Global Health. 2015; 11: 17.
Published online 2015 Apr 25. doi: 10.1186/s12992-015-0103-2
PMCID: PMC4415294
Abstract
Background
Complementary
and alternative medicine (CAM), such as acupuncture and herbal
medicine, is popular in many countries. Yet, treatment outcomes of CAM
are found to vary significantly between medical trials in different
social environments. This paper addresses how the social organization of
medicine affects medical treatment outcomes. In particular, it examines
the extent to which two popular complementary and alternative medicine
(CAM) interventions (acupuncture and herbal medicine) are coordinated
with biomedicine and how coordination characteristics are related to the
treatment outcomes of the two CAM interventions.
Methods
This
paper conducts an archival analysis of the institutional settings of
the CAM interventions in Japan and the U.S. It also conducts a
systematic content analysis of the treatment outcomes in 246 acupuncture
reports and 528 herbal medicine reports that are conducted in Japan or
the U.S. and registered in the Cochrane Library’s Central Register of
Controlled Trials (CENTRAL), and 716 acupuncture reports and 3,485
herbal medicine reports that are from Japan or the U.S. and listed in
MEDLINE. It examines the association between the treatment outcomes of
the two interventions and the geographical location of the reports; it
also explores how the institutional settings of the interventions are
related to the treatment outcomes.
Results
Japanese
herbal medicine is integrated into the national medical system the most
and American herbal medicine the least; American acupuncture and
Japanese acupuncture fall in the middle. Treatment outcomes are the most
favorable for Japanese herbal medicine and the least favorable for
American herbal medicine. The outcomes of American acupuncture and
Japanese acupuncture fall in the middle.
Conclusions
The
co-utilization of CAM with biomedicine can produce difficulties due to
tensions between CAM and biomedicine. These difficulties and subsequent
CAM treatment outcomes vary, depending on how CAM is institutionalized
in relation to biomedicine in the national medical system. Coordinated
CAM interventions are more likely to be effective and synergic with
biomedicine, when compared to uncoordinated ones.
Keywords: Complementary and Alternative Medicine (CAM), Japan, U.S, Different Treatment Outcomes of CAM, Institutionalization
Background
Complementary and alternative medicine (CAM), such as acupuncture and herbal medicine, is popular in many countries [1-3]. Health care systems have accordingly organized CAM along with mainstream biomedicine in various ways [4-8]. Treatment outcomes of CAM are found to vary significantly between medical trials in different social environments [9-11]. However, social scientific interest in the effectiveness and reliability of CAM as a medical resource [12-16]
has paid little attention to an organizational sociological insight
that the social organization of medicine can affect the outcomes of
medical treatments [17,18].
I draw on this organizational sociological perspective and investigate
how variations in the effectiveness of CAM are related to differences in
the institutionalization of CAM into a national health care system.
This
empirical inquiry is situated at the intersection of two traditions in
medical sociology. One, or the sociology of medicine, is relatively
established in the discipline with its tenet being the social
construction of medicine [19-22].
Its insight is consistent with the observation that CAM has been
constructed and institutionalized differently into health care systems
in the world. The other, or the sociology of the effects of medicine, is
relatively nascent in the literature. Early studies have only
demonstrated the significance of social factors intervening in the
outcomes of biomedicine, by proposing cultural accounts of the successes
or failures of biomedical treatments [23-26], bio-social models of treatment outcomes [27], and the society–gene interaction model of genetic causation [28]. It has yet to be examined how social contextual influences exist among the puzzlingly varying treatment outcomes of CAM.
At
the conjuncture of the two traditions, I hypothesize that the degree to
which CAM is institutionalized within the mainstream biomedical health
care system has consequences for the effects of CAM. This hypothesis is
based on existing ethnographic observations that the institutional
settings of CAM affect how users perceive and what they expect from CAM
treatments [29]
and that negative social labeling of illnesses and unconventional
medicines may lead to secretive and uninformed uses of informal medical
resources ([30]:
1814). Most importantly, this hypothesis pays heed to the theoretical
and political tensions and conflicts between CAM and biomedicine in
addressing illnesses [20,31-33].
In addition, the tensions and conflicts can vary, depending on the
extent to which CAM is institutionalized within the dominant biomedical
system. When institutionalized, CAM is likely to have less tensions and
conflicts with biomedicine. Varying tensions and conflicts can
subsequently shape how CAM is practiced alongside biomedicine in
specific treatment contexts, which has in turn consequences for the
treatment outcomes of CAM.
The purpose of this paper,
therefore, is twofold. First, I investigate quantitatively whether there
is a discernible correspondence between CAM institutionalization and
CAM treatment outcomes. Second, I provide a sociological explanation of
the correspondence by qualitatively revealing specific treatment
episodes from reports in medical journal databases.
I
take a methodological cue from the medical science community (i.e. the
meta-analytic approach based on a systematic content analysis) and adapt
it into a sociologically informed meta-analysis. The medical science
community has responded to the inconsistent outcomes of medical
interventions with meta-analyses of research findings [34-36].
Meta-analyses are expected to produce generalizable evidence by
adjusting inconsistent outcomes to differences in trial design (e.g. the
size of trial subjects), outcome measures, or the statistical models
used. Indeed, some early agreements have ensued with regard to the
efficacy and safety of CAM interventions [37-39].
Medical
meta-analyses, however, have two significant limitations compared to
medical sociological interests. First, they neglect the treatment
outcomes reported by users and practitioners in real-world medical
practices outside “scientific” clinical trials. Aiming to re-calibrate
the effects of only technological interventions arguably independent of
social circumstances, medical meta-analyses focus on clinical trials
(e.g. randomized controlled trials [RCTs]) where the impacts of the
social environment are designed to be non-existent. Thus, they have
excluded treatment outcomes that are reflected in patient case reports
and practitioner commentaries in medical journals. Treatment outcomes in
real-world treatment settings outside clinical trials and those from
practical medicine in clinics rather than theoretical science in
laboratories have been obscured.
