Feng Hui (馮輝), Ma Ying-hui (馬迎輝), Wang Xiao-mei (王曉梅)

1 Shanghai Guanghua Integrative Medicine Hospital, Shanghai 200052, China

2 Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China

3 Shanghai Research Institute of Acupuncture and Meridian, Shanghai 200030, China

Moxibustion on Governor Vessel for ankylosing spondylitis due to kidney yang deficiency: a clinical controlled study

Feng Hui (馮輝)1,2, Ma Ying-hui (馬迎輝)1, Wang Xiao-mei (王曉梅)3

1 Shanghai Guanghua Integrative Medicine Hospital, Shanghai 200052, China

2 Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China

3 Shanghai Research Institute of Acupuncture and Meridian, Shanghai 200030, China

Objective:To observe the clinical effect of moxibustion on Governor Vessel for ankylosing spondylitis (AS) due to kidney yang deficiency.

Moxibustion Therapy; Indirect Moxibustion; Garlic-partitioned Moxibustion; Spondylitis, Ankylosing

Ankylosing spondylitis (AS), a seronegative spondyloarthropathy, is an inflammatory spinal joint disease characterized by lesions in the sacroiliac joint and axial joint, and is clinically manifested by spinal and peripheral arthritis, possibly accompanied by lesions in the ocular, pulmonary, cardiovascular and renal systems[1]. Its etiology and pathogenesis are still unknown. Currently, there is no curative method for this condition. Moxibustion on Governor Vessel is a specific therapy for AS by inducing blisters with herbalpartitioned moxibustion on the spinal segment of Governor Vessel. Based upon syndrome differentiation and clinical practice, in accordance with the long duration of AS and its feature of deficient in root cause and excessive in symptoms, as well as coexistence of deficiency and excess, the Rehabilitation Clinic of our hospital developed a comparative observation on the therapeutic effects of moxibustion on Governor Vessel and sham moxibustion for AS due to kidney yang deficiency, in order to evaluate and explore the application value based upon oral administration of Sulfasalazine tablets. Now, the findings of the study are reported as follows.

1 Clinical Materials

1.1 Diagnostic criteria

1.1.1 Diagnostic criteria of Western medicine

The diagnostic criteria of Western medicine were based upon New York criteria revised by American College of Rheumatology in 1984[2].

Clinical criteria: Low back pain and stiffness over three months, relieved by exercises but not relieved at rest, restricted movement in the frontal and sagittal plane of the lumbar vertebrae, thoracic mobility lower than the normal same-gender adults of corresponding age.

Radiological criteria: Bilateral sacroiliitis ≥ grade 2 or unilateral sacroiliitis in grade 3-4.

AS was diagnosed when the radiological criteria and one item of clinical criteria were complied with.

1.1.2 Syndrome differentiation criteria of traditional Chinese medicine (TCM)

The syndrome differentiation criteria of TCM were stipulated based upon criteria for AS with pattern of kidney yang deficiency in theGuiding Principles for Clinical Study of New Chinese Medicines[3].

Major symptoms: Pain in the lumbar and sacral region, low back and neck, limited movement, morning stiffness, aching or insidious pain in the low back and back, soreness and weakness in the low back and knee, and heel pain.

Associated symptoms: Low spirit, pale complexion, cold sensation in the hand and foot, preference of warmth, aversion to cold, a pale tongue with thin coating, a deep and thready or a weak pulse.

1.2 Inclusion criteria

In conformity with the diagnostic criteria of Western medicine, in conformity with the diagnostic criteria of TCM pattern identification; at the age of 14-55 years old; willing to participate in the clinical study and signed the informed consent.

1.3 Exclusion criteria

Other seronegative spondyloarthropathy, such as psoriatic arthritis, Reiter syndrome, reactive arthritis; undifferentiated spondyloarthropathy; spinal rigidity in the later stage of illness, serious joint deformity; women in pregnancy or lactation; patient with a long-term administration of hormones; and those complicated with serious primary diseases, such as cardiocerebrovascular diseases, hepatic, renal or hematopoietic system diseases.

