Chronic Rhinosinusitis, Postoperative Care
Conditions
Brief summary
Investigators tried to evaluate the efficacy and safety of Chinese herbal medicine nasal irrigation as an adjuvant therapy after FESS.
Detailed description
In this study, patients with chronic rhinosinusitis who received FESS were recruited and randomly assigned to 2 groups at one month post-surgery. Patients in the xylitol group received 240ml of Chinese herbal medicine nasal irrigation daily for 2 months, and those in the normal saline (NS) group received 240ml of NS nasal irrigation daily for 2 months. Before FESS as well as before and after nasal irrigation, sino-nasal symptoms were assessed by a 22-item Sino-Nasal Outcome Test questionnaire and patients received endoscopic examination, nasal function tests, cytokine measurement of nasal irrigant, and bacterial culture from the middle meatus. The safety of nasal irrigation was assessed by self-reported adverse events, and blood test. This study tried to evaluate the efficacy and safety of Chinese herbal medicine nasal irrigation as an adjuvant therapy after FESS.
Interventions
DRUGChinese herbal medicine Powder
The bilateral nasal cavity was irrigated by using a NeilMed® SINUS RINSE™ Squeeze Bottle containing 240ml of Chinese herbal medicine solution twice a day for 2 months.
DRUGSalt Powder
The bilateral nasal cavity was irrigated by using a NeilMed® SINUS RINSE™ Squeeze Bottle containing 240ml of of normal saline twice a day for 2 months.
Sponsors
Taichung Veterans General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Patients with chronic rhinosinusitis who failed medical treatment 2.Patients underwent bilateral primary functional endoscopic sinus surgery.
Exclusion criteria
* 1\. Patients with a history of immunodeficiency 2.Patients with a history of sinus surgery 3.Patients who receiving antibiotic treatment within a week before functional endoscopic sinus surgery 4.Patients with a pathological diagnosis of fungal sinusitis 5.Patients with a pathological diagnosis of sinonasal tumor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Taiwanese version of the 22-item Sino-Nasal Outcome Test | From before operation to 3 months after surgery | The Taiwanese version of the 22-item Sino-Nasal Outcome Test contains 22 items of symptoms and social/emotional consequences from nasal disorder. Patients are asked to rate their problems based on how they have been over the past two weeks. Each item is graded from 0 (no problem) to 5 (as bad as it can be) according to its severity and frequency. |
| Self-reported adverse events | From before nasal irrigation to after 2-month nasal irrigation | Any adverse events occurring during the 2 months period of nasal irrigation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of the second minimal cross-sectional area of the nasal cavity | From before operation to 3 months after surgery | The second minimal cross-sectional area of the nasal cavity was measured by acoustic rhinometry. |
| Change of endoscopic score | From before operation to 3 months after surgery | The endoscopic appearances were categorized into polyps (0: no polyps; 1: polyps present within the middle meatus; 2: polyps beyond the middle meatus); nasal secretion (0: no secretion; 1: clear, thin secretion; 2: thick, purulent secretion); mucosal edema; scarring; crusting; (0: absent; 1: mild; 2: severe). The score ranged from 0 to 20 for both nostrils together. |
| Change of saccharine transit time | From before operation to 3 months after surgery | The saccharine transit test involved placing saccharine granules under the head of the inferior turbinate in the more severely affected nostril. The time interval (minute) between placement of saccharine granules and sensation of sweetness in the throat was recorded. |
Countries
Taiwan
Contacts
Primary ContactRong-San Jiang, MD, PhD
Outcome results
None listed