Development and validation of self-report Mizaj identification questionnaire Based on Persian Medicine for the elders (age over 60).

Background: Introduction: Mizaj is the basis of attention to individual differences in Persian Medicine (PM). Regarding the importance of Mizaj for health preservation and treating diseases, it is necessary to achieve a standard tool for Mizaj identification. The purpose of this study was to design a standard self-reporting Mizaj identification questionnaire for elders. Methods: In this exploratory sequential study, criteria of Mizaj identification were extracted by reviewing PM literatures and interview with PM experts and elders. The primary questionnaire was designed and its validity and reliability were assessed, using weighted Kappa statistics, Pearson correlation coefficient (PCC) assessment, receiver operating characteristic (ROC) curve and determining the specificity and sensitivity of cut-off points. Results: Among the 101 items in the primary questionnaire, 73 items had acceptable reliability. The final 20-item questionnaire was obtained after the criterion validity and PCC assessment. The sensitivity and specificity of this questionnaire were 83% and 88% for warmness, 49% and 80% for moderate in warmness-coldness, 72% and 91% for coldness, 57% and 78% for wetness, 30% and 79% for moderate in wetness-dryness, and 81% and 67% for dryness, respectively. Conclusion: The standard Mizaj identification is recommended as a supplementary diagnostic tool for clinicians and researchers in PM. Also, the people with age over 60 can use it to identify their own Mizaj and then, choose the suitable PM or Unani medicine lifestyle recommendations based on their Mizaj.

Serum Vitamin D Status in Older Adults: A Cohort Study.

Background: Vitamin D is best known as a key regulator of bone metabolism and calcium and phosphate homeostasis. This study aimed to assess the effect of different factors on the five-year changes in serum vitamin D concentration among older adults. Methods: This cohort study was conducted on adults aged ≥60 years living in Amirkola, in the North of Iran, from 2012 to 2017. Serum 25-hydroxyvitamin D (25-OH vitamin D) concentrations of <20, 20-29.99, and ≥30 ng/mL, respectively, were used to designate vitamin D deficiency, insufficiency, and sufficiency. Any variation between the second and baseline values of the 25-OH vitamin D concentration was reported as a five-year difference. Data were analyzed using SPSS version 17.0, and Chi square, t test, one-way ANOVA, and Tukey HSD post hoc tests were employed. P values less than 0.05 were considered statistically significant. Results: The mean serum concentration of 25-OH vitamin D at baseline and follow-up examination in 1011 individuals was 34.68±33.18 and 23.88±14.91, respectively (P<0.001). Following a five-year follow-up, vitamin D deficiency, insufficiency, and sufficiency were found in 452 (44.7%), 334 (33.0%), and 225 (22.3%) cases, respectively. The reduction in serum 25-OH vitamin D concentration after five years was significantly influenced by the administration of vitamin D (P=0.013) and calcium (P=0.007) supplements, serum profile of parathyroid hormone (PTH) (P=0.010), calcium (P=0.021), and phosphorous (P=0.021). However, age, sex, body mass index, metabolic syndrome, and physical activity had no significant impact (P>0.05). Conclusion: Regardless of age, sex, body mass index, metabolic syndrome, or physical activity, the mean serum concentration of vitamin D decreased over a five-year follow-up.

Anti-Cancer Effect of Bromelain and Its Combination with Cisplatin on HN5 Cell Line (Squamous Cell Carcinoma).

