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com J Tradit Chin Med 2017 August 15; 37(4): 522-529


info@journaltcm.com ISSN 0255-2922
© 2017 JTCM. This is an open access article under the CC BY-NC-ND license.

RESEARCH ARTICLE
TOPIC

Prescriptions from Traditional Chinese Medicine compared with sal-


butamol and montelukast for the treatment of pediatric asthma: a
randomized controlled trial

Du Hui, Wang Yonghong, Yu Jian, Shi Yumin, Li Suhuan, Sun Wen, Zhang Yiqun, Hu Hong
aa
Du Hui, Wang Yonghong, Yu Jian, Shi Yumin, Li Suhuan, those in the SM group (91.67% and 76.83%, respec-
Sun Wen, Zhang Yiqun, Hu Hong, Department of Tradition- tively, P = 0.006). Scores for abnormal feces (P <
al Chinese Medicine, Children's Hospital of Fudan University, 0.001), hyperhidrosis (P < 0.001), and tongue ap-
Shanghai 201102, China
pearance (P = 0.001) in the TCM group were signifi-
Supported by a Major Research Project of Shanghai Tradi-
tional Chinese Medicine Three-year Action Plan (No. ZYS-
cantly better than those in the SM group. However,
NXD-CC-ZDYJ034), Shanghai Science and Technology Re- the total scores of TCM symptom patterns and SC
search Program (No. 12401905500) and a Development Proj- scores did not differ significantly between the two
ect of Shanghai Peak Disciplines-Integrated Chinese and groups (P > 0.05).
Western Medicine (No. 20150407)
Correspondence to: Prof. Wang Yonghong, Department CONCLUSION: Compared with salbutamol and
of Traditional Chinese Medicine, Children's Hospital of Fu- montelukast, the TCM prescriptions tested were
dan University, Shanghai 201102, China. wyhekyy@126.com better for symptom control in children with asthma.
Telephone: +86-18017591038
Accepted: September 21, 2016 © 2017 JTCM. This is an open access article under the
CC BY-NC-ND license.

Keywords: Asthma; Albuterol; Feces; Hyperhidro-


sis; Abnormal tongue presentations; Syndrome dif-
Abstract ferentiation; Chinese medical formula; Randomized
OBJECTIVE: To compare the effects of a series of controlled trial
Traditional Chinese Medicine (TCM) empirical pre-
scriptions with salbutamol and montelukast (SM) in INTRODUCTION
children with asthma.
Asthma is a relatively common chronic respiratory dis-
METHODS: A total of 182 children with asthma ease in children. The worldwide annual incidence of
were randomized into the TCM group (n = 97) or pediatric asthma has increased in recent years.1 If ex-
posed to physical, chemical, or biologic factors, chil-
SM group (n = 85). Patients in the TCM group were
dren with asthma are prone to airflow limitation, result-
treated with a series of TCM prescriptions, whereas
ing in recurrent episodes of wheezing, cough, and dys-
those in the SM group received salbutamol and pnea, which are often exacerbated during the night and
montelukast; both groups received their respective early morning.2
treatment for 12 weeks. Asthma control, changes in Based on its etiology and pathogenesis, and combined
scores of TCM symptom patterns, and asthma with the experience of the expert Professor Shi Yumin,
symptom control (SC) scores after treatment were a series of empirical prescriptions based on Traditional
compared between the two groups. Chinese Medicine (TCM) have been used to treat asth-
ma. Relief from asthma and coughing, the expectora-
RESULTS: A higher percentage of patients in the tion of phlegm, and cough suppression are the thera-
TCM group had asthma control compared with peutic principles for asthma during acute exacerba-

