Self-administered acupressure for allergic rhinitis: Study protocol for a randomized controlled trial

Self-administered acupressure for allergic rhinitis: Study protocol for a randomized, single blind, non-specific controlled, parallel trial

10.21203/rs.2.87/v2 ◽

2019 ◽

Author(s):

Yaqun Liang ◽

George Binh Lenon ◽

Angela Wei Hong Yang

Keyword(s):

Allergic Rhinitis ◽

Scientific Evidence ◽

Life Questionnaire ◽

Efficacy And Safety ◽

Chi Square ◽

Non Invasive ◽

Ige Mediated ◽

Single Blind

Abstract Background Allergic rhinitis (AR) is an IgE-mediated inflammatory disease. Current conventional therapies for AR are unsatisfactory. Acupuncture has been recommended as an optional treatment for AR patients who are interested in non-pharmacotherapy in the new clinical practice guidelines for AR. Acupressure is a sub-type of acupuncture which is non-invasive with a low risk and can be self-administered. However, the current limited evidence is compromised by the high risk of bias and heterogeneity of methodology. Therefore, rigorously designed randomized controlled trials (RCTs) are needed. This proposed RCT aims to evaluate the efficacy and safety of self-administered acupressure for the management of AR. Methods/design We have designed a randomized, single blind, non-specific controlled, two-arm, parallel clinical trial involving a 2-week run-in period, a 4-week intervention period and an 8-week follow-up period. The eligible participants will be randomized into either specific or non-specific acupressure group. They will be required to perform self-administered acupressure on either 5 specific acupressure points or 5 non-specific acupressure points, one minute for each point, twice a day for 4 weeks. Participants will be asked to complete self-administered questionnaires for outcome measures including 7-point scale of symptom severity, Rhinoconjunctivitis Quality of Life Questionnaire with Standardized Activities (RQLQs), relief medication scores, adverse events and participants’ opinion of this study at the different assessment points throughout the trial period. Data will be analyzed by chi-square or t-test using Statistical Package for Social Science (SPSS) software. Discussion The findings from this study will provide scientific evidence for the efficacy and safety of self-administered acupressure for the management of AR. This study may assist to develop a non-cost, non-invasive self-management method for AR sufferers.

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Self-administered acupressure for allergic rhinitis: Study protocol for a randomized, single blind, non-specific controlled, parallel trial

10.21203/rs.2.87/v3 ◽

2019 ◽

Author(s):

Yaqun Liang ◽

George Binh Lenon ◽

Angela Wei Hong Yang

Keyword(s):

Allergic Rhinitis ◽

Scientific Evidence ◽

Life Questionnaire ◽

Efficacy And Safety ◽

Chi Square ◽

Non Invasive ◽

Ige Mediated ◽

Single Blind

Abstract Background Allergic rhinitis (AR) is an IgE-mediated inflammatory disease. Current conventional therapies for AR are unsatisfactory. Acupuncture has been recommended as an optional treatment for AR patients who are interested in non-pharmacotherapy in the new clinical practice guidelines for AR. Acupressure is a sub-type of acupuncture which is non-invasive with a low risk and can be self-administered. However, the current limited evidence is compromised by the high risk of bias and heterogeneity of methodology. Therefore, rigorously designed randomized controlled trials (RCTs) are needed. This proposed RCT aims to evaluate the efficacy and safety of self-administered acupressure for the management of AR. Methods/design We have designed a randomized, single blind, non-specific controlled, two-arm, parallel clinical trial involving a 2-week run-in period, a 4-week intervention period and an 8-week follow-up period. The eligible participants will be randomized into either specific or non-specific acupressure group. They will be required to perform self-administered acupressure on either 5 specific acupressure points or 5 non-specific acupressure points, one minute for each point, twice a day for 4 weeks. Participants will be asked to complete self-administered questionnaires for outcome measures including 7-point scale of symptom severity, Rhinoconjunctivitis Quality of Life Questionnaire with Standardized Activities (RQLQs), relief medication scores, adverse events and participants’ opinion of this study at the different assessment points throughout the trial period. Data will be analyzed by chi-square or t-test using Statistical Package for Social Science (SPSS) software. Discussion The findings from this study will provide scientific evidence for the efficacy and safety of self-administered acupressure for the management of AR. This study may assist to develop a non-cost, non-invasive self-management method for AR sufferers.

