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The Acupuncture Treatment for Postmenopausal Hot Flushes (Acuflash) Study: Traditional Chinese Medicine Diagnoses and Acupuncture Points Used, and Their Relation to the Treatment Response

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the multicentre, pragmatic, randomised controlled Acuflash study evaluated the effect of traditional Chinese medicine (TCM) acupuncture on postmenopausal vasomotor symptoms and health-related quality of life. It concluded that use of acupuncture in addition to self-care can contribute to a clinically relevant reduction of hot flushes and increased health-related quality of life. This article reports on the TCM syndrome diagnoses and acupuncture points used and their relation to the treatment response, and on treatment reactions and adverse events. the acupuncture group (n = 134) received 10 acupuncture treatment sessions and advice on self-care; the control group (n = 133) received advice on self-care only. The study acupuncturists met the current membership criteria of the Norwegian Acupuncture Society, and had at least 3 years' experience of practising TCM acupuncture. They were free to diagnose and select acupuncture points for each participant, after initial discussion. fifty per cent of the participants in the acupuncture group were diagnosed with Kidney Yin Xu as their primary TCM syndrome diagnosis. No statistically significant differences were demonstrated between the syndrome groups regarding the distribution of responders and non-responders, nor regarding the change in health-related quality of life scores. A core of common acupuncture points (SP6, HT6, KI7, KI6, CV4, LU7, LI4, and LR3) were used in all the syndromes, and in addition multiple idiosyncratic points. Core point selection and frequency of use did not differ between responders and non-responders. No serious adverse events were reported. factors other than the TCM syndrome diagnoses and the point selection may be of importance regarding the outcome of the treatment.
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The acupuncture treatment for postmenopausal hot
flushes (Acuflash) study: traditional Chinese
medicine diagnoses and acupuncture points used,
and their relation to the treatment response
Einar Kristian Borud,
1
Terje Alræk,
1
Adrian White,
3
Sameline Grimsgaard
1,2
1
The National Research Center
in Alternative and
Complementary Medicine,
University of Tromsø,
N-9037 Tromsø, Norway;
2
Clinical Research Center,
University Hospital of North
Norway, N-9038 Tromsø,
Norway;
3
Department of
General Practice and Primary
Care, Peninsula Medical School,
Universities of Exeter and
Plymouth, UK
Correspondence to:
Einar Kristian Borud, The
National Research Center in
Complementary and Alternative
Medicine, University of Tromsø,
N-9037 Tromsø, Norway;
einar.borud@uit.no
ABSTRACT
Introduction: The multicentre, pragmatic, randomised
controlled Acuflash study evaluated the effect of
traditional Chinese medicine (TCM) acupuncture on
postmenopausal vasomotor symptoms and health-related
quality of life. It concluded that use of acupuncture in
addition to self-care can contribute to a clinically relevant
reduction of hot flushes and increased health-related
quality of life. This article reports on the TCM syndrome
diagnoses and acupuncture points used and their relation
to the treatment response, and on treatment reactions
and adverse events.
Methods: The acupuncture group (n = 134) received 10
acupuncture treatment sessions and advice on self-care;
the control group (n = 133) received advice on self-care
only. The study acupuncturists met the current member-
ship criteria of the Norwegian Acupuncture Society, and
had at least 3 years’ experience of practising TCM
acupuncture. They were free to diagnose and select
acupuncture points for each participant, after initial
discussion.
Results: Fifty per cent of the participants in the
acupuncture group were diagnosed with Kidney Yin Xu as
their primary TCM syndrome diagnosis. No statistically
significant differences were demonstrated between the
syndrome groups regarding the distribution of responders
and non-responders, nor regarding the change in health-
related quality of life scores. A core of common
acupuncture points (SP6, HT6, KI7, KI6, CV4, LU7, LI4,
and LR3) were used in all the syndromes, and in addition
multiple idiosyncratic points. Core point selection and
frequency of use did not differ between responders and
non-responders. No serious adverse events were
reported.
Conclusion: Factors other than the TCM syndrome
diagnoses and the point selection may be of importance
regarding the outcome of the treatment.
Acupuncture is one of the most frequently used
complementary therapies in Norway. In two
recent surveys, 28% reported lifetime use, and
10.8% reported use within the previous year.
12
In
the 2002 National Health Interview Survey in the
USA, 4.1% reported lifetime use and 1.1% reported
use of acupuncture within the preceding year.
3
The
theoretical framework, understanding and practice
of acupuncture vary considerably. Traditional
Chinese medicine (TCM) acupuncture is based on
the traditional Chinese medical theories,
4
whereas
‘‘Western medical’’ acupuncture draws on the
principles of established medical physiology.
5
Although TCM is one of the oldest healing systems
in the world, it is a fully institutionalised part of
Chinese healthcare, accounting for 10–20% of
healthcare in China in 2006.
6
Acupuncture is
considered safe in the hands of competent practi-
tioners.
78
A National Institutes of Health Consensus
Development Panel on Acupuncture has recom-
mended that future research should place an
emphasis on ‘‘studies that examine acupuncture
as used in clinical practice and that respect the
theoretical basis for acupuncture therapy’’.
9
Acupuncture researchers have suggested the use
of a pragmatic trial design to answer practical
questions.
10
In the Acuflash study we aimed to
estimate the effectiveness of ‘‘real life’’ acupunc-
ture treatment on postmenopausal hot flush
frequency and intensity and health-related quality
of life as measured by the Women’s Health
Questionnaire (WHQ).
11
Hot flush frequency
decreased by 5.8/24 h in the acupuncture group
(n = 134) and 3.7/24 h in the control group
(n = 133), a difference of 2.1 (p,0.001). Hot flush
intensity decreased by 3.2 units (1–10 visual
analogue scale) in the acupuncture group and 1.8
units in the control group, a difference of 1.4
(p,0.001). The acupuncture group experienced
statistically and clinically significant improvements
in the vasomotor (p,0.001), sleep (p = 0.002) and
somatic symptoms (p = 0.011) dimensions of the
WHQ, compared with the control group.
12
Previous research has suggested that, among
patients with recurrent cystitis, those with TCM
diagnosis of Kidney fare better than patients with
other diagnoses.
13
The objective of this paper is to
report on the TCM syndrome diagnoses and the
acupuncture points used in the Acuflash study. We
report on secondary research questions: do TCM
diagnoses predict the overall treatment response,
and are patients with different diagnoses likely to
experience a differential response in their symp-
toms?We also report on the relation between the
acupuncture points used and the treatment
response, on other treatment interventions used
by the acupuncturists, and on treatment reactions
and adverse events.
METHODS
The study was a multicentre (Tromsø, Bergen and
Oslo), pragmatic, randomised controlled trial
(RCT) with two parallel arms, conducted in
2006/2007. It was approved by the Norwegian
Original paper
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Data Inspectorate, the Norwegian Biobank Registry and the
Regional Committee for Medical Research Ethics.
11
Altogether 267 women were included in the study. Mean
(SD) age at inclusion was 53.8 (4.4) years, and mean (SD) age at
menopause was 48.9 (3.7) years. For further sample character-
istics, see table 1. The participants were stratified by centre and
thereafter block randomised (random block size of four, six or
eight) to receive additional acupuncture or not receive addi-
tional acupuncture. Block randomisation (organising study
participants into blocks and randomising within each block)
was used to ensure close balance of the numbers in each group
at any time during the trial.
Practitioners of TCM acupuncture
The 10 study acupuncturists were trained in TCM acupuncture;
nine were graduates from the ‘‘Akupunkturhøyskolen’’, a school
located in Oslo, offering a Bachelors degree in TCM acupunc-
ture. Hence, the TCM acupuncture approach tested was TCM
acupuncture as taught in Norway. They met the current
membership criteria of the Norwegian Acupuncture Society
(NAFO) (2500 h of training), and had at least 3 years’
experience of practising TCM acupuncture. They were sug-
gested as study acupuncturists by NAFO. Two acupuncturists
were teachers at the ‘‘Akupunkturhøyskolen’’. There were four
acupuncturists in Oslo, three in Bergen and three in Tromsø, all
practising in private clinics. Before the start of the study, all the
acupuncturists participated in a group meeting with the
researchers to discuss the expected TCM diagnoses and the
relevant acupuncture points.
Intervention
Both groups received a one-page leaflet with information about
self-care strategies to relieve menopausal symptoms. This
information included advice about sufficient sleep and rest,
reduction of physical and psychological stress, regular exercise,
healthy food and limited tobacco smoking and alcohol intake.
