ZHANG Bi-meng, et al. Treatment of Lumbar Intervertebral Disk Herniation with Electric Acupuncture DOI: 10.1007/s11726-007-0220-4

Clinical Study

Treatment of Lumbar Intervertebral Disk Herniation with Electric Acupuncture ZHANG Bi-meng(张必萌)1, WU Yao-chi(吴耀持)1, SHAO Ping(邵 萍)2 1. No 6 People's Hospital, Shanghai Jiaotong University, Shanghai 200233, P. R. China 2. Shanghai Municipal TCM Hospital, Shanghai 200000, P. R. China

摘要 目的：对电针治疗腰椎间盘突出症的疗效进行客观评价。方法：采用随机对照的 研究方法，将 200 例患者分为两组，观察组 100 例，采用电针疗法进行治疗；对照组 100 例，采用口服莫比可药物治疗。结果：观察组治疗腰突症的总有效率为 86.5％，对照组 总有效率为 75.0％，两组间差异存在显著性意义（P＜0.01） 。结论：电针疗法治疗腰突症 疗效显著，安全性高。 关键词 椎间盘移位；针灸疗法；电针 Abstract Objective: To make objective evaluation on treatment of lumbar intervertebral disc herniation with electric acupuncture. Method: All 200 cases were randomly allocated into an observation group (100 cases) and a control group (100 cases). Cases in the observation group were treated with electric acupuncture. Cases in the control group were treated with oral administration of Mobic. Result: The total effective rate in the observation group was 86.5%, and the total effective rate of the control group was 75.0%. There was a significant difference between the two groups (P<0.01). Conclusion: Electric acupuncture is a safe and remarkably effective way for lumbar intervertebral disc herniation. Key Words Intervertebral disk Displacement; Acupuncture-Moxibustion Therapy; Electroacupuncture CLC Number: R246.6 Document Code: A Lumbar intervertebral disc herniation (LDH) is a disorder caused by rupture of fibrous rings and compression of nucleus pulposus evagination on the nerve root or spinal cord on the basis of degeneration of lumbar intervertebral discs. It may result from acute injury, accumulative strain and external contraction of wind and cold. It is clinical characterized by the lower back pain, the referred pain or numbness in the unilateral or bilateral lower limbs, possibly restricted motor function, incontinence of urine and bowel movement, and muscular atrophy. LDH may severely affect the people's normal life and work [1-3]. About 18.0% of low back pain or leg pain sufferers may develop LDH. All kinds of therapies Author: ZHANG Bi-meng (1974- ), male, medical doctor. Research orientation: Clinical and Pre-clinical study on Treatment of Pain and Immune Diseases with Acupuncture. E-mail: [email protected] ●

for LDH have their respective limitations. We made a clinical study on 200 LDH cases, treated 100 cases with electric acupuncture and obtained satisfactory results.

Clinical Data 1. Diagnostic criteria Unilateral, bilateral and central LDH cases were selected by referring to the relevant LDH diagnostic criteria in the Diagnostic and Therapeutic Effect Criteria of TCM Syndromes issued by the State Administration of Traditional Chinese Medicine and the Shanghai Diagnose and Treatment Routines of TCM syndromes [4] issued by Shanghai Municipal Health Bureau. 2. Inclusive criteria Men or women aged from 25 to 60 years old; they

216 ●︱Copyright © 2007 Shanghai Research Institute of Acupuncture and Meridian

Journal of Acupuncture and Tuina Science, Volume 5, Number 4, 2007 August

discontinue other therapies during this clinical study; and they are willing to participate in this study and sign the Informed Consent. 3. Exclusive criteria The LDH cases have complications of lumbar spondylolisthesis; complications of general collagenous immune diseases or other acute or chronic infection; or those who are using glucocorticoids that may affect the result evaluation; and those who became worse or got severe complications during the study. 4. Termination or drop-out criteria Those who got allergic reaction or severe adverse reactions before completing the treatment course should be terminated by the doctor. However, those who finished more than 1/2 of the treatment course should also be counted into the therapeutic effect statistics. Those who deteriorated or may get life-threatening conditions should be terminated immediately by the doctor. However, those who finished more than 1/2 of the treatment course should not be counted into the therapeutic effect statistics. 5. Source of cases The 200 cases are from LDH diagnose and treatment center of No 6 People's Hospital, Shanghai Jiaotong University and outpatient department of Shanghai Municipal TCM Hospital. All cases are willing to participate in this study. The 200 cases were randomly allocated into an electric acupuncture group (100 cases) and a Western drug group (100 cases) by simple numeration table methods. (During the study, one case in the electric acupuncture group dropped out and one cases lost contact with us; one case in the Western drug group dropped out and 3 cases lost contact with us. All those cases were not considered in the final effect counting. The detailed information about the cases is shown in table 1. The rank-sum test indicated that there is no significant difference (P>0.05) between the two groups in terms of age and pre-treatment grades on

symptoms and sign, and the two groups are comparable.

