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The Cochrane Database of Systematic... Jun 2010Use of topical NSAIDs to treat acute musculoskeletal conditions is widely accepted in some parts of the world, but not in others. Their main attraction is their... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Use of topical NSAIDs to treat acute musculoskeletal conditions is widely accepted in some parts of the world, but not in others. Their main attraction is their potential to provide pain relief without associated systemic adverse events.
OBJECTIVES
To review the evidence from randomised, double-blind, controlled trials on the efficacy and safety of topically applied NSAIDs in acute pain.
SEARCH STRATEGY
We searched MEDLINE, EMBASE, The Cochrane Library, and our own in-house database to December 2009. We sought unpublished studies by asking personal contacts and searching on-line clinical trial registers and manufacturers web sites.
SELECTION CRITERIA
We included randomised, double-blind, active or placebo (inert carrier)-controlled trials in which treatments were administered to adult patients with acute pain resulting from strains, sprains or sports or overuse-type injuries (twisted ankle, for instance). There had to be at least 10 participants in each treatment arm, with application of treatment at least once daily.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trial quality and validity, and extracted data. Numbers of participants achieving each outcome were used to calculate relative risk and numbers needed to treat (NNT) or harm (NNH) compared to placebo or other active treatment.
MAIN RESULTS
Forty-seven studies were included; most compared topical NSAIDs in the form of a gel, spray, or cream with a similar placebo, with 3455 participants in the overall analysis of efficacy. For all topical NSAIDs combined, compared with placebo, the number needed to treat to benefit (NNT) for clinical success, equivalent to 50% pain relief, was 4.5 (3.9 to 5.3) for treatment periods of 6 to 14 days. Topical diclofenac, ibuprofen, ketoprofen, and piroxicam were of similar efficacy, but indomethacin and benzydamine were not significantly better than placebo. Local skin reactions were generally mild and transient, and did not differ from placebo. There were very few systemic adverse events or withdrawals due to adverse events. There were insufficient data to reliably compare individual topical NSAIDs with each other or the same oral NSAID.
AUTHORS' CONCLUSIONS
Topical NSAIDs can provide good levels of pain relief, without the systemic adverse events associated with oral NSAIDs, when used to treat acute musculoskeletal conditions.
Topics: Acute Disease; Administration, Topical; Adult; Anti-Inflammatory Agents, Non-Steroidal; Athletic Injuries; Humans; Pain; Randomized Controlled Trials as Topic; Sprains and Strains
PubMed: 20556778
DOI: 10.1002/14651858.CD007402.pub2 -
Molecular Pain 2023Benzydamine is an active pharmaceutical compound used in the oral care pharmaceutical preparation as NSAID. Beside from its anti-inflammatory action, benzydamine local...
Benzydamine is an active pharmaceutical compound used in the oral care pharmaceutical preparation as NSAID. Beside from its anti-inflammatory action, benzydamine local application effectively reliefs pain showing analgesic and anaesthetic properties. Benzydamine mechanism of action has been characterized on inflammatory cell types and mediators highlighting its capacity to inhibit pro-inflammatory mediators' synthesis and release. On the other hand, the role of benzydamine as neuronal excitability modulator has not yet fully explored. Thus, we studied benzydamine's effect over primary cultured DRG nociceptors excitability and after acute and chronic inflammatory sensitization, as a model to evaluate relative nociceptive response. Benzydamine demonstrated to effectively inhibit neuronal basal excitability reducing its firing frequency and increasing rheobase and afterhyperpolarization amplitude. Its effect was time and dose-dependent. At higher doses, benzydamine induced changes in action potential wavelength, decreasing its height and slightly increasing its duration. Moreover, the compound reduced neuronal acute and chronic inflammatory sensitization. It inhibited neuronal excitability mediated either by an inflammatory cocktail, acidic pH or high external KCl. Notably, higher potency was evidenced under inflammatory sensitized conditions. This effect could be explained either by modulation of inflammatory and/or neuronal sensitizing signalling cascades or by direct modulation of proalgesic and action potential firing initiating ion channels. Apparently, the compound inhibited Na1.8 channel but had no effect over K7.2, K7.3, TRPV1 and TRPA1. In conclusion, the obtained results strengthen the analgesic and anti-inflammatory effect of benzydamine, highlighting its mode of action on local pain and inflammatory signalling.
