Oral Drops Research Articles

Применение растительного лекарственного препарата комплексного действия в лечении рецидивирующего тонзиллофарингита у детей

Acute tonsillopharyngitis (ATP) is an acute inflammation of the oropharyngeal mucosa and lymphatic structures usually caused by viruses and less frequently by bacteria, primarily group A beta-hemolytic streptococci (GABHS). Children often have recurrent ATP with 3 or more episodes per year. Objective. In this randomized clinical trial, we evaluated the efficacy of Tonsilgon® N, a combination herbal medicine with the immunomodulatory and anti-inflammatory effects, in the treatment of children with recurrent ATP. Patients and methods. Seventy-two children aged between 3 and 12 years with recurrent ATP were randomized into two equal groups: children in the experimental group received symptomatic therapy and Tonsilgon® N (oral drops for 14 days), whereas children in the control group received symptomatic therapy alone. Patients with ATP caused by GABHS (n = 13) additionally received an antibiotic. Disease manifestations (overall patient condition, fever, sore throat, pharyngoscopy findings, and lymph node reaction) were evaluated using a scoring system before the initiation of therapy and then after 3, 10, and 30 days. All patients were followed up for 6 months. Results. Seventy-one children were included into the final analysis (one patient from the experimental group was excluded due to an allergic reaction). Initially, there were no significant differences between the two groups. Treatment ensured positive dynamics in both groups; however, 10 days after therapy initiation, the score in the experimental group was significantly lower than that in the control group (p = 0.02). Follow-up demonstrated that patients in the experimental group were less likely to develop recurrent ATP (p = 0.013), had fewer ATP relapses (p = 0.003) and antibiotic courses (p = 0.01) compared to controls. Conclusion. The use of Tonsilgon® N in children with recurrent ATP increases treatment efficacy, reduces the number of relapses, and the need for antibiotics. Key words: children, acute tonsillopharyngitis, recurrent respiratory infections, herbal therapy, Tonsilgon® N

Oral morphine drops for prompt relief of breathlessness in patients with advanced cancer-a randomized, double blinded, crossover trial of morphine sulfate oral drops vs. morphine hydrochloride drops with ethanol (red morphine drops).

Episodic breathlessness is frequent in palliative cancer patients. Opioids are the only pharmacological agents with sufficient evidence in treatment. In Denmark, the main recommendation is red morphine drops (RMD), an off-label solution of morphine, ethanol, and red color (cochenille) described since 1893 (Pharmacopoea Danica). In 2015, the Danish Medicines Agency increased focus on off-label medicines and recommended registered morphine drops without ethanol instead. However, our palliative patients told us that RMD was better. For that reason, we conducted a clinical trial to clarify any perceived difference between the two types of drops. We conducted a randomized, double blinded, crossover trial. Patients were asked to perform standardized activity (2-min walk) aiming to provoke breathlessness. Primary endpoint (breathlessness NRS) and secondary endpoints (saturation, pulse, respiratory frequency) were measured before (t = 0) and after test medicine at t = 1, t = 3, t = 5, t = 10, and t = 20 min. After 2-4 days (washout period), the patients repeated the test, receiving the alternative drops in a blinded setup (crossover). In the first 3 min, the relative drop in breathlessness for morphine drops with ethanol (RMD) was significant more than for morphine drops without ethanol. We found no significant difference in secondary endpoints. A conclusion could be that ethanol might facilitate morphine absorption in the mouth. Our results needs further research of opioid absorption in the mouth as well as trials, testing morphine vs. more lipophilic opioids. The RMD drops are cheap, easy to use, and noninvasive and keep the patient independent of health care professionals.

