Visual abstract

Introduction

Pharmacopuncture is a Korean medicine intervention where purified herbal extracts are injected into disease/condition-related acupoints. It was introduced into the field of Korean medicine in the mid/late 1990s, and through a variety of research activities has been reported to achieve remarkable treatment success [1,2]. Despite the wide acceptance of pharmacopuncture in clinical practice due to its multiple advantages (wide application range, rapid effect through intramuscular or intradermal injections, and low side effects [1,2]), there are not many high-quality evidence-based studies.

Case reporting is an important method of retrospective research with detailed descriptions of new features of medical issues, symptoms, diagnosis, or therapy [3]. A case report provides detailed descriptions of symptoms and diagnosis, as well as optimized intervention based on them. Its clinical reproducibility allows the same treatment in patients with similar conditions. In addition to these advantages, case reports also help practitioners better understand important medical discoveries that can be overlooked in research methodologies such as clinical trials [3,4]. In addition, the research questions presented in a case report can be used as hypotheses for follow-up research with a high level of evidence, and often becomes the starting point of a range of follow-up studies [5]. However, among the reported cases of pharmacopuncture, there are large variations in the reported items and quality of reporting. There are currently no standardized guidelines for pharmacopuncture case reporting.

Given the nature of case reporting, through which the researcher can elaborate on the issue in any desired detail, efforts have been made to establish case reporting guidelines to ensure more objective information transfer within a standardized framework. As a result, the CAse REports (CARE) guidelines [3,4] were developed to support the reporting of various clinical cases. The CARE [3,4] guidelines, which use a checklist developed in 2013 consisting of 13 items to improve the quality of case reporting, was the first guideline that covered detailed items for case reporting [4,6]. In the field of Korean medicine, reporting guidelines are currently available for interventions such as acupuncture, herbal medicine, and moxibustion: (1) STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) [7], reporting guidelines for randomized controlled trials (RCTs) on acupuncture intervention; (2) STandards for Reporting Interventions in Clinical Trials of Moxibustion (STRICTOM) [8], which covers acupuncture and Korean medicine interventions with moxibustion application; (3) case report in Chinese medicine (CARC) [9], case reporting guidelines for acupuncture and herbal medicine interventions; and (4) case report for Sasang medicine (CARES) [10], case reporting guidelines for Four-Constitution Medicine [CARE + S standing for Sasang (Four Constitution) Medicine].

The development of case reporting guidelines comes with the advantage of enhancing the reporting rate, as demonstrated by the report of the improved quality of reports in studies conducted after the development of case reporting guidelines [11]. The study “Assessment of the Quality of Reporting on Case Reports in the Journal of Sasang Constitutional Medicine from June 2018 to December 2021: Using CARE Guideline” [11] published in 2022 in the Journal of Sasang Constitutional Medicine compared the quality of the studies published during the five-year period before and after the publication of the CARE guidelines with 2018 as the reference year. This study determined that the reporting rate assessed as “sufficient” increased by 7.8% and those assessed as “insufficient” and “unreported” decreased by 4.1% and 3.5%, respectively, in the years following the publication of the CARE guidelines. This demonstrated the significant positive effect of case reporting guidelines on the quality of case reports.

However, case reporting guidelines for pharmacopuncture interventions have yet to be developed. While admitting that the aforementioned guidelines can also be used for writing pharmacopuncture case reports, development of pharmacopuncture case reporting guidelines is required. Standardized reporting guidelines are needed to consider the complex properties of pharmacopuncture which have the attributes of both acupuncture and herbal medicine. Therefore, the aim was to improve the quality of pharmacopuncture case reports by examining the literature to develop pharmacopuncture-specific case reporting guidelines. The goal was to propose the items to be included in the development of pharmacopuncture case reporting guidelines to improve the quality of case reporting in the future. To this end, pharmacopuncture case report studies were selected for review and the items reported were extracted. Existing reporting guidelines for Korean medicine intervention, such as acupuncture, herbal medicine, and moxibustion, were reviewed to gather essential items that should be included in pharmacopuncture case reporting guidelines.