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Du H et al. / Research Article

tions. For asthma in clinical remission, stimulation of ber of dropouts, we assumed that the percentage of par-
the spleen to remove phlegm, invigoration of Qi, ticipants lost to follow-up would be 15% . Therefore,
and "tonifying" of the kidneys are the therapeutic sample collection was completed when the sample size
principles.3 in each group reached 59 cases.
We conducted a randomized controlled trial (RCT) to
compare the clinical effect of a series of TCM empiri- Implementation of a randomization plan
cal prescriptions with that of salbutamol and montelu- Patients were grouped according to a random grouping
kast on pediatric asthma. In this way, we wished to en- scheme generated by the Excel ™ computer program (a
courage use of TCM prescriptions in clinical practice. simple randomization using the recruitment sequence
number as the randomization sequence number) with
different treatments for 3 months. According to the sin-
MATERIALS AND METHODS gle-blinded principle, data were collected by specific
physicians in a uniform way, and hospitalized children,
Study design children's parents, and data analyst were blinded to the
This study was a single-blinded RCT conducted at the study protocol.
Children's Hospital of Fudan University (Fudan, Chi-
na). This study protocol was approved by the Ethics Collection of baseline data
Committee of Fudan University (grant number [2013] Between March 2013 and December 2014, 182 chil-
065) and was registered on ClinicalTrials.gov (registra- dren with asthma admitted at the Children's Hospital
tion number: NCT02341573). This study includes all of Fudan University were recruited after obtaining writ-
the information required for CONSORT 2010. ten informed consent. Age, sex, disease course, the
scores of TCM symptom patterns, symptom control
Patients (SC) scores, and the childhood asthma control test
The study followed diagnostic criteria established in (C-ACT) score were recorded before treatment.
2008 that were in accordance with the Guideline of The C-ACT score was obtained according to the child-
Childhood Bronchial Asthma by the Pulmonology hood asthma control test. The baseline C-ACT score
Group within the Pediatric Branch of the Chinese was adopted to evaluate the pre-treatment status of
Medical Association.2 A TCM-based symptom pattern children with asthma. The C-ACT includes separate
was identified according to the Diagnosis and Clinical sections for the parent and child to complete. If the
Effects on Chinese Medical Symptoms by the State Ad- child is too young to answer these questions, this sec-
ministration of Traditional Medicine.4 Patients with a tion would be completed by their parent(s).6
pattern meeting the criteria mentioned above for the The scores of TCM symptom patterns were assessed
diagnosis of pediatric asthma and cough-variant asth- based on the main symptoms: cough, expectoration of
ma and who were aged 3-12 years were enrolled into phlegm, and wheezing. Secondary symptoms were hy-
the study. Asthmatic episodes were catalogued accord- perhidrosis, the appearance of feces, and tongue appear-
ing to the identification of symptom patterns in terms ance. Scoring criteria, in accordance with the guiding
of TCM: a form of phlegm-heat obstructing the lungs principles of the clinical research of new TCM drugs7
or retention of cold fluid in the lungs; lung and spleen were that the: main symptoms were catalogued as
deficiencies; deficiency of the kidneys in clinical remis- "none" (0), "light" (1), "moderate" (2), or "heavy" (3);
sion. Patients with congenital diseases of the respirato- secondary symptoms were scored as "normal" (0) or
ry system, cancer, immunodeficiency diseases, or car- "abnormal" (1). Summation of each symptom score
diovascular diseases were excluded. was termed the "TCM total score".
SC scores were classified according to the Infantile
Estimation of sample size Bronchial Asthma Prevention and Treatment Guide-
The size of the study sample was estimated according lines (trial).8 The main symptoms were daytime and
to relevant data provided in the literature.5 We were nighttime cough and nasal symptoms, which were
planning a study of independent cases and controls based on the guideline mentioned above and relevant
with one control per case. Previous data suggested that studies.9, 10 Secondary symptoms were wheezing and
the failure rate among controls is 0.8. If the "true" fail- moist rales, which were classified as "none" (0), "light"
ure rate for participants was 0.5, then we would need (1), "moderate" (2), or "heavy" (3). Summation of
to assess 51 participants in the TCM group and 51 sub- each SC score was termed the "SC total score".
jects in the salbutamol and montelukast (SM) group to
reject the null hypothesis with a probability (power) of Interventions
0.9. The probability of a type-Ⅰ error associated with TCM group: patients received a series of empirical
a test of this null hypothesis was 0.05. We used an un- TCM-oriented prescriptions. The initial treatment was
corrected χ2 statistic to evaluate this null hypothesis. Shegan (Rhizoma Belamcandae) mixture (hospital prep-
Given the time limitations for acquiring cases, the per- aration; Shanghai Liantang Pharmaceuticals, Shanghai,
centage of participants lost to follow-up, and the num- China; batch number, 20130101) corresponding to an

