Hangzhou Chinese Medicine Hospital, Zhejiang 310015, China

CLINICAL STUDY

Chinese Herbal Foot Bath plus Acupoint Massage Beneficial to the Improvement of Grade 0 Diabetic Foot

Lin Xiao-xia, Xu Xu-yuan, Shangguan Bin-bin

Hangzhou Chinese Medicine Hospital, Zhejiang 310015, China

Author:Lin Xiao-xia, bachelor, nurse practitioner.

E-mail: happytrouble@163.com

Objective: To observe the clinical effect of foot bath withTao Hong Si Wu Tangplus massage on acupoints at the sole for grade 0 diabetic foot.

Methods: One hundred and sixty eligible cases were randomly divided into an observation group and a control group, 80 cases in each group. The two groups were treated with routine basic medications to control blood sugar. The patients in the observation group were given foot bath withTao Hong Si Wu Tangplus massage on acupoints at the sole, once every day. At the same time, the patients were instructed to understand the knowledge of diabetes, accept the education on foot care and to know the self-management for diabetes. The patients in the control group only accepted the education on foot care and studied the self-management for diabetes. The patients in the two groups were followed up once every week by phone. The local examination was intensified for the patients in their clinical visit every month. The therapeutic effects were assessed after three months of continuous treatment.

Results: The total effective rate was 92.5% in the observation group, remarkably higher than 65.0% in the control group. The difference in comparison of the general therapeutic effect was statistically significant (P＜0.01).

Conclusion: Foot bath withTao Hong Si Wu Tangplus massage on acupoints at the sole was beneficial to the improvement of clinical symptoms of grade 0 diabetic foot.

Acupuncture Points; Acupressure; Diabetes Complications; Diabetic Foot

A diabetic foot refers to a pathological state of tissue necrosis, ulcers and gangrene of the foot or lower limb in patients with diabetes, a result of combined action of ischemia, neuropathy and infection. It is an important reason to cause disability and death in the diabetics, and seriously influences the quality of life of the patients[1]. By Wagner grading method[2], diabetic foot can be divided into 0-5 grades, among which grade 0 diabetic foot means no ulcer in foot, but accompanied by one or multiple risk factors. For the patients with grade 0 diabetic foot, the management in Western medicine is focused on education and prevention, and the measures are comparatively limited. Although the symptoms of the patients with grade 0 diabetic foot are mild, improper management can induce foot infection, ulcer or deep tissue damage at any time[3]. In accordance with the idea to treat unformed diseases in Chinese medicine, we intervened grade 0 diabetic foot with foot bath withTao Hong Si Wu Tangplus massage onacupoints at the sole by pattern identification of traditional Chinese medicine.

1 Clinical Materials

1.1 Diagnostic criteria

In conformity with the diagnostic criteria of World Health Organization (WHO) in 1999[4]. Diabetic foot refers to infection, ulcer formation and/or deep tissue damage of the lower limb caused by neuropathy, peripheral vascular diseases at varying degrees in the patients with diabetes.

By Wagner grading method[2], diabetic foot can be divided into 0-5 grades.

Grade 0: The diabetic patients do not have ulcer, but accompanied by one or multiple risk factors, with risk factor inducing foot ulcer, such as cyanosis or pallor in color, and cold sensation, numbness, insensitivity or loss of sensation in the extremity, and stinging pain or burning pain in the extremity, but without ulceration currently.

Grade 1: Superficial ulcer, no infection.

Grade 2: Deep and penetrating ulcer, often complicated with soft tissue infection, but without osteomyelitis or deep abscesses.

Grade 3: Deep ulcer, often involving bone tissue, complicated with osteomyelitis or deep abscesses.

Grade 4: Characterized by ischemic ulcer localized. Grade 5: Extensive gangrene involving the whole foot.

1.2 Inclusion criteria

Those in conformity with the diagnostic criteria of grade 0 diabetic foot; hospitalized patients; those signed informed consent, with voluntary participation; at the age of 18-80, with clear consciousness and ability to communicate effectively and to cooperate with the treatment.

1.3 Exclusion criteria

Those not in conformity with the diagnostic criteria of grade 0 diabetic foot; those complicated with serious diseases in the cardiac, cerebral, hepatic, renal or hemopoietic system; those with history of neurological, mental disorders or serious cognitive impairment; women in pregnancy or lactation; and those with poor compliance.

1.4 Statistical methods

The SPSS 17.0 version software package was used for statistical analysis. The grading data were processed by rank-sum test.P＜0.05 meant a statistically significant difference.