Maxillary Growth Evaluation Of Patients With Unilateral Complete Cleft Lip And Palate After Two Flap Palatoplasty With Honey Oral Drops


 
 
 
 Background : Honey given as oral drops significantly precipitate epithelialization of the lateral palatal defects post two-flap palatoplasty by 2.1 times. Honey is believed to reduce wound contraction, scar formation, and would contribute as an important factor that will result in a satisfactory maxillary growth. The aim of this study is to evaluate maxillary growth as the long-term effect of rapid epithelialization of the palates treated by honey oral drops.
 Method : This is a case control study consisting of 2 groups; comparing maxillary growth of the UCCLP patients that were and were not given honey as oral drops following their two-flap palatoplasty in 2011-2012. The cephalometric measurements were recorded and the dental cast are evaluated using GOSLON Yardstick method.Result : This study included a total of 20 patients. Goslon Yardstick type IV are the most frequent GOSLON on both groups (40%) with moderate inter-rater reliability between examiner 1-2 and 2-3 (kappa; 0.583 and 0.512) and substantial between examiner 1-3 (kappa 0.716). Forty-percent of SNA angle in the honey group were considered as normal, while only 20% normal SNA angle were found in the control group.Conclusion: Honey oral drops following two-flap palatoplasty resulted in satisfactory SNA angle. As the completion of maxillary growth occurs at the age of 20, the results of this study would only serve as a preliminary report. Other measures to support maxillary growth should also be taken into account. Further studies are warranted to discover innovations in surgical technique that may be a major contributing factor in maxillary growth.
 
 
 
 
 Keywords: Maxillary growth, Two Flap Palatoplasty, honey
 
 
 
 
 
 
 

Immunogenicity of the truncated NDV F protein surface-displayed on Lactobacillus casei

To evaluate immune efficacy of the recombinant Lactobacillus casei, we constructed pLA-Newcastle disease virus (NDV)-F/L. casei and obtained the expression products. PCR amplified the NDV F gene carrying part of the major epitopes. The target gene was inserted to the shuttle plasmid pLA, and then transformed into Escherichia coli BL21 (DE3) in order to screen positive recombinant plasmid. The positive recombinant plasmid was transformed into L. casei by electroporation to construct pLA-NDV-F/L. casei. The positive strains were identified by PCR. The reactivity of the recombinant bacteria was identified by Western blotting and the protein expression was detected by indirect immunofluorescence, flow cytometry and laser confocal microscopy. The 14-day-old chickens in each group were vaccinated by oral plus nose drops. The pLA-NDV-F/L. casei twice immunization group and three times immunization group, the commercial vaccine group, the pLA/L. casei group, the unchallenge PBS and the challenge PBS group were established. IgG in serum and sIgA in the lavage fluid of intestinal, nasal and lung were detected by ELISA. The protection rate of chickens was evaluated. The results showed that 94.10% of the recombinant bacteria expressed the F protein. The recombinant protein was highly expressed on the surface of L. casei with a protein size of 62 kDa, which specifically bound to anti-NDV serum. The levels of anti-F IgG and sIgA antibodies in each test group were significantly higher than those in the control groups. The duration of antibody in the pLA-NDV-F/L. casei three-time immunization group lasted 28 days longer than that in the twice immunized group, and there was no significant difference between antibody peak values. The attack protection rates in each group of immunized pLA-NDV-F/L. casei three times, twice, attenuated vaccine, pLA/L. casei and PBS were 80%, 80%, 90%, 0% and 0%, respectively. Therefore, the antigenic protein of NDV F was successfully expressed by L. casei expression system, which has of reactogenicity and immunogenicity, and could induce protective immune responses in chickens.

The effects of Vitex agnus-castus on menstrual bleeding: A systematic review and meta-analysis.