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Du H et al. / Research Article

acute exacerbation. The composition of this prescrip- ti-allergic agents, and oral antibiotic treatment. All out-
tion was: Mahuang (Herba Ephedra Sinica) 9 g; Kuxin- comes were measured at week 12.
gren (Semen Armeniacae Amarum) 9 g; Shegan (Rhi-
zoma Belamcandae) 6 g; Hancai (Herba Rorippae Island- Statistical analyses
icae) 9 g; Huangqin (Radix Scutellariae Baicalensis) 9 g; Intention-to-treat analysis was undertaken. Demo-
Jiangcan (Bombyx Batryticatus) 9 g. It was administered graphic data were analyzed to identify baseline equiva-
three times daily in a 10-mL mixture over 7 days. At lencies and differences between the two groups. Con-
follow-up visits at week 4 and week 8, the prescription tinuous variables are presented as the mean ± standard
was adjusted according to TCM symptom patterns and deviation ( xˉ ± s) evaluated by the Student's t-test
SC scores. Patients with chronic persistent asthma were based on a normal distribution of data. Categorical
treated with Shegan (Rhizoma Belamcandae) mixture variables are presented as frequencies and percentages
and Huangqi (Radix Astragali Mongolici) kidney tonic and were compared using the χ2 or Fisher's exact test,
mixture. Patients in clinical remission were treated as appropriate. Data were analyzed using SPSS v19.0
with Huangqi (Radix Astragali Mongolici) kidney tonic (IBM, Armonk, NY, USA). P < 0.05 was considered
mixture, which comprised: Huangqi (Radix Astragali significant.
Mongolici) 9 g; Baizhu (Rhizoma Atractylodis Macro-
cephalae) 9 g; Shanyao (Rhizoma Dioscoreae Oppositae)
15 g; Taizishen (Radix Pseudostellariae) 9 g; Fulin (Po- RESULTS
ria) 12 g; Bajitian (Radix Morindae Officinalis) 9 g.
Complementary herbs were added or removed accord- General data
ing to presenting symptoms. For instance, Xinyi (Flos A total of 182 children with asthma were evaluated.
Magnoliae Biondii Immaturus) and Cang'erzi (Fructus They were randomized (using the random number ta-
Xanthii) were administered for nasal congestion and ble method) into the SM group (n = 85) or TCM
sneezing, Mahuanggen (Radix Ephedrae Sinicae) and group (n = 97).
Fuxiaomai (Fructus Tritici Levis) were given for hyperhi- In the SM group, 82 patients completed the study, two
drosis, and Laifuzi (Semen Raphani Sativi) and Lianq- patients were lost to follow-up because of transport dif-
iao (Fructus Forsythiae Suspensae) were prescribed for
ficulties and one patient due to hospitalization with
dry feces. These treatments were administered for 12
pneumonia. In the TCM group, 96 patients completed
weeks.
the study and one patient was lost to follow-up due to
The criteria for the quality of the herbs used were in ac-
prior commitments (Figure 1).
cordance with the Pharmacopoeia of the People's Re-
public of China (2010).11
SM group: patients with an acute exacerbation were Patients assessed
treated mainly with a bronchial relaxant, salbutamol for recruitment
(n = 200)
sulfate (sustained-release capsules; Ethypharm Pharma- Ineligible patients
ceuticals, Shanghai, China; batch number 121201; 2-4 (n = 18)
mg, b.d.), for 7 days. Patients in clinical remission were Randomized patients
treated with the leukotriene receptor antagonist monte- (n = 182)
Allocated to Allocated to
lukast sodium (chewable tablets; MSD, Kenilworth, TCM group SM group
NJ, USA; batch number, 120054; 4-5 mg) every night (n = 97) (n = 85)
for 3 months. Patients with chronic persistent asthma Discontinued Discontinued
were treated with salbutamol and montelukast. (n = 1) (n = 3)
Antibiotics given via the oral route or anti-allergic Patients complete Patients complete
agents given as nebulizers were employed in case of the trial the trial
acute bacterial infection and severe wheezing. (n = 96) (n = 82)
Figure 1 Patients flow chart
Outcomes There were no significant differences in sex, age, dis-
The long-term goals of asthma management are to: (a) ease course, cough, expectoration of phlegm, or wheez-
achieve symptom control; (b) minimize the future risk ing between the two groups (P = 0.691, 0.217, 0.344,
of exacerbations. Therefore, the primary outcome was 0.687, 0.443, 0.114). A greater proportion of children
asthma control, which was evaluated based on the with nighttime cough and a moderate degree of nasal
C-ACT score. With a possible total of 27 points, scores symptoms in the TCM group were found compared
of 23-27 are classified as "well controlled"; 20-22 as with those in the SM group. However, fewer children
"partially controlled"; "0-19" as "very poorly con- with abnormal feces were found in the TCM group
trolled". "Asthma control" was defined as C-ACT ≥20, compared with those in the SM group (P = 0.023;
which included well-controlled and partially controlled Table 1).
components. The secondary outcome included the
scores of TCM symptom patterns, SC scores, preva- Asthma control after 12 weeks of treatment
lence of asthma attacks, nebulizer treatment using an- The percentage of patients who had asthma control was