Statement of the Problem: Squamous cell carcinoma (SCC) comprises over 90% of oral malignancies. Cisplatin, as a selective chemotherapy agent to treat SCC, has many side effects despite its high effectiveness. There are some studies on the effects of bromelain derived from pineapple stems on different malignancies. Purpose: The aim of this study was to investigate the effect of bromelain alone and in combination with Cisplatin on oral squamous cell carcinoma (OSCC) and fibroblast cell lines. Materials and Method: In this interventional study, the HN5 cell line of OSCC and fibroblast cell line were treated with different concentrations of bromelain alone and in combination with cisplatin. Cell viability test was performed after 24, 48 and 72 hours using MTT (3-)4,5-dimethylthiazol-2-yl(-2,5 diphenyl tetrazolium bromide) assay. In the final stage, the drug-treated cells underwent flow cytometry to assess apoptosis patterns. Data were analyzed using SPSS 17, ANOVA (for general comparison of groups) and LSD post hoc tests (for comparison two groups). p< 0.05 was considered statistically significant. Results: The findings suggested that although bromelain showed toxic effects on HN5 cancer cells, its combination with Cisplatin resulted in little improvement in its effectiveness. Bromelain alone and in combination with Cisplatin presented cytotoxic effects against fibroblasts, which depended on the dosage and time exposure (p< 0.05). The flow cytometry results did not support the superior effect of the combination of two medications over Cisplatin alone (p> 0.05). Conclusion: According to the findings, although adding bromelain to Cisplatin reduced toxicity on normal tissues, the combination of these two drugs did not increase the anticancer effect of Cisplatin. Thus, bromelain in combination with Cisplatin is not recommended as an adjuvant drug for OSCC.

Mizaj assessment and data analysis methods in Amirkola health and aging project (AHAP cohort).

Background: One of the principles of Persian medicine (PM) is the individualized approach that is presented with the concept of Mizaj. In this viewpoint, on the whole body, Mizaj is determined for every person based on 10 criteria, which is a result of the Mizaj of the main organs, including the brain, liver, and heart. There is no standard diagnostic tool for Mizaj assessment yet. The purpose of this study is to explain the method of Mizaj assessment and data analysis in the elderly in one of the biggest health and aging projects in Iran. The second phase of the Amirkola health and aging project (AHAP) evaluated more than 1,700 clinical and laboratory examinations of 2135 elderly people. Methods: In this study, a novel Mizaj assessment method in two phases is presented. In the first phase, 1541 elderly were assessed by a PM expert and typical diagnoses (the high confidence of expert's proficiency) were determined. At the second phase, an expert panel including 5 PM experts evaluated the cases. The data of the elderly whose Mizaj agreed in the expert panel was used to assess its correlation with Mizaj. Also, the Mizaj of the main organs of these cases was evaluated this way. Conclusion: In the lack of valid and reliable questionnaires to assess the personalized viewpoint of PM, a new expert-based method has been introduced that can be used in similar studies. The result of the Mizaj assessment in this way will be used to obtain objective values for the Mizaj assessment.

The effect of Achillea Millefolium L. on vulvovaginal candidiasis compared with clotrimazole: A randomized controlled trial.

INTRODUCTION: Vulvovaginal candidiasis is the second most common cause of vulvovaginal infections. The aim of this study is to evaluate the effectiveness of vaginal cream of Achillea millefolium extract in women with vulvovaginal candidiasis in comparison with vaginal clotrimazole. MATERIALS AND METHODS: This double-blind randomized clinical trial study was conducted on 80 women diagnosed with vulvovaginal candidiasis clinically and by laboratory test; 40 women received vaginal cream clotrimazole 1 % and 40 received vaginal cream containing the aqueous extract of A. millefolium for 7 days. Clinical and laboratory assessments were performed before and after the intervention. Minimum inhibitory concentration of the extract was evaluated with Broth micro-dilution procedure. RESULTS: The Dermatology life quality index score showed significant reduction in both groups after treatment, but it was significantly more reduced in control group (p < 0.05). Improvement in vulvar erythema was observed in both groups with no statistically difference (p = 0.1). Vaginal culture was negative in term of Candida in 28(77 %) patients of control group and in 18(53 %) patient of experimental group (p < 0.05). The Minimum inhibitory concentration of the extract was 37.5 mg/mL for the standard strain. DISCUSSION AND CONCLUSION: Study results showed that vaginal cream containing A. millefolium could reduce the complaints of vulvovaginal candidiasis. But, future studies with a larger sample size and different dosages are recommended to assess the outcomes of this new treatment.

Comparison of the efficacy of ranitidine and quince syrup on gastroesophageal reflux disease in children.

