Download Abstract

A Randomised Pilot Study on the Acupuncture of Si Guan Xue
for the Treatment of Cancer Pain
Specialty: Department of Oncology, Guangzhou University of Chinese
Medicine
Author: Lin Dao Yi (Lam To Yi)
Tutor:
Professor Lin Li Zhu
Abstract
Objective
To determine the efficacy and safety of acupuncture on si guan xue
for treating cancer pain.
Design, setting and participant
A Randomized Controlled Trial was conducted in the Department of
Oncology of the First Affiliated Hospital of Guangzhou University of
Chinese Medicine and the OncWell Integrated Cancer Centre in Hong Kong
(May 2012 to February 2014). Advanced stage cancer patients (45 patients
age from 24 to 91 years old with moderate to severe cancer pain) were
treated by Chinese Medicine Practitioners.
Intervention
The treatment arm was sub-divided into the treatment arm 1 (the si
guan xue arm, n=14) and treatment arm 2 (the si guan xue plus commonly
used acupoints arm, n=14), while the control arm was the commonly used
acupoints arm (n=14). A course of acupuncture treatment consisted of seven
treatment sessions, which were delivered to the patients either daily or
alternate day. The analyst was blinded to the data analysis.
Outcomes and Measures
Primary outcomes were efficacy of acupuncture in relieving the cancer
pain and patient’s subjective improvement as measured by the Patient
Global Impression of Change (PGIC). Secondary outcomes included the
assessment by the European Organization for Research and Treatment of
Cancer Quality of Life Questionnaire-Core (EORTC QLQ-C30) and the
Karnofsky's Performance Status (KPS) score.
Results
Analysis showed cancer pain reduction in treatment arm 2 with the most
1
remarkable improvement on day 5 and 6. Statistically significant
improvements in comparison with the control arm（P＜0.05）. The difference
in their PGIC scores was not statistically significant （ P ＜0.05）.
Secondary outcomes was no statistically significant difference in all
these EORTC QLQ-C30 and KPS score （P＞0.05）. There was no serious adverse
event.
Conclusion
The study supported the efficacy and safety of acupuncture on si guan
xue plus commonly used acupoints for cancer pain management. Further large
scale, multi-centers, and randomized controlled trials peculiar to
different types of cancer are warranted to confirm its treatment effects
in more detail, and to further improve the acupuncture treatment protocol.
Key words： Acupuncture ;Si Guan Xue ;Cancer pain ;Randomized controlled
trial
2
Cancer，is one the major factors that cause death in the world.
According to the recent reports, there were 12.7million people who were
newly diagnosed in 2008, and 7.6million people were died because of cancer
（13% of all deaths）. By predicting，the total number of deaths that caused
by cancer would be increased from 13% in 2007 to 45% in 2030. For the newly
developed countries, the number would be increased from 11.3 million in
2007 to 15.5 million in 2030〔1〕.
Cancer pain is one of the most common symptoms of those suffering from
cancer. According to the World Health Organization (WHO), there are
24.6million cancer patients in total, 20% to 30% of them are suffering
from different level of pain. The three-step analgesic ladder of WHO is
widely used, but there are still a lot of cancer patients (particularly
in advanced stages) lack of effective pain control. Many of them may need
central nervous analgesics（eg. opioids）for pain control but it may bring
many serious side effects，including nausea, vomiting, constipation,
dryness of mouth, urinary retention, sleep disturbance，or even confusion,
hallucinations, respiratory distress ， which bringing intolerance to
〔2-3〕
patients and their families are difficult to cope with
.
A wide range of indications for acupuncture and show significant
effects especially in pain control. It is safe to use, benefits include
analgesic effect， rapid onset， long sustained remission， basically no
side effects ， easy to apply ， harmless and no drugs dependence or
addiction etc〔4〕.
Acupuncture of“si guan xue” ， is a very unique combination of
acupuncture. “Si guan” was firstly seen in "Twelve of the original
nine-pin, Lingshu"，indicated that "there are five zang and six Fu, and
six fu has twelve original, twelve original proceed from si guan, si guan
treating five zang". The famous Chinese Medicine Practitioner of Ming,
Yang Jizhou added that: "Si guan, is taichong and hegu."
