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Journal of Cosmetic Dermatology Feb 2024Topical minoxidil (MNX) 2%-5% and oral finasteride (F) 1 mg/day are the only two pharmacological treatments authorized for androgenetic alopecia (AGA). Recently, a... (Randomized Controlled Trial)
Randomized Controlled Trial
Efficacy of the association of topical minoxidil and topical finasteride compared to their use in monotherapy in men with androgenetic alopecia: A prospective, randomized, controlled, assessor blinded, 3-arm, pilot trial.
PURPOSE
Topical minoxidil (MNX) 2%-5% and oral finasteride (F) 1 mg/day are the only two pharmacological treatments authorized for androgenetic alopecia (AGA). Recently, a 2.2 mg/mL topical formulation of F was developed to minimize the systemic adverse effects associated with the oral formula. MNX and F act through different mechanisms; therefore, their association could improve clinical efficacy. To evaluate the efficacy of the association of 5% MNX and 0.25% topical F compared to their use in monotherapy, a 6-month, prospective, randomized, assessor-blinded trial was conducted.
PATIENTS AND METHODS
Forty-two males, mean age 24 ± 3 years, with AGA (I-VII of Norwood-Hamilton Grading Scale), treatment naive or free from any therapy for at least 6 months, were enrolled and randomly assigned to three arm treatment groups (2:1:1): group A (n = 19, the subjects applied 5% MNX in the morning and F spray in the evening), group B (n = 12, the subjects applied F spray in the evening), and group C (n = 11, the subjects applied 5% MNX twice daily). The efficacy of treatments was evaluated at baseline and after 3 and 6 months using a global photography score (GPAS; from -3 to +3) and trichoscopy evaluation and assessed by an investigator unaware of treatment allocation. At baseline and after treatments, the serum levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), dehydroepiandrosterone sulfate (DHEA-S), and testosterone were also evaluated.
RESULTS
All treatments resulted in an increase in hair density compared to baseline. However, this improvement was significant only for group A (MNX + F), both at three (+56 density/cm , p < 0.05) and six (+81 density/cm , p < 0.001) months. The mean change from baseline in hair density was higher for group A compared to other groups and statistically different compared to group B (F) (p < 0.01), both after 3 and 6 months. Group A showed a global photographic assessment score (GPAS) significantly higher compared to group B (p < 0.001) and group C (p < 0.05) both at 3 and 6 months (2.0 ± 0.7 vs. 0.6 ± 0.8 and 1.3 ± 0.6; respectively). A significantly greater percentage of subjects in Group A achieved a GPAS score of ≥2 in comparison with Groups B and C both after 3 and 6 months (79% vs. 8% and 41%, respectively). No significant differences were observed in mean hair diameter and hormonal levels between the three groups. Good tolerability was observed in all treated groups.
CONCLUSION
The association of 5% MNX lotion and 0.25% F in spray formulation in patients with AGA showed a significantly higher clinical and instrumental efficacy compared to the monotherapies, with comparable tolerability and safety profile.
Topics: Male; Humans; Young Adult; Adult; Minoxidil; Finasteride; Prospective Studies; Pilot Projects; Alopecia; Treatment Outcome; Double-Blind Method
PubMed: 37798906
DOI: 10.1111/jocd.15953 -
Journal of Ethnopharmacology Dec 2023Berberis aristata (BA) has been described in Ayurveda in formulations for treating conditions related to the buccal cavity, including tumours and inflammation. Oral...
Buccal spray of standardized Berberis aristata extract causes tumour regression, chemoprotection and downregulation of inflammatory mediators in oral cancer hamster model.
ETHNOPHARMACOLOGICAL RELEVANCE
Berberis aristata (BA) has been described in Ayurveda in formulations for treating conditions related to the buccal cavity, including tumours and inflammation. Oral cancer (OC) is a major global health problem with high rates of recurrence and metastasis. Natural product based therapies are being explored as safer therapeutic strategies for OC.
AIM OF THE STUDY
Evaluating the potential of standardized BA extract loaded buccal spray formulation in OC.
MATERIAL AND METHODS
BA stem bark extract was prepared using sonication and standardized with respect to Berberine. The standardized extract was characterized and formulated as a buccal spray (SBAE-BS) using hydroxyl propyl methyl cellulose K15M, polyethylglycol 400, Miglyol®812N and ethanol. The SBAE-BS was characterized and evaluated in vitro in KB cell line and in vivo in OC hamster model.