The participants in the acupuncture group had to receive 10
acupuncture sessions over 12 weeks. The minimum number of
Table 1 Baseline characteristics of the study participants in the Acuflash study
Characteristics Acupuncture group (n= 134) Self-care group (n= 133)
Mean (SD) age at randomisation, years 53.5 (4.4) 54.1 (3.7)
Mean (SD) age at menopause, years 49.3 (4.0) 48.6 (4.9)
Mean (SD) baseline hot flush frequency/24 h 12.0 (4.3) 13.1 (4.9)
Mean (SD) baseline hot flush intensity (0–10) 6.7 (2.0) 7.1 (1.7)
Mean (SD) self-reported weight, kg 71 (12) 70 (12)
Mean (SD) self-reported height, cm 167 (6) 168 (6)
Years of education, n (%)
(10 60 (44.8) 64 (48.1)
11–13 12 (9.0) 13 (9.8)
14–17 31 (23.1) 18 (13.5)
.17 31 (23.1) 36 (27.1)
Missing 0 2 (1.5)
Previous use of HRT, n (%) 71 (53.0) 61 (45.9)
Previous use of acupuncture, n (%) 86 (64.2) 85 (63.9)
Expect acupuncture relieves hot flushes, n (%)
Yes 80 (59.8) 68 (51.1)
No 0 (0) 0 (0)
Uncertain 53 (39.5) 61 (45.9)
Missing 1 (0.7) 4 (3.0)
Self-reported health, n (%)
Very bad 2 (1.5) 3 (2.3)
Bad 31 (23.1) 37 (27.8)
Good 78 (58.2) 74 (55.6)
Excellent 22 (16.4) 16 (12.3)
Missing 1 (0.7) 3 (2.3)
Sleep problems, n (%)
Never 32 (23.9) 33 (24.9)
1–3 nights per month 22 (16.4) 19 (14.3)
Once a week 14 (10.4) 12 (9.0)
.Once a week 66 (49.3) 66 (49.6)
Missing 0 3 (2.3)
Tobacco smoking, n (%)
Present 34 (25.4) 39 (29.3)
Past 67 (50) 53 (39.8)
Never 33 (24.6) 39 (29.3)
Missing 0 2 (1.5)
Teetotaller, n (%) 6 (4.5) 6 (4.5)
Mean (SD) baseline WHQ score
Vasomotor symptoms domain 0.98 (0.09) 0.98 (0.10)
Sleep problems domain 0.57 (0.33) 0.61 (0.32)
Somatic symptoms domain 0.48 (0.26) 0.55 (0.24)
HRT, hormone replacement therapy; WHQ, Women’s Health Questionnaire.
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sessions accepted as ‘‘per protocol’’ was six. The acupuncturists
were asked to use diagnostic methods according to the
principles of TCM, and diagnose TCM syndromes associated
with the menopausal symptoms. Only the participants in the
acupuncture group were diagnosed. After the initial diagnosis,
each participant had to be treated with points selected
according to the syndrome diagnosis. The acupuncturists were
free to add individualised points to treat other symptoms
related to the menopause (ie, those included on the WHQ such
as depression, anxiety, insomnia), but not unrelated symptoms.
Point location was not standardised, but left to the acupunc-
turists to decide. They could use moxibustion (warmed needles)
if indicated. Herbal treatment was not allowed during the
study. De qi (a characteristic dull and numb sensation) had to be
obtained, and needle manipulation with even, reducing or re-
enforcing methods could be used.
Outcomes
The primary endpoint was change in mean hot flush frequency
and intensity per 24 h. Participants were defined as responders
if they gained a 50% or greater reduction in hot flush frequency.
Secondary endpoint was health-related quality of life, measured
by the WHQ.
14
The questionnaire consisted of 36 items covering
the following nine domains: depressed mood, somatic symp-
toms, anxiety/fears, vasomotor symptoms, sleep problems,
sexual behaviour, menstrual symptoms, memory/concentra-
tion, and attractiveness. Within each domain, an average score
between 0 and 1 was calculated, where 0 is an indicator of
‘‘good health status’’ and 1 is an indicator of ‘‘poor health
status’’.
15 16
We selected the vasomotor symptoms, sleep
problems and somatic symptoms domains for the present
analysis because the participants in the acupuncture group
reported significant improvements in these domains compared
with the control group.
Statistical analysis
SPSS version 15.0 (SPSS Inc., Chicago, Illinois, USA) was used
for all statistical analyses. The subgroup analysis was per
protocol. Differences in change between groups were evaluated
with two-sample t tests and analysis of variance, and x
2
tests
were used for categorical variables. Two-sided p,0.05 was
considered statistically significant.
Data collection form
The data collection form prompted for each of nine specific
TCM syndrome diagnoses, as listed in table 3. The consensus of
the group meeting between acupuncturists and researchers
before the start of the study was to list the syndrome patterns
described by Maciocia as the main causes of menopausal
problems,
17
with the addition of Liver Qi Stagnation and
Stomach Heat. In addition, practitioners were free to diagnose
any other syndrome pattern, without any restrictions. They
were asked to record primary and secondary diagnoses at each
session. Characteristic symptoms and signs in the most
frequently used syndrome diagnoses are listed in table 2.
At each session, practitioners were asked to record acupunc-
ture points used, and indicate laterality of needling, needle
technique, whether de qi was obtained, and reasons for eventual
change of acupuncture points from the previous treatment
session. They were asked to record the use of moxa and use of
other interventions (massage, cupping, electro-acupuncture,
herbs or other). Finally, they had to record the prescription of
home-based self-treatment such as specific physical exercises, tai
chi, yoga, self-massage, relaxation exercises or other.
If the acupuncturist gave advice on facilitating and support-
ing lifestyle changes such as dietary advice (low dairy, avoid
wine and spirits, low wheat, stop/reduce coffee, ensure food is
warm and cooked) or non-dietary advice (more exercise, stop/
reduce smoking, more rest, protection from cold and damp,
general support and empowerment or other), this had to be
recorded.
The acupuncturists were asked to record treatment reactions
and adverse events. Treatment reactions were reactions which
could be positive indicators of treatment effect, but could be
experienced as adverse by acupuncture-naı¨ve participants.
Treatment reactions were communicated spontaneously by
the patient during or after treatment, or at the next visit
(recorded under the headings light-headedness, energised, tired,
relaxed, hungry, drowsy, other). Adverse events such as faint-
ing, forgotten needle, fit (convulsions), broken needle, skin
reactions, moxa burn, unacceptable bruising, pneumothorax,
unacceptable bleeding, infection, unacceptable pain at a point
from needling, unacceptable worsening of symptoms or other,
had to be recorded. These events were listed, and the
acupuncturists could tick the appropriate box.
In addition to the reporting carried out by the acupuncturist,
the women in the acupuncture group were asked in the
questionnaires they filled in at weeks 8 and 12 if they had
experienced any of the following treatment reactions during the
study: temporary worsening of hot flushes, dizziness, tiredness,
increased energy, more relaxed, hungrier.
RESULTS
Between February 2006 and March 2007, 535 women contacted
the study coordinators, and 267 met the inclusion criteria.
12
They were randomised to self-care plus acupuncture (n = 134)
or self-care only (n = 133). Altogether 19 women (7%) dropped
out: 16 in the control group and three in the acupuncture group.
A total of 131 participants in the acupuncture group were
included in the final analyses. The study groups were well
balanced with respect to background characteristics at baseline
(table 1).
At the first acupuncture treatment session, 127 participants
received an initial primary syndrome diagnosis and 106
participants received an initial secondary syndrome diagnosis
(table 3). During the treatment sessions, the primary syndrome
was revised once in 11 participants, and twice in one
participant. The secondary syndrome was revised once in 14
participants, twice in three, three times in three, and four times
in one participant. Fifty per cent of the participants were
diagnosed with Kidney Yin Xu as their primary syndrome
(table 3).
Among the secondary syndromes, Liver Qi stagnation was the
most prevalent diagnosis, with 19 per cent of the participants.
The distribution of responders/non-responders and change in
WHQ scores among primary syndromes are shown in tables 4
and 5. The distribution of responders and non-responders and
change in WHQ scores did not differ statistically between the
primary syndrome groups.
Altogether 131 participants received a total of 1285 treatment
sessions. Of these participants, 123 received 10 treatment
sessions, two received nine sessions, three received eight
sessions, one received seven sessions and two received three
sessions. The mean number of treatments per participant was
9.8, and the median number of points stimulated per treatment
session was 6.0 (SD 2.8, range 9). A total of 8599 acupuncture
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point stimulations were performed during the study, and a total
of 104 different acupuncture points were used once or more.
The most commonly used acupuncture points are presented in
fig 1 and table 6.
In the acupuncture group, 67 participants were responders,
and 64 participants were non-responders. A total of 4217 point
stimulations were performed among responders, and 4382
among non-responders. The 10 most frequently used points
were identical among responders and non-responders (table 6),
and these 10 points constituted two-thirds of the total number
of point stimulations throughout the study. The distribution of
points used according to syndrome diagnosis is shown in table 7.
The eight most frequently used acupuncture points in total
were among the 13 most frequently used points in every
syndrome group.
Moxa was used in one treatment session during the study.
Cupping, electro-acupuncture and Chinese herbs were not used
at all. One of the 10 acupuncturists used massage in addition to
needling in altogether 191 treatment sessions. Due to a
significant number of missing values, we do not report on
acupuncture point laterality, needling technique, reasons for
eventual change of acupuncture points or if de qi was obtained.
The acupuncturists advised 13 participants to use massage as
a home-based self-treatment, six participants to use relaxation
techniques, and one was advised to use tai chi. They advised five
participants to use a low dairy diet, two to use a low wheat diet,
nine to ensure the food was warm and cooked, five to quit
tobacco smoking, 11 to take more exercise, nine to take more
rest, seven to avoid alcohol, and 15 to reduce coffee drinking.
One participant was advised protection from cold and damp.
Eighty-four participants were not given any of these recom-
mendations.
Treatment reactions as reported by the acupuncturists and
self-reported by the participants are shown in table 8. The
acupuncturists reported one or more treatment reactions for 76
participants, and 120 participants self-reported one or more
treatment reactions.
The distribution of responders and non-responders and
change in health-related quality of life did not differ between
the groups that were reported to experience these treatment
reactions by the acupuncturists, and those that were not.
