| BackgroundIn traditional Chinese medicine,the use of acupuncture as a medical therapy to treat disease carries relatively minimal risk.Acupuncture can,however,have certain dangers as it is an invasive procedure,particularly when practitioners are inexperienced and don’t adhere to best practices.There are a large number of studies evaluating the safety of acupuncture,but evaluating the safety of acupuncture is not the same as studying the risks of acupuncture,and the definitions and scope of the two studies differ slightly.In the General Requirements for the Risk Control in the Safe Use of Acupuncture(WFAS 005:2019)published lately by World Federation of Acupuncture-Moxibustion Societies(WFAS),the definition of "acupuncture risks" is the possibility of physical or mental damages,injuries,or other adverse conditions associated with acupuncture.The scope of acupuncture risks is divided into three categories:risks to acupuncture receivers,risks to acupuncture providers and environmental risks.Among them,risks to acupuncture receivers refers to the likelihood of various types of acupuncture adverse events,which can be subdivided into the likelihood of adverse reactions to acupuncture,acupuncture accidents and acupuncture negligence.Risks to acupuncture providers refers to the possibility of exposing to multiple occupational hazards in practice.Needlestick injuries and infections are held as two major issues.Environmental risks refers to the possibility of contamination by acupuncture devices and other medical wastes contaminated by blood and tissue of the receiver.As the receiver of the traumatic stimulus of acupuncture,the receiver is the main bearer of the risk of acupuncture,and there are many factors that may pose a risk to him/her,and the types of risk are complicated.The majority of recent research on acupuncture risks has been on risks to the acupuncture receiver.Contrarily,environmental risk has a long latency time and a very homogenous source and type,and there is currently less original research on these two categories of risk.Despite the relatively large number of studies on the risk of acupuncture receivers,the evaluation indexes selected for the studies were relatively unclear,mainly because the connotations of the 4 main concepts associated with the risk of acupuncture receivers(adverse events of acupuncture,adverse reactions to acupuncture,acupuncture accidents and acupuncture negligence)were not properly distinguished.Adverse events of acupuncture refers to a broad category that includes adverse reactions to acupuncture,acupuncture accidents and acupuncture negligence.The term "adverse events of acupuncture" describes all adverse medical events that occur during or after acupuncture treatments,such adverse medical events may not necessarily have a causal relationship with the acupuncture treatment itself;"adverse reactions to acupuncture" means the adverse medical events that occur during or after a normative acupuncture treatment and are caused by the acupuncture treatment itself and are not related to the purpose of the treatment.Normative acupuncture treatment includes normative diagnosis,normative needle manipulations,and normative using of acupuncture instruments;"acupuncture accidents " means unpredictable and hard to prevent adverse medical events that occur during or after a normative acupuncture treatment.Such adverse medical events are caused by unpredictable and irresistible reasons,and are not related to the intended purpose of the acupuncture treatment itself;"acupuncture negligence" denotes the adverse medical events that causing personal injuries to acupuncture receivers,and are caused by acupuncture practitioners’ negligent violations of health laws,administrative regulations,departmental rules,and/or diagnosis and treatment norms and routines in the process of acupuncture treatments.It should be emphasized that acupuncture receivers risk includes the possibility of all acupuncture adverse events,but is not necessarily caused by the acupuncture treatment itself.When evaluating the safety of acupuncture,the target of evaluation should be the acupuncture treatment itself,and therefore the evaluation index should be "acupuncture adverse reactions"rather than "acupuncture adverse events".The majority of studies were unable to provide a somewhat ordered and thorough picture of the sources and types of risk among acupuncture receivers as they confounded the evaluation index.Based on these findings,this study offers a thorough review and evaluation of the risks to acupuncture receivers in an effort to shed light on the sources and varieties of risks that acupuncture may pose to patients,to maximize the avoidance of risks to acupuncture receivers,and to promote the growth and promotion of acupuncture globally.ObjectivesThe aim is to identify the sources and types of risk factors associated with acupuncture receiver,to systematically evaluate the extent of risk to acupuncture receivers,to provide evidence to risks acupuncture receivers.MethodsThe study adopted a systematic evaluation approach.Inclusion and exclusion criteria and literature search strategies were set according to the Cochrane Handbook for Systematic Reviews,and a comprehensive search was conducted of the CNKI,Wanfang,SinoMed,VIP,PubMed,SCIE,EMbase,Cochrane Library,Scopus,Epistemonikos,Clinical Trials,EU Clinical Trials Register,WHO ICTRP,and the Chinese Clinical Trials Registry,from their establishment to October 2022.Strict inclusion/exclusion criteria were established for screening the literature and extracting the literature data.The risk of bias assessment tool for randomized controlled trials in the Cochrane Handbook for Systematic Reviews of Interventions,the minors entry(Methodological index for non-randomized studies),the Newcastle Ottawa Scale(NOS)and