1.5 General data

One hundred and sixty cases in conformity with the diagnostic criteria of grade 0 diabetic foot were selected from the hospitalized patients in the Department of Endocrinology of our hospital between 2012 and 2013, numbered according to the order of clinical visits and randomly divided into an observation group and a control group, 80 cases in each group. The differences in gender, age, diabetic duration, and cultural background of the patients between the two groups were not statistically significant (allP＞0.05), indicating that the two groups were comparable. Please see Table 1 for the details.

Table 1. Comparison of general data between the two groups (case)

2 Therapeutic Methods

By the medical advice, the patients in the two groups routinely used the anti-diabetic drugs and drugs for activating blood flow and dispersing blood stasis, and strictly control diet. In accordance with the patient’s situation and hobby, proper sports were selected and done persistently.

2.1 Observation group

2.1.1 Composition of herbal formula

Tao Hong Si Wu Tang: Shu Di Huang(Radix Rehmanniae) 30 g,Chuan Xiong(Rhizoma Chuanxiong) 15 g,Bai Shao(Radix Paeoniae Alba) 10 g,Dang Gui(Radix Angelicae Sinensis)12 g,Tao Ren(Semen Persicae) 9 g, andHong Hua(Flos Carthami) 12 g.

2.1.2 Foot reflex zone[5]

Foot reflex zones of Hypophysis, Kidney, Suprarenal Gland, Pancreas, Stomach, Duodenum, and Spleen were selected. Please see Figure 1 for the details.

2.1.3 Operation

The boiled herbal liquid ofTao Hong Si Wu Tangwas poured into a homothermal foot bath tub, added with lukewarm water to 2 500 mL and was adjusted to 38-40℃ for soaking the two lower limbs. By whole foot massage and intensified foot massage on the major zones, the above reflex zones were massagedpredominantly, with moderate, gentle and stable force. The treatment was given once a day and lasted for 30 min each time.

Figure 1. Foot reflex zones

During the hospitalization, massage was given by the nurses every afternoon. The patients or their family members were taught the method to massage the acupoints. At the discharge, the patients took back the decocted herbal liquid, for foot bath withTao Hong Si Wu Tangplus foot massage on the acupoints, before going to bed every day.

2.1.4 Health education

The nurse in charge explained the knowledge of diabetes to the patients, gave health education on foot care, and taught the patients the selfmanagement method for diabetes.

2.2 Control group

In addition to the basic drugs to control blood sugar, the patients in the control group only obtained health education same as in the observation group.

2.3 Follow-up check

After the patients were discharged from the hospital, the nurses in the special clinic gave a follow-up phone call once every week. The patients had foot examination during their visit to the clinic every month. After the continuous intervention for three months, the therapeutic effects were assessed.

3 Therapeutic Effects

3.1 Observed indexes

Ankle brachial index (ABI) is the ratio between the systolic pressure of the malleolus artery and the systolic pressure of the brachial artery[5], i.e. the systolic pressure of the posterior tibial artery or dorsal artery of foot went into the systolic pressure and brachial artery.

Normal range: ABI was 1.0-1.4. Risk factor: ABI was 0.91-0.99. Abnormal situation: ABI＜0.9.

3.2 Criteria of therapeutic effects

The criteria of the therapeutic effects for diabetic foot were stipulated upon theStage, Pattern Identification and Therapeutic Evaluation of Traditional Chinese Medicine for Xiao Ke (Diabetes)in theNursing of Internal Medicine[6].

Remarkable effect: The clinical symptoms of cold sensation, brown color in skin, numb, pricking and burning pain, and dysesthesia or loss of sensation disappeared or basically disappeared, with obvious improvement of blood flow velocity, and ABI in the normal range.

Effect: The clinical symptoms of cold sensation, brown color in skin, numb, pricking and burning pain, and dysesthesia or loss of sensation were improved by varying degrees, with somewhat improvement in the blood flow velocity, but with risk factor in ABI.

Failure: The clinical symptoms and indexes did not reach the above criteria.

3.3 Therapeutic results

The total effective rate was 92.5% in the observation group, remarkably higher than 65.0% in the control group (Table 2).

Table 2. Comparison of clinical effects between the two groups (case)

4 Discussion

In traditional Chinese medicine, diabetic foot belongs to the scope of ‘Xiao Ke’ and ‘gangrene’[7]. Gangrene, as a complication of diabetes, its etiology and pathogen are kidney yang deficiency due to long-term diabetes, or Ying-Nutrient yin burnt due to internal accumulation of dryness and heat, or internal obstruction of stagnant blood due to internal accumulation of toxin and heat[7]. The key pathogenic factor of diabetic foot is cold coagulation due to deficiency of qi and yang, failure of yang in performing warming ability. As a result, blood flow becomes stagnant due to cold coagulation, henceleading to necrosis and gangrene after long duration[7]. The obstruction is the key pathogenic reason. Therefore, in the treatment of this disease, it is necessary to focus on the fundamental measure to activate blood and disperse blood stasis, based upon the investigation of pathogenic factor by pattern identification. In this study, the observation group is given foot bath withTao Hong Si Wu Tangplus massage on acupoints at the sole in order to produce warm effect in the local area, improve microcirculation, and promote blood circulation, so as to realize the goals to activate blood flow and disperse blood stasis.

