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J. Acupunct. Tuina. Sci.

2010, 8 (4): 249-252


DOI: 10.1007/s11726-010-0420-1

Clinical Study

Study on the Effect of Acupuncture plus Methylcobalamin in


Treating Diabetic Peripheral Neuropathy
ZUO Lin ()1, ZHANG Lin ()2
1 Guilin Hospital of Traditional Chinese Medicine, Guangxi 541001, P. R. China
2 No. 1 Hospital Affiliated to Guangxi Medical University, Guangxi 530021, P. R. China

75 40 35
4
(P<0.05)

AbstractObjective: To study the clinical effect of acupuncture combined with methylcobalamin


in the treatment of diabetic peripheral neuropathy. Methods: Seventy-five diabetic patients
complicated with peripheral neuropathies were included and randomly allocated into a treatment
group (40 cases) and a control group (35 cases). The patients in the treatment group all received
acupuncture therapy plus methylcobalamin. In the control group, patients only received
methylcobalamin for treatment. The therapeutic effect was evaluated 4 weeks later. Results: Both of
the two groups presented improvement in nervous symptoms, signs and nerve conduction, and the
improvement of the treatment group was significantly better than that of the control group (P<0.05).
Conclusion: The therapy of acupuncture in combination with methylcobalamin is more effective than
the monotherapy with methylcobalamin in the treatment of diabetic peripheral neuropathy.
Key WordsAcupuncture-moxibustion Therapy; Acupuncture Medication Combined; Diabetic
Neuropathies
CLC NumberR246.6
Document CodeA
Diabetic peripheral neuropathy (DPN) is one of
the common complications of diabetes. With an
insidious onset, it can severely affect the physical
and mental health of the patients as well as their
quality of life. In Western medicine, DPN is treated
by conventional drugs, which cannot obtain a
satisfactory result despite the high price. Traditional
Chinese medicine has an advantage of an overall
regulation. It has, therefore, become a focus of the
scholars to combine Chinese and Western medicines
together in the treatment of DPN. We have adopted
acupuncture therapy in combination with
medication in the management of DPN, and now
report as follows.
Author: ZUO Lin (1979- ), male, attending physician

1 Clinical Data
1.1 Diagnostic criteria
Diabetes is diagnosed in reference to the diabetic
diagnostic criteria issued by the American Diabetes
Association in 1997.
The diagnostic criteria of peripheral neuropathy
cover the following aspects.
Sensory neuropathies are manifested by pain
(the pain can be burning, stabbing, dull or bursting,
etc.), hypersensitivity to temperature, numbness,
and stocking-glove distribution.
Motor neuropathies are manifested by
instability of gait, loss of ability to walk on heels, or
limited motion.

Shanghai Research Institute of Acupuncture and Meridian and Springer-Verlag Berlin Heidelberg 2010 249

J. Acupunct. Tuina. Sci. 2010, 8 (4): 249-252

Deep or superficial sensations are obviously


degenerated, as well as degenerated or diminished
Achilles reflex.
The electromyography reveals disturbance in
sensorimotor nerve conduction.
The peripheral neuropathies produced by
other causes should be excluded.
1.2 General data
The 75 diabetic patients complicated with
peripheral neuropathies were included between
March 2007 and March 2009, and then randomly
divided into a treatment group and a control group.
Of the 40 cases in the treatment group, 21 were
male and 19 were female, aged between 28 and
75 years (57.6 years on average), with duration
ranged from 5 to 20 years (8.7 years on average). Of
the 35 cases in the control group, 20 were male and
15 were female, aged between 26 and 75 years
(57.1 years on average), with duration ranged from
4 to 21 years (8.5 years on average).
The two groups were comparable as there was no
statistical significance in the comparison of the
general data between the two groups according to
statistical analysis.
1.3 Statistical analysis
The measurement data were expressed by ( x s),
with the inter-group comparisons pre- and
post-treatment performed by two independent
sample t test, and the inner-group comparison
performed by paired t test. The effectiveness was
expressed by percentage, and the inner-group
comparison of the effectiveness was performed by
Chi-square test. P<0.05 was considered to have a
statistically significant difference. All data analyses
were performed by using SPSS 16.0 version
software.