Materials and Methods

1. Data collection

In terms of dosage and procedure, “pharmacopuncture,” which is extensively used in Korea, differs slightly from “herbal injection,” which is utilized as an intravenous injection method in China. Therefore, the scope of this review was limited to “pharmacopuncture” research. The search was also confined to databases of Korean studies, which mostly reported cases of Korean pharmacopuncture. Four electronic databases were searched for relevant studies published over the past five years up to August 1, 2022: Oriental Medicine Advanced Searching Integrated System (OASIS), ScienceON, Research Information Sharing Service (RISS), and Korea Citation Index (KCI). To retrieve case reports on pharmacopuncture intervention the search terms used were “pharmacopuncture” and “yakchim[Korean]” in OASIS and “(yakchim[Korean]|bongdokyakchim[Korean]|bongdok[Korean]| pharmacopuncture|aquacupuncture|acupoint-injection|acupuncture-point-injection|pharmaco-acupucture|hydro-acupucture|herbal-medicine-injection|traditional-medicine-injection|bee|bee-venom|apitherapy|apitoxin)” in ScienceON, RISS, KCI databases.

2. Inclusion and exclusion criteria

2.1. Inclusion criteria

The inclusion criteria were case reports on a single pharmacopuncture intervention case using a single or composite material produced in Korea.

2.2. Exclusion criteria

Studies excluded from this study: (1) No relevance to pharmacopuncture; (2) Not a single case; (3) Korean pharmacopuncture materials not used (e.g., materials from China or Japan); and (4) No source documents.

For case reports covering complex interventions without focusing on pharmacopuncture, the decision on inclusion or exclusion was made after a full-text review.

The term “case series” describes the treatment of numerous patients, and the description of pharmacopuncture treatment may be less extensive than that of a single patient’s “case report.” Therefore, in this study, only the “case report” of a single patient was included, whereas the “case series” was excluded.

2.3. Literature search

As a result of the literature search, a total of 3,684 studies were retrieved from the four databases. After removing duplicates, 2,307 studies remained. In the title and abstract review, 1,709 studies were deemed “not related to the topic,” leaving 411 studies to be reviewed in full. A total of 29 studies were included in this review (Fig. 1).

2.4. Data collection and analysis

There were 29 case reports selected and reviewed to derive basic information and pharmacopuncture-related details. Patient demographics including age, disease/condition, and non-pharmacopuncture interventions were determined for further analysis. Classification of disease/condition was performed according to the 9th edition of the Korean Standard Classification of Diseases (KCD-9). Pharmacopuncture-related details which were examined included: pharmacopuncture type, manufacturing methods, manufacturing facilities, ingredients and composition, needling location, dose, injection method, and intervention period.

Furthermore, reporting guidelines related to Korean medicine interventions were retrieved and reviewed. There were three cases reporting guidelines and two clinical trial reporting guidelines for reporting Korean medicine interventions. The case reporting guidelines were CARE [3,4], which proposes general guidelines, and CARES [10], which extends CARE by adding Four-Constitution Medicine, and CARC [9], which covers Chinese herbal medicine and acupuncture interventions. The clinical trial reporting guidelines for reporting Korean medicine interventions were STRICTA [7] related to acupuncture, and STRICTOM [8] related to moxibustion were selected.

The contents were organized based on the report items of each reporting guideline, and items that were omitted, or that showed characteristics of medicinal acupuncture were identified and further supplemented. As guidelines for Korean medicine intervention, acupuncture-related STRICTA [7] and moxibustion-related STRICTOM [8] were selected as RCT reporting guidelines Each of these clinical reporting guidelines were classified centering on the report items, and complemented missing items and the items representing the characteristics of pharmacopuncture were additionally considered.