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Table 1 Patients' characteristics ( xˉ ± s)


TCM group SM group P
Variable
(n = 97) (n = 85) value
Female [n (%)] 37 (38.14) 30 (30.29) 0.691
Age (years) 5.1 5±1.89 4.84±1.43 0.217
Course of disease (month) 11.57±10.03 10.11±10.73 0.344
Cough score [n (%)] None (0) 0 (0.00) 0 (0.00) 0.687
Light (1) 6 (6.19) 8 (9.41)
Moderate (2) 84 (86.60) 70 (82.35)
Heavy (3) 7 (7.22) 7 (8.24)
Coughing-up phlegm score [n (%)] None (0) 7 (7.22) 5 (5.88) 0.443
Light (1) 43 (44.33) 45 (52.94)
Moderate (2) 47 (48.45) 34 (40.00)
Heavy (3) 0 (0.00) 1 (1.18)
Wheezing score [n (%)] None (0) 38 (39.18) 25 (29.41) 0.114
Light (1) 35 (36.08) 43 (50.59)
Moderate (2) 24 (24.74) 16 (18.82)
Heavy(3) 0 (0.00) 1 (1.18)
Hyperhidrosis [n (%)] Absent (0) 60 (61.86) 63 (74.12) 0.083
Present (1) 37 (38.14) 22 (25.88)
Feces [n (%)] Normal 51 (52.58) 59 (69.41) 0.023
Abnormal 46 (47.42) 26 (30.59)
Tongue-appearance [n (%)] Normal (0) 38 (39.18) 45 (52.94) 0.074
Abnormal (1) 59 (60.82) 40 (47.06)
TCM total score 8.40±2.06 8.33±1.79 0.801
Daytime cough [n (%)] None (0) 0 (0.00) 0 (0.00) 0.488
Light (1) 19 (19.59) 18 (21.18)
Moderate (2) 74 (76.29) 60 (70.59)
Heavy (3) 4 (4.12) 7 (8.24)
None(0) 3 (3.09) 0 (0.00)
Nighttime cough [n (%)] Light(1) 33 (34.02) 50 (58.82) 0.070
Moderate(2) 61 (62.89) 34 (40.00)
Heavy(3) 0 (0.00) 1 (1.18)
Nasal symptoms [n (%)] None (0) 14 (14.43) 17 (20) 0.014
Light (1) 65 (67.01) 64 (75.2)
Moderate (2) 18 (18.56) 4 (4.71)
Heavy (3) 0 (0) 0 (0)
Wheezing rales [n (%)] None (0) 50 (51.55) 33 (38.82) 0.174
Light (1) 36 (37.11) 35 (41.18)
Moderate (2) 11 (11.34) 16 (18.82)
Heavy (3) 0 (0) 1 (1.18)
SC total score 5.20±1.62 5.29±1.66 0.687
C-ACT score 16.8±1.86 16.87±2.35 0.832
Notes: characteristics of patients in two groups at baseline; TCM: Traditional Chinese Medicine; SM: salbutamol and montelukast; SC to-
tal score: symptom control total score; C-ACT: children asthma control test.

