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The Atkins Diet Modified (ADM) is the best alternative treatment for drug-resistant epilepsy, There is a high prevalence worldwide , especially in Latin American countries, including Mexico.
Low income earners, many of which do not have a social security, must meet the high costs by Antiepileptic Drugs (AEDS), which in addition should be used in conjunction or combination therapy, because monotherapy is insufficient .
The diet adkins makes some changes in the traditional food habits by others that are accessible and not necessarily expensive, whose mechanism allows for better control of the seizures.
Objective: To assess the efficacy, tolerability and adherence of the modified adkins diet in adult patients with drug-resistent epilepsy Materials and Methods: Clinical trial, made up of patients with drug-resistent epilepsy, selected by convenience, who will be handled pharmacologically with the standard treatment of this condition for a period of not less than 6 months, after which they will be treated with adkins diet modified, prior informed consent, to establish its effect and a comparative analysis later.
The objective of this work is to analyze the efficacy, tolerability and adherence of the modified atkins diet in adult patients with drug-resistant epilepsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| modified adkins diet | Active Comparator | modified adkins diet. It consists in the free intake of proteins and fats, and the restriction of carbohydrates that are gradually being installed. Its mechanism of action that induces a state of ketosis. |
|
| Pharmacotherapy without diet | Active Comparator | It consists in administer only pharmacological treatment withot a special diet, Drug-resistant epilepsy is characterized by the use of antiepileptic drugs and in optimal doses, depending on the type of epilepsy, at least on two consecutive occasions without response to management. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| modified adkins diet | Other | Patients were assigned to two groups, one of them received modified adkins diet for treatment of drug-resistant epilepsy. It consists in the free intake of proteins and fats, and the restriction of carbohydrates that are gradually being installed. Its mechanism of action that induces a state of ketosis |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of epileptic seizures | Frequency of epileptic seizures measured according to the clinical criteria of therapeutic evaluation of Huttenlocher | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic response observed in electroencephalogram | Panic electroencephalographic criteria on the therapeutic response. Having regard to the standardization, improvement or worsening of the crisis in the electroencephalogram | 3 months |
| Measurement of quality of life and decrease in seizures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MarÃa I Alanis | Instituto Mexicano del Seguro Social | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Medical Center, Mexican Institute of Social Security | Guadalajara | Jalisco | 44340 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2502382 | Background | Proposal for revised classification of epilepsies and epileptic syndromes. Commission on Classification and Terminology of the International League Against Epilepsy. Epilepsia. 1989 Jul-Aug;30(4):389-99. doi: 10.1111/j.1528-1157.1989.tb05316.x. No abstract available. | |
| 10742989 | Background | Panico LR, Rios VG, Demartini MG, Carniello MA. [The electroencephalographic evolution of a group of patients on a ketonic diet]. Rev Neurol. 2000 Jan 1-15;30(1):8-15. Spanish. |
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| ID | Term |
|---|---|
| D000069279 | Drug Resistant Epilepsy |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D004032 | Diet |
| D013812 | Therapeutics |
| D000927 | Anticonvulsants |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D002491 | Central Nervous System Agents |
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Clinical trial, Parallel, controled
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MD MarÃa Ingrid Alanis Guevara. Neurologist Hospital of the Western National Medical Center. Guadalajara. Mexico
|
|
| Pharmacotherapy without diet | Drug | Patients were assigned to two groups, one of them received conventional treatment with antiepileptic drugs without a special diet |
|
|
Interrogate the patient with a questionnaire of refractory epilepsy drugs. And ask to the patient with this questionnaire if improved their quality of life and have decreased seizures after using the atkins diet modified. |
| 3 months |
| Blood tests (Hematic biometry) | Take this blood test to assess the general conditions of the patient and see their levels of hemoglobin, hematocrit, leukocyte and platelet count. | 3 months |
| Blood chemistry (serum electrolytes) | It will evaluate the general condition of the patient and with this test rule out the presence of electrolyte imbalance | 3 months |