Results

1. General characteristics of the included studies

In the 29 case-reporting studies that used pharmacopuncture as a primary intervention, all age groups were distributed relatively evenly, with studies involving patients in their 40s and 50s accounting for the highest proportion (n = 6 each, 20.7%). The diseases/conditions mentioned in the 29 case reports were classified according to KCD-9. Musculoskeletal and nervous system disorders were the most frequently reported (n = 7, 24.1% each), followed by disorders of the digestive system and not classified (n = 3, 10.3% each). Fourteen types of pharmacopuncture were used in the 29 studies. Bee venom pharmacopuncture was the most frequently used (n = 13, 44.8%), followed by Hwangryeonhaedoktang pharmacopuncture (n = 5, 17.2%). Fifteen different types of non-pharmacopuncture interventions were mentioned in 29 studies. Herbal medicine was the most frequently used concomitant intervention mentioned in 24 studies (82.8%), followed by acupuncture in 23 studies (79.3%; Table 1 [12–40], Supplementary Table 1).

2. Analysis of the current status of reporting of pharmacopuncture-related items

All pharmacopuncture-related items reported in the selected 29 papers are outlined in Supplementary Table 2 [12–40]. Pharmacopuncture manufacturing methods, ingredients and composition, patient’s posture during the therapy, needling direction and depth were not mentioned in over 50% of the studies reviewed.

3. A proposal for extending pharmacopuncture case reporting guidelines based on comparative analysis of existing reporting guidelines

CARE [3,4], its extended version CARES [10], and CARC [9] guidelines cover 19 items, which include the Title, Keywords, Abstract, Introduction, Patient Information, Clinical Findings, Diagnostic Assessment, Therapeutic Intervention, Outcome, Follow-up, Discussion, and Informed Consent. CARC [9] guidelines cover three items (Advice and precautions, References, and Figures/Tables) that are not covered in the CARE and CARES guidelines, but it does not cover the timeline which is covered in the CARE and CARES guidelines. It also provides in-depth descriptions of traditional medicine interventions including herbal intervention, acupuncture, electropuncture, and moxibustion. For these items, the CARC guidelines speculate the case reporting requirements more elaborately; in case of herbal intervention for example, items are presented in divisions of proprietary medicine and self-prepared herbal intervention. The CARC guidelines also include the quality control standard in the report items, and distinguishes between integrated treatments (including herbal intervention, acupuncture, electropuncture, and moxibustion), and non-integrated treatments in the item settings.

The focus of the Consolidated Standards of Reporting Trials (CONSORT)-based STRICTA [7] and STRICTOM [8] guidelines are not on general case-reporting issues, but on specific treatment interventions. For example, items related to the formal aspects of case reporting, such as keywords, abstract, and introduction, are not included. Except for “Precaution Measures” in the STRICTOM [8] guidelines, both provide intervention-related regulations in great detail and present six items regarding treatment interventions: Treatment Rationale, Details of Treatment, Treatment Regimen, Other Components of Treatment, Practitioner Background, and Control and Comparator Intervention. The item covered only by STRICTOM [8] guidelines, i.e., Precaution Measures, recommends that if precaution measures are provided, they should be reported in full detail. These two guidelines share the overall aspects, but contain contents modified to suit the characteristics of each intervention under the item “Details of Treatment.” For example, the STRICTA [7] guidelines require the time of needle retention and needle stimulation, whereas the STRICTOM [8] guidelines require the specifications of the materials used for moxibustion and the procedure and technique for moxibustion (Table 2 [7,8]).

