Blood samples from the cubital vein of each patient was put into a 5 ml lavender tube. Plasma samples were prepared by centrifugation and then stored at −80°C. Plasma CGRP levels were measured using a commercial enzyme-linked immuno-sorbent assay kit. The miRNAs expression was evaluated by real-time reverse transcription (RT) Polymerase Chain Reaction (PCR) in peripheral blood mononuclear cell (PBMCs). PBMCs were isolated immediately after blood collection. Blood samples were collected within ethylenediamine tetra-acetic acid (EDTA) containing tube and diluted in 1:1 ratio with Phosphate Buffer Saline (PBS). Then, diluted blood samples were slowly loaded into Ficoll separating solution (15 ml) (Sigma) and centrifuged at 800 g for 30 min at room temperature. PBMCs accumulated as the middle white monolayer, were washed twice in sterile PBS at 300 g for 15 min. After washing, PBMCs pellet was resuspended in trizol and stored at −80 °C until use.

Migraine

Headache Science Center

Plasma Levels of CGRP and Expression of Specific microRNAs in Blood Cells of Episodic and Chronic Migraine Subjects

Plasma Levels of CGRP and Expression of Specific microRNAs in Blood Cells of Episodic and Chronic Migraine Subjects: Toward the Identification of a Panel of Peripheral Biomarkers of Migraine?

In order to identify individual or a panel of potential biomarkers of migraine subtypes

In the subjects with CM-MO after detoxification in order to gather more insights into the mechanisms that are involved in the improvement of migraine pattern following the withdrawal of the overused medications.

IRCCS National Neurological Institute "C. Mondino" Foundation

University of Pavia

7-day detoxification protocol + 5 consecutive days of anodal tDCS treatment over the primary motor cortex.

7-day detoxification protocol + 5 consecutive days of sham treatment over the primary motor cortex.

Chronic Migraine

Medication Overuse Headache

Patients randomized to the tDCS group were treated with the following parameters: duration of stimulation of 20 minutes per session with a 2 mA intensity of anodal stimulation.

Transcranial direct current stimulation (tDCS) group

In the sham group, the stimulation setting was exactly the same but the stimulation intensity was set according to a ramping up/ramping down method and delivered only in the first and last 30 seconds of each session.

Sham group

Anodal tDCS in Chronic Migraine With Medication Overuse

Anodal Transcranial Direct Current Stimulation in Chronic Migraine With and Medication Overuse Headache: a Pilot Randomized Sham-controlled Trial

Headache frequency measured by number of migraine days per month recorded in a headache diary.

Migraine related disability measured by the MIDAS. MIDAS test: 0-5 (grade I): minimal disability, 6-10 (grade II): mild disability, 11-20 (grade III): moderate disability, 21-40 (grade IVa): severe disability, 41 and higher (grade IVb): very severe disability.

Migraine related disability measured by the HIT-6. A score of 49 or less: no impact, 50-55: some impact, 56-59: substantial impact, 60-78 severe impact.

Migraine related disability measured by VAS for pain intensity. VAS is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

Migraine related disability measured by MSQ. It is a 14-item assessment, with each item rated on a 6-point scale (ranging from "none of the time" to "all of the time"). The investigators evaluated 3 scores, namely Role Function-Restrictive (RR), Role Function- Preventive (RP), and Emotional Function (EF). Raw scores have been transformed to a 100-point scale, with higher scores indicating better quality of life.

Migraine related disability measured by SF-36.It gives information about 8 different domains: physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items).

Sleep quality measured by SCI. It is a 8-item questionnaire, with a score that range from 0 to 32. A higher score points toward a better sleep, while a score below 16 is significant for insomnia disorders.

Sleep quality measured by PSQI. The questionnaire differentiates "poor" from "good" sleepers. A global score greater than five indicates poor sleep quality, with a maximum score of 21 (the worst overall sleep).

