Current Status of Acupuncture Safety Promotion Strategies in Japan

Abstract

Introduction:

The Japan Society of Acupuncture and Moxibustion (JSAM) and experts on the safety of acupuncture and moxibustion (AM) in Japan have focused on safety improvement among acupuncturists, moxibustionists (AMists), and AM-practicing physicians. This article provides an overview of the activities conducted by academic experts in AM safety, primarily from the JSAM, to improve AM safety.

Discussion:

The JSAM formed the Safety Committee in 1998 to collect data regarding AM-related adverse events, provide relevant information to members, and conduct educational activities to prevent malpractice. Early literature reviews on AM-related adverse events in Japan published by the committee significantly shifted the paradigm regarding the awareness of AM safety among Japanese AMists and AM-practicing physicians. The committee has been holding educational workshops on safe clinical AM practices at the annual conferences of the JSAM, managing a website on AM safety strategies, conducting various surveys on AM safety, and performing periodic literature reviews of AM-related adverse events. In recent years, the committee has focused on publishing guidelines and manual books. This article briefly describes the guidelines published in 2020, as well as a practical manual based on these guidelines that was published in 2024.

Conclusion:

Despite extensive efforts in this area, further enhancement of safety management education in Japan is essential. The information provided herein is expected to stimulate the exchange of ideas, discussions, and innovations for improving AM safety worldwide.

INTRODUCTION

Acupuncture and moxibustion (AM) in Japan were introduced from China about 1,500 years ago and have developed into a style unique to Japan over the years.¹ Some of the unique characteristics of Japanese-style acupuncture include its use of relatively fine needles (for example, inventory records from Morinomiya University of Medical Sciences Center for Clinical Acupuncture indicate that 82% of the 35,100 needles used in FY2024 had a diameter ≤0.18 mm), use of an acupuncture tube to penetrate the skin, and insertion of the needle body while supporting it with “Oshide” (a pressing hand). Therefore, it was important to conduct safety assessments of Japanese-style AM by itself. Prospective surveys^2,3 in Japan have indicated that most adverse events were minor and transient, including fatigue (3.3%),² pain at the needling site (2.3%),² and subcutaneous bleeding/hematoma (2.6%),³ which is consistent with global trends.^4,5

However, there have been rare but consistent reports of serious organ injuries, including pneumothorax.^6,7 Additionally, cases of infection after acupuncture treatment have been reported in Japan; however, causal relationships have not been established in most cases. Although hygienic needling has been taught and practiced in AM training schools, there remains room for further improvement.⁸ Additionally, postgraduate AM education, including safety management, is not widespread.⁹

Accordingly, the Japan Society of Acupuncture and Moxibustion (JSAM)¹⁰ and experts on the safety of AM in Japan have made efforts to further improve safety awareness and practice among acupuncturists, moxibustionists (AMists), and AM-practicing physicians. This article provides an overview of the activities conducted by academic experts in AM safety, primarily from JSAM, to improve AM safety.

HISTORY AND ACTIVITIES OF THE SAFETY COMMITTEE OF THE JSAM

Concerns regarding the safety of acupuncture in Japan began to arise after the increasing public awareness of AIDS in the 1980s. Accordingly, Japan’s first guidelines for preventing AM-related infections were published in 1993 by an AM and infection control expert group.¹¹ In 1997, the Safety Assessment Group was established by the JSAM, which evolved into the Safety Committee (or “Committee for Safe Acupuncture”) in 1998, to collect data regarding AM-related adverse events, provide relevant information to members, and conduct educational activities to prevent malpractice. The committee was formed the year before the WHO “Guidelines on Basic Training and Safety in Acupuncture (1999)”¹² was released, which coincided with a period of worldwide interest in the safety of AM.

The Safety Committee initially focused primarily on collecting and analyzing published literature regarding AM-related adverse events, holding safety workshops at the JSAM annual conference, and surveying AM safety guidelines in various countries. Specifically, literature reviews on AM-related adverse events in Japan^13–21 significantly shifted the paradigm regarding the awareness of AM safety among Japanese AMists and AM-practicing physicians at the turn of the millennium.