Second, the variations
in treatment outcomes across doctors’ offices and hospitals have also
been obscured. Medical meta-analyses aim at generating consensus rather
than identifying disagreements. The limitation of this approach to
re-calibrating the universal – rather than differential – effects of
medical interventions is evident, when acupuncture and herbal medicine
of an identical quality and of an identical trial design (a randomized
controlled trial [RCT]) are intriguingly found to produce varying and
even conflicting treatment outcomes at different trial sites [10,11].
Through
a sociological meta-analysis, I purport to systematically document the
varying outcomes of CAM in two different social contexts. My analysis
aims not to bracket these variations out of consideration, as medical
meta-analyses have done in search of the universal effects of CAM
interventions. Instead, I examine two popular CAM treatments,
acupuncture and herbal medicine, to show how divergent their treatment
outcomes are between Japan and the U.S. I then examine how these
treatment outcomes are related to the institutional environment of the
interventions in the two countries. I stress the significance of
coordinating acupuncture and herbal medicine treatments with mainstream
biomedicine in order for the CAM interventions to produce tangible
health care benefits. I also argue for the relevance of a sociological
meta-analysis to identify and explain the differential outcomes of
medicine.
Data and methods
Case selection: acupuncture and herbal medicine in Japan and the U.S.
I
examine the treatment outcomes of acupuncture and herbal medicine in
Japan and the U.S. for two reasons. First, acupuncture and herbal
medicine are institutionalized differently in the two countries.
Theoretically, acupuncture and herbal medicine together form the whole
system of “oriental medicine” or “traditional Chinese medicine”. Japan
and the U.S. have, however, institutionalized acupuncture and herbal
medicine being disconnected from each other. Furthermore, the two
countries show reversed institutional prominence between acupuncture and
herbal medicine. Acupuncture has been incorporated into the American
medical system as one of the legitimate medical practices, whereas
herbal medicine still remains illegitimate. In Japan, to the contrary,
both have been institutionalized into the national medical system, where
herbal medicine has gained the status of a legitimate medicine as kampo whereas acupuncture has been institutionalized as a second-class pseudo-medicine.
Second,
studies suggest cross-national differences between East-Asian countries
and Euro-American countries in the degree to which acupuncture and
herbal medicine are found to be effective [9,40,41]. Among these countries, Japan and the U.S. are two of the countries that conduct most medical research in the world [42].
Thus, they do not only provide the richest empirical reports about the
treatment experiences of acupuncture and herbal medicine but also
constitute an interesting pair that invites a sociological investigation
of how different institutional settings are related to treatment
outcomes.
Meta-analysis
To
specify the treatment outcomes of acupuncture and herbal medicine in
the two countries, I have used medical journal papers as the unit of
analysis. Medical journal papers are from two prominent medical
databases: the Cochrane Library’s Central Register of Controlled Trials
(CENTRAL) (http://www.thecochranelibrary.com/) and the U.S. National Library of Medicine’s MEDLINE (http://www.nlm.nih.gov/bsd/pmresources.html) both of which hold medical reports from across the world.
As
of May 2012, there are 673,964 controlled clinical trials registered in
CENTRAL. I have retrieved 5,243 trials of acupuncture, which refer to
“acupuncture” in the title, abstract, or keywords. Of the total
acupuncture trials, 108 and 138 trials have been conducted by
researchers based in Japan and the U.S., respectively. I have retrieved a
total of 5,812 trials on herbal medicine, which refer to “herbal
medicine”, “herbal therapy”, “herbal supplement”, “herbal preparation”,
“herbal remedy”, “kampo”, “kanpo”, “medicinal plant”, or “plant extract”
in the title, abstract, or keywords. Of these trials, 228 have been
conducted by researchers in Japan and 300 in the U.S. I analyze the
content of all 246 acupuncture trials and 528 herbal medicine trials. I
focus on four measures: treatment effectiveness, biomedicine–CAM
synergy, adverse treatment outcomes, and negative biomedicine–CAM
interactions.
As of 2012, the second database, MEDLINE,
includes over 700,000 records in the subset of CAM (“Complementary
Medicine”) that is developed by the U.S. National Center for
Complementary and Alternative Medicine (NCCAM) (for the detailed
strategies used for the subset, see http://www.nlm.nih.gov/bsd/pubmed_subsets/comp_med_strategy.html).
Unlike CENTRAL which lists only controlled clinical trials, MEDLINE
covers various reports, such as patient case reports, practitioner
opinions and comments, news reports, policy analyses, and historical
reviews (see Table 1
for details). Thus, MEDLINE uniquely incorporates reports from users
and practitioners in real-world medical practices outside of controlled
laboratorial trials. Based on Boolean search queries where I utilize the
MeSH (Medical Subject Headings) terms for CAM modality and geographical
location (see Appendix
for each query in detail), I have retrieved 115 reports of acupuncture
practiced in Japan and 601 reports in the U.S. as of May, 2012; there
are 1,071 reports of herbal medicine from Japan and 2,414 reports from
the U.S. Table 1 presents how these reports are distributed across different report types.
I analyze the content of all 716
acupuncture reports and 3,485 herbal medicine reports in the same four
measures. The four measures have been operationalized in the following. I
apply the method of “closed coding” [43]
in which I code each report 1 or 0 for each of the four measures,
depending on whether the report provides a positive or a negative answer
to a pre-determined question for the measure.
First, treatment effectiveness
measures whether acupuncture or herbal medicine intervention was found
to be effective in treating or preventing medical conditions, compared
to the outcomes in pre-treatment or control groups. When a paper found
the intervention effective, the paper is coded 1 (0 otherwise).
Second, biomedicine–CAM synergy
refers to the presence of positive outcomes from the concurrent use of
CAM with biomedicine treatments (coded 1; 0 otherwise). From the data,
two types of synergy have emerged. First, the combined treatments of
biomedicine and CAM were often found to be effective when the lone
treatment of either biomedicine or CAM was not. In other cases, the
effectiveness of combined treatments was found greater than that of
either lone treatment. Second, synergy was shown in cases where CAM was
used to relieve the side effects of biomedical treatments and to help
patients to continue their biomedical treatments. Without CAM and its
synergic effects, it would have been difficult to continue the
biomedical treatments.
Third, adverse treatment outcomes
refer to the presence of unforeseen adverse medical events from CAM
(coded 1; 0 otherwise). I code adverse events as were reported in
clinical trials in CENTRAL; for reports from MEDLINE, I use the MeSH
term “adverse effects” to code the presence.
Fourth, negative biomedicine–CAM interactions
measure the presence of adverse treatment interactions between
biomedicine and CAM (coded 1; 0 otherwise). Whereas adverse treatment
outcomes refer to adverse events from CAM only, this measure reflects
adverse events that occur through the interactions between biomedicine
and CAM. I code the interactions as reported in CENTRAL trials; I use
the MeSH term “herb–drug interactions” for MEDLINE reports. Negative
herb–drug interactions are defined as adverse outcomes that are not
expected of separate applications of each of the concurrently used drug
and herbal medicine ([44]: 631).
Through
this coding process, each report is given a value of 1 or 0 for each of
the four measures of treatment outcomes. In addition, each report is
coded whether it is about acupuncture or herbal medicine (modality); whether it is from Japan or the U.S. (geographical location). Then, I use Pearson’s χ2
test of independence for the relationship between the geographical
location (Japan vs. the U.S.) and each of the four measures of treatment
outcomes and that between modality (acupuncture vs. herbal medicine)
and each of the four measures. This test gives quantitative answers to
whether there are cross-national differences in CAM treatment outcomes
between Japan and the U.S. and how they correspond to differences in the
institutional settings of acupuncture and herbal medicine. This
quantitative test of independence between the institutional settings of
CAM treatments in different countries on the one hand and the treatment
outcomes on the other constitutes the first unique feature of the
sociologically informed meta-analysis that this paper performs.
In
addition, I complement this quantitative analysis with a qualitative
analysis, by extracting the details of institutional settings from the
reports. I apply the method of “open coding” [43]
to discover themes related to the treatment contexts in which
acupuncture or herbal medicine is practiced. For each report, therefore,
these contexts are coded descriptively in text. Several themes have
emerged from this open coding process that explain the results from the
quantitative analysis, such as practitioner skills, the holistic
practices of CAM, the organizational coordination of CAM with
biomedicine, patient–physician communication of CAM use, and
cross-cultural utilization of healthcare services. This open coding
process, which focuses on the treatment contexts and subsequently
extracts these themes emerging from the contexts, is the second unique
feature of the sociologically informed meta-analysis.
The
emergent themes from the open coding process are all grounded in the
reports that I refer to with unique document identifiers:
CENTRAL-generated CNIDs (i.e. 8-digit numbers led by “CN–”) and
MEDLINE-generated PMIDs (i.e. 8-digit numbers led by “PMID”). With these
unique identifiers, one can easily access the full reports in each of
the online databases (use CNIDs in the search box at http://www.thecochranelibrary.com/view/0/index.html; use PMIDs in the search box at http://www.ncbi.nlm.nih.gov/pubmed).
Results from the comparison of the institutional settings in Japan and the U.S.
Japan: acupuncture and herbal medicine integrated into the medical system
Japanese herbal medicine kampo literally means “Chinese or Oriental (kam) theory or therapeutics (po)” that does not only include herbal medicine but also acupuncture, cupping, and moxibustion. Since the 1970s, however, kampo
refers in practice to herbal medicine only. Herbal medicine has since
managed to remain at the center of traditional oriental medicine whereas
other elements, such as acupuncture and moxibustion, have been
marginalized.
From a historical perspective, however,
it was herbal medicine, rather than acupuncture, that was first
marginalized. First established as traditional medical practices in the
6th century [45],
acupuncture and herbal medicine underwent major tumults during the
Meiji government-driven medical modernization (1868–1912). Meiji
legalized only medical practices that were adopted from the Netherlands
and Germany. Both acupuncture and herbal medicine were denied legal
recognition.
Around 1885, however, acupuncture gained
official recognition from prefecture governments as a vocational course
for the blind and not as a legitimate medical tradition. The
reinstatement of acupuncture in the vocational context culminated in the
1911 legislation that permitted the practices of acupuncture and
moxibustion as business entities and not as medical practices. It was
under the post-World War II American rule that acupuncture and
moxibustion were recognized as medical practices that required formal
education and licensure ([46]: 8–9).
Acupuncture education was further formalized, as it expanded into universities like Meiji Shinkyu Daigaku
established in 1983. Subsequently, the Japanese government initiated a
nation-wide standardized licensure in 1993, replacing the fragmented
systems overseen by local governments. Acupuncture has since maintained
the institutional recognition. Currently, there are 80 three-year
vocational schools, 6 four-year colleges occasionally with post-graduate
programs, and medical schools all teaching acupuncture as a required or
elective course [47-49].
It is estimated that there are about 130,000 licensed and 80,000
practicing acupuncturists in about 50,000 clinics throughout Japan [50]. National surveys estimate that 6–7% of Japanese adults visit acupuncture clinics [51,50].
To the contrary, herbal medicine remained outlawed for a century from 1868 to 1967. Then, four traditional herbal medicine (kampo)
formulae in 1967 and 43 formulae in 1976 were suddenly recognized by
the national government and sanctioned in the national insurance system,
comparable to pharmaceutical drugs [52,53]. Several accounts exist for this sudden institutional acceptance of kampo after a century of long neglect, some of which stresses the strong lobbying of the Japanese Medical Association [54], the needs of patient groups, or the business interests of kampo manufacturers [53]. Kampo has since been prescribed only by medical doctors like biomedical drugs.
This
reinstatement of herbal medicine into the center of medicine has in
fact been accompanied by several deliberate – although hidden – efforts.
First, doctors at Meiji-era medical schools kept studying kampo and conducting research with students, even though they could not teach it officially ([55]: 7). The successful pharmacologic isolation of alkaloid ephedrine from the kampo herb mao (Ephedra sinica) in 1887 was another achievement ([56]: 52). Facing denial from the Meiji government, kampo researchers appropriated government-espoused pharmaceutical models for underground research into kampo and produced the achievement. Second, unofficial kampo research by three distinct groups of medical doctors brought about a historic event in kampo, or the publication of The Practice of Clinical Kampo Medicine in 1941 ([55]: 7–8). The publication provided a list of formulated kampo prescriptions that are matched to patient symptoms. Thus, physicians without theoretical knowledge of kampo
were able to practice it with a ready-made set of symptom-specific
formulae. This publication was followed by the Japanese Medical
Association’s endorsement of kampo for its acceptance into the national insurance system.
Several
regulatory measures, comparable to those of biomedical drugs, further
promoted the full institutionalization of herbal medicine, such as the
introduction of toxicity tests, three-phased clinical trials, and
efficacy evaluations [53,57]. Currently, 148 formulae and over 200 herbs are being supported by the national health insurance system [52].
Herbal remedies can be purchased from pharmacies with the support of
national insurance when they are prescribed by a physician or without
the insurance support when there is no physician prescription. About 70%
of physicians reportedly prescribe kampo (Nikkei Medical October 2003: 33–39). The total annual expenditure for kampo is estimated to be more than one billion dollars [56]. Following a government mandate, 79 out of the 80 Japanese medical schools teach kampo courses. There are 2,420 kampoi (or, board-certified physicians for kampo practices) and about 6,000 non-certified kampo-practicing physicians among the total number of 280,000 physicians (http://www.jsom.or.jp/).
The U.S.: acupuncture integrated in the system while herbal medicine being an outcast
Not
until the 1970s did acupuncture and Oriental medicine (AOM) begin to be
officially recognized by state governments. AOM had remained as
unofficial and underground medical practices known only to Asian
immigrant communities [58].
From the 1970s, acupuncture was readily decoupled from the whole system
of Oriental medicine and achieved early acceptance in the American
medical system. Herbal medicine, on the contrary, is still left outside
of the established medical field.
The relatively
advanced institutionalization of acupuncture began with practitioner
associations organized in the 1970s. Along the way, acupuncture schools
were formed, resulting in 13 acupuncture and oriental medicine schools
by 1981 [59]. State-level developments soon led to the birth of national organizations and orchestrated examining bodies [60,61].
By 1982, a decade after the initial organizing efforts, acupuncture
established itself as a self-sufficient medical profession with its own
education, certification, and practitioner associations at the national
level. Most state governments subsequently began legalizing the practice
of acupuncture.
American acupuncture has also been
established in other institutional measures. In 1996, the Food and Drug
Agency (FDA) reclassified acupuncture needles as “safe and effective
medical devices”, replacing the 1973 classification as experimental
“investigational devices” [61]. The National Institute of Health (NIH) produced a consensus report in 1997 supporting the potential efficacy of acupuncture [39].
Over 65 schools and colleges confer either a 3-year Master of
Acupuncture degree, a 4-year Master of Acupuncture and Oriental Medicine
degree, or a Doctor of Acupuncture and Oriental Medicine [62].
There are over 27,000 licensed acupuncturists in 45 states, five of
which even allow acupuncturists to hold the title of primary care
practitioner (PCP) who can perform biomedical test requests and patient
referrals to other specialists. Insurance coverage is relatively limited
yet. Federal healthcare schemes do not cover acupuncture and less than a
quarter of state Medicaid programs cover acupuncture [63]. Eleven states have private insurance mandates [64].
About 47% of private policies cover acupuncture and they limit
reimbursement to visits only to physician acupuncturists or
pre-designated acupuncturists [65].
The
current institutional status of herbal medicine is much less prominent
than acupuncture. There is no sole medical degree of herbal medicine or
certification of herbalists. Instead, acupuncture schools have gradually
promoted herbal medicine by expanding the scope of practice by
acupuncturists. It is, however, still illegal for acupuncturists to
practice herbal medicine in half of the states [62]. Chiropractors, naturopaths, and midwives may only occasionally practice herbal medicine [64].
A majority of herbalists are food and nutrition specialists and not
medical practitioners. This institutional under-development is
surprising, considering herbal medicine’s central position within
Oriental medicine and its long tradition in Native American medicine ([66]: 190, [67]).
The
current status of herbal medicine practiced mostly in food stores and
not by medical professionals is related to the American history of food
and drug regulation. Manufacturers of herbal medicine have managed to
define herbal medicine as “dietary supplements”, a regulatory category
for a subgroup of food under the 1994 Dietary Supplement Health and
Education Act (DSHEA). Accordingly, herbal medicine is not required to
be registered and approved by the FDA for safety or efficacy.
Manufacturers are required only to report its post-marketing adverse
side effects while herbs cannot be marketed to have any medical effects [68].
Competing
efforts still exist to place herbal medicine under the category of
legitimate medicine rather than dietary supplements. On one hand,
medical doctors have requested to officially recognize the high
physiological potency of herbal medicine and bring it under strict FDA
regulations equivalent to drugs [69,70].
On the other, acupuncturists have tried to enlist herbal medicine under
the scope of practice by acupuncturists. Meanwhile, manufacturers can
supply herbal medicine directly to users without any mediation from
physicians, nurses, acupuncturists, or herbalists.
Results from the meta-analysis of treatment outcomes
Treatment effectiveness
I
found a cross-national difference in the treatment effectiveness of
acupuncture and herbal medicine in both CENTRAL and MEDLINE. Acupuncture
was found to be more effective in Japan than in the U.S. Eighty four
out of 108 Japanese trials and 87 out of 138 American trials in CENTRAL
found it effective (78% vs. 63%; p-value for Pearson’s χ2
test of independence = 0.013). Eleven out of 115 Japanese reports and 40
out of 601 American reports in MEDLINE found it effective (10% vs. 7%;
p-value = 0.266).