INTRODUCTION: Since the treatment of gastroesophageal reflux disease (GERD) symptoms in children is of the utmost importance, the current study is aimed to evaluating the efficacy of quince syrup and ranitidine in the management of pediatric patients with symptomatic GERD. METHODS AND MATERIALS: This double-blind, randomized clinical trial was performed on 96 children suspected of suffering from GERD. The patients referred to the gastrointestinal clinic of Ghaem Hospital, Iran, during 2017. The participants were randomly categorized into two groups (ranitidine and ranitidine plus quince syrup). The GERD symptoms, including the severity and frequency of vomiting, refusal of eating, difficulty in swallowing, choking at the time of eating, burping or belching, and abdominal or belly pain, were gathered before and after the intervention (4 weeks) using standardized Global Severity Questionnaire (GSQ-YC). RESULTS: The comparison of two groups in terms of vomiting, refusal of eating, burping or belching, and abdominal or belly pain showed a significant difference 4 and 6 weeks after the intervention (P< 0.05). However, the comparison of difficulty in swallowing and choking at the time of eating between the two groups showed that there was no significant difference after 2, 4, and 6 weeks of the intervention (P > 0.05). The comparison of the total scores between the two groups showed that there was a significant difference 2 (17.8 ±â€¯2.6 vs 23.4 ±â€¯4.0; P < 0.05), 4 (11.5 ±â€¯2.3 vs 18.8 ±â€¯3.6; P< 0.05), and 6 (12.2 ±â€¯2.3 vs 21.1 ±â€¯4.1; P<  0.05) weeks after the intervention. CONCLUSION: The results showed that the administration of ranitidine plus quince syrup was useful to improve pediatric GERD. However, it is recommended to conduct the future studies with a larger sample size and different dosage.

Effect of Alpinia officinarum Hance rhizome extract on spermatogram factors in men with idiopathic infertility: A prospective double-blinded randomised clinical trial.

Despite scientific advances, many of the treatments in male infertility remained indeterminate. In recent years, the attention to herbal remedies as an effective treatment for male infertility is considerable. We designed this study to determine the effects of Alpinia officinarum on the results of semen analysis in men with idiopathic infertility. In this clinical trial, seventy-six participants with idiopathic infertility were included in the intervention (plant treatment: n = 31; placebo: n = 29). Participants were randomised to take capsules containing dried extract of A. officinarum rhizome or placebo on a daily (total daily dosage of 300 mg) basis for 3 months. After 12 weeks of intervention, the sperm count and total number of spermatozoa with normal morphology were increased in participants treated with A. officinarum extract compared with the placebo group. The mean sperm count was initially 52 × 106  ± 24 × 106 /ml which changed to 71 × 106  ± 23 × 106 /ml, after intervention (p = 0.043). Also, the mean percentage of spermatozoa with normal morphology was 14.34% ± 9.16% before the treatment which significantly increased to 19% ± 14.89% (p < 0.001). Alpinia officinarum, a traditional medicine remedy, can be effective in the improvement of sperm morphology and sperm count in idiopathic infertility without causing adverse effects.

The First Step of Health Policy-Making for Lifestyle Modifications at Middle Age: Problem Identification in 40- to 60-Year-Old Population, Northern Iran.

Background: The purpose of this study was to determine the current situation of lifestyle behaviors and related outcomes, as the first step to make proper local health policies for improvement of health lifestyle behaviors. Materials and Methods: This analytic research has been conducted as a cross-sectional study on the middle-aged (40-60 years old) population of Amirkola, Northern Iran. The Persian translation of the Health-Promoting Lifestyle Profile II questionnaire and the International Physical Activity Questionnaire were used for data collection. Also, anthropometric variables, blood pressure, fasting blood sugar, and serum lipids profile were examined. Results: Three hundred one individuals have been enrolled in the study. Results showed that 10.6% of the participants had unhealthy lifestyle behaviors in the subdomain of spiritual growth; 46.8% in the subdomain of health responsibility; and 48.2% in the subdomains of stress management, physical activity, and nutrition; men had more physical activity than women (p < 0.001). Totally, 189 persons (63.9%) had serum cholesterol greater than or equal to 200 mg/dL; seventy-five individuals (25%) had high blood pressure. One hundred twenty-six persons (81.8%) of women and 103 (70.1%) of men were overweight or obese. Conclusions: Health lifestyle behaviors in 40- to 60-year-old population need a proper intervention to improve the current situation.