〔5〕
In the
combination of two acupoints, yin and yang, zang and fu, up and down,
mainly qi and blood and thus complement each other. Si guan is widely used
clinically, the features are highly efficacy, easy to get arrival of qi,
3
acupuncture stimulation is strong, manipulation is simple, safe to use
〔6-7〕
. It is highly recommended for deserving of further study.
Methods
A randomized clinical trial was conducted. The institutional human
ethics committee approved the study. Participants provided written
informed consent.
We recruited participants from the Department of Oncology of the First
Affiliated Hospital of Guangzhou University of Chinese Medicine and the
OncWell Integrated Cancer Centre in Hong Kong between May 2012 to February
2014. All patients in this study were confirmed advanced cancer patients
in both clinical and pathology, and pain was their chef complaint.
Patients’ age from 24 to 91 years old, were well enough and had sufficient
proficiency to complete assessment forms. Pain Assessment Form with
Numeric rating scale〔8〕is used and the result of Patient Global Impression
of Change: PGIC〔9〕 will be assessed. The Pain Assessment Form with Numeric
rating scale (NRS) is a 0 to 10 numerical scale (0 = the best, 10 = the
worst) to rate severity of pain. 3 sets of EORTC QLQ-C30 〔 10 〕 will be
completed by patients：before the starting of study，after completing the
7th acupuncture treatment，and 2 weeks after the treatment in follow-up
visiting.
Randomization and Blinding
Participants initially consented, were recruited and interviewed by
trained investigator, who assisted the patient to complete the EORTC
QLQ-C30 and pain assessment form. Randomization hidden program is used,
a computer random method for encoding〔11〕 and random coding were sealed
into the envelopes so as to avoid human intervention. The analyst of this
study was blinded to the data analysis.
Interventions
We used a Chinese Medicine style of acupuncture. Acupuncture was done
4
by the experienced Chinese Medicine Practitioners (9 and 12 years of
clinical practice, 3 and 10 years of acupuncture experience) who had
completed Bachelor and Master degree in Chinese Medicine (one is Master
degree in acupuncture), and well trained in acupuncture. A course of
acupuncture treatment consisted of seven treatment sessions, which were
delivered to the patients either daily or alternate day.
Chinese Medicine Treatments
In this study, acupuncture was used for treatment of cancer pain. The
common Chinese Medical Diagnosis is combination of deficiency and
strength. The strength is including accumulation of qi and blood. The
deficiency is including deficiency of qi and blood, ying and yang, and
Zang-fu etc. Deficiency is more prominent for advanced cancer patients
〔12-13〕
.
The choice of acupoints
The treatment arm was sub-divided into the treatment arm 1 (the si
guan xue arm) and treatment arm 2 (the si guan xue plus commonly used
acupoints arm), while the control arm was the commonly used acupoints arm
(the combination of Neiguan, Zusanli and Sanyinjiao xue acupoints chosen,
according to the previous literature review〔14-28〕).
These acupoints, especially those located below the elbow and knee
joints of the Twelve Regular Meridians, have the therapeutic effects on
the diseases of the local and the remote regions.
Single-use MOCM needles (0.25x25mm or 0.30x40mm) were inserted under
skin 10-20mm depth vertically, and then used reinforcing-reducing method
to activate the qi until the sensation of arrival of qi (numbness, fullness
and heaviness). Patient lying down and needles were left in situ for 30
minutes. A course of acupuncture treatment consisted of seven treatment
sessions either daily or alternate day.
Statistical Analysis
Statistical analysis was performed by PASW Statistic 18.0 (IBM SPSS
Inc., Armonk, New York, USA) and SAS 9.2 software (SAS Institute Inc.,
Cary, USA). Intention-to-treat (ITT) population was the main statistical
5
method in our research.
1. Analysis of efficacy
Descriptive
analysis ： Baseline
demographic
and
clinical
characteristics were performed by descriptive analysis. Cross-sectional
data analysis：compare the efficacy of the intervention group at some point，
using analysis of variance (ANOVA) for pairwise comparison； Longitudinal
data analysis：comparison on the effects of different interventions at
different times by repeated measures design approach, analysis of the
intervention
group
effect,
time
effect,
intervention
and
time
interaction.