Currently, the JSAM Safety Committee is engaged in the following activities: (1) publication of guidelines and practical manuals on AM safety, (2) literature review of AM-related adverse events, (3) conducting various surveys on AM safety, (4) holding educational workshops on AM safety, (5) management of a website on AM safety strategies, (6) handling issues related to the International Organization for Standardization (ISO), and (7) other activities as needed.

Publication of Guidelines and Practical Manuals on AM Safety

Among the most efficient methods of raising awareness and improving AM safety is to publish guidelines, practice manuals, recommendations, and workshop records. Table 1 presents the history of publication activities in Japan. The most recent publication by the JSAM Safety Committee is the “Practical Manual for Safety Management of Acupuncture and Moxibustion Therapy,”³¹ which is discussed below. Currently, the committee is revising the “Guidelines for Safety Management of Acupuncture and Moxibustion Therapy 2020,”³⁰ on which the above manual is based, as well as writing and editing a safety manual on cosmetic AM. Additionally, other expert groups in Japan have published guidelines and manuals (Table 1), with most of their authors being past members of the Safety Committee.

Table 1.

History of Publication Activities to Improve Safety in Acupuncture and Moxibustion Practice within Japan

Year	JSAM safety committee	Other expert groups
1993		“Guidelines of Infection Control for the Acupuncture-Moxibustion Treatment”11
1997	Established “Safety Assessment Group”
1998	Developed into “Safety Committee”	“Color Atlas of Topographical Anatomy for Practitioners of Acupuncture and Moxibustion and Practitioners of Judoseifuku”22
2007		“Guideline for the Treatment by Acupuncture & Moxibustion”23
2009	“Acupuncture Safety Knowledge for Clinical Practice”24
2010		“Risk Management Manual for the Treatment by Acupuncture & Moxibustion”25 “Clinical Color Atlas of Acupoint Local Anatomy”26
2011		“Manual for Medical Accidents and an Atlas of Cross Sections of Dangerous Acupuncture Points for a Practitioner in Acupuncture and Moxibustion”27
2012		“Manga Case Reports on Problematic Practice of Acupuncture”28
2017		“Manga Case Reports on Problematic Practice of Acupuncture, Enlarged and Revised Edition”29
2020	“Guidelines for Safety Management of Acupuncture and Moxibustion Therapy 2020”30 “Guidelines for Preventing COVID-19 in Acupuncture Clinic in Japan”
2024	“Practical Manual for Safety Management of Acupuncture and Moxibustion Therapy”31

Books are shown in bold and Italic.

In addition to the activities listed in the table, the JSAM holds workshops on safe clinical practices at its annual conferences almost every year and publishes reviews of case report articles on adverse events in its journal every 3–4 years. As for the books published by other expert groups, most of the authors include past members of the JSAM Safety Committee.

Literature Review of AM-Related Adverse Events

The Safety Committee has been collecting domestic and international literature on AM-related adverse events and reviewing it every 3–4 years. Presenting examples of AM-related adverse events in workshops at the JSAM Annual Conference and in its journal has contributed to maintaining awareness of safety issues among AMists and physicians. Analysis of the occurrence and problems associated with various adverse events has informed the development of relevant guidelines and practice manuals.

Various Surveys on AM Safety

The Safety Committee requests information from the lead author of case reports and persons involved in incidents of serious adverse events within Japan to clarify the details. Moreover, surveys on adverse events and safety measures have been conducted among AM clinics in Japan, albeit irregularly.⁷ Furthermore, depending on the social context, surveys on hepatitis B vaccination status and countermeasures against coronavirus disease 2019 (COVID-19) have been conducted on an ad hoc basis.^32,33

Holding Educational Workshops on the Safety of AM

The committee conducts workshops almost annually. In addition to providing members with the latest information regarding AM safety, including serious adverse events, countermeasures against COVID-19 infection, and related guidelines and practical manuals, the committee discusses these issues with JSAM members, collects their opinions, and provides feedback for future activities. Workshop contents are submitted to the Journal of JSAM annually.

Management of a website on AM Safety Strategies

In 2012, the committee launched the “Acupuncture Safety Measures website (https://safety.jsam.jp/index.html)” to publish reports on the aforementioned surveys and other activities, as well as to disseminate useful and up-to-date information on improving AM safety widely in Japan. Most documents and guidelines are available for free download, and some are written in English. Additionally, the site has an inquiry form on AM safety measures and a form for reporting adverse events.

