Ginger-partitioned moxibustion plus pediatric massage for treating infantile diarrhea due to spleen deficiency: a randomized controlled clinical trial

Ma Jie (马洁), Yu Fang-hui (余方辉), Tao Shan-ping (陶善平), Chu Xiao-yan (褚晓彦), Zhou Li-yan (周丽艳), Bing Xing-hong (邴兴红), Wu Dan-yan (吴丹艳), Duan Xi-dong (段希栋), Ding Jin-lei (丁金磊), He Tian-feng (何天峰), Song Yin-hua (宋银花) Jiading Hospital of Traditional Chinese Medicine, Shanghai, Shanghai 201800, China

Abstract

Keywords: Moxibustion Therapy; Indirect Moxibustion; Ginger-partitioned Moxibustion; Massage; Pediatric Massage (Tuina); Diarrhea; Spleen Deficiency; Infant

Infantile diarrhea, which belongs to the category of ‘diarrhea’ in Western medicine, is a common disease in pediatrics. Its incidence ranks second among pediatric diseases in China[1], and it is one of the leading cause of death in children under 5-year-old[2]. Diarrhea mainly refers to a digestive tract syndrome with increased bowel movements frequency, loose or watery stool, may accompanied by undigested food, residue and mucus, which is one of the main causes of malnutrition and growth retardation in children[3]. The disease occurs frequently in spring and autumn. Both infectious and non-infectious factors are involved in the etiology of this disease[4]. Non-infectious factors are mainly improper feeding while infectious factors include bacterial and viral infection. Rotavirus is the most important viral agent[5]. Clinical treatments for infantile diarrhea in Western medicine are mostly rehydration, nutritional support and anti-infection[6]. However, excessive use of antibiotics and rehydration is common, and poor compliance among children might lead to a poor treatment efficacy. The combination of ginger- partitioned moxibustion and pediatric massage (tuina) as an economical and safe treatment may lead to a significant improvement in clinical symptoms in infants with diarrhea[7].

1 Clinical Materials

1.1 Diagnostic criteria

1.1.1 Diagnostic criteria in Western medicine

The diagnostic criteria referred theZhu Futang Textbook of Pediatrics[8]: disease course ＞1 week; increased defecation frequency, over 3 times per day; accompanied by altered stool amount or trait (large amount, mostly loose); routine stool examination may detect undigested food or a small amount of fat droplets.

1.1.2 Diagnostic criteria in traditional Chinese medicine (TCM)

Adopting the diagnostic criteria in thePediatrics of Traditional Chinese Medicine[9]. Primary symptoms: lingering diarrhea, diarrhea mostly after meals, or recurrent episode in varying severities, loose or watery stool, with milk curd or undigested food residue. Secondary symptoms: low spirit, poor appetite, lustrousless complexion, a slightly pale tongue with thin and greasy coating, and weak and forceless pulses.

1.2 Inclusion criteria

Those who met the diagnostic criteria in both Western medicine and TCM; were able to receive moxibustion and pediatric massage; with no skin lesion in the areas for manipulation; less than 3 years old, male or female; with no abnormality in stool microscopic examination; oral informed consent was obtained from both infants and their guardians and written informed consent was signed by infants’ guardians.

1.3 Exclusion criteria

Those who took other medicines before visit; with severe vomiting or dehydration; with other diseases; with infectious diarrhea (including dysentery, cholera, or enteritis).

1.4 Criteria for elimination and drop-out

Took medications during the trial; unable to carry out treatment as prescribed by the doctor due to poor compliance; self-withdrew from the trial.

1.5 Statistical analysis

All the data were analyzed by the SPSS version 21.0 statistical software. The measurement data were in accordance with normal distribution, were expressed as mean ± standard deviation (±s). Measurement data such as age, disease course and scale score were evaluated by independent-sample analysis of variance or rank rank-sum test for inter-group comparisons, and repeated measurement analysis of variance or rank rank-sum test for intra-group comparisons. Gender and efficacy were tested by Chi-square test or rank rank-sum test. For dropouts, data from the final visit would be taken for analysis.P＜0.05 was taken as statistically significant.

1.6 General materials

All the subjects were from the Acupuncture & Massage Department or Pediatrics Department, Jiading Hospital of Traditional Chinese Medicine, Shanghai. The cases were collected between March 2016 and September 2018.

A total of 90 infants were randomly assigned into a massage plus moxibustion group, a massage group and a drug group by the random number table method, with 30 cases in each group. During treatment and follow-ups, 7 subjects did not complete all the visits (the dropout rate: 7.78%), with 1 case in the massage plus moxibustion group, 2 cases in the massage group and 4 cases in the drug group. There were no statistically significant differences across the three groups in baseline characteristics (gender, age and disease course, allP＞0.05), confirming that the three groups were appropriately comparable (Table 1).

