Perennial Allergic Rhinitis
Conditions
Keywords
Perennial Allergic rhinitis, Traditional Chinese Medicine
Brief summary
Allergic rhinitis(AR) is one of the most common allergic disorders throughout the world.The conventional therapies are effective in alleviating symptoms but the efficacy are limited and not persistent. Furthermonre, the cost and side-effect are known defects. A classical Chinese herbal formula, has been used for AR for centries. Our study purpose is to evaluate the clinical efficacy and safety of this formula verus placebo in perennial allergic rhinitis (PAR). Hypothesis: the classical herbal formula would improve the symptoms of PAR patients and change some immunological parameters in the peripheral blood when comparing with the placebo.
Detailed description
It is a randomized, double-blind, placebo-controlled trial.
Interventions
DRUGShi-Bi-Lin
4 weeks of treatment, dose of 1 g (two capsules), twice daily
OTHERPlacebo
4 weeks of colormatched placebo capsules, dose of 1 g (two capsules), twice daily
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Aged from 18 to 65 years old * Have typical symotoms of PAR including rhinirrhea, sneezing, nasal obstruction and itching in nose and eyes for at least 2 previous consecutive years. * Postive skin prick test(SPT) to hose dust mite, mold, animal dander and cockcroach with regular AR medications withould for 3 days prior to the test
Exclusion criteria
* Pregnant women and women at risk of conception * Received allergen injections in previous 2 years * Regular medications for AR or cold and other allergic disorder * Seasonal allergic rhinitis, vasomotor rhinitis and rhinitis medicamentosa * Nasal structure deformities, nasal polyps and hypertrophic rhinitis * Systematic cortisosteroid used within recent 3 months or nasal cortisosteroid with 15 days * Other active respiratory disorders * Active medical disorders: cancer, infection, hematology, renal, hepatic, cardiovascular, metabolic and gastrointestinal diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4 | 4 week | The severity of PAR was evaluated by means of a daily symptom diary chart. Patients were instructed to grade retrospectively everyday before bedtime, their generalwell-being, nasalsymptoms (nasal blockage, rhinorrhea, nose itching, sneezing) and non-nasal symptoms(itching eyes, tearing eyes, redness of eyes, itching of ears or palate) on the diary chart. A 4-point severity scale from no symptoms (0), mild (1), moderated (2) to severe (3) was used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (Difference Between Baseline and Week 4) | 4 week | SF-36 QOL questionnaire administrated before and after treatment. It has eight domains: general health (GH), physical functioning (PF), social functioning (SF), role limitation caused by physical problems (RP), bodily pain (BP), role limitations caused by emotional problem (RE), mental health (MH), and vitality (VT). Each domain was started from 0 (worst health) to 100 (best health). |
Countries
Hong Kong
Participant flow
Recruitment details
Recruitment started at Jan 2004. Patients were recruited as volunteers from the Prince of Wales hospital, the Yan Chai hospital and the Alice Ho Mui Ling Nethersole Hospital specialist clinics.
Pre-assignment details
Confirmed perennial allergic rhinitis and have a positive skin test to house-dust mite, mold antigens and/or animal dander was required. Enter 1-week run-in-period, during which symptom diary was given to each subject for the evaluation of symptoms. Eligible case with total score higher than 4.
Participants by arm
| Arm | Count |
|---|---|
| Shi-Bi-Lin Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba). | 63 |
| Placebo The placebo contained brown colored starch resembling the SBL powder | 63 |
| Total | 126 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | Shi-Bi-Lin | Placebo | Total |
|---|---|---|---|
| Age Continuous Age | 41.19 Year STANDARD_DEVIATION 12.38 | 36.02 Year STANDARD_DEVIATION 11.14 | 38.60 Year STANDARD_DEVIATION 12.01 |
| Region of Enrollment Hong Kong | 63 participants | 63 participants | 126 participants |
| Sex: Female, Male Female | 40 Participants | 43 Participants | 83 Participants |
| Sex: Female, Male Male | 23 Participants | 20 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 63 | 0 / 63 |
| serious Total, serious adverse events | 0 / 63 | 0 / 63 |
Outcome results
Primary
Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4
The severity of PAR was evaluated by means of a daily symptom diary chart. Patients were instructed to grade retrospectively everyday before bedtime, their generalwell-being, nasalsymptoms (nasal blockage, rhinorrhea, nose itching, sneezing) and non-nasal symptoms(itching eyes, tearing eyes, redness of eyes, itching of ears or palate) on the diary chart. A 4-point severity scale from no symptoms (0), mild (1), moderated (2) to severe (3) was used.
