Evaluation of a Polyherbal Formulation on the Management of Migraine Headaches due to Functional Dyspepsia: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial.

A holistic concept based on traditional Persian medicine (TPM) describes a headache with a gastrointestinal (GI) origin (gastric-headache). Although the neurological manifestations of this headache are similar to those of other headaches, its etiology is different. Considering its simultaneous effects on the brain and GI system, a formulation was designed based on this concept. This study aimed to determine the safety and efficacy of the designed formulation on migraine headache (MH) associated with functional dyspepsia (FD). A total of 75 diagnosed cases of MH patients with concurrent FD were randomly divided equally into 3 groups: (i) the polyherbal formulation, sodium valproate (VPA), and amitriptyline group, (ii) VPA, amitriptyline, and polyherbal formulation placebo group, and (iii) the polyherbal formulation and VPA placebo group. The primary outcomes, including frequency, duration, and severity of MH attacks, were measured at baseline and weeks 4, 8, and 12. However, secondary outcomes, including the Headache Impact Test 6 (HIT-6) Questionnaire and Parkman's score, were evaluated at baseline and end of treatment. The frequency, duration, and severity of migraine (P < 0.001 for all cases), HIT-6 (P < 0.001 for all cases), and FD (P < 0.001 for all cases) scores at the end of treatment showed a significant decrease in the 3 groups compared to the baseline. However, the differences in those variables between the 3 groups were not significant at the end of the study. The polyherbal formulation alone may improve the symptoms of migraine patients and other groups. This effect could be due to improving digestion and FD in migraine patients.

Efficacy and tolerability of hydroalcoholic extract of Paeonia officinalis in children with intractable epilepsy: An open-label pilot study.

Despite a wide range of medications available to control epilepsy, seizures in more than 30 % of patients remain uncontrolled. However, in traditional medicine, Paeonia officinalis (P. officinalis), a native perennial herb of Southern Europe and Western Asia, has been used for an anticonvulsant effect for over 2000 years globally. In an open-label pilot study implemented on 30 children with intractable epilepsy aged 1-14 years, the hydroalcoholic extract of P. officinalis was administered. This study's purpose was to assess the efficacy and tolerability of the P. officinalis extract as an adjunct therapy to a patient's antiseizure medications in reducing the frequency and duration of the seizures in childhood intractable epilepsy. The mean frequency of seizures decreased significantly during treatment with the P. officinalis extract (P < 0.05). At the end of the intervention, 62.5 % and 36.7 % of the patients showed a≥50 % and a≥75 % reduction in seizure frequency, respectively. Regarding safety and tolerability, no serious adverse events occurred during the trial, although restlessness was reported in one child and the other children who experienced constipation, stopped treatment. The results show that the P. officinalis root extract was well tolerated and has contributed to a significant improvement in seizure control in children with medically intractable epilepsy. This trial was registered with the Iranian Registry of Clinical Trials (www.irct.ir; registration number: IRCT20131125015533N2.