RESULTS
The SBAE-BS had pH, viscosity, mucoadhesive strength and BBR content corresponding to 6.8, 25.9 cP, 345 dyne/cm2 and 0.6 mg/mL respectively. In vitro cytotoxicity of SBAE-BS was comparable to 5 fluorouracil (5FU). In hamsters, SBAE-BS treatment lead to tumour regression (p = 0.0345), improved body weights (p < 0.0001), no organ toxicity, downregulation of inflammatory mediators and improved survival outcomes as compared to standard systemic 5FU.
CONCLUSION
Thus, SBAE-BS showed cytotoxic and chemo-protective effects in the OC hamster model, evidencing its ethnopharmacological use and demonstrating translational potential to be developed as therapy for OC.
Topics: Humans; Cricetinae; Plant Extracts; Berberis; Down-Regulation; Mouth Neoplasms; Fluorouracil
PubMed: 37315644
DOI: 10.1016/j.jep.2023.116732 -
Sleep Medicine Apr 2024Pediatric obstructive sleep apnea (OSA) is a common disease that can have significant negative impacts on a child's health and development. A comprehensive evaluation of... (Meta-Analysis)
Meta-Analysis Review
IMPORTANCE
Pediatric obstructive sleep apnea (OSA) is a common disease that can have significant negative impacts on a child's health and development. A comprehensive evaluation of different pharmacologic interventions for the treatment of OSA in children is still lacking.
OBJECTIVE
This study aims to conduct a comprehensive systematic review and network meta-analysis of pharmacological interventions for the management of obstructive sleep apnea in pediatric population.
DATA SOURCES
PubMed, Web of Science, Embase, The Cochrane Library, and CNKI were searched from 1950 to November 2022 for pediatric OSA.
STUDY SELECTION
Multiple reviewers included Randomized controlled trials (RCTs) concerning drugs on OSA in children.
DATA EXTRACTION AND SYNTHESIS
Multiple observers followed the guidance of the PRISMA NMA statement for data extraction and evaluation. Bayesian network meta-analyses(fixed-effect model) were performed to compare the weighted mean difference (WMD), logarithmic odds ratios (log OR), and the surface under the cumulative ranking curves (SUCRA) of the included pharmacological interventions. Our protocol was registered in PROSPERO website (CRD42022377839).
MAIN OUTCOME(S) AND MEASURE(S)
The primary outcomes were improvements in the apnea/hypopnea index (AHI), while secondary outcomes included adverse events and the lowest arterial oxygen saturation (SaO2).
RESULTS
17 RCTs with a total of 1367 children with OSA aged 2-14 years that met the inclusion criteria were eventually included in our systematic review and network meta-analysis. Ten drugs were finally included in the study. The results revealed that Mometasone + Montelukast (WMD-4.74[95%CrIs -7.50 to -2.11], Budesonide (-3.45[-6.86 to -0.15], and Montelukast(-3.41[-5.45 to -1.39] exhibited significantly superior therapeutic effects compared to the placebo concerning apnea hypopnea index (AHI) value with 95%CrIs excluding no effect. Moreover, Mometasone + Montelukast achieved exceptionally high SUCRA values for both AHI (85.0 %) and SaO2 (91.0 %).
CONCLUSIONS AND RELEVANCE
The combination of mometasone furoate nasal spray and oral montelukast sodium exhibits the highest probability of being the most effective intervention. Further research is needed to investigate the long-term efficacy and safety profiles of these interventions in pediatric patients with OSA.
