Joan Izquierdo-Casas1, Oriol Comas-Basté2, M Luz Latorre-Moratalla2, Marian Lorente-Gascón3, Adriana Duelo4, Luis Soler-Singla1, M Carmen Vidal-Carou5. 1. Department of Neurology, Hospital General de Catalunya, C/ Pere i Pons 1, 08915, Sant Cugat del Vallès, Spain; Department of Basic Sciences, Universitat Internacional de Catalunya, C/ Pere i Pons 1, 08915, Sant Cugat del Vallès, Spain. 2. Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, School of Pharmacy and Food Sciences, University of Barcelona, Avinguda Prat de la Riba 171, 08921, Santa Coloma de Gramenet, Spain. 3. Department of Basic Sciences, Universitat Internacional de Catalunya, C/ Pere i Pons 1, 08915, Sant Cugat del Vallès, Spain. 4. Department of Nutrition, Instituto Clínico del Déficit de DAO (ICDDAO), C/ Pere i Pons 1, 08195, Sant Cugat del Vallès, Spain. 5. Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, School of Pharmacy and Food Sciences, University of Barcelona, Avinguda Prat de la Riba 171, 08921, Santa Coloma de Gramenet, Spain. Electronic address: mcvidal@ub.edu.
Abstract
BACKGROUND & AIMS: Histamine intolerance is a disorder in the homeostasis of histamine due to a reduced intestinal degradation of this amine, mainly caused by a deficiency in the enzyme diamine oxidase (DAO). Among histamine related symptoms, headache is one of the most recorded. Current clinical strategies for the treatment of the symptomatology related to this disorder are based on the exclusion of foods with histamine or other bioactive amines and/or exogenous DAO supplementation. The aim of this study was to assess the efficacy of a food supplement consisting of DAO enzyme as a preventive treatment of migraine in patients with DAO deficiency through a randomized double-blind trial. METHODS:100 patients with confirmed episodic migraine according to current International Headache Society (IHS) criteria and DAO deficiency (levels below 80 HDU/ml) were randomized in two groups. One group received DAO enzyme supplementation and the other received placebo for one month. Clinical outcomes assessed were duration and number of attacks, perception of pain intensity and adverse effects during treatment. The use of triptans was also recorded. RESULTS: Great variability was found in the duration of migraine attacks reported by placebo and DAO groups. A significant reduction (p = 0.0217) in hours of pain was achieved in patients treated with DAO supplement, with mean durations of 6.14 (±3.06) and 4.76 (±2.68) hours before and after treatment, respectively. A smaller reduction without statistical signification was also observed for this outcome in the placebo group, from 7.53 (±4.24) to 6.68 (±4.42) hours. Only in DAO group, a decrease in the percentage of patients taking triptans was observed. The number of attacks and the scores of pain intensity showed a similar reduction in both groups. No adverse effects were registered in patients treated with DAO enzyme. CONCLUSIONS: Migrainous patients supplemented with DAO enzyme during one month significantly reduced the duration of their migraine attacks by 1.4 h. No statistically significant reduction was found in placebo group before and after treatment. The reduction of pain hours observed in placebo group (0.9 h) could explain the lack of significant differences between both study groups. One month of DAO supplementation has demonstrated a positive trend in the improvement of migraine but more studies with a longer treatment period are needed to better assess the efficacy of DAO supplementation. CLINICAL TRIAL REGISTRATION NUMBER: ISRCTN10091019; www.isrctn.org.
RCT Entities:
BACKGROUND & AIMS:Histamine intolerance is a disorder in the homeostasis of histamine due to a reduced intestinal degradation of this amine, mainly caused by a deficiency in the enzyme diamine oxidase (DAO). Among histamine related symptoms, headache is one of the most recorded. Current clinical strategies for the treatment of the symptomatology related to this disorder are based on the exclusion of foods with histamine or other bioactive amines and/or exogenous DAO supplementation. The aim of this study was to assess the efficacy of a food supplement consisting of DAO enzyme as a preventive treatment of migraine in patients with DAO deficiency through a randomized double-blind trial. METHODS: 100 patients with confirmed episodic migraine according to current International Headache Society (IHS) criteria and DAO deficiency (levels below 80 HDU/ml) were randomized in two groups. One group received DAO enzyme supplementation and the other received placebo for one month. Clinical outcomes assessed were duration and number of attacks, perception of pain intensity and adverse effects during treatment. The use of triptans was also recorded. RESULTS: Great variability was found in the duration of migraine attacks reported by placebo and DAO groups. A significant reduction (p = 0.0217) in hours of pain was achieved in patients treated with DAO supplement, with mean durations of 6.14 (±3.06) and 4.76 (±2.68) hours before and after treatment, respectively. A smaller reduction without statistical signification was also observed for this outcome in the placebo group, from 7.53 (±4.24) to 6.68 (±4.42) hours. Only in DAO group, a decrease in the percentage of patients taking triptans was observed. The number of attacks and the scores of pain intensity showed a similar reduction in both groups. No adverse effects were registered in patients treated with DAO enzyme. CONCLUSIONS:Migrainouspatients supplemented with DAO enzyme during one month significantly reduced the duration of their migraine attacks by 1.4 h. No statistically significant reduction was found in placebo group before and after treatment. The reduction of pain hours observed in placebo group (0.9 h) could explain the lack of significant differences between both study groups. One month of DAO supplementation has demonstrated a positive trend in the improvement of migraine but more studies with a longer treatment period are needed to better assess the efficacy of DAO supplementation. CLINICAL TRIAL REGISTRATION NUMBER: ISRCTN10091019; www.isrctn.org.
Authors: Oriol Comas-Basté; Sònia Sánchez-Pérez; Maria Teresa Veciana-Nogués; Mariluz Latorre-Moratalla; María Del Carmen Vidal-Carou Journal: Biomolecules Date: 2020-08-14