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From the Department of Clinical Neuroscience, Section of Neurology
(G.G.-H., L.C., J.C., C.B., M.F.), Sahlgrenska University Hospital;
Göteborg College of Health Sciences, Department of Rehabilitation
(G.G.-H., L.C., U.K., J.C.); Department of Clinical Neuroscience, Section of
Psychiatry (B.O.), Mölndal/Sahlgrenska University Hospital; and
Department of Medicine, Section of Internal Medicine (B.F.), Sahlgrenska
University Hospital, Göteborg, Sweden.
Correspondence to Associate Professor Christian Blomstrand, Department of Clinical Neuroscience, Section of Neurology, Sahlgrenska University Hospital, S-413 45 Göteborg, Sweden. E-mail cbl{at}neuro.gu.se
Methods—One hundred four consecutive patients >40 years of age
admitted to hospital because of an acute stroke were randomized to 3
groups: deep, superficial, and no acupuncture treatment. The
acupuncture treatment given by 4 physiotherapists started 4 to 10 days
after randomization and was given twice a week for 10 weeks. All
patients underwent conventional stroke rehabilitation as well. Two
occupational therapists, blinded regarding the patients' allocation,
evaluated the treatment effects. The assessments were performed 4 times
during the first year after randomization by means of interviews and
observations.
Results—There were no differences between the groups with
reference to changes in the neurological score and the Barthel and
Sunnaas activities of daily living index scores after 3 and 12 months.
Regarding the Nottingham Health Profile, the no acupuncture group had
somewhat fewer mobility problems. No differences in health care and
social services were found between the groups.
Conclusions—The present study does not give support to the
previous studies, which indicates that acupuncture treatment may have a
beneficial effect on acute stroke patients' ability to perform daily
life activities, their health-related quality of life, and their use of
health care and social services.
In summary, the cited studies comprise small numbers of patients, and
the inclusion criteria vary as well as the time from the stroke onset
to the start of acupuncture treatment. In addition, the type of
acupuncture treatment, as well as the evaluation methods and criteria
used to define improvement, differs from study to study.
The present study was designed with the specific purpose of
examining possible placebo components of acupuncture treatment. It can
be assumed that the extra time and attention given to the patients, in
combination with the expectation effects associated with acupuncture
treatment, may confer an unspecific beneficial effect that has nothing
to do with the specific effect of deep acupuncture. It is important to
clarify such a specific effect of acupuncture, from both the
perspective of understanding the underlying mechanism and that of
making decisions whether to use such time-consuming treatment in
clinical practice. Thus, the aim of the present study was to
compare the effects of deep acupuncture, superficial acupuncture, and
no acupuncture in the acute stage of stroke with respect to ability in
ADL, quality of life, and use of health care and social services.
Inclusion Criteria
Exclusion Criteria
Overall Design, Sample Size, and Randomization
The sample size calculation was based on the results from a previous
study.6 Thus, it was assumed that in comparison
with the control group, treatment with deep acupuncture would lead to a
20% improvement in the Barthel ADL Index and that 30% of the patients
would not participate in the 1-year follow-up. The calculations
revealed that 32 patients had to be recruited to each of the 3 groups
(
The computer-generated randomization was stratified for side of
cerebral lesion (right/left), diabetes mellitus (yes/no), and hospital
(Mölndal/Sahlgrenska/Östra). The responsible doctor called
the randomization center and gave stratification data. At the
randomization center, the list with the combination of stratification
variables specific for the individual patient was defined. The
patient obtained the consecutive number on this list, which resulted in
allocation to 1 of 3 groups-deep acupuncture, superficial acupuncture,
or no acupuncture-as previously generated by the computer.
All patients received conventional stroke rehabilitation as well. The
acupuncture, deep and superficial, was performed by 4 physiotherapists
(PTs), trained together to give the same information and to use the
same techniques. The treatment started in both groups 4 to 10 days
after randomization and was given twice a week for 10 weeks.
Deep Acupuncture
The needles were 30 mm long. The needles on the nonparetic side
were stimulated manually, every 5 minutes, each time until the "de
chi" sensation was achieved. Electrical stimulation at a frequency of
2 Hz was applied to the needles on the paretic side. The intensity of
stimulation was increased until pronounced muscle contractions were
achieved. Each treatment was given for 30 minutes.
