Volume 1, Special Edition | Current Japanese Acupuncture and Moxibustion 2010

Clinical Trials on Acupuncture in Japan
Shoko Masuyama1), Hitoshi Yamashita1)
Hiroshi Tsukayama2)
1) Department of Acupuncture, Morinomiya University of
Medical Sciences, Osaka, Japan
2) Center for Integrative Medicine, Tsukuba University ofTechnology, Tsukuba, Japan

3. Results
We located 87 RCTs/CCTs on acupuncture
conducted in Japan. In fact, some clinical trials werereported in the 1960’s, most of which papers, however,were unavailable. Consequently, whether these papers
are of independent trial or duplicates was not clear.
Therefore, trials after CCT by Kinoshita published in1969 will be analyzed in this paper.

1. Introduction
The concept of evidence-based medicine (EBM) has
permeated Japanese clinical research on acupuncture
and moxibustion, and the number of randomized
controlled trials (RCT) is also increasing in Japan. For
RCTs conducted in Japan, some reviews werepublished 1-3). However, data has not been updated forseveral years. Therefore, we reviewed and evaluated

The 87 trails were RCTs or CCTs conducted during
1969 through 2007 and their abstracts have been

the relevant papers in order to identify the current
status of clinical trials on acupuncture conducted inJapan and to assess the quality of them.

11 were reported in English. Eighty-one trials wereparallel-armed, and 6 were cross-over trials. There

2. Methods
We performed a literature search by using “Ichushi(Japana Centra Revuo Medicina) Web”, PubMed,reviewing papers already published2,3), and our own
files. In using Ichushi Web and PubMed, we used thekeywords “acupuncture” and limited to RCT or quasi-RCT.
We included only controlled clinical trials (CCTs) orRCTs which were conducted in Japan, published before
2008, focusing on the effect of acupuncture forpatients. Cross-over RCTs were included. We

published in journals as full paper or abstract. Thesetrials do not contain experimental RCTs which stressedor loaded healthy volunteers or athletes. If we
included trials using healthy subjects or athletes, thenumber of trials would have been more than 150.
Of the 87 trials, 76 were reported in Japanese, andwere 5 multi-center RCTs.
between 4 and 170.

Sample size ranged

RCT on acupuncture was conducted at a relatively
early stage. This may be because of the influence of Dr.
Kosei Takahashi and Oubu-Kai. However, there wasno publication of clinical trial on acupuncture between
1990 and 1996, after which the number of clinical trials
increased again, especially after 2000. (Fig. 2)

excluded experimental studies which stressed orloaded healthy subjects/athletes, N of 1 trials, trials on
moxibustion.

Aftereliminating

duplications,

weextracted data from the located papers, and assessed
sample size, randomization, blinding, language, type ofcontrol group, modified Jadad score, and so on. (Fig. 1)

Most of the trials were published in acupuncture
journals. While some trials used more than 100
subjects, the sample size has not been increasing evenafter 2000. Most of the trials used patients withmusculoskeletal problems such as low back pain orneck and shoulder pain. (Fig. 3, Table 1)
At the early stage, until the 1980s, clinical trials
were mainly conducted and published by practicing

36

The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)

Volume 1, Special Edition | Current Japanese Acupuncture and Moxibustion 2010acupuncturists, but after the 1990s, the authors aremainly acupuncturists who work for a university orschool. (Fig. 4)

If we look at the average Jadad score (Table 2) ineach decade, the quality of the trials improved
gradually. However, even after 2000, the Jadad scoreis 0 in some trials. Sample size decreased after the1980s. The reason for low quality has two aspects: oneis that the trial itself is poor, and the other is thatreporting methods are poor, but actually both may bepoor in the trials of zero score. (Fig. 6,7)

At an early stage, trials focused on comparison ofdifferent styles of acupuncture, and then shifted tocomparison of acupuncture with sham needling after
2000. This may be related to the author’s acupuncture
affiliation because it is difficult to set the no treatment
or sham needling group for practicing acupuncturists.
(Fig. 5)

There were 5 multi-center RCTs. However, thesample size is not very large, and average Jadad scoreis 2.2. This means that the quality of multi-center

The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)

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Volume 1, Special Edition | Current Japanese Acupuncture and Moxibustion 2010

RCTs on acupuncture in Japan is not necessarily high.
(Table 3)

literature was written by Strom in 19744). In contrast,
it deserves special mention that RCT literature waspublished in the 1960s in Japan. Although far more
RCT literature on acupuncture has been published inEuropean countries and the U.S. than in Japan, there
weresomepractitioners

inacupunctureandmoxibustion who had interest in RCT from earlier
times and implemented it in Japan. Then-RCTs wereperformed by private-practice acupuncturists andmoxibustionists under the guidance of scholars ofuniversities. In the latter half of 1990s and onward,
most of the RCTs have begun to be conducted byacupuncturists

andmoxibustionists

workinginuniversities. This may have caused a rise after 2000
in the number of RCTs comparing acupuncture withsham needling.
Through the evaluation of the trials we found someproblems withcontrolled clinical trials in Japan. The
trials on acupuncture in Japan are not easy accessible
from overseas, because most of the reports are written
in Japanese and published in domestic acupuncture
journals.

There were some inappropriate papers,such as duplicate publications or so-called “salami”
papersto increase the number of literature entries byfragmentation of data. Data fragmentation, which

4. Discussion
We summarize the points as follows: RCTs or CCTs

may be seen in other countries, is a major impedimenton acupuncture in Japan suddenly increased after

for literature reviews to get muddled and also an2000.

byobjectionable act as a researcher. Overall, we have anpracticing acupuncturists, and then mainly by school

impression that acupuncture RCTs in Japan tends toacupuncturists after 1990s.

beTheyonce

wereconducted

mainlyInitially, they focused mainly on comparison ofconductedconsideration.

tooWe

easilyproposewithout
that

carefulacupuncture

different styles of acupuncture, then shifted toschools/societies in Japan strengthen the functions ofcomparison of acupuncture with sham needling after

their Institutional Review Board for better quality of2000. Most trials assessed the effect of acupuncture

clinical trials on acupuncture in Japan.

for musculoskeletal conditions. The quality of theIn conclusion, the number of RCTs on acupuncture

trials is improving slightly, but generally not very

and moxibustion is growing, whereas the quality ishigh.

not necessarily high. Thus we consider it necessary toTheresultofPubMedsearch(Keyword:cope with the tasks ahead; quality improvement,acupuncture, Limits: randomized controlled trial)

adequate

as of December 31, 2007 showed that the earliest

publications accessible from abroad.

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controlgroup

The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)

setting,andEnglish

Volume 1, Special Edition | Current Japanese Acupuncture and Moxibustion 2010

References

3) Tsutani K, Suyama S. Nippon-no sinkyu RCT1) Shichido T. Shinkyu no rinsyo-hyouka(32). Ido nodata-base(JRC-RCT)[Acupuncture RCT database inNippon [The Journal of Japanese Acupuncture &Japan].

Moxibustion] 1996; 55(7): 95-102.

http://jhes.umin.ac.jp/JAC-RCT/020605/JAC-AT21.pdf;

2) Tsukayama H, Yamashita H. Systematic review of2002 Mar 31.

clinical trials on acupuncture in the Japanese

4) Strom H. Acupuncture treatment of post-tonsillectomy

literature. Clin Acupunct Orient Med 2002; 3:

pain. The analgesic effect compared with blind

105-113.

puncture. Ugeskr Laeger 1974; 136: 1855-1856.

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