Regarding the self-reported treatment reactions, it was an equal
number of responders and non-responders within the groups
experiencing these symptoms. However, the mean reduction in
the WHQ vasomotor symptoms domain score from baseline to
week 12 was significantly larger in the groups that had felt more
relaxed and experienced increased energy, and the mean
reduction in the WHQ sleep domain score was significantly
larger in the group that had felt more relaxed (table 9). Change
in health-related quality of life did not differ between those
experiencing and not experiencing the other treatment reac-
tions.
No fainting, convulsions or bleeding were reported during the
treatment sessions. One skin reaction and one unacceptable
bruising were reported, as were five episodes of unacceptable
needling pain. Two episodes with a forgotten needle were
reported, but no broken needle, moxa burn, pneumothorax or
infections were reported.
DISCUSSION
In this study of acupuncture for menopausal hot flushes, seven
different primary TCM syndromes were diagnosed (table 3),
and 50 per cent of the participants in the study were diagnosed
with Kidney Yin Xu. Distribution of responders and non-
responders and change in health-related quality of life did not
differ between the TCM syndromes. The most frequently used
acupuncture points were identical among responders and non-
responders, and the eight most frequently used acupuncture
Table 2 Characteristic symptoms and signs in the most frequently used syndrome diagnoses in the Acuflash
study
Syndromes Symptoms and signs
KI Yin Xu empty heat Night sweating; hot flushes; restless; anxious; dry hair, skin, mouth; deep
weak pulse; tongue red without coating
KI Yang Xu empty cold Hot flushes but cold hands and feet; night sweating (early morning); tiredness;
low energy; depressed; deep pulse; tongue pale
KI Yin and KI Yang Xu Hot flushes but cold hands and feet; night sweating; frequent pale urination;
flushed around neck when talking; tongue pale or red
KI and LR Yin Xu with LR yang rising Hot flushes; irritability; dizziness; blurred vision; tongue red without coating
KI and HT not harmonised Hot flushes; palpitations; insomnia; mental restlessness; poor memory;
tongue red without coating, redder tip
Table 3 Primary and secondary traditional Chinese medicine
syndromes on initial diagnoses in the Acuflash study
Syndromes
n as primary
(%)
n as secondary
(%)
KI Yin Xu empty heat 67 (50) 17 (13)
KI Yang Xu empty cold 22 (16) 10 (7)
KI Yin and KI Yang Xu 11 (8) 8 (6)
KI and LR Yin Xu with LR yang rising 10 (8) 12 (9)
KI and HT not harmonised 14 (10) 18 (13)
Accumulation of phlegm and stagnation of Qi 1 (1) 12 (9)
LR Qi stagnation 0 (0) 25 (19)
Stomach heat 2 (2) 3 (2)
Stasis of blood 0 (0) 1 (1)
Missing 3 (2) 3 (2)
No syndrome 4 (3) 25 (19)
Total 134 (100) 134 (100)
Table 4 Distribution of responders and non-responders among primary
syndromes in the Acuflash study
Primary syndromes n Responder
Non-
responder
KI Yin Xu empty heat 67 33 34
KI Yang Xu empty cold 22 14 8
KI Yin and KI Yang Xu 11 5 6
KI and LR Yin Xu with LR yang rising 10 5 5
KI and HT not harmonised 14 6 8
Other syndromes 3 1 2
No primary syndrome 4 3 1
Total 131 67 64
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points in total were among the 13 most frequently used points
among all TCM syndromes. No serious adverse events were
reported.
The primary goal for the TCM diagnostic process is to obtain
a TCM syndrome diagnosis. This is a procedural process that
may open up for constructive dialogue between the acupunc-
turist and the patient. It can introduce the patients for ways to
reflect and understand their own disease/imbalance.
The diagnostic syndromes in TCM are clusters of different
symptoms and signs. Symptom clusters were used to diagnose
most diseases in Western medicine before the twentieth
century, and Western medicine still uses symptom diagnoses
when the biological mechanisms are not well understood.
18
The
concept of symptom clusters has gained new interest in
Western medicine, and a symptom cluster has been defined as
a ‘‘stable group of two or more concurrent symptoms that are
related to each other and independent of other symptoms or
symptoms clusters’’.
19
The TCM diagnostic process divides
individuals diagnosed with one biomedical diagnosis into several
subgroups, each with a characteristic symptom cluster or
syndrome. This process may contribute to new insight, for
instance by identifying subgroups of individuals responding
particularly well to an intervention or treatment.
The TCM syndrome diagnosis, defined by symptoms and
signs, is guiding the treatment.
6
Fifty per cent of the
participants in the study were diagnosed with Kidney Yin Xu.
According to a widely used TCM textbook by Maciocia, a
Kidney deficiency is always at the root of menopausal
problems.
17
Zell et al found that ‘‘practitioners of TCM who
diagnose postmenopausal women with vasomotor symptoms
are likely to make a diagnosis that includes Kidney Yin
deficiency’’.
20
However, Scheid defines TCM as ‘‘that inter-
pretation of Chinese medical practice that is presented to us in
contemporary Chinese medical textbooks, emerging in the late
1950s’’.
21
Menopausal problems, as such, have not been
described in ancient Chinese medical texts, but a TCM
approach towards menopausal symptoms was ‘‘constructed’’
by textbook authors in the 1960s for use in textbooks suitable
for a Western audience.
21 22
According to Scheid, the TCM
understanding of menopausal symptoms, like TCM itself, is a
direct consequence of Chinese medical modernisation.
Practitioners in contemporary China have, in addition to the
above-mentioned modern textbooks, other sources of informa-
tion to draw on, such as direct access to the classical medical
texts and personal transmission of knowledge from teachers.
21
These sources are not readily available in the West, and may
suggest different syndrome patterns and point selection for the
treatment of menopausal symptoms.
21
Thus, the current
interpretation of menopausal symptoms as mainly a result of
Kidney deficiency is only one of several possible understandings,
and the correct TCM diagnoses for menopausal vasomotor
symptoms remain unclear. The TCM acupuncture practised in
our study was mostly based on theories and principles from the
above-mentioned textbooks from the 1960s and a more recent
interpretation by Maciocia.
17
The validity and reliability of the TCM diagnostic process has
been questioned, as has the inter-rater reliability.
23
A study
showed that TCM diagnosis and treatment recommendations
for specific patients with chronic low back pain vary widely
across practitioners,
24
as did a study assessing the variability in
the TCM diagnoses among patients with rheumatoid arthritis.
25
Therefore, the validity and reliability of the diagnostic process
in the present study may be low, resulting in ‘‘wrong’’ diagnoses
in some or many cases. In addition, as discussed earlier, the
correct TCM syndrome patterns for menopausal vasomotor
symptoms remain unclear. These facts may obviously affect the
study results, which must be interpreted with this in mind.
When stratifying the results on syndromes, we found the
highest proportion of responders among the participants
diagnosed with Kidney Yang Xu empty cold; 14 participants
were responders and eight non-responders. This is comparable
to what was found in a study of acupuncture for recurrent
cystitis by Alraek and Baerheim.
13
However, our study was not
powered to identify differences between the syndrome groups.
The differences regarding the ratio of responders to non-
responders or change in WHQ scores between the syndrome
groups were not statistically significant. Hence, being diagnosed
with a certain syndrome was of no prognostic value for patients
treated with acupuncture for menopausal complaints in this
study. The acupuncture points used in this syndrome group did
not differ from those used in the other syndrome groups, nor
did the points differ between responders and non-responders.
Table 5 Change in Women’s Health Questionnaire (WHQ) scores in the vasomotor symptoms, sleep
problems and somatic symptoms domains stratified on primary syndromes in the Acuflash study
Primary syndromes
Change in WHQ
vasomotor domain
Change in WHQ sleep
domain
Change in WHQ somatic
domain
KI Yin Xu empty heat (n= 67) 20.32 20.17 20.10
KI Yang Xu empty cold (n= 22) 20.15 20.20 20.14
KI Yin and KI Yang Xu (n = 11) 20.23 20.03 20.10
KI and LR Yin Xu with LR yang rising (n = 10) 20.20 20.23 20.31
KI and HT not harmonised (n = 14) 20.29 20.17 20.08
Figure 1 Most commonly used acupuncture points in the Acuflash
study*. *Usage as percentage of total number of treatments (n =1285).
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The participants in the control group were not diagnosed
according to TCM; hence we were not able to assess whether
certain TCM syndrome patterns were generally more responsive
regardless of whether acupuncture was provided.
The distribution of points used according to syndrome
diagnosis is shown in table 7. Although the acupuncturists
have applied different TCM diagnostic syndromes, eight ‘‘core’’
acupuncture points were used in all syndromes, with some
differences regarding frequency of use. A possible reason for the
application of eight ‘‘core’’ points in all syndromes may be that
the points were used for ‘‘symptomatic’’ treatment of hot
flushes, rather than addressing the TCM syndromes. However,
the acupuncturists were asked to select acupuncture points and
treat according to the syndrome diagnoses, and the majority of
‘‘core’’ points are described in a TCM textbook
17
as indicated for
KI Xu (Kidney deficiency) syndromes (SP6, KI3 – nourish the
Kidneys, KI7 – tonifies Kidney Yang, LU7 and KI6 – tonifies the
Kidneys, CV4 – tonifies Kidney Yang). Thus, a TCM syndrome
differentiation may not result in major differences regarding the
selection of acupuncture points when treating women with
postmenopausal vasomotor symptoms.
There was no difference between responders and non-
responders regarding the acupuncture points used or their
frequency of use. The point combination KI7–HT6 was
frequently used throughout the study, regardless of the
syndrome diagnosis. This point combination is described in
the literature as indicated for the treatment of menopausal
complaints, or more specifically to stop night sweating,
17
and
Table 6 Acupuncture points used in the Acuflash study
Responders* (n = 67) Non-responders* (n = 64)
Acupuncture
points
Number of
stimulations
Per cent of
total
Cumulative
per cent
Acupuncture
points
Number of
stimulations
Per cent of
total
Cumulative
per cent
SP6 424 10.1 10.1 SP6 390 8.9 8.9
HT6 419 9.9 20.0 KI6 368 8.4 17.3
KI7 416 9.9 29.9 KI7 359 8.2 25.5
KI6 291 6.9 36.8 HT6 336 7.7 33.2
CV4 262 6.2 43.0 CV4 313 7.1 40.3
LU7 260 6.2 49.1 LU7 293 6.7 47.0
LI4 199 4.7 53.9 LI4 227 5.2 52.2
LR3 196 4.6 58.5 LR3 219 5.0 57.2
ST36 177 4.2 62.7 KI3 193 4.4 61.6
KI3 173 4.1 66.8 ST36 171 3.9 65.5
GV20 115 2.7 69.5 GB34 119 2.7 68.2
LI11 109 2.6 72.1 PC6 96 2.2 70.4
PC6 106 2.5 74.6 GV20 95 2.2 72.5
CV12 94 2.2 76.9 CV12 85 1.9 74.5
SP4 91 2.2 79.0 LI11 79 1.8 76.3
LR8 78 1.8 80.9 LR8 64 1.5 77.7
GB34 73 1.7 82.6 SP4 62 1.4 79.2
68 other points{734 17.4 100.0 65 other points{913 20.8 100.0
Total 4217 4382
The eight most frequently stimulated acupuncture points in total are shown in bold.
*Responder: >50% reduction in hot flush frequency, non-responder: ,50% reduction of hot flush frequency.
{32 points were stimulated 59–10 times, 36 points were stimulated ,10 times.
{26 points were stimulated 59–10 times, 39 points were stimulated ,10 times.
Table 7 Acupuncture points used according to syndrome diagnosis in the Acuflash study*
KI Yin Xu empty heat (n = 69)
KI Yang Xu empty cold
(n = 22)
KI Yin and KI Yang Xu
(n = 11)
KI and LR Yin Xu with LR yang
rising (n = 10)
KI and HT not harmonised
(n = 14)
Acupuncture
points*
No of
stimulations{
Acupuncture
points
No of
stimulations
Acupuncture
points
No of
stimulations
Acupuncture
points
No of
stimulations
Acupuncture
points
No of
stimulations
SP6 6.3 SP6 7.1 KI7 6.5 CV4 6.0 CV4 7.8
KI7 5.7 KI7 6.5 HT6 5.4 LR8 5.0 KI6 7.6
HT6 5.5 HT6 6.4 SP6 5.2 HT6 4.7 KI7 7.1
KI6 5.1 KI6 5.0 LR3 3.5 KI7 4.0 SP6 7.1
CV4 4.3 LU7 4.6 CV4 3.4 LR3 3.9 LU7 6.9
LU7 4.1 LI4 2.6 KI3 3.3 KI6 3.8 HT6 6.6
KI3 3.7 CV4 2.4 LU7 3.3 LI11 3.8 CV15 4.1
LI4 3.6 ST36 2.3 KI6 3.0 SP4 3.8 LR3 3.8
ST36 3.3 PC6 2.1 CV12 1.8 LI4 3.5 LI4 3.7
LR3 3.3 LR3 2.0 GV20 1.7 GV20 3.4 GV20 2.3
GB34 1.9 SP4 1.8 LI4 1.6 PC6 3.1 KI3 1.9
LI11 1.5 KI3 1.7 ST36 1.6 LU7 3.0 SP4 1.9
CV12 1.3 CV12 1.5 KI10 1.5 SP6 2.9 HT7 1.9
66 other points 15.1 34 other points 13.3 32 other points 15.8 28 other points 24.5 32 other points 18.4
*The eight most frequently stimulated acupuncture points in total are shown in bold.
{Mean number of stimulations per participant.
Original paper
106 Acupunct Med 2009;27:101–108. doi:10.1136/aim.2009.000612
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may have been used as ‘‘symptomatic’’ treatment in this study.
The points selected and their frequency of use were almost
similar among responders and non-responders. Hence, when
treated with almost identical points, 50% of the participants in
this study were responders, and 50% were non-responders. A
more flexible approach, resulting in the selection of other
acupuncture points for the treatment of women in the non-
responder group, might have produced other results. Another
possible interpretation of these results may be that factors other
than the acupuncture point selection are of importance for the
outcome of the treatment.
The 10 most frequently used acupuncture points constituted
two-thirds of all point stimulations, and a total of 104 different
acupuncture points were used once or more. Hence, the
acupuncturists used a ‘‘core’’ of common acupuncture points
in all syndromes and in addition to these a wide selection of
idiosyncratic points. These findings correspond with the
findings by Napadow et al, studying the points used in two
acupuncture clinics in China.
26
When comparing the point
selection in this study with the points used in other studies
evaluating acupuncture for menopausal symptoms,
27–32
the only
point in common between all the studies was SP6. The
agreement between the eight most frequently stimulated points
in this study and the basic acupuncture points used in the
studies cited was moderate, and varied between two of nine
points,
28 31
and two of three
30
and four of six.
27
A TCM diagnostic syndrome differentiation, leading to an
appropriate selection of traditional acupuncture points, is
considered mandatory in the practice of TCM.
6
However, these
postulates have not been confirmed in clinical studies.
6
Cochrane reviews show that acupuncture is an effective
treatment for preventing headaches, but for migraine, studies
show similar results in groups receiving ‘‘true’’ acupuncture and
groups receiving ‘‘sham’’ acupuncture (‘‘interventions mimick-
ing ‘true’ acupuncture/‘true’ treatment, but deviating in at least
one aspect considered important by acupuncture theory, such as
skin penetration or correct point location’’).
33 34
Superficial
needling in non-acupuncture points (‘‘minimal acupuncture’’),
often used as a placebo control in RCTs of acupuncture, most
likely has physiological and clinical effects.
35
In the Acuflash
study, a ‘‘core’’ group of acupuncture points was used for all the
TCM diagnostic syndromes, rendering a clinically and statisti-
cally significant effect.
12
However, we do not know whether
these acupuncture points were superior to treat menopausal
symptoms, nor if the acupuncture ‘‘dose’’ was optimal. The
contribution of all the idiosyncratic acupuncture points used a
few times during the study remains unknown. Needle location
may not be as relevant as generally thought.
There is no agreement on what is adequate acupuncture point
stimulation or ‘‘dose’’.
36
In a systematic review of acupuncture
for knee pain, adequate acupuncture was defined as ‘‘consisting
of at least six treatments, at least one per week, with at least
four points needled for each painful knee for at least
20 minutes, and either needle sensation (de qi) achieved in
manual acupuncture, or electrical stimulation of sufficient
intensity to produce more than minimal sensation’’.
37
The
acupuncture treatment in the present study satisfied these
requirements.
The participants who felt more relaxed after treatment
experienced a larger decrease in the WHQ vasomotor symptoms
and sleep problems domains, and the participants feeling more
energised experienced a larger decrease in the WHQ vasomotor
symptoms domain. Consequently, both feeling relaxed and
energised after acupuncture treatment is associated with a
positive response on acupuncture therapy for menopausal
symptoms. However, there were equal numbers of responders
and non-responders within the groups experiencing these
treatment reactions.
Acupuncture is described as a safe procedure, with few
adverse events occurring among trained practitioners.
73839
In
this study, five episodes with unacceptable pain during needle
insertion, one episode with unacceptable bruising, two episodes
with a forgotten needle and one skin reaction were reported.
Altogether nine events classified as side effects were reported,
and a total of 1285 treatments were performed during the
study. Hence, the frequency of adverse events per treatment
was less than one per cent, confirming that TCM acupuncture
is a safe procedure. No serious adverse events were reported.
Table 8 Number of participants in the acupuncture group (n = 134) experiencing treatment reactions as
reported by acupuncturists and self-reported by participants
Treatment
reactions
More
relaxed
More
energy
More
tired
More
hungry
Light-
headed{Drowsy{
Temporary
worsening of
hot flushes* Dizziness*
Reported by
acupuncturists
44 39 30 7 11 7
Self-reported 86 76 53 24 26 13
*The acupuncturists were not asked to report these treatment reactions.
{The participants were not asked to report these treatment reactions.
Table 9 Change in Women’s Health Questionnaire (WHQ) scores in groups reporting treatment reactions at
12 weeks
More relaxed* (n = 86) Increased energy* (n = 76)
WHQ
dimensions Yes No
Mean
difference p Value Yes No
Mean
difference p Value
Vasomotor
symptoms
20.36 (0.40) 20.13 (0.31) 20.23 0.004 20.35 (0.39) 20.20 (0.39) 20.15 0.045
Sleep
problems
20.21 (0.35) 20.05 (0.39) 20.16 0.033 20.18 (0.38) 20.15 (0.34) 20.03 0.64
*Values are mean change in WHQ score from baseline to 12 weeks (SD).