Psychological aspects measured by the Zung scale for anxiety. It is a 20-item questionnaire, with a score that range from 20 to 80. A score above 36 is clinically significant for the presence of anxiety.

Psychological aspects measured by the Zung scale for depression. It is a 20-item questionnaire with a score that range from 20 to 80. A score above 40 is clinically significant for the presence of depression.

For the EEG signal analysis, the investigators used a spectral analysis through a fast Fourier transformation. Epochs with eye movements, artifacts or periods of drowsiness were excluded from analysis. Power spectral density was calculated on the whole track, using a time windows of 5 seconds, with an overlapping of the samples equal to 50% and introducing zeropadding to reach a resolution of 0.1 Hz.

Transcranial direct current stimulation (tDCS) was delivered by a technician that was not otherwise involved in the management of patients. The managing physician and the patient were instead blind to the type of stimulation.

ferrous bisglycinate chelate 1 tablet daily

ferrous bisglycinate chelate 2 tablets daily

Participants received ferrous bisglycinate chelate, 1 tablet of 60 mg, once-daily after dinner, via oral route for 8 weeks.

Ferrous Bisglycinate Chelate 60 mg 1 Once-daily

Participants received ferrous bisglycinate chelate, 1 tablet each of 60 mg, twice-daily after breakfast and dinner, via oral route for 8 weeks.

Ferrous Bisglycinate Chelate 60 mg 1 Twice-daily

Participants received ferrous ascorbate, 1 tablet of 100 mg once-daily after dinner, via oral route for 8 weeks.

Ferrous Ascorbate 100 mg 1 Once-daily

Total

Sex: Female, Male

Region of Enrollment

At fortnightly visits, blood was collected for Hb. Baseline (Visit 0) was not more than 5 days from Week 1 or randomization. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.

Change From Baseline in Hemoglobin (Hb) After 8 Weeks of Treatment in Each Ferrous Bisglycinate Chelate Group (1 Tablet Daily and 2 Tablets Daily)

Mean Change in Hb From Baseline to 8 Weeks

At fortnightly visits, blood was collected for Hb. Number of participants who achieved a target Hb of more than or equal to 12 gm/dL is presented.

Percentage of Participants Who Achieved a Target Hb More Than or Equal to 12 gm/dL After 8 Weeks of Treatment

At fortnightly visits, blood was collected for Hb. Mean change in Hb at Week 2, Week 4, Week 6 and Week 8 are presented.

Mean Change in Hb During 8 Weeks Therapy

The comparison in percentage of participants with gastrointestinal side effects during 8 week treatment period is reported. Gastrointestinal side effects during 8 weeks treatment included abdominal discomfort, gastritis, nausea, dyspepsia, change in bowel habit, constipation, faeces discolored, diarrhea and flatulence.

Difference in Percentage of Participants With Gastrointestinal Side Effects During 8 Weeks Treatment With Ferrous Bisglycinate Chelate and Ferrous Ascorbate

Overall Study

GSK Response Center

Haematopoiesis

ferrous ascorbate

ferrous bisglycinate chelate 1 OD

ferrous bisglycinate chelate 2 OD

GSK Investigational Site

A Study to Demonstrate the Efficacy and Tolerability of Ferrous Bisglycinate Chelate in Iron Deficiency Anaemia and to Compare These With Those of Ferrous Ascorbate.

A Multicentre, Randomized, Laboratory-blinded, Parallel-group Study to Demonstrate the Efficacy and Tolerability of Ferrous Bisglycinate Chelate in Iron Deficiency Anaemia and to Compare These With Those of Ferrous Ascorbate.

cyanocobalamin/päänsärky

Plasma Levels of CGRP and Expression of Specific microRNAs in Blood Cells of Episodic and Chronic Migraine Subjects

Anodal tDCS in Chronic Migraine With Medication Overuse

A Study to Demonstrate the Efficacy and Tolerability of Ferrous Bisglycinate Chelate in Iron Deficiency Anaemia and to Compare These With Those of Ferrous Ascorbate.

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