Therapeutic Approaches 1. Observation group Basic points: Jiaji points (Ex-B 2), Yaoyangguan (GV 3), Huantiao (GB 30), and Yanglingquan (GB 34). For cold-dampness, add Hegu (LI 4); for blood stasis, add Geshu (BL 17); and for deficiency of the liver and kidney, add Sanyinjiao (SP 6). All the points are located according to the WHO standard. Operation: After routine sterilization with 75% alcoholic cotton ball, stainless filiform needles 0.38mm in diameter and 40 mm or 70 mm in length (Huatuo Brand manufactured by Suzhou Medical Equipment Factory, SYXDZ 91 No 2150012, manufacture permission No: XK24-005-0030) were inserted 1.5-2 cun, followed by 2-min reinforcing and reducing manipulations by rotating for each point until a electric shock sensation. The needling sensation of Huantiao (GB 30) should radiate to the external genitalia. After that, the needles were connected to G6805-II electric stimulator for 20 min (Manufactured by Shanghai Gaoxin Medical Equipment Company, standard No: Q/CYBV24-2000, registration No: HYGXZZ2001 No 2260532) with continuous wave, a frequency of 40HZ, current intensity of 2mA. The treatment was done once every day; 10 days make up one treatment course. The patients were treated for two courses (a 5-day interval between the two courses). 2. Control group Cases in the control group took 7.5mg of Mobic tablet (manufactured by Boehringer Ingelheim Group from Germany, Permission No: GYZZ (2001) Z_58, 7.5mg/tablet) each day with water or liquid food after meals, 10 days make up one treatment course. After a 5-day interval, the patients continued to take the tablets for another 10 days.

Table 1. Baseline comparison between the two groups Mean age(x¯ ±s)

Duration

Pre-treatment grades (x¯ ±s)

46

47.6±5.23

1month-20years

10.1±1.87

47

46.9±6.12

3 weeks-20 years

9.86±1.80

Group

N Male

Female

Observation group

98

52

Control group

96

49

Copyright©2007 Shanghai Research Institute of Acupuncture and Meridian ●︱ 217

●

Journal of Acupuncture and Tuina Science, Volume 5, Number 4, 2007 August Table 2. Scoring standard for clinical symptoms and signs Scores

0

1

2

3

Low back pain

Not obvious

Occasional and mild

Occasional and severe; or

Frequent and severe

Pain or numbness

Not obvious

Occasional

Sensation

Normal sensation in

Mild sensory disturbance

Obvious sensory disturbance in

the lower limbs

in the lower limbs

the lower limbs

Walking ability

Normal walking

Pain, numbness or

Pain, numbness or weakness

Pain, numbness or

ability

weakness after walking

within 500 meters of walking

muscle weakness within

frequent and mild Frequent and mild or

in the lower limbs

Frequent and severe

occasional and severe

for more than 500 meters

100 meters of walking

Straight leg raising test

>70°

30°-70°

<30°

Muscle power

Normal muscle

Mild decrease of muscle

Severe decrease of muscle

power

power

power

Table 3. Treatment effect comparison between the two groups (cases) Group

N

Recovery

Better

Failure

Effective rate (%)

Observation group

98

43

42

13

86.5

Control group

96

22

50

24

75.0

Table 4. Improvement on different symptoms by different therapies Symptoms Low back pain

Group

Cases Recovery

Better Failure Effective rate (%)

Mean R value

u

P

2.97

P＜0.01

4.29

P＜0.01

2.60

P＜0.01

2.90

P＜0.01

2.97

P＜0.01

2.97

P＜0.01

Observation

90

43

39

8

91.1

0.5390

Control

89

20

53

16

82.0

0.4073

Pain or numbness

Observation

96

56

30

10

89.6

0.5905

in the lower limbs

Control

91

23

42

26

71.4

0.4046

Walking ability

Observation

85

44

31

10

88.2

0.5567

Control

80

26

34

20

75.0

0.4398

Sensory function

Observation

80

40

30

10

87.5

0.5670

of the lower limbs

Control

84

24

37

23

60.7

0.4361

Straight leg raising Observation

82

42

30

10

87.8

0.5683

test

Control

88

26

38

24

72.7

0.4364

Muscle power

Observation

72

38

24

10

86.1

0.5719

Control

74

20

34

20

72.9

0.4300

Table 5. Comparison of adverse reactions between the two groups Group

N

Poor appetite

Nausea Edema

Dizziness & headache

Local hematoma

Epigastric pain

Observation

98

0

0

0

0

3

0

Control

96

12

21

1

2

0

18

Therapeutic Efficacy Observation 1. Scoring standard for clinical symptoms and signs (table 2) 2. Evaluation of clinical effect The evaluation is based on the effect standard of LDH from the Shanghai Diagnose and Treatment Routines of TCM Syndromes issued by Shanghai Municipal Health Bureau in 1988. ●