1.4 Statistical methods

Statistical management was processed by the SPSS 13.0 statistical software. The measurement data were expressed by mean ± standard deviationThe pairedt-test was used for comparison within the group before and after treatment. The variance analysis was applied in comparison between the groups. The Chi-square test was used for the enumeration data.P＜0.05 indicated a statistical significance.

1.5 General data

Totally 60 cases were recruited from inpatients and outpatients of the Rehabilitation Clinic of our hospital from June 2012 to May 2014. In accordance with their visit order, all cases were randomly divided into the treatment group or the control group by random digital table, 30 cases in each group. In the study, 4 cases dropped off (due to personal reasons of the subjects), and there were 56 effective cases, including 29 cases in the treatment group and 27 cases in the control group. The differences in gender, average age, average duration, symptoms integral, physical functions, erythrocyte sedimentation rate (ESR) and C reactive protein (CRP) were not statistically significant by statistical analysis in the patients who finally finished the treatment (allP＞0.05), indicating that the two groups were comparable (Table 1).

2 Therapeutic Methods

The patients in the two groups took Sulfasalazine tablets (manufactured by Shanghai Sunway Pharmaceuticals Co. Ltd., China), 1.0 g every day, twice per day. Four weeks constituted a course. Totally, two courses were given.

Table 1. Comparison of the general data between the two groups

2.1 Treatment group

The patients in the treatment group were treated with moxibustion on Governor Vessel in addition to oral administration of the medication.

Acupoints: Spinal region between Dazhui (GV 14) and Yaoshu (GV 2).

Method: The patient took a prone position to fully expose the back. After routine disinfection of the skin of the acupoints area, ginger juice was applied to the acupoints area. Then, herbal powder [Main ingredients were Rou Gui (Cortex Cinnamomi), Ding Xiang (Flos Caryophylli), She Xiang (Moschus) and Ban Mao (Mylabris)] was sprinkled in a line evenly along the spinous processes. And then, garlic paste was applied in width of 2 cun and thickness of 0.5 cun on the Governor Vessel between Dazhui (GV 14) and Yaoshu (GV 2). Finally, moxa wool was put on the garlic paste, with the transverse section of moxa cone in a triangular form. Afterward, moxa cone was ignited at its head, middle and tail to burn naturally. After it burnt off, new moxa cone was applied for continuous moxibustion. Three moxa cones were given in each session. After moxibustion, garlic paste was removed and the back was cleaned gently with a towel (Figure 1).

2.2 Control group

In addition to oral administration of medication, the patients in the control group were given sham moxibustion. Namely, the acupoints and moxibustion method were as same as those for the treatment group. But, thick paper pad was used between garlic paste and moxa wool. Paper pad could be made of ordinary single-carton paperboard, in thickness of 0.5-1.0 cm, and then garlic paste in thickness of 0.5 cun was put on paperboard again, in order to isolate the heat from burning moxa cone partially. In application, the patient felt gentle heat. Three moxa cones were given in each session. After sham moxibustion, garlic paste was removed and the back was cleaned gently with a towel (Figure 2).

Figure 1. Moxibustion on Governor Vessel

Figure 2. Sham moxibustion

2.3 Daily nursing

One week prior to the treatment, the patient must take light food and vegetable protein, and avoid all seafood, alcohol, sweet and greasy and spicy food. Within one month after moxibustion, the patient must be forbidden to take uncooked, cold, greasy and sweet food, and to take cold-water shower. If blisters appeared after moxibustion, they should be absorbed naturally, by applying the sterile gauze to the back.