Introduction Vitex agnus-castus, also called Vitex, is a plant with many medicinal properties. This systematic study examined the evidence of the effectiveness and safety of Vitex on menstrual bleeding (primary outcome) and its side effects (secondary outcomes). Materials and methods This systematic review study examined all papers that were a randomized controlled trial, quasi-experimental, and cross-over conducted on the effect of Vitex on menstrual bleeding, following the PICO (population, intervention, control, and outcomes) criteria without any time limits in December 2017. The participants were women of reproductive age with no gynecologic disorders. The intervention included the use of Vitex in form of tablets, capsule, or oral drops with different doses. The control group included the placebo or mefenamic acid group. The search strategy in this study was in accordance with MeSH terms. The keywords used separately or in combination with other words were Menstrual bleeding OR Menstruation OR Menorrhagia AND Vitexcastus OR Vitex OR Chasteberry AND randomized controlled trial OR randomized trial OR randomized clinical trial OR randomized controlled. All papers, including Persian or English, were searched for in the databases; Medline (through PubMed), Scopus, Embase (through Ovid), Cochrane Library, Web of Sciences, Google Scholar, SID, Magiran, Irandoc, and Iranmedex, without any time limits. Two authors independently reviewed the quality of the papers and assessed the risk of bias based on Cochrane handbook, and the disputes were resolved through discussion and consensus with a third person. The meta-analysis was done on continuous data (mean of menstrual bleeding). In meta-analysis, subgroup analysis was performed based on the type of comparison group. Results Out of the 8,905 searched papers in the databases, 8,905 titles, 720 abstracts, 85 full texts, and 20 references of the papers were reviewed, of which 5 papers entered this study. Based on the subgroup analysis, the consumption of Vitex did not have a significant effect on the amount of menstrual bleeding compared to the placebo group in the first (mean difference [MD]: 3.08; 95% CI: -3.11-9.26; p=0.33; I2=0%) and second menstrual cycles (MD: 0.00; 95% CI: -5.75-5.75; p=1.00; I2=0%). Also, the Higham mean score was statistically more in the Vitex group compared to the mefenamic acid group in the first menstrual cycle (MD: 7.17; 95% CI: 0.33-14.01; p=0.04; I2=0%) but there was no statistical significant difference between Vitex and mefenamic acid groups in the second menstrual cycle (MD: 12.18; 95% CI: -5.57-29.94; p=0.18; I2=75%). Only nausea and abdominal pain were reported as side effects of Vitex in the included studies. Conclusions The results of this study showed that the consumption of Vitex in the intervention group did not have a significant effect on menstrual bleeding in comparison with the placebo group. However, due to the relatively low quality of the papers, it is essential to perform clinical trials with an appropriate design to determine the effect of Vitex on menstrual bleeding.

Biochemical and Histopathological Evidence for Beneficial Effects of Pelargonium graveolens Essential Oil on the Rat Model of Inflammatory Bowel Disease

Background and objectivesPelargonium graveolens L'Her. is an essential oil bearing plant used in traditional medicine of Iran for the treatment of inflammatory disease and pain, anxiety, sadness and also for the relief of gastrointestinal symptoms. Its pharmaceutical product is presently used in Iran for the treatment of depression disorders. Since colitis is a brain-gut interactive disorder, the authors were prompted to investigate the preventive effect of P. graveolens essential oil product (Deproherb®) to control the induced inflammatory bowel disease (IBD) in rats.MethodsExperimentally ulcerative colitis was induced by acetic acid in animals pretreated with three different doses of Deproherb® (100, 200 and 400 mg/kg, p.o.) for five consecutive days. Anti-inflammatory effects of Deproherb® were compared with orally administrated sulfasalazine (4 mg/kg). Biochemical [Myeloperoxidase (MPO) activity] and macroscopic and microscopic examinations of the colon was performed. Deproherb® was also analyzed by GC and GC/MS in order to identify the potentially responsible compounds for observed property.ResultsThe obtained results indicated that the activity of MPO increased in acetic acid-treated groups, while it was recovered by pretreatment with Deproherb® (100-400 mg/kg) and sulfasalazine. All doses of Deproherb® and sulfasalazine-treated groups showed significant lower score values of macroscopic and microscopic characters when compared to the acetic acid-treated group. It was concluded that Deproherb® inhibited the acetic acid toxic reactions in the rat bowel.ConclusionsThe present study proved the anti-inflammatory potential of Deproherb® Oral Drop, in the experimentally induced colitis. Proper clinical investigations are suggested to confirm the observed activities in human.

Non-inferiority double-blind randomised controlled trial comparing gabapentin versus tramadol for the treatment of chronic neuropathic or mixed pain in children and adolescents: the GABA-1 trial—a study protocol

IntroductionGabapentin is currently used ‘off-label’ in children and adolescents with chronic neuropathic pain, and reliable evidence of its effects and optimal dosing are lacking.ObjectivesThe GABA-1 trial aims to compare the...