Discussion

This study aimed to propose a draft of pharmacopuncture case reporting guidelines. Existing pharmacopuncture case reports and case-reporting guidelines for Korean medicine intervention were analyzed with a view to accumulating high-quality pharmacopuncture case reports and preparing the clinical research framework for future research. To this end, we reviewed 29 eligible studies to determine the current status of pharmacopuncture case reporting in Korea. The analysis revealed that pharmacopuncture case reports do not properly consider necessary items related to detailed contents of pharmacopuncture intervention. After pooling the analysis results of the case reports and those of case-reporting guidelines for Korean medicine therapies, we derived the following report items that should be included in a pharmacopuncture case report: (1) Treatment Rationale–pharmacopuncture type; and (2) Details of Treatment–number of points treated during a treatment session, total dose per treatment session and single dose per point, acupoint names (muscle or anatomical location) and the rationale for selection, needling depth and direction, patient’s posture during the therapy, treatment environment, pharmacopuncture procedure and technique, and responses sought (patient’s perception or adverse effects).

Pharmacopuncture is a Korean medicine intervention technique that combines the advantages of acupuncture (physical stimulation) and herbal medicine (biochemical effects). It was admitted into insurance scheme in 2001 under the National Health Insurance Act, but was excluded from insurance coverage in 2006. Later, it was included in the automobile insurance medical fee system. Park et al [41] conducted a survey in 2018 in 393 Korean medicine doctors on the clinical practice of pharmacopuncture therapy, and reported that 88% of the respondents had experience of administering a pharmacopuncture intervention and that pharmacopuncture was being widely used in the clinical setting. From the results of this study the characteristics of the clinical application of pharmacopuncture could also be confirmed, albeit indirectly.

Analysis of the patient age distribution in the selected 29 pharmacopuncture case reports revealed that patients in their 40s and 50s accounted for 41% of cases (6 studies and 20.7% each, 12 studies and 41.4% together). According to a basic report on the status of Korean medicine utilization in 2020, outpatients in their 60s and over, accounted for the highest proportion of cases treated (35.5%), followed by the patients in their 50s (22.4%), and 40s (17.9%), which is consistent with the patient ratios analyzed in the current study.

As a result of classifying the diseases/conditions treated in the case studies using KCD-8, there were seven studies each (24.1%) for musculoskeletal and nervous system disorders and these diseases/conditions were identified as the cases that received the highest clinical application of pharmacopuncture. In addition, pharmacopuncture was used in treating various diseases/conditions such as digestive system diseases/conditions, injury and poisoning and certain other consequences of external causes, neoplasms, psychiatric and behavioral disorders, and skin and subcutaneous tissue system disorders. The clinical treatment frequency reported in a study conducted by Park et al [41] was similar to that of this study: musculoskeletal disorders (41.7%), nervous system disorders (18.0%), and digestive system disorders (9.0%).

In the classification of pharmacopuncture interventions 14 different types of pharmacopuncture were used 37 times in the 29 cases reviewed. Among these 14 pharmacopuncture types, bee venom pharmacopuncture was used most frequently (n = 13, 44.8%), accounting for close to half the total pharmacopuncture interventions. Bee venom pharmacopuncture was reportedly first used in 168 B.C. in a primitive form, as recorded in an ancient Korean medicine book, and has been used ever since in clinical practice [42]. It has a broad application field including musculoskeletal and nervous system disorders, which explains why bee venom pharmacopuncture occupied the highest proportion among the 14 different types of pharmacopuncture [43].