2. Analysis of influencing factors
In the main outcomes of cancer pain relief scores as the dependent
variable ， independent variable is the intervention group ， included
different demographic, different types of cancer and different clinical
centres as controls. Multi-level statistical model was performed with
data divided into 2 levels: individual level and group level，or individual
level and hospital level.
3. Sensitivity analyzes
Per protocol analysis without lost data was performed and compared
with results of ITT analysis. Mix-effects model was performed to adjust
for baseline covariates and clustering among individuals within a
hospital.
Analysis of safety
By using descriptive analysis, analyze the unsafe events, numbers,
symptoms, treatment and consequences.
Results
Demographic data analysis
1. General Information of patients
In between May 2012 to February 2014, 45 numbers of cancer patients were
invited. 3 invitees refused to participate in this study because of living
6
far away or unwilling to accept acupuncture. There are only 42
participants, 30 from China and 12 from Hong Kong, randomized into the
treatment arm and control arm, 14 for each arm (Figure 1).
7
Patients were invited
(n=45)
Unwilling patients (n=3)
Residing at distant (n=2)
Unwilling for acupuncture (n=1)
Patients participated
(n=42)
Treatment Arm
Control Arm (n=14)
Treatment Arm 1
(n=14)
Treatment Arm 2
(n=14)
Patients’ condition
Patients could not complete
Patients could not complete
deteriorated and could not
treatment (n=5)
treatment (n=5)
complete treatment (n=2)
Not interested (n=3)
Not interested (n=1)
Condition deteriorated
Condition deteriorated
(n=2)
死亡
(n=2)
(n=4)
死亡
(n=2)
Patients completed
treatment (n=12)
Patients completed
treatment (n=9)
Patients completed
treatment (n=9)
Patients completed
follow up (n=12)
Patients completed
follow up (n=8)
Patients completed
follow up (n=29)
Patient Death and
could not complete
follow up (n=1)
12 patients included
12 patients included
12 patients included
in analysis
in analysis
in analysis
Figure 1 Research Flowchart
8
Baseline characteristics of patients were list in Table 1, number of
male patient was 20 and female was 22 respectively. For patients in
Mainland China, their primary majorly was lung cancer (n=11), and for Hong
Kong was head and neck cancer (n=4). Most of the patients were suffering
from cancer with stage IV (n=37), and some of them were suffering from
another chronic diseases too (n=26) (Table 1). Before treatment, the
average pain level was 5.81, according to NRS belonged to moderate pain
〔8〕
. KPS was 70% indicated that they could live independently but could
not maintain normal activities or works〔29〕.
Table 1 Baseline Characteristics of Patients (n=45)
Participants
All patients
Mainland China
General Information
Sex
Male
Female
Age
Average
Range
Marital status
Single
Married
Widowed
Education
Illiteracy
Primary school
Secondary school
High school
University or above
Primary Disease Site
Head and neck
Lung
Breast
Gynecological
Liver
Upper GI(Oesophagus,
stomach and spleen)
) Lower GI(Colon)
Others
Hong Kong
Unwilling
Participant
HongsKong
No.
%
No.
%
No.
%
No.