2 Treatment Methods

All the infants in the three groups received the same basic treatment: oral rehydration or intravenous rehydration depending on the degree of dehydration; serum electrolyte testing if necessary in order to correct acid-base and electrolyte imbalance in time; light and digestible diet during treatment; routine symptomatic treatment was given if there were other conditions.

Table 1. Baseline characteristics of infants among the three groups

2.1 Massage plus moxibustion group

2.1.1 Pediatric massage

Bu-reinforcing Pijing: The doctor kept the infant's thumb upward with the left thumb and index finger, and carried out clockwise circular movement on the infant's thumb belly with the right thumb belly for 100 times (Figure 1).

Figure 1. Bu-reinforcing Pijing

Bu-reinforcing Dachang: The doctor held the infant's hand with his left hand and Tui-pushed along the radial side of the infant's index finger from tip to the root part with the right thumb for 100 times (Figure 2).

Figure 2. Bu-reinforcing Dachang

Tui-pushing Sanguan: The doctor pushed straight along the radial side of the infant's forearm from the transverse wrist crease to the cubital crease for 100 times with the thumb or the index and middle fingers together (Figure 3).

Mo-rubbing abdomen: The infant was in a supine position, and the doctor used the palm or four fingers to do a counterclockwise circular movement around the navel of the infant for 200 times (Figure 4).

Tui-pushing up Qijiegu: The infant was in a prone position, and the doctor pushed upward from the end of the caudal vertebra for 50 times with the pulp of the thumb or index finger and middle fingers (Figure 5).

Figure 3. Tui-pushing Sanguan

Figure 4. Mo-rubbing abdomen

Figure 5. Tui-pushing up Qijiegu

Nie-pinching the spine: The infant assumed a prone position. The doctor used two thumbs to press against the middle skin of the waist back and the index and middle finger to press forward, clamping and lifting the skin at the same time and moving forward alternately. Manipulating from Guiwei to Dazhui (GV 14) along both sides of the Governor Vessel was counted for once and it was repeated for 3 to 5 times (Figure 6).

Rou-kneading Baihui (GV 20): The doctor Rou- kneaded the infant's Baihui (GV 20) with the middle or index finger of one hand for 100 times (Figure 7).

The infants received intervention once a day, 5 d as a course, for a total of 2 consecutive courses.

Figure 6. Nie-pinching the spine

Figure 7. Rou-kneading Baihui (GV 20)

2.1.2 Ginger-partitioned moxibustion

Point: Shenque (CV 8).

Method: Ginger slices were cut into coin-sized pieces, 2 mm in thickness. Poked five small holes in each ginger slice with a toothpick and placed it on Shenque (CV 8). The moxibustion barrel of Baixiao moxibustion (Product Standard No.: YZB/Yu 0047-2011, Chongqing Baixiao Medical Equipment Co., Ltd., China) was affixed to ginger slices with adhesive tape. The moxa cone was attached to the moxibustion cover by a magnet. After igniting the moxa cone, inserted the moxibustion cover into the moxibustion cylinder, and kept the moxa cone burning at 8-24 mm above the skin. The temperature of moxibustion was adjusted according to the tolerance of infants (slight redness of the skin) by regulating the overlap of the moxibustion cover and the moxibustion barrel (Figure 8). The infants received intervention once a day, 5 d as a course, for a total of 2 consecutive courses (Figure 9).

In order to ensure the quality of the study, massage and ginger-partitioned moxibustion were performed by TCM doctors with more than 5 years of clinical experience, and they were able to follow the standard operating procedures after receiving strict training.

2.2 Massage group

The infants in the massage group were only given the same pediatric massage as those in the massage plus moxibustion group, and the manipulation, procedures, treatment courses and doctors’ qualification were the same as those in the massage plus moxibustion group.

Figure 8. The instrument of ginger-partitioned Baixiao moxibustion

Figure 9. Ginger-partitioned Baixiao moxibustion

2.3 Drug group

The infants in the drug group were given smecta orally (the ingredient is dioctahedral smectite, State Food and Drug Administration Approval No.: H20000690, Beaufour Ipsen Pharmaceutical Co., Ltd., China).

The corresponding doses of smecta were 1/3 pack for infants under 1 year old, 1/3-1/2 pack for infants of 1-2 years old and 1/2-1 pack for infants of 2-3 years old. Smecta was dissolved in warm water (50 mL for per pack) and administered 3 times a day between meals, while the very first dose was doubled. The infants received intervention for a total of 2 consecutive courses with 5 d as a course.

