Efficacy of Individualized Homeopathic Remedies on Migraine: a Randomized, Triple-blind, Placebo Controlled Study. (HOMEOMIG)

Hospital General de Agudos Bernardino Rivadavia

Status: Enrolling

Conditions: Migraine

Treatments: Other: Placebo; Other: Individualized Homeopathic Remedy

Study type: Interventional

Funder types: Other

Identifiers

NCT05468801

136/18

Details and patient eligibility

About

Migraine, a chronic and often lifelong neurological disorder, is the second leading cause of years lived with disability worldwide. To reduce this global burden, concerted efforts are needed to implement and improve migraine health-care policies. Several observational studies showed significant improvement of different headaches types with homeopathy. The purpose of this study is the assessment of the efficacy of Individualized Homeopathic Remedies (specific remedies for each patient) versus Conventional pharmacological treatment in patients with migraine.

Full description

This is a randomized, triple-blind, placebo-controlled, parallel group study in adult subjects with diagnosis of migraine with or without aura. All patients will be assessed in a screening visit at the Study Hospital Dept. of Neurology in order to confirm and certify migraine diagnosis and evaluate correctness and stability of usual acute and preventive standardized pharmacological treatment. Patients will fulfill a 30 day baseline period to monitor headache activity, migraine related symptoms, and medication usage. Subjects agreeing to participate in the study and meeting clinical-neurological eligibility criteria will then assist to a first homeopathic consultation to assess viability of homeopathic treatment and selection of the individualized homeopathic remedy. Patients who meet both neurological and homeopathic inclusion criteria will begin a three month treatment phase. An estimated of 72 patients, calculated according to the Open-Epi program ((c) 2003, 2008 Andrew G. Dean and Kevin M. Sullivan, Atlanta, GA, USA) , will be randomized according to statistics Epidat Program (4.2 version, july 2016 Panamerican Health Organization (PHO-WHO); to receive Individualized homeopathic treatment + standard pharmacological treatment OR unidentified placebo + standard pharmacological treatment. Study homeopathic remedy or placebo will be administered for a minimum period of 12 weeks with control visits every 4 weeks to assess neurological and homeopathic evolution, adherence and possible adverse events. During the study period patients will continue filling the migraine diary collecting frequency, length and type of headaches, acute medication usage and migraine associated symptoms. At the end of treatment, a final clinical homeopathic visit will take place as well as a final Neurological visit at study Hospital. Hospital visits are independent of clinical visits and performed by different study physicians.

After conclusion of treatment phase patients will have three more follow up visits for the assessment of clinical and homeopathic evolution, possible adverse events and general satisfaction with the study.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with certified diagnosis of migraine with or with out aura of at least one year of evolution according to the Subcommittee of Headaches Classification of the International Headache Association 3rd edition (ICHD-III)
• Patients receiving acute or preventive standardized pharmacological treatment for migraine for at least one year prior to study inclusion
• Patients do not have chronic migraine defined as Headache occurring on 15 or more days per month for more than 3 months, which has the features of migraine headache on at least 8 days per month (ICHD-III)
• Patients meeting ICHD-III criteria of probable medication overuse headache (MOH)
• Female patients in reproductive age that are correctly using a standardized contraceptive method
• Participants who are able to maintain a prospectively collected simple headache diary

Exclusion criteria

• Patients under standardized pharmacological treatment who have significantly (>50%) added or modified migraine preventive drugs doses within 3 months prior to study baseline

• Patients who have initiated or significantly (>50%) modified doses of any drug for any chronic treatment with any agent with proven analgesic action or psychiatric action (antidepressants, antipsychotics, mood stabilizers, etc) or neurological action (anticonvulsivants, antiparkinsonians, etc) within 3 months prior to study baseline

• Patients suffering any cause of secondary headache like trauma, metabolic or vascular disorders, non vascular intracranial lesions, abuse of alcohol or other psychoactive substances.

• Pregnant or probably pregnant patients according to date of last menstruation referred by the patient of more than 35 days in women with regular cycles or plasma beta sub-unit of human chorionic gonadotrophin in women with irregular menstrual cycles

• Patients with history of anaphylaxis, non controlled diabetes, severe disorders being neurological, cardiac, pulmonary and/or hepatic as well as psychosis or suicide ideation and/or attempts.

• Patients with other acute or chronic pain disorders, history of hemiplegic migraine or migraine with brain stem aura, history of cerebral-vascular accident, convulsions, severe coronary disease, non controlled hypertension or cognitive dysfunctions.

• Patients not meeting homeopathic clinical criteria of High Pathological Similitude defined as an homeopathic previous success probability for the selected homeopathic remedy of of 5 to 7 points in a probability scale of 1 to 7

  • NOTE: Please contact the investigator for additional information about Homeopathic criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

Individualized Homeopathic Remedy plus Standard Pharmacologic Treatment

Experimental group

Description:

Each subject receives an individually selected homeopathic remedy (individualized homeopathic remedy) as an add on to the conventional standardized pharmacological treatment he/she is receiving prior and during study. Standardized pharmacological treatment will be monitored and approved at first hospital neurological visit and as a requirement needs to be unchanged within 3 months prior inclusion and throughout the study.

Treatment:

Other: Individualized Homeopathic Remedy

Placebo plus Standard Pharmacologic Treatment

Placebo Comparator group

Description:

Subjects receive an indistinguishable placebo plus the conventional standardized pharmacological treatment he/she is receiving prior and during study. Standardized pharmacological treatment will be monitored and approved at first hospital neurological visit and as a requirement needs to be unchanged within 3 months prior inclusion and throughout the study.

Treatment:

Other: Placebo