Original paper
Acupunct Med 2009;27:101–108. doi:10.1136/aim.2009.000612 107
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CONCLUSION
The Acuflash study showed that TCM acupuncture as practised
in Norway in addition to self-care can contribute to a clinically
relevant reduction of hot flushes. The results did not differ
between the TCM syndrome groups, and there were no major
differences in point selection and frequency of use between
responders and non-responders. Factors other than the TCM
syndrome diagnoses and the point selection may be of
importance regarding the outcome of the treatment.
Funding: This work was supported by The Research Council of Norway. The principal
investigator was funded by the University Hospital of North Norway.
Competing interests: Adrian White is employed by the British Medical Acupuncture
Society as journal editor. Other authors declare no competing interests.
Ethics approval: Approved by the Norwegian Data Inspectorate, the Norwegian
Biobank Registry and the Regional Committee for Medical Research Ethics.
Editorial handling: In view of the third author’s conflict of interest as editor of this
journal, all editorial handling and decisions about acceptance of this article were
carried out by Simon Hayhoe on behalf of the editorial board.
Provenance and peer review: Not commissioned; externally peer reviewed.
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Original paper
108 Acupunct Med 2009;27:101–108. doi:10.1136/aim.2009.000612
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doi: 10.1136/aim.2009.000612
2009 27: 101-108Acupunct Med
Einar Kristian Borud, Terje Alræk, Adrian White, et al.
and their relation to the treatment response
diagnoses and acupuncture points used,
study: traditional Chinese medicine
postmenopausal hot flushes (Acuflash)
The acupuncture treatment for
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... 5 Although there is no exact correspondence between the symptoms of the climacteric syndrome and TCM syndromes, the main syndromes that occur during this stage are Kidney yin deficiency (50%), Kidney yang deficiency (16%), Kidney yin and yang deficiency (8%), Kidney yin and Liver yin deficiency (8%), Kidney and Heart not harmonized (10%). 6 Calcitonin gene-related peptide (CGRP) is a potent vasodilator that plays an important role in maintaining vascular homeostasis. 7 CGRP was discovered when the alternative processing (tissue-specific splicing) of the mRNA for calcitonin in the thyroid of the aging rat leads to CGRP production, and CGRP was found to be widely expressed in neuronal tissue, 8 endothelial cells, adipocytes, keratinocytes, and immune cells. ...
... Point selection was made according to Deadman's acupuncture text 17 and some other points used in other previous studies. 4,6 After asepsis and antisepsis the needles were inserted until acupuncture sensation (Deqi) was obtained, then the electrodes were placed, which were placed and oriented: 1. Fuliu (KID-7) was connected to the negative pole and Taixi (KID-3) to the positive pole, 2. Pishu (BL-20) to the positive pole and Shenshu (BL-23) to the negative pole, 3. in Guanyuan (REN-4), Neiguan (P-6), and Sanyinjiao (SP-6), a needle separated 3 mm from each point was placed with a positive and a negative electrode on each needle. Silverstar needles (0.30 mm x 40 mm) were used. ...
... In previous studies in the Australian population, Kidney yin deficiency (50%) is reported as the main syndrome, however, the diagnosis of spleen Qi deficiency is unusual. 6 This difference can be explained by different dietary and life habits in both populations. ...
Article
Objective The purpose of the current study was to evaluate the modulation of Calcitonin gene-related peptide (CGRP) associated to the efficacy of Electroacupuncture (EA) in the reduction of climacteric symptoms. Methods Nine women between 51 and 59 years old with climacteric syndrome in menopause or perimenopause were included. Patients with hormone replacement therapy, psychiatric treatment with antidepressants, or acupuncture treatment in the last 3 months were excluded. A 4 Hz EA treatment was performed at acupoints Shenshu (BL-23), Pishu (BL-20), Guanyuan (REN-4), Taixi (KID-3), Fuliu (KID-7), Sanyinjiao (SP-6) and Neiguan (P-6) points. Women were treated two times a week for five consecutive weeks for a total treatment of 10 sessions. The menopause rating scale (MRS) was used to evaluate symptoms reduction and CGRP gene expression was measured before and after 10 EA session. Results The results shown that climacteric symptoms diminish significantly after EA therapy. CGRP gene expression was down-regulated, evidencing a decrease of 5-fold after EA therapy respect to the initial condition. Conclusion EA treatment was associated with improvement in patients with climacteric syndrome and may be related to modulation of CGRP levels.
... De plus, la prise en charge en Occident se réalise généralement tardivement dans l'histoire de la maladie du patient. Par ailleurs, l'acupuncture en Occident est souvent perçue comme une relaxation pour personnes stressées, comparable à un placébo optimisé, probablement du fait des résurgences des études cliniques négatives ne montrant pas de modification d'efficacité quels que soient les points choisis [6,7]. A contrario, l'essence de l'application traditionnelle de l'acupuncture correspond au traitement de la douleur, dont l'efficacité nécessite d'être la plus rapide et durable possible [4] : c'est donc dans l'optique de traiter des douleurs effectives d'origine non-psychogènes que l'acupuncture balancée trouve toute sa place [5]. ...
... L'acupuncture balancée permet aussi de traiter les pathologies internes [8], bien qu'il n'y ait aucune preuve à ce jour de sa supériorité par rapport à une approche plus classique basée sur le concept des zang fu [9,10]. De plus, la validité de l'approche diagnostique en médecine traditionnelle chinoise a été remise en question de par sa faible reproductibilité inter-individuelle [11,12], tant dans le diagnostic que le choix des points [6]. Cette approche basée sur les zang fu, bien qu'essentielle à la compréhension de la médecine chinoise, dérive grandement de la forte influence occidentale des livres de Macciocia [13], qui n'est pourtant qu'un des multiples outils de l'acupuncture [2,5,6,14,15]. ...
... De plus, la validité de l'approche diagnostique en médecine traditionnelle chinoise a été remise en question de par sa faible reproductibilité inter-individuelle [11,12], tant dans le diagnostic que le choix des points [6]. Cette approche basée sur les zang fu, bien qu'essentielle à la compréhension de la médecine chinoise, dérive grandement de la forte influence occidentale des livres de Macciocia [13], qui n'est pourtant qu'un des multiples outils de l'acupuncture [2,5,6,14,15]. ...
Article
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L'association des points d'acupuncture nécessite la réalisation de combinaisons synergiques afin d'être le plus efficace possible tout en évitant d'éventuelles aggravations. A cette fin, l'acupuncture balancée basée sur les 6 systèmes de Richard Tan issus des connaissances traditionnelles (1 er grand méridien, 2 e couche, 3 e intérieur-extérieur, 4 e midi-minuit, 5 e cycle nycthéméral, 6 e méridien lésé) ou l'horloge chinoise (Sven Schroeder) représente un outil mnémotechnique utile en pratique clinique. Intégrée à l'outil des zang fu et aux points détente musculaire, elle permet une approche complète de la pathologie. Un cas clinique utilisant l'acupuncture balancée en analgésie thoracique est aussi présenté. Mots clefs: Acupuncture balancée-méridiens-jingluo-analgésie thoracique. Sumary: The combination of acupuncture points requires the realization of synergistic combinations in order to be as effective as possible while avoiding possible aggravations. To this end, balanced acupuncture based on the 6 systems of Richard Tan derived from traditional knowledge (1 rst chinese meridian name, 2 nd branching meridians, 3 rd interior-exterior pairs, 4 th opposite clock, 5 th neighbouring channels, 6 th affected meridian) or the Chinese clock (Sven Schroeder) represents an useful mnemonic tool in clinical practice. Integrated into the zang fu tool and trigger points, it allows a complete approach in pathology. A clinical case using balanced acupuncture in thoracic analgesia is also presented.
... Postmenopausal women (amenorrhea for 12 months or more) 32,33 who suffered from hot flashes included if they aged 45-60, experienced at least 20 hot flashes episodes per week, had Yin and Yang deficiency syndrome according to Chinese Medicine, and signed the informed consent for participating in the study. 33,34 There are 5 patterns for menopausal symptoms in Chinese Medicine. The most common one is Yin and Yang deficiency syndrome according to ACUFLASH study. ...
... The most common one is Yin and Yang deficiency syndrome according to ACUFLASH study. 34 Participants with Yin and Yang deficiency syndrome experience hot flashes but cold hands and feet, night-sweating, frequent pale urination, flashes around the neck when talking, slightly agitated, chilliness, dry throat, dizziness, tinnitus, and backache symptoms. 34 ...
... 34 Participants with Yin and Yang deficiency syndrome experience hot flashes but cold hands and feet, night-sweating, frequent pale urination, flashes around the neck when talking, slightly agitated, chilliness, dry throat, dizziness, tinnitus, and backache symptoms. 34 ...