Topics: Child; Humans; Network Meta-Analysis; Acetates; Sleep Apnea, Obstructive; Mometasone Furoate; Cyclopropanes; Quinolines; Sulfides
PubMed: 38460418
DOI: 10.1016/j.sleep.2024.01.030 -
Antioxidants (Basel, Switzerland) Jul 2023leaves have gained notoriety over the past years due to their rich bioactive composition with human pro-healthy effects, particularly in relation to antioxidants....
leaves have gained notoriety over the past years due to their rich bioactive composition with human pro-healthy effects, particularly in relation to antioxidants. Nevertheless, antioxidants are well known for their chemical instability, making it necessary to develop suitable delivery systems, such as microparticles, to provide protection and ensure a controlled release. The aim of this work was to produce polymeric particles of leaves extract by spray-drying that may improve the oral mucositis condition. Microparticles were characterized by size, shape, antioxidant/antiradical activities, swelling capacity, moisture content, and effect on oral cells (TR146 and HSC-3) viability, with the aim to assess their potential application in this oral condition. The results attested the microparticles' spherical morphology and production yields of 41.43% and 36.40%, respectively, for empty and leaves extract microparticles. The leaves extract microparticles obtained the highest phenolic content (19.29 mg GAE/g) and antioxidant/antiradical activities (FRAP = 81.72 µmol FSE/g; DPPH = 4.90 mg TE/g), being perceived as an increase in moisture content and swelling capacity. No differences were observed between empty and loaded microparticles through FTIR analysis. Furthermore, the exposure to HSC-3 and TR146 did not lead to a viability decrease, attesting their safety for oral administration. Overall, these results highlight the significant potential of leaves extract microparticles for applications in the pharmaceutical and nutraceutical industries.
PubMed: 37627491
DOI: 10.3390/antiox12081496 -
Environmental Pollution (Barking, Essex... Feb 2024The environmental input of microplastics from personal care products has received significant attention; however, less focus has been paid to oral healthcare products....
The environmental input of microplastics from personal care products has received significant attention; however, less focus has been paid to oral healthcare products. The present study assessed the occurrence of microplastics in commercially available oral healthcare products such as toothbrushes, toothpastes, toothpowder, mouthwash, dental floss, and mouth freshener spray that have a pan-India distribution. The extracted microplastics were quantified and characterised using a microscope and ATR-FTIR. All products showed microplastic contamination, where toothbrushes showed the maximum particles (30-120 particles/brush) and mouth freshener sprays (0.2-3.5 particles/ml) had the least abundance. Fragments, fibres, beads, and films were the various shapes of microplastics observed, where fragments (60%) were dominant. Various colours such as pink, green, blue, yellow, black, and colourless were observed, where colourless (40%) particles were dominant. Microplastics were categorized into three sizes: <0.1 mm (63%), 0.1-0.3 mm (35%), and >0.3 mm (2%). Four major types of polymers, such as polyethylene (52%), polyamide (30%), polyethylene terephthalate (15%), and polybutylene terephthalate (3%), were identified. Risk assessment studies such as Daily Microplastics Emission (DME), Annual Microplastics Exposure (AME), and Polymer Hazard Index (PHI) were carried out. The DME projection for India was the highest for mouthwash (74 billion particles/day) and the least for mouth freshener sprays (0.36 billion particles/day). The AME projection for an individual was the highest in toothbrushes (48,910 particles ind. yr.) and the least in mouth freshener sprays (111 particles ind. yr.). PHI shows that the identified polymers fall under the low-to high-risk categories. This study forecasts the community health risks linked to microplastics in oral healthcare products and suggests mitigation strategies. It has the potential to shape environmental policy development in response.
Topics: Plastics; Microplastics; Environmental Monitoring; Mouthwashes; Water Pollutants, Chemical; Polymers; Polyethylene Terephthalates; Environmental Health
PubMed: 38092338
DOI: 10.1016/j.envpol.2023.123118 -
Scientific Reports May 2024This study aims to investigate the effects of intraoral cold water spray on thirst, frequency of oral care and postoperative period pain at surgical incision site in... (Randomized Controlled Trial)
Randomized Controlled Trial
This study aims to investigate the effects of intraoral cold water spray on thirst, frequency of oral care and postoperative period pain at surgical incision site in patients having abdominal surgery. The study was carried out as a randomized controlled trial, registered under Clinical Trial Number: NCT05940818. The study involved 110 participants, divided equally into two groups (n = 55): the experimental group and the control group. Data were collected using patient information form, NRS, Intensive Care Oral Care Frequency Assessment Scale (ICOCFAS) and Visual Analog Scale (VAS). The severity of thirst at 1st, 8th, 16th h of post-operative period (p < 0.01) and the frequency of oral care application at 16th h were statistically significantly decreased in the experimental group when compared to the control group (p < 0.01).There wasn't statistically significant difference between the patients in the experimental and control groups in terms of pain at surgical incision site (p > 0.05). The patient's thirst and need for frequent oral care in the postoperative period were reduced by the application of a cold water spray. In patients undergoing abdominal surgery, the use of cold water spray application may be recommended to reduce thirst and the need for frequency of oral care application.