%
20
22
47.62
52.38
15
15
50
50
5
7
41.67
58.33
0
3
0
100
57.59
24-91
56
24-79
59.17
42-91
78.33
74-82
2
38
2
4.76
90.48
4.76
0
30
0
0
100
0
2
8
2
16.67
66.66
16.67
0
2
1
0
67
33
8
13
2
14
5
19.05
30.95
4.76
33.33
11.91
6
12
2
9
1
20
40
6.67
30
3.33
2
1
0
5
4
16.67
8.33
0
41.67
33.33
1
1
0
1
0
33
33
0
33
0
5
12
3
6
5
5
11.9
28.57
7.14
14.29
11.9
11.9
1
11
1
5
5
3
3.33
36.67
3.33
16.67
16.67
10
4
1
2
1
0
2
33.33
8.33
16.67
8.33
0
16.67
1
1
0
0
33
33
0
0
0
0
3
3
7.14
7.14
2
2
6.67
6.66
1
1
8.33
8.34
0
1
0
33
9
Stage of cancer
Ⅲ
Ⅳ
Other chronic diseases
Level of pain
Average
Range
KPS score
Average
Range
5
37
26
11.9
88.1
61.9
1
29
20
3.33
96.67
66.67
4
8
6
33.33
66.67
50
0
3
2
5.81
2-8
5.9
2-8
5.58
5-8
7
5-8
70
40-90
69
40-90
72.5
60-80
70
60-80
2. Information on patients of pain before treatment
The minimum number of pain sites for each participant was 1, maximum
was 7. There were 90 pain sites totally, most of the pain sites were located
on lower limb (n=20) (Table 2). The most intensive average pain in the
past 24 hours before treatment is 7.48. According to NRS, it belonged to
severe pain. Occurrence of severe pain was 4.74 in average, the average
of the minimum pain is 3.1, and mean of pain is 5.62. The average of pain
just before the treatment was 5.8, which belonged to moderate pain〔8〕.
Table 2 Pretreatment data on site of pain
Site of pain
Head
Neck and shoulder
Upper limb
Upper back
Lower back
Chest
Upper abdomen
Lower abdomen
Lower limb
Others
All patients
No.
2
10
8
12
10
8
7
8
20
5
Mainland China
No.
0
2
1
8
8
5
5
5
11
2
Hong Kong
No.
2
8
7
4
2
3
2
3
9
3
Table 3 Pretreatment data on level of pain in the last 24 hours
Level of pain
Average of the most severe pain
Range
Average number on outbreaks of
severe pain
Range
All patients
Score
7.48
3-10
4.74
0-9
10
Mainland China
Score
7.87
5-10
4.3
1-8
Hong Kong
Score
6.5
3-9
5.83
0-9
0
100
67
Average of the slightest pain
Range
Average of pain
Range
Average of current pain
Range
3.1
0-8
5.62
3-8
5.8
0-9
2.93
0-7
5.73
3-8
5.9
1-8
3.5
0-8
5.33
3-8
5.58
0-9
Analysis of outcome
1. Primary outcome
The primary outcome of this study was to evaluate the effectiveness
of acupuncture on si guan xue for treating cancer pain. According to the
analysis on the seven treatment sessions, the pain relieving score of the
treatment arm 1 and control arm had the tendency to decrease. But the
treatment arm 2 was increased, especially over the fifth and sixth day
of treatment (Table 4) （P＜0.05）. Therefore, the most effectiveness of
acupuncture in relieving the cancer pain was the combination of the si
guan xue and commonly used acupoints (Figure 1).
Table 4 Changes of cancer pain reduction score among 3 groups
Time
Day 1
Day 2
Day 3
Day 4
Day 5
Day 6
Day 7
Main effect of time
（P-value）*
Arm 1
（n=14）
1.93±1.21
1.93±1.14
1.93±1.14
1.43±1.16
1.36±1.01
1.29±1.14
1.36±1.08
Control arm
（n=14）
1.36±1.15
1.14±0.77
1.07±1.07
1.21±0.97
0.86±0.86
0.93±0.83
1.00±1.04
＞0.05
Arm 2
（n=14）
1.86±1.03
1.57±1.28
1.64±1.22
1.43±1.02
1.79±0.89#
1.79±1.19#
1.29±1.07
P-value
0.36
0.17
0.14
0.83
0.04
0.11
0.65
Note：* There was no interaction among the changing trend over time of pain reduction
scores and intervention factor of the three groups.
# Compared with the control group, cancer pain reduction scores were statistically
significant difference, P＜0.05.
11
Cancer pain
Reduction
score
Figure 2 Changes of pain reduction score among 3 groups
（Group 1: Arm 1； Group 2：Control group； Group 3：Arm 2）
PGIC score is based on the patient's perception of the overall change,
it is patient’s subjective efficacy measures. Whereas the results of PGIC
measurement across the three arms revealed that the difference in their
PGIC scores was not statistically significant （P＜0.05）(Table 5).