3 Observation of Therapeutic Efficacy

3.1 Observation items

According to infant's bowel movement frequency and stool form, the main symptoms were graded as normal, mild, moderate and severe, with corresponding scores of 0, 1, 3 and 5 points[10].

According to infant's appetite, postprandial abdominal distension, mental and physical status, the degree of secondary symptoms was scored 0, 1, 2 and 5 points in normal, mild, moderate and severe grades, respectively. The score was evaluated before treatment, after treatment, 1 and 3 months after treatment.

3.2 Criteria of therapeutic efficacy

The therapeutic criteria in theCriteria of Diagnosis and Therapeutic Effects of Diseases and Syndromes in Traditional Chinese Medicinewere adopted[11].

Cured: Stool was well formed and the systemic symptoms disappeared. The microscopic examination of stool was normal and the etiological examination showed negative. The bowel movement frequency and stool form, and the abnormal physiological and biochemical parameters completely returned to normal.

Effective: Bowel movement frequency and moisture content decreased and the systemic symptoms showed improvement. The fat globules or red and white blood cells were occasionally found in the stool by microscopic examination.

Invalid: The bowel movement frequency and moisture content of stool did not improve, or the symptoms worsened.

3.3 Results

3.3.1 Comparison of the therapeutic efficacy

The total effective rate was significantly higher in the massage plus moxibustion group versus the drug group (P＜0.05), but was significantly different neither in massage plus moxibustion group nor the drug group versus the massage group (bothP＞0.05) by Kruskal- Wallis test (Table 2).

3.3.2 Comparison of the score of primary symptoms

Statistical significance was determined by Kruskal- Wallis test. The scores of primary symptoms of the three groups decreased significantly at each time point, after treatment, at 1-month and 3-month follow-ups compared with those before treatment (allP＜0.05). After treatment, the score of primary symptoms was significantly lower in the massage plus moxibustion group versus the drug group (P＜0.05), but was significantly different neither in the massage plus moxibustion group nor the drug group versus the massage group (bothP＞0.05). There was no significant difference in the score of primary symptoms among the three groups both at 1 month and 3 months after treatment (allP＞0.05), (Table 3).

Table 2. Comparison of the total effective rate among the three groups (case)

Table 3. Comparison of the score of primary symptoms among the three groups ( ±s, point)

Table 3. Comparison of the score of primary symptoms among the three groups ( ±s, point)

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

Group n Before treatment After treatment 1 month after treatment 3 months after treatment Massage plus moxibustion 30 6.0±1.8 0.9±1.81)2) 1.0±1.51) 0.7±1.21) Massage 30 6.3±1.5 2.2±2.31) 1.5±2.31) 0.9±1.81) Drug 30 5.5±1.8 2.7±2.21) 1.6±2.11) 1.3±1.91)

3.3.3 Comparison of the time to recover normal bowel movement frequency

There was no significant difference in the time to recover normal bowel movement frequency among the three groups by Kruskal-Wallis test (allP＞0.05), (Table 4).

Table 4. Comparison of the time to recover normal bowel movement frequency among the three groups ( ±s, d)

Table 4. Comparison of the time to recover normal bowel movement frequency among the three groups ( ±s, d)

Group n Time to recover normal bowel movement frequency Massage plus moxibustion 25 5.4±2.4 Massage 23 7.2±3.3 Drug 23 7.7±3.6

3.3.4 Comparison of the score of secondary symptoms

Statistical significance was determined by Kruskal- Wallis test. The scores of secondary symptoms of the three groups decreased significantly at each time point, after treatment, at the 1-month and 3-month follow- ups compared with those before treatment (allP＜0.05). At 1-month and 3-month after treatment, the scores of secondary symptoms were significantly lower in both massage plus moxibustion group and massage group versus the drug group (allP＜0.05), but it was not significantly different in the massage plus moxibustion group versus the massage group (allP＞0.05), (Table 5).

Table 5. Comparison of the score of secondary symptoms among the three groups (±s, point)

Table 5. Comparison of the score of secondary symptoms among the three groups (±s, point)

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

1 month after treatment 3 months after treatment Massage plus moxibustion 30 5.8±2.8 1.3±1.71)2) 0.8±1.61)2) 0.6±1.51)2) Massage 30 5.0±1.8 1.7±1.41)2) 1.0±1.31)2) 0.5±1.71)2) Drug 30 5.3±1.4 3.4±2.11) 2.7±1.81) 2.0±1.91)

4 Discussion

Infantile diarrhea belongs to the category of ‘diarrhea’ in TCM, and deficiency of spleen and stomach is the main pathogenesis of the disease[12-13]. Children’s spleen is often insufficient. Improper milk or food intake or exogenous invasion may disturb the function of spleen and stomach, causing abnormal transportation and transformation, as well as disorder of digestion. Therefore, diarrhea occurs.