Handling Issues Related to ISO

Since 2014, the committee has sent members to ISO/Technical Committee 249 (TC249 Traditional Chinese Medicine) Working Groups 3, 4, and 5 to develop international standards and gather information regarding AM safety.

GUIDELINES AND THE CORRESPONDING PRACTICAL MANUAL

As aforementioned, the JSAM Safety Committee published the “Guidelines for Safety Management of Acupuncture and Moxibustion Therapy 2020” in 2020 (Fig. 1).³⁰ These guidelines comprise five sections: (1) Definition and classification of terminology, (2) General requirements and precautions for safety management, (3) Infection control, (4) Preventing adverse events, and (5) Safety management in related therapies. These were developed based on Japanese AM-related laws as well as domestic and international literature surveys on AM-related adverse events. Additionally, they indicate safety-related compliances and practices for AMists and physicians. The descriptions have been bulleted, and only the main points have been briefly stated. The wording of these guidelines attempts to suggest the strength of recommendations, using words such as “must,” “must not,” “should,” “should not,” “recommended,” “not recommended,” and “need to beware,” in accordance with the magnitude of the risk, legal provisions, ethical obligations, research evidence, common sense, etc. These guidelines will be revised every 5 years.

FIG. 1.

“Guidelines for Safety Management of Acupuncture and Moxibustion Therapy 2020” published in 2020. The publisher has granted permission to publish the cover image. English version is available at https://safety.jsam.jp/safety_guidelines.html.

The “Practical Manual for Safety Management of Acupuncture and Moxibustion Therapy,” (Fig. 2),³¹ which was published in 2024, presents specific safety measures in response to the recommendations of the above guidelines. The manual comprises three chapters: general AM safety measures, specific AM safety measures, and safety measures for related therapies. The book contains numerous photographs and diagrams such that even a novice reader can understand and practice its content. The guidelines and corresponding manual chapters are listed in Table 2.

FIG. 2.

“Practical Manual for Safety Management of Acupuncture and Moxibustion Therapy” published in 2024. The publisher has granted permission to publish the cover image.

Table 2.

Table of Contents of the Guidelines 2020 and the Corresponding Practical Manual

Guidelines for safety management of acupuncture and moxibustion therapy 202030	Practical manual for safety management of acupuncture and moxibustion Therapy31
I. Definitions and classification of terminology	I. General principles of safety management in acupuncture and moxibustion	Informed consent, incident reporting, safety management of medical devices, contraindications and precautions, liability insurance, etc.
II. General requirements and precautions for safety management
III. Infection Control	II. Specific safety measures in acupuncture and moxibustion	Infection control (hand hygiene, hygienic needling method), preventing pneumothorax, side effects, nerve injury, etc.
IV. Preventing adverse events
V. Safety management in related therapies	III. Specific safety measures in related therapies	Electroacupuncture therapy, intradermal acupuncture, press-tack needle, etc.

This manual describes specific methods and devices. For example, the section on incident reports proposes a standard incident report form. In Japan, most AMists work in private practice, with many of them lacking the habit of preparing such reports when an incident occurs. This impedes elucidation of the overall incidence of AM-related adverse events in Japan. Therefore, the proposed incident report form was developed to establish a large-scale adverse event monitoring system. Additionally, the section on hygienic acupuncture methods proposes measures for preventing acupuncture-related infections. Specifically, the section describes details regarding hand hygiene, personal protective equipment (e.g., medical gloves), the Clean Needle Technique,³⁴ etc. In the section on the prevention of pneumothorax, the dangers of deep needling are first indicated by presenting a case of pneumothorax-related death following acupuncture treatment, followed by a demonstration of the anatomical distance from the body surface to the pleura in the thorax and the safe needling depths at this site.

Therefore, this manual can be used as a textbook for safety management education of AM students and practitioners.

