Journal of Research in Pharmacy Practice

Abstract Objective: This study aimed to assess the efficacy of an herbal formulation 
based on Boswellia sacra in improving cognitive and behavioral symptoms 
in patients with mild cognitive impairment (MCI) and mild-to-moderate 
stages of Alzheimer’s disease (AD). Methods: A 3-month, parallel-group, 
placebo-controlled trial was implemented from October 2021 to April 
2022. Patients with MCI and mild-to-moderate stages of AD aged above 
50 years (n = 60; 40 women, 20 men) enrolled in the study using clinical 
diagnosis and a score of 10–30 on the mini-mental state examination (MMSE) 
test. They were assigned into two groups; one receiving a herbal formulation) 
include B. sacra, Melissa officinalis, Piper longum, Cinnamomum verum, and 
Physalis alkekengi) three times a day and the other receiving a placebo for 
3 months. The main efficacy measures were the changes in cognitive domains 
based on the MMSE and changes in behavioral and psychiatric symptoms 
based on neuropsychiatric inventory (NPI) scores compared with baseline. Side 
effects were also recorded. Findings: Results of this study showed significant 
differences between the two groups after 3 months in terms of all the assessed 
variables, including the overall result of the mean score of MMSE and NPI 
tests (P ≤ 0.001). The herbal formulation had the most considerable effects 
on the domains of orientation, attention, working memory, delay recall, and 
language of the MMSE test. Conclusion: Herbal formulation based on B. sacra
was significantly effective compared to a placebo in improving cognitive and 
behavioral symptoms in patients with MCI and mild-to-moderate AD.

Abstract Objective: Psychiatric disorders are chronic in nature which require medications 
for a long duration. These medications have been associated with many adverse 
events. Failure to recognize an adverse drug reaction (ADR) exposes the patient 
to continuing risk of ADR, leading to a significant impact on patient’s quality of 
life. Thus, the present study carried out to identify the pattern of ADRs reported 
due to psychotropic medication. Methods: This was a cross-sectional study 
conducted to analyze ADRs reported from the psychiatry department of a tertiary 
care teaching hospital from October 2021 to March 2022. Findings: A total of 
137 ADRs were identified from 102 patients. Majority of the ADRs were reported 
from antidepressants, with paroxetine being the leading offending drug. The 
central nervous system was most commonly affected, and dizziness (13.13%) 
was the most common ADR noted. On causality assessment, 97 ADRs (70.8%) 
were of “possible” type. Almost half of the patients with ADRs (47.5%) recovered 
spontaneously. No ADR encountered turned out to be fatal. Conclusion: The 
present study revealed that the majority of ADRs reported from psychiatry OPD 
were mild in nature. We reinforce the identification of ADR is crucial in the 
hospital setting process as it gives an insight into the risk‑benefit ratio for rational 
use of the drug.

Abstract Objective: Trace elements deficiency is common among end‑stage renal 
disease (ESRD) patients due to excessive loss during dialysis and the lower intake 
secondary to loss of appetite. Selenium (Se) is a trace element that plays an important 
role in the radical scavenging system and helps the body defend against oxidative 
stress. This study aims to evaluate the effects of Se supplementation on lipid 
profile, anemia, and inflammation indices in ESRD patients. Methods: Fifty-nine 
hemodialysis patients enrolled and were randomly divided into two groups. Two 
hundred microgram Se capsules once daily for the case group and matching placebo 
for the control group were administered for three months. Demographic data 
were collected at the study beginning. Uric acid (UA), anemia and inflammation 
indices, and lipid profiles were recorded at the beginning and the end of the study. 
Findings: UA and UA‑to‑HDL (high‑density lipoprotein) ratio decreased significantly 
in the case group (P < 0.001). The changes in lipid profile were not significant among 
both groups. Hemoglobin slightly increased in the case group, however, it decreased 
significantly in the control group (P = 0.031). High-sensitivity C-reactive protein (hsCRP) decreased in the case group and increased in the control group, however, none 
of these changes were significant. Conclusion: According to the results of this study, 
selenium supplementation in ESRD patients could reduce some risk factors related to 
their mortality, such as the ratio of uric acid to HDL. However, the changes related to 
lipid profile, hemoglobin level and hs-CRP biomarker were not significant.