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Efficacy and safety of two Ayurvedic dosage forms for Allergic rhinitis: Study protocol for an open-label randomized controlled trial

10.21203/rs.2.13359/v2 ◽

2019 ◽

Author(s):

JM Dahanayake ◽

Pathirage Kamal Perera ◽

P Galappaththy ◽

D Samaranayake

Keyword(s):

Quality Of Life ◽

Allergic Rhinitis ◽

Controlled Trial ◽

Dosage Forms ◽

Efficacy And Safety ◽

Open Label ◽

Randomized Controlled ◽

Nasal Symptoms ◽

Freeze Dried

Abstract Background: Allergic rhinitis (AR) is an immune response of the nasal mucosa to airborne allergens and involves nasal congestion, watery nasal discharge, itching of the nose and sneezing. The symptoms of allergic rhinitis may significantly affect a patient’s quality of life and can be associated with conditions such as fatigue, headache, cognitive impairment and sleep disturbances. Various complementary and alternative medicine treatments have been used for this condition in clinical practice. The Ayurveda system of medicine is the most common complementary medicine system practiced in Sri Lanka. The aim of this study is to examine the efficacy and safety of a decoction used in traditional Ayurveda for allergic rhinitis and it’s ready to use freeze dried formulation in comparison to an antihistamine over a period of 4 weeks on relief of symptoms in allergic rhinitis. Study design: This is a three arm, open label, non-inferiority, randomized controlled clinical trial enrolling patients with AR. Tamalakyadi decoction containing 12 ingredients (TMD12), used in traditional Ayurveda and its freeze dried formulation are the test products. The efficacy and safety of the two Ayurvedic dosage forms will be tested against the antihistamine loratidine Patients with symptoms of AR will be allocated randomly into the 3 arms after a 1 week run-in period and the medications will be given orally for 28 days. Total Nasal symptom Score (TNSS) of the patients will be used as the primary efficacy endpoint. TNSS will be recorded and compared between the 3 arms prior to visit 1, at the end of 28 days, end of the and second months of follow up. Symptom scores of daytime nasal symptoms, night time nasal symptoms, non-nasal symptoms and Health Related Quality of Life questionnaire are used as secondary end points. Discussion: This clinical trial will be able to provide evidence based scientific data on Ayurvedic dosage form, TMD12 and the freeze-dried formulation in the treatment of allergic rhinitis. This trial is expected to develop capacity to scientifically evaluate various Ayurvedic treatments that are claimed to have efficacy in treatment of various disease conditions. Trial registration:ISRCTN18149439 (06 May 2019) Keywords: Allergic rhinitis, Ayurvedic dosage forms, Tamalakyadi decoctions, Randomized controlled trial

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Feasibility of self-administered acupressure for allergic rhinitis: a pilot randomized controlled trial and lessons learnt for future studies

Acupuncture in Medicine ◽

10.1177/09645284211055757 ◽

2021 ◽

pp. 096452842110557

Author(s):

Yaqun Liang ◽

George Binh Lenon ◽

Mingdi Li ◽

Angela Wei Hong Yang

Keyword(s):

