The Treatment of Allergies Using Sanfujiu: A Method of Applying Chinese Herbal Medicine Paste to Acupoints on Three Peak Summer Days

The American Journal of Chinese Medicine, Vol. 32, No. 6, 967 976 2004 World Scientific Publishing Company Institute for Advanced Research in Asian Science and Medicine The Treatment of Allergies Using Sanfujiu: A Method of Applying Chinese Herbal Medicine Paste to Acupoints on Three Peak Summer Days Chen-Jei Tai Department of Traditional Chinese Medicine, Taipei Medical University Hospital and Department of Medicine, Taipei Medical University, Taipei, Taiwan Li-Yin Chien Institute of Community Health Nursing, National Yang Ming University, Taipei, Taiwan Abstract: Sanfujiu is a method of applying herbal drug paste onto acupoints Fengmen and Feishu during the 3 hottest summer days, to treat patients with allergies using traditional Chinese medicine. The objectives of this study were to describe the immediate reactions (adverse effects and perceived efficacy) to the Sanfujiu treatment, and examine the variations in the prevalence of the reactions to and perceived efficacy of Sanfujiu among different sub-groups, based on patient age and diagnosis. The study subjects included 119 patients who completed Sanfujiu treatment at a regional hospital in Taipei. One week after treatment, trained interviewers conducted telephone interviews with the patients. More than 80% of the patients reported having reactive symptoms after using the Sanfujiu treatment. Younger subjects ( 16 years of age) were more likely to have reactive symptoms. Patients with rhinitis were more likely to have runny noses and nasal congestion after the treatment. Patients with allergic eczema were more likely to have skin itching all over the body. Overall, 44.6% of patients perceived the treatment as being effective, while 52.1% of patients did not notice any effects, either good or bad, from the treatment. The perceived efficacy of Sanfujiu treatment was not related to patient age, sex, or diagnosis. This study demonstrated that Sanfujiu treatment was moderately effective, as perceived by the patients, in treating their allergic symptoms immediately after the treatment. Correspondence to: Dr. Li-Yin Chien, 155 Li-Nong Street, Sec. 2, Pei-Tou, Taipei 112, Taiwan. Tel: (+886) 2-2822-5056, Fax: (+886) 2-2704-5034, E-mail: lychien@ym.edu.tw 967

968 C.-J. TAI & L.-Y. CHIEN Symptoms reactive to the treatment were common but are usually mild. This information is essential for patient consultation, and serves as a reference for clinicians. Keywords: Sanfujiu; Semen Sinapis Albae; Herba Asari; Radix Kansui; Rhizoma Cordalis; Allergy; Therapeutic Effect; Reactive Symptoms. Introduction Diseases due to allergic reactions are very common, with one in three people likely to suffer from an allergy at some time (Davis, 1999). The prevalence of allergies has increased substantially during the last two to three decades in more than 20 countries around the world (Jarvis and Burney, 1998). The most common types of allergic diseases are eczema, rhinitis and asthma. These allergic diseases significantly interfere with the patient s functioning and quality of life, and are sometimes life-threatening. The treatment for allergic diseases consists of allergen avoidance, immunotherapy for specific allergens and anti-allergic medication (including anti-histamines, steroids, anti-cholinergic agents and bronchodilators) (Gillissen and Lecheler, 2003; Kay, 2001; Magnussen, 2003; Zitt, 2003). In traditional Chinese medicine, herbs such as Xiao-qinglong-tang (Kao et al., 2001a), Ma-xing-gan-shi-tang (Kao et al., 2001b), Ryokan-kyomishinge-nin-to (Sakaquchi et al., 2002) and Bakumondo-to (Watanabe et al., 2003) are prescribed for allergic diseases. Other treatment methods include acupuncture, moxibustion and external applications of drug paste. Sanfujiu is a method of applying Chinese herbal medicine paste onto selected acupoints during the 3 hottest days (or dog days) of the summer (Zhang, Qing Dynasty). In traditional Chinese medicine, human and environment are seen as one. According to the lunar calendar, the dog days are those days with the highest temperatures and highest amount of yang qi. The body surface and blood vessels are ecstatic as a result of the human body being full of yang qi. Therefore, it is easier for the drug to penetrate the acupoints and reach the weak or ill areas inside the body, to dispel wind, remove cold and strengthen primary qi. Since many allergic diseases are due to deficiencies in the lung (respiratory system), which belongs to the Metal element according to the tradition of the Five Elements, treating lung-related diseases during the Geng day, the 7th of the traditional ten Heavenly Stems (belonging to Metal in the concept of the Five Elements), in the hot summer allows the borrowing of qi from the environment. This enhances the drug effect as it is going through the routes and strengthens lung qi. This type of treatment can help prevent allergic attacks into the winter months. A number of studies in China have demonstrated the effects of Sanfujiu in treating allergic diseases (Jin, 1992; Yan, 1992; Liu et al., 2001; Sun, 1995; Xia, 1996; Lin, 2000; Lu, 1998; Chen et al., 2000; Lai et al., 2001). Sanfujiu has been increasingly used in Chinese medicine clinics in Taiwan during the past few years. However, no reports on patient reactions to the use of this treatment, as well as the treatment efficacy have been published. The objectives of this study were to describe the immediate reactions (adverse effect and perceived efficacy) to Sanfujiu treatment and to examine the variations in the prevalence of reactions to and perceived efficacy of Sanfujiu among different sub-groups, based on patient age and diagnosis.