The proportion of ND, i.e., not described in the case report, exceeded 50% in four out of 12 items related to pharmacopuncture case reporting: needling direction and depth (89.7%), pharmacopuncture manufacturing methods (82.8%), patient’s posture during the therapy (75.9%), and pharmacopuncture ingredients and composition (69.0%). Another four items had the proportions of ND exceeding 20%: the diameter, length, and manufacturer of the needle used for treatment (34.5%, 37.9%, and 24.1%, respectively), and the total dose administered per treatment session (24.1%). A quality assessment performed by applying the existing reporting guidelines revealed that the study by Son et al [44], which performed quality assessment of acupuncture therapy in compliance with the recommendation of the STRICTA guidelines, had low reporting ratios of literature sources, depth of injection, details of other interventions, and description of acupuncturists’ professional affiliation. Kim et al [45] assessed the quality of reporting on moxibustion therapy which was in compliance with the recommendation of the STRICTOM [8] guidelines, and reported that moxibustion-related studies had low reporting ratios in treatment protocol setting and context, patient information, explanation to patients, and responses sought (e.g., warm feeling, skin reddening, stinging pain). Insufficient or improper reporting of the above items pertaining to the category of “details of treatment” can lower the likelihood of clinical application, which is an important objective of case reporting [46]. Such case studies also attract less follow-up research. Therefore, there is a compelling need to standardize the pharmacopuncture case reporting process by detailing the reporting standards for these items in pharmacopuncture case reporting guidelines. Another important finding of this study was that pharmacopuncture therapy was rarely administered as a single intervention, as demonstrated by the high proportions of non-pharmacopuncture concomitant interventions. For example, herbal medicine and acupuncture were used in 24 (82.8%) and 23 studies (79.3%), respectively, as the most widely used concomitant interventions, and a variety of other concomitant interventions were also used, including moxibustion, cupping, electropuncture, and Western medicine and physiotherapy. Therefore, it is also essential to include the reporting of concomitant interventions other than pharmacopuncture in pharmacopuncture case reporting guidelines.

Case reporting refers to describing a specific case believed to have medicinal value such as a new clinical discovery, i.e., a new symptom or treatment method for a specific disease/condition, and the related clinical course [5,6]. Major advantages of case reports include the reproducibly of treatment modalities, the important role they play for case-based medical education and medical textbooks which may result from them, and they provide the basis for studies with a high level of evidence [5]. However, since they are written in subjectively by the individual clinician, the research quality is not homogeneous across case reports and depends on their own observations or insights [47,48]. There has been a constant demand to establish the standards for case reporting aiming upward for the standardization of the quality of case studies [49]. Currently, the available clinical study reporting guidelines include the CARE [3,4] guidelines for clinical case reporting, the CONSORT [50] guideline checklist for randomized controlled trials (RCTs), the Strengthening the Reporting of Observational studies in Epidemiology [51] guidelines for observational studies, and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses [52] guideline checklist for systematic literature reviews and meta-analyses. Various reporting guidelines for Korean medicine interventions have also been developed, such CARE [3,], CARES [10] (extended edition of CARE), CARC [9], STRICTA [7], and STRICTOM [8] (extended editions of CONSORT [50]). The Template for Intervention Description and Replication guideline [53] is used for reporting complex interventions, which suits the characteristics of Korean medicine therapies using a variety of interventions in an integrated manner. In the field of Korean medicine, the need for intervention-specific reporting guidelines is constantly being raised.

Of the aforementioned five reporting guidelines related to Korean medicine interventions, the CARE [3,4] guidelines, its extended edition CARES [10] (added by Four-Constitution Medicine), and the CARC [9] guidelines, provide general descriptions of Korean medicine interventions such as acupuncture and moxibustion, and mention general features of case reporting, unlike the STRICTA [7] and STRICTOM [8] guidelines. Comparative analysis of the CARE, CARES, and CARC guidelines showed that these three guidelines contain quasi-identical items. Therefore, we propose the use of CARE [3,4] guidelines as the basic frame for pharmacopuncture intervention to be added to in order to compile pharmacopuncture case reporting guidelines for the future.

