The Influence of Jia Wei Cang Er San on the Postoperative Bacteriology of Chronic Rhinosinusitis: A Randomized, Placebo-Controlled, Double-Blind Study ()
1. Introduction
Functional endoscopic sinus surgery (FESS) has become a standard surgical modality for treating chronic rhinosinusitis (CRS) [1]. Recently, it has been emphasized that postoperative care is very important in the outcome of FESS [2]. Antibiotics are used routinely for post-FESS care [3], because it is generally believed that damaged sinuses are prone to bacterial infection [2]. However, increased bacterial growth was found after antibiotic treatment [4].
Jia Wei Cang Er San which is one of most common used Chinese herbal medicines (CHM) to treat rhinosinusitis in Taiwan has been reported to alleviate the nasal symptoms of allergic rhinitis by way of its inhibitory effect on type I anaphylaxis reactions and eosinophil infiltration in the nasal tissues as well as the inhibition of some mediators related to allergic rhinitis [5,6]. One of its active components, Angelica dahurica, has been shown to possess antibiotic and cyclooxygenase-2 inhibitory activities and is used to treat rhinosinusitis [7]. When both antibiotics and CHM were commonly used to treat CRS in Taiwan, we tried to compare the influence of Jia Wei Cang Er San with amoxicillin on the post-FESS bacteriology in CRS patients.
2. Materials & Methods
A randomized, placebo-controlled, double-blind study was performed to investigate the influence of Jia Wei Cang Er San on the bacteriology after FESS. CRS patients who had poor response to medical treatment and subsequently underwent FESS were included in this study. The diagnosis of CRS was based on a history of rhinosinusitis for more than 12 weeks, the findings of nasal endoscopy, and an examination of CT scans. Any patient who had a history of immunodeficiency or a previous sinus surgery was excluded from the study. Patients who took antibiotics within a week before FESS were also excluded. This study was approved by the Institutional Review Board of Taichung Veterans General Hospital (TCVGHC06215).
On the day before FESS, all patients received endoscopic examination, and endoscopic appearances were quantified on a 0-2 point scale according to the staging by Lund and Mackay [8]. Endoscopic appearances included the presence of polyps (0: no polyp; 1: polyps confined to the middle meatus; 2: polyps beyond the middle meatus), discharge (0: no discharge; 1: clear, thin discharge; 2: thick, purulent discharge) and edema. The endoscopic appearances were scored unilaterally.
A swab specimen was taken from the right and left middle meati and sent to the laboratory for aerobic and anaerobic cultures.
After surgery, patients were randomly assigned to 3 groups by a technician. In the CHM group, patients were given a capsule of Jia Wei Cang Er San tid for 8 weeks and a placebo capsule for amoxicillin q8h for 4 weeks. A capsule of Jia Wei Cang Er San contains 2 g of Cang Er San and 1 g of Yuxingcao. In the amoxicillin group, patients were given a capsule of amoxicillin 250 mg q8h for 4 weeks and a placebo capsule for Jia Wei Cang Er San tid for 8 weeks. In the placebo group, patients were given a placebo capsule for Jia Wei Cang Er San tid for 8 weeks and a placebo capsule for amoxicillin q8h for 4 weeks. During this period, no antihistamine, oral or nasal steroid was prescribed. Nasal irrigation was not performed either.
At 8 weeks after FESS, patients received another endoscopic examination and swab specimens were taken from the right and left middle meati for aerobic and anaerobic cultures. At 12 weeks after FESS, patients received another endoscopic examination again. Swab specimens were also taken from the right and left middle meati for aerobic and anaerobic cultures. The postoperative endoscopic appearances were quantified on a 0-2 point scale according to the staging method described by Lund and Mackay [8]. Endoscopic appearances included the presence of polyps (0: no polyp; 1: polyps confined to the middle meatus; 2: polyps beyond the middle meatus), discharge (0: no discharge; 1: clear, thin discharge; 2: thick, purulent discharge), edema, scarring or adhesions and crusting.
The rates of bacterial culture were compared before and after FESS, and among the three groups using the Chi-square test. The endoscopic scores before and after FESS were compared using the Wilcoxon signed rank test. The endoscopic score were compared among the three groups using the Kruskal Wallis test. The bacterial culture rate was calculated by the number of specimens which grew bacteria per total number of specimens. Two-tailed p-values <0.05 were considered statistically significant. All computations were performed using the SPSS version 12.0 (SPSS Inc., Chicago, IL, USA).
3. Results
There were 97 patients enrolled in this study. Sixty-nine (45 males, 24 females) completed the study with 23 in the CHM group, 27 in the amoxcillin group and 19 in the placebo group. Their ages ranged from 14 to 82 years with a mean of 41.8 years.
Table 1 shows endoscopic scores and prevalence rates of positive bacterial culture before and after FESS in the 3 groups. When endoscopic scores were compared before and after FESS, the scores significantly decreased at 8 weeks after FESS in all 3 groups (p = 0.001 for CHM group, 0.002 for amoxicillin group and 0.002 for placebo group, respectively) and were lower still at 12 weeks after FESS (p ≤ 0.0001 for CHM group, 0.0001 for amoxicillin group and 0.001 for placebo group, respectively).