It is believed in traditional Chinese medicine that meridians are the network of the structures of various component parts of the human body, and are the pathways for circulation of qi and blood, they can be divided into two major categories: meridians and collaterals[8]. The meridians can transmit the information of the body, circulate qi and blood. They belong to the important component parts of the body. The meridians link five Zang and six Fu organs, tissues and organs of the human body to be a whole, and are the pathways of qi and blood circulation for various component parts of the body. Through the meridians, qi and blood are able to circulate and nourish the whole body, and regulate yin and yang, so as to guarantee metabolism of the body and the normal process of the life activities.

It is believed in traditional Chinese medicine that foot is ‘the second heart’ of human being. Various zones of the foot reflect five Zang and six Fu organs. The stimulation on the foot acupoints can excite the meridian qi, dredge the meridians and collaterals, and promote the circulation of qi and blood, so as to realize the effects to regulate the balance between qi and blood and regulate the functions of Zang-fu organs[8]. Massage on the foot reflex zones is a valuable treasure in traditional Chinese medicine and can promote blood circulation. The two feet are situated in the most distal part of the human body. The two feet are full of capillaries and the circulatory metabolic products are most easily deposited, leading to the symptoms of cold sensation, and aversion to cold in the skin, due to poor circulation of qi and blood. Massage on the foot not only can effectively promote blood circulation, but also can promote the metabolism of the metabolic products in the whole body, beneficial to the excretion of metabolic products, so as to improve the lowered functions of the organism. Foot massage on the acupoints has the effects to reinforce qi, circulate qi and assist yang, and can effectively relieve the pressure of the foot, promote local blood circulation, and improve local blood supply, so as to nourish the local tissue and effectively relieve the symptoms of cold sensation and pricking pain in the limbs[8].

The formula ofTao Hong Si Wu TangincludesShu Di Huang(Radix Rehmanniae),Chuan Xiong(Rhizoma Chuanxiong),Bai Shao(Radix Paeoniae Alba),Dang Gui(Radix Angelicae Sinensis),Tao Ren(Semen Persicae), andHong Hua(Flos Carthami). This formula is composed of the strong blood-breaking agents, such asTao Ren(Semen Persicae) andHong Hua(Flos Carthami), for activating blood and dispersing blood stasis;Shu Di Huang(Radix Rehmanniae) andDang Gui(Radix Angelicae Sinensis)in sweet and warm property, for nourishing yin and reinforcing the liver;Bai Shao(Radix Paeoniae Alba) for nourishing blood and harmonizing Ying-Nutrient system;Chuan Xiong(Rhizoma Chuanxiong) for activating blood, circulating qi and regulating qi to activate blood[9]. The composition of the whole formula is appropriate, obviously characterized by expelling blood stasis, producing new blood, smoothening qi dynamic, disperse blood stasis and produce new blood. By dual effect of heat and herbal drugs, the therapeutic effects can be achieved from external wash of feet with herbal drugs. The high temperature can relax the muscle and tendons, activate blood and dredge the collaterals. By direct absorption of herbal drugs into blood collaterals through the skin acupoints under heat energy, herbal drugs are distributed to the whole body for displaying the potency of herbal drugs, able to promote blood circulation, dilate blood vessels, improve the nutrition of the peripheral tissues and excite the autoregulation of the body[10].

Based upon the above study, we believe that foot bath with warm liquid ofTao Hong Si Wu Tangplus massage on acupoints at the sole, can strengthen blood supply in the extremity, and relieve the symptoms of cyanosis or pallor in the lower limb, cold and numb sensation, dysesthesia or loss of sensation in the extremity, pricking pain or burning pain in the extremity, prevent the development of diabetic foot from grade 0 to grade 5, so as to reduce the amputation rate. Moreover, this therapeutic method is safe, economic, convenient and easily-acceptable, and needs to be further studied.

Conflict of Interest

There was no potential conflict of interest in this article.

Acknowledgments

This work was supported by Hangzhou Chinese Medicine Hospital.

Statement of Informed Consent

All of the patients signed the informed consent.

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Translator:Huang Guo-qi

R246.6

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Date:June 20, 2014