Modern medicine believes that the incidence of infantile diarrhea is mainly related to virus, bacteria or parasites, improper feeding, respiratory tract infection, fever, etc. The disorder of intestinal flora caused by drug abuse is also a common cause of diarrhea in children[14]. Four predominant principles of treatment are dehydration avoidance, rational administration, diet control and the prevention of complications. Antibiotic therapy is a commonly used administration, but it is easy to produce drug resistance and has some adverse reactions. Therefore, it has been a hot topic in academic circles to actively explore non-pharmacologic and non-traumatic treatment s for infantile diarrhea.

TCM mainly uses herbal medicine, acupuncture, cupping, acupoint injection therapy, Chinese massage, moxibustion, acupoint sticking therapy and other methods to treat infantile diarrhea[15]. Among them, acupuncture and acupoint injection therapy are not easy to be accepted by infants and their parents.

Pediatric massage is guided by the basic theory of TCM. According to the principles of yin and yang, five elements, Zang-fu organs, meridian and syndrome differentiation[16], as well as the physiology and pathology of infant, the manipulation at specific acupoints or body parts can improve the function of spleen and stomach and regulate the whole body[17]. For infants with diarrhea due to spleen deficiency, the treatment principle is to strengthen the spleen, invigorate qi and consolidate the foundation. The basic prescription is: Bu-reinforcing Pijing, Bu-reinforcing Dachang, Tui-pushing Sanguan, Mo-rubbing abdomen (counterclockwise), Tui-pushing up Qijiegu, Nie-pinching the spine, Rou-kneading Baihui (GV 20) and Guiwei[18]. Bu-reinforcing Pijing, Bu-reinforcing Dachang, and Nie-pinching the spine can strengthen the spleen, invigorate qi and consolidate the intestine for stopping diarrhea[19]. Mo-rubbing abdomen (counterclockwise), Tui-pushing up Qijiegu and Rou-kneading Guiwei can warm yang and relieve diarrhea. Tui-pushing Sanguan can warm yang for dispelling cold. Rou-kneading Baihui (GV 20) can raise up yang energy for lifting prolapsed Zang-fu organs and consolidate the foundation. The compatibility of these acupoints can strengthen the spleen to invigorate qi, and warm yang to stop diarrhea.

Ginger, which is pungent and warm in nature, goes to the Lung, Spleen and Stomach Meridians, and can warm the spleen and stomach for dispelling cold. Ginger-partitioned moxibustion can warm the meridians to dissipate cold, and promote qi to activate blood, and also reinforce the spleen and stomach[20]. Moxibustion with moxa cone is difficult to be used in infants due to its tedious procedure and difficulty controlling temperature, while Baixiao moxibustion can overcome these difficulties[21].

The results of this study suggested that there was a significant difference in the therapeutic efficacy between the massage plus moxibustion group and the massage group or drug group, indicating that the therapeutic efficacy of ginger-partitioned moxibustion plus pediatric massage was better than that of using pediatric massage or smecta alone. After treatment, the scores of primary symptoms in the three groups were significantly different from those before treatment, indicating that the symptoms of the infants in all groups were improved. There was a significant difference in the primary symptoms score between the massage plus moxibustion group and the massage group or drug group, indicating that use of ginger-partitioned moxibustion plus pediatric massage showed superior benefits in improving the bowel movement frequency and stool form. The score of secondary symptoms in the three groups after treatment or at follow-ups time were significantly different from those before treatment, indicating that the spleen deficiency symptoms of the infants in all groups were improved. At all three time points, the score of secondary symptoms in both the massage plus moxibustion group and the massage group were significantly different from that in the drug group, indicating that the efficacy of both ginger- partitioned moxibustion plus pediatric massage and pediatric massage monotherapy in improving appetite, physique and postprandial abdominal distension was better than that of smecta alone.

To conclude, compared with pediatric massage or smecta monotherapy, ginger-partitioned moxibustion plus pediatric massage showed superior clinical efficacy in treating infantile diarrhea due to spleen deficiency, and improved appetite and physique. This study was limited by the open-label, single-center design and a relatively small sample size. Thus, well-designed multicenter study with a larger sample size is desirable in the future.

Conflict of Interest

There was no potential conflict of interest in this article.

Acknowledgments

This work was supported by Health and Family Planning Commission of Jiading District, Shanghai (上海市嘉定区卫生和计划生育委员会, No. 2016-KY-ZYY-11).

Statement of Informed Consent

Informed consent was obtained from the guardians of the recruited children in this study.

Received: 15 November 2019/Accepted: 9 March 2020