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Medicine Mar 2023Acute sore throat (ST) can occur as part of a common cold of viral origin or caused by pharyngeal bacterial pathogens. The majority of patients with acute ST complain of... (Randomized Controlled Trial)
Randomized Controlled Trial
Comparative evaluation of rapidity of action of benzydamine hydrochloride 0.3% oromucosal spray and benzydamine hydrochloride 3 mg lozenges in patients with acute sore throat: A phase IV randomized trial.
BACKGROUND
Acute sore throat (ST) can occur as part of a common cold of viral origin or caused by pharyngeal bacterial pathogens. The majority of patients with acute ST complain of pain on swallowing and dry scratchiness which can have a negative impact on the quality of life (QoL). This study aimed to evaluate the time to pain relief in patients with acute ST, following a single administration of benzydamine hydrochloride (HCl) 0.3% oromucosal spray or benzydamine HCl 3 mg lozenges.
METHODS
This multicenter, randomized, active-controlled, open label, parallel-group, international phase IV study was conducted at 12 investigational centers in Poland, Hungary, and Russian Federation. The study population consisted of 363 adult patients with recent onset (≤3 days) of ST and a diagnosis of tonsillopharyngitis. The primary endpoint was to assess the efficacy of benzydamine HCl in ST pain relief at 2 minutes after a single-dose administration. Secondary endpoints included, among others, the assessment of a first perceived ST relief at 1 minute after a single-dose administration of benzydamine HCl spray or lozenge.
RESULTS
Both the spray and lozenges are effective in providing a ST relief starting already at 2 minutes after a single administration, with an effect lasting up to up to 4 hours. Clinical efficacy after 7 days of treatment and a good safety profile were also demonstrated.
CONCLUSION
Anesthetic and analgesic properties of benzydamine spray and lozenges effectively addressed the patient priority of a rapid relief of symptoms of upper respiratory tract infections (URTI).
Topics: Adult; Humans; Benzydamine; Quality of Life; Common Cold; Pharyngitis; Tablets; Pain; Double-Blind Method
PubMed: 37000110
DOI: 10.1097/MD.0000000000033367 -
PLoS Medicine Jul 2005Postherpetic neuralgia (PHN) is a complication of acute herpes zoster, which is emerging as a preferred clinical trial model for chronic neuropathic pain. Although there... (Review)
Review
BACKGROUND
Postherpetic neuralgia (PHN) is a complication of acute herpes zoster, which is emerging as a preferred clinical trial model for chronic neuropathic pain. Although there are published meta-analyses of analgesic therapy in PHN, and neuropathic pain in general, the evidence base has been substantially enhanced by the recent publication of several major trials. Therefore, we have conducted a systematic review and meta-analysis for both efficacy and adverse events of analgesic therapy for PHN.
METHODS AND FINDINGS
We systematically searched databases (MEDLINE 1966-2004, EMBASE 1988-2004, CINAHL 1982-2002, and PubMed [29 October 2004]) for trials of PHN. We also searched references of retrieved studies and review articles for further trials. We included trials that examined adult patients with PHN of greater duration than 3 mo, that were blinded, randomised, and had at least one measure of pain outcome. Dichotomous pain outcome data were extracted for 50% decrease in baseline pain using a hierarchy of pain/pain-relief measurement tools. Where available, dichotomous data were also collected for adverse events. Calculated estimates of efficacy included relative benefit and number needed to treat. Of 62 studies identified, 35 were randomised controlled trials. Of these, 31 were placebo controlled and suitable for meta-analysis, from which it was possible to extract dichotomous efficacy outcome data from 25. This meta-analysis revealed that there is evidence to support the use of the following orally administered therapies: tricyclic antidepressants, "strong" opioids, gabapentin, tramadol, and pregabalin. Topical therapies associated with efficacy were lidocaine 5% patch and capsaicin. Finally, a single study of spinal intrathecal administration of lidocaine and methyl prednisolone demonstrated efficacy, although this has yet to be replicated. Data suggest that the following therapies are not associated with efficacy in PHN: certain NMDA receptor antagonists (e.g., oral memantine, oral dextromethorphan, intravenous ketamine), codeine, ibuprofen, lorazepam, certain 5HT1 receptor agonists, and acyclovir. Topical administration of benzydamine, diclofenac/diethyl ether, and vincristine (iontophoresis) are similarly not associated with efficacy, nor are intrathecal administration of lidocaine alone or epidural administration of lidocaine and methylprednisolone, intravenous therapy with lidocaine, subcutaneous injection of Cronassial, or acupuncture. However, many of the trials that demonstrated a lack of efficacy represented comparatively low numbers of patient episodes or were single-dose studies, so it may be appropriate to regard such interventions as "not yet adequately tested" rather than demonstrating "no evidence of efficacy." Topical aspirin/diethyl ether has not been adequately tested.