Correspondingly, acupuncture and
herbal medicine were practiced differently in Japan and the U.S. First,
acupuncturists had different skill levels. Experienced acupuncturists
applied acupuncture needles in the following first trial, whereas, in
the second trial, staff nurses and research assistants practiced
acupuncture with minimal training.
“[State-licensed] senior acupuncturists (5 + years in practice) decided where to needle and junior acupuncturists (2 - years in practice) practiced the interventions”. (CN-00735199)
“Dr. Ji-Sheng Han … provided an in-depth training to Dr. Meade and Ms. Eldridge. They, in turn, trained study staff (research assistants and nurses)… This staff was certified to administer treatments”. (CN-00728884)
As regards herbal medicine, in explaining the puzzle that a Japanese kampo formula (i.e. keishibukuryogan),
which had been found efficacious for menopausal symptoms in Japan,
produced unexpected adverse effects (i.e. diarrhea) in 20% of the trial
subjects in the U.S. and only marginal treatment effects, a report
pointed out the deficient knowledge about the proper dosage of kampo
for American women (CN-00810843). The American trial had simply
followed the dosage instruction made in the Japanese context. Two more
studies evidenced that cross-national outcome differences were related
to more or less informed ways of practicing herbal medicine
(CN-00482723; CN-00750876).
Second, American
trials applied acupuncture in a fragmented and less effective way,
compared to the holistic Japanese practices. For example,
“Acupuncture treatments were performed at the Harvard-Thorndike General Clinical Research Center at Beth Israel Deaconess Medical Center. … However, massage, herbal prescriptions (or any other medical prescription), moxa, cupping, and lifestyle modifying therapies were not allowed”. (CN-00610755)
“Limitation: A prescription of acupuncture at fixed points may differ from acupuncture administered in clinical settings, in which therapy is individualized and often combined with herbal supplementation and other adjunctive measures”. (CN-00511534)
Better
outcomes were indeed found in a “whole system clinical trial” that
adhered to the holistic practices (CN-00640342). A growing emphasis is
placed on “pragmatic” trials designed to capture the overall impact of
acupuncture as a whole system vis-à-vis the fragmented “drug model” of
trials [71].
Third,
treatment effectiveness was dependent upon whether acupuncture was
coordinated with other conventional treatments. For example, two
clinical trials conducted on the same site, on the same subjects (i.e.
cocaine-dependent patients at the Yale School of Medicine), and with the
same acupuncture treatment, produced different treatment results
(CN-00403270). Acupuncture was ineffective in treating cocaine addiction
in one trial; it was effective in the other. In the effective trial,
subjects were additionally provided with a manual-based conventional
psychological therapy called “coping skill therapy (CST)” which was
absent in the ineffective trial. So, the study concluded that:
“acupuncture, a nonverbal treatment that does not in and of itself teach skills requisite for abstinence, may need to be embedded within an appropriate psychological framework in order to be effectively utilized. … The absence of the CST may have constituted a significant omission”. (CN-00403270)
Biomedicine–CAM synergy
In the Pearson χ2
test of independence among the CENTRAL trials, herbal medicine was
found to produce synergy with biomedicine more often in Japan than in
the U.S. (13% vs. 3%; p-value < 0.001). The cross-national difference
was less obvious in acupuncture (22% vs. 11%; p-value = 0.028). In
Japan, herbal medicine was found to be as synergic with biomedicine as
acupuncture was (13% vs. 11%; p-value = 0.674). In the U.S., to the
contrary, herbal medicine was significantly less synergic than
acupuncture (9% vs. 30%; p-value < 0.001).
The
details of biomedicine–CAM synergy were identifiable in two categories.
First, synergy was represented in an additive manner. For many medical
conditions, the addition of acupuncture or herbal medicine to biomedical
treatments often produced effective treatment results, compared to the
ineffective lone treatment of either biomedicine or CAM. The addition
sometimes produced greater effects, compared to the effects of either
lone treatment.
For example, acupuncture produced
additive effects on infertile women under in-vitro fertilization
treatments (CN-00730574; CN-00768745; CN-00700432), opioid drug addicts
on medications (CN-00728884), cancer survivors under biomedical
treatments for neck pain (CN-00761076), people on medications for
chronic musculoskeletal pains (CN-00720285; CN-00457236), and people on
medications for irritable bowel syndrome (CN-00698848). Acupuncture also
produced analgesic or anesthetic benefits to pediatric surgery
(CN-00734541), cardiac surgeries (CN-00720700), oncological surgeries
(CN-00579120; CN-00664750), and dental surgeries (CN-00330168).
Herbal
medicine produced additive synergy among people with rheumatoid
arthritis on a conventional medication (CN-00729697), surgical patients
under a variety of post-operative cares for surgery-induced intestinal
bowel syndrome, inflammation, liver dysfunction, and pains (CN-00668598;
CN-00686725; CN-00410068; CN-00556925; CN-00347524; CN-00434525;
CN-00609214; CN-00512697; CN-00373691; CN-00793124; CN-00790633;
CN-00793458), and cancer patients under radiation therapy (CN-00132749;
CN-00347726; CN-00330625).
Second, biomedicine–CAM
synergy was revealed in an interactive and corrective way, as well. In
this case, CAM was used to relieve the adverse side effects of
biomedical treatments and help patients to continue biomedical treatment
until they got desirable treatment outcomes from biomedicine.
For
example, acupuncture helped HIV patients to continue HAART (Highly
Active Anti-Retroviral Therapy) by alleviating gastrointestinal syndrome
in HIV patients on HAART, such as diarrhea, nausea, and vomiting
(CN-00558827; PMID 21705396). It also reduced vasomotor symptoms, such
as hot flashes and night sweats, developing from anti-estrogen hormone
therapy on breast cancer patients and, thus, helped the patients to
continue biomedical cancer treatments (CN-00700744; CN-00733070). At the
same time, acupuncture produced fewer adverse effects than venlafaxine
(a conventional antidepressant for cancer patients on anti-estrogen
treatment) and more positive outcomes, such as energy and sex drive
(CN-00733070). In addition, acupuncture was found effective for managing
a common side effect (joint pains) of the AI hormone therapy for early
breast cancer patients who often discontinued the hormone therapy due to
the side effect (CN-00649930; CN-00729624). Acupuncture also slowed the
decrease in the ability of bone marrow to produce blood cells, a side
effect of chemotherapy for gynecologic cancers (CN-00722277).
In herbal medicine, the kampo remedies maoto and shosaikoto
were found effective in reducing discomfort, general malaise, and
arthralgia induced by the established interferon treatment for patients
with chronic hepatitis C, while not reducing the interferon’s antiviral
effects and sometimes improving its effects (CN-00794206; CN-00793700;
CN-00472711). Another group of herbal remedies helped cancer patients to
continue biomedical treatments, by relieving the side effects of cancer
treatments, such as neurotoxicity, diarrhea, and insomnia (CN-00728144;
CN-00437238; CN-00779065). Examples in other contexts were juzentaihoto for addressing anemia in patients on hemodialysis (CN-00667345), rikkunshi-to
for adverse gastrointestinal symptoms among people on anti-depressant
fluvoxamine (CN-00795653), and maca root for anti-depressant
SSRI-induced sexual dysfunction (CN-00665598).
Adverse treatment outcomes of CAM
Among
the CENTRAL trials, I found no reports of adverse treatment outcomes
from acupuncture in Japan or the U.S., whereas there were several trials
of herbal medicine in the U.S. where unforeseen difficulties developed.
Reported events were diarrhea caused by a Japanese kampo formula keishibukuryogan
used for menopausal symptoms (CN-00810843), high blood pressure among
users of athletic performance-enhancing dietary supplements
(CN-00647862), increased blood pressure and heart rates among people who
took bitter orange for controlling obesity (CN-00553213), and the
damaging effects on male reproductive cells from St. John’s wort,
ginkgo, and echinacea in high concentrations (PMID 10065791).
In
the MEDLINE reports as well, herbal medicine was found to produce
adverse outcomes more often than acupuncture. Adverse treatment outcomes
were mentioned in 23% of the 3,485 herbal medicine reports vs. 5% of
the 716 acupuncture reports (p-value < 0.001). In the U.S., this
contrast between herbal medicine and acupuncture was greater (25% vs.
4%; p-value < 0.001), whereas the contrast was significantly weaker
in Japan (16% vs. 10%; p-value = 0.078). Put in a cross-national
perspective, herbal medicine produced more adverse outcomes in the U.S.
than in Japan (25% vs. 17%; p-value < 0.001); acupuncture produced
adverse outcomes less often in the U.S. than in Japan (4% vs. 10%;
p-value = 0.010).
Content analysis revealed some of the
specific occasions that contributed to producing these adverse events.
Out of the 12 Japanese reports of adverse effects from acupuncture, a
majority reported minor injuries, such as localized argyria and minor
hemorrhages, caused by acupuncture needles left in the body (PMID
1464937; PMID 11444889; PMID 12459543; PMID 20934166). In most cases,
tiny acupuncture needles were intentionally and permanently embedded in
patient bodies for therapeutic purposes according to Japanese
acupuncture theory. On the other hand, major injuries were often caused
by accidentally broken needles during laypeople’s self-treatments.
Another
common category of the adverse effects was virus infection through
improperly sterilized acupuncture needles, such as hepatitis C virus
infections (PMID 9816817; PMID 8194707; PMID 7689501; PMID 1908912) and
other infections (PMID 1488961). Unlike the reports of minor injuries,
these infection reports originated in earlier years. According to more
recent reports, the association between acupuncture and infection was
found to be weak in hepatitis C virus (PMID 7681088; PMID 8329759; PMID
9033214; PMID 9094854; PMID 10756668) and HIV (PMID 8329759; PMID
9094854).
Reports of needle-induced
infections existed in the U.S. as well, such as the contraction of
hepatitis C (PMID 22239506; PMID 16379222; PMID 10235216) and hepatitis B
(PMID 3341362; PMID 3944549; PMID 3417241). Some other U.S. reports
were about subarachnoid hemorrhages and spinal injuries in a Latino
immigrant who visited an unproven thoracic acupuncturist in California
(PMID 1464937), forgotten needles and minor hemorrhages from
poorly-trained practitioners (PMID 11829162; PMID 11874310), minor skin
problems from moxibustion (PMID 3965232), contact dermatitis from
needles, and unspecific general worries about acupuncture (PMID 1137233;
PMID 4406704; PMID 4408150; PMID 4607022; PMID 4590887). Across these
reports, the lack of practitioner skills or institutional regulations on
practitioner education was found to be a cause of the adverse events.
Negative biomedicine–CAM interactions
Out
of the 3,485 MEDLINE reports on herbal medicine, only a small fraction
(39 reports; 1.1%) reported negative interactions with biomedical drugs.
While reports of negative interactions were rare in general, I found a
significant cross-national difference in the proportion of these reports
among all the reports on herbal medicine (0.1% in Japan vs. 1.6% in the
U.S.; p-value < 0.001). Thirty eight out of the total 39 reports of
negative interactions were from the U.S., except for one Japanese report
about a 48 year old woman who developed extensive red round rashes over
her legs hours after she took kakkoto for general fatigue. This woman was already taking several medications for atypical psychosis when she took kakkoto. These drugs in combination with the herbal medicine kakkoto reportedly developed the adverse interactions (PMID 14674921).
A
majority of U.S. reports (24 out of 38) were about popular herbal
supplements, such as garlic, ginkgo, echinacea, ginseng, St John’s wort,
and kava, and their potential interactions with drugs among the general
population as well as among patients with cancers, cardiovascular
conditions, or endocrine disorders. These reports stressed mostly that
adverse interactions could be prevented by doctors and nurses who elicit
the history of patients’ herbal medicine use (PMID 10737289; PMID
19390395) and prescribe herbal supplements appropriately based on this
history (PMID 15581442). The following is an exemplar quote about how
drug–herb interactions could complicate biomedical treatments.
“CAM and antiretroviral therapies [for HIV patients] can produce side effects, such as weight loss. Additional drug interactions with nutritional supplements can increase health complications. … Providers may attribute these adverse effects to the antiretroviral drug, prompting them to incorrectly switch [antiretroviral] medications. This can be expensive and may lead to increased antiretroviral resistance. These and similar situations can be avoided by creating and maintaining an open dialogue about CAM use”. (PMID 19181175)
Among
the CENTRAL trials, there was no report of acupuncture producing
adverse treatment interactions with biomedicine. On the other hand,
among trials of herbal medicine, I found three types of adverse
treatment interactions between herbal medicine and biomedicine. First,
herbal medicine interfered with biomedical treatments as follows: St.
John’s wort’s interference with contraceptives (CN-00528293),
oncological drugs (CN-00491970), and intestinal P-glycoprotein
(CN-00470658); American ginseng’s interference with Warfarin’s
anti-coagulant mechanism in postoperative care (CN-00467683). Second,
herbal medicine inadvertently concentrated the effects of biomedical
drugs. For example, ephedrine’s co-utilization with the caffeine in
herbal supplements (e.g. green tea) for obesity inadvertently produced
abnormal cardiovascular, metabolic, and hormonal responses
(CN-00470658). Third, it caused a delay in seeking relevant medical
treatments, such as the delay of professional biomedical treatments for
asthma during patients’ self-care with herbal supplements (PMID
9438488). Children were significantly less likely to receive
vaccinations when they were seeing a naturopathic physician (PMID
19760163). There were negative associations between CAM use and
Chlamydia screening and between naturopathy and mammography among women
(PMID 19630554).
There were several specific treatment
contexts in which drug–herb interactions occurred most often. First,
drug–herb interactions occurred in “cross-cultural” or “multi-cultural”
settings in the U.S. Border cities between the U.S. and Mexico (e.g. El
Paso, Texas) were examined in a number of studies as a difficult social
context where the risk of drug–herb interactions was higher than that of
the general U.S. population (PMID 16396061; PMID 19552494; PMID
18928136). Studies pointed to two contributing factors: 1) higher
utilization rates of herbal medicine among residents in border cities
and 2) herbal medicine users’ cross-border healthcare utilization that
made it difficult for healthcare providers on both sides to trace and
coordinate patients’ plural medical behavior.
Another
group of reports revealed that adverse drug–herb interactions were more
probable among U.S. immigrant minorities, such as Mexican-Americans
(PMID 17405676) and Slavic-Americans (PMID 17900071). In addition, a
survey of six university-affiliated outpatient clinics in California
(PMID 17405676) reported that 85 adverse drug–herb interactions were
found in 49 patients (40% of herbal medicine users); 12 potential
adverse drug–herb interactions were found in 8 patients (7% of the
users); among these 12 cases, 8 cases were hypoglycemia among diabetics
who took prickly pear cactus along with biomedical drugs. These 8 cases
were all from first-generation Mexican-Americans who also tended to use
herbal medicine more often than others.
In
addition, several categories of users were identified as most likely to
experience adverse treatment interactions. Many cancer patients were
using herbal medicine concurrently with anti-cancer treatments. However,
a significant number of these users did not consult their doctors (PMID
15856334; PMID 14991387). The same situation existed among elderly
people who were highly subject to “polypharmacy” (i.e. multiple drugs)
and “polyherbacy” (i.e. multiple herbal remedies) for high comorbidity
(PMID 17785609; PMID 15018694; PMID 15037491). Another category was
illicit stimulant users among whom certain herbal remedies (e.g.
yohimbe), that have high potentials to interact adversely with
biomedical drugs for treating the stimulant users, were wrongfully
promoted as sexual enhancers (PMID 18570167).
Discussion
Japan
has integrated acupuncture and herbal medicine more systemically and
formally into the national medical system than the U.S. In addition,
herbal medicine has been more closely integrated with biomedicine than
acupuncture in Japan. In the U.S., to the contrary, acupuncture has been
incorporated in the system whereas herbal medicine has not. Although
institutionalized more discursively than systemically, American
acupuncture has been given a similar status in the American medical
system as Japanese acupuncture has in the Japanese system. American
acupuncture even seems to be positioned better. Whereas Japanese
acupuncture has been detached from herbal medicine and the whole system
of Japanese traditional medicine, American acupuncture has not been
explicitly detached from the whole Oriental medical system. Put in an
order, Japanese herbal medicine has been integrated into the national
medical system the most and American herbal medicine the least; American
acupuncture and Japanese acupuncture have fallen in the middle.
The
treatment outcomes of acupuncture and herbal medicine in Japan and the
U.S. correspond with these differences in institutionalization. First,
acupuncture and herbal medicine that were carefully coordinated with
other treatment options in CENTRAL clinical trials produced better
outcomes, such as more occasions of desirable outcomes and
biomedicine–CAM synergies with no reports of adverse treatment effects,
compared to MEDLINE reports that included uncontrolled and uncoordinated
real-world treatment cases. Second, among CENTRAL trials and among
MEDLINE reports, treatment outcomes were the most favorable for Japanese
herbal medicine and the least favorable for American herbal medicine.
The outcomes of American acupuncture and Japanese acupuncture fell in
the middle. Thus, in Japan, herbal medicine was found to be more
effective than acupuncture; in the U.S., acupuncture was found more
effective than herbal medicine.
This correspondence
between the institutionalization of acupuncture and herbal medicine on
one hand and the CAM treatment outcomes on the other provides empirical
evidence to the notion that the co-utilization of CAM along with
biomedicine involves difficulties for users and practitioners due to
theoretical and political tensions between the two [16,32,72].
In addition, my paper further enriches this notion by adding that these
difficulties can be relieved and result in various treatment outcomes
of CAM, depending on the extent to which CAM interventions are
coordinated with biomedicine. Moreover, through content analysis, my
paper provides an in-depth understanding of social contexts in which the
co-utilization of CAM and biomedicine produces negative biomedicine–CAM
interactions and adverse CAM treatment outcomes. These contexts existed
at several levels, such as regulatory policies, practitioner expertise,
user–provider communication, and users’ cross-cultural health behavior.
