The Reporting Quality of Acupuncture-Related Infections in Korean Literature: A Systematic Review of Case Studies

Objective. Acupuncture is generally accepted as a safe intervention when it is administered in appropriate clinical setting by well-educated and experienced practitioners. In this study, we reviewed observational studies on adverse events (AEs) or complications relevant to acupuncture practice in Korean literature for assessing their reporting quality and suggested recommendations for future ones on acupuncture-related infections. Method. Electronic databases including Medline, Embase, Cochrane library, Korean studies Information Service System, DBpia, National Digital Science Library, and Korean National Assembly Library were searched until May 2015. Combination of keywords including “acupuncture” and “infection” were used for searching databases. Result. A total of 23 studies from 2,739 literature articles were identified from electronic database searching until May 2015. From this review, we found that most case studies did not report enough information for judging causality between acupuncture and the AEs (or complications) as well as appropriateness of the acupuncture practice. In addition, acupuncture experts rarely participated in the reporting of these AEs (or complications). Conclusion. Based on these limitations, we suggest a tentative recommendation for future case studies on acupuncture-related infection. We hope that this recommendation would contribute to the improvement of the reporting quality of acupuncture-related AEs (or complications) in the future.


Introduction
Acupuncture is a considerably safe intervention when it is administered in an appropriate clinical setting by welleducated and experienced practitioners. According to a largescaled prospective survey result, only self-limited minor adverse events (AEs) (e.g., bleeding and needling pain) occurred in few cases with an incidence rate of 671/10,000 consultations [1]. Moreover, most of the severe complications of acupuncture are mainly related to the improper practice settings and inexperience of half-fledged practitioners. In particular, acupuncture-related infections have been reported to be closely related to the poor usage of acupuncture and disinfection procedures [2].
By the way, acupuncture-related AEs have been reported continuously, and the number of AE cases has not decreased even until recently [3]. The most serious problem among these AE cases was that essential information for judging the appropriateness of the acupuncture practice was not reported clearly [3,4]. In this sense, case studies on acupuncturerelated AEs are not regarded to be adequately informative to reduce errors and to enhance safety in future acupuncture practices and only lead to exaggeration of acupuncturerelated harm among the general public. For predicting future AEs and promoting prevention measures in avoidable AE cases, it is important to identify whether the AEs and complications in the past studies were caused by negligence in practice or adverse reaction to acupuncture, which is not possible to determine retrospectively.
Reporting guidelines have been developed for transparent and easy reporting of clinical trials [5] and cases studies [6]. Regarding AEs, the Consolidated Standards of Reporting Trials' (CONSORT) AE reporting guideline is available for clinical trials [7]. Guideline for acupuncture-related AE reporting was suggested earlier [8], but it has not been adopted frequently in the case studies since its publication. There 2 Evidence-Based Complementary and Alternative Medicine are both similarities and differences between AEs related to acupuncture practice and those of drug-related AEs in some aspects; therefore, the guideline for acupuncture-related AEs should include common components such as description of patient's demographic data, medical history, and risk factors for, detailed condition of, and clinical outcomes of the current AEs [9] as well as acupuncture-specific aspects such as details of acupuncture intervention (e.g., needling points, needling depth, practitioner's types and experience level, and acupuncture materials used) [8]. In addition, evaluation of the appropriateness of acupuncture practice and the correlation between acupuncture and AEs, which is a key for improving quality of future practice, need to be reported.
Acupuncture-related infection is one of the commonly reported AEs of acupuncture. Compared with other types of AEs, it shows comparatively low incidence [2], but it is considered to be one of the major issues for good acupuncture practice, because infection often introduces considerable harm to patient's safety [3,4]. Considering this situation, transparent and rigorous reporting on acupuncture-related infection is necessary for acupuncture practitioners as well as medical consumers.
In this sense, the purpose of this study was to assess the status of the reporting quality of case studies on acupuncture-related AEs or complications, especially focusing on acupuncture-related infections in the Korean literature, and to suggest tentative reporting guidelines for future case reports.