| liver function tests | Will be evaluated with this test levels of transaminases as can be raised by treatment anticonvulsant and see if there are any changes with the changes in the diet of patients | 3 months |
| ketonuria | It will assess the levels of ketones in urine due to the change in the diet of patients with the Atkins diet | 3 months |
| 16523530 | Background | Freeman J, Veggiotti P, Lanzi G, Tagliabue A, Perucca E; Institute of Neurology IRCCS C. Mondino Foundation. The ketogenic diet: from molecular mechanisms to clinical effects. Epilepsy Res. 2006 Feb;68(2):145-80. doi: 10.1016/j.eplepsyres.2005.10.003. |
| 18823325 | Background | Kossoff EH, Zupec-Kania BA, Amark PE, Ballaban-Gil KR, Christina Bergqvist AG, Blackford R, Buchhalter JR, Caraballo RH, Helen Cross J, Dahlin MG, Donner EJ, Klepper J, Jehle RS, Kim HD, Christiana Liu YM, Nation J, Nordli DR Jr, Pfeifer HH, Rho JM, Stafstrom CE, Thiele EA, Turner Z, Wirrell EC, Wheless JW, Veggiotti P, Vining EP; Charlie Foundation, Practice Committee of the Child Neurology Society; Practice Committee of the Child Neurology Society; International Ketogenic Diet Study Group. Optimal clinical management of children receiving the ketogenic diet: recommendations of the International Ketogenic Diet Study Group. Epilepsia. 2009 Feb;50(2):304-17. doi: 10.1111/j.1528-1167.2008.01765.x. Epub 2008 Sep 23. |
| 16499772 | Result | Berg AT, Kelly MM. Defining intractability: comparisons among published definitions. Epilepsia. 2006 Feb;47(2):431-6. doi: 10.1111/j.1528-1167.2006.00440.x. |
| 11971127 | Result | Brodie MJ, Kwan P. Staged approach to epilepsy management. Neurology. 2002 Apr 23;58(8 Suppl 5):S2-8. doi: 10.1212/wnl.58.8_suppl_5.s2. |
| 19889013 | Result | Kwan P, Arzimanoglou A, Berg AT, Brodie MJ, Allen Hauser W, Mathern G, Moshe SL, Perucca E, Wiebe S, French J. Definition of drug resistant epilepsy: consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia. 2010 Jun;51(6):1069-77. doi: 10.1111/j.1528-1167.2009.02397.x. Epub 2009 Nov 3. |
| 19914135 | Result | Kwan P, Brodie MJ. Definition of refractory epilepsy: defining the indefinable? Lancet Neurol. 2010 Jan;9(1):27-9. doi: 10.1016/S1474-4422(09)70304-7. Epub 2009 Nov 13. No abstract available. |
| 10660394 | Result | Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9. doi: 10.1056/NEJM200002033420503. |
| 22278892 | Result | Martinez-Juarez IE, Lopez-Zapata R, Gomez-Arias B, Bravo-Armenta E, Romero-Ocampo L, Estevez-Cruz Z, Hernandez-De la Cruz G, Moran-Molina S. [Refractory epilepsy: use of the new definition and related risk factors. A study in the Mexican population of a third-level centre]. Rev Neurol. 2012 Feb 1;54(3):159-66. Spanish. |
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| 1418457 | Result | Hauser WA. The natural history of drug resistant epilepsy: epidemiologic considerations. Epilepsy Res Suppl. 1992;5:25-8. |
| 17903391 | Result | Marson AG, Appleton R, Baker GA, Chadwick DW, Doughty J, Eaton B, Gamble C, Jacoby A, Shackley P, Smith DF, Tudur-Smith C, Vanoli A, Williamson PR. A randomised controlled trial examining the longer-term outcomes of standard versus new antiepileptic drugs. The SANAD trial. Health Technol Assess. 2007 Oct;11(37):iii-iv, ix-x, 1-134. doi: 10.3310/hta11370. |
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| 17642053 | Result | Gomez-Alonso J, Giraldez BG. [Epilepsy: a new definition for an old disease]. Rev Neurol. 2007 Jul 16-31;45(2):126-7. No abstract available. Spanish. |
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| 11254763 | Result | Duncan JS. The outcome of epilepsy surgery. J Neurol Neurosurg Psychiatry. 2001 Apr;70(4):432. doi: 10.1136/jnnp.70.4.432. No abstract available. |
| 5166216 | Result | Huttenlocher PR, Wilbourn AJ, Signore JM. Medium-chain triglycerides as a therapy for intractable childhood epilepsy. Neurology. 1971 Nov;21(11):1097-103. doi: 10.1212/wnl.21.11.1097. No abstract available. |
| 10996924 | Result | Panico LR, Demartini MG, Rios VG, Carniello MA. [The ketogenic diet in infantile refractory epilepsy: electroclinical response, complications and secondary effects]. Rev Neurol. 2000 Aug 1-15;31(3):212-20. Spanish. |
| 10742367 | Result | Lefevre F, Aronson N. Ketogenic diet for the treatment of refractory epilepsy in children: A systematic review of efficacy. Pediatrics. 2000 Apr;105(4):E46. doi: 10.1542/peds.105.4.e46. |
| 17641989 | Result | Vicente-Hernandez M, Garcia-Garcia P, Gil-Nagel A, Lopez-Munoz F, Alamo C. [Therapeutic approach to epilepsy from the nutritional view: current status of dietary treatment]. Neurologia. 2007 Oct;22(8):517-25. Spanish. |
| 17444813 | Result | Yudkoff M, Daikhin Y, Melo TM, Nissim I, Sonnewald U, Nissim I. The ketogenic diet and brain metabolism of amino acids: relationship to the anticonvulsant effect. Annu Rev Nutr. 2007;27:415-30. doi: 10.1146/annurev.nutr.27.061406.093722. |
| 32588435 | Derived | Martin-McGill KJ, Bresnahan R, Levy RG, Cooper PN. Ketogenic diets for drug-resistant epilepsy. Cochrane Database Syst Rev. 2020 Jun 24;6(6):CD001903. doi: 10.1002/14651858.CD001903.pub5. |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |