Abstract
BackgroundCurcumin, a derivative of the spice turmeric, has been adopted by Eastern medicine for centuries as an adjunct to treat several medical conditions (e.g., anorexia and arthritis) because of its well-established anti-inflammatory properties. Studies have shown that the use of curcumin in mice models has led to reduction in several inflammatory markers as well as key inflammatory pathway enzymes. As a result, studies in Western medicine have developed to determine if this recognized benefit can be utilized for patients with inflammatory lung diseases, such as asthma. This study will seek to better understand if curcumin can be used as an adjunctive therapy for improving asthma control of patients with moderate to severe asthma; a finding we hope will allow for a more affordable treatment.MethodsThis study will utilize a randomized, placebo controlled, double blinded pilot superiority phase 2 trial at an outpatient pulmonary clinic in Southern California, USA. Subjects will be receiving Curcumin 1500 mg or matching placebo by mouth twice daily for the study period of 12 weeks. Subjects will be randomized to either a placebo or intervention Curcumin. Subjects will have 6 clinic visits: screening visit, a baseline visit, monthly clinic visits (weeks 4, 8, and 12), at weeks 4, 8, and a follow-up clinic visit or phone-call (week 16). Changes in asthma control test scores, number of days missed from school/work, FEV1 (% predicted), FEV1/FVC ratio, FVC (% predicted), blood eosinophil count, blood total IgE, and FeNO levels will be compared by group over time.DiscussionThe therapeutic effects of curcumin have been studied on a limited basis in asthmatics and has shown mixed results thus far. Our study hopes to further establish the benefits of curcumin, however, there are potential issues that may arise from our study design that we will address within this paper. Moreover, the onset of the COVID-19 pandemic has resulted in safety concerns that have delayed initiation of our study. This study will contribute to existing literature on curcumin’s role in reducing lung inflammation as it presents in asthmatics as well as patients suffering from COVID-19.Trial registrationThis study protocol has been approved by the Institutional Review Board at Loma Linda University Health, (NCT04353310). IND# 145101 Registered April 20th, 2020. https://clinicaltrials.gov/ct2/show/NCT04353310.
Highlights
Curcumin, a derivative of the spice turmeric, has been adopted by Eastern medicine for centuries as an adjunct to treat several medical conditions because of its well-established antiinflammatory properties
A 2-groupX 4-time points mixed factorial analysis of variance (ANOVA) will be used to examine changes in asthma control test scores, number of days missed from school/ work, Forced Exhaled Volume in 1 s (FEV1) (% predicted), FEV1/Forced vital capacity (FVC) ratio, FVC (% predicted), blood eosinophil count, blood total Immunoglobulin E (IgE), and Nitric oxide (FeNO) levels by group over time
The therapeutic effects of curcumin have been studied in asthmatic patients in the past albeit with mixed results
Summary
A derivative of the spice turmeric, has been adopted by Eastern medicine for centuries as an adjunct to treat several medical conditions (e.g., anorexia and arthritis) because of its well-established antiinflammatory properties. Studies have shown that the use of curcumin in mice models has led to reduction in several inflammatory markers as well as key inflammatory pathway enzymes. A derivative of turmeric (Curcuma longa), has been commonly used as a dietary spice and coloring agent. It has been used for centuries in Eastern medicine has been used for centuries in Ayurveda and traditional Chinese medicine to treat anorexia, hepatic disorders, and arthritis [1]. More recent studies in vitro and in vivo mice models have discovered that curcumin inhibits cyclooxygenase-2 (COX-2), a key enzyme involved in the development of prostaglandins [4]. Curcumin has been found to decrease the release of eotaxin, monocyte chemotactic protein 1, and monocyte chemotactic protein 3 from IL-1β stimulated human airway smooth muscle cells [6]
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