the JBI were used respectively.The Centre for Evidence-Based Health Care’s Quality Assessment Tool for Case Reports evaluated the quality of the literature for included randomized controlled trials,clinical controlled trials,observational studies and case reports.Meta-analysis of adverse reactions and adverse events to acupuncture in included randomized controlled trials was performed using RevMan 5.3 software,with dichotomous variables presented as Risk Ratio(RR)and 95%Confidence Interval(CI),heterogeneity of included studies assessed by I2,and publication bias expressed in funnel plots.Qualitative descriptive analysis was used for case reports,observational studies and controlled studies that could not be combined for analysis,and the sources and types of risk for acupuncture receiver were presented in tables or descriptive language.The ten thousandth ratio((?))was used to express risk incidence.The SPSS 26.0 software was used to perform the chi-square test for the relevant count data.Results1.Basic characteristics of the included studiesA total of 782 literature were included,including 122 RCTs,54 CCTs,75 observational studies and 531 case reports,with a total sample size of 1,066,899 cases.Countries included in the study comprised 29 countries across 5 continents and a range of 8 languages were covered.A total of 22 acupuncture techniques were involved in the included studies,including filiform acupuncture(including special needling methods),electro-acupuncture,auricular acupuncture,fire needling,three-edged needle/blood-letting therapy,catgut-embedding therapy,acupoint injection,warm needling,acupotomy,scalp acupuncture,eye acupuncture,abdominal acupuncture,umbilical acupuncture,wrist-ankle acupuncture,the dermal needle,the intradermal needle,floating acupuncture,awn needle,balance acupuncture,electro-thermal acupuncture,Korean gold thread acupuncture and permanent acupuncture needle implants.There were also studies using two or more acupuncture techniques,such as filiform acupuncture combined with acupoint injection,filiform acupuncture combined with the three-edged needle for bloodletting,electro-acupuncture combined with auricular acupuncture,electro-acupuncture combined with scalp acupuncture,etc.2.Results of Meta-analysis2.1 acupuncture vs.conventional drugs A total of 115 studies used acupuncture and conventional drugs as control with 10,908 samples included(5,873 in the acupuncture group and 5,035 in the conventional drugs group).The safety outcome was evaluated by the number or incidence of adverse events,with a total amount of 846 cases.Among them,there were 232 cases in the acupuncture group and 614 cases in the conventional drugs group;the incidence of adverse events was 395.03(?)(232/5873)in the acupuncture group and 1219.46(?)(614/5035)in the conventional drugs group.Meta-analysis showed that the difference between the two groups was statistically significant(RR=0.37,95%CI:0.29-0.47,P<0.00,001),indicating that the acupuncture risks were significantly lower than that of conventional drugs.2.2 acupuncture vs.other non-pharmacological therapiesA total of seven studies used acupuncture and other non-pharmacological therapies(such as electrical therapy,traction,massage,etc.)as controls and included 1,499 samples(888 in the acupuncture group and 611 in the other non-pharmacological therapies group).The safety outcome was evaluated by the number or incidence of adverse events,with a total amount of 365 cases.Among them,there were 208 cases in the acupuncture group and 157 cases in the control group;the incidence of adverse events was 2342.34(?)(208/888)in the acupuncture group and 2569.56(?)(157/611)in the control group.Meta-analysis showed that the difference between the two groups was statistically significant(RR=0.68,95%CI:0.58 to 0.79,P<0.00,001),demonstrating that the acupuncture risks were lower than that of other non-pharmacological therapies.3.Descriptive analysis3.1 Results of the analysis of types and incidence of risks for acupuncture receivers3.1.1 Overall data analysis resultsThe total sample size of receivers treated with all types of acupuncture techniques in the included studies was 1,066,899,and the sample affected by the acupuncture risks was 8,758,with an overall risk incidence of 82.09(?).The total incidence of adverse reactions to acupuncture was 27.32(?),with the highest incidence of adverse reactions being subcutaneous hemorrhage/hematoma(8.28(?)),followed by local pain from needling(7.00(?));the total incidence of acupuncture accidents was 1.57(?),and dizziness had the highest incidence(1.37(?)),followed by broken needles(0.09(?));the total incidence of acupuncture negligence was 53.19(?),and the highest incidence of it was infection(45.94(?)),followed by pneumothorax(4.38(?)).It is evident that the main source of acupuncture receiver risk is from acupuncture negligence,followed by adverse reactions to acupuncture.The incidence of infection,subcutaneous bleeding/hematoma,local pain from needling,and pneumothorax was higher in all categories of acupuncture receiver risk,which is consistent with the results of previous studies.3.1.2 Results of data analysis based on different study types(1)RCTThe 122 RCTs included a total of 12,407 samples,of which 6,761 were in the intervention(acupuncture)group and 5,646 in the control(conventional drugs or other non-pharmacological therapies)group.Twenty-six studies reported no risk of acupuncture in both the intervention and control groups.The remaining ninety-six studies included a total of 10,251 samples,of which 5,627 were in the intervention group and 4,624 in the control group,with a total of 1,211 cases of acupuncture risks,of which 440 were in the intervention group with an incidence of 650.79(?)(440/5627)and 771 in the control group with an incidence of 1365.57(?)