Clinical effectiveness of decoction form of herbal medicine in primary care treatment of allergic rhinitis: A retrospective cohort study

Background: The decoction form of herbal medicine (D-HM) is mainly prescribed to patients with allergic rhinitis (AR) in Korean Medicine (KM) clinics in the Republic of Korea; however, it is difficult to conduct clinical trials of D-HM due to regulatory issues. This study investigated the clinical s...

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Main Authors: Mi Ju Son, Sungha Kim, Young-Eun Kim, Bo-Young Kim, Chang-Sub Yeum, Jong Cheol Lee, Jae Hoon Cha, Soonsik Kang, Ching Hao Chang, Seokho Son
Format: Article
Language:English
Published: Elsevier 2023-09-01
Series:Integrative Medicine Research
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Online Access:http://www.sciencedirect.com/science/article/pii/S2213422023000525
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author Mi Ju Son
Sungha Kim
Young-Eun Kim
Bo-Young Kim
Chang-Sub Yeum
Jong Cheol Lee
Jae Hoon Cha
Soonsik Kang
Ching Hao Chang
Seokho Son
author_facet Mi Ju Son
Sungha Kim
Young-Eun Kim
Bo-Young Kim
Chang-Sub Yeum
Jong Cheol Lee
Jae Hoon Cha
Soonsik Kang
Ching Hao Chang
Seokho Son
author_sort Mi Ju Son
collection DOAJ
description Background: The decoction form of herbal medicine (D-HM) is mainly prescribed to patients with allergic rhinitis (AR) in Korean Medicine (KM) clinics in the Republic of Korea; however, it is difficult to conduct clinical trials of D-HM due to regulatory issues. This study investigated the clinical safety and effectiveness of D-HM combination therapy for the treatment of AR by analyzing the AR outpatient data from 17 KM clinics. Methods: This retrospective cohort study included patients who visited KM clinics for AR treatment from January 1, 2021, to March 31, 2022. Cases were collated using structured case report forms and divided into the D-HM with KM usual care group (D-HM group) and the KM usual care group (UC group). Since D-HM therapy could not be randomly assigned to the study population, we used optimal propensity score (PS) matching to investigate the effectiveness and safety of D-HM combination therapy in the treatment of AR. Results: Data from 228 patients were collected. After PS matching, 144 patients were finally analyzed. The total nasal symptom score (TNSS) and mini-rhinoconjunctivitis quality of life questionnaire (mini-RQLQ) were significantly improved in the D-HM group compared with those in the UC group (TNSS: p=0.02; mini-RQLQ: p=0.04). Four patients in the D-HM group experienced minor adverse events that were mild and resolved within 15 days. Conclusions: D-HM combination therapy may be beneficial in the management of symptoms and rhinitis-associated quality of life and potentially useful in clinical practice. However, randomized placebo-controlled clinical trials are required to confirm their effectiveness. Study registration: This study has been registered at Clinical Research Information Service (KCT0007242).
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spelling doaj-art-0d77dd6c5bf642dea84eb2e628b845892025-08-20T03:17:02ZengElsevierIntegrative Medicine Research2213-42202023-09-0112310097310.1016/j.imr.2023.100973Clinical effectiveness of decoction form of herbal medicine in primary care treatment of allergic rhinitis: A retrospective cohort studyMi Ju Son0Sungha Kim1Young-Eun Kim2Bo-Young Kim3Chang-Sub Yeum4Jong Cheol Lee5Jae Hoon Cha6Soonsik Kang7Ching Hao Chang8Seokho Son9R&D Planning Team, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea; Corresponding author at: R&D Planning Team, Korea Institute of Oriental Medicine, 1672, Yuseong-daero, Yuseong-gu, Daejeon, Republic of Korea.KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of KoreaKM Data Division, Korea Institute of Oriental Medicine, Daejeon, Republic of KoreaKM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of KoreaSNB Korean Medicine Clinic, Seoul, Republic of Korea365 Cha Korean Medicine Clinic, Yeosu, Republic of Korea365 Cha Korean Medicine Clinic, Yeosu, Republic of KoreaMoa Korean Medicine Clinic, Seoul, Republic of KoreaMoa Korean Medicine Clinic, Wonju, Republic of KoreaI-Bone Korean Medicine Clinic, Asan, Republic of KoreaBackground: The decoction form of herbal medicine (D-HM) is mainly prescribed to patients with allergic rhinitis (AR) in Korean Medicine (KM) clinics in the Republic of Korea; however, it is difficult to conduct clinical trials of D-HM due to regulatory issues. This study investigated the clinical safety and effectiveness of D-HM combination therapy for the treatment of AR by analyzing the AR outpatient data from 17 KM clinics. Methods: This retrospective cohort study included patients who visited KM clinics for AR treatment from January 1, 2021, to March 31, 2022. Cases were collated using structured case report forms and divided into the D-HM with KM usual care group (D-HM group) and the KM usual care group (UC group). Since D-HM therapy could not be randomly assigned to the study population, we used optimal propensity score (PS) matching to investigate the effectiveness and safety of D-HM combination therapy in the treatment of AR. Results: Data from 228 patients were collected. After PS matching, 144 patients were finally analyzed. The total nasal symptom score (TNSS) and mini-rhinoconjunctivitis quality of life questionnaire (mini-RQLQ) were significantly improved in the D-HM group compared with those in the UC group (TNSS: p=0.02; mini-RQLQ: p=0.04). Four patients in the D-HM group experienced minor adverse events that were mild and resolved within 15 days. Conclusions: D-HM combination therapy may be beneficial in the management of symptoms and rhinitis-associated quality of life and potentially useful in clinical practice. However, randomized placebo-controlled clinical trials are required to confirm their effectiveness. Study registration: This study has been registered at Clinical Research Information Service (KCT0007242).http://www.sciencedirect.com/science/article/pii/S2213422023000525Allergic rhinitisRetrospective cohort studyHerbal medicinePropensity score matching
spellingShingle Mi Ju Son
Sungha Kim
Young-Eun Kim
Bo-Young Kim
Chang-Sub Yeum
Jong Cheol Lee
Jae Hoon Cha
Soonsik Kang
Ching Hao Chang
Seokho Son
Clinical effectiveness of decoction form of herbal medicine in primary care treatment of allergic rhinitis: A retrospective cohort study
Integrative Medicine Research
Allergic rhinitis
Retrospective cohort study
Herbal medicine
Propensity score matching
title Clinical effectiveness of decoction form of herbal medicine in primary care treatment of allergic rhinitis: A retrospective cohort study
title_full Clinical effectiveness of decoction form of herbal medicine in primary care treatment of allergic rhinitis: A retrospective cohort study
title_fullStr Clinical effectiveness of decoction form of herbal medicine in primary care treatment of allergic rhinitis: A retrospective cohort study
title_full_unstemmed Clinical effectiveness of decoction form of herbal medicine in primary care treatment of allergic rhinitis: A retrospective cohort study
title_short Clinical effectiveness of decoction form of herbal medicine in primary care treatment of allergic rhinitis: A retrospective cohort study
title_sort clinical effectiveness of decoction form of herbal medicine in primary care treatment of allergic rhinitis a retrospective cohort study
topic Allergic rhinitis
Retrospective cohort study
Herbal medicine
Propensity score matching
url http://www.sciencedirect.com/science/article/pii/S2213422023000525
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