scholarly journals Efficacy of Bimin Decoction on patients with perennial allergic rhinitis: an open-label non-inferiority randomized controlled trial

2019 ◽  
Author(s):  
Jingyi Zhao ◽  
Xinyu Yan ◽  
Jianqing Gai ◽  
Jinshuai Han ◽  
Hong Zhang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Allergic Rhinitis ◽  
Nasal Spray ◽  
Controlled Trial ◽  
Life Quality ◽  
Control Group ◽  
Nasal Resistance ◽  
Perennial Allergic Rhinitis ◽  
Open Label ◽  
Randomized Controlled

Abstract Abstract Background: Allergic rhinitis (AR) is a common allergic disease which affects people worldwide and traditional Chinese medicine is getting popular among AR patients for definite clinical effect and less adverse reactions. Lung qi deficiency and cold syndrome (LQDCS) is a frequent type of AR, and Chinese herbal medicine Bimin Decoction (BMD) was generated for AR patients with LQDCS. This study aimed to compare the clinical efficacy of BMD for AR patients with LQDCS to conventional medicine loratadine and fluticasone nasal spray. Methods/Design: The study was designed as an open-label, non-inferiority, randomized controlled trial. A total of 108 AR patients with LQDCS aged 19 to 60 were 1:1 randomly allocated to BMD group and control group by central computer system in Beijing Hospital of Traditional Chinese Medicine from January 2017 to April 2018. 98 completed the study (n=51; n=47). Patients in BMD group received Bimin Decoction while the control group received fluticasone nasal spray and loratadine tablets for a 4-week treatment. The primary outcome was change of the Total Nasal Symptom Score (TNSS) at baseline and the end of treatment. Alterations in Rhinoconjunctivitis Quality Life quality Questionnaire (RQLQ), nasal resistance (NR) and acoustic rhinometry parameters were second outcomes. Any side effect of treatment was observed and recorded. Results: After the 4-week treatment the TNSS total score was significantly reduced in both groups from baseline ( P < 0.05), no significant between-groups differences were observed for the changes of TNSS scores [-0.298 (95% CI -0.640 to 0.140)], which was within the defined non-inferiority margin. RQLQ in both groups decreased significantly ( P < 0.001) from baseline and more obvious reduction in BMD group was observed ( P < 0.001). There was no significant difference in the nasal resistance, the nasal volume and the nasal minimum cross-sectional area after treatment between groups ( P > 0.05). Conclusions: These findings indicated that BMD helps relieve PAR symptoms and improve rhinitis-related life quality. Our study indicated that BMD is non-inferior to loratadine tablets and fluticasone nasal spray for AR patients with LQDCS. Trial registration: Chinese Clinical Trial Registry, ChiCTR-INR-16010063. Registered on 2 December, 2016 Keywords: Perennial allergic rhinitis, Chinese traditional medicine, Randomized controlled trial, Clinical efficacy

scholarly journals Efficacy of Bimin Decoction on patients with perennial allergic rhinitis: an open-label non-inferiority randomized controlled trial

2019 ◽  
Author(s):  
Jingyi Zhao ◽  
Xinyu Yan ◽  
Jianqing Gai ◽  
Jinshuai Han ◽  
Hong Zhang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Allergic Rhinitis ◽  
Nasal Spray ◽  
Controlled Trial ◽  
Life Quality ◽  
Control Group ◽  
Nasal Resistance ◽  
Perennial Allergic Rhinitis ◽  
Open Label ◽  
Randomized Controlled

Abstract Background: Allergic rhinitis (AR) is a common allergic disease which affects people worldwide and traditional Chinese medicine is getting popular among AR patients for definite clinical effect and less adverse reactions. Lung qi dificiency and cold syndrome (LQDCS) is a frequent type of AR, and Chinese herbal medicine Bimin Decoction (BMD) was generated for AR patients with LQDCS. This study aimed to compare the clinical efficacy of BMD for AR patients with LQDCS to conventional medicine loratadine and fluticasone nasal spray. . Methods/Design: The study was designed as an open-label, non-inferiority, randomized controlled trial. A total of 108 AR patients with LQDCS aged 19 to 60 were 1:1 randomly allocated to BMD group and control group by central computer system in Beijing Hospital of Traditional Chinese Medicine from January 2017 to April 2018. 98 completed the study (n=51; n=47). Patients inBMD group received Bimin Decoction while the control group received fluticasone nasal spray and loratadine tablets for a 4-week treatment. The primary outcome was change of the Total Nasal Symptom Score (TNSS) at baseline and the end of treatment. Alterations in Rhinoconjunctivitis Quality Life quality Questionnaire (RQLQ), nasal resistance (NR) and acoustic rhinometry parameters were second outcomes. Any side effect of treatment was observed and recorded. Results: After the 4-week treatment the TNSS total score was significantly reduced in both groups from baseline (P < 0.05), no significant between-groups differences were observed for the changes of TNSS scores [-0.08 (95% CI -0.56 to 0.40)], which was within the defined non-inferiority margin. RQLQ in both groups decreased significantly (P < 0.001) from baseline and more obvious reduction in BMD group was observed (P < 0.001). There was no significant difference in the nasal resistance, the nasal volume and the nasal minimum cross-sectional area after treatment between groups (P > 0.05). Conclusions: These findings indicated that BMD helps relieve PAR symptoms and improve rhinitis-related life quality. Our study indicated that BMD is non-inferior to loratadine tablets and fluticasone nasal spray for AR patients with LQDCS. Trial registration: Chinese Clinical Trial Registry, ChiCTR-INR-16010063. Registered on 2 December, 2016 Keywords: Perennial allergic rhinitis, Chinese traditional medicine, Randomized controlled trial, Clinical efficacy