2 Methods
Prior to treatment, all patients had received a
diabetic diet, studied the knowledge about diabetes
mellitus, and they were undergoing kinetotherapy.
And they had also learnt to self-detect the severity
of diabetes and to take hypoglycemic agents

reasonably to keep the glucose level within the


normal range.
2.1 Treatment group
2.1.1 Acupuncture
Acupoints: Bilateral Zusanli (ST 36), Sanyinjiao
(SP 6), Taixi (KI 3), Quchi (LI 11), Hegu (LI 4),
Waiguan (TE 5), as well as Guanyuan (CV 4) and
Qihai (CV 6).
Operation: The operator did acupuncture
treatment when the patient lay on his or her back,
with needles of 0.30 mm in diameter, puncturing
perpendicularly by depth of 0.5-3.0 cun. The
needles were retained for 60 min, and the even
reinforcing-reducing manipulation was applied once
every 30 min, lasting for about 1 min each time. The
acupuncture treatment was given once everyday.
2.1.2 Medication
Methylcobalamin of 500 g was administered by
i.v., once a day.
2.2 Control group
The patients in the control group only received
medication treatment with methylcobalamin, by the
same way as in the treatment group.
For both of the two groups, 4 weeks of treatment
made up a treatment session, and the therapeutic
effect would be evaluated at the end of a session.

3 Results
3.1 Evaluation indexes
3.1.1 Evaluation of symptoms and signs
The symptoms and signs were examined by the
same doctor, in accordance with the Guiding
Principles for Clinical Study of New Chinese
Medicines.
Marked effectiveness: The patient tells that the
symptoms and signs are diminished.
Effectiveness: The patient tells that the symptoms
and signs are reduced.
Failure: The patient complains of no
improvement in symptoms or signs.

250 Shanghai Research Institute of Acupuncture and Meridian and Springer-Verlag Berlin Heidelberg 2010

J. Acupunct. Tuina. Sci. 2010, 8 (4): 249-252

significantly higher than that of the control group


(P<0.05).

3.1.2 Nervous system examination


According to the scoring table of Dyck[1], the
protective sensation of the limbs were detected by
single-fiber nylon thread of 10 g. 0 standing for
normal; 1 for damage limited at toes; 2 for damage
limited in the lower half of the sole; 3 for damage
located under the ankle joint; 4 for damage
approaching to the middle of the calf; 5 for damage
approaching to the knee joint.
The examinations of patellar reflex and Achilles
jerk: 0 stands for normal; 1 for hyperreflexia and
2 for hyporeflexia.
3.1.3 Nerve conduction velocity
The motor and sensory nerve conduction
velocities of the median and peroneal nerves were
detected[2].
3.2 Therapeutic results
3.2.1 Improvement of symptoms and physical signs
Of the 40 cases in the treatment group, 20 cases
got marked effectiveness, and 16 cases showed
effective, but 4 cases failed, with the effective rate
of 90.0%. Among the 35 cases in the control group,
11 cases showed marked effectiveness, and
9 showed effective, but 10 failed, with the effective
rate of 77.1%. Performed by the Chi-square test, the
effective rate of the treatment group was

3.2.2 Comparison of nervous system examination


There was no significant difference between the
two groups in the comparison of nervous signs
before treatment. After treatment, the nervous
system score of the treatment group had a
significant decrease compared with that of the
control group (P<0.001). And the difference of the
nervous system score between pre-treatment and
post-treatment of the treatment group was also
statistically significant (P<0.001) (table 1).
Table 1. Changes of nervous system scores ( x s, score)
Groups

Pre-treatment

Post-treatment

Treatment

40

2.260.49

1.120.591)2)

Control

35

2.190.51

1.640.45

Note: Compared with the control group post-treatment, 1P<0.001;


intra-group comparison with pre-treatment, 2P<0.001

3.2.3 Changes of nerve conduction velocity


There was no significant difference between the
two groups in the comparison of nerve conduction
velocities. After treatment, the MCV and SCV of
the treatment group was markedly faster than that of
pre-treatment (P<0.01), and it had a significant
increase compared with the control group (P<0.01)
(table 2).

Table 2. The comparison of nerve conduction velocity between pre-treatment and post-treatment ( x s, m/s)
Groups

Treatment

40

Control

35

Time

MCV
Median nerve

SCV
Peroneal nerve

Median nerve

Peroneal nerve

Pre-treatment

41.111.46

39.914.23

36.453.61

33.493.64

Post-treatment

47.656.131)

46.705.931)

41.826.511)

40.696.421)

Pre-treatment

39.092.74

38.703.98

36.123.42

33.992.91

Post-treatment

40.344.59

39.793.66

38.433.941)

37.284.011)

Note: Intra-group comparison with pre-treatment, 1) P<0.01

4 Discussion
Diabetes mellitus is a commonly encountered
metabolic and endocrine disease. It falls under the
category of "Xiao Ke (wasting & thirsting
disorder)" in traditional Chinese medicine. DPN is
one of the chronic complications and causes for
disability, usually preceding the occurrence of

diabetic symptoms. In is covered by Bi-impediment


or Wei-flaccidity syndrome in Chinese medicine.
Currently, with knowledge of the pathogenesis and
clinical manifestations of DPN, a cohort of
physicians hold that DPN results from poor
circulation of qi and blood, malnutrition of muscles
and tendons, which causes qi deficiency, blood
stasis and phlegm retention in collaterals. This

