We also communicated with experts and review ed bibliographies of identified articles to find additional studies . At a meeting in Montebello , Quebec , Canada , in May 2003 , CONSORT Group members , including several journal editors and additional experts in related fields , held a structured discussion of recommendations about reporting of harms-related issues in RCTs . The discussion s led to a written document that we circulated among the team members for comment . The present manuscript describes our recommendations on the appropriate reporting of harms in RCTs . Table 1 . Original CONSORT Checklist The terminology of harms-related issues in RCTs is confusing and often misleading or misused ( see Glossary ) ( 4 , 5 ) . Safety is a reassuring term that may obscure the real and potentially major harms that drugs and other interventions may cause . We encourage authors to use the term harms instead of safety . In addition to misused terminology , reporting of harms in RCTs has received less attention than reporting of efficacy and effectiveness and is often inadequate ( 6 - 14 ) . In short , both scientific evidence and ethical necessity call for action to improve the quality of reporting of harms in RCTs ( 15 , 16 ) . Here , we present a set of recommendations and accompanying explanations for the proper reporting of harms in RCTs . These recommendations should complement the existing CONSORT statement ( Table 2 ) . Examples are presented on the Annals and CONSORT ( www.consort-statement.org ) Web sites . Table 2 . Checklist of Items To Include When Reporting Harms in R and omized , Controlled Trials Recommendations Title and Abstract Recommendation 1 . If the study collected data on harms and benefits , the title or abstract should so state . The title should mention harms if the study of harms was a key trial objective . Many phase I and phase II trials , some phase II/III trials , and most phase IV trials ( 17 , 18 ) target harms as primary outcomes . Yet , the title and abstract seldom contain the word harm . Among 375143 entries in the Cochrane Central Register of Controlled Trials ( Cochrane Library , issue 3 , 2003 ) , search ing titles with the search terms harm or harms yielded 337 references ( compared with 55374 for efficacy and 23415 for safety ) . Of the 337 , excluding several irrelevant articles on self-harm or harm reduction , only 3 trial reports and 2 abstract s contained the word harm in their titles . Authors should present information on harms in the abstract . If no important harms occurred , authors should so state . Explicit reference to the reporting of adverse events in the title or abstract is also important for appropriate data base indexing and information retrieval ( 19 ) . Introduction Background Recommendation 2 . If the trial addresses both harms and benefits , the introduction should so state . The introduction states the scientific background and rationale of an RCT . This requires a balanced presentation whereby the possible benefits of the intervention under investigation are outlined along with the possible harms associated with the treatment . R and omized , controlled trials that focus primarily on harms should clearly state this interest when describing the study objectives in the Introduction and in defining these objectives in the Methods . Methods Outcomes Recommendation 3 . List addressed adverse events with definitions for each ( with attention , when relevant , to grading , expected vs. unexpected events , reference to st and ardized and vali date d definitions , and description of new definitions ) . The Methods section should succinctly define the recorded adverse events ( clinical and laboratory ) . Authors should clarify whether the reported adverse events encompass all the recorded adverse events or a selected sample . They should explain how , why , and who selected adverse events for reporting . In trials that do not mention harms-related data , the Methods section should briefly explain the reason for the omission ( for example , the design did not include the collection of any information on harms ) . Authors should also be explicit about separately reporting anticipated and unexpected adverse events . Expectation may influence the incidence of reported or ascertained adverse events . Making participants aware in the consent form of the possibility of a specific adverse event ( priming ) may increase the reporting rate of the event ( 20 ) . Another example of priming is the finding that the rates of withdrawals due to adverse events and the rates of specific adverse events were significantly higher in trials of aspirin , diclofenac , or indomethacin with comparator drugs compared with placebo-controlled trials ( 21 ) . Presumably , participants were more eager to come forth and report an adverse event or to withdraw from treatment when they knew they could not be receiving inactive placebo . Authors should report whether they used st and ardized and vali date d measurement instruments for adverse events . Several medical fields have developed st and ardized scales ( 22 - 32 ) . Use of nonvali date d scales is common . The source document for well-established