CONCLUSION
The evidence base supports the oral use of tricyclic antidepressants, certain opioids, and gabapentinoids in PHN. Topical therapy with lidocaine patches and capsaicin is similarly supported. Intrathecal administration of methylprednisolone appears to be associated with high efficacy, but its safety requires further evaluation.
Topics: Analgesics; Antidepressive Agents; Antidepressive Agents, Tricyclic; Clinical Trials as Topic; Herpes Zoster; Humans; Lidocaine; Methylprednisolone; Narcotics; Neuralgia; Receptors, N-Methyl-D-Aspartate; Time Factors
PubMed: 16013891
DOI: 10.1371/journal.pmed.0020164 -
ACS Omega Nov 2023Aqueous solubility of pharmaceutical substances plays an important role in small molecule drug discovery and development, with ionizable groups often employed to enhance...
Aqueous solubility of pharmaceutical substances plays an important role in small molecule drug discovery and development, with ionizable groups often employed to enhance solubility. Drug candidate compounds often contain ionizable groups to increase their solubility. Recognizing that the electrostatically charged form of the compound is much more soluble than the uncharged form, this work proposes a model to explore the relationship between the p shift of the ionizable group and dissolution equilibria. The model considers three forms of a compound: dissolved-charged, dissolved-uncharged, and aggregated-uncharged. It analyzes two linked equilibria: the protonation of the ionizable group and the dissolution-aggregation of the uncharged form, with the observed p shift depending on the total concentration of the compound. The active concentration of the aggregates determines this shift. The model was explored through the determination of the p shift and intrinsic solubility of specific compounds, such as ICPD47, a high-affinity inhibitor of the Hsp90 chaperone protein and anticancer target, as well as benzoic acid and benzydamine. The model holds the potential for a more nuanced understanding of intrinsic solubility and may lead to advancements in drug discovery and development.
PubMed: 38046347
DOI: 10.1021/acsomega.3c04071 -
Anaesthesia Nov 1985
Topics: Benzydamine; Herpes Zoster; Humans; Neuralgia; Pyrazoles
PubMed: 4073436
DOI: 10.1111/j.1365-2044.1985.tb10627.x -
Interventions for the physical aspects of sexual dysfunction in women following pelvic radiotherapy.The Cochrane Database of Systematic... 2003Following pelvic radiotherapy (RT), a proportion of women experience problems related to sexual function, which are multifactorial in origin. The physical components... (Review)
Review
BACKGROUND
Following pelvic radiotherapy (RT), a proportion of women experience problems related to sexual function, which are multifactorial in origin. The physical components relate to distortion of the perineum and vagina, which may occur as a result of surgery and/or radiotherapy and compromise sexual activity resulting in considerable distress.
OBJECTIVES
The aim of this review was to evaluate the evidence for treatment options addressing the physical components of sexual dysfunction arising from pelvic radiotherapy as prevention or treatment of acute or late complications.
SEARCH STRATEGY
The concepts used included synonyms for radiation therapy and brachytherapy and synonyms for the spectrum of physical aspects of sexual dysfunction in women. randomized. We searched the Cochrane Controlled Trials Register (CENTRAL), issue 1, 2002, MEDLINE 1966 to 2002, EMBASE 1980 to 2002, CANCERCD 1980 to 2002, Science Citation Index 1991 to 2002, CINAHL 1982 to 2002, as well as sources of grey literature. We also hand searched relevant textbooks and contacted experts in the field.