3 Observation of Therapeutic Effects

3.1 Observed items

3.1.1 Symptom grading of TCM

In reference to the grading and quantified score criteria of AS main symptoms in the Guiding Principles for Clinical Study of New Chinese Medicines[3], the following 16 symptoms were observed: lumbosacral pain, spinal and back pain, joint tumefaction, fever, restricted mobility in the lumbar spine, morning stiffness, feverish sensation in the joints, cold sensation in the joints, lassitude, pricking pain, soreness and weakness of low back and knee, thirst without desire for drinks, brown urine, heavy sensation in the limbs, dry skin, and seminal emission.

Grading criteria: No symptom was marked as 0 point. Slight symptoms were marked as 2 points. Moderate symptoms were marked as 4 points. Severe symptoms were marked as 6 points.

In this study, 16 symptoms were observed totally. The highest score was 96 points. The lower the points were, the milder the pathological situation was.

The treatment was given once every other day and 4 weeks made a course, for totally 2 courses. The scores were assessed at the end of every course.

3.1.2 Observation scales of Western medicine

Before treatment, after 1-course and 2-course treatments, the observation was processed respectively by the assessment plan for AS therapeutic effects recommended by Assessment in Ankylosing Spondylitis International Society (ASAS), including Bath ankylosing spondylitis disease activity index (BASDAI), visual analogue scale (VAS), Bath ankylosing spondylitis functional index (BASFI) and Bath ankylosing spondylitis metrology index (BASMI). For the thoracic mobility of the patients, Schober experiment was used to observe the ground distance, lateral flexion and backward leaning of the lumbar vertebrae, and occiput-wall distance.

3.2 Criteria of therapeutic effects

In reference to the criteria of quantified scores of TCM syndromes for AS in the Guiding Principles for Clinical Study of New Chinese Medicines[3], Nimodipine method was used to calculate the score-reducing rate of scores of TCM syndromes.

The score-reducing rate ＝ (Total score before treatment － Total score after treatment) ÷ Total score before treatment × 100%.

Clinical cure: Clinical symptoms and signs of TCM disappeared or basically disappeared, and the score-reducing rate ≥95%.

Remarkable effect: Clinical symptoms and signs of TCM were obviously improved, and the score-reducing rate ≥70%, but ＜95%.

Effect: Clinical symptoms and signs of TCM were relieved, and the score-reducing rate ≥30%, ＜70%.

Failure: Clinical symptoms and signs of TCM were not relieved and even aggravated, and the score-reducing rate was less than 30%.

3.3 Lab safety items

Before treatment, after 1-course and 2-course treatments, blood, urine and feces routine, and hepatic functions [alanine transaminase (ALT), aspartate transaminase (AST)], and renal functions [creatinine (Cr) and blood urea nitrogen (BUN)] were respectively inspected.

3.4 Therapeutic results

3.4.1 Changes in quantified scores of TCM syndromes

After 1-course and 2-course treatments, the quantified scores of TCM syndromes obviously improved than those before treatment in the two groups (all P＜0.05). In comparison of the scores between the two groups after 1-course treatment and after 2-course treatment, the statistical differences existed between the treatment group and the control group (P＜0.05). In comparison of scores improvement values between the two groups after 1-course treatment and after 2-course treatment, the treatment group was better than the control group (P＜0.05), and there was no statistical significance in the difference within the groups between the scores after 1-course treatment and after 2-course treatment (P＞0.05). All of the changes indicated that the quantified scores of TCM syndromes in both groups were improved after treatment, and the improvements in the treatment group were better than those in the control group, without significant differences between two courses (Table 2).