scholarly journals Efficacy of Bimin Decoction on patients with perennial allergic rhinitis: an open-label non-inferiority randomized controlled trial

2019 ◽  
Author(s):  
Jingyi Zhao ◽  
Xinyu Yan ◽  
Jianqing Gai ◽  
Jinshuai Han ◽  
Hong Zhang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Allergic Rhinitis ◽  
Nasal Spray ◽  
Controlled Trial ◽  
Life Quality ◽  
Control Group ◽  
Nasal Resistance ◽  
Perennial Allergic Rhinitis ◽  
Open Label ◽  
Randomized Controlled

Abstract Abstract Background: Allergic rhinitis (AR) is a common allergic disease which affects people worldwide and traditional Chinese medicine is getting popular among AR patients for definite clinical effect and less adverse reactions. Lung qi deficiency and cold syndrome (LQDCS) is a frequent type of AR, and Chinese herbal medicine Bimin Decoction (BMD) was generated for AR patients with LQDCS. This study aimed to compare the clinical efficacy of BMD for AR patients with LQDCS to conventional medicine loratadine and fluticasone nasal spray. Methods/Design: The study was designed as an open-label, non-inferiority, randomized controlled trial. A total of 108 AR patients with LQDCS aged 19 to 60 were 1:1 randomly allocated to BMD group and control group by central computer system in Beijing Hospital of Traditional Chinese Medicine from January 2017 to April 2018. 98 completed the study (n=51; n=47). Patients in BMD group received Bimin Decoction while the control group received fluticasone nasal spray and loratadine tablets for a 4-week treatment. The primary outcome was change of the Total Nasal Symptom Score (TNSS) at baseline and the end of treatment. Alterations in Rhinoconjunctivitis Quality Life quality Questionnaire (RQLQ), nasal resistance (NR) and acoustic rhinometry parameters were second outcomes. Any side effect of treatment was observed and recorded. Results: After the 4-week treatment the TNSS total score was significantly reduced in both groups from baseline ( P < 0.05), no significant between-groups differences were observed for the changes of TNSS scores [-0.298 (95% CI -0.640 to 0.140)], which was within the defined non-inferiority margin. RQLQ in both groups decreased significantly ( P < 0.001) from baseline and more obvious reduction in BMD group was observed ( P < 0.001). There was no significant difference in the nasal resistance, the nasal volume and the nasal minimum cross-sectional area after treatment between groups ( P > 0.05). Conclusions: These findings indicated that BMD helps relieve PAR symptoms and improve rhinitis-related life quality. Our study indicated that BMD is non-inferior to loratadine tablets and fluticasone nasal spray for AR patients with LQDCS. Trial registration: Chinese Clinical Trial Registry, ChiCTR-INR-16010063. Registered on 2 December, 2016 Keywords: Perennial allergic rhinitis, Chinese traditional medicine, Randomized controlled trial, Clinical efficacy

scholarly journals Efficacy of Bimin Decoction on patients with perennial allergic rhinitis: an open-label non-inferiority randomized controlled trial

2019 ◽  
Author(s):  
Jingyi Zhao ◽  
Xinyu Yan ◽  
Jianqing Gai ◽  
Jinshuai Han ◽  
Hong Zhang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Allergic Rhinitis ◽  
Nasal Spray ◽  
Controlled Trial ◽  
Life Quality ◽  
Control Group ◽  
Nasal Resistance ◽  
Perennial Allergic Rhinitis ◽  
Open Label ◽  
Randomized Controlled

