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PubMed2002

Benzydamine: an alternative nonsteroidal anti-inflammatory drug in patients with nimesulide-induced urticaria.

BACKGROUND: Cutaneous adverse reactions to nonsteroidal anti-inflammatory drugs (NSAIDs), in particular urticaria/angiedema syndrome, represent a frequent problem in clinical practice. To date laboratory tests for the diagnosis of these adverse reactions are not available. A patient with an adverse drug reaction to NSAIDs needs an alternative drug to assume if necessary. Nimesulide is a highly prescribed nonsteroidal anti-inflammatory drug (NSAID) world-wide. It is also described as one of the most tolerated NSAID. In this paper we present data on the tolerability of benzydamine in nimesulide-sensitive patients. PATIENTS AND METHODS: One hundred and thirty-seven patients with nimesulide-induced urticaria were submitted to a single-blind, placebo-controlled peroral challenge with increasing doses of benzydamine. RESULTS: One hundred and thirty-four out of 137 (98%) patients tolerated benzydamine without adverse effects, only three (2%) experienced immediate systemic urticaria (1 at the first dose and 2 at the second dose). CONCLUSION: Benzydamine is a well tolerated drug in patients with nimesulide-induced urticaria and it may represent a valid alternative NSAID in nimesulide-sensitive patients.

Acetaminophen↗
PubMed1986

Bendazac and benzydamine for treatment of cataract: individualized therapy by the "BLOA test".

It was found that two chemically very close Non-Steroid Antiinflammatory Drugs (NSAID), bendazac and benzydamine, were able to reduce the Biological Liquid Oxidant Activity (BLOA) in vitro (bendezac) and in vivo (bendazac and benzydamine). Four hundred and seven patients were treated with bendazac and 599 with benzydamine. After a single dose oral administration they effected a BLOA Reducing Activity (BRA) ranging from 5% to over 20% in about 40% of cataractous patients. When these drugs were able to reduce the BLOA, they showed anticataract activity in about 50% and about 90% of patients according to the extent of BRA, i.e., less than 20% and greater than or equal to 20% of the basal value. This fact suggests that the anticataract agent is not the original NSAID (prodrug) but a NSAID metabolite or an elicited endogenous compound which produced the BLOA reduction. Individual BLOA could be reduced in vivo by benzydamine or bendazac, by both or by neither of them. This finding may be accounted for by selective biotransformation of each patient's original NSAID into the antioxidant anticataract compound. However, other possible mechanisms of the anticataract activity beside antioxidant activity might take place, such as protein and membrane stabilization, together with a not yet defined activation of enzymes within the lens effecting the reversal of cataractous opacity. Several side effects were apparent in short and long term treatments. The final conclusion of our study is that bendazac at a dosage ten-fold lower than that used in the clinics is anticataract drug when orally administered to "BLOA test selected" patients, at least for short term treatment of young, otherwise healthy humans with cortical cataract.

Adult↗
PubMed1989

Use of ultrasound to enhance percutaneous absorption of benzydamine.

The influence of ultrasound on the percutaneous absorption of benzydamine hydrochloride from a gel base was investigated in a double-blind, placebo-controlled clinical study of 10 healthy volunteers. Using two similar experimental protocols, the effect of both 1:1 (2 msec on, 2 msec off) pulsed-output ultrasound (3.0 MHz at 1.0 W/cm2 and 0.0 W/cm2 [control]) and continuous-output ultrasound at a range of frequencies (0.75, 1.5, and 3.0 MHz at 1.5 W/cm2) were investigated. A placebo control (benzydamine gel massaged with ultrasound applicator switched off) was incorporated into each protocol. Percutaneous absorption of benzydamine was assessed by measurement of the residual amount of drug in the formulation base after treatment. Drug assay was by reversed-phase high-performance liquid chromatography and ultraviolet detection. Statistical analysis of the results for both continuous and pulsed ultrasound treatment showed that no significant differences existed between data for ultrasound treatment versus no ultrasound. In conclusion, although phonophoresis has been alleged to enhance percutaneous absorption of numerous drugs, ultrasound did not enhance the percutaneous absorption of benzydamine under the experimental conditions of this study.

Adult↗
PubMed1984

Nimesulide for the treatment of painful inflammatory process in the ear, nose and throat areas: a double-blind controlled study with benzydamine.

Nimesulide, 4-nitro-2-phenoxymethanesulphonanilide, a new non-steroidal anti-inflammatory drug endowed with potent anti-inflammatory, analgesic and antipyretic activities, was tested at a daily dose of 200 mg b.i.d. against Benzydamine on a double-blind basis, in a randomized trial with fifty out-patients suffering from inflammatory ear, nose and throat diseases (otitis media, sinusitis, rhinitis). Nimesulide treatment brought about an immediate and significant improvement in over-all pain, exudation, oedema and headache and produced a rapid lowering in body temperature. The recovery was more rapid and significant in patients with Nimesulide than in those with Benzydamine. The signs and symptoms under consideration reached almost complete resolution within the set treatment-period of 10 days. Clinical tolerability of Nimesulide was better than that of Benzydamine: one case of moderate gastric pyrosis and drowsiness was complained of by the Nimesulide-treated patients versus eleven cases of gastro-intestinal discomfort, mouth dryness, and/or drowsiness which were complained of by the Benzydamine-treated patients.