Superficial Acupuncture
No Acupuncture
Evaluation Method
The assessments were performed 4 times during the first year: 3 days
after randomization and at 3 weeks, 3 months, and 12 months. The
assessments were done by means of interviews and observations at the
hospitals, nursing homes, and/or in the patients' homes. If there was
any doubt about patients' abilities, they were asked to perform the
activity. The occupational therapist did all the scoring and followed
the same patients at the 4 assessment times.
The study was approved by the Ethics Committee of the Faculty of
Medicine, University of Göteborg, Sweden.
Measurement Instruments
Daily life activity outcome was evaluated with the Barthel
Index14 and Sunnaas Index of
ADL.8 15 The Barthel Index is an instrument with
a maximum of 100 points that includes 10 personal activities: feeding,
personal hygiene, bathing self, dressing, toilet, bladder control,
bowel control, chair/bed transfer, ambulation/wheelchair, and
stair/climbing. The Sunnaas Index includes 12 daily life activities,
personal as well as instrumental, including eating, continence, indoor
mobility, toilet management, transfer, dressing and undressing,
hygiene, bath/shower, cooking, housework, outdoor mobility, and
communication. The maximum score is 36 points. A higher score indicates
fewer problems in both of these ADL indexes.
Health-related quality of life was estimated by means of the Nottingham
Health Profile (NHP), part I.16 17 18 It reflects
the patient's degree of discomfort or distress within 6 dimensions
(emotional relations, sleep, lack of energy, pain, physical mobility,
and social isolation), in a total of 38 yes/no questions. The ratings
on each item are weighted to give a score of 0 to 100; a higher score
indicates more problems.
The NHP questionnaire, a self-instructive instrument, was given to the
patient and collected on the assessment occasion by the occupational
therapist. In a few cases, the patient needed assistance to fill in the
questionnaire. Most often help was needed because of a visual deficit
or writing problems. The interviewer then read the questions aloud and,
if necessary, wrote down the answers. Structured questionnaires were
used to collect data about the patient's clinical picture, marital
status, and social and living conditions. Social services were defined
as formal care, and assistance from relatives was designated informal
care.
Statistical Methods
The Fisher permutation test was used in the statistical
analyses for the outcome.20 21 The
Within the groups, 4 patients died in the deep acupuncture group; the
causes of death were cardiac death (n=2), pneumonia (n=1), and cerebral
infarction (n=1). In the superficial acupuncture group, 10 patients
died of cardiac death (n=6), cerebral infarction (n=2), renal
insufficiency (n=1), and gastrointestinal bleeding (n=1).
In the no acupuncture group, 5 patients died of cardiac death (n=3),
cerebral infarction (n=1), and pneumonia (n=1).
The mean age among the deceased patients was 81 years and among the
others 76 years.
All dropouts were analyzed regarding survival. One man died of
pneumonia 9 months after inclusion. Two of the female dropouts
were still alive when the study was completed, the one who refused to
participate and the one who dropped out after 3 months.
The proportional hazards model showed that neither deep nor superficial
acupuncture was associated with any differences in mortality risks
compared to the no acupuncture group (relative risk, 1.1 [95% CI,
0.29 to 4.1] and 2.5 [95% CI, 0.8 to 7.9], respectively).
Entry Characteristics
Changes During Follow-Up
For the ADL index scores after 3 and 12 months (Table 2
In all 3 groups, the neurological score and the Barthel and
Sunnaas ADL index scores showed that most of the improvement occurred
between 3 days and 3 weeks. After that time, the improvement continued
but leveled off, as expected. At the 12-month assessment, 5 patients in
the deep acupuncture group, 5 in the superficial acupuncture group, and
6 in the no acupuncture group had Barthel Index scores of 100
points.