Abstract Abstract Background: Allergic rhinitis (AR) is a common allergic disease which affects people worldwide and traditional Chinese medicine is getting popular among AR patients for definite clinical effect and less adverse reactions. Lung qi deficiency and cold syndrome (LQDCS) is a frequent type of AR, and Chinese herbal medicine Bimin Decoction (BMD) was generated for AR patients with LQDCS. This study aimed to compare the clinical efficacy of BMD for AR patients with LQDCS to conventional medicine loratadine and fluticasone nasal spray. Methods/Design: The study was designed as an open-label, non-inferiority, randomized controlled trial. A total of 108 AR patients with LQDCS aged 19 to 60 were 1:1 randomly allocated to BMD group and control group by central computer system in Beijing Hospital of Traditional Chinese Medicine from January 2017 to April 2018. 98 completed the study (n=51; n=47). Patients in BMD group received Bimin Decoction while the control group received fluticasone nasal spray and loratadine tablets for a 4-week treatment. The primary outcome was change of the Total Nasal Symptom Score (TNSS) at baseline and the end of treatment. Alterations in Rhinoconjunctivitis Quality Life quality Questionnaire (RQLQ), nasal resistance (NR) and acoustic rhinometry parameters were second outcomes. Any side effect of treatment was observed and recorded. Results: After the 4-week treatment the TNSS total score was significantly reduced in both groups from baseline ( P < 0.05), no significant between-groups differences were observed for the changes of TNSS scores [-0.298 (95% CI -0.640 to 0.140)], which was within the defined non-inferiority margin. RQLQ in both groups decreased significantly ( P < 0.001) from baseline and more obvious reduction in BMD group was observed ( P < 0.001). There was no significant difference in the nasal resistance, the nasal volume and the nasal minimum cross-sectional area after treatment between groups ( P > 0.05). Conclusions: These findings indicated that BMD helps relieve PAR symptoms and improve rhinitis-related life quality. Our study indicated that BMD is non-inferior to loratadine tablets and fluticasone nasal spray for AR patients with LQDCS. Trial registration: Chinese Clinical Trial Registry, ChiCTR-INR-16010063. Registered on 2 December, 2016 Keywords: Perennial allergic rhinitis, Chinese traditional medicine, Randomized controlled trial, Clinical efficacy

scholarly journals Efficacy of Bimin decoction for patients with perennial allergic rhinitis: an open-label non-inferiority randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Jingyi Zhao ◽  
Xinyu Yan ◽  
Jianqing Gai ◽  
Jinshuai Han ◽  
Hong Zhang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Allergic Rhinitis ◽  
Nasal Spray ◽  
Controlled Trial ◽  
Control Group ◽  
Nasal Resistance ◽  
Open Label ◽  
Randomized Controlled

Abstract Background Allergic rhinitis (AR) is a common allergic disease. It affects people worldwide and traditional Chinese medicine is becoming popular among AR patients because it has a definite clinical effect and there are few adverse reactions. Lung qi deficiency and cold syndrome (LQDCS) is a frequent type of AR, and the Chinese herbal medicine bimin decoction (BMD) is prescribed for it. This study compared the clinical efficacy of BMD for AR patients with LQDCS to the conventional medicine loratadine and fluticasone nasal spray. Methods The study was an open-label non-inferiority randomized controlled trial. A total of 108 AR patients with LQDCS aged 19 to 60 were randomly allocated in a 1:1 ratio to the BMD group or the control group by the central computer system in Beijing Hospital of Traditional Chinese Medicine from January 2017 to April 2018. In total, 98 participants completed the study (BMD group n = 51 and control group n = 47). Patients in the BMD group received BMD while those in the control group received fluticasone nasal spray and loratadine tablets for 4 weeks. The primary outcome was the change in the Total Nasal Symptom Score (TNSS) between the baseline and the end of treatment. Changes in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), nasal resistance, and acoustic rhinometry parameters were secondary outcomes. All side effects due to the treatments were recorded. Results After the 4-week treatment, the total TNSS was significantly reduced in both groups compared to the baseline (P <  0.05). No significant between-groups differences were observed for changes in TNSS scores [− 0.298 (95% confidence interval −0.640 to 0.140)], which was within the defined non-inferiority margin. RQLQ in both groups decreased significantly (P <  0.001) from baseline, though a more obvious reduction was observed for the BMD group (P <  0.001). There were no significant differences in nasal resistance, nasal volume, or nasal minimum cross-sectional area between groups after treatment (P > 0.05). Conclusions These findings indicate that BMD helps relieve the symptoms of perennial AR and improves rhinitis-related quality of life. Our study indicates that BMD is non-inferior to loratadine tablets and fluticasone nasal spray for AR patients with LQDCS. Trial registration Chinese Clinical Trial Registry, ChiCTR-INR-16010063. Registered on 2 December 2016.

scholarly journals Efficacy of probiotic in perennial allergic rhinitis under five year children: A randomized controlled trial