Topics: Humans; Benzydamine; Pain; Nociceptors; Inflammation; Anti-Inflammatory Agents; Analgesics
PubMed: 37710969
DOI: 10.1177/17448069231204191 -
European Review For Medical and... Oct 2018The purpose of this study was to investigate oral ulcer healing and anti-Candida efficacy of an alcohol-free 0.1% chitosan-curcumin mouthwash. (Comparative Study)
Comparative Study
OBJECTIVE
The purpose of this study was to investigate oral ulcer healing and anti-Candida efficacy of an alcohol-free 0.1% chitosan-curcumin mouthwash.
MATERIALS AND METHODS
A buccal mucosal ulcer was induced in hamster by topical application of acetic acid. The test mouthwash was applied to the ulcer twice a day for 7 consecutive days beginning on the fourth day after the ulcer induction. The anti-Candida efficacy of the mouthwash was determined against both free floating and biofilm forms of Candida albicans.
RESULTS
The mouthwash significantly decreased the ulcer severity with a better ulcer healing efficacy than that of a standard benzydamine mouthwash. The mouthwash also exerted a comparable anti-Candida efficacy to a standard chlorhexidine mouthwash.
CONCLUSIONS
An alcohol-free 0.1% chitosan-curcumin mouthwash may serve as a safe and potential topical alternative agent in the management of oral inflammatory ulcer and of candidiasis.
Topics: Animals; Biofilms; Candida; Candida albicans; Chitosan; Chlorhexidine; Cricetinae; Curcumin; Female; Male; Mouthwashes; Oral Ulcer; Wound Healing
PubMed: 30402869
DOI: 10.26355/eurrev_201810_16173 -
Minerva Anestesiologica Mar 2020Laryngeal mask airway (LMA) use is very common during anesthesia practice. Sore throat, earache, hoarseness and swallowing difficulties may occur on LMA insertion. The...
BACKGROUND
Laryngeal mask airway (LMA) use is very common during anesthesia practice. Sore throat, earache, hoarseness and swallowing difficulties may occur on LMA insertion. The primary aim of this study was to describe the effects of topical application of a spray formula of chlorhexidine gluconate and benzydamine hydrochloride (Kloroben® oral spray, 30 mL) on postoperative sore throat due to LMA use. The secondary aims were to evaluate earache, swallowing difficulty, nausea and vomiting and the hemodynamic responses due to LMA insertion and the incidence of coughing, tooth clenching, desaturation and laryngeal spasms during LMA removal.
METHODS
After obtaining Institutional Ethics Committee approval and written informed consent (Ref no 29/15), a total of 100 adult patients were included. In Group C, four puffs of a spray formula of chlorhexidine gluconate and benzydamine hydrochloride were applied to the nasopharyngeal area 15 min before surgery. In Group S, 0.9% saline was applied, using the same protocol.
RESULTS
When both groups were compared, more patients in Group S had cough, sore throat and swallowing difficulties one hour after surgery (P<0.05), but there was no statistically significant difference at 6, 12, and 24 h between the two groups (P>0.05). The incidence of nausea, vomiting, and earaches was similar in both groups at all measurement times (P>0.05).
CONCLUSIONS
Preemptive topical benzydamine hydrochloride and chlorhexidine gluconate in a spray formula may decrease the incidence of sore throat, cough and swallowing difficulties associated with LMA use.
Topics: Administration, Topical; Adult; Aged; Airway Extubation; Anti-Inflammatory Agents, Non-Steroidal; Benzydamine; Chlorhexidine; Cough; Deglutition Disorders; Disinfectants; Earache; Female; Humans; Incidence; Laryngeal Masks; Male; Middle Aged; Pain, Postoperative; Pharyngitis; Postoperative Complications; Postoperative Nausea and Vomiting
PubMed: 31818083
DOI: 10.23736/S0375-9393.19.13970-3 -
Acta Pharmaceutica Sinica. B Mar 2020Bone diseases such as osteoporosis and periodontitis are induced by excessive osteoclastic activity, which is closely associated with inflammation. Benzydamine (BA) has...