definitions and scales should be referenced . New definitions for adverse events should be explicit and clear . Authors should describe how they developed and vali date d new scales . For interventions that target healthy individuals ( for example , many preventive interventions ) , any harm , however minor , may be important to capture and report because the balance of harms and benefits may easily lean toward harms in a low-risk population . For other population s and for interventions that improve major outcomes ( for example , survival ) , severe and life-threatening adverse events may be the only ones that are important in the balance of benefits and harms . Recommendation 4 . Clarify how harms-related information was collected ( mode of data collection , timing , attribution methods , intensity of ascertainment , and harms-related monitoring and stopping rules , if pertinent ) . It is important to describe the question naires , interviews , and tests used to collect information on harms , as well as their timing during follow-up . Passive surveillance of harms leads to fewer recorded adverse events than active surveillance ( 4 ) . Open-ended questions may yield different information , both quantitatively and qualitatively , than structured question naires ( 33 ) . Studies of nonsteroidal , anti-inflammatory drugs ( NSAIDs ) exemplify how data collection methods can affect the detection and reporting of harms . When selective NSAIDs with fewer gastrointestinal adverse events became available , trials reported more than 10 times as many ulcers when comparing these drugs with older NSAIDs as when older NSAIDs were compared with placebo . In the newer trials , more ulcers were detected because participants had regular endoscopy , and the case definition of ulcers was more sensitive ( 34 ) . Authors should specify the time frame of surveillance for adverse events . Some investigators stop recording adverse events at the end of the intervention period or a certain number of days afterward ( for example , 30 days after discontinuation of drug therapy ) and miss events with long latency ( 35 ) . Surgical trials often capture only the adverse events that occur intraoperatively . Several important surgical complications are likely to occur later . Finally , in crossover trials , delayed events might occur while the patient is taking a subsequent assigned treatment . Attribution is the process of deciding whether an adverse event is related to the intervention . Whenever authors filter events through an attribution process , they should state who makes the attribution ( investigators , participants , sponsors , or combinations ) , whether the process is blinded to assigned treatment , and what definitions of adverse events they use ( 4 ) . Discontinuations and withdrawals due to adverse events are especially important because they reflect the ultimate decision of the participant and /or physician to discontinue treatment . Although treatment may occasionally be discontinued for mild or moderate adverse events , attributing discontinuation to a specific reason ( to toxicity , lack of efficacy , other reasons , or combinations of reasons ) may be difficult . For example , in psychopharmacology , dropouts may reflect treatment ineffectiveness as much as toxicity-related intolerance ( 36 ) . Trial reports should specify who gave the reasons for discontinuation ( participants or physicians ) and whether attribution was blinded to the assigned treatment . For example , even in blinded trials , participants and their clinicians are often unblinded before they decide whether to discontinue the intervention . It is important to report participants who are nonadherent or lost to follow-up because their actions may reflect their inability to tolerate the intervention . Moreover , authors should specify how they h and led withdrawals in the analyses of the data . R and omized , controlled trials should report any plan for monitoring for harms and rules for stopping the trial because of harms ( 37 ) . They should clarify whether stopping guidelines examine benefits and harms The disturbance of balance function is one of main etiology result ing in falling down in stroke patients . A number of studies report that acupuncture may improve the motor function of stroke patients . Therefore , the aim of the present study was to investigate the effect of acupuncture on balance function . We design ed a single-blinded , controlled , r and omized study . A total of 30 stroke patients were r and omized into experimental and control groups . Experimental groups received acupuncture treatment accompanied by the manual twisting of needles and obtaining of qi ( the subjects experienced sensations of soreness , numbness , swelling and heaviness , while the acupuncturist experienced a sensation of needle resistance ) , whereas the control group did not receive manual twisting of needles and without obtaining of qi .  All of the subjects were first-time stroke patients ; infa rct ion location was limited to either the left or right hemisphere , and all subjects were able to walk for at least 6 meters .  