significantly different between the TCM group and treatment (Table 3). However, there were no signifi-
SM group (91.67% vs 76.83%, P = 0.006) (Table 2). cant differences in total TCM score, cough, expecto-
ration of phlegm, or wheezing scores between the
Changes in the scores of TCM symptom patterns two groups (P > 0.05).
after 12 weeks of treatment
Compared with the SM group, more patients in the Changes in symptom control scores after 12 weeks of
TCM group showed an increased in TCM syndrome treatment
score, such as normal feces (P < 0.001), fewer epi- Table 4 reveals that there was no significant difference
sodes of hyperhidrosis (P < 0.001), and a significant- in SC score, daytime cough or wheezing between the
ly improved tongue appearance (P = 0.001) after two groups after treatment (P > 0.05).

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Prevalence of asthma attacks, antibiotic treatment death) or adverse reactions (rash, nausea, vomiting,
and nebulizer treatment at study cessation diarrhea) were observed in either group during the
Patients suffering from asthma attacks and severe study.
wheezing at 12-week follow-up were treated with an-
ti-allergic agents in nebulized form; if this was compli-
cated by severe bacterial infection, combination treat- DISCUSSION
ment with antibiotics was administered. Compared In this present study, we treated asthma in children
with the SM group, patients in the TCM group experi- with TCM prescriptions according to symptoms, expec-
enced fewer asthma attacks (P = 0.014), and fewer in-
toration of phlegm, and cough suppression: these are
stances of antibiotic and nebulizer combination treat-
the therapeutic principles for an acute exacerbation of
ment (P = 0.007, P < 0.001, respectively; Table 5).
asthma. For chronic persistent asthma, treatment com-
Adverse reactions prised Shegan (Rhizoma Belamcandae) mixture, which
No complications (e.g., pneumonia, severe dyspnea, is administered for the dispelling of wind, removal of
Table 2 Asthma control after 12 weeks of treatment [n (%)]
Group Well controlled Partly controlled Poorly controlled χ2 value P value χ2'value P' value
TCM 53 (55.21) 35 (36.46) 8 (8.33) 7.92 0.019 7.57 0.006
SM 41 (50.00) 22 (26.83) 19 (23.17)
Notes: TCM group: patients at acute exacerbation stage of asthma were treated with Shegan (Rhizoma Belamcandae) Mixture, 10 mL, 3 times a
day, for 7 days. Patients at clinical remission stage of asthma were treated with Huangqi (Radix Astragali Mongolici) kidney tonic mixture,
60-90 mL, 2 times a day, for 3 months. SM group: patients at acute exacerbation stage of asthma were treated with 4 mg (weight ≥ 20 kg)
or 2 mg (weight < 20 mg) of salbutamol sulfate, at clinical remission stage were treated with 4-5 mg of leukotriene receptor antagonists
Montelukast Sodium, once daily for 3 months. well controlled: C-ACT score of 23-27; partly controlled: C-ACT score of 20-22; poorly
controlled: C-ACT score ≤ 19. χ2', P': well or partly controlled verse poorly controlled.