Stoss therapy using fortified biscuit for vitamin D-deficient children: a novel treatment.

BACKGROUND: To evaluate the efficacy of stoss therapy using fortified biscuit for vitamin D-deficient children. METHODS: A total of 108 children aged 30-72 months with vitamin D deficiency were studied in a randomized single-blind clinical trial. The deficient children were assigned to three groups, namely, vitamin D-fortified biscuit (BG), capsule vitamin D (CG), and ampoule vitamin D (AG). Capsules and biscuits containing 50,000 IU of cholecalciferol were consumed twice per week for 3 consecutive weeks. Ampoules with 300,000 IU of cholecalciferol were injected intramuscularly in a single dose. Three weeks after treatment, serum 25(OH)D concentrations were measured, and the three groups were compared. RESULTS: Each method of treatment could increase the mean serum 25(OH)D concentration to optimal level. Serum 25(OH)D concentrations ≥100 ng/mL were observed in six children, including four from AG and two from CG (P = 0.09). The comparison of the mean serum 25(OH)D concentrations after treatment showed between ampoule and capsule (P = 0.3) and capsule and biscuit (P = 0.62) were insignificant; however, the ampoule and biscuit groups differed significantly (P = 0.012). CONCLUSION: Stoss therapy using fortified biscuit may be an effective way to improve compliance in children who cannot take capsules without adverse effects and may also be recommended for prevention purposes.

Hyponatremia, bone mineral density and falls in the elderly; Results from AHAP study.

BACKGROUND: Hyponatremia (HN) can be associated with osteoporosis, falls and bone fractures in the elderly. Recent researches demonstrated different results about the correlation of HN with bone mineral density and bone fractures. METHODS: This analytic research came from the AHAP project in northern IRAN. All people aged 60 years and over were included in the study. Individuals with severe comorbidities and then who had concurrent conditions which could have impact on bone mineral densities (BMD) such as long-term use of steroids, calcium and/or vitamin D supplements, bisphosphonates, calcitonin, thiazides and hormonal medications were excluded. RESULTS: One thousand and one hundred and thirteen older persons entered in the study. More than 10 percent of the participants had HN (serum Na+ level ≤ 137mEq/L). No significant difference has been observed between hyponatremic and nonhyponatremic individuals about their balance abilities; bone mineral density; incidence of falls and/or bone fracture during the previous 6 months; dependency in activities of daily living; and osteoporosis. CONCLUSION: HN was not a prevalent problem in older adults who met the inclusion criteria of this research. No significant difference has been observed between HN and bone mineral density and falls in the elderly.

Cohort Profile Update: The Amirkola Health and Ageing Project (AHAP).

The original cohort study of AHAP started in 2011 on 1616 elderly residents of Amirkola, northern part of Iran near the Caspian Sea. The main goal of this study was to comprehensively evaluate the health of the elderly in the region with the emphasis on chronic diseases such as osteoporosis. The first cohort profile was published in the International Journal of Epidemiology in 2014. The phase 1 AHAP showed the elevated level of some diseases and conditions including osteoporosis, metabolic syndrome, obesity, vision problems and relatively low levels of oral health. Therefore, the second phase of this cohort started with more complete population coverage in 2016, not only to collect and record the information based on previous protocol, but also consider new areas such as nutritional status, complete eye and dental examinations and health assessment on the basis of Iranian Traditional Medicine. The new aspect of this project is to conduct clinical and laboratory examinations at the health center to extend more facilities to the elderly. In addition to serum and DNA, samples of saliva, hair and nails are collected and kept under standard conditions in the biobank of this cohort. Researchers can apply for access to data or suggest a collaborative study by submitting the proposal to AHAP committee.

Dyshomeostasis of Serum Oxidant/Antioxidant Status and Copper, Zinc, and Selenium Levels in Elderly Physically Disabled Persons: an AHAP-Based Study.