ALLERGY TREATMENT USING SANFUJIU 969 Material and Methods According to the lunar calendar, the 1st dog day is the 3rd Geng day after the summer solstice. The 2nd dog day is the 4th Geng day after the summer solstice. The 3rd dog day is the 1st Geng day after the beginning of autumn. Sanfujiu is the application of herbal drugs on acupoints during these three specific days (Zhang, Qing Dynasty). In the Chinese Farmer s daily calendar, each day is assigned a name of the combination of the ten Heavenly Stems and 12 Earthly Branches. There is a Geng day every 10 days. The dates of the 3 dog days may not be the same for each year. The exact date should be referenced from the Chinese Farmer s daily calendar for the indicated year. In the year 2003, these days were July 16th, July 26th and August 15th. Therapeutic Methods Equal amounts of Bai Jie Zi (Semen Sinapis Albae), Xi Xin (Herba Asari), Gan Sui (Radix Kansui) and Yan Hu Suo (Rhizoma Cordalis) were dried and ground into powder. The powder was then mixed and made into paste with ginger (Zingiber officinale) juice. The drug paste was divided into small cubes of 3 g each and placed on the selected acupoints during the 3 days described above. The acupoints selected were Fengmen (BL12) and Feishu (BL13), bilaterally. Medical tape was used to keep the drug paste in place on the acupoints for 1 to 2 hours. The use of Fengmen and Feishu was based on the rationale that the two acupoints regulate lung qi, open the lungs and benefit all aspects of lung function (Huang, 1991). In addition, Fengmen and Feishu are located on the upper back, thus, the drug paste was easy to apply and stayed in place. Study Subjects The study subjects included 119 patients who had completed the Sanfujiu treatment at a medical university hospital in Taipei City in 2003. Patients who had undergone this treatment, but had not been diagnosed with allergic diseases were excluded. Measurements Questionnaires were designed to determine the patient s reactions to the treatment and the perceived efficacy of the treatment. The study subjects gave their consent to participate in the study during their first visit for Sanfujiu treatment at the hospital. One week after each of the three treatments, a telephone interview was conducted with the patients by trained interviewers. For patients under 12 years of age, questions were answered by their primary caregivers. The study variables included patient background information (age, sex, history of allergic diseases, medicine used before treatment), reactions to the treatment (blisters, itching, pain, local heat, local redness, headache, insomnia, runny nose, nasal congestion, sore throat, aches all over the body, itching all over the body, constipation and diarrhea), and