Regarding the Nottingham Health Profile, the no acupuncture group
scored significantly lower in the dimension "physical mobility"
(P=0.048) compared with the deep acupuncture group after 12
months. This indicates that the no acupuncture group had somewhat fewer
mobility problems. In the other 5 dimensions in NHP (emotional
reactions, sleep, lack of energy, pain, and social isolation), no
significant differences were found between the groups (Table 4
After 3 months 35% of the patients in the deep acupuncture group still
remained at the rehabilitation units compared with 24% in the
superficial acupuncture group and 15% in the no acupuncture group.
After 12 months the proportion of patients living in their own homes
was 73% in the deep acupuncture group, 53% in the superficial
acupuncture group, and 82% in the no acupuncture group. After 12
months there were no differences between the groups regarding acute
hospital care, nursing home care, living and social conditions, use of
formal/informal care and need of personal assistance, or help with
instrumental ADL. It was found that all 3 groups had more informal than
formal care. Spouses and children assisted more frequently in personal
ADL than persons from the social services (Table 5
However, these findings have to be considered from the perspective of
four methodological issues, eg, design, treatment program, evaluation
methods, and representativity of the patient sample.
In regard to the first issue, ie, the design of the study, we chose a
randomized parallel group study with 3 arms. The rationale for having
both a superficial acupuncture group and a no acupuncture group was to
clarify whether the acupuncture treatment situation per se was
associated with any effect. As no such effect was found, these 2 groups
were used as a combined control group in the following comparisons with
the deep acupuncture group. The power of the study is largely dependent
on the sample size, which was calculated through use of the results of
a recently published study.6 Thus, our study had
an 80% power to detect the same magnitude of favorable effects that
had been reported previously.6 Furthermore, to
make the present and the previous studies comparable, similar
patient inclusion criteria and acupuncture methods were applied.
It may still be argued that the present study was underpowered and
that important beneficial effects of acupuncture have remained
undetected. However, the 95% CIs of the net effects on the main
variables do not indicate that this is the case.
The second methodological issue to be addressed relates to
treatment. Acupuncture has been used in Sweden for the treatment of
chronic pain conditions during the past decade. Some trials also
address the possibility of improving the rehabilitation outcome after
stroke.6 8 However, in contrast to the fairly
good scientific support for pain treatment with acupuncture, the
scientific rationale for treating different diseases is still poorly
substantiated.23
In the present study, the acupuncture treatment was similar to that
performed in the study by Johansson et al (personal communication, B.B.
Johansson, 1992). The only difference between that study and
ours was that the locations chosen for the needles were strictly
formalized in our study, because the treatment was given by more than
one PT. This was considered important to make easier deductions for
future practical use in stroke treatment and care. The occurrence of
sensory deficits was limited, and only a minority of patients failed to
perceive the typical "de chi" sensation from the paralyzed
extremities. The choice of placebo treatment with a few superficial
needles close to acupuncture points was based on previous experience.
This type of treatment does not influence acute (B. Olausson, J.
Sagvik, unpublished data, 1997) or chronic25 pain
conditions. It may still be argued that even superficial needles may
have an effect when applied to acupuncture points. However, when
comparing the outcome in the superficial and the no acupuncture groups,
there was not the slightest indication of a better effect in the former
group. If anything, the reverse was observed. Placebo has been widely
used as a control procedure for a number of different symptoms and
treatments, including acupuncture. Regarding acupuncture, a number of
different control measures have been used; for instance, needles in
points other than true acupuncture points, needles placed
superficially, needles glued to the skin, and mock transcutaneous nerve
stimulation. Preferably, the psychological impact of the placebo
treatment should be of the same magnitude as that of the true
treatment.26 Superficial acupuncture (ie, needles
inserted superficially into the skin, using classical Chinese
acupuncture points) has been used as placebo in studies on
pain25 27 28 29 30 and usually found to have less
effect than manual acupuncture or electroacupuncture. In the
present study, deep acupuncture (10 classical acupuncture points)
was compared with superficial acupuncture (4 classical acupuncture
points) to minimize the treatment effect and maintain a psychological
impact. The 2 acupuncture groups were compared with a control group
receiving no acupuncture, thus taking into account that both
acupuncture treatments could be effective. The patient's expectancy of
the efficacy of treatment may influence the
result.31 Coller et al32
found, however, that neither attitudes nor knowledge of acupuncture
influenced the response to acupuncture. The use of a credibility scale
is one way of ascertaining the strength of the patient's expectations
of improvement. Such a scale was not used in this study. Status,
behavior, and attitudes of the therapist may also influence the size of
the treatment effect.31 The therapists in the
present study were all carefully instructed to maintain a neutral
attitude so as not to influence the patient's view of the treatment in
any way.