Oral Cannabidiol Use in Children With Autism Spectrum Disorder to Treat Related Symptoms and Co-morbidities.

Objective: Children with autism spectrum disorder (ASD) commonly exhibit comorbid symptoms such as aggression, hyperactivity and anxiety. Several studies are being conducted worldwide on cannabidiol use in ASD; however, these studies are still ongoing, and data on the effects of its use is very limited. In this study we aimed to report the experience of parents who administer, under supervision, oral cannabinoids to their children with ASD.Methods: After obtaining a license from the Israeli Ministry of Health, parents of children with ASD were instructed by a nurse practitioner how to administer oral drops of cannabidiol oil. Information on comorbid symptoms and safety was prospectively recorded biweekly during follow-up interviews. An independent group of specialists analyzed these data for changes in ASD symptoms and drug safety.Results: 53 children at a median age of 11 (4–22) year received cannabidiol for a median duration of 66 days (30–588). Self-injury and rage attacks (n = 34) improved in 67.6% and worsened in 8.8%. Hyperactivity symptoms (n = 38) improved in 68.4%, did not change in 28.9% and worsened in 2.6%. Sleep problems (n = 21) improved in 71.4% and worsened in 4.7%. Anxiety (n = 17) improved in 47.1% and worsened in 23.5%. Adverse effects, mostly somnolence and change in appetite were mild.Conclusion: Parents’ reports suggest that cannabidiol may improve ASD comorbidity symptoms; however, the long-term effects should be evaluated in large scale studies.

Clinical application of seven-item Eustachian Tube Dysfunction Questionnaire

Objective: To investigate the clinical value of the seven-item Eustachian Tube Dysfunction Questionnaire(ETDQ-7) in evaluating Eustachian tube dysfunction before and after treatment.Method: A retrospective analysis of 50 patients with Eustachian tube dysfunction diagnosed. All the patients were given chymotrypsin 4 000 IU and dexamethasone injection 5 mg by blowing through the Eustachian tube under nasal endoscopic guidance once daily for 3-6 consecutive days. At the same time, azelastine hydrochloride nasal spray and budesonide nasal spray were applied, 2 sprays each time, 2 times a day; oral Olongma drops, 3 ml each time, 3 times a day. ETDQ-7 was completed before and after treatment, and the results of ear endoscopy, pure tone audiometry, acoustic impedance test, and Eustachian tube function test were analyzed comprehensively. Result: The ETDQ-7 score(15.6±7.1) after treatment was significantly higher than that before treatment(23.1±6.5) points (P<0.05), and the difference was statistically significant. After treatment, all patients felt that aural fullness, tinnitus or discomfort, hearing loss and other symptoms were relieved. The tympanic membrane was observed to be better than before treatment. The tympanic effusion and tympanic membrane invagination were improved, which was in line with the change of ETDQ-7 score. Conclusion: ETDQ-7 has a good clinical value in the evaluation of Eustachian tube dysfunction before and after treatment. It is a reproducible and effective method for evaluating Eustachian tube dysfunction(ETD).

Current Safety Data of the Complex Herbal Medicine with Sedative and Cardioprotective Actions

Background. The risk management plan is the one of main documents of pharmacovigilance system – a document focuses on the planning of pharmacovigilance activities and minimization of risks. As the use of herbal medicines has increased, so too have the reports of suspected toxicity and adverse events. As many herbal products on the market have not been thoroughly tested for their pharmacology and toxicology, pharmacovigilance has paramount importance in detecting unwanted reactions. One of the herbal preparations widely used to support the cardiovascular system under stress, neurocirculatory dystonia, cardiac neurosis, in the complex treatment of arterial hypertension, angina pectoris, arrhythmia is a complex medicinal product Carvelis, oral drops, solution. The active pharmaceutical ingredients of the drug are: extract from a mixture of hawthorn leaves, flowers and fruit (Сrataegi folii cum flore, fructus extractum); herb extract of canine nettle (Leonuri herbae extractum); melissae herbia extract Melissae herbae extractum); valerian root extract (Valerianae radix extractum). Objective. Сritical analysis of current scientific data on the benefit/risk ratio of a complex herbal medicine with sedative and cardioprotective effects. Results. Pathophysiological and epidemiological characteristic of following nosological forms have been analyzed: stress, neurocirculatory dystonia, cardiac neurosis, arterial hypertension, angina pectoris, arrhythmia. Current data on phytopreparation safety and estimation benefit/risk ratio have been generalized. Available clinical data were analyzed for individual phytocomponents or its combinations. Conclusions. The prevalence, seriousness and severity of the course of all manifestations of neurocirculatory dystonia, stress, nervous excitement, heart neurosis, especially with disproportionate approaches to the treatment of these diseases, is a serious medical and social problem. Given the proven efficacy of the use of Carvelis preparation components, and also that the risks are predictable, and their occurrence can be countered, and if they occur it can be effectively suppress with other drugs, the benefit of using the phytopreparation prevails above the risks.