970 C.-J. TAI & L.-Y. CHIEN perceived efficacy of treatment. Reactions to the treatment were determined by the presence of the symptoms. Perceived treatment efficacy was obtained by asking the patient to rate the efficacy as very effective, somewhat effective, no change (neither good nor bad), or worse than before the treatment. Data Analysis Statistical analyses were carried out using the Statistical Package for the Social Sciences, SPSS for Windows, Version 10.0 (SPSS Inc., Chicago, Ill). Individual variables were examined by percentage, median, mean and standard deviation. Chi-squared statistics were performed to examine the variations of reactions to the treatments and perceived efficacy among different age groups and diagnosis groups. Results The median age of the study subjects was 16 years (range, 1 84 years). There were more male subjects (58%) than female subjects (42%) in the study. More than 70% of our study Sex Male Female Table 1. Patient Characteristics (N = 119) N 69 50 Percentage 58.0 42.0 History of allergy Allergic rhinitis Asthma Allergic eczema Others Prior drug treatment for allergies None Bronchodilators Steroids Chinese medicine Others Allergic symptoms during the past year Wheezing Runny nose Nasal congestion Cough Nose itching Eye itching Dark circles around eyes Skin itching Others 86 48 35 20 59 39 29 45 13 47 89 92 76 76 75 61 54 4 72.3 40.3 29.4 16.8 49.6 32.8 24.4 37.8 10.9 39.5 74.8 77.3 63.9 63.9 63.0 51.3 45.4 3.4

ALLERGY TREATMENT USING SANFUJIU 971 subjects reported having allergic rhinitis, followed by asthma (40%) and allergic eczema (29.4%). As for allergic symptoms during the past year, more than 75% had nasal congestion and runny nose. More than 50% reported cough, itchy nose and eyes, and dark circles around the eyes. About 40% of the study subjects reported having skin itching and wheezing during the past year. About 50% of the study subjects did not use any drugs to treat their allergies; for those who did used Chinese medicine (37.8%), bronchodilators (32.8%) and steroids (24.4%; Table 1). A high proportion of patients reported having reactive symptoms after the Sanfujiu treatment (Table 2). Overall, about 80% of patients reported having local redness or local heat after the removal of the drug paste, at any of the three treatment times. Local itching and local pain occurred in 63% and 52% of the study subjects, respectively. Runny nose and nasal congestion occurred in more than 50% of the study subjects. Dry mouth or thirst was reported in more than 25% of patients. Other symptoms that were reported included insomnia, sore throat, headache, skin itching all over the body, constipation, diarrhea, aches all over the body and local blisters, with about 10% to 20% of the patients having these symptoms. More patients reported local redness, local heat and local pain after the 3rd treatment. All other symptoms appeared to have a similar prevalence on each of the 3 treatment days. We further investigated whether the occurrence of reactive symptoms was associated with patient age and diagnosis (Table 3). More of the younger subjects ( 16 years of age, or the median age of our study subjects) reported having local blisters (16.7% versus 5.1%), local itching (75.0% versus 50.8%), local pain (61.7% versus 42.4%) and itching all over the body (21.7% versus 8.5%), but fewer reported having aches all over the body (5.0% versus 18.6%). Patients with rhinitis were less likely to have local blisters (7.0% versus Table 2. Reactions to Sanfujiu Among Patients with Allergic Diseases (N = 119) Any The First The Second The Third Local redness 97 (81.5%) 45 (37.8%) 52 (43.7%) 82 (68.9%) Local heat 95 (79.8%) 59 (49.6%) 55 (46.2%) 72 (60.5%) Local itching 75 (63.0%) 60 (50.4%) 57 (47.9%) 46 (38.7%) Runny nose 68 (57.1%) 47 (39.5%) 45 (37.8%) 37 (31.1%) Nasal congestion 65 (54.6%) 42 (35.3%) 38 (31.9%) 33 (27.7%) Local pain 62 (52.1%) 17 (14.3%) 20 (16.8%) 46 (38.7%) Dry mouth or thirst 33 (27.7%) 23 (19.3%) 22 (18.5%) 22 (18.5%) Insomnia 23 (19.3%) 5 (4.2%) 17 (14.3%) 11 (9.2%) Sore throat 21 (17.6%) 9 (7.6%) 12 (10.1%) 6 (5.0%) Headache 19 (16.0%) 8 (6.7%) 11 (9.2%) 7 (5.9%) Itching all over the body 18 (15.1%) 10 (8.4%) 10 (8.4%) 11 (9.2%) Constipation 16 (13.4%) 8 (6.7%) 10 (8.4%) 9 (7.6%) Diarrhea 15 (12.6%) 9 (7.6%) 8 (6.7%) 4 (3.4%) Ache all over the body 14 (11.8%) 4 (3.4%) 9 (7.6%) 4 (3.4%) Local blisters 13 (10.9%) 6 (5.0%) 6 (5.0%) 5 (4.2%) Others 9 (7.6%) 5 (4.2%) 0 4 (3.4%) Data were ordered from high to low according to the numbers in the Any category.