Bone diseases such as osteoporosis and periodontitis are induced by excessive osteoclastic activity, which is closely associated with inflammation. Benzydamine (BA) has been used as a cytokine-suppressive or non-steroidal anti-inflammatory drug that inhibits the production of pro-inflammatory cytokines or prostaglandins. However, its role in osteoclast differentiation and function remains unknown. Here, we explored the role of BA in regulating osteoclast differentiation and elucidated the underlying mechanism. BA inhibited osteoclast differentiation and strongly suppressed interleukin-1 (IL-1) production. BA inhibited osteoclast formation and bone resorption when added to bone marrow-derived macrophages and differentiated osteoclasts, and the inhibitory effect was reversed by IL-1 treatment. The reporter assay and the inhibitor study of IL-1 transcription suggested that BA inhibited nuclear factor-B and activator protein-1 by regulating IB kinase, extracellular signal regulated kinase and P38, resulting in the down-regulation of IL-1 expression. BA also promoted osteoblast differentiation. Furthermore, BA protected lipopolysaccharide- and ovariectomy-induced bone loss in mice, suggesting therapeutic potential against inflammation-induced bone diseases and postmenopausal osteoporosis.
PubMed: 32140392
DOI: 10.1016/j.apsb.2019.11.004 -
Pharmaceuticals (Basel, Switzerland) Apr 2023Benzydamine is a non-steroidal anti-inflammatory drug with distinct pharmacological properties from other compounds in the same therapeutic class. The differences are... (Review)
Review
Benzydamine is a non-steroidal anti-inflammatory drug with distinct pharmacological properties from other compounds in the same therapeutic class. The differences are structural and pharmacological in nature; the anti-inflammatory mechanism is not strictly explained by the ability to interfere with the synthesis of prostaglandins. The compound is used strictly in local inflammatory diseases (inflammation in the oral and vaginal mucosa). In addition to the therapeutic indications found in the summary of product characteristics (SPC), the compound is used, in high doses, as a psychotropic substance for oral administration, having similar properties to lysergic acid diethylamide (LSD). As an over-the-counter (OTC) compound, it is easy to obtain, and the consequences of using it for purposes other than those assumed by the manufacturer raise various concerns. The reasons are related to the pharmacodynamic and pharmaco-toxicological properties, since neither the mechanism of action nor the possible side effects that would result from systemic consumption, in high doses, even occasionally, have been fully elucidated. The present review aims to analyze the pharmacodynamic properties of benzydamine, starting from the chemical structure, by comparison with structurally similar compounds registered in therapy (as an anti-inflammatory or analgesic) or used for recreational purposes.
PubMed: 37111323
DOI: 10.3390/ph16040566 -
Journal of Physiology and Pharmacology... Dec 2016Econazole is an anti-mycotic agent widely used for the treatment of cutaneous fungal infections, and for the therapy of vaginal candidiasis. Topical application of this...
Econazole is an anti-mycotic agent widely used for the treatment of cutaneous fungal infections, and for the therapy of vaginal candidiasis. Topical application of this azole is generally safe, although some patients have complained of mild burning sensation/cutaneous irritation and itching, especially when administered intravaginally. The underlying mechanisms responsible of these adverse effects are poorly understood, though they suggest excitation of cutaneous nociceptor terminals. We report that exposure of primary cultures of rat nociceptors to econazole augments neuronal excitability. This effect appears mediated by increments in the intracellular Ca by stimulating Ca entry and release from the endoplasmic reticulum. Ca entry was not due to activation of thermo transient receptor potential (TRP) channels, suggesting a different ion channel targeted by the azole. Noteworthy, econazole-evoked responses were potentiated by a pro-inflammatory agent, which resulted in an increase in neuronal excitability. Econazole-elicited action potential firing was significantly abolished by the inflammatory cytokine inhibiting drug benzydamine via blockade of voltage-gated Na (Nav) channels. Collectively, our results indicate that the burning sensation of econazole is due at least in part to modulation of nociceptor excitability, and such sensation is increased in the presence of pro-inflammatory stimuli and blocked by benzydamine. These findings imply that a combination of the azole with benzydamine has the potential to reduce significantly the unpleasant symptoms related to infection and to the adverse effects of topical econazole formulations.
Topics: Animals; Antifungal Agents; Benzydamine; Calcium; Cells, Cultured; Cytokines; Econazole; Endoplasmic Reticulum; Inflammation; Nociceptors; Rats; Rats, Wistar; Sensory Receptor Cells; Transient Receptor Potential Channels
PubMed: 28195065
DOI: No ID Found -
Heliyon Apr 2023Concurrent chemoradiation (CCRT) has been the standard treatment for organ preservation or locally advanced head and neck cancer (LAHNC). Radiation-induced oral...
