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Efficacy and Safety of Sanfu Herbal Patch at Acupoints for Persistent Allergic Rhinitis: Study Protocol for a Randomized Controlled Trial.

Chen X, Lu C, Stålsby-Lundborg C, Li Y, Li X, Sun J, Ouyang W, Li G, Su G, Lu L, Fu W, Wen Z - Evid Based Complement Alternat Med (2015)

Bottom Line: SHP has been reported to be effective for managing the symptoms of AR, but the evidence suffers from methodological limitations.The waiting-list group will receive no treatment in the first year but will receive SHP in the following two years.The primary outcome, total nasal symptoms score, is self-assessed at the beginning of each treatment session and during each annual follow-up.

View Article: PubMed Central - PubMed

Affiliation: Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China.

ABSTRACT
Background. The Sanfu herbal patch (SHP) has been widely used to treat allergic rhinitis (AR) in China. SHP has been reported to be effective for managing the symptoms of AR, but the evidence suffers from methodological limitations. Therefore, we designed a three-armed, randomized, and placebo-controlled trial to evaluate the efficacy and safety of SHP for persistent allergic rhinitis (PAR). Methods. The trial consists of 5 treatment sessions along with a one-year follow-up. This process is then repeated in the second and third years. Eligible participants diagnosed with PAR were randomized at a ratio of 2 : 2 : 1 into one of three groups: (a) SHP group; (b) placebo group; or (c) waiting-list group. The waiting-list group will receive no treatment in the first year but will receive SHP in the following two years. The primary outcome, total nasal symptoms score, is self-assessed at the beginning of each treatment session and during each annual follow-up. Secondary outcomes include the Rhinoconjunctivitis Quality-of-Life Questionnaire, allergic rhinitis attacks, and relief medications. The trial will be stopped if early termination criteria are met during the interim analysis. Ethics. This protocol has been approved by site ethics committee (number B2014-014-01) and is registered with ClinicalTrials.gov NCT02192645.

No MeSH data available.


Related in: MedlinePlus

Trial flow diagram in the SPAR study. SPAR: Sanfu herbal patch at acupoints for persistent allergic rhinitis, SHP: Sanfu herbal patch, TNSS: Total Nasal Symptom Score, RQLQ: rhinitis quality-of-life questionnaire, ARA: allergic rhinitis attack, RM: relief medication, AE: adverse event, PE: placebo effect, T1: treatment in the first year, FU1: follow-up in the first year, T2: treatment in the second year, FU2: follow-up in the second year, T3: treatment in the third year, and FU3: follow-up in the third year.
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fig1: Trial flow diagram in the SPAR study. SPAR: Sanfu herbal patch at acupoints for persistent allergic rhinitis, SHP: Sanfu herbal patch, TNSS: Total Nasal Symptom Score, RQLQ: rhinitis quality-of-life questionnaire, ARA: allergic rhinitis attack, RM: relief medication, AE: adverse event, PE: placebo effect, T1: treatment in the first year, FU1: follow-up in the first year, T2: treatment in the second year, FU2: follow-up in the second year, T3: treatment in the third year, and FU3: follow-up in the third year.

Mentions: This is a three-armed, randomized, and placebo-controlled trial, conducted in Guangdong Provincial Hospital of Chinese Medicine (GPHCM), Guangzhou, China. A flow chart of this trial is provided in Figure 1. The trial consists of 5 TSs conducted during the Sanfu period along with a one-year follow-up. This process is then repeated in the second and third years after treatment is begun. After providing written informed consent, eligible participants were randomized at a ratio of 2 : 2 : 1 into one of three groups: an SHP group receiving SHP treatment; a placebo group receiving placebo patch treatments; a waiting-list group receiving no treatment in the first year but then receiving SHP treatments the following two years. To allow for early termination, the trial will be assessed in two equally spaced interim analyses at the end of the first and second years, respectively. The trial will be stopped if a statistically significant difference between SHP and placebo is obtained during the interim analysis.


Efficacy and Safety of Sanfu Herbal Patch at Acupoints for Persistent Allergic Rhinitis: Study Protocol for a Randomized Controlled Trial.

Chen X, Lu C, Stålsby-Lundborg C, Li Y, Li X, Sun J, Ouyang W, Li G, Su G, Lu L, Fu W, Wen Z - Evid Based Complement Alternat Med (2015)

Trial flow diagram in the SPAR study. SPAR: Sanfu herbal patch at acupoints for persistent allergic rhinitis, SHP: Sanfu herbal patch, TNSS: Total Nasal Symptom Score, RQLQ: rhinitis quality-of-life questionnaire, ARA: allergic rhinitis attack, RM: relief medication, AE: adverse event, PE: placebo effect, T1: treatment in the first year, FU1: follow-up in the first year, T2: treatment in the second year, FU2: follow-up in the second year, T3: treatment in the third year, and FU3: follow-up in the third year.
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4537715&req=5

fig1: Trial flow diagram in the SPAR study. SPAR: Sanfu herbal patch at acupoints for persistent allergic rhinitis, SHP: Sanfu herbal patch, TNSS: Total Nasal Symptom Score, RQLQ: rhinitis quality-of-life questionnaire, ARA: allergic rhinitis attack, RM: relief medication, AE: adverse event, PE: placebo effect, T1: treatment in the first year, FU1: follow-up in the first year, T2: treatment in the second year, FU2: follow-up in the second year, T3: treatment in the third year, and FU3: follow-up in the third year.
Mentions: This is a three-armed, randomized, and placebo-controlled trial, conducted in Guangdong Provincial Hospital of Chinese Medicine (GPHCM), Guangzhou, China. A flow chart of this trial is provided in Figure 1. The trial consists of 5 TSs conducted during the Sanfu period along with a one-year follow-up. This process is then repeated in the second and third years after treatment is begun. After providing written informed consent, eligible participants were randomized at a ratio of 2 : 2 : 1 into one of three groups: an SHP group receiving SHP treatment; a placebo group receiving placebo patch treatments; a waiting-list group receiving no treatment in the first year but then receiving SHP treatments the following two years. To allow for early termination, the trial will be assessed in two equally spaced interim analyses at the end of the first and second years, respectively. The trial will be stopped if a statistically significant difference between SHP and placebo is obtained during the interim analysis.

Bottom Line: SHP has been reported to be effective for managing the symptoms of AR, but the evidence suffers from methodological limitations.The waiting-list group will receive no treatment in the first year but will receive SHP in the following two years.The primary outcome, total nasal symptoms score, is self-assessed at the beginning of each treatment session and during each annual follow-up.

View Article: PubMed Central - PubMed

Affiliation: Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China.

ABSTRACT
Background. The Sanfu herbal patch (SHP) has been widely used to treat allergic rhinitis (AR) in China. SHP has been reported to be effective for managing the symptoms of AR, but the evidence suffers from methodological limitations. Therefore, we designed a three-armed, randomized, and placebo-controlled trial to evaluate the efficacy and safety of SHP for persistent allergic rhinitis (PAR). Methods. The trial consists of 5 treatment sessions along with a one-year follow-up. This process is then repeated in the second and third years. Eligible participants diagnosed with PAR were randomized at a ratio of 2 : 2 : 1 into one of three groups: (a) SHP group; (b) placebo group; or (c) waiting-list group. The waiting-list group will receive no treatment in the first year but will receive SHP in the following two years. The primary outcome, total nasal symptoms score, is self-assessed at the beginning of each treatment session and during each annual follow-up. Secondary outcomes include the Rhinoconjunctivitis Quality-of-Life Questionnaire, allergic rhinitis attacks, and relief medications. The trial will be stopped if early termination criteria are met during the interim analysis. Ethics. This protocol has been approved by site ethics committee (number B2014-014-01) and is registered with ClinicalTrials.gov NCT02192645.

No MeSH data available.


Related in: MedlinePlus