Methods
This is a systematic review of the observational studies on acupuncture-related infections. In this review, we defined AEs and complications differently as follows: AEs and complications are common unexpected signs or symptoms related to acupuncture treatment, but AEs occur when acupuncture procedure is appropriate while complications are caused by the practitioner's negligence [10]. Distinction between these two concepts is crucial in the reporting of acupuncturerelated infections, because complications are more relevant to individual practitioner's skill level and compliance with clinical guideline for safe practice including clean needle technique, whereas AEs are actually related to acupuncture itself.
Electronic databases including Medline, Embase, Cochrane library, Korean studies Information Service System (KISS), DBpia, National Digital Science Library (NDSL), and Korean National Assembly Library were searched until May 2015. Combination of keywords including "acupuncture" and "infection" was used for developing search strategies based on the characteristics and structures of the individual databases.
The search strategy for Medline was as follows: acupuncture AND (infection OR hepatitis OR HIV OR (auricular chondritis) OR endocarditis OR meningitis OR (spinal infection) OR septicaemia OR (necrotizing fasciitis and toxic shock) OR (septic arthritis) OR abscess OR skin OR herpes).
For this review, we only included case studies or series that reported infectious conditions related to acupuncture in Korean literature. Acupuncture covers a broad range of nondrug interventions including moxibustion in traditional East Asian medicine (TEAM) [11], but we only included the classic types of acupuncture (i.e., needle insertion into the skin) in this review. However, if other interventions including moxibustion, cupping, and blood-letting were added to classic acupuncture and it was impossible to define which intervention might be first cause of the AEs (or complications), we included them the study.
To assess the reporting quality of the individual studies, the following data were analyzed based on the literature: (1) data related to patient information: patient characteristics, disease or symptoms for which acupuncture treatment was performed, risk factors for AEs or complications, underlying diseases, detailed features of AEs or complications, final clinical outcomes and (2) data related to AE: occurrence time after acupuncture, laboratory or pathological findings, other possible causes, and spatial relationship between needling site and affected lesion. In addition, a description of acupuncture treatment including practitioner's type, needling site, depth of insertion, needle type, stimulation method, and acupuncture settings (i.e., where the acupuncture was practiced and disinfection procedure) was analyzed. Each item was judged as "well documented (WD)" when all the related information was reported appropriately in the literature, as "documented but not enough for the judgment (DE)" when information was suggested but not enough to clearly describe the patient's presentation and as "not documented (ND)" when no information was available in the literature.
Causality between the acupuncture and AEs (or complications) and appropriateness of acupuncture practice was evaluated subsequently. Causality was assessed according to the modified WHO-UMC causality assessment criteria: "Certain" when plausible time relationship between the event and acupuncture was observed in the literature without possible cause of other treatments or underlying diseases for AEs (or complications), "Probable" when reasonable time relationship was observed and AEs (or complications) are unlikely to be explained by other causes, "Possible" when reasonable time relationship was observed and AEs (or complications) were possibly explained by other causes, "Unlikely" when improbable time relationship was observed with other plausible causes, "Conditional" when more data from current undergoing examination was necessary for the evaluation, and "Unassessable" when information was insufficient for judgment [12]. The appropriateness of acupuncture was assessed based on the information of acupuncture practice in the literature: "Appropriate" when all the acupuncture procedure could not be a probable cause of the AEs (or complications), "Inappropriate" when any of the procedures might be the possible cause of the AEs (or complications), and "Unclear" when there was not enough information for the judgment of acupuncture procedure.
Data extraction and appraisal of causality and acupuncture appropriateness were conducted by two authors (Tae-Hun Kim and Jung Won Kang) independently. If there was any discordance between the two authors, which could not be solved by discussion, a third author (Wan-Soo Park) arbitrated them.
In this sense, all the included studies insisted that strong association between acupuncture treatment and the event existed, but causality of the acupuncture-related AEs (or complications) could not be concluded with the information provided in most studies ( Table 2).

Items Content
Title Types of acupuncture practice and AEs (or complications) should be included in the title.

Authors
Acupuncture specialists need to be included among the authors. Description for the patient Demographic data Sex, age, ethnicity, and residence need to be described. Preceding conditions or reasons for seeking acupuncture The patient's diseases or symptoms for seeking acupuncture treatment should be described for assessing appropriateness of acupuncture. Description on the risk factors for AEs (or complications) Patient's underlying conditions or cointerventions which might be related to AEs (or complications) need to be declared. Details of acupuncture intervention [37] Acupuncture practitioner's type Certification, education status, and clinical experience level need to be declared.
Needling sites (acupuncture points) Location and number of points for acupuncture or needling need to be described in detail using WHO standard acupuncture point locations guideline [38]. Usage of disposable, sterile needles Usage of disposable, sterile needles should be assessed and reported.

Depth of insertion
Depth and direction of needle insertion should be suggested.
Needle type Length, diameter, material, and manufacturer of acupuncture needles should be declared.

Stimulation method
Stimulation method for acupuncture including manual, electric stimulation, or other stimulating methods needs to be reported.

Acupuncture settings
Medical institutions or conditions of the physician's office need to be suggested.
Disinfection procedure Detailed disinfection measure before and after acupuncture should be reported in detail. Description for the AEs (or complications) Time relation between acupuncture and AEs (or complications) Time line of acupuncture treatment and the occurrence of AE (or complication) symptoms should be suggested clearly. Explanation on the association between needling site and affected lesion Relationship between needling site and affected lesion should be evaluated appropriately.

Features of AEs (or complications)
Information on the clinical presentation of AEs (or complications) needs to be suggested sufficiently to assess the causality between acupuncture and the event.
Laboratory or pathological findings Laboratory or pathological findings related to the AEs (or complications) should be suggested.