Although CONSORT [50]-based STRICTA [7] and STRICTOM [8] are guidelines for reporting RCT, their design focus on treatment interventions allowed items to be derived for pharmacopuncture case reporting. They are similar in overall details, with differences arising from the two different interventions mainly covered, i.e., acupuncture and moxibustion, respectively. Since pharmacopuncture case reporting guidelines should be compiled in line with the interventional characteristics specific to pharmacopuncture, the items specific to acupuncture and moxibustion were excluded. Then the following pharmacopuncture-specific items derived by analyzing the study results can be added: needling direction and depth, patient’s posture during the therapy, pharmacopuncture manufacturing methods, pharmacopuncture ingredients and composition, the diameter, length, and manufacturer, and total dose of pharmacopuncture administered per treatment session (Table 2 [7,8]). Regarding the items generally applicable to Korean medicine interventions (e.g., intervention type and treatment frequency), it is appropriate to follow these two guidelines. Moreover, “Other Treatment” (non-pharmacopuncture or concomitant treatments) of Korean medicine are usually practiced by combining various interventions, and it is recommended that they are considered items in “Therapeutic intervention” specific to CARC [9] which is suitable for complex interventions (Supplementary Table 1). These items include the name of the herbal medicine, administration method, administration path, manufacturer name, and manufacturing process (Supplementary Table 2 [12–40]). Given that these proposals are based on a literature review, they need to be confirmed and/or supplemented by clinicians and methodology experts.

In this study, literature review-based proposals were made for a draft proposal of pharmacopuncture case reporting guidelines. However, there are several limitations to this study. Firstly, the proposals are based on a literature review of case studies rather than an expert committee proposing guidelines by recruiting clinical and research experts. In addition, the development of reporting guidelines should be confirmed using the Delphi technique. Based on the findings of this study, a committee of pharmacopuncture specialists from several associations should be formed. Research funding support is required for the Delphi studies. Secondly, by excluding the case series in the selection process because of the limitation of the research environments, the sample was limited to the case reports in Korea. This study’s proposed draft guideline should be reinforced with a feasibility study that is used for actual pharmacopuncture case studies. Lastly, Chinese herbal injection is often performed by intravenous administration and its clinical application of pharmacopuncture shows a different tendency from Korean clinical application [54]. It can be expected to be a more meaningful study if all the contents related to intravenous administration and Chinese research data used in clinical studies are included in the follow-up studies. In this study, we attempted to create a draft proposal for pharmacopuncture guidelines for practice in Korea. Follow-up research is required to create an extension for herbal injections, which is primarily conducted in China. Despite these limitations, this study is significant in that it identified the aspects of pharmacopuncture research in need of improvement by analyzing the current status of pharmacopuncture case reports and that it drew attention to the need to develop pharmacopuncture case reporting guidelines by making proposals for improving the reporting of existing pharmacopuncture case reports. The results of this study can serve as basic data for developing pharmacopuncture case reporting guidelines aiming at standardizing the reporting process and items. The results can be used in pharmacopuncture intervention reports of clinical studies with a high level of evidence, such as observational studies and controlled trials.

Conclusion

This study examined the report items of pharmacopuncture case reporting and evaluated the compliance of existing pharmacopuncture case reporting with those items. By analyzing the characteristics of the existing reporting guidelines we derived additional items to be included in pharmacopuncture case reporting guidelines to ensure reproducible pharmacopuncture case reporting. The items derived include: pharmacopuncture type, number of points treated during a treatment session, total dose per treatment session and single dose per point, acupoints and the rationale for selecting them, needling depth and direction, patient’s posture during the intervention, treatment environment, pharmacopuncture procedure and technique, and responses sought. This study is significant in that it drew attention to the need to develop pharmacopuncture case reporting guidelines and prepared basic data to develop them. Follow-up research is necessary for pharmacopuncture case reporting guideline development performed through discussion and consensus among experts.

Supplementary Materials

Article information

Author Contributions

Conceptualization: GY. Formal analysis: SJ, CS, and HK. Investigation: SJ, CS, and HK. Methodology: SJ, CS, and HK. Project administration: JL. Supervision: HC. Validation: HC. Writing original draft: SJ, and CS. Writing-review and editing: JL.

Conflicts of Interest

The authors have no conflicts of interest to declare.

Ethical Statement

This research is literature review that does not require IRB approval

Data Availability

All relevant data are included in this manuscript.

Funding

This research article was supported by Wonkwang University in 2022.

Fig. 1

Flow chart.

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