Table 5 PGIC score of 3 groups
Time
Day 7
Arm 1
（n=14）
2.42±0.79
Control arm
（n=14）
2.64±0.67
Arm 2
（n=14）
2.56±0.53
P-value
0.74
2. Secondary outcome
Both the Global Health Scale and Functional Scale were increasing
during the treatment course (Table 6,7 and Figure 3), whereas the Symptom
Scale was decreasing (Table 8). However, there was no statistically
significant difference found across the three arms in all these EORTC
QLQ-C30 domains（P＞0.05）.
12
Table 6 Global health score and changes of 3 groups
Time
Baseline
Day 7
Follow up
Main effect of time
（P-value）*
Arm 1
（n=14）
39.88±19.39
50.60±17.13
50.60±19.47
Control arm
（n=14）
32.74±18.90
44.64±20.83
45.24±16.89
＜0.05
P-value
Arm 2
（n=14）
35.12±15.04
48.81±16.62
46.43±18.98
0.57
0.68
0.73
Note：* There was no interaction among the changing trend over time of Global Health
scores and intervention factor of the three groups.
Global
health
Figure 3 Global health score and changes of 3 groups
（Group 1: Arm 1； Group 2：Control group； Group 3：Arm 2）
Table 7 Functional Scale score and changes of 3 groups
Time
P-value
Arm 1
Control arm
Arm 2
（n=14）
（n=14）
（n=14）
Baseline
90.29±4.00#
87.24±3.89
88.60±3.56
0.12
Day 7
91.56±4.94
89.21±4.16
90.35±4.10
0.38
Follow up
90.79±4.85
89.78±3.53
90.48±4.27
0.81
Main effect of time
＜0.05
（P-value）*
Note：* There was no interaction among the changing trend over time of Functional scale
scores and intervention factor of the three groups.
13
Table 8 Symptom Scale score and changes of 3 groups
Time
Arm 1
（n=14）
4.46±1.59
3.36±2.39
3.72±2.02
Baseline
Day 7
Follow up
Main effect of time
（P-value）*
Control arm
（n=14）
5.45±1.88
3.93±1.90
3.91±1.78
＜0.05
Arm 2
（n=14）
5.21±1.86
4.17±1.92
4.27±2.10
P-value
0.32
0.57
0.28
Note：* There was no interaction among the changing trend over time of Symptom scale
scores and intervention factor of the three groups.
KPS score of the three arms showed an increasing trend during the
treatment course, but the difference across the three arms was not
statistically significant（P＞0.05）(Table 9 and Figure 4).
Table 9 KPS score and changes of 3 groups
Time
Day 1
Day 2
Day 3
Day 4
Day 5
Day 6
Day 7
Main effect
（P-value）*
Arm 1
（n=14）
70.00±15.19
70.00±15.19
70.00±15.19
70.00±15.19
70.71±14.92
70.71±14.92
70.71±14.92
of
time
Control arm
（n=14）
72.86±13.83
72.86±13.83
73.57±13.36
73.57±13.36
73.57±13.36
73.57±13.36
73.57±13.36
＜0.05
Arm 2
（n=14）
67.14±9.14
67.14±9.14
67.86±9.75
68.57±9.49
68.57±9.49
68.57±9.49
68.57±9.49
P-value
0.51
0.51
0.51
0.57
0.59
0.59
0.59
Note：* There was no interaction among the changing trend over time of KPS scores and
intervention factor of the three groups.
14
KPS
score
Figure 4 KPS score and changes of 3 groups
（Group 1: Arm 1； Group 2：Control group； Group 3：Arm 2）
3. Subgroup analyzes
The subgroup analysis shown that the different types of cancer and
cancer pain reducing score of different age groups, both have no
statistically significant difference（P＞0.05）， The finding excluded the
influence of subgroups，the result was reliable and stable(Table 10 and
11).
15
Table 10 Reduction pain score and changes of different types of cancer of 3 groups
Time
Lung（n=12）
Day 1
1.75±1.36
Day 1
1.50±1.0
Day 1
1.42±1.31
Day 1
1.25±1.22
Day 1
1.50±1.09
Day 1
1.33±0.89
Day 1
1.50±1.17
Main effect of time
（P-value）*
Gyne(n=6)
2.50±0.55
2.0±1.26
2.0±0.63
1.67±1.03
1.83±1.17
1.50±1.05
1.67±0.82
Liver(n=5)
2.20±1.30
0.80±0.84
1.20±1.10
1.00±0.71
0.80±0.45
1.20±0.45
1.00±0.00
Primary Disease Site
Upper GI(n=5)
Head & Neck(n=5)
1.00±1.00
2.00±1.41
1.20±1.10
2.80±1.30
1.20±1.30
2.40±1.67
1.40±1.14
2.00±1.22
0.80±0.84
1.80±1.10
0.60±1.34
2.40±1.82
0.40±0.55
1.60±1.67
＞0.05
Breast(n=3)
1.00±0.0
1.33±0.58
1.67±1.15
1.33±1.53
1.33±1.53
1.33±1.53
1.33±1.53
Colon(n=3)
1.33±0.58
1.67±0.58
1.67±0.58
1.00±0.00
1.00±0.00
1.00±0.00
0.67±0.58
Others(n=3)
1.00±0.00
0.67±0.58
0.67±0.58
1.00±0.00
1.00±0.00
1.00±0.00
0.67±0.58
P-value
0.26
0.08
0.53
0.82
0.48
0.37
0.38
Note：* There was no interaction among the changing trend over time of cancer reduction pain score on different types of cancers and intervention
factor of the three groups.
16
Table 11 Reduction pain score and changes of different age groups of 3
groups
Time
≤44（n=10）
Day 1
1.70±1.25
Day 1
1.00±0.94
Day 1
1.40±1.17
Day 1
1.60±1.07
Day 1
1.40±0.97
Day 1
1.80±0.92
Day 1
1.70±1.16
Main effect of time
（P-value）*
45-59（n=14）
1.93±0.92
1.79±1.19
1.71±0.99
1.43±1.02
1.29±0.99
1.14±0.86
1.21±1.05
60-74（n=12）
1.50±1.24
1.50±1.09
1.42±1.38
1.25±1.06
1.33±1.07
1.17±1.53
1.17±0.94
＞0.05
≥75（n=6）
1.67±1.37
2.00±1.10
1.67±1.37
1.00±1.10
1.33±1.03
1.33±0.82
0.50±0.84
P-value
0.83
0.26
0.89
0.70
1.00
0.49
0.18
Note：* There was no interaction among the changing trend over time of cancer reduction
pain score on different age group and intervention factor of the three groups.
4. Sensitivity analyzes
According to the analysis of without lost data, per protocol analysis
through observation, the combination of si guan xue and commonly used
acupoints in the treatment of cancer pain, patients cancer pain relieving
scores were gradually increased, especially in the fifth and sixth day,
the difference was statistically significant (P <0.05). These results in
Table 4 were similar to the results of the ITT analysis, this study also
suggested that the ITT analysis results were more stable and reliable
(Table 12).
17
Table 12 Reduction pain score and changes of 3 groups per protocol analysis
Time
Arm 1（n）
Day 1
Day 1
Day 1
Day 1
Day 1
Day 1
Day 1
Main effect of time
（P-value）*
Control arm（n）
1.93±1.21(14)
1.92±1.16(12)
1.92±1.16(12)
1.33±1.15(12)
1.25±0.97(12)
1.17±1.11(12)
1.25±1.06(12)
1.36±1.15(14)
1.14±0.77(14)
1.08±1.12(13)
1.18±0.87(11)
0.73±0.65(11)
0.82±0.60(11)
0.91±0.94(11)
＞0.05
Arm 2（n）
1.86±1.03(14)
1.54±1.33(13)
1.62±1.26(13)
1.36±1.12(11)
1.82±0.98#(11)
2.00±1.41#(9)
1.22±1.30(9)
Note：* There was no interaction among the changing trend over time of pain reduction
scores and intervention factor of the three groups.
# Compared with the control group, cancer pain reduction scores were statistically
significant difference, P＜0.05.
For mix-effects model, incorporate the effects of baseline and
clinical center, these variables had little effect on the outcome,
suggested that changes in the primary outcome of this study were mainly
caused by the intervention of factors, result was reliable and stable
(Table 12).
Table 13 Sensitivity analyzes on the primary outcome of different factors
Different time
point
Different types
of cancer
Different age
groups
Different
centre
Molecular
degrees of
freedom
6
Denominator
degrees of
freedom
110
F value
P-value
1.40
0.22
7
41.9
2.88
0.35
3
41.9
1.00
0.40
1
41.9
2.97
0.09
5. Safety analyzes
This study also considered the safety of acupuncture, the side effects
of acupuncture included：fainting, hematoma, curved needle, broken needle
etc.
18
P-value
0.36
0.22
0.21
0.91
0.02
0.06
0.72
In this study, safety precautions had been done before patients
receiving acupuncture treatment. Throughout the study, there were no
serious accidents related to acupuncture treatment.
Discussion
Acupuncture is extremely useful in controlling the pain experienced
by many cancer patients. It is a complementary and conservative therapy
that traditionally helps to balance the flow of vital energy, which in
turn helps to relieve pain. It may be an effective analgesic adjunctive
method for cancer patients and its widespread acceptance〔30-32〕.
According to the analysis on the seven treatment sessions, the pain
relieving score of the treatment arm 1 and control arm had the tendency
to reduce. But the treatment arm 2 was increased, especially over the fifth
and sixth day of treatment. Therefore, the most effectiveness of
acupuncture in relieving the cancer pain was the combination of the si
guan xue and commonly used acupoints. A course of acupuncture treatment
consisted of fourteen treatment sessions was suggested for further
improve the acupuncture treatment protocol〔33〕. The special technique of
acupuncture over treatment arm 2 was used. Opening of si guan xue at first
and then regulating the commonly used acupoints, is a stronger efficacy
mechanism〔34-35〕. There were studies to mention that acupuncture over si guan
xue could activate the qi and replenish the vital substances of the body,
strengthen the visceral organs etc〔6-7〕 . It would be more effective to
control cancer pain.
There was no statistically significant difference found across the
three arms in the PGIC, EORTC QLQ-C30, and KPS score （P＞0.05）.
According to the manual of EORTC QLQ-C30〔36〕, for Symptom Scale, the
higher the score means the more symptoms or problems, which leads to the
poor quality of life. EORTC QLQ-C30 scoring showed that the decreased
score in symptom area, mean the better quality of life to patients.
Some studies show that acupuncture treatment in patients with stage
IV cancer symptoms, KPS score of 60%, for Stage III symptoms, KPS score
19
of 70%, indicating that the quality of life has been improved〔37〕. The KPS
of this study was 70%, believed that the quality of life of patients had
been improved
Some studies show that patients with advanced cancer, considering
they are late stage cancer, the attrition rate of 40% or less is still
acceptable〔38〕. The attrition rate of this study was 28.57%, less than 40%,
the effectiveness was still acceptable.
Limitation and advantage
The main limitation of this study is the small sample size, the
representation is not enough to support acupuncture's efficacy in
treatment of cancer pain.
The second limitation is inadequate treatment time. Some studies
considered the longer acupuncture treatment time maybe more effective in
controlling cancer pain and improving quality of life of the patients
〔38〕
.
During the study，the pain of two patients was reduced after the 2nd
acupuncture treatment, and the amount of analgesia was reduced too. When
the study was ended, there were 7 patients requested to continue the
acupuncture treatment. Shown that acupuncture of si guan xue may help
cancer patients to control pain and improve their quality of life.
Conclusion
The study supported the efficacy and safety of acupuncture on si guan
xue plus commonly used acupoints for cancer pain management. Further large
scale, multi-centers, and randomized controlled trials peculiar to
different types of cancer are warranted to confirm its treatment effects
in more detail, and to further improve the acupuncture treatment protocol.
Key words： Acupuncture ;Si Guan Xue ;Cancer pain ;Randomized controlled
trial
20
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