Table 3 Changes in symptom scores of Traditional Chinese Medicine after 12 weeks of treatment ( xˉ ± s )
TCM group SM group
Variable P value
(n = 97) (n = 85)
TCM total score 4.5±2.2 4.1±1.8 0.172
Cough score [n (%)] None (0) 10 (10.42) 6 (7.32) 0.797
Light (1) 78 (81.25) 70 (85.37)
Moderate (2) 8 (8.33) 6 (7.32)
Heavy (3) 0 (0.00) 0 (0.00)
Coughing-up phlegm score [n (%)] None (0) 60 (62.50) 61 (74.39) 0.174
Light (1) 29 (30.21) 19 (23.17)
Moderate (2) 7 (7.29) 2 (2.44)
Heavy (3) 0 (0.00) 0 (0.00)
Wheezing score [n (%)] None (0) 87 (90.63) 77 (93.90) 0.878
Light (1) 8 (8.33) 5 (6.10)
Moderate (2) 1 (1.04) 0 (0.00)
Heavy (3) 0 (0.00) 0 (0.00)
Hyperhidrosis [n (%)] Absent (0) 88 (92.63) 30 (36.59) < 0.001
Present (1) 7 (7.37) 52 (63.41)
Feces [n (%)] Normal (0) 79 (83.16) 27 (32.93) < 0.001
Abnormal (1) 16 (16.84) 55 (67.07)
Tongue-appearance [n (%)] Normal (0) 82 (86.32) 53 (64.63) 0.001
Abnormal (1) 13 (13.68) 29 (35.37)
Notes: TCM group: patients at acute exacerbation stage of asthma were treated with Shegan (Rhizoma Belamcandae) Mixture, 10 mL,
3 times a day, for 7 days. Patients at clinical remission stage of asthma were treated with Huangqi (Radix Astragali Mongolici) kidney tonic
mixture, 60-90 mL, 2 times a day, for 3 months. SM group: patients at acute exacerbation stage of asthma were treated with 4 mg
(weight ≥ 20 kg) or 2 mg (weight < 20 mg) of salbutamol sulfate, at clinical remission stage were treated with 4-5 mg of leukotriene recep-
tor antagonists Montelukast Sodium, once daily for 3 months.

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Du H et al. / Research Article

phlegm, and for stimulation of the spleen and Qi. Pa- multiple indices of lung function.12 Also, Tang and col-
tients in clinical remission were treated mainly with a leagues, using a Yang-warming and kidney essence-re-
kidney tonic mixture to stimulate the spleen to remove plenishing herbal paste, could reduce cold-related asth-
phlegm, invigorate Qi, and to tonify the kidneys. Previ- ma exacerbation and scores of kidney-deficiency pat-
ously, we observed the clinical effect of a series of TCM terns compared with conventional treatment based on
prescriptions from Professor Shi Yumin for the treat- guidelines set by the Global Initiative for Asthma.13
ment of pediatric asthma by assessing the Lung Func- C-ACT scores are consistent with symptoms and lung
tion Index. We found that these TCM prescriptions function, so C-ACT can enable the detection of uncon-
could control asthma attacks effectively and improve trolled asthma in patients within a short time period.