Randomized Controlled Trial ◽

Allergic Rhinitis ◽

Adverse Events ◽

Symptom Severity ◽

Controlled Trial ◽

Life Questionnaire ◽

Point Scale ◽

Medication Usage ◽

Randomized Controlled ◽

Severity Scores

Objectives: Allergic rhinitis (AR) is an immunoglobulin (Ig)E-mediated inflammatory condition that is highly prevalent worldwide. The aim of this pilot trial was to evaluate the feasibility and safety of self-administered acupressure for AR. Methods: A randomized, single-blind, non-specific controlled clinical trial was conducted at Royal Melbourne Institute of Technology (RMIT) University, Melbourne, Australia. Fifteen AR patients were randomized into two groups: self-administered acupressure at five specific acupressure (SA) points or five non-specific acupressure (NSA) points (1 min/point, twice a day), and treated for 4 weeks with an 8-week follow-up period. The primary outcome was the change in 7-point scale symptom severity. Secondary outcomes included the rhinoconjunctivitis quality of life questionnaire and standardized activities (RQLQs), medication usage, adverse events and participants’ opinions of the blinding method. The Statistical Package for the Social Science (SPSS) version 26 was used for data analyses. Results: Fourteen participants completed the study and no major adverse events were reported. No statistically significant differences between SA and NSA groups were identified in 7-point scale symptom severity scores, RQLQs or medication usage. However, participants in the SA group believed that SA was useful for AR and recommended it for self-care. The credibility of the blinding method was successful. No adverse effects were considered to be related to the intervention. Conclusion: Acupressure is feasible and appears to be safe for self-administration by AR sufferers. Experience from this pilot study has guided minor amendments to the protocol. A large-scale randomized controlled trial is warranted to further investigate the efficacy and safety of self-administered acupressure for the management of AR.

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Efficacy and safety of using a warming needle for persistent allergic rhinitis: study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-016-1432-z ◽

2016 ◽

Vol 17 (1) ◽

Cited By ~ 2

Author(s):

Yuxiu Sun ◽

Hong Zhao ◽

Yongming Ye ◽

Wenbin Nie ◽

Wenjing Bai ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Allergic Rhinitis ◽

Study Protocol ◽

Controlled Trial ◽

Efficacy And Safety ◽

Randomized Controlled ◽

Persistent Allergic Rhinitis

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Non-invasive ventilation alternating with high-flow nasal oxygen versus high-flow nasal oxygen alone after extubation in COPD patients: a post hoc analysis of a randomized controlled trial

Annals of Intensive Care ◽

10.1186/s13613-021-00823-7 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Arnaud W. Thille ◽

◽

Rémi Coudroy ◽

Mai-Anh Nay ◽

Arnaud Gacouin ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

High Flow ◽

Trial Registration ◽

Invasive Ventilation ◽

Non Invasive ◽

Randomized Controlled ◽

Copd Patients ◽

Non Invasive Ventilation ◽

Post Hoc

Abstract Background Several randomized clinical trials have shown that non-invasive ventilation (NIV) applied immediately after extubation may prevent reintubation in patients at high-risk of extubation failure. However, most of studies included patients with chronic respiratory disorders as well as patients without underlying respiratory disease. To date, no study has shown decreased risk of reintubation with prophylactic NIV after extubation among patients with chronic obstructive pulmonary disease (COPD). We hypothesized that prophylactic NIV after extubation may decrease the risk of reintubation in COPD patients as compared with high-flow nasal oxygen. We performed a post hoc subgroup analysis of COPD patients included in a multicenter, randomized, controlled trial comparing prophylactic use of NIV alternating with high-flow nasal oxygen versus high-flow nasal oxygen alone immediately after extubation. Results Among the 651 patients included in the original study, 150 (23%) had underlying COPD including 86 patients treated with NIV alternating with high-flow nasal oxygen and 64 patients treated with high-flow nasal oxygen alone. The reintubation rate was 13% (11 out of 86 patients) with NIV and 27% (17 out of 64 patients) with high-flow nasal oxygen alone [difference, − 14% (95% CI − 27% to − 1%); p = 0.03]. Whereas reintubation rates were significantly lower with NIV than with high-flow nasal oxygen alone at 72 h and until ICU discharge, mortality in ICU did not differ between groups: 6% (5/86) with NIV vs. 9% (6/64) with high-flow nasal oxygen alone [difference − 4% (95% CI − 14% to 5%); p = 0.40]. Conclusions In COPD patients, prophylactic NIV alternating with high-flow nasal oxygen significantly decreased the risk of reintubation compared with high-flow nasal oxygen alone. Trial registration The study was registered at http://www.clinicaltrials.gov with the trial registration number NCT03121482 (20 April 2017)