Article
Objectives: The purpose of this research was to investigate the effect of Urtica dioica in comparison with placebo, acupuncture and combined therapy on hot flashes and quality of life in postmenopausal women. Methods: In a double-blinded randomized controlled trial, patients were treated for 7 weeks then followed up 4 weeks. Seventy-two postmenopausal women who reported at least 20 hot flashes attacks per week were randomly allocated into one of the 4 groups of Urtica dioica 450 mg/day and acupuncture 11 sessions (A), acupuncture and placebo (B), sham acupuncture and Urtica dioica (C), and sham acupuncture and placebo (D). The primary outcomes were the change in hot flashes score from baseline to the end of treatment and follow up; and the change in the quality of life (MENQOL) from baseline to the end of treatment. Secondary outcomes included changes in FSH, LH, and ESTRADIOL levels from baseline to the end of treatment. The trial was conducted from October 2017 to July 2018 in Acupuncture clinic of a teaching hospital in Iran. Results: A total of 72 women 45-60 years old were enrolled, and 68 were included in the analyses. The median (IQR) hot flashes score decreased in the A group by 20.2 (31.7) and 21.1 (25.1), B group by 19 (18) and 17.3 (27), C group by 14.6 (25.4) and 20.8 (13), and D group by 1.6 (11.6) and 1 (13.3) at the end of treatment and follow up (P < 0.0001, P < 0.0001); no significant difference between A, B and C groups. The mean (SD) of MENQOL score decreased in the A group by 42.6 (21.1), B group by 40.7 (29.8), C group by 37.8 (26.8) and D group by 9.8 (14.3) at the end of treatment (P = 0.001); no significant difference between A, B and C groups. Conclusions: Urtica dioica can decrease menopausal hot flashes and increase the quality of life of postmenopausal women better than placebo-sham control but same as acupuncture. The combination of Urtica dioica and acupuncture did not add to the effects of those therapies.
... As with other treatments, acupuncture point (AP) selections (also called AP prescriptions) differ according to the type of disease. Some AP selections are frequently used or recommended for certain diseases [8,9]. For example, SP6, HT6, KI7, KI6, CV4, LU7, LI4, and LR3 are commonly used for postmenopausal hot flushes [8]. ...
... Some AP selections are frequently used or recommended for certain diseases [8,9]. For example, SP6, HT6, KI7, KI6, CV4, LU7, LI4, and LR3 are commonly used for postmenopausal hot flushes [8]. BL24, BL25, BL31, BL33, BL31, and BL34 are frequently used for low back pain [10], among others. ...
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Acupuncture point (AP) selections can vary depending on clinicians’ acupuncture style, and therefore, acupuncture style is an important factor in determining the efficacy of acupuncture treatment. However, few studies have examined the differences in AP selections according to the acupuncture styles and theoretical backgrounds causing the differences. We compared the AP prescriptions used for 14 diseases in three classical medical textbooks, Dongeuibogam (DEBG), Saamdoinchimgooyogyeol (SADI), and Chimgoogyeongheombang (CGGHB), which represent unique acupuncture styles and have affected clinicians during this time. AP prescriptions showed more diversity between textbooks than between types of diseases. Among the three textbooks, AP prescriptions of SADI were most different compared to those of DEBG and CGGHB. Importantly, we found each style can be more clearly explained by AP attributes than by the APs per se. Specifically, SADI, DEBG, and CGGHB preferred five transport points located on the limbs, APs of the extra meridians, and source points, respectively. This suggests the possibility that the theoretical diversity of acupuncture styles results in the heterogeneity of AP selections.
... Existing trial comparing individualized CHM treatment based on patterndifferentiation, with standardized CHM treatment showed that the individualized approach is favoured for improving longer term outcome among patients with irritable bowel syndrome [11]. However, another trial on acupuncture for postmenopausal hot flushes did not observe clinical benefits of pattern-differentiation [12]. Also, slow progress in pattern differentiation research has eroded confidence in its application [13], and increasingly, CHM is prescribed solely based on conventional diagnosis. ...
Article
Objectives COVID-19 sparked a pandemic in December 2019 and is currently posing a huge impact globally. Chinese herbal medicine is incorporated into the Chinese national guideline for COVID-19 management, emphasising the individualisation of herbal treatment guided by pattern differentiation, which is an ICD-11-endorsed approach. However, this was not widely implemented with many provincial governments and hospitals developing their own guideline, suggesting the use of standardised herbal formulae and herbal active ingredients without pattern differentiation. Methods Through the case study of COVID-19 guideline implementation, we compared the three approaches of developing Chinese herbal medicine, namely pattern differentiation-guided prescription, standardised herbal formulae, and herbal active ingredients, in terms of their strengths, limitations, and determinants of adoption. Results Pattern differentiation-guided prescription is the practice style taught in the national syllabus among universities of Traditional Chinese Medicine in China, yet the lack of relevant diagnostic research reduces its reliability and hinders its implementation. Application of standardised herbal formulae is straightforward since the majority of clinical evidence on Chinese herbal medicine is generated using this approach. Nevertheless, it is downplayed by regulatory bodies in certain jurisdictions where the use of pattern differentiation is required in routine practice. Although herbal active ingredients may have clear in vitro therapeutic mechanisms, this may not be translated into real world clinical effectiveness. Conclusions Multiple COVID-19 clinical trials evaluating the effectiveness and safety of Chinese herbal medicine prescribed using one of the three approaches described above are progressing. These results will demonstrate the comparative effectiveness among these approaches. Forthcoming clinical evidence from these trials should inform the updating process of the national guideline, such that its recognition and compliance may be strengthened. For longer-term development Chinese herbal medicine, serious investment for establishing high-quality clinical research infrastructure is urgently needed.
... Since then, increasingly attention has been paid to the use of pattern differentiation in clinical trials [13][14] pointed out that the evaluation of TCM clinical trials have mainly been conducted according to the efficacy assessment of TCM pattern differentiation (e.g. patternrelated outcomes), although how to properly incorporate treatment based on pattern differentiation into a clinical trial remains complex [33]. ...
Article
Introduction Pattern differentiation is a critical component for traditional Chinese medicine (TCM) diagnosis and treatment. However, the issue of whether pattern differentiation is appropriately applied in TCM interventional trials, including Chinese herbal medicine (CHM) interventions and non-herbal TCM interventions, is unclear. The aim of this study was to i) systematically review the current status of pattern differentiation used in WHO-registered clinical trials for different types of TCM interventions; and ii) provide suggestions for improving the use of pattern differentiation in future clinical trial design. Methods The World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) database was searched for all TCM interventional trials registered up to 31 December 2017. In this systematic review trials with a TCM pattern differentiation in their design were included. Descriptive statistics were collated to demonstrate the characteristics of pattern differentiation applied for different TCM interventional trials. Results Among 2955 TCM interventional trials registered during 1999–2017, 376 (12.7%) trials included pattern differentiation. Of 376 trials, the use of pattern differentiation was identified in; –the title (30.6%), objective (50.5%), participants inclusion (100%), outcomes (43.6%) and study background (12.5%). Further, 85.4% reported the specific name of the TCM intervention, 10.6% provided the intervention’s targeted pattern, 83.8% reported the specific name of the TCM pattern, 7.2% presented diagnostic criteria for the pattern studied, and 19.1% adopted a pattern-related outcome as primary outcome for evaluation. Conclusion The reporting and application of pattern differentiation in TCM trials were inadequate and confusing, which was mainly due to lack of clarity regarding study design, objectives, diagnostic criteria and outcomes.
... 5 Likewise, while expert consensus in a recent trial examining the effectiveness of acupuncture for menopausal hot flushes mirrored Chinese medicine textbooks, the practitioners in the study, who were free to treat based on actually presenting symptoms, assessed patients as manifesting different clinical patterns. 17,18 We therefore argue that a crucial first step in seeking to evaluate the use of Chinese medicine in the treatment of menopausal symptoms is the design of potentially effective interventions for specific local populations. PRC medical textbooks and the "Criteria for diagnosis and therapeutic effect of diseases and syndromes in traditional Chinese medicine" published in 1994 as part of the official Standards for the Practice of Chinese Medicine of the People's Republic of China , 19 which are based on these textbooks, are not automatic or even best possible starting points for defining these interventions. ...
Article
The objective of the study described in this paper was to define Chinese medicine formula patterns for the treatment of menopausal women in London. These formula patterns are intended to inform the development of best practice guidelines for a future pragmatic randomised controlled trial, with the ultimate goal of evaluating the possibility of integrating Chinese medicine treatment strategies for menopausal symptoms into the UK National Health Service. Data from a clinical study that had demonstrated the effectiveness and safety of Chinese medicine in treating 117 perimenopausal women at the Westminster University Polyclinic in London were analysed for symptom occurrence and herb use. The frequency of occurrence of different presenting symptoms and the frequency of use of individual herbs is described, the patterns of combined herb use were analysed by means of factor analysis, and the correlations between these patterns and the presenting symptoms were analysed using the chi square test. Treating the emergent use patterns as Chinese herbal medicine formulas, five distinctive formula patterns emerged in the course of this study. While there is some overlap between these formulas and their associated symptom patterns and those described in Chinese medicine textbooks and guidelines, some formula patterns appear to be unique to London women. This indicates that best practice guidelines for the Chinese medicine treatment of menopausal symptoms, which have been shown to vary cross-culturally, need to be derived from local clinical practice.