SELECTION CRITERIA
Any study describing the therapeutic trial of a treatment to relieve the physical aspects of female sexual dysfunction which had developed following pelvic radiotherapy was considered. The quality of each study was then assessed by two reviewers independently to determine its suitability for inclusion in statistical analysis.
DATA COLLECTION AND ANALYSIS
Thirty-two references met the inclusion criteria for the search but of these only four were suitable to be included for statistical analysis.
MAIN RESULTS
The strongest evidence for benefit is the grade IC data in the topical oestrogens and benzydamine sections which describes the treatment of acute radiation vaginal changes. The use of vaginal dilators to prevent the development of vaginal stenosis is supported by grade IIC evidence. The value of hyperbaric oxygen therapy and surgical reconstruction is supported by the much weaker grade IIIC evidence in the form of case series.
REVIEWER'S CONCLUSIONS
These findings reflect the quality of published data regarding interventions for this aspect of the management of radiation induced complications. Although there is grade IC evidence, these studies are not recent, the allocation concealment is unclear in the text, and overall there is a variable level of assessment of the response, emphasising the need for more studies to be conducted with improved designs to clarify the investigative process and support the final result.
Topics: Brachytherapy; Dyspareunia; Female; Humans; Pelvic Neoplasms; Radiation Injuries; Randomized Controlled Trials as Topic; Sexual Dysfunction, Physiological
PubMed: 12535485
DOI: 10.1002/14651858.CD003750 -
Supportive Care in Cancer : Official... Dec 2023Radiation-induced oral mucositis (RIOM) is the most frequent side effect in head and neck cancer (HNC) patients treated with curative radiotherapy (RT). A standardized... (Review)
Review
AIM
Radiation-induced oral mucositis (RIOM) is the most frequent side effect in head and neck cancer (HNC) patients treated with curative radiotherapy (RT). A standardized strategy for preventing and treating RIOM has not been defined. Aim of this study was to perform a real-life survey on RIOM management among Italian RT centers.
METHODS
A 40-question survey was administered to 25 radiation oncologists working in 25 different RT centers across Italy.
RESULTS
A total of 1554 HNC patients have been treated in the participating centers in 2021, the majority (median across the centers 91%) with curative intent. Median treatment time was 41 days, with a mean percentage of interruption due to toxicity of 14.5%. Eighty percent of responders provide written oral cavity hygiene recommendations. Regarding RIOM prevention, sodium bicarbonate mouthwashes, oral mucosa barrier agents, and hyaluronic acid-based mouthwashes were the most frequent topic agents used. Regarding RIOM treatment, 14 (56%) centers relied on literature evidence, while internal guidelines were available in 13 centers (44%). Grade (G)1 mucositis is mostly treated with sodium bicarbonate mouthwashes, oral mucosa barrier agents, and steroids, while hyaluronic acid-based agents, local anesthetics, and benzydamine were the most used in mucositis G2/G3. Steroids, painkillers, and anti-inflammatory drugs were the most frequent systemic agents used independently from the RIOM severity.
CONCLUSION
Great variety of strategies exist among Italian centers in RIOM management for HNC patients. Whether different strategies could impact patients' compliance and overall treatment time of the radiation course is still unclear and needs further investigation.
Topics: Humans; Mucositis; Radiation Oncology; Mouthwashes; Sodium Bicarbonate; Hyaluronic Acid; Stomatitis; Radiation Injuries; Head and Neck Neoplasms; Steroids
PubMed: 38110572
DOI: 10.1007/s00520-023-08185-5 -
Acta Medica Academica Aug 2019Lysozyme is a natural antimicrobial and immunomodulatory enzyme, which is produced as a host response to infectious agents. The objective of this study was to compare...
OBJECTIVE
Lysozyme is a natural antimicrobial and immunomodulatory enzyme, which is produced as a host response to infectious agents. The objective of this study was to compare the efficacy and safety of lysozyme-based versus benzydamine and chlorhexidinebased oral spray in patients with an acute tonsillopharyngitis associated with a common cold.