Shanghai Research Institute of Acupuncture and Meridian and Springer-Verlag Berlin Heidelberg 2010 251

J. Acupunct. Tuina. Sci. 2010, 8 (4): 249-252

condition is closely related to the liver, spleen and


kidney. Qi deficiency is the root cause, while blood
stasis and phlegm are external manifestations[3].
According to Western medicine, the major
pathogenic changes of DPN are the fragmental
demyelination of nerve fiber and axon regeneration
dysfunction, and finally there degeneration appears.
The general mechanism includes blood circulation
dysfunction (diabetic microangiopathies affect the
function of vascular endothelial cells, resulting in
the blockage in small vessels), diabetic dysfunction
(hyperglycemia activates multi-membrane channels,
causing deficit of inositol, and decreased
concentration of diacylglycerol, which acting as the
second messenger of Na+-K+-ATP enzyme).
Compared with the limited treatment methods and
indefinite therapeutic results of Western medicine,
Chinese medicine addresses this problem in an
integral way. Lots of clinical trials have proved that
DPN responds well to acupuncture-moxibustion
therapy, with the total therapeutic rate beyond
80.0%. The treatment principle of acupuncturemoxibustion therapy is to reinforce qi and activate
the blood circulation, and to resolve phlegm and
unblock the collaterals. Its therapeutic result goes in
direct proportion with the treatment time, and in
inverse proportion to the disease duration.
This study chose Zusanli (ST 36), the He-Sea
point of the stomach meridian, to diminish dry-heat,
tonify qi of the spleen, and resolve phlegm and
unblock the stagnation. The acupoint Quchi (LI 11)
is the He-Sea point of the large intestine meridian,
acting to treat the diseases related to this meridian.
Hegu (LI 4) is the Yuan-Primary point of the large
intestine meridian. Combined with Sanyinjiao
(SP 6), it functions to regulate qi of the Spleen
Meridian, by strengthening the spleen, invigorating
blood and resolving turbidity. As the Yuan-Primary
point of the Kidney Meridian, Taixi (KI 3) can
nourish kidney yin. Waiguan (TE 5) works to
unblock the stagnation in collaterals and nurture
tendons and meridians. Guanyuan (CV 4) and Qihai
(CV 6) can regulate qi and blood. Clinical studies
have revealed that acupuncture cannot directly
reduce the content of glucose, but it mitigates the
insulin resistance and endocrine disorders, improves
the glucose and lipid metabolism through
modulating the body function in a general way[4-6].

Methylcobalamin, a vitamin B12 analogue, can


penetrate into the organelles of the neuronal cells,
acting as a role in the metabolism of lipid. In the
process of methyl transfer, methylcobalamin helps
the synthesis of lecithin to heal the damaged nerve
fiber, speed up the nerve conduction, and finally
enhance the synthesis of DNA and RNA, and the
formation of the myelin sheath. Therefore,
methylcobalamin can help repair the damaged
peripheral nerves. This study suggests that
acupuncture in combination with methylcobalamin
can significantly improve the nervous symptoms
and signs, as well as the MCV and SCV of the
median and peroneal nerves. This method had a
better treatment result than the application of
methylcobalamin alone in the treatment of DPN,
and it did not show any adverse effect in the whole
study. It indicates that it is safe and effective to
apply acupuncture therapy in the management of
DPN. Moreover, it can address the problem of a
variety of pathogenesis for DPN in combination
with methylcobalamin with a better therapeutic
result.

References
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Polyneuropathy: Assessed in Diabetics. Muscle Nerve,
1998, 11(1): 21-32.
[2] CHANG Hong. The Detective Analysis on the
Comprehensive Electrophysiology of EMG, SCV, MCV
and SEP in Diabetic Peripheral Neuropathologies. Acta
Academiae Medicinae Xuzhou, 2000, 20(5): 427-428
[3] ZHENG Hui-tian, LI Yong-fang, CHEN Guo-mei, et al.
Influence of the Kidney-tonifying and Meridian-dredging
Method in Acupuncture on Nerve Conduction Velocity of
Diabetic Peripheral Neuropathy. Acta Universitatis
Traditionis Medicalis Sinensis Pharmacologiaeque
Shanghai, 2000, 14(2): 58-60
[4] SUN Yuan-zheng, XU Ying-ying. Clinical Observations
on Treatment of 26 Diabetic Peripheral Neuropathy
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[5] ZHANG Xiu-hong. Clinical Study on Diabetic Peripheral
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[6] YAN Ji-hong. Treatment of 46 Cases with Diabetic
Peripheral Neuropathy by Acupuncture plus Methycobal.
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Translator: HONG Jue ()
Received Date: April 20, 2010

252 Shanghai Research Institute of Acupuncture and Meridian and Springer-Verlag Berlin Heidelberg 2010