Article
Introduction: Behavioral factors are the leading cause of ill-health worldwide. Diet, physical activity, smoking, and alcohol consumption are the focus of public health targets on promotion of healthy behavior. The science of behavior change is rapidly growing and has largely evolved within mainstream health care treatments. Traditional Chinese Medicine includes self-care practices that encourage healthy behavior alongside treatments such as acupuncture. Exploring behavior change within traditional acupuncture could potentially highlight new techniques and approaches, and contribute to developing models of behavior change. Aims: In this review, the authors aimed to critically appraise research exploring health behavior change within traditional acupuncture, to highlight gaps in the field, identify questions, and enable theory development. Design/Method: The authors were guided by a critical interpretive synthesis (CIS) method to explore a diverse mixture of research including qualitative and quantitative articles. Eight databases were searched up to October 2017 for articles published in English. Eleven thousand four hundred eighty-eight articles were identified (7,149 after deduplication). Titles and abstracts were screened by one reviewer (10% by a second reviewer). Eligible articles were selected using a Population, Intervention, Comparison, Outcome framework. CIS methods, including purposive sampling of eligible articles and a reflexive, dialectic process of critiquing evidence and theory, were used to synthesize the evidence. Results: Several articles examined the prevalence and patterns of behavior change and support for change, although methods varied and reliability of results was limited. There was more evidence concerning diet/exercise than alcohol/smoking. Aspects of acupuncturists' work identified as potential key elements for promoting behavior change included: individualized advice based on symptoms; holistic/biopsychosocial explanations; therapeutic relationship; simultaneous treatment of behavior-limiting symptoms; and patients' physical involvement with intervention. A logic model of the process of behavior change was developed, proposing that perceived support, mutual understanding, and active participation may facilitate change. Possible moderators included: single/multicomponent acupuncture; setting; patient/practitioner characteristics; treatment experience; timing; and treatment duration. Conclusion: These findings suggest behavior change work is a significant part of traditional acupuncture practice, although more reliable evidence is needed to understand the effectiveness, prevalence, and patterns of this work (in particular the patterns suggesting acupuncturists are more likely to work on changes to diet and physical activity than alcohol and smoking behaviors, and more likely to support changes in long-term compared with acute conditions). The proposed model of behavior change should be developed and tested with a view to refining the model and elaborating the suggested links with a wider theory of behavior and behavior change. This review was preregistered with PROSPERO as "Health behaviour change in traditional acupuncture treatment: a protocol for a critical interpretive synthesis": CRD42018099766.
Article
Objective: The aim of this study was to assess the correlation between the body constitution and menopausal symptoms in climacteric women. Methods: This cross-sectional study recruited 427 women aged 40-60 years from the hospital and nearby community. In addition to filling out a questionnaire on menopause rating scale - Traditional Chinese version, the participants completed the body constitution questionnaire. This classifies a person to 1 or more of 3 imbalanced constitutional types, which are yin-xu, yang-xu and stasis-stagnation. We constructed logistic regression models to estimate probabilities of the menopausal symptoms among climacteric women presenting with various menopausal status and differing body constitutions. Results: The frequency and scores of the yin-xu, yang-xu, and stasis-stagnation constitutions were significantly higher in perimenopausal and postmenopausal than premenopausal women. Compared to the non-constitution women, the odds ratio of having hot flushes, sleeping disorders, sexual problems, irritability, and anxiety were significantly higher with the yin-xu constitution. The women with a yang-xu constitution had significantly higher odds ratios for having bladder problems, muscle and joint problems, depressive mood, and heart discomfort. Symptoms of heart discomfort, physical and mental exhaustion, and sleeping disorders were correlated to the stasis-stagnation constitution. Conclusion: With the additional key symptoms related to the 3 constitutional types, physicians performing traditional Chinese medicine (TCM) are able to diagnose the menopausal syndrome more accurately. Integrating menopausal symptoms with TCM constitutional theory will contribute to a more rapid diagnosis and treatment of menopausal syndrome.
Article
Objetivo: Descrever as técnicas de acupuntura aplicadas para alívio de ondas de calor decorrentes do período do climatério. Método: Revisãosistemática na base de dados Medline, pelo método P.I.C.O, onde P=Postmenopausal, I=Acupuncture e O= Hot Flashes. Foram selecionadosartigos científicos controlados e randomizados sobre o tema em questão. Um total de 12 artigos preencheu os critérios de inclusão;mulheres saudáveis na fase pré e pós-menopausa e mulheres com risco para utilização de terapia hormonal, relatando ondas de calor, submetidas às técnicas de acupuntura sistêmica e eletroacupuntura. Resultados: Estudos analisados indicam alívio dos sintomas para ondas de calor nas variantes severidade (média 50%) e frequência (média 45%), porém a eletroacupuntura, quando observada em longo prazo, apresenta melhor resultado em relação à acupuntura sistêmica. Conclusões: Estudos sugerem que a prática da acupuntura é segura e eficaz para amenizar ondas de calor, tanto em mulheres saudáveis como em mulheres com contra indicação para a reposição hormonal.
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Placebo-control of acupuncture is used to evaluate and distinguish between the specific effects and the non-specific ones. During 'true' acupuncture treatment in general, the needles are inserted into acupoints and stimulated until deqi is evoked. In contrast, during placebo acupuncture, the needles are inserted into non-acupoints and/or superficially (so-called minimal acupuncture). A sham acupuncture needle with a blunt tip may be used in placebo acupuncture. Both minimal acupuncture and the placebo acupuncture with the sham acupuncture needle touching the skin would evoke activity in cutaneous afferent nerves. This afferent nerve activity has pronounced effects on the functional connectivity in the brain resulting in a 'limbic touch response'. Clinical studies showed that both acupuncture and minimal acupuncture procedures induced significant alleviation of migraine and that both procedures were equally effective. In other conditions such as low back pain and knee osteoarthritis, acupuncture was found to be more potent than minimal acupuncture and conventional non-acupuncture treatment. It is probable that the responses to 'true' acupuncture and minimal acupuncture are dependent on the aetiology of the pain. Furthermore, patients and healthy individuals may have different responses. In this paper, we argue that minimal acupuncture is not valid as an inert placebo-control despite its conceptual brilliance.
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The Women's Health Questionnaire (WHQ) was designed specifically to study possible changes that occur during menopause. The purpose of this study was to perform a psychometric evaluation of the Norwegian version of the WHQ by examining the factor structure and construct validity of the instrument. Data used for the evaluation were collected at baseline of the ACUFLASH study, a randomized, controlled clinical trial that evaluated the effect of acupuncture treatment on menopausal symptoms. Altogether, 267 women with a very high frequency of hot flushes were included in the study. Some deficiencies in the WHQ questionnaire were observed when applied to this sample, including an unclear factor structure, low alpha values for some dimensions, and a strong floor effect in the vasomotor symptoms dimension. The total scale score appears reliable, but care should be taken when interpreting some of the subscales.
Article
Objective.— To provide clinicians, patients, and the general public with a responsible assessment of the use and effectiveness of acupuncture to treat a variety of conditions.Participants.— A nonfederal, nonadvocate, 12-member panel representing the fields of acupuncture, pain, psychology, psychiatry, physical medicine and rehabilitation, drug abuse, family practice, internal medicine, health policy, epidemiology, statistics, physiology, biophysics, and the representatives of the public. In addition, 25 experts from these same fields presented data to the panel and a conference audience of 1200. Presentations and discussions were divided into 3 phases over 212 days: (1) presentations by investigators working in areas relevant to the consensus questions during a 2-day public session; (2) questions and statements from conference attendees during open discussion periods that were part of the public session; and (3) closed deliberations by the panel during the remainder of the second day and morning of the third. The conference was organized and supported by the Office of Alternative Medicine and the Office of Medical Applications of Research, National Institutes of Health, Bethesda, Md.Evidence.— The literature, produced from January 1970 to October 1997, was searched through MEDLINE, Allied and Alternative Medicine, EMBASE, and MANTIS, as well as through a hand search of 9 journals that were not indexed by the National Library of Medicine. An extensive bibliography of 2302 references was provided to the panel and the conference audience. Expert speakers prepared abstracts of their own conference presentations with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience.Consensus Process.— The panel, answering predefined questions, developed their conclusions based on the scientific evidence presented in the open forum and scientific literature. The panel composed a draft statement, which was read in its entirety and circulated to the experts and the audience for comment. Thereafter, the panel resolved conflicting recommendations and released a revised statement at the end of the conference. The panel finalized the revisions within a few weeks after the conference. The draft statement was made available on the World Wide Web immediately following its release at the conference and was updated with the panel's final revisions within a few weeks of the conference. The statement is available at http://consensus.nih.gov.Conclusions.— Acupuncture as a therapeutic intervention is widely practiced in the United States. Although there have been many studies of its potential usefulness, many of these studies provide equivocal results because of design, sample size, and other factors. The issue is further complicated by inherent difficulties in the use of appropriate controls, such as placebos and sham acupuncture groups. However, promising results have emerged, for example, showing efficacy of acupuncture in adult postoperative and chemotherapy nausea and vomiting and in postoperative dental pain. There are other situations, such as addiction, stroke rehabilitation, headache, menstrual cramps, tennis elbow, fibromyalgia, myofascial pain, osteoarthritis, low back pain, carpal tunnel syndrome, and asthma, in which acupuncture may be useful as an adjunct treatment or an acceptable alternative or be included in a comprehensive management program. Further research is likely to uncover additional areas where acupuncture interventions will be useful.