(771/4624).The risk incidence in the intervention group was significantly lower than that in the control group(χ2=209.930,P<0.001).(2)CCTThe 54 CCTs included 5,687 samples,of which 3,211 were in the intervention(acupuncture)group and 2,476 were in the control group(interventions were conventional drugs or other non-pharmacological therapies such as intermediate frequency electrotherapy,liquid nitrogen freezing,air wave pressure therapy,traction,massage,etc.).Fourteen studies reported no risk of acupuncture in both the intervention and control groups,and the remaining forty studies included 3,089 samples with a total of 469 cases at risk,of which eighty-nine were in the intervention group with a risk incidence of 277.17(?)(89/3211)and 380 were in the control group with a risk incidence of 1534.73(?)(380/2476).The risk incidence of the intervention group was significantly lower than that of the control group(χ2=78.465,P<0.001).(3)Observational studiesA total.of 75 observational studies with a sample size of 1,061,798 were included.Twenty-six studies reported no risk of acupuncture and the remaining forty-nine studies with a sample size of 1,060,850 had 7,001 cases of acupuncture risks without fatalities,with an overall risk incidence of 65.99(?).The most frequent adverse reaction was subcutaneous haemorrhage/haematoma in 775 cases,with an incidence of 7.30(?);the most frequent acupuncture accident was dizziness in thirty cases,with an incidence of 0.28(?);the most frequent acupuncture negligence was infection in 4,643 cases,with an incidence of 43.72(?).(4)Case reportThere were 1,228 cases in the 531 case reports that were included.The most frequent adverse reaction was local redness and swelling from acupuncture for thirty-one cases(252.44(?)of the total amount of cases reported);the most frequent acupuncture accident was dizziness for ninety-four cases(765.47(?)of the total amount of cases reported);and the most frequent acupuncture accident was pneumothorax for 384 cases(3127.04(?)of the total amount of cases reported).3.1.3 Types and incidence of risks for acupuncture receiversThe risk incidence was 10,000.00(?)for all cases of awn needles,electrothermal needles,Korean gold thread acupuncture and permanent acupuncture needle implants as they all originated from single case reports;The other acupuncture techniques were The risk incidence was 2608.70(?)for wrist-ankle needle receivers;2128.03(?)for fire needling receivers;2068.97(?)for scalp acupuncture receivers;2061.43(?)for catgut-embedding therapy receivers;1578.95(?)for eye acupuncture receivers;1295.90(?)for acupotomy receivers;846.15(?)for floating acupuncture receivers;610.16(?)for electro-acupuncture receivers;470.09(?)for warm needling receivers;418.41(?)for three-edged needle/blood-letting therapy receivers;376.58(?)for acupoint injection receivers;363.64(?)for intradermal needle receivers;346.02(?)for abdominal acupuncture receivers;and 333.33(?)for umbilical receivers;256.41(?)for balance acupuncture receivers;73.38(?)for filiform acupuncture receivers;the dermal needle did not have any risks for receivers.3.2 Sources of risk for acupuncture receiversA total of 406 case reports analyzed the sources of acupuncture risks in 534 receivers.From the acupuncture provider’s perspective,the high probability factors of causing risk to the acupuncture receivers were inappropriate angle,direction and depth of needle insertion(201 times),excessive stimulation(92 times)and poor sterilization(51 times);from the receivers’point of view,their own history of illness or medication was the greatest source of risk of acupuncture with 38 times,followed by low tolerance of pain(27 times),and a state of excessive hunger and strain prior to acupuncture.In terms of needles,repeated use of needles,aging or substandard needles can all contribute to the acupuncture risks;there are also other possible causes of risk for acupuncture receivers such as the nature of the disease itself.Conclusion① The concept of "adverse reactions of acupuncture" should be considered when evaluating the safety of acupuncture therapy itself as the occurrence of the risk of acupuncture does not always have a certain causal relationship with the acupuncture itself.The acupuncture receiver risks are divided into three categories:acupuncture adverse reactions,acupuncture accidents and acupuncture negligence,all of which are belonged to acupuncture adverse events.② As an invasive treatment method,acupuncture does carry some risk,but the receiver risk is significantly lower compared to conventional drugs and other non-pharmacological therapies.③ The incidence of risk varies depending on the type of acupuncture technique.with most common adverse reactions are subcutaneous hemorrhage or hematoma and pain from needling,the most probably acupuncture accidents are fainting and broken needles,and the most frequent adverse acupuncture negligence are infection and pneumothorax.④ The main causes of acupuncture risk include the acupuncture providers,acupuncture receivers,the needle itself,and other factors,with the acupuncture providers being the most significant source of risk.The most significant source of infection is a lack of rigorous aseptic principles prior to the application of acupuncture.Excessive needling depth,deviations in the angle and direction of needling,and powerful stimulation methods are also significant sources of risk for the recipients.Risks can also result from the second cause,which is the recipient’s poor acupuncture tolerance and lack of compliance.The hazards to acupuncture recipients can,however,be significantly decreased or even eliminated if the acupuncturist providers adhere to strict operational guidelines and the recipient cooperates as much as possible. |
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