Analysis of assortment and availability indicators of spasmolytic drugs for gastrointestinal tract functional disorders in Ukraine

Gastrointestinal tract (GIT) functional disorders are one of the most urgent problems in modern gastroenterology, which is due to the widespread nature of this pathology and the problems associated with it. They form a group of heterogeneous (different in nature and origin) clinical states, manifested by various symptoms and disorders of gastrointestinal tract functions, and are not accompanied by structural, metabolic or systemic changes. According to the results of numerous epidemiological studies, up to 50-60 % of adults and up to 30-40 % of children who apply to gastroenterologists suffer from various functional disorders in the digestive system. The World Health Organization (WHO) states: over the past 60 years, the incidence of these disorders has increased 24-fold. Aim. To analyze the range, prices and availability indicator Ca.s. of anesthetic drugs in Ukraine during 2014-2016, and to determine the dynamics of these characteristics for the study period. Results. In 2016 there were 9 INN on the Ukrainian pharmaceutical market , 69 trade names (TN) of drugs were detected. The structural analysis of antispasmodics assortment (2016) showed the largest TN assortment is characteristic of INN: Drotaverin – 30 TN; Simethicone – 16 TN; Papaverine – 10 TN. Medicines are presented on the market in a wide assortment and in an affordable price range, which enables the physician to choose a drug based on its effectiveness and safety. Spasmolytics are presented in a variety of forms: tablets, capsules, syrups, rectal suppositories, oral drops (in the form of emulsions), and solutions / suspensions for the preparation of injections. The most common form of release in this pharmacological group is the pill. In the process of analysis the antispasmodics drugs assortment during the period of 2014-2016, a tendency was observed in the decreased number of foreign manufactured medicines, but there was a slight increase in domestic drug production. By the indicator of economic availability, most generic drugs used for treatment functional disorders in gastrointestinal tract, are highly available. In most cases, imported medicines are in average availability. Conclusions. During the three years studies, the number of domestic generic drugs increased, which are more accessible to Ukrainian consumers, and the number of imported medicines is slightly decreased. The range of prices varied from low to high, and this gave the opportunity to individually choose drugs based on the active ingredients, dosage forms and prices. It ranged from 4.35 to 266.31 UAH, and within the limits of one INN Drotaverin. The study of antispasmodic drugs availability allowed us to establish the vast majority of SLS is represented by highly available medicines, and only some of the INNs are mediated by spasmolytic action medications of mebeverine, drotaverin and pinaverium bromide.