Adult↗
PubMed2006

An evaluation of the efficacy of aspirin and benzydamine hydrochloride gargle for attenuating postoperative sore throat: a prospective, randomized, single-blind study.

Postoperative sore throat (POST), although a minor complication, remains a source of postoperative morbidity. We compared the efficacy of dispersible aspirin gargle to benzydamine hydrochloride (a topical nonsteroidal anti inflammatory drug) gargles for prevention of POST. We enrolled 60 consecutive female patients, 16-60 yr of age, ASA physical status I or II, undergoing elective modified radical mastectomy under general anesthesia in this prospective, randomized, placebo-controlled, single-blind study. Patients were randomly divided into 3 groups of 20 subjects each: Group 1 (C) mineral water; Group 2 (AS) tab aspirin 350 mg; and Group 3 (BH) 15 mL of benzydamine hydrochloride (0.15%). All the medications were made into 30 mL of solution. Patients were asked to gargle this mixture for 30 s, 5 min before induction of anesthesia. Grading of POST was done at 0, 2, 4, and 24 h postoperatively on a 4-point scale (0-3). Aspirin gargles reduced the incidence of POST for 4 h whereas benzydamine hydrochloride gargles reduced POST for 24 h. POST was more severe in the control group at 0 and 2 h (P < 0.05). Aspirin and benzydamine hydrochloride gargles significantly reduced the incidence and severity of POST (P < 0.05).

Adolescent↗
PubMed2005

[The effectiveness of a benzydamine rinse in the management of stomato-glossopyrosis].

Burning mouth syndrome (BMS) is a frequent source of oral discomfort and sensation mainly at middle-aged or elderly women without identifiable local pathology. Forty-two patients with stomato-glossopyrosis were registered at the Department of Periodontology, Dental School, University Pécs, between August 2002 and January 2003. Oral clinical examination failed to identify physical explanation for the complaint of painful or burning mouth. After complete examination (blood test included), scaling, root planning and oral hygiene instructions were given. Six patients reported decreasing mucosal pain or burning. Two patients had iron-deficiency and Sjögren's syndrome was suspected and verified at another two patients. Thirty-two patients completed the benzydamine-study. They were divided into two groups. The study group (16 patients) rinsed with benzydamine containing solution, the control group (16 patients) received placebo solution for rinsing the same way for ten days. Differences were found between the two groups favouring the benzydamine containing solution. Pain reduction, mouth dryness and diminution of burning sensation were detected by means of visual analog scale (VAS). Benzydamine rinses could be effective in the management of BMS, but clinicians need to monitor patients for possible side effects in the case of long-term use.

Analgesics, Non-Narcotic↗
PubMed1989

[Value of benzydamine, the first anti-inflammatory vaginal solution].

This clinical study concerns thirty women with vaginal infections caused by Trichomonas and Candida, showing major inflammatory reactions and painful symptomatology: smarting, pruritus, oedema. Its aim is to measure the activity of benzydamine, the first NSAID to appear as a vaginal solution for local application in the treatment of vaginal inflammation and painful symptomatology. The product is prescribed with the etiological treatment. Benzydamine vaginal douche acts most rapidly on local discomfort, the foremost criterion of this study. From the very first application all the patients have noticed substantial relief which can only be attributed to benzydamine and allows for a better observance of the etiological treatment. Owing to its efficacy and immediate action on vaginal inflammation, benzydamine is a real therapeutic contribution to gynecology.

Administration, Intravaginal↗
PubMed1987

Effects of benzydamine on the oral mucositis during antineoplastic radiotherapy and/or intra-arterial chemotherapy.

In view of the good results obtained with benzydamine against oral radio-chemomucositis in a previous trial, a double-blind/placebo study was undertaken in order to ascertain the possible oral histoprotective effect of benzydamine mouthwash during the intra-arterial polychemotherapy and/or radiotherapy for neoplasms of the head and neck. Statistical comparison of the results obtained in these two groups, treated with benzydamine and placebo mouthwash, revealed a marked difference in the clinical evolution of iatrogenic tissue damage. The benzydamine topical application was more effective than placebo in the control of mucositis symptoms and signs produced by radiotherapy and/or intra-arterial antineoplastic chemotherapy.

Administration, Topical↗
PubMed1987

[Antithrombotic action of benzydamine].

The non-steroidal antiinflammatory drug benzydamine (Tantum) was studied for antithrombotic properties. In vitro, rat platelet aggregation induced by adenosine diphosphate (ADP) and collagen was inhibited (IC50 about 10(-4) mol/l) and malondialdehyde formation induced by arachidonic acid in dog platelets was not influenced. The classical non-steroidal antiinflammatory drugs as indomethacin showed opposite effects. In vivo benzydamine hardly inhibited pulmonary thromboembolism induced by arachidonic acid in mice, which indicates