Topics: Humans; Thirst; Female; Male; Middle Aged; Intensive Care Units; Pain, Postoperative; Adult; Aged; Oral Hygiene; Cold Temperature; Pain Measurement; Critical Care
PubMed: 38693271
DOI: 10.1038/s41598-024-58199-0 -
Clinical and Experimental Dental... Dec 2023This study explored the changes in bacterial flora composition and total bacterial count in the saliva and tongue coating, along with the change in the tongue coating... (Randomized Controlled Trial)
Randomized Controlled Trial
Changes in oral microflora following 0.3% cetylpyridinium chloride-containing mouth spray intervention in adult volunteers after professional oral care: Randomized clinical study.
OBJECTIVES
This study explored the changes in bacterial flora composition and total bacterial count in the saliva and tongue coating, along with the change in the tongue coating index (TCI) following an intervention with 0.3% cetylpyridinium chloride (CPC) mouth spray after professional oral care.
MATERIALS AND METHODS
Fifty-two adult volunteers aged 30-60 years were equally divided into CPC spray (n = 26) and control (n = 26) groups. All subjects underwent scaling and polishing. The CPC spray group was administered four puffs of CPC spray to the tongue dorsum four times a day for 3 weeks. The control group performed only routine daily oral care (brushing) and did not use any other spray. Bacteriological evaluation of saliva and tongue coating was performed using 16S ribosomal RNA gene sequencing and quantitative polymerase chain reaction. The tongue coating was evaluated to calculate the TCI. A per-protocol analysis was conducted for 44 subjects (CPC spray group, n = 23; control group, n = 21).
RESULTS
At 1 and 3 weeks after CPC spray use, the flora of the saliva and tongue coating changed; the genus Haemophilus was dominant in the CPC spray group, whereas the genus Saccharibacteria was dominant in the control group. The sampling time differed among individual participants, which may have affected the bacterial counts. There was no significant intragroup change in TCI in either group.
CONCLUSIONS
CPC spray affected the bacterial flora in the saliva and tongue coating, particularly with respect to an increase in the abundance of Haemophilus. However, CPC spray did not change the TCI. These results suggest that it may be optimal to combine CPC spray with a physical cleaning method such as using a tongue brush or scraper. Clinical Trial Registration: University Hospital Medical Information Network UMIN000041140.
Topics: Adult; Humans; Cetylpyridinium; Anti-Infective Agents, Local; Mouthwashes; Dental Plaque; Tongue; Double-Blind Method; Volunteers
PubMed: 38041504
DOI: 10.1002/cre2.810 -
Journal of Pain Research 2024Skeletal muscle relaxants (SMRs) are widely used in treating musculoskeletal conditions. All SMRs, with the exception of baclofen and tizanidine, are on the list of 2023... (Review)
Review
BACKGROUND
Skeletal muscle relaxants (SMRs) are widely used in treating musculoskeletal conditions. All SMRs, with the exception of baclofen and tizanidine, are on the list of 2023 American Geriatrics Society Beers Criteria for potentially inappropriate medication use in older adults. In our geriatric practice, off-label use of tizanidine as preemptive analgesia drove us to find recent advances in its pharmacology and therapeutics. An update review of tizanidine was thus presented, aiming to bring the latest knowledge to clinicians and promote further research and practical exploration.
METHODS
Relevant literature up to December 2023 was identified through searches of PubMed, Web of Science, and Embase.