S41. SHORT- AND LONG-TERM OUTCOMES OF VITAMIN D SUPPLEMENTATION IN CLOZAPINE TREATED CHRONIC SCHIZOPHRENIA PATIENTS

BackgroundVitamin D deficiency is highly prevalent in patients with psychosis. While accumulating data suggests that vitamin D deficiency may be involved in the clinical and metabolic outcomes of schizophrenia, there are no vitamin D supplementation studies in this context. Objective: To assess the short- and long-term impact of vitamin D supplementation on psychiatric and metabolic status in chronic clozapine-treated schizophrenia patients.MethodsFollowing a first phase of eight-week, randomized, double blind, placebo-controlled clinical trial, in which schizophrenia patients who had been maintained on clozapine treatment for at least 18 weeks with total PANSS scores >70 and with low levels of vitamin D (<75 nmol/L) were recruited, a second phase, post-RCT, was performed. In the RCT patients were randomly allocated to either weekly oral drops of vitamin D (14,000 IU) or placebo and subsequently assessed at two-week intervals regarding psychosis severity, mood, cognition and metabolic status. In the post-RCt phase, all participants were assessed at 24 weeks’ time point, while being prescribed 800 IU vitamin D daily supplementation in an open-label design.ResultsTwenty-four patients were randomly assigned to vitamin D and the other 23 patients to the placebo arm. No between-group differences were found in baseline measures. After eight weeks, the vitamin D group had higher increase in vitamin D levels (31.4 vs -0.4 nM, p<0.0001). There was no significant effect of vitamin D on PANSS score, depression or metabolic parameters. The vitamin D group, however, showed a positive small effect on cognitive function (effect size=0.17). On the long-term follow up, 37 patients completed the 24-week assessment. Mean vitamin D levels did not change from baseline (57.56 nM to 57.28 nM) and no association was found between this change and the changes in psychiatric, metabolic and cognitive measures. The only significant inverse association was found between vitamin D levels and HDL (p=0.007).DiscussionThis is the first study to assess the outcomes of vitamin D as an adjunct to clozapine in chronic schizophrenia patients, in the short and long term. The increase in vitamin D levels on the short-term was associated with a small positive effect on cognition, without any effect on psychosis, mood or metabolic status. There were no significant effects of vitamin D supplementation on the assessed measures in the long-term either.

Authorised medicinal product Aspecton® Oral Drops containing thyme extract KMTv24497 shows antiviral activity against viruses which cause respiratory infections

The common cold is a respiratory disease often caused by viral pathogens, including a major group of human rhinoviruses (HRV). Currently, there is no specific antiviral approach available against these viruses. Another viral pathogen that causes respiratory diseases is the influenza virus (IV). Even though a few approved drugs are available for antiviral treatment against IV, these are prone to lose their effectiveness due to the rapid emergence of resistant virus variants. Therefore, new effective approaches characterised by a broad antiviral activity and wide availability would be very advantageous. In this study the authors aimed to investigate the antiviral potential of an authorised medicinal product (Aspecton® Oral Drops) containing a specific thyme extract (KMTv24497) against human rhinovirus serotype 1a (HRV1a), as well as against an influenza A virus isolate of the 2009 pandemic (H1N1pdm09) at non-toxic concentrations. To the best of the authors knowledge, they were able to demonstrate, for the first time, the in vitro antiviral activity of a thyme extract containing an authorised medicinal product in non-toxic concentrations against an HRV, as well as against an influenza A virus strain in cell culture. This study represents a first approach to prove a causal therapeutic effect in addition to the already described symptomatic effects for a thyme preparation. Patients with common cold infections may profit from the additional causal therapeutic effects of an expectorant.

Preparation and evaluation of carfentanil nasal spray employing cyclodextrin inclusion technology

Carfentanil (CFTN), a derivative of fentanyl, is highly effective as an analgesic, but its relatively poor solubility in water has limited its nasal application. The objective of this study was to develop the new CFTN-CD inclusion technology to increase the solubility of CFTN. The inclusion compound CFTN–DM-β-CD was prepared by the ultrasonic method and characterized using X-ray powder diffraction and morphological shapes analysis (the scanning electron microscopy). The in vitro dissolution profiles of CFTN–DM-β-CD were assessed in hydrochloric acid and phosphate buffer. Nasal ciliotoxicity studies were carried out using isolated toad palate. Rats were treated with CFTN–DM-β-CD (250 µg/kg) by intravenous, intramuscular injection, oral, or nasal drops. The results showed that CFTN was successfully enveloped by DM-β-CD. The in vitro cumulative dissolution of CFTN–DM-β-CD was obviously enhanced compared to free CFTN in two buffers. Nasal ciliotoxicity studies have shown that the CFTN–DM-β-CD does not exhibit higher nasal ciliotoxicity than that of free CFTN. Pharmacokinetic studies demonstrated that CFTN–DM-β-CD by nasal administration was absorbed more rapidly and has higher Cmax and bioavailability than that of either intramuscular injection or oral administration. In conclusion, the CFTN–DM-β-CD nasal spray was shown to be a relatively safe dosage form for the rapid and effective intranasal delivery of CFTN.