Table 2. Comparison of the quantified scores of TCM syndromes

Table 2. Comparison of the quantified scores of TCM syndromes

Note: Compared with the same group before treatment, 1) P＜0.05; compared with the control group, 2) P＜0.05

Group n Before treatment After 1-course treatment Improvement after 1-course treatment After 2-course treatment Improvement after 2-course treatment Treatment 29 26.5±5.3 8.3±2.51)2) 18.2±3.82) 6.8±1.11)2) 19.7±4.32)Control 27 25.8±6.4 16.7±2.61) 9.1±4.6 15.5±2.11) 10.3±3.7

3.4.2 Changes of scores in Western medicine scales

After 1-course treatment, the scores of the observed items in the two groups were all improved than those before treatment, with statistical differences (all P＜0.05). After 1-course treatment, the differences in the scores of the items between the two groups were statistically significant (all P＜0.05). After 2-course treatment, the differences in scores of the items between the two groups were significantly improved than before treatment (all P＜0.05). The differences of between the two groups were statistically significant (all P＜0.05). In inter-group comparisons of the items scores between 1-course and 2-course, the differences were not statistically significant (P＞0.05). It indicated that the scores in Western medicine scales in the two groups were all improved, better in the treatment group (Table 3).

3.4.3 Clinical effect

After 2-course treatment, the difference in the total effective rate between the two groups was not statistically significant (P＞0.05), but the difference of the curative and remarkable effective rate was statistically significant (P＜0.05), indicating that the therapeutic effect was better in the treatment group than that in the control group (Table 4).

Table 3. Comparison of scores of scales

Table 3. Comparison of scores of scales

Note: Compared with the same group before treatment, 1) P＜0.05; compared with the control group at the same time point, 2) P＜0.05

Group n Time BASDAI VAS BASFI BASMI Before treatment 9.74±3.25 5.87±1.23 5.63±1.89 4.88±1.41 Treatment 29After 1-course treatment 4.65±1.131)2) 1.93±0.691)2) 2.16±0.761)2) 1.64±0.431)2)After 2-course treatment 4.64±1.641)2) 1.86±0.831)2) 1.84±0.471)2) 1.53±0.391)2)Before treatment 10.84±3.95 5.67±1.06 5.86±1.85 4.96±1.35 Control 27After 1-course treatment 7.65±1.891) 3.84±1.261) 3.14±1.351) 2.93±1.271)After 2-course treatment 6.78±2.681) 3.45±1.171) 3.04±1.121) 2.74±0.851)

Table 4. Comparison of therapeutic effect between the two groups (case)

3.5 Evaluation of safety

In the treatment group, diarrhea occurred in one case, dizziness in one case and increase of AST in 2 cases. In the control group, headache occurred in one case, stomachache and acid regurgitation in 4 cases and increase of AST in 3 cases.

After symptomatic and liver-protecting treatment, the patients’ symptoms were alleviated and the items were normal, and the treatment continued.

4 Discussion

It is believed in TCM that AS is caused by deficiency of original yang, insufficiency of yin essence in the liver and kidney, deficiency of the Governor Vessel, plus invasion of pathogenic wind, cold, dampness and heat. As a result, interna and external pathogens may block the meridians and cause malnutrition of the tendons and bones. The pathological position of this disease is mostly situated in the spinal column, belonging to the Governor Vessel. The Governor Vessel starts from the uterus, goes through the spine and links with the brain, and intersects with the six yang meridians and governs yang qi of the whole body. This disease is closely associated with the liver, kidney and Governor Vessel. Its pathogenesis is mostly related to deficiency and weakness of yang qi failing to warm up the low back and spine, or deficiency of liver, kidney, essence and blood failing to nourish and moisten the tendons and bones, plus invasion of pathogenic wind, cold and dampness into the lumbar region. Moxibustion on Governor Vessel refers to a specific technique of TCM external therapy by applying herbal-partitioned blistering moxibustion on the Governor Vessel from Dazhui (GV 14) to Yaoshu (GV 2). By the marvelous application of combining skill of Chinese herbs together with the comprehensive effects of the meridians, acupoints, medicine and moxibustion, this technique is designed to target the pathogenesis of ‘deficiency of kidney essence’ in this disease, and also directlyfunction on the pathological position, fully display its effect to replenish essence and benefit marrow, warm up the kidney, strengthen yang and dredge the Governor Vessel, so as to deal with the causative reason in the treatment of the disease. This technique has an advantage irreplaceable by other therapies for AS in pattern of kidney yang deficiency.