Table 4 Changes in symptom control (SC) scores after 12 weeks of treatment ( xˉ ± s )


TCM group SM group
Variable P value
(n = 97) (n = 85)
SC total score 3.1±1.9 3.4±1.7 0.213
Daytime cough [n (%)] None (0) 17 (17.71) 12 (14.63) 0.112
Light (1) 70 (72.92) 68 (82.93)
Moderate (2) 9 (9.38) 2 (2.44)
Heavy (3) 0 (0.00) 0 (0.00)
Nighttime cough [n (%)] None (0) 54 (56.25) 47 (57.32) 0.355
Light (1) 35 (36.46) 33 (40.24)
Moderate (2) 7 (7.29) 2 (2.44)
Heavy (3) 0 (0.00) 0 (0.00)
Nasal symptoms [n (%)] None (0) 54 (56.25) 47 (57.32) 0.355
Light (1) 35 (36.46) 33 (40.24)
Moderate (2) 7 (7.29) 2 (2.44)
Heavy (3) 0 (0.00) 0 (0.00)
Wheezing rales [n (%)] None (0) 92 (95.83) 76 (92.68) 0.516
Light (1) 4 (4.17) 6 (7.32)
Moderate (2) 0 (0.00) 0 (0.00)
Heavy (3) 0 (0.00) 0 (0.00)
Notes: TCM group: patients at acute exacerbation stage of asthma were treated with Shegan (Rhizoma Belamcandae) Mixture, 10 mL, 3 times a
day, for 7 days. Patients at clinical remission stage of asthma were treated with Huangqi (Radix Astragali Mongolici) kidney tonic mixture,
60-90 mL, 2 times a day, for 3 months. SM group: patients at acute exacerbation stage of asthma were treated with 4 mg (weight ≥ 20 kg)
or 2 mg (weight < 20 mg) of salbutamol sulfate, at clinical remission stage were treated with 4-5 mg of leukotriene receptor antagonists
Montelukast Sodium, once daily for 3 months.

Table 5 Prevalence of asthma attacks, antibiotic treatment, and nebulizer treatment [n (%)]

TCM group SM group


Variable χ2 value P value
(n = 97) (n = 85)
Incident of asthma attack
1, yes 11 (11.34) 23 (27.06) 7.368 0.007
0, no 86 (88.66) 62 (72.94)
Atomization treatment
1, yes 8 (8.25) 21 (24.71) 9.161 0.002
0, no 89 (91.75) 64 (75.29)
Antibiotics treatment
1, yes 3 (3.09) 11 (12.94) - 0.023a
0, no 94 (96.91) 74 (87.06)
Notes: TCM group: patients at acute exacerbation stage of asthma were treated with Shegan (Rhizoma Belamcandae) Mixture, 10 mL, 3
times a day, for 7 days. Patients at clinical remission stage of asthma were treated with Huangqi (Radix Astragali Mongolici) kidney tonic
mixture, 60-90 mL, 2 times a day, for 3 months. SM group: patients at acute exacerbation stage of asthma were treated with 4 mg
(weight ≥ 20 kg) or 2 mg (weight < 20 mg) of salbutamol sulfate, at clinical remission stage were treated with 4-5 mg of leukotriene recep-
tor antagonists Montelukast Sodium, once daily for 3 months; a Fisher's exact test was used.