Consideration of the other possible causes of AEs (or complications)
Based on the preceding risk factors, other treatments, assessment of acupuncture appropriateness, and other possible causes of AEs (complications) should be evaluated fairly and scientifically.
Appraisal for the appropriateness of acupuncture Appropriateness of acupuncture practice appraised based on the information about acupuncture intervention, procedure, settings, and disinfection method should be reported.
Causality assessment Causality category according to the WHO-UMC criteria needs to be suggested based on the clear reason for the decision [39]. Discussion and conclusion Previous evidence on the AEs (or complications) related to acupuncture Previous case reports or literature with rigorous evidence on the current AEs (or complications) needs to be reported.

Conclusion
Conclusion should be written based on the results of the appraisal for the appropriateness of acupuncture practice and causality between acupuncture and the event in a neutral position.

Clinical implication
Preventive measures against current acupuncture-related infection need to be suggested based on the analysis of appropriateness of acupuncture for future safe practice.
could not be appraised in all studies except for one [23] ( Table 3).

Discussion
From this systematic review on the acupuncture-related infection case reports in Korean literature, we found that essential information for judging causality and appropriateness of acupuncture practice was not reported adequately. In particular, preceding risk factors, other possible causes, and spatial association between acupuncture needling and the affected lesion, which are necessary information when deciding causality, were not reported sufficiently. In this sense, we could not find concrete evidence in each report for the judgment of the causality between acupuncture practice and occurrence of the AEs (or complications) except for the time-order relationship. Description of the acupuncture procedure could not confirm the appropriateness of the acupuncture practice because it was insufficient and inadequate. Acupuncture specialists with expertise in these cases were not involved in the reporting process. These factors negatively affect the reporting quality of acupuncture-related AEs (or complications).
This review has several specific points. First, we assessed individual components in the case reports to identify possible errors related to the practice in these studies. When assessing the reporting quality of case reports on acupuncturerelated infections, appropriateness of acupuncture practice should be evaluated. In this review, only one case had a complication that was definitely introduced by a wrong practice of acupuncture [23] and in other cases it could not be conclusively established whether the events were AEs or complications because the description was improper and deficient. However, previous systematic reviews on acupuncture-related infections only focused on the type and frequency of AEs but did not pay much attention to the appropriateness of acupuncture [4,36]. Misconduct or errors during acupuncture can affect clinical outcomes; therefore, the assessment of appropriateness can give insight into future safe practice for acupuncture. Second, we evaluated causality rigorously based on the original case reports. To ensure transparency, two different authors whose specialty is acupuncture assessed causality individually and discussed the results. From this review, we found that most studies did not assess causality between acupuncture and AEs (or complications) appropriately, so case reports, although abundant, have limitations in that they do not help warn practitioners against the risks of acupuncture and are not informative enough to improve acupuncture practice. Causality of acupuncture-related AEs (or complications) should be assessed transparently and fairly based on the time association between the practice and the event, pathological mechanism of AEs (or complications), and exclusion of other potential causes [12]. In addition, acupuncture-related AEs (or complications) are different from drug-related AEs in that discontinuation and readministration of acupuncture hardly affect the clinical outcomes unlike with drugs [12]. Judging the causality between acupuncture and AEs (or complications), these factors need to be analyzed appropriately.
This study has limitations as well. First, we only assessed Korean literature, which reflects the reality of clinical practice in Korean context. Two different expert occupations in health-care sector, conventional medical doctors and Korean Medicine doctors, are in charge of national health with equal legal position, and competition among them is intensifying. Considering this conflicting situation, reporting of AEs (or complications) related to acupuncture might be overexaggerated (even with malicious intention) and not based on sound scientific evidence. Another explanation for this status could be that acupuncture specialists hardly participated in the case reporting of the included studies. The purpose of this study was to evaluate the quality of Korean literature, so this limitation is inevitable. Second, we only assessed acupuncturerelated infections in this study. Apart from infections, other frequently reported acupuncture-related conditions such as traumatic injuries including pneumothorax and nerve injury need to be assessed in similar manner. We only assessed a small portion of acupuncture-related AEs (or complications), and the same issues on the reporting quality can be adapted to other types of AEs (or complications). These two limitations will be covered through further successive reviews in the future.
Based on the current review results, we now suggest a recommendation for reporting cases of acupuncturerelated infections (Table 4). This recommendation includes items on patient's condition and AEs (or complications) in detail, which are necessary to establish the causality between acupuncture and the event and to provide information for judging appropriateness of acupuncture practice. Compared with a previously published reporting guideline for acupuncture-related AEs [8], this recommendation includes detailed information which is necessary for the judgment of causality between acupuncture and AEs (or complications) such as time and spatial relationship between acupuncture and AEs as well as the assessment of the other possible causes of AEs and appropriateness of acupuncture practice. In addition to this, we recommend that acupuncture specialists join as one of the authors for the AE reporting which is important for scientific and transparent reporting and lessons for future safe practice of acupuncture practice from the AE accident, which can be suggested as a clinical implication of the report. We hope that this tentative recommendation can be useful for reporting future cases of acupuncturerelated infections in a clear and informative way as well as developing more advanced recommendation based on the future multidisciplined, mixed-method researches.