972 C.-J. TAI & L.-Y. CHIEN Table 3. Prevalence of Reactions to Sanfujiu by Patients According to Age and Diagnosis Local Local Local Runny Nasal Ache All Over Itching All Over Constipation Thirst and Blisters Itching Pain Nose Congestion the Body the Body Dry Mouth Age (years) P = 0.04 P = 0.006 P = 0.04 P = 0.08 P = 0.24 P = 0.02 P = 0.045 P = 0.099 P = 0.057 < 16 16.7% 75.0% 61.7% 65.0% 60.0% 5.0% 21.7% 8.3% 20.0% > 16 5.1% 50.8% 42.4% 49.2% 49.2% 18.6% 8.5% 18.6% 35.6% Asthma P = 0.29 P = 0.77 P = 0.71 P = 0.83 P = 0.77 P = 0.71 P = 0.51 P = 0.40 P = 0.90 Yes 14.6% 64.6% 54.2% 58.3% 56.3% 10.4% 12.5% 16.7% 27.1% No 8.5% 62.0% 50.7% 56.3% 53.5% 12.7% 16.9% 11.3% 28.2% Allergic rhinitis P = 0.035 P = 0.74 P = 0.086 P = 0.005 P = 0.004 P = 0.94 P = 0.57 P = 0.79 P = 0.60 Yes 7.0% 64.0% 57.0% 65.1% 62.8% 11.6% 16.3% 14.0% 29.1% No 21.2% 60.6% 39.4% 36.4% 33.3% 12.1% 12.1% 12.1% 24.2% Allergic eczema P = 0.45 P = 0.10 P = 0.13 P = 0.68 P = 0.24 P = 0.05 P = 0.037 P = 0.86 P = 0.56 Yes 14.3% 74.3% 62.9% 54.3% 62.9% 2.9% 25.7% 14.3% 31.4% No 9.5% 58.3% 47.6% 58.3% 51.2% 15.5% 10.7% 13.1% 26.2%