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This strategy can counteract the limitations associated shown that healthy children treated with montelukast
with the measurement of lung function and identifica- for 12 weeks did not experience a reduction in the
tion of symptoms for assessment of asthma control.6 prevalence of infections in the upper respiratory tract.19
C-ACT is easy to operate and suitable for pediatric pa- This may have been one of the reasons why TCM treat-
tients who are unable to undergo lung-function tests. ment was superior to a conventional agent for the pre-
Therefore, we adopted C-ACT to assess asthma con- vention of asthma attacks.
trol in children via a large-cohort RCT to evaluate the The present study elicited four main findings. First,
effect of TCM treatment on pediatric asthma. Our re- more patients in the TCM group had asthma control
sults showed that, after 3 months of a TCM treatment than those in the SM group, suggesting that TCM can
regimen, patients in the TCM group had increased control asthma attacks effectively. Second, after treat-
C-ACT scores, and more patients had asthma control ment, there was no significant difference in SC scores
in the TCM group than those in the SM group. between the two groups. This finding suggested that
Recent studies have shown that the effectiveness of the effect of TCM treatment on pediatric asthma in
TCM upon asthma involves multiple pathways, target terms of improving SC scores was similar to that of sal-
points, and elements. In this present study, the pre- butamol and montelukast. Third, compared with the
scription for the TCM group, Shegan (Rhizoma Belam- SM group, more patients in the TCM group showed
candae) mixture, was derived from a Shegan (Rhizoma improvements in the scores of TCM symptom patterns
Belamcandae) and Mahuang (Herba Ephedra Sinica) de- (appearance of feces, hyperhidrosis, tongue appear-
coction. Luo et al 14 found that, compared with an asth- ance), suggesting that TCM treatment can improve the
ma model group, the Shegan (Rhizoma Belamcandae) physique of asthmatic children. Finally, patients in the
and Mahuang (Herba Ephedra Sinica) decoction group TCM group suffered fewer asthma attacks, and re-
showed reduced expression of transforming growth fac- quired fewer sessions of antibiotic and nebulizer treat-
tor beta-1 (TGF-β1), decreased thickness of the bron- ment, than patients in the SM group. These observa-
chial wall and smooth muscle, and a reduction in the tions suggest that TCM reduces the opportunity for
number of infiltrating inflammatory cells. The reduc- bacterial infections after treatment and, therefore, re-
tion in TGF-β1 expression and inflammation, and re- duces the occurrence of respiratory-tract infections. In
straint of airway remodeling in lung tissue, suggests addition, TCM can reduce the requirement for the ad-
that the Shegan (Rhizoma Belamcandae) and Mahuang ministration of antibiotics and glucocorticoid inhala-
(Herba Ephedra Sinica) decoction can reduce asthmatic tion during asthma treatment.
symptoms such as phlegm and wheezing. The Shegan Our study had three main limitations. First, patients
(Rhizoma Belamcandae) and Mahuang (Herba Ephedra with severe asthma were not included. Therefore, we
Sinica) decoction has also been shown to improve im- could not observe the effects of TCM treatment on
mune function to prevent hypersensitivity,15 improve these patients. Second, the taste of TCMs is not well-re-
clinical effects in the treatment of pediatric cough-vari- ceived by some patients and might, therefore, have af-
ant asthma, and modify serum levels of tumor necro- fected compliance in our study. Finally, the potential
sis factor (TNF)-α, interleukin (IL)-10, and IL-13.5 biases of the family environment and the educational
The TCM regimen for tonifying the kidneys and re- level of parents were not assessed.
plenishing Qi can improve the function of the hypo- In conclusion, our findings suggest that a series of em-
thalamus-pituitary-adrenal axis, change the balance of pirical TCM prescriptions can improve asthma control
T-helper (Th)1 and Th2 cytokines, increase the level of better than salbutamol and montelukast. It can also
corticotrophin-releasing hormone mRNA, and pro- control asthma attacks and, to a certain extent, im-
mote secretion of adrenocortical hormones. It can also prove constipation, hyperhidrosis, abnormal tongue ap-
effectively reduce the synthesis of TNF-α, in serum, pearance, and induce recovery from disease, thereby im-
and restrict the activity of nuclear transcription factors proving quality of life.
in lung tissue, which may explain the mechanisms be-
hind its treatment of recurrent asthma.16 The Wuhu de-
coction can be used to regulate the co-stimulatory mol- ACKNOWLEDGMENTS
ecules of dendritic cells in asthmatic infants to reduce The authors thank all patients for their participation.
expression of cluster of differentiation (CD)80 and Special thanks are also extended to colleagues at the
CD86, which could provide a practical basis for the Children's Hospital of Fudan University.
treatment of infantile asthma.17
This present study demonstrated that TCM treatment
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JTCM | www. journaltcm. com 529 August 15, 2017 | Volume 37 | Issue 4 |