Abstract Objective: Epilepsy is a chronic neurological disorder that affects 0.5%–1% 
of children. 30%–40% of patients are resistant to current anti-epileptic drugs. 
Lacosamide (LCM) appeared to be effective, safe, and well tolerated in children 
and adolescents. This study was aimed to evaluate whether LCM could be an 
effective add-on therapy in children with refractory focal epilepsies. Methods: This 
study was conducted from April 2020 to April 2021 in Imam Hossein Children 
Hospital, Isfahan, Iran. We included 44 children aged 6 months to 16 years with 
refractory focal epilepsy (based on International League Against Epilepsy criteria). 
LCM was given in divided doses of 2 mg/kg/day, increasing by 2 mg/kg every 
week. The first follow‑up visit was 6 weeks later, when all patients had reached 
the therapeutic dose. Findings: The average age of the patients was 89.9 months. 
72.5% of children had focal motor seizures. Evaluation of percent change in seizure 
frequency and duration before and after treatment showed a 53.22% reduction in 
seizure frequency and 43.72% reduction in seizure duration after treatment. Our 
study group tolerated LCM well, with few side effects. Headache, dizziness, and 
nausea were common side effects. In line with other studies, none of the suspected 
risk factors could predict response to LCM treatment. Conclusion: LCM appears 
to be an effective, safe, and well-tolerated medication in children with uncontrolled 
drug-resistant focal epilepsy.

Abstract Objective: We aimed to evaluate the efficacy of an oral combined tablet of 
Glycyrrhiza glabra, Viola odorata, and Operculina turpethum (Anti-Asthma®) as 
an add-on therapy for the relief of the severity of symptoms in mild-to-moderate 
childhood asthma. Methods: This randomized placebo-controlled clinical trial 
was performed on 60 children and adolescents with chronic mild-to-moderate 
childhood asthma. Patients were randomly divided into cases who received 
Anti-Asthma® oral combined tablets 2 tablets twice dailt for 1 month and controls, 
received placebo tablets identically the same to Anti-Asthma® (2 tablets, twice 
daily, for 1 month) as add-ons to their standard therapy according to the guideline. 
The severity and frequency of cough attacks and shortness of breath, respiratory 
test indices (based on spirometry), and the extent of disease control and treatment 
adherence were measured clinically by validated questionnaires at the beginning 
and after the study. Findings: Respiratory test indices improved and the severity 
of activity restriction decreased significantly in the cases compared to the controls 
However, the mean difference before and after the study was significantly different 
between the cases and controls only for the number and severity of coughs and the 
severity of activity restriction. In the scores of the Asthma Control Questionnaire, 
the cases group had a significant improvement compared to the controls. 
Conclusion: Anti-Asthma® oral formulation may be effective as an adjunct add-on 
treatment in the maintenance therapy of mild-to-moderate childhood asthma.

Abstract Objective: The objective of this study is to assess the association between exposure 
to atorvastatin (ATV) and low-plasma folate (PF) status. Methods: The sample 
consisted of patients admitted to the internal medicine service of a basic general 
hospital, located in Zaragoza (Spain). We adopted a pharmacoepidemiological 
case–control study design. For this, the number of treatment days (TDs) of all 
the drugs part of their treatment during the study period was obtained from each 
patient in the sample. The cases were comprised by the number of patient’s TDs 
for which PF ≤3 mg/dl and the controls by the number of patient’s TDs for which 
PF >3 mg/dl. To measure the strength of the association, the odds ratios (ORs) 
were calculated. The Chi-square test, using the Bonferroni correction, was 
used to calculate the statistical significance. Findings: The sample consisted of 
640 polymedicated patients. The mean PF obtained were 8.0 ± 4.6 mg/dl and 
2.1 ± 0.6 mg/dl, for the cases and controls, respectively; the total number of 
TDs for the cases and controls were 7615 and 57899, respectively. We obtained 
a U-shaped curve when representing the dose of ATV against the corresponding 
ORs when comparing cases with control. Conclusion: Exposure to ATV at 10 or 
80 mg is associated with an augmented risk of low folate status. We recommend 
implementing guidelines for mandatory folic acid fortification in patients exposed 
to ATV doses of 10 or 80 mg.