At the same time, various types of synergic benefits were evident when
CAM and biomedicine were coordinated in institutional settings.
This
paper also supports with ample evidence the ethnographic insight that
institutional settings affect how unconventional CAM interventions are
perceived and practiced [29].
It further advances this insight by additionally finding that it is not
only the perception and expectation of medical practices but also their
concrete treatment outcomes that are affected by institutional
settings. It is possible that effective medical interventions are more
likely to be institutionalized, which is another empirical question that
has yet to be answered. Meanwhile, based on empirical episodes in
medical reports, my current evidence demonstrates that interventions of a
similar nature lead to varying outcomes in different institutional
settings. When the nature (e.g. CAM) is doubted by dominant theories
(e.g. biomedicine) and politics in the medical field, the sociological
perspective that I practiced in this paper seems to be the one that the
sociology of the effects of medicine and science needs to carry forward.
The literature already evidences that unorthodox and alternative
entities are being incorporated into medicine and science in various
manners [73]. It would be even more fruitful to investigate what effects these different manners of incorporation produce.
In
the sociology of the effects of medicine, broader social contexts of
medical practices have often been held accountable for the varying
treatment outcomes of biomedical interventions. This wisdom, however,
has not been seriously applied when considering the varying outcomes of
popular CAM, such as acupuncture and herbal medicine. The varying
outcomes of CAM have instead been dominantly ascribed to their arguably
inferior and incomplete nature as medical technologies. This asymmetry
is uneasy. When an intervention in biomedicine does not deliver its
expected outcomes, studies have implied that the relationship between
medicine and social contexts should be addressed. In CAM, on the other
hand, the dominant view is that medicine by itself has to be
reengineered, corrected, and improved technologically. Without
addressing this asymmetry, the sociology of medicine runs the risk of
becoming one of the “engines” [74] of “biomedicalization” [75],
by inadvertently stressing social contextual re-organization tuned only
to biomedicine and, simultaneously, the biomedical transformation of
CAM. This paper provides a counter-perspective. It is social contexts as
well as medicine by itself that generate varying treatment outcomes in
CAM. This paper suggests that social contexts also need to be tuned to
CAM in order to produce better treatment outcomes.
Methodologically,
this paper’s content analysis can be labeled as a sociological
meta-analysis, which is in distinction to meta-analysis in the medical
science community. Medical meta-analysis aims to produce a model of the
universally consistent effects of medicine by bracketing the contextual
differences out of consideration. My sociological meta-analysis, to the
very contrary, purports to generate a model of the differential effects
of medicine by shedding light on the very contextual differences. There
is still room for improvement on this front. My current meta-analysis is
largely a bivariate analysis of the relationship between treatment
outcomes and social contexts (i.e. the U.S. versus Japan) both
quantitatively and qualitatively. It needs to be expanded into a
multi-variate analysis that can verify the robustness of the findings
even in the presence of other covariates. On the qualitative front, the
characteristics of social contexts can be specified further.
Conclusion
Acupuncture
and herbal medicine, which have tensions with the mainstream
biomedicine, are institutionalized differently in Japan and the U.S.
Depending on the extent to which these CAM interventions are coordinated
with biomedicine in the national medical system, they produce different
treatment outcomes. When coordinated with biomedicine, acupuncture and
herbal medicine produce more beneficial treatment outcomes.
Appendix
One
can get the MEDLINE papers that I used for content analysis, by copying
the following search queries into the search box of PubMed (i.e. the
user interface for the MEDLINE database). There could be minor
discrepancies between the materials in this paper (retrieved on May 9,
2012) and the materials that one gets currently from the interface.
These discrepancies are all additional materials that are deposited to
MEDLINE since I accessed it.
A. the subset of CAM: cam[sb]
B.
acupuncture reports from Japan: japan[MeSH Terms] AND (acupuncture[MeSH
Terms] OR acup* OR acupoint[MeSH Terms] OR ear acupuncture[MeSH Terms]
OR auricular acupuncture[MeSH Terms] OR analgesia, acupuncture[MeSH
Terms] OR anesthesia, acupuncture[MeSH Terms])
C.
acupuncture reports from the U.S.: united states[MeSH Terms] AND
(acupuncture[MeSH Terms] OR acup* OR acupoint[MeSH Terms] OR ear
acupuncture[MeSH Terms] OR auricular acupuncture[MeSH Terms] OR
analgesia, acupuncture[MeSH Terms] OR anesthesia, acupuncture[MeSH
Terms])
D. herbal medicine reports from Japan:
japan[MeSH Terms] AND (“*herb*” OR “plant extract*” OR “kampo” OR
“kanpo” OR herbal medicine[MeSH Terms] OR herbal preparation[MeSH Terms]
OR herb therapy[MeSH Terms] OR herbal therapy[MeSH Terms] OR herb,
medicinal[MeSH Terms] OR drug herb interaction[MeSH Terms] OR herb drug
interaction[MeSH Terms] OR medicinal plant[MeSH Terms] OR medicinal
herb[MeSH Terms] OR phytotherapy[MeSH Terms])
E.
herbal medicine reports from the U.S.: united states[MeSH Terms] AND
(“*herb*” OR “plant extract*” OR “kampo” OR “kanpo” OR herbal
medicine[MeSH Terms] OR herbal preparation[MeSH Terms] OR herb
therapy[MeSH Terms] OR herbal therapy[MeSH Terms] OR herb,
medicinal[MeSH Terms] OR drug herb interaction[MeSH Terms] OR herb drug
interaction[MeSH Terms] OR medicinal plant[MeSH Terms] OR medicinal
herb[MeSH Terms] OR phytotherapy[MeSH Terms])
Footnotes
Competing interests
The author declares that no competing interests exist.
Authors’ contributions
JM
Shim as the sole author carried out all the steps in this study, such
as theoretical conception, data analyses, and manuscript writing.
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