2019 ◽  
Vol 35 (6) ◽  
Author(s):  
Mubashir Ahmed ◽  
Abdul Gaffar Billoo ◽  
Khalid Iqbal
Keyword(s):  
Randomized Controlled Trial ◽  
Allergic Rhinitis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Study Participant ◽  
Control Group ◽  
Perennial Allergic Rhinitis ◽  
Under Five ◽  
Randomized Controlled ◽  
And Control

Objective: To determine the efficacy of probiotic (Lactobacillus Paracasei, LP-33) and compare it with cetirizine for the treatment of perennial allergic rhinitis in under five year’s children. Methods: The randomised clinical trial was conducted at Kharadar General Hospital, Karachi, from Dec 2016 to Nov 2017. Children aged 6 to 60 months, clinically presented with allergic rhinitis were included in the study. Total 212 children, randomized into intervention group A (received probiotic LP-33) and control group B (received cetirizine) for six weeks, were included in the analysis. Baseline allergic rhinitis symptoms (rhinorrhea, sneezing, nasal blocking, coughing, feeding & sleeping difficulties) were assessed after two and six weeks follow up and correlated both groups by using Pearson chi-square test. A p value of <0.05 were considered statistically significant. Results: Total 212 children were analysed, out of them 113 (53.3%) were male. Mean age of study participant was 26 ± 16.64 months and mean body weight was 10.1 ± 3.26 Kg. More than 95% cases have shown significant improvement in their baseline symptoms (rhinorrhea, sneezing, nasal blocking, coughing, feeding difficulties and sleeping difficulties) in both intervention (L-33 Probiotic) and control (Cetirizine) groups. Statistically there was no difference in effectiveness of probiotic and cetirizine treatment for perennial allergic rhinitis (P > 0.05). Conclusions: Probiotic (LP-33) was equally effective as cetirizine in under five year’s children for the treatment of perennial allergic rhinitis. Probiotic has additional benefit to treat allergic rhinitis without causing any major side effect in children reported by the study. doi: https://doi.org/10.12669/pjms.35.6.744 How to cite this:Ahmed M, Billoo AG, Iqbal K. Efficacy of probiotic in perennial allergic rhinitis under five year children: A randomized controlled trial. Pak J Med Sci. 2019;35(6):1538-1543. doi: https://doi.org/10.12669/pjms.35.6.744 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

2021 ◽  
pp. 019459982199474
Author(s):  
Maggie Xing ◽  
Dorina Kallogjeri ◽  
Jay F. Piccirillo
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Training ◽  
Mixed Model ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Functional Index ◽  
Open Label ◽  
Randomized Controlled ◽  
The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

scholarly journals Pharmacist-guided pre-emptive pharmacogenetic testing in antidepressant therapy (PrePGx): study protocol for an open-label, randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Céline K. Stäuble ◽  
Markus L. Lampert ◽  
Samuel Allemann ◽  
Martin Hatzinger ◽  
Kurt E. Hersberger ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Antidepressant Treatment ◽  
Controlled Trial ◽  
Response Rates ◽  
Control Group ◽  
Open Label ◽  
Randomized Controlled ◽  
Link Type ◽  
Increased Risk ◽  
Antidepressant Pharmacotherapy

Abstract Background It is known that only 50% of patients diagnosed with major depressive disorders (MDD) respond to the first-line antidepressant treatment. Accordingly, there is a need to improve response rates to reduce healthcare costs and patient suffering. One approach to increase rates of treatment response might be the integration of pharmacogenetic (PGx) testing to stratify antidepressant drug selection. The goal of PGx assessments is to identify patients who have an increased risk to experience adverse drug reactions or non-response to specific drugs. Especially for antidepressants, there is compiling evidence on PGx influencing drug exposure as well as response. Methods This study is an open-label, randomized controlled trial conducted in two study centers in Switzerland: (1) the Psychiatric Clinic of Solothurn and (2) the Private Clinic Wyss in Münchenbuchsee. Adult inpatients diagnosed with a unipolar moderate or severe depressive episode are recruited at clinic admission and are included in the study. If the adjustment to a new antidepressant pharmacotherapy is necessary, the participants are randomized to either Arm A (intervention group) or Arm B (control group). If no new antidepressant pharmacotherapy is introduced the participants will be followed up in an observational arm. The intervention is the service of pharmacist-guided pre-emptive PGx testing to support clinical decision making on antidepressant selection and dosing. As a comparison, in the control group, the antidepressant pharmacotherapy is selected by the treating physician according to current treatment guidelines (standard of care) without the knowledge of PGx test results and support of clinical pharmacists. The primary outcome of this study compares the response rates under antidepressant treatment after 4 weeks between intervention and control arm. Discussion The findings from this clinical trial are expected to have a direct impact on inter-professional collaborations for the handling and use of PGx data in psychiatric practice. Trial registration ClinicalTrials.govNCT04507555. Registered on August 11, 2020. Swiss National Clinical Trials Portal SNCTP000004015. Registered August 18, 2020.

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