The information before randomization was also held in as neutral a form
as possible. Though placebo effects seem fairly well controlled in this
study, such mechanisms cannot be excluded. Even in double-blind drug
trials, therapists obtain results in accord with their respective
expectations,33 which means that the therapist
may have more subtle influences on the placebo
response.31
Since there was no difference between any of the groups, the results of
this study do not reinforce the need for acupuncture as additional
treatment for patients with acute stroke.
Regarding the third methodological issue, optimally objective
evaluation methods are of particular importance in this type of study.
In our study, 2 OTs not participating in the treatment program
evaluated the results. They were blinded with respect to patient
allocation after randomization. They were aware of the importance of
not discussing the kind of acupuncture treatment with the patients. If
the patient mentioned having had acupuncture, neither the patient nor
the occupational therapist would know whether it had been deep or
superficial acupuncture. All patients were approached in the same way,
and the OTs strictly adhered to the procedures related to the
evaluation instruments. The OTs were trained together and experienced
assessing ADL both from neurological clinics and primary health care.
Most of the examinations were done by interviews in the patients'
homes. Having the possibility of assessing the ADL in a patient's own
environment is a great advantage. Ability to perform ADL is to a
certain extent dependent on the environment and acts to enable or to
constrain engagement in some activities.34 If the
OT had any doubt about a patient's ability, the patient was asked to
perform the activity under observation. This could be the case, for
instance, for patients with neglect problems. Each patient was followed
by the same OT, which probably kept both the variability and the
dropout rate low.
When choosing instruments for evaluation, it is important to look at
the responsiveness, ie, whether the instrument has the sensitivity to
detect sufficiently small differences35 both in
terms of differences between groups and changes over
time.36 The Barthel ADL Index was chosen because
it has widely been used in other stroke
studies6 7 37 38 39 and tested for interrater
reliability.40 The Sunnaas Index was chosen
because other studies have shown that ADL dependence in elderly
populations generally occurs in instrumental
activities.41 However, such a finding was not
made in our study. According to earlier validation of these
instruments, sum scores were used. No differences between the groups
were seen in either of the ADL indexes.
However, it should be pointed out that sum scores do not reveal
in which activities the problems occur. Certain activities are more
essential to independence than others. Thus, not being able to go to
the toilet means that the patient is much more dependent on personal
assistance several times a day, whereas not being able to take a bath
corresponds to personal assistance a couple of times a week. Objections
have been raised against sum scores and the way in which assessments on
an ordered categorical level are treated like interval
scores.22 42 43 44 45 Using a sum score therefore has
its limitations but gives the reader the opportunity to compare the
result with those in previous studies.
To assess health-related quality of life in this study, a
self-instructive instrument, NHP, was used to examine some specific
aspects. A few patients had problems with reading/writing. In these
cases, the OT read the questions or/and wrote down the answers. In
addition, some patients were unable to fill in the NHP questionnaire
for various reasons, such as perception of illness, fatigue, a language
problem, or a psychological problem. If it had been possible to include
these patients in the assessment, a further decrease in the quality of
life would probably have been found. Hypothetically, the mean score
would have been even higher, indicating a still lower quality of life,
if these patients had been able to complete the questionnaires.
NHP is a sum score organized into 6 dimensions, each of which consists
of 3 to 9 questions. The only dimension that showed a significantly
better result was physical mobility in the no acupuncture group, at the
12-month assessment, compared with the deep acupuncture group. This is
probably a chance finding, as it was a single observation that, in
addition, favored the group that received no acupuncture treatment.