ALLERGY TREATMENT USING SANFUJIU 973 21.2%), but were more likely to have runny nose (65.1% versus 36.4%) and nasal congestion (62.8% versus 33.3%) after the treatment. Patients with allergic eczema were more likely to have itching all over the body (25.7% versus 10.7%), but less likely to have aches all over the body (2.9% versus 15.5%). The diagnosis of asthma was unrelated to the prevalence of reactive symptoms to Sanfujiu. Of the 119 patients, 62 (52.1%) felt the treatment was neither good nor bad (did not have any changes). Seven patients (5.9%) perceived the treatment as being very effective, and 46 (38.7%) reported it as somewhat effective. Four patients (3.4%) felt that their allergic symptoms were worse after the treatment. The perceived efficacy of Sanfujiu treatment was not related to patient age, sex and diagnosis (Table 4). We divided the variable of perceived efficacy into two categories: effective and not effective. Then, we further examined whether the occurrence of reactive symptoms was associated with the perceived efficacy of the treatment. Only the presence of aches all over the body was associated with perceived efficacy: 71.4% of patients with aches all over the body perceived the treatment as being effective, while 41.0% of patients without aches all over the body perceived the treatment as being effective (p = 0.03). The mean number of reactive symptoms was 1.34 for patients who perceived the treatment as being effective and 1.35 for patients who perceived the treatment to be ineffective (p = 0.97). Table 4. Perceived Efficacy of Sanfujiu in Alleviating Allergic Symptoms 2 Weeks After Treatment (Based on Patient Characteristics) Age (years) < 19 19 40 > 40 Sex Male Female Allergic rhinitis Yes No Asthma Yes No Allergic eczema Yes No P value from X 2 statistics. Percentage Improved 48.4 31.0 50.0 46.4 42.0 45.3 42.4 41.7 46.5 47.7 48.5 P 0.24 0.64 0.77 0.60 0.94

974 C.-J. TAI & L.-Y. CHIEN Discussion To our knowledge, this study is the first to document the reactive symptoms to Sanfujiu treatment. To treat the patients, we placed the drug paste on the acupoints for shorter durations (1 to 2 hours), compared with those reported in other studies (4 to 12 hours) (Lai et al., 2001; Chen et al., 2000; Lu, 1998). Even so, our results suggested that the topical reactive symptoms to the paste area are common (Table 2), and likely to be induced by the stimulation of the drug. The reactive symptoms (local redness, heat and itching) were relieved by removing the paste. A high proportion of our study subjects had reactive symptoms of nasal congestion or runny nose (Table 2). This may be associated with the fact that most of our study subjects had allergic rhinitis (Table 1). Since this treatment strengthened the qi by means of the drug, the acupoints and the seasonal qi in the environment, it may be that these reactions were evidence of expelling the illness via the acupoints. Further study is needed to validate this speculation. In this study, we found that age and diagnoses were associated with the presence of reactive symptoms. Younger patients ( 16 years) were more likely to have itching over all the body and topical reactions at the site of the drug paste. Patients with rhinitis were more likely to have runny noses and nasal congestion, while patients with eczema were more likely to have itching and aches over all the body (Table 3). The reasons for the variations in the reactive symptoms remain unclear and further study is needed. Nonetheless, our study showed a high rate of reactive symptoms to the Sanfujiu treatment. In addition, the occurrence of reactive symptoms differed in terms of patient age and diagnosis. This information is essential when consulting with patients and serves as a reference for clinicians. Previously, researchers in China have shown that Sanfujiu had an effectiveness rate of more than 80% in treating rhinitis, chronic bronchitis and asthma (Jin, 1992; Xia, 1996; Lu, 1998; Liu et al., 2001; Sun, 1995; Lai et al., 2001). One study found that using Sanfujiu for 3 years increased the effective rate to 90% (Chen, 1999). In the present study, the rate of perceived treatment efficacy was 44.6%, while 52.1% of patients did not notice any good or bad effects from the treatment. Since the study followed the patients for only 2 weeks, the real efficacy cannot be determined until the end of winter, when the allergic symptoms are most evident. We did not find the short-term treatment efficacy (2 weeks) to be different among the different age groups. In previous studies with 1 year or longer periods of follow-up, the treatment effects were better for children than adults and for subjects with new onset rather than subjects with longer duration of allergies (Lu, 1998). Long-term follow-up is needed in order to examine the issues further. The application of Chinese herbal drugs on acupoints in treating allergic diseases is an area that has not been well studied. In the theory of Chinese medicine, allergic diseases are classified as winter diseases, since the allergic symptoms usually become worse in the autumn and winter. The winter diseases are best treated in the summer according to the theory. Several studies in China support the principle of winter diseases being treated in the summer. A study by Liang et al. (1992) showed that treating patients with asthma during the 3 dog days had similar effects to treating patients a few days apart from the dog days. However, the treatment effects disappeared when the patients were treated in

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