Effect of Vitamin D Supplementation on Intracytoplasmic Sperm Injection Outcomes: A Randomized Double-Blinded Placebo-Controlled Trial

OBJECTIVE: To assess the effect of vitamin D supplementation on enhancement of embryos implantation rates in intracytoplasmic sperm injection procedures. STUDY DESIGN: A randomized double-blinded controlled trial. SETTING: Assisted Reproduction Unit of Obstetrics and Gynecology Department, Faculty of Medicine, South Valley University, Egypt. DURATION: From December 1st 2017 to the end of October 2018. SUBJECTS and METHDS: Eighty infertile couples that underwent ICSI procedure were entrapped in this study. Patients were divided into two groups; Group I (Vitamin D group) = 40 patients (received vitamin D supplementation in the form of Vidrop oral drops 600 IU/day starting after ovum pickup) and Group II (placebo group) = 40 patients (received a placebo “normal saline oral drop”). RESULTS: There was a significantly increased embryo implantation rates (53.2% in vitamin D group versus 46.7% in placebo group), there was a mild statistically significant difference in the clinical pregnancy rates (45.9% in vitamin D group versus 39.4% in placebo group) with p-value CONCLUSIONS: Vitamin D supplementation could improve embryos implantation rates and rate of ongoing pregnancy by decline in the first trimester miscarriage rate.

Comparing the effect of rose drop, ginger, and cinnamon on sexual function in depressed women with sexual dysfunction

Background: Sexual dysfunction is caused by multiple anatomical, physiological, medical, and psychological factors. Many studies have shown the efficacy of herbal remedies on increasing libido and sexual function. This study aimed to evaluate and compare the effects of three herbs of ginger, cinnamon, and rose on sexual function of depressed women with low sex drive. Materials and Methods: This randomized double-blinded clinical trial was conducted on 140 depressed women with sexual dysfunction who were divided into four groups receiving oral drops of rose, ginger, cinnamon, or placebo. The information about the two variables of sexual function and depression were collected by Female Sexual Function inventory questionnaire and Beck Depression Inventory, respectively. Data were analyzed using Chi-square, Wilcoxon signed-rank test, Kruskal–Wallis test, and Pearson correlation coefficient. Results: The mean scores of sexual dysfunction and depression were significantly improved in the three groups after treatment (P 0.05). The factors such as received treatments with impact factor of 0.723 and age with impact factor of 0.170 had direct relation and depression with impact factor of −0.078 had reverse relation to sexual performance improvement (P Abbreviations Used: FSFI: Female sexual function inventory, BDI: Beck depression inventory, Spss: Statistical package for social science.

Vitamin D Supplementation in Chronic Schizophrenia Patients Treated with Clozapine: A Randomized, Double-Blind, Placebo-controlled Clinical Trial

BackgroundWhile accumulating evidence suggests that vitamin D deficiency may be involved in the risk to develop schizophrenia and its outcome, there are no studies on vitamin D supplementation in this context. We sought to assess the effect of vitamin D supplementation on psychiatric, cognitive and metabolic parameters in chronic clozapine-treated schizophrenia patients. MethodsThis eight-week, randomized, double-blind, placebo-controlled clinical trial, recruited schizophrenia patients who had been maintained on clozapine treatment for at least 18weeks and had low levels of vitamin D (<75nmol/l) and total PANSS scores >70 (to ascertain the presence of residual symptoms). Patients were randomly allocated to either weekly oral drops of vitamin D (14,000IU) or placebo and subsequently assessed at two-week intervals for psychosis severity, mood, cognition and metabolic profile. ResultsTwenty four patients were randomly assigned to vitamin D (aged 39.4±9.6years, 75% males) and the other 23 patients to the placebo arm (aged 42.5±11.2years, 60.9% males). After eight weeks, the vitamin D group exhibited a significant increase in vitamin D levels (31.4 vs −0.4nmol/l, p<0.0001). There was no significant effect of vitamin D on psychotic, depressive or metabolic parameters. However, in the vitamin D group, there was a trend towards improved cognition (effect size=0.17, significance lost following Bonferroni correction). ConclusionsVitamin D supplementation was associated with a trend towards improved cognition, but did not affect psychosis, mood or metabolic status. It is possible that the robust decrease in the PANSS scores in both groups may have obscured an effect of vitamin D supplementation.