Since we had no baseline values from NHP (only those after 3 and 12
months), we could not present a comparison of change from baseline
as was done with the other outcome variables. The reason for not
trying to establish a prestroke baseline is that such an estimate would
be very unreliable by the acute stroke phase. A comparison of the NHP
scores at 12 months with a 76-year-old reference
population46 shows that the scores were higher in
most of the dimensions among our patients, indicating a lower quality
of life. However it must be taken into consideration that this group of
stroke patients is not representative of all stroke
patients, because the inclusion criteria excluded the less disabled
patients.
A confounding factor when evaluating ability to perform ADL and quality
of life among elderly patients is the high comorbidity rate. Thus, many
80-year-old patients who have had a stroke are also suffering from a
variety of other dysfunctions and diseases, which might influence all
of the dimensions in NHP.47 Moreover, in this age
group, there is a high incidence of other negative events, such as the
loss of a spouse, which also affects the quality of
life.48
The last methodological issue deals with the representativity
of the patients. Although they were consecutively recruited among acute
patients at 3 hospitals, they are not representative of
the total stroke population, because specific recruitment criteria were
used. However, the method of selection was similar to that in a
previous study.6
The majority of patients were living in their own homes at the 12-month
assessment (Table 5
Acupuncture might influence intrinsic cortical circuits in the focally
damaged brain. Thus, the brain tissue could tentatively modify itself
through changes at the cellular level, including neuronal and glial
cell extensions and synapses. Such neocortical plasticity should
possibly be tested on a higher level than motor function. Accordingly,
the evaluation was focused on the disability
level54 instead of a motor function level. The
reason for this choice is that it is very important to evaluate whether
acupuncture has an effect not only on an impairment level but also on
the patient's ability to manage ADL. If this is not the case, such
treatment would be of less value to both the individual and society.
The evaluations showed, as expected, that all 3 groups recovered from
stroke onset up to the follow-up assessment after 12 months, but the
recovery in the deep acupuncture group was not superior to that in the
other 2 groups.
The question is why our study showed so consistently that
acupuncture has no discernible effect on the outcome after stroke,
whereas previous studies have shown favorable
results.4 5 6 7 8 9 10 11 Apart from differences in patient
selection or design, several of the previous studies may be criticized
for their limited sample size4 6 7 8 9 10 11 and lack of
independent evaluation procedures,4 5 6 7 8 9 10 11 factors
that may affect study results. In 2 of the
studies,8 9 selection of patients for a
rehabilitation center was probably made with consideration of age and
rehabilitation potential, which might influence the result. It is
probable that different ages and different subtypes of stroke,
including different localizations of the brain damage, could influence
the potential for brain plasticity. Thus, it is not possible to
generalize the results from the present study to all types of
clinical settings.
Nevertheless, it can be concluded that the present study does not
confirm the findings in previous studies which have indicated that
acupuncture treatment may have a beneficial effect on acute stroke
patients in terms of functional ability, quality of life, and use of
health care and social services. The costs for stroke rehabilitation
are high,55 and it is important that every
component of the rehabilitation program has well-documented effects
regarding clinical outcome, particularly with respect to effects on the
ability to perform ADL and on health-related quality of life.
Received June 5, 1998;
revision received July 22, 1998;
accepted July 22, 1998.
© 1998 American Heart Association, Inc.
Original Contributions
Effects of Acupuncture Treatment on Daily Life Activities and Quality of Life
A Controlled, Prospective, and Randomized Study of Acute Stroke Patients
Abstract
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
References
Background and Purpose—A number
of studies have indicated that acupuncture might improve the functional
recovery of stroke patients. These studies vary in inclusion criteria,
sample size, and evaluation methods. The present study was designed
to investigate whether electroacupuncture treatment favorably affects
stroke patients' ability to perform daily life activities, their
health-related quality of life, and their use of health care and
social services.
Key Words: activities of daily living • acupuncture • cerebrovascular disorders • quality of life • stroke outcome
Introduction
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
References
A number of Chinese studies1 2 3
have indicated that acupuncture might improve patients who have had a
stroke. However, with a few exceptions,4 5 these
studies have not been randomized and properly controlled. Formally
randomized studies in this area have been performed mainly in the
Scandinavian countries and the United
States.6 7 8 9 10 11 One of the randomized
studies11 was small and was not properly
controlled, because it used the treated patients as their own controls.