A prospective randomized study comparing the efficacy between povidone-iodine gargling and benzydamine hydrochloride for mucositis prevention in head and neck cancer patients receiving concurrent chemoradiotherapy.
BACKGROUND
Concurrent chemoradiation (CCRT) has been the standard treatment for organ preservation or locally advanced head and neck cancer (LAHNC). Radiation-induced oral mucositis (RIOM) is an important treatment-limiting toxicity. Benzydamine hydrochloride was recommended to prevent oral mucositis. Povidone-iodine had also been adopted to use as an oral rinse to prevent mucositis.
OBJECTIVE
This study compared the efficacy between benzydamine hydrochloride and 0.1% povidone-iodine to prevent RIOM in HNC patients who received concurrent chemoradiotherapy.
METHODS
We conducted a randomized control study in HNC patients receiving CCRT with curative intent. The stratification factors were primary site of disease, treatment modality, chemotherapy regimen, and schedule. The primary outcome was RIOM assessed by Oral Mucositis Assessment Scale (OMAS). Secondary outcomes included RIOM assessed by NCI-CTCAE, use of analgesic, antibiotics and anti-fungal drugs, hospitalization, and participant satisfaction.
RESULTS
There were 83 participants recruited for this study with 71 completing the trial. Demographic characteristics were well-balanced between both arms. The univariate regression analysis revealed that povidone-iodine correlated with less RIOM compared to benzydamine hydrochloride (coefficient -2.25, 95% CI -4.37 to -0.012, -value 0.03). The incidence of grade III-IV CTCAE RIOM during the study period was 51.4% with benzydamine hydrochloride compared to 26.5% with 0.1% povidone iodine (-value 0.032). The peak incidence of grade III-IV CTCAE RIOM occurred in the 7th week of treatment (40.5% vs. 11.8%, -value 0.01). This indicated the efficacy of povidone-iodine to prevent severe RIOM which usually most severity in the last week of CCRT treatment. The multivariate analysis revealed that the CCRT setting (definitive vs. adjuvant) and gargling agents (povidone-iodine vs. benzydamine hydrochloride were the factors associated with RIOM.
CONCLUSION
This study demonstrated higher efficacy of 0.1% povidone-iodine gargle than benzydamine hydrochloride in mucositis prevention.
PubMed: 37151677
DOI: 10.1016/j.heliyon.2023.e15437 -
Infectious Diseases in Obstetrics and... 2020A novel fixed-dose combination of 150 mg of econazole with 6 mg of benzydamine formulated in vaginal ovules was investigated in a randomised, double-blind,... (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
A novel fixed-dose combination of 150 mg of econazole with 6 mg of benzydamine formulated in vaginal ovules was investigated in a randomised, double-blind, four-parallel group, tolerability, and pharmacokinetic Phase I study in healthy women.
METHODS
The fixed-dose combination was compared to econazole and benzydamine single-drug formulations and with placebo after daily applications for 3 consecutive days. Safety and tolerability were evaluated recording the adverse drug reactions, local and general tolerability scores, clinical laboratory assays, and vital signs. Econazole, benzydamine, and its metabolite benzydamine N-oxide pharmacokinetics were investigated after single and multiple applications.
RESULTS
Local reactions were generally absent. Pruritus and pain at the application site were infrequently reported. According to the subjects' evaluations, the overall tolerability of the ovules was rated as excellent or good. No significant effect of any treatment on laboratory parameters, vital signs, body weight, vaginal pH, or ECG was observed. Very low econazole, benzydamine, and benzydamine-N-oxide concentrations were measured in plasma, though quantifiable in almost all samples.
CONCLUSION
The tested fixed-dose combination showed a good safety profile consistently with the known tolerability of both active substances. In addition, the confirmed low bioavailability of the drugs excludes the possibility of any accumulation effects and limits the risk of undesired systemic effects. This trial is registered at ClinicalTrials.gov with the identifier NCT02720783 last updated on 07 February 2017.
Topics: Administration, Oral; Adult; Antifungal Agents; Area Under Curve; Benzydamine; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Drug Delivery Systems; Econazole; Female; Healthy Volunteers; Humans; Middle Aged; Vagina; Young Adult
PubMed: 32410819
DOI: 10.1155/2020/7201840