scholarly journals Providing open-label placebos remotely—A randomized controlled trial in allergic rhinitis

PLoS ONE ◽  
2021 ◽  
Vol 16 (3) ◽  
pp. e0248367
Author(s):  
Tobias Kube ◽  
Verena E. Hofmann ◽  
Julia A. Glombiewski ◽  
Irving Kirsch

Background Placebos can reduce physical symptoms even when provided with full honesty and disclosure. Yet, the precise mechanisms underlying the effects of “open-label placebos” (OLPs) have remained subject of debate. Furthermore, it is unclear whether OLPs are similarly effective when provided remotely, as is sometimes required e.g. in the current COVID-19 pandemic. Methods In a randomized-controlled trial, we examined the effects of OLP plus treatment as usual (TAU) compared to TAU alone on symptom reduction in people with allergic rhinitis (N = 54) over the course of two weeks. Due to the COVID-19 pandemic, OLP was provided remotely (i.e. sent via postal service). To investigate the potential influence of the clinical encounter on the effects of OLP, we manipulated the perception of the virtual clinical encounter, both with respect to verbal and nonverbal factors (augmented vs. limited encounter). Results The results of the manipulation check confirmed that the augmented clinical encounter was evaluated more positively than the limited encounter, in terms of perceived warmth of the provider. Participants from all treatment groups showed significant symptom reduction from baseline to two weeks later, but OLP had no incremental effect over TAU. Participants benefitted more from OLP when they did not take any other medication against allergic symptoms than when taking medication on demand. When controlling for baseline symptoms, a significant treatment by encounter interaction was found, pointing to greater symptom improvement in the OLP group when the encounter was augmented, whereas the control group improved more when the encounter was limited. Discussion The study demonstrates that providing OLP and enhancing the encounter remotely is possible, but their effectiveness might be lower in comparison to previous studies relying on physical patient-provider interaction. The study raises questions for future research about the potential and challenges of remote placebo studies and virtual clinical encounters. The study has been registered as a clinical trial at ISRCTN (record number: 39018).

2019 ◽  
Author(s):  
Jingyi Zhao ◽  
Xinyu Yan ◽  
Jianqing Gai ◽  
Jinshuai Han ◽  
Hong Zhang ◽  
...  

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


Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Jingyi Zhao ◽  
Xinyu Yan ◽  
Jianqing Gai ◽  
Jinshuai Han ◽  
Hong Zhang ◽  
...  

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.


2019 ◽  
Author(s):  
Jingyi Zhao ◽  
Xinyu Yan ◽  
Jianqing Gai ◽  
Jinshuai Han ◽  
Hong Zhang ◽  
...  

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


2019 ◽  
Author(s):  
Jingyi Zhao ◽  
Xinyu Yan ◽  
Jianqing Gai ◽  
Jinshuai Han ◽  
Hong Zhang ◽  
...  

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


2019 ◽  
Author(s):  
Jingyi Zhao ◽  
Xinyu Yan ◽  
Jianqing Gai ◽  
Jinshuai Han ◽  
Hong Zhang ◽  
...  

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


PLoS ONE ◽  
2021 ◽  
Vol 16 (6) ◽  
pp. e0252850
Author(s):  
Tobias Kube ◽  
Verena E. Hofmann ◽  
Julia A. Glombiewski ◽  
Irving Kirsch

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