None of the studies were placebo controlled. Johansson et
al6 found significant improvement in a group of
stroke patients who received acupuncture during the acute phase,
compared with an untreated group, regarding assessments of walking,
balance, activities of daily living (ADL), quality of life, mobility,
and emotional state. The acupuncture group also spent fewer days in
nursing homes and rehabilitation wards compared with the control group.
In a follow-up study by Magnusson et al,7 it was
shown that the acupuncture treatment had enhanced recovery of the
postural function, an improvement that was still evident after 2 years.
In a study by Sällström et al8 in
subacute stroke patients, the acupuncture group improved
significantly more than the control group, as assessed by motor
function, ADL, and quality of life. The follow
up-study9 after 1 year states that the
improvement remained. Naeser et al10 11 have done
smaller controlled studies. In one, a randomized, controlled
study,10 real and sham acupuncture were compared
in subacute stroke patients. All subjects were given conventional
treatment in addition to acupuncture. Four of 10 patients who received
real acupuncture showed a good response, and those who received sham
acupuncture showed a poor response. However, because of the small
sample sizes, the results are inconclusive, as there are considerable
risks for type I and II errors. Hu et al4 studied
30 acute stroke patients and found that the improvement was greatest in
patients with a poor neurological score at baseline. Zhang et
al5 studied the use of acupuncture in 94 patients
with limb paralysis after stroke. Although both the acupuncture
treatment group and the control group showed improvement, that in the
acupuncture group was significantly greater.
Subjects and Methods
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
References
One hundred four consecutive patients admitted to the hospital
because of acute stroke were included in the study. After their
informed consent had been obtained, the patients were randomized to 3
different treatment groups.
Patients 
40 years with an acute focal ischemic
nonhemorrhagic lesion were invited to take part in the study. The
stroke onset had to be less than 1 week before the randomization. The
extent of the paresis had to be such that the patient could not walk
without support and/or could not eat and/or dress without assistance.
The patient had to be able to cooperate mentally and be willing to
participate in the study.
These criteria included other severe disease necessitating
hospital or nursing home care; severe aphasia or unconsciousness; an
earlier cerebral lesion, with a documented need of care; and treatment
with a cardiac pacemaker.
The design was a multicenter, randomized, open and prospective
study, with 3 parallel groups followed for 1 year. 
=0.05 and ß=0.80).
Ten acupuncture points, according to traditional Chinese
medicine, were used: LI 4, LI 11, ST 38, and Ex mob on both the paretic
and the nonparetic sides; Sj 5 on the nonparetic side; and DU 20 on the
scalp.12 (The point Sj 5 is currently called TE
5, and the point DU 20 is called GV 20.)
Four short needles (15 mm) were used, 1 in each extremity.
The needles were placed superficially just under the skin, where they
were left for 30 minutes. The points used were LI 11 bilateral and Ex
mob bilateral. No electrical or manual stimulation was applied to the
needles.
The no acupuncture group received conventional stroke
rehabilitation only.
Two occupational therapists (OTs), who were blinded to patient
allocation after randomization, evaluated the treatment effects on ADL,
health-related quality of life, and use of health care and social
services.
Functional outcome was based on the neurological score according
to the Scandinavian Stroke Study Group,13
including motor function of the arm, hand, and leg; ambulation;
orientation; and speech. The maximum score is 48 points.
The analyses were planned to be performed in 2 steps. In
the first step, the superficial acupuncture group and the no
acupuncture group were compared. If no differences were observed
between these groups, they were combined. In the next step, comparisons
were made between the deep acupuncture group and the combined
superficial acupuncture/no acupuncture group. Comparisons were
thereafter carried out for entry characteristics and changes from entry
to follow-up after 3 and 12 months. The changes within each group
(follow-up minus baseline) were then used to calculate the net effect
(change in the deep acupuncture group minus change in the combined
superficial acupuncture/no acupuncture group). The analyses
were performed according to the intention-to-treat
principle.19 Loss of data on neurological score
and ADL indexes in patients who had died before the 12-month follow-up
assessment were not adjusted for in additional analyses unless
there was a difference in mortality rates between the groups. 