PATIENTS AND METHODS
A prospective twoarm pilot study (lysozyme/cetylpyridinium/lidocaine spray versus: benzydamine spray-arm 1; chlorhexidine/lidocaine spray-arm 2) was conducted in the primary health care unit. Efficacy was evaluated by the patient's self-assessment of pain, difficulty in swallowing and the throat swelling, by using the visual analog scale (VAS) at baseline and three follow-up visits. Safety was evaluated by the assessment of the frequency and severity of adverse effects.
RESULTS
Lysozyme-based spray reduced pain faster than benzydamine-based spray and slower than chlorhexidine-based spray. Lysozyme-based and chlorhexidinebased sprays similarly reduced difficulty in swallowing, but were faster than benzydamine-based spray. Similar effects on the reduction of throat swelling were seen in all treated groups. All tested products showed proper safety and were well tolerated, with no serious adverse events reported.
CONCLUSIONS
The lysozyme-based oral spray was shown to be effective and safe in the reduction of pain, difficulty in swallowing and throat swelling in patients with acute tonsillopharyngitis associated with a common cold. Lysozyme-based oral spray (containing natural compound with advantages of influencing immune system and preventing recurrences) had similar activity to benzydamine and chlorhexidine-based oral antiseptic sprays.
Topics: Acute Disease; Administration, Oral; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Infective Agents, Local; Anti-Inflammatory Agents; Benzydamine; Chlorhexidine; Female; Humans; Male; Middle Aged; Oral Sprays; Pharyngitis; Pilot Projects; Prospective Studies; Tonsillitis; Young Adult
PubMed: 31718214
DOI: 10.5644/ama2006-124.252 -
PloS One 2022Oral mucositis (OM) is a common side effect of chemotherapy and radiotherapy in patients with cancers. The prevention or treatment of OM in cancer patients is crucial in... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Oral mucositis (OM) is a common side effect of chemotherapy and radiotherapy in patients with cancers. The prevention or treatment of OM in cancer patients is crucial in the treatment of cancer.
METHODS
We searched PubMed, Embase, and Cochrane Library for the randomized control trials (RCTs) of interventions for preventing and treating OM. Network meta-analysis (NMA) was performed to estimate odds ratios (ORs) and 95% confidence intervals (CI) from both direct and indirect evidence. The prespecified primary efficacy outcome was the treatment effect of moderate to severe oral mucositis with 12 interventions. The outcome was moderate to a severe grade of OM.
RESULTS
This study included 55 RCTs with 3,552 participants. The results showed that honey significantly lowered the risk of chemo/radiotherapy-induced moderate to severe oral mucositis than placebo (OR: 0.01, 95%CI 0.00 to 0.45), followed by lignocaine (OR: 0.07, 95%CI 0.00 to 0.95). The surface under cumulative ranking curve (SUCRA) values for honey were 0.95, followed by lignocaine (SUCRA, 0.81) and benzydamine (SUCRA, 0.78).
CONCLUSIONS
The honey is effective for patients with cancer undergoing chemotherapy or radiotherapy-induced oral mucositis.
Topics: Humans; Network Meta-Analysis; Stomatitis; Neoplasms
PubMed: 36480513
DOI: 10.1371/journal.pone.0278102 -
Polymers Dec 2021The aim of the present work was to optimize the process parameters of the nano spray drying technique for the formulation of benzydamine-loaded casein nanoparticles and...
The aim of the present work was to optimize the process parameters of the nano spray drying technique for the formulation of benzydamine-loaded casein nanoparticles and to investigate the effect of some process variables on the structural and morphological characteristics and release behavior. The obtained particles were characterized in terms of particle size and size distribution, surface morphology, production yield and encapsulation efficiency, drug-polymer compatibility, etc., using dynamic light scattering, scanning electron microscopy, differential scanning calorimetry, and Fourier transformed infrared spectroscopy. Production yields of the blank nanoparticles were significantly influenced by the concentration of both casein and the crosslinking agent. The formulated drug-loaded nanoparticles had an average particle size of 135.9 nm to 994.2 nm. Drug loading varied from 16.02% to 57.41% and the encapsulation efficiency was in the range 34.61% to 78.82%. Our study has demonstrated that all the investigated parameters depended greatly on the polymer/drug ratio and the drug release study confirmed the feasibility of the developed nanocarriers for prolonged delivery of benzydamine.
PubMed: 34960907
DOI: 10.3390/polym13244357