Acupuncture stimulation ( AS ) was applied to Baihui ( GV 20 ) acupoint as well as to 4 spirit acupoints ( 1.5 cun anterior , posterior , left and right laterals from Baihui acupoint , respectively ) for 20 min . Balance function outcome measures were : ( 1 ) the displacement area of the patient 's center of gravity ; ( 2 ) the time taken for a patient to st and vertically from a seated position ; ( 3 ) the time taken for a patient to walk a distance of 6 meters ; ( 4 ) muscle strength of both lower extremities . Results indicated that the displacement area from the center of gravity decreased in the experimental group , but not in the control group . There was greater reduction in the displacement area in the experimental group than in the control group . Following AS , the time taken to reach a st and ing position from a seated position , as well as the time taken to walk 6 meters was decreased equally in both the experimental and control groups . The muscle strength of the hip flexor and knee extensor were increased in the paralyzed and non-paralyzed sides of patients in the experimental group , but not in the control group . The results of the present study suggest that acupuncture stimulation may induce an immediate effect that improves balance function in stroke patients OBJECTIVE To observe the therapeutic effects of filiform needle acupuncture combined with dermal needle tapping for vertebrobasilar ischemic vertigo .  METHODS Based on the etiopathogenesis of TCM , the disease is caused by turbid phlegm clouding the heart orifice combined with wind , leading to insufficient nourishment of the brain due to deficiency of blood . Fenglong ( ST 40 ) was punctured with filiform needle to resolve phlegm ; Fengchi ( GB 20 ) to dispel wind ; Baihui ( GV 20 ) to stop dizziness ; and Lieque ( LU 7 ) to widen the inner diameter of the vertebral arteries and increase peak systolic velocity and minute blood flow volume , so as to improve blood supply to the vertebral arteries . Dazhui ( GV 14 ) was stimulated by tapping with a dermal needle to improve blood supply to the head . RESULTS Of 50 patients in this series , 39 cases ( 78 % ) were cured , 6 cases ( 12 % ) relieved , 4 cases ( 8 % ) improved , and 1 case ( 2 % ) failed , with a total effective rate of 98 % . CONCLUSION Acupuncture combined with dermal needle tapping is an effective therapy for treating vertebrobasilar ischemic vertigo OBJECTIVE To probe into an effective method for treatment of poststroke depression . METHODS Two hundred and fifty-six cases of poststroke depression were r and omly divided into a control group ( n = 76 ) treated by oral administration of amitilin and an acupuncture group ( n = 180 ) treated by activating brain and regaining consciousness needling method . Their clinical therapeutic effects and changes of relative factors of poststroke depression and plasma contents of monoamine neurotransmitters were observed . RESULTS In the acupuncture group , the clinical symptoms and the relative indexes in the depression scales improved and plasma contents of the monoamine neurotransmitters increased significanty as compared with the control group ( P < 0.05 ) . CONCLUSION The needling method for activating brain and regaining consciousness can improve relative factors to cure poststroke depression OBJECTIVES Although the local response induced by acupuncture manipulation has been considered to be among the important factors that induce the effects of acupuncture , this connection has not yet been properly studied with st and ardized tools . The aims of this study are to examine the local changes in microcirculation that occur at different manipulation intensities and explore any associations of these changes with the analgesic effects of acupuncture . PARTICIPANTS / INTERVENTIONS Twelve healthy volunteers received three acupuncture interventions ( insertion only , a single manipulation , and repeated manipulations ) at the right LI4 ( Hegu  or  Hapgok  ) in r and om order . OUTCOME MEASURES Skin blood perfusion was measured in a 100-mm(2 ) area ellipse centered on LI4 by using laser Doppler perfusion imaging ( LDPI ) before , during , and after acupuncture stimulation . Pressure pain thresholds ( PPTs ) were measured at ipsilateral areas , including acupoints ST25 ( abdomen ) , LI5 ( h and ) , LI10 ( arm ) , and SP9 ( leg ) . RESULTS Repeated acupuncture manipulations enhanced microcirculatory perfusion compared with the insertion-only ( p<0.01 ) and the single-manipulation ( p<0.05 ) conditions . The repeated acupuncture manipulations significantly decreased the pressure pain at ST25 compared with the other groups ( each p<0.05 ) . Of note , Spearman correlation analysis revealed significant correlation between changes of local perfusion and PPTs ( r=0.393 ; p=0.018 ) . CONCLUSIONS These results suggested that repeated manipulation induced higher local microcirculatory changes that were correlated with the analgesic effects at the relevant sites . The findings suggest that a proper dose of acupuncture stimulation might be essential to elicit the acupuncture effects
Objective This study aims to evaluate the efficacy and safety of acupuncture for the treatment of  cervical vertigo ( CV ) .