Short-Term Vitamin D3 Supplementation in Children with Neurodisabilities: Comparison of Two Delivery Methods

Background/Aims: Vitamin D deficiency is common in children with neurodisabilities. Oral vitamin D₃ may not be absorbed appropriately due to dysphagia and tube feeding. The aim of this study was to compare efficacy of vitamin D₃ buccal spray with that of oral drops. Methods: Twenty-four children with neurodisabilities (5–17 years) and vitamin D deficiency (25(OH)D ≤20 ng/mL) were randomized to receive vitamin D₃ buccal spray 800 IU/daily (n = 12) or oral drops 750 IU/daily (n = 12) for 3 months during winter. Results: Both groups had a significant increase in 25(OH)D (z = 150; p < 0.0001). The differences between baseline and final parathyroid hormone measurements did not reach significance in both groups. Markers of bone formation and resorption did not change significantly in both groups. The satisfaction with the formulation was significantly higher in the patients using spray. Conclusion: Vitamin D₃ supplementation with buccal spray and oral drops are equally effective in short-term treatment of vitamin D deficiency in children with neurodisabilities. Buccal spray may be more acceptable by the patients.

Effect of Probiotics on Infantile Colic Using the Quadratic Inference Functions

Background: Infantile colic is defined as episodes of extreme and excessive crying due to unknown causes. Various results have been reported regarding the management of colic with probiotics in terms of effectiveness, with no side effects or health risks in the infants. The present study aimed to evaluate the effect of probiotics on the infants with colic using the quadratic inference functions (QIF).Methods: This single-blind, randomized, clinical trial was conducted on 98 infants admitted to the pediatric gastroenterology clinic of Bu Ali Sina Hospital in Sari, Iran. The neonates were diagnosed with infantile colic by a pediatric gastroenterologist. Patients were randomly divided into two groups (49 subjects per each). In the control group, the infants received placebo, and in the case group, the neonates were administrated with BioGaia probiotic oral drops for 21 days. The QIF method was fitted to analyze the influential factors in the improvement of infantile colic.Results: According to the QIF results in data analysis, mean duration of crying had a significant difference between the infants in the case and control groups (P<0.001). Moreover, time (first, second, and third week) was determined as a leading variable in the improvement of infantile colic (P=0.001).Conclusion: According to the results of longitudinal data analysis, use of probiotics in the evolving gut could reduce infantile colic and improve the quality of life in the studied neonates

Antibacterial Activity of Anti-Aphthous Spray and Oral Drop: Two Thymus Commercial Products

Background: Today, traditional medicine is developed globally as an important source for health care of the world's population. The current study describes the antibacterial activity of thymus commercial products against both Gram-positive including Staphylococcus aureus, Streptococcus pyogenes and Gram-negative bacteria including Escherichia coli, Pseudomonas aeruginosa. Methods: Two commercial products of thymus with standard expiration date (and in three different batch numbers) including anti-aphthous spray and oral drop were purchased from the pharmacies of Tabriz city. Minimum Inhibitory Concentration (MIC) and disk diffusion are used to investigate the antibacterial efficiency of the mentioned products. Results: The results of disk diffusion method showed zones of growth inhibition against S. aureus and S. pyogenes for the investigated products. Based on MICs, thymus oral drop had inhibitory effects against S. aureus, S. pyogenes while anti-aphthous spray showed inhibitory effects against S. aureus, S. pyogenes and P. aeruginosa. The findings also indicated that the thymus anti-aphthous spray had more inhibitory effects than thymus oral drop. Conclusion: This study showed that thymus can be used as an optimistic antibacterial agent against the selected microorganisms.