In recent years, the biological agents, such as inhibitor of tumor necrosis factor-α (TNF-α), has been used for AS and is the greatest progress in the treatment of AS. But, due to safety and high cost, the biological agents have not been a popular therapy for AS. Instead, Chinese medicine is advantageous in its safety, efficacy and low cost in the treatment of AS. Clinically, the satisfactory effects have been achieved in the treatment of AS by multiple moxibustion methods[5-6]. There are many reports by Chinese scholars about the treatment of AS by moxibustion on Governor Vessel[7]. Zhou ZH, et al discovered that acupuncture-moxibustion at Jiaji (EX-B 2) points could effectively alleviate the clinical symptoms and reduce the inflammatory reaction of the active period for AS patients[8]. Deng YX, et al found out the therapeutic effects of moxibustion on Governor Vessel are satisfactory in relieving fatigue, main signs and main lab indexes of AS patients[9]. Wang Q found out that herbal cake-partitioned moxibustion plus Cloud G for AS is better than singular Cloud G therapy in reducing BASDAI and BASFI[10]. It has also been indicated by the study that ginger-partitioned moxibustion on Governor Vessel could alleviate the symptoms, signs and bone metabolic measurements of AS patients[11]. Zhang WY, et al treated AS by using self-made herbal power for Governor Vessel moxibustion, producing the total effective rate of 100% and alleviating the symptoms and signs of AS patients[12]. Wang SM, et al treated AS by applying moxibustion on the Governor Vessel between Dazhui (GV 14) and Yaoshu (GV 2), able to reduce the inflammatory factors of AS patients and achieve the remarkable clinical effects[13]. Hu SJ, et al treated AS by moxibustion on Governor Vessel plus moving cupping and bleeding method, able to alleviate the patient’s symptoms and signs[14]. Sun XH got remarkable effect in treatment of AS with moxibustion on Governor Vessel plus functional training[15].

It has been proven by the study that after 2-course treatment, the scores of the scales of Western medicine have been improved in the patients of the two groups, better in the treatment group than in the control group, indicating that moxibustion on Governor Vessel can effectively relieve the clinical symptoms of AS patients, reduce the inflammatory reaction of the active period. In comparison after one course of the treatment and two courses of the treatment, the differences of the symptom integrals were not statistically significant in the two groups, indicating the symptoms can be alleviated quickly by one course of the treatment with moxibustion on Governor Vessel plus Sulfasalazine tablets. Because the course of the treatment is short in this study, and the immunological and imaging indexes of AS patients are not observed, it is unable to assess the long-term and comprehensive clinical effects of this therapy for AS. These need to be explored further.

Conflict of Interest

The authors declared that there was no conflict of interest in this article.

Acknowledgments

This work was supported by Traditional Chinese Medicine Project of Shanghai Municipal Commission of Health and Family Planning (上海市衛(wèi)計(jì)委中醫(yī)藥課題資助項(xiàng)目, No. 2012QL045A); Project of Health and Family Planning of Changning District, Shanghai (上海市長(zhǎng)寧區(qū)衛(wèi)計(jì)委課題資助項(xiàng)目, No. 20124ZY03001); Shanghai Cultivation Plan of New Stars in Xinglin (上海市“杏林新星”計(jì)劃資助項(xiàng)目，No. ZYSNXD011-RCXLXX-20130042).

Statement of Informed Consent

Informed consent was obtained from all individual participants included in this study.