RESULTS
Tizanidine, a centrally acting alpha-2 adrenoceptor agonist with both antispastic and antispasmodic activity, shows efficacy in the common indications for all SMRs. From the perspective of drug safety, tizanidine has lower incidences of adverse events (injury, delirium, encephalopathy, falls, and opioid overdose) compared to baclofen, no association with risk of Alzheimer's disease as with orphenadrine, no risk of serotonin syndrome like metaxalone when comedicated with serotonergic drugs, no significant pharmacokinetic changes in CYP2C19 poor metabolizers unlike diazepam and carisoprodol, and no physically addictive or abuse properties like carisoprodol and diazepam. From the perspective of new and potential therapeutic uses, tizanidine has additional benefits (eg, gastroprotection that can improve patient tolerance to nonsteroidal anti-inflammatory agents, anti-neuropathic pain, a key component of multimodal analgesia strategy to reduce early postoperative pain, and anti-tumor effects). New delivery systems of tizanidine are developing to improve the pharmacokinetics of oral products, including buccal patches, transdermal delivery systems, nasal spray, and in situ rectal gel.
CONCLUSION
Tizanidine is an SMR with unique features and may be an optimal initial choice for older adults. There would be more scientific studies, wider therapeutic applications, and new drug formulations in the future.
PubMed: 38529017
DOI: 10.2147/JPR.S461032 -
Expert Opinion on Pharmacotherapy Apr 2024Gastroparesis is a chronic disorder characterized by decreased gastric emptying and presents with nausea, vomiting, and abdominal pain which impacts patients' quality of... (Review)
Review
INTRODUCTION
Gastroparesis is a chronic disorder characterized by decreased gastric emptying and presents with nausea, vomiting, and abdominal pain which impacts patients' quality of life greatly. The treatment modalities available for gastroparesis have been expanding over the past 2 decades. Currently, there are multiple options available for gastroparesis, albeit with only one FDA-approved medication until June 2021.
AREAS COVERED
We review the different treatments available for gastroparesis and discuss the recently FDA-approved intranasal formulation of metoclopramide. This nasal spray guarantees metoclopramide absorption within 15 min of application bypassing first pass metabolism in the liver and overcoming the limitations of the oral formulation not passing into the small intestine for absorption because of a gastroparetic stomach or a patient unable to take the oral metoclopramide because of nausea and vomiting.
EXPERT OPINION
We now find ourselves in an oasis after spending many years in a 'desert' regarding pharmacologic therapies available for gastroparesis. The expansion of the research involving dopamine receptor antagonists and delving into alternative mechanisms of alleviating gastroparesis symptoms has been crucial in the landscape of gastroparesis. This is especially true as our knowledge of gastroparesis has proven that simply improving gastric emptying does not necessarily translate to clinical improvement.
Topics: Humans; Administration, Intranasal; Dopamine Antagonists; Gastric Emptying; Gastrointestinal Agents; Gastroparesis; Metoclopramide; Quality of Life
PubMed: 38629943
DOI: 10.1080/14656566.2024.2344646 -
Respiratory Research Feb 2024Seasonally circulating viruses, such as Influenza, as well as newly emerging viruses and variants thereof, and waning immunity urge the need for safe, easy-to-use and...
Seasonally circulating viruses, such as Influenza, as well as newly emerging viruses and variants thereof, and waning immunity urge the need for safe, easy-to-use and inexpensive drugs to protect from these challenges. To prevent transmission of these viruses and subsequent excessive inflammatory reactions on mucous membranes, we tested the efficacy of the natural essence P80 as spray and in form of lozenges against respiratory infections caused by SARS-CoV-2 variants of concern (VoCs), influenza A (H3N2) and influenza B (Victoria). P80 natural essence, a Dimocarpus longan extract, shielded highly differentiated human airway epithelia from SARS-CoV-2 wildtype and Omicron variant as well as Influenza A and B infection and dampened inflammation by down-modulating pro-inflammatory cytokine and anaphylatoxin secretion. A single application of P80 natural essence spray maintained tissue integrity long-term. This also significantly reduced the release of infectious viral particles and the secretion of IP10, MCP1, RANTES and C3a, all of which mediate the migration of immune cells to the sites of infection. Even P80 lozenges dissolved in distilled water or non-neutralizing saliva efficiently prevented SARS-CoV-2 and Influenza-induced tissue destruction. Consequently, our in vitro data suggest that P80 natural essence can act as antiviral prophylactic, both in form of nasal or oral spray and in form of lozenges, independent of circulating respiratory challenges.
Topics: Humans; Influenza, Human; Influenza A Virus, H3N2 Subtype; SARS-CoV-2; COVID-19; Inflammation
PubMed: 38419061
DOI: 10.1186/s12931-024-02718-0