Time frame: 4 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Shi-Bi-Lin | Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4 | Nose Blockage | 1.19 Unit Score | Standard Deviation 0.68 |
| Shi-Bi-Lin | Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4 | Eyes Itching | 0.73 Unit Score | Standard Deviation 0.67 |
| Shi-Bi-Lin | Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4 | Sneeze Frequency | 1.15 Unit Score | Standard Deviation 0.64 |
| Shi-Bi-Lin | Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4 | Tears | 0.52 Unit Score | Standard Deviation 0.71 |
| Shi-Bi-Lin | Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4 | Rhinorrhea volume | 1.26 Unit Score | Standard Deviation 0.71 |
| Shi-Bi-Lin | Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4 | Eye Congestion | 0.37 Unit Score | Standard Deviation 0.6 |
| Shi-Bi-Lin | Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4 | Nose Itching | 1.11 Unit Score | Standard Deviation 0.58 |
| Shi-Bi-Lin | Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4 | Ear itching | 0.81 Unit Score | Standard Deviation 0.65 |
| Shi-Bi-Lin | Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4 | General Health | 2.82 Unit Score | Standard Deviation 0.8 |
| Placebo | Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4 | Ear itching | 0.61 Unit Score | Standard Deviation 0.78 |
| Placebo | Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4 | General Health | 2.8 Unit Score | Standard Deviation 0.78 |
| Placebo | Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4 | Nose Blockage | 1.21 Unit Score | Standard Deviation 0.77 |
| Placebo | Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4 | Rhinorrhea volume | 1.24 Unit Score | Standard Deviation 0.7 |
| Placebo | Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4 | Sneeze Frequency | 1.18 Unit Score | Standard Deviation 0.7 |
| Placebo | Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4 | Nose Itching | 0.99 Unit Score | Standard Deviation 0.75 |
| Placebo | Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4 | Eyes Itching | 0.56 Unit Score | Standard Deviation 0.76 |
| Placebo | Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4 | Tears | 0.43 Unit Score | Standard Deviation 0.67 |
| Placebo | Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4 | Eye Congestion | 0.26 Unit Score | Standard Deviation 0.58 |
Secondary
Quality of Life (Difference Between Baseline and Week 4)
SF-36 QOL questionnaire administrated before and after treatment. It has eight domains: general health (GH), physical functioning (PF), social functioning (SF), role limitation caused by physical problems (RP), bodily pain (BP), role limitations caused by emotional problem (RE), mental health (MH), and vitality (VT). Each domain was started from 0 (worst health) to 100 (best health).
Time frame: 4 week
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Shi-Bi-Lin | Quality of Life (Difference Between Baseline and Week 4) | Physical functioning | 4 Unit Score | Standard Deviation 14 |
| Shi-Bi-Lin | Quality of Life (Difference Between Baseline and Week 4) | Role limitation by physical problem | 7 Unit Score | Standard Deviation 33 |
| Shi-Bi-Lin | Quality of Life (Difference Between Baseline and Week 4) | Bodily pain | -3 Unit Score | Standard Deviation 25 |
| Shi-Bi-Lin | Quality of Life (Difference Between Baseline and Week 4) | General Health | -7 Unit Score | Standard Deviation 20 |
| Shi-Bi-Lin | Quality of Life (Difference Between Baseline and Week 4) | Vitality | 8 Unit Score | Standard Deviation 22 |
| Shi-Bi-Lin | Quality of Life (Difference Between Baseline and Week 4) | Socail functioning | 17 Unit Score | Standard Deviation 18 |
| Shi-Bi-Lin | Quality of Life (Difference Between Baseline and Week 4) | Role limitation by emotional problem | 13 Unit Score | Standard Deviation 29 |
| Shi-Bi-Lin | Quality of Life (Difference Between Baseline and Week 4) | Mental health | 1 Unit Score | Standard Deviation 23 |
| Placebo | Quality of Life (Difference Between Baseline and Week 4) | Mental health | 1 Unit Score | Standard Deviation 18 |
| Placebo | Quality of Life (Difference Between Baseline and Week 4) | Physical functioning | 0 Unit Score | Standard Deviation 10 |
| Placebo | Quality of Life (Difference Between Baseline and Week 4) | Vitality | 13 Unit Score | Standard Deviation 20 |
| Placebo | Quality of Life (Difference Between Baseline and Week 4) | Role limitation by physical problem | 3 Unit Score | Standard Deviation 30 |
| Placebo | Quality of Life (Difference Between Baseline and Week 4) | Role limitation by emotional problem | 3 Unit Score | Standard Deviation 28 |
| Placebo | Quality of Life (Difference Between Baseline and Week 4) | Bodily pain | -10 Unit Score | Standard Deviation 21 |
| Placebo | Quality of Life (Difference Between Baseline and Week 4) | Socail functioning | 17 Unit Score | Standard Deviation 19 |
| Placebo | Quality of Life (Difference Between Baseline and Week 4) | General Health | -9 Unit Score | Standard Deviation 23 |