SAFETY ISSUES SPECIFIC TO JAPANESE-STYLE AM

In Japanese-style AM, needles finer than those in Traditional Chinese Medicine (mostly 0.1–0.2 mm in diameter) are generally used.³⁵ To stably insert such fine needles, a method was developed in which the skin is penetrated using an acupuncture tube, followed by insertion of the needle while being supported by “Oshide” (a pressing hand) (Fig. 3). In addition, Oshide locates the area to be needled and senses changes, including muscle twitches and subtle hardness of the needling area. However, Oshide may cause infection since it often supports the needle body using bare fingers and directly touches the body surface of the needling area. Reviews of case reports regarding adverse events^4–6 suggest that acupuncture-related infections are relatively rare in Japan. Nevertheless, to ensure the safety of this uniquely Japanese technique, it was necessary to propose the aforementioned safety measures.

FIG. 3.

Needling using “Oshide.” The thumb and the index finger support the needle body. In this photo, the fingers in contact with the needle wear finger cots.

Other characteristics of Japanese-style AM and possible problems include forgotten needles and complaints about moxibustion scars. In Japan, there may be forgotten needles given the large number of needles inserted per patient. Regarding moxibustion scars, Japanese AMists used to place pure moxa cones directly on the skin, which led to scar formation (heat-penetrating moxibustion); however, this method is currently practiced by only a few AMists. Instead, hot but non-scarring moxibustion is commonly performed in Japan (Fig. 4 presents examples of such a technique). However, even when using these techniques, skin burns and scarring may occur due to an AMist’s negligence or lack of explanation to patients. The aforementioned manual describes the prevention and management of these problems.

FIG. 4.

Non-scaring moxibustions. The photo on the left shows cylindrical indirect moxibustion, and that on the right shows direct moxibustion through a heat-relieving tool made of paper and aluminum foil. Both of these techniques cause a sensation of heat but leave no scar.

FUTURE CHALLENGES

In our opinion, the most important factor for improving AM safety is safety management education. However, as described by Kawai et al.,⁹ there is diversity in terms of training schools and years of learning required to become an AMist in Japan, resulting in a wide variation in the number of hours of classes on safety management. Consequently, there are differences in the quality of knowledge and skills in safety measures among AMists. Notably, physicians are not required to obtain education on AM. Furthermore, few AMists and physicians receive postgraduate training in AM, and it is not mandatory to attend continuing education sessions held by AM-related societies and professional bodies.⁹ Therefore, there is a need to establish clear incentives for AMists and physicians to belong to relevant academic societies and professional bodies, as well as receive the necessary education and training after obtaining the qualification. This may include positive incentives, such as promotion of the certified AMist system by the JSAM, and negative incentives, such as the inability to obtain liability insurance unless one has taken a defined continuing education course. As a positive incentive, the JSAM updated and strengthened its certified AMist system in 2021, which began in 1999.⁹ We believe that a similar certification system should be established for physicians in the future.

It is important to accurately determine the incidence of relevant adverse events in Japan, which will inform the development of AM safety management education. Currently, we are working to establish a large-scale adverse-event monitoring system in collaboration with academic societies and professional associations.

CONCLUSION

It is important to further enhance safety management education with respect to AM, which requires understanding the current status of adverse events, enhancing educational content based on this understanding, promoting continuing education programs by academic societies and professional bodies, and creating incentives to encourage active participation in these educational programs. Although not all these measures have been implemented, we introduced AM safety measures being undertaken in Japan, focusing on the activities of JSAM, the largest AM academic organization in Japan. We hope that this information will stimulate the exchange of ideas, discussions, and innovations to improve AM safety worldwide.

AUTHORS’ CONTRIBUTIONS

M.S.: Conceptualization, drafting of Chapters 2, 3, and 5. H.S.: Conceptualization, drafting of Chapters 1, 2, 3 and 6. N.F.: Drafting of Chapters 1 and 2. H.Y.: Conceptualization, drafting of Chapters 1, 2, 4 and 6, editing, and finalizing the article. S.K. Drafting Chapter 4, reviewing and editing. I.W.: Supervision, drafting Chapter 4, and finalizing the article.

All the authors have read and approved the final article.

ETHICAL STATEMENT

Ethical approval was not required because this study did not involve human participants or laboratory animals.

AUTHOR DISCLOSURE STATEMENT

I.W. is a member of the editorial board of this journal but was not involved in the decision to accept or reject this article. The authors declare no conflict of interest.

FUNDING INFORMATION

Faculty research funding at Morinomiya University of Medical Sciences.