Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Participants' expectation about therapeutic benefits from acupuncture |
Participants in the acupuncture and placebo acupuncture groups will be asked the following question: "How helpful you believe the acupuncture modality you received would be for your allergic rhinitis?" |
At baseline |
|
Other |
The proportion of participants remained blinded to treatment arm in acupuncture and placebo acupuncture groups. |
Each participant in the acupuncture and placebo acupuncture groups will be asked the following question: "Which treatment do you think you have received (acupuncture or placebo acupuncture)?" |
Five minutes after the end of the last treatment in the fourth week, |
|
Other |
Incidence of adverse events |
Any potential adverse events (AEs) will be monitored and documented in the CRFs within 24 hours after their occurrence during the treatment and follow-up period. According to their potential association with acupuncture, AEs will be categorized as acupuncture-associated AEs (e.g., subcutaneous hemorrhage, dizziness, fainting, serious pain, and local infection fainting, localized hematoma), and non-treatment-related AEs. |
during weeks 1-8 in the first year and the first week following symptoms onset in the second year |
|
Primary |
The change from baseline in the average daily Combined Symptoms and Medication Score (CSMS) over weeks 1- 4 |
The average daily Combined Symptoms and Medication Score (CSMS) is the sum of the daily symptom score (dSS) plus daily medication score (dMS) . The dSS contains a 6-item scale referring to nasal symptoms (4 items) and ocular symptoms (2 items), with each item scored using a Likert scale of 0 to 3. The dSS will be calculated as a mean of all non-missing dSS divided by the number of individual symptoms (range, o to 3). The dMS will again be calculated as an average of daily symptom relief medication score, with a range of 0 to 3. |
weeks 1-4 |
|
Secondary |
The change from baseline in the average daily Combined Symptoms and Medication Score (CSMS) over weeks 5- 8 and the first week following symptoms onset in the second year |
The average daily Combined Symptoms and Medication Score (CSMS) is the sum of the daily symptom score (dSS) plus daily medication score (dMS) . The dSS contains a 6-item scale referring to nasal symptoms (4 items) and ocular symptoms (2 items), with each item scored using a Likert scale of 0 to 3. The dSS will be calculated as a mean of all non-missing dSS divided by the number of individual symptoms (range, o to 3). The dMS will again be calculated as an average of daily symptom relief medication score, with a range of 0 to 3. |
over weeks 5- 8 and the first week following symptoms onset in the second year |
|
Secondary |
Change in the average daily symptom score (dSS) and daily medication score (dMS) from baseline over weeks 1- 4, weeks 5-8 in the first year and the first week following symptoms onset in the second year. |
The daily symptom score (dSS) contains a 6-item scale referring to nasal symptoms (4 items) and ocular symptoms (2 items), with each item scored using a Likert scale of 0 to 3. The dSS will be calculated as a mean of all non-missing dSS divided by the number of individual symptoms (range, o to 3). The daily medication score (dMS) will again be calculated as an average of daily symptom relief medication score, with a range of 0 to 3. |
over weeks 1- 4, weeks 5-8 in the first year and the first week following symptoms onset in the second year. |
|
Secondary |
The proportion of participants with a minimum of 23% improvement in average daily Combined Symptoms and Medication Score (CSMS) from baseline over weeks 1-4, weeks 5-8 in the first year and at the first week following symptoms onset in the second year. |
A difference of 23% on the average daily Combined Symptoms and Medication Score (CSMS) was chosen to demonstrate a minimum clinically important difference. |
over weeks 1- 4, weeks 5-8 in the first year and the first week following symptoms onset in the second year. |
|
Secondary |
Change in the Rhinoconjunctivitis Quality of Life Questionnaires (RQLQ) total score and subscale scores from baseline to the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year. |
The RQLQ is a well-established and validated questionnaire consisted of 28 questions covering 7 domains: sleep (3 items), practical problems (3 items), non-nasal and eye symptoms (7 items), nasal symptoms (4 items), eye symptoms (4 items), activities that have been limited by nose or eye symptoms (3 items), and emotional function (4 items). Each item will be evaluated on a 7-point rating scale ranging from 0 (no impairment) to 6 (severe impairment) during the previous week. |
At the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year |
|
Secondary |
Change in the Visual analog scale score for the overall allergic symptoms severity from baseline to the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year. |
Patients will be asked to grade the severity of allergic symptoms using the self-rated 0-100mm Visual analog scale (0, no symptoms, to 100, worst-ever symptoms, in 1-point increment). |
At the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year |
|
Secondary |
A global evaluation in comparison to previous years by each participant at the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year. |
Each participant will be asked the following question: ''Compared to your symptoms in previous grass pollen seasons, how have you felt overall in this grass pollen season? (Tick only one)". The possible answers are coded as follows:1, "Very much better"; 2, "Much better"; 3, "A little better"; 4, "No change"; 5, "A little worse"; 6, "Much worse"; and 7, "Very much worse". |
At the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year |
|
Secondary |
Patient global evaluation of improvement at the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year. |
Patient global evaluation of improvement will be rated by the participants using a 7-point Likert scale with the following options: 1, "Very much better"; 2, "Much better"; 3, "A little better"; 4, "No change"; 5, "A little worse"; 6, "Much worse"; and 7, "Very much worse" at each study visit. |
At the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year |
|
Secondary |
The average weekly number of medication-free days during weeks 1-4, weeks 5-8 in the first year. |
The average weekly number of medication-free days during weeks 1-4, weeks 5-8 in the first year will be compared among three groups |
during weeks 1-4, weeks 5-8 in the first year |
|
Secondary |
The average weekly number of symptom-free days during weeks 1-4, weeks 5-8 in the first year. |
The average weekly number of symptom-free days during weeks 1-4, weeks 5-8 in the first year will be compared among three groups |
during weeks 1-4, weeks 5-8 in the first year |
|