The percentage of elderly persons is rapidly growing. Physical disability is one of the main age-related diseases which affect life quality. There are some studies that suggest the oxidative stress and trace elements are involved in physical disability in elderly persons, but the results are inconclusive. Therefore, the aim of this study was to investigate the status of aforementioned parameters in elderly physically disabled patients vs. healthy ones. According to the Katz questionnaire form, 44 subjects with physical disability and 66 age-gender-matched healthy subjects were selected from Amirkola Health and Aging Project (AHAP). The results indicated that patient group had lower serum Zn, Se, and total antioxidant levels than the control group (p < 0.001), whereas serum total oxidant level and Cu to Zn ratio (CZr) were higher in control group than in healthy one (p < 0.001). A positive correlation was found between Zn, Se, total antioxidant, and bone mineral density of femur (BMD.F) with activities of daily living (ADL) score (p < 0.01); meanwhile, a negative correlation between CZr and total oxidant with ADL score was observed (p < 0.01). Serum total oxidant level and CZr index had the highest area under the curve in receiver operating characteristic (ROC) analysis among the included parameters for discrimination of physically disabled patients than the normal ones. Decrease in serum Zn and Se levels, low BMD, and increase in CZr and oxidative stress were observed in physically disabled patients. It seems that CZr is more reliable parameter than the others to discriminate the physically disabled patients than the healthy persons.

Antioxidant capacity of calendula officinalis flowers extract and prevention of radiation induced oropharyngeal mucositis in patients with head and neck cancers: a randomized controlled clinical study.

This study was designed to determine the effect of Calendula officinalis flowers extract mouthwash as oral gel on radiation-induced oropharyngeal mucositis (OM) in patients with head-and-neck cancer. Forty patients with neck and head cancers under radiotherapy or concurrent chemoradiotherapy protocols were randomly assigned to receive either 2% calendula extract mouthwash or placebo (20 patients in each group). Patients were treated with telecobalt radiotherapy at conventional fractionation (200 cGy/fraction, five fractions weekly, 30-35 fractions within 4-7 weeks). The oropharyngeal mucositis was evaluated by two clinical investigators (a radiation oncologist and a dentist), using the oral mucositis assessment scale (OMAS). Trying to find out the possible mechanism of action of the treatment, total antioxidant, polyphenol and flavonoid contents, and quercetin concentration of the mouth wash were measured. Calendula mouthwash significantly decreased the intensity of OM compared to placebo at week 2 (score: 5.5 vs. 6.8, p = 0.019), week 3 (score: 8.25 vs. 10.95, p < 0.0001) and week 6 (score: 11.4 vs. 13.35, p = 0.031). Total antioxidant, polyphenol and flavonoid contents and quercetin concentration of the 2% extract were 2353.4 ± 56.5 µM, 313.40 ± 6.52 mg/g, 76.66 ± 23.24 mg/g, and 19.41 ± 4.34 mg/l, respectively. Calendula extract gel could be effective on decreasing the intensity of radiotherapy- induced OM during the treatment and antioxidant capacity may be partly responsible for the effect.

Cord blood -fetoprotein as a predictive index for indirect hyperbilirubinemia in term neonates.

BACKGROUND: Prediction of severe neonatal hyperbilirubinemia is very important for early treatment and prophylaxis of neurologic sequels. The aim of this study was to evaluate the predictive role of umbilical cord -fetoprotein (UCAFP) as a marker of an increased risk for neonatal hyperbilirubinemia in full term babies. METHODS: Umbilical cord blood was collected from 400 term singleton full term well newborn babies who met our inclusion criteria and stored in -20°C. Those who developed jaundice and admitted for phototherapy (34 newborns: 22 males and 12 females), considered as case group and 31 non-jaundiced infants (13 males and 18 females) gestational age-weight-matched considered as the control group. The serum level of UCAFP was checked in these 65 newborns and was compared between these two groups. RESULTS: Mean UCAFP in case group was 523.429±174.158 and in control group was 664.548±154.894 µg/L. In the non-jaundiced group, mean UCAFP values was higher than neonate with hyperbilirubinemia (664.548 vs. 523.429µg/L). The mean UCAFP in males was 519.023 µg/L and in females was 531.508 µg/L (p=0.066). Sixty (92.3%) babies delivered by cesarean section (CS) and 5 (7.7%) by normal vaginal delivery (p=0.566). CONCLUSION: According to our study, there was no significant positive association between UCAFP and subsequent neonatal indirect hyperbilirubinemia or serum bilirubin level.