2 test and Kruskal-Wallis test were used in
the statistical analyses for the entry
characteristics.22 The proportional hazards model
was used to calculate whether either of the 2 acupuncture treatments
was associated with a change in mortality risk compared with the group
with no acupuncture treatment. Confidence intervals (CIs) were
calculated for the main variables.22
P<0.05 (2 sided) was regarded as statistically
significant.
Results
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
References
One patient initially randomized to the deep acupuncture group was
dropped from the study immediately because of refusal to participate.
Further, 1 patient receiving deep acupuncture dropped out of the
evaluation program. This 86-year-old man was referred to geriatric
rehabilitation and left the hospital after 2 months. Nine months after
the first stroke, he died of pneumonia. Three patients did not complete
the deep acupuncture treatment and withdrew for various reasons (2
disliked the acupuncture treatment; 1 developed an erysipeloid arm
infection). All 3 patients had received most of their treatment (14,
15, and 18 sessions, respectively). In the superficial acupuncture
group, 1 patient did not want to continue the treatment after
completing 4 sessions. These 4 patients are all included i the
analyses according to the intention-to-treat
principle.19 Nine women and 10 men died during
the study. All patients except 1 among the survivors were completely
assessed, leaving 82 patients at the 12-month follow-up (Figure 1
).
View larger version (18K):
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Figure 1. Flow chart describing access to follow-up data
(n=104).
There were no statistically significant differences in the entry
characteristics between the groups (Table 1). There were no
differences between the groups in the systolic and
diastolic blood pressures (data not shown). The women as a
group were older than the men, and they also more often had a history
of treated hypertension (n=30 [52%] versus n=14 [30%];
P=0.029).
View this table:
[in a new window]
Table 1. Characteristics of the Patients (n=104) at Entry, by
Group
No differences were seen between the superficial acupuncture and
the no acupuncture groups when comparing the changes in the
neurological score and the Barthel and Sunnaas index scores. ), no differences were
seen between the deep acupuncture and the combined superficial/no
acupuncture groups making the same comparisons (Table 3).
View this table:
[in a new window]
Table 2. Changes from Baseline: Comparison of the Superficial
Acupuncture Group and the No Acupuncture
Group
View this table:
[in a new window]
Table 3. Changes from Baseline (3 Days): Comparison of the
Deep Acupuncture Group and the Combined Superficial Acupuncture/No
Acupuncture Group ).
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[in a new window]
Table 4. Health-Related Quality of Life by Group as Assessed
by NHP at 3 and 12 Months ).
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[in a new window]
Table 5. Living and Social Conditions by Group at 3 and 12
Months
Discussion
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
References
This randomized, controlled study in elderly patients with acute
stroke was unable to demonstrate that deep acupuncture, given twice
weekly for 10 weeks, was associated with any beneficial effect as
measured in different dimensions. Thus, neither ADL scores,
neurological scores, use of health care and social services, nor
quality of life showed more improvement in the deep acupuncture group
than in the other groups. 
). Many of them were dependent on formal or informal
care, or a combination of both. In this study, as well as in previous
reports, informal care was predominant.49 50 51
More attention is now being paid to this problem, and studies have
shown the importance not only of assessing the patient's ability in
performing ADL but also of having assessment instruments to identify
the relatives at risk of high levels of burden and problems related to
caregiving.52 53 Considering the burden of care
that stroke might give rise to, it is of greatest importance that
caregivers and care planners in the Health and Social Welfare System
involve the relatives in patient care and give them information and
support.
Acknowledgments
This study was supported by the John and Brit Wennerström
Foundation for Neurological Research, the Vårdal Foundation, and the
Swedish Stroke Association. We would also like to express our gratitude
to Dr Mats Andersson; Dr Lena Bokemark; physiotherapists Gerd
Setterberg, Margit Simonsson, Doris Michel-Niklasson, and Anna Olsson;
and occupational therapist Marianne Eriksson, who were involved with
the treatment and the data collection. We would also like to thank
Agneta Hallén and Henrik Siverbo for valuable help with the data
administration and Anders Odén for valuable help with
statistics.
References
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
References
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