Received: 15 May 2015/Accepted: 23 June 2015

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Translator: Huang Guo-qi (黃國(guó)琪)

督灸治療腎陽虧虛型強(qiáng)直性脊柱炎臨床對(duì)照研究

目的：觀察督灸治療腎陽虧虛型強(qiáng)直性脊柱炎(ankylosing spondylitis, AS)的臨床療效。方法：將60例活動(dòng)性腎陽虧虛型AS患者按隨機(jī)數(shù)字表隨機(jī)分為治療組和對(duì)照組, 每組30例。兩組均予口服柳氮磺吡啶片治療,治療組在此基礎(chǔ)上予督灸, 對(duì)照組予安慰灸。隔天治療1次, 4星期為1個(gè)療程, 共治療2個(gè)療程。分別于治療前、治療1個(gè)和2個(gè)療程后觀察并記錄中醫(yī)證候量化積分和國(guó)際AS評(píng)價(jià)組推薦的癥狀積分[包括Bath強(qiáng)直性脊柱炎疾病活動(dòng)性指數(shù)(Bath ankylosing spondylitis disease activity index, BASDAI)量表、疼痛視覺模擬量表(visual analogue scale, VAS)評(píng)分、Bath強(qiáng)直性脊柱炎功能指數(shù)(Bath ankylosing spondylitis functional index, BASFI)量表和Bath強(qiáng)直性脊柱炎測(cè)量學(xué)指數(shù)(Bath ankylosing spondylitis metrology index, BASMI)], 監(jiān)測(cè)安全性指標(biāo)的變化。結(jié)果：治療1、2個(gè)療程后, 兩組患者中醫(yī)證候量化積分均較治療前明顯改善(P＜0.05),治療組改善情況優(yōu)于對(duì)照組(P＜0.05)。兩組組內(nèi)比較, 治療1個(gè)療程和2個(gè)療程后的評(píng)分均無統(tǒng)計(jì)學(xué)差異(P＞0.05)。兩組患者治療1個(gè)療程后癥狀積分各項(xiàng)指標(biāo)均較治療前改善(P＜0.05); 治療 2個(gè)療程后, 治療組的療效更顯著, 與對(duì)照組差異有統(tǒng)計(jì)學(xué)意義(P＜0.05)。治療過程中兩組安全性指標(biāo)未發(fā)現(xiàn)明顯異常。結(jié)論：督灸能有效緩解AS患者的臨床癥狀, 無明顯不良反應(yīng)。

灸法; 間接灸; 隔蒜灸; 脊柱炎, 強(qiáng)直性

R245.6 【

】A

Author: Feng Hui, grade 2011 doctor degree candidate, deputy chief physician.

E-mail: fh207@hotmail.com

Methods:A total of 60 patients of AS due to kidney yang deficiency were randomly divided into a treatment group and a control group by random digital table, 30 cases in each group. Both of the two groups were treated by oral administration of Sulfasalazine tablets. Additionally, the treatment group was given moxibustion on Governor Vessel, and the control group was given sham moxibustion. The treatment was given once every other day, 4 weeks constituted one course, 2 courses in total. Before treatment, after 1-course and 2-course treatments, the quantified scores of traditional Chinese medicine (TCM) syndromes and the symptoms scores recommended by AS International Society [including Bath ankylosing spondylitis disease activity index (BASDAI), visual analogue scale (VAS), Bath ankylosing spondylitis functional index (BASFI) and Bath ankylosing spondylitis metrology index (BASMI)] were respectively observed and recorded, and the change of safety item was monitored.

Results:After 1-course and 2-course treatments, the quantified scores of TCM syndromes were obviously improved than those before treatment in the two groups (P＜0.05), and the score was improved better in the treatment group than that in the control group (P＜0.05). In comparison within the group, there were no statistical differences between the scores after 1-course treatment and 2-course treatment in the two groups (P＞0.05). After 1-course treatment, the items of the symptoms scores were improved than those before treatment in the two groups (P＜0.05). After 2-course treatment, the therapeutic effect was more remarkable in the treatment group, with a statistical difference between the two groups (P＜0.05). During treatment, no obvious abnormality in all safety items was noticed in the two groups.

Conclusion:Moxibustion on Governor Vessel can effectively relieve the clinical symptoms of AS patients, without obvious adverse reaction.