3. Treatment result The treatment effect comparison between the two groups is shown in table 3. Ridit analysis showed the mean R values of the electric acupuncture group and the Western drug group were 0.5613 and 0.4374 respectively, u=2.99＞ 2.58 and P＜0.01. There was a significant difference between the two groups. Research findings indicated that the effect of the electric acupuncture group was

218 ●︱Copyright©2007 Shanghai Research Institute of Acupuncture and Meridian

Journal of Acupuncture and Tuina Science, Volume 5, Number 4, 2007 August

better than the Western drug group. The improvement on different symptoms by different therapies is shown in table 4. Ridit analysis suggested that there was a significant difference between the two groups in terms of treatment effect (P<0.01), indicating that electric acupuncture works better than Western drugs on symptoms such as low back pain, pain or numbness in the lower limbs, walking ability, skin sensory function of the lower limbs, straight leg raising and muscle power. The comparison of adverse reactions between the two therapies is shown in table 5. The main adverse reaction from electric acupuncture was local hematoma: the incidence rate was 3.1%; and it can be managed by pressure or cold compression within 24 hours and hot compression after 24 hours. The main adverse reaction from Western drug was gastrointestinal reaction: mostly mild or moderate and may not need special management and some may need symptom-oriented measures.

Discussion Since mechanical compression used to be considered as the direct cause for LDH-related low back pain and leg pain, removal of herniated disc has been the first choice to eradicate the compression to the nerve root. However, the up-to-date study suggested that the herniation degree and compression degree to the nerve root are not always consistent with the patients' clinical symptoms[5]. Myriad clinical data indicated that most patients still have herniation by re-examination of CT scanning and MRI even after they recovered from non-surgical therapies, and there is a slim chance for complete reduction. That tells us the treatment of LDH does not necessarily mean a removal or reduction of the herniated nucleus pulposus. There was no LDH in traditional Chinese medicine. It falls under the category of "Bi-arthralgia syndrome" or "low back pain or back pain". The yang meridians pass through the lumbar area. External contraction of six pathogenic factors may affect the meridians through the skin and skin hair, cause qi and blood stagnation of the meridians and result in low back pain. The Bai Bing Shi Sheng No 66 of Ling Shu ·(《灵

枢·百病始生第六十六》) states that "Exogenous pathogenic factors always attack the body skin first and cause skin pain. Then they go deeper and enter meridians and collaterals and cause muscle pain, joint pain and low back pain." The Nei Jing 《内经》 ( ) listed six pathogenic factors may attack the meridians and cause low back pain: cold, dampness, heat, dryness, damp-heat and cold-dampness, especially wind, cold and dampness. The Bi Lun Pian of Nei Jing (《内经· 痹论篇》) states that "Wind, cold and dampness may attack the body simultaneously and cause Bi-arthralgia syndrome". In addition to the knowledge about wind, cold and dampness may cause low back pain and leg pain, doctors in different generations also mentioned that deficiency may cause Bi-arthralgia syndrome as well. The Yin Yang Ying Xiang Da Lun Pian of Su Wen 《 ( 素问·阴阳应象大论篇》) states that "After 40 years old, the body's yin-qi lost almost half". The Zhang Shi Yi Tong (《张氏医通》) mentions the theory of "Sitting a long time to read and play chess may cause low back pain", which is exactly the same as the modern medicine in that accumulative strain causes low back pain and leg pain. In short, the extrinsic factors of low back pain and leg pain include wind, cold, dampness and chronic strain (or sitting position for a long time), and the intrinsic factor is deficiency of the liver and kidney. Its pathogenesis is deficiency in the root cause but excess in symptoms. Based on the point selection principle of "All points are indicated for problems along the running course of their meridians", local points and points of Governor Vessel, bladder meridian and gallbladder meridian are always selected for LDH. The point Yaoyangguan (GV 3) is located below the spinous process of L4 and has been proved by doctors in different generations to strengthen the lumbus and knee joints. Modern electrophysiology study proved that electric stimulation on the Governor Vessel can kill pain by exciting the descending inhibition and controlling or affecting the pain impulse within the spinal cord. The neurochemistry study showed that electric stimulation on the Governor Vessel can increase the level of 5-HT and its metabolic product 5-HIAA in the brain stem and caudate nucleus, and tryptamine plays a key role in acupuncture analgesia. The point Huantiao (GB 30), a crossing point of gallbladder meridian and bladder meridian, can remove wind, resolve dampness and dredge meridians. Doctors in different generations

