Efficacy and safety of panchgavya GHRIT along with flunarizine in prophylaxis for migraine patients: a comparitive study

Abstract

Background: Propranolol and flunarizine have proven to be useful tools in migraine prophylaxis. This trial aims the comparison of the efficacy of flunarizine, flunarizine and placebo and flunarizine and panchgavya ghrit in migraine prophylaxis.Methods: The present study was a prospective, randomized, open-label, blinded-endpoint trial. Patients with chronic migraine were randomized (1:1:1) to flunarizine and flunarizine and placebo and flunarizine and panchgavya ghrit in three treatment groups. The study was carried out in outdoor patients in the department of Psychiatry, T.S. Mishra Medical College and Hospital, Lucknow and K.G.M.U, Ayush Department, Lucknow after clearance from Institutional Ethical Committee. Data was analysed using SPSS software.Results: The prevalence of migraine was found to be higher in the age group greater than 30 years and females. Overall there was more reduction in CGI scores in flunarizine with panchgavya ghrit and the other two groups equally at the end of 4, 6 8 and 10 weeks. Decrease in MIDAS score was observed after the therapy. Clinical Global Impression rating scale employed revealed that to start with subjects scored 7 which stands for pathology interfering in many life functions which reduced drastically in Group C as compared to Group B and Group A in descending order. Pain scales namely VAS (visual analogue scale), NPRS (Numeric Pain Rating Scale), VRS (verbal rating scale) when employed denoted there was decreased migraine frequency, decreased perception of pain, less intake of abortive medication consumed by subjects implying there were reduction in number of migraine days and there was decrease in the abortive medications taken for the same. Group C scored better on pain scales followed by Group B and Group A. Lower proportion of individuals in group C had Behavioural Toxicity and Neurological Side effects as compared to Group A and B.Conclusions: Panch gavya ghrit when administered along with flunarizine was more efficacious and safe when compared with other two groups. However large multicentric RCTs of long duration and involving more number of subjects are required to ascertain these facts.

Ayurveda for management of migraine: A narrative review of clinical evidence

“…[ 12 13 ] One clinical trial has included Behavioral Toxicity and Neurological Side effect as assessed by DOTES (Dose recorded and treatment-emergent symptom scale) criteria and found minimal side effects. [ 14 ] No side effects or adverse events were reported in any other studies.…”

“…A lower proportion of patients had Behavioural Toxicity and Neurological Side effects as compared to the Flunarizine-placebo and Flunarizine-only groups. [ 14 ] A study on Shatahvadi taila showed significant improvement in migraine severity, frequency, and duration of attack. [ 24 ] Anutaila nasya, every alternate day for fourteen days, showed good relief in 70% of cases in comparison to 60% of subjects with Kaphaketu rasa.…”

“…Migraine Disability Assessment (MIDAS) questionnaire was utilized for assessment in three studies. [ 11 12 14 ] Visual Analogue Scale (VAS) for measurement of the intensity of the pain was employed in three studies. [ 11 13 14 ] Headache Impact Test-6 and Perceived Stress Scale-10 were utilized in two studies.…”

“…[ 11 12 14 ] Visual Analogue Scale (VAS) for measurement of the intensity of the pain was employed in three studies. [ 11 13 14 ] Headache Impact Test-6 and Perceived Stress Scale-10 were utilized in two studies. [ 2 12 ] Clinical Global Impression rating scale to assess severity, as well as improvement after therapy (CGI, CGI-I), Numeric pain rating scale (NPRS), Verbal Rating Scale (VRS), were used in one study.…”

“…Behavioral Toxicity and Neurological Side effects using DOTES criteria as well as presenting the patient-reported side effects or symptoms associated with migraine during the therapy were administered in one study. [ 14 ] One study appreciably incorporated Heart Rate Variability (HRV) and surface Electromyography (sEMG). In this study, ten patients with migraine with aura (MA) had reduced SDNN, as well as an increased LF/HF ratio, suggesting sympathetic hyperactivity.…”