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Efficacy and safety of electric heating moxibustion for perennial allergic rhinitis: protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-019-3550-x ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 3

Author(s):

Chan-Yung Jung ◽

Min-Jin Cho ◽

Ha-Ra Kang ◽

Seung-Ug Hong ◽

Won-Suk Sung ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Allergic Rhinitis ◽

Controlled Trial ◽

Electric Heating ◽

Efficacy And Safety ◽

Perennial Allergic Rhinitis ◽

Randomized Controlled

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

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2015/214846 ◽

2015 ◽

Vol 2015 ◽

pp. 1-10 ◽

Cited By ~ 3

Author(s):

Xiankun Chen ◽

Chuanjian Lu ◽

Cecilia Stålsby-Lundborg ◽

Yunying Li ◽

Xiaoyan Li ◽

...

Keyword(s):

Allergic Rhinitis ◽

Controlled Trial ◽

Treatment Session ◽

Waiting List ◽

Life Questionnaire ◽

Efficacy And Safety ◽

Persistent Allergic Rhinitis ◽

One Year ◽

Group B

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.govNCT02192645.

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Efficacy and safety of two Ayurvedic dosage forms for Allergic rhinitis: Study protocol for an open-label randomized controlled trial

10.21203/rs.2.13359/v3 ◽

2019 ◽

Author(s):

JM Dahanayake ◽

Pathirage Kamal Perera ◽

P Galappaththy ◽

D Samaranayake

Keyword(s):

Quality Of Life ◽

Allergic Rhinitis ◽

Controlled Trial ◽

Dosage Forms ◽

Efficacy And Safety ◽

Open Label ◽

Randomized Controlled ◽

Nasal Symptoms ◽

Freeze Dried

Abstract Background: Allergic rhinitis (AR) is an immune response of the nasal mucosa to airborne allergens and involves nasal congestion, watery nasal discharge, itching of the nose and sneezing. The symptoms of allergic rhinitis may significantly affect a patient’s quality of life and can be associated with conditions such as fatigue, headache, cognitive impairment and sleep disturbances. Various complementary and alternative medicine treatments have been used for this condition in clinical practice. The Ayurveda system of medicine is the most common complementary medicine system practiced in Sri Lanka. The aim of this study is to examine the efficacy and safety of a decoction used in traditional Ayurveda for allergic rhinitis and it’s ready to use freeze dried formulation in comparison to an antihistamine over a period of 4 weeks on relief of symptoms in allergic rhinitis. Study design: This is a three arm, open label, non-inferiority, randomized controlled clinical trial enrolling patients with AR. Tamalakyadi decoction containing 12 ingredients (TMD12), used in traditional Ayurveda and its freeze dried formulation are the test products. The efficacy and safety of the two Ayurvedic dosage forms will be tested against the antihistamine loratidine Patients with symptoms of AR will be allocated randomly into the 3 arms after a 1 week run-in period and the medications will be given orally for 28 days. Total Nasal symptom Score (TNSS) of the patients will be used as the primary efficacy endpoint. TNSS will be recorded and compared between the 3 arms prior to visit 1, at the end of 28 days, end of the and second months of follow up. Symptom scores of daytime nasal symptoms, night time nasal symptoms, non-nasal symptoms and Health Related Quality of Life questionnaire are used as secondary end points. Discussion: This clinical trial will be able to provide evidence based scientific data on Ayurvedic dosage form, TMD12 and the freeze-dried formulation in the treatment of allergic rhinitis. This trial is expected to develop capacity to scientifically evaluate various Ayurvedic treatments that are claimed to have efficacy in treatment of various disease conditions. Trial registration:ISRCTN18149439 (06 May 2019) Keywords: Allergic rhinitis, Ayurvedic dosage forms, Tamalakyadi decoctions, Randomized controlled trial

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