Article
This study compared the effectiveness of individualized acupuncture plus self-care versus self-care alone on hot flashes and health-related quality of life in postmenopausal women. This study involved a multicenter, pragmatic, randomized, controlled trial with two parallel arms. Participants were postmenopausal women experiencing, on average, seven or more hot flashes per 24 hours during seven consecutive days. The acupuncture group received 10 acupuncture treatment sessions and advice on self-care, and the control group received advice on self-care only. The frequency and severity (0-10 scale) of hot flashes were registered in a diary. Urine excretion of calcitonin gene-related peptide was assessed at baseline and after 12 weeks. The primary endpoint was change in mean hot flash frequency from baseline to 12 weeks. The secondary endpoint was change in health-related quality of life measured by the Women's Health Questionnaire. Hot flash frequency decreased by 5.8 per 24 hours in the acupuncture group (n = 134) and 3.7 per 24 hours in the control group (n = 133), a difference of 2.1 (P < 0.001). Hot flash intensity decreased by 3.2 units in the acupuncture group and 1.8 units in the control group, a difference of 1.4 (P < 0.001). The acupuncture group experienced statistically significant improvements in the vasomotor, sleep, and somatic symptoms dimensions of the Women's Health Questionnaire compared with the control group. Urine calcitonin gene-related peptide excretion remained unchanged from baseline to week 12. Acupuncture plus self-care can contribute to a clinically relevant reduction in hot flashes and increased health-related quality of life in postmenopausal women.
Article
Acupuncture is often used for tension-type headache prophylaxis but its effectiveness is still controversial. This review (along with a companion review on 'Acupuncture for migraine prophylaxis') represents an updated version of a Cochrane review originally published in Issue 1, 2001, of The Cochrane Library. To investigate whether acupuncture is a) more effective than no prophylactic treatment/routine care only; b) more effective than 'sham' (placebo) acupuncture; and c) as effective as other interventions in reducing headache frequency in patients with episodic or chronic tension-type headache. The Cochrane Pain, Palliative & Supportive Care Trials Register, CENTRAL, MEDLINE, EMBASE and the Cochrane Complementary Medicine Field Trials Register were searched to January 2008. We included randomized trials with a post-randomization observation period of at least 8 weeks that compared the clinical effects of an acupuncture intervention with a control (treatment of acute headaches only or routine care), a sham acupuncture intervention or another intervention in patients with episodic or chronic tension-type headache. Two reviewers checked eligibility; extracted information on patients, interventions, methods and results; and assessed risk of bias and quality of the acupuncture intervention. Outcomes extracted included response (at least 50% reduction of headache frequency; outcome of primary interest), headache days, pain intensity and analgesic use. Eleven trials with 2317 participants (median 62, range 10 to 1265) met the inclusion criteria. Two large trials compared acupuncture to treatment of acute headaches or routine care only. Both found statistically significant and clinically relevant short-term (up to 3 months) benefits of acupuncture over control for response, number of headache days and pain intensity. Long-term effects (beyond 3 months) were not investigated. Six trials compared acupuncture with a sham acupuncture intervention, and five of the six provided data for meta-analyses. Small but statistically significant benefits of acupuncture over sham were found for response as well as for several other outcomes. Three of the four trials comparing acupuncture with physiotherapy, massage or relaxation had important methodological or reporting shortcomings. Their findings are difficult to interpret, but collectively suggest slightly better results for some outcomes in the control groups. In the previous version of this review, evidence in support of acupuncture for tension-type headache was considered insufficient. Now, with six additional trials, the authors conclude that acupuncture could be a valuable non-pharmacological tool in patients with frequent episodic or chronic tension-type headaches.
Article
Background: Acupuncture is often used for migraine prophylaxis but its effectiveness is still controversial. This review (along with a companion review on 'Acupuncture for tension-type headache') represents an updated version of a Cochrane review originally published in Issue 1, 2001, of The Cochrane Library. Objectives: To investigate whether acupuncture is a) more effective than no prophylactic treatment/routine care only; b) more effective than 'sham' (placebo) acupuncture; and c) as effective as other interventions in reducing headache frequency in patients with migraine. Methods: Search methods: The Cochrane Pain, Palliative & Supportive Care Trials Register, CENTRAL, MEDLINE, EMBASE and the Cochrane Complementary Medicine Field Trials Register were searched to January 2008. Selection criteria: We included randomized trials with a post-randomization observation period of at least 8 weeks that compared the clinical effects of an acupuncture intervention with a control (no prophylactic treatment or routine care only), a sham acupuncture intervention or another intervention in patients with migraine. Data collection and analysis: Two reviewers checked eligibility; extracted information on patients, interventions, methods and results; and assessed risk of bias and quality of the acupuncture intervention. Outcomes extracted included response (outcome of primary interest), migraine attacks, migraine days, headache days and analgesic use. Pooled effect size estimates were calculated using a random-effects model. Main results: Twenty-two trials with 4419 participants (mean 201, median 42, range 27 to 1715) met the inclusion criteria. Six trials (including two large trials with 401 and 1715 patients) compared acupuncture to no prophylactic treatment or routine care only. After 3 to 4 months patients receiving acupuncture had higher response rates and fewer headaches. The only study with long-term follow up saw no evidence that effects dissipated up to 9 months after cessation of treatment. Fourteen trials compared a 'true' acupuncture intervention with a variety of sham interventions. Pooled analyses did not show a statistically significant superiority for true acupuncture for any outcome in any of the time windows, but the results of single trials varied considerably. Four trials compared acupuncture to proven prophylactic drug treatment. Overall in these trials acupuncture was associated with slightly better outcomes and fewer adverse effects than prophylactic drug treatment. Two small low-quality trials comparing acupuncture with relaxation (alone or in combination with massage) could not be interpreted reliably. Authors' conclusions: In the previous version of this review, evidence in support of acupuncture for migraine prophylaxis was considered promising but insufficient. Now, with 12 additional trials, there is consistent evidence that acupuncture provides additional benefit to treatment of acute migraine attacks only or to routine care. There is no evidence for an effect of 'true' acupuncture over sham interventions, though this is difficult to interpret, as exact point location could be of limited importance. Available studies suggest that acupuncture is at least as effective as, or possibly more effective than, prophylactic drug treatment, and has fewer adverse effects. Acupuncture should be considered a treatment option for patients willing to undergo this treatment.
Article
According to an article by Wald in the November 2000 issue of Strategic Healthcare Marketing, through physician education, integrated medicine shall continue to be adopted by conventional medical establishments in the United States. With many leading medical schools now adding courses on alternative medicine and hospital administrators recognizing this growing trend, responding to the patients' needs and demands remains paramount. According to a study of 3200 physicians conducted by Health Products Research, physicians expect to offer and embrace therapeutic alternatives outside of the traditional pharmaceutical realm. Greater than 50% will begin or increase using alternative medicine in the next 12 months. Physicians also believe that patient acceptance is greater for alternative therapies, resulting in therapeutic compliance. Most physicians continue to be skeptical about certain treatments, citing a lack of clinical information. With these factors understood, more clinical research to be completed in a teaching hospital environment becomes paramount.
Article
This study presents the adverse effects of acupuncture as recorded in the Medline database for the years 1981-1994. A total of 125 papers were localized by the keywords acupuncture adverse effects. Articles without case reports were excluded, and 78 reports forms the basis for the present paper. A total of 193 patients were reported with adverse effects of acupuncture in 14 years. Pneumothorax is the most common mechanical organ injury, while hepatitis dominates among infections. Acupuncture treatment is claimed to be responsible in the death of three patients. One patient died from bilateral pneumothorax, another got endocarditis, and died of complications. The third patient died of severe asthma while under acupuncture treatment. Most adverse effects of acupuncture seem to rely on insufficient basic medical knowledge, low hygienic standard, and inadequate acupuncture education. The study confirms the adverse effects of acupuncture under certain circumstances. Serious adverse effects, however, are few, and acupuncture can generally be considered as a safe treatment.
Article
Acupuncture is an ancient Chinese method to treat diseases and relieve pain. We have conducted a series of studies to examine the mechanisms of this ancient method for pain relief. This article reviews some of our major findings. Our studies showed that acupuncture produces analgesic effect and that electroacupuncture (EA) is more effective than manual acupuncture. Furthermore, electrical stimulation via skin patch electrodes is as effective as EA. The induction and recovering profiles of acupuncture analgesia suggest the involvement of humoral factors. This notion was supported by cross-perfusion experiments in which acupuncture-induced analgesic effect was transferred from the donor rabbit to the recipient rabbit when the cerebrospinal fluid (CSF) was transferred. The prevention of EA-induced analgesia by naloxone and by antiserum against endorphins suggests that endorphins are involved. More recent work demonstrated the release of endorphins into CSF following EA. In addition, low frequency (2 Hz) and high frequency (100 Hz) of EA selectively induces the release of enkephalins and dynorphins in both experimental animals and humans. Clinical studies suggesting its effectiveness for the treatment of various types of pain, depression, anxiety, spinally induced muscle spasm, stroke, gastrointestinal disorders, and drug addiction were also discussed.
Article
To learn more about the way that practitioners of traditional Chinese medicine (TCM) diagnose women who have menopausal symptoms. We assembled a cohort of 23 postmenopausal women who had hot flushes and were otherwise healthy. Each woman was examined independently by nine practitioners of TCM on the same day. Examination consisted of medical history and physical examination. Diagnoses were recorded and counted. The most frequent diagnosis made by the practitioners of TCM was kidney yin deficiency, which was the diagnosis made after 168 of 207 visits (81%); 23 women seen by nine TCM practitioners. Practitioners showed good agreement regarding presence of kidney yin deficiency: in 12 women (52%), this diagnosis was made by eight of nine practitioners; in 16 women (70%), seven of nine practitioners made this diagnosis; and in all 23 women (100%), at least five of nine practitioners made this diagnosis. Practitioners of TCM who diagnose postmenopausal women with vasomotor symptoms are likely to make a diagnosis that includes kidney yin deficiency.