Copyright©2007 Shanghai Research Institute of Acupuncture and Meridian︱ ● 219

●

Journal of Acupuncture and Tuina Science, Volume 5, Number 4, 2007 August

have been selecting this point for pain in the lower limbs and hemiplegia. The empirical study from both home and abroad proved that electric stimulation on Huantiao (GB 30) can stop pain. The patients in the control group didn't show any obvious changes in the pain threshold within 1 hour of the experiment. But the patients in the electric stimulation group showed an obvious increase of the pain threshold. The study also suggested that the analgesic action from electric stimulation on Huantiao (GB 30) relates to individual response. The point Yanglingquan (GB 34), one of the five-Shu points and the influential point of the tendon, can remove wind, stop spasm, soothe the liver and gallbladder, relax tendons and dredge meridians. Modern study proved that stimulating this point can relieve the spasm of sphincter Oddi and stop pain. Other studies also suggested that needling this point can influence the changes of cerebral blood flow. This study adopted the randomly controlled method for treatment effect comparison between electric acupuncture and Western drug on LDH. The result indicated that electric acupuncture showed a significantly better effect (P<0.01) in improving symptoms such as the low back pain, pain or numbness in the lower limbs, walking ability, straight leg raising and muscle power than Western drug. The observation on adverse reactions of the two therapies showed that Western drug may cause adverse reactions such as a poor appetite, nausea, epigastric pain, edema, and dizziness and headache. However, electric acupuncture didn't show any obvious adverse reactions except for local hematoma. The above

findings suggested that electric acupuncture is superior to Western drug in terms of improving the main symptoms of LDH and avoiding adverse reactions. Since the samples in this study are not large enough, the conclusion needs further study. Also, because of the limited condition, we didn't do further study on combination of the electric acupuncture and Western drug and cannot answer the following two questions: Does the combined electric acupuncture and Western drug have the strong points in "enhancing the effect but reducing the adverse reactions"? Can the combined electric acupuncture and Western drug have similar action after reducing the dose of Western drug?

Reference [1] Saal JA, Saal JS. Nonoperative Treatment of Herniated Lumbar Intervertebral Disc with Radiculopathy, An Outcome Study. Spine, 1989; 14:431-7 [2] Wiesel SW, Tsourmas N, Feffer HL, et al. A Study of Computer-Assisted Tomography. I. The Incidence of Positive CAT Scans in an Asymptomatic Group of Patients. Spine, 1984; Sep; 9(6): 549-51 [3] HU You-gu. Lumbar Intervertebral Disc Herniation. 2nd Edition. Beijing: People's Medical Publishing House, 1995: 44-136 [4] Shanghai Municipal Health Bureau. Shanghai Diagnose and Treatment Routines on TCM Syndromes. 1998: 310. [5] Kawakami M, Tamaki T, Hayashi N, et al. Possible Mechanism of Painful Radiculopathy in Lumbar Disc Herniation. Clin Orthop Relat Res, 1998, Jun; 351: 241-51. Translator: HAN Chou-ping (韩丑萍) Received date: May 6, 2007

● Advance Notice ● Main Contents of the Fifth Issue in 2007 ● Observations on the Clinical Curative Effect of Acupuncture on Chloasma ● Clinical Observations on Treatment of Lumbar Vertebra Disease by Aligned Point through point Acupuncture ● Observations on the Efficacy of Multineedle Pointthroughpoint Acupuncture for Treating 55 Patients with Shoulder Periarthritis ● Observations on the Longterm Efficacy of Acupuncture and Moxibustion Lus Neck Immobilization for Treating Cervical Spondylopathy ● Influence of Early Acupuncture on Cerebral Resuscitation in Cardiac Arrest Patients ● Observation on the Curative Effect of Acupuncture on Child Tourette's Syndrome ● Treatment of 73 Cases of Bed Sores with Warming Moxibustion ● Clinical Observation of Electroacupuncture in Treating Spastic Paralysis Following Cerebral Infarction

●

220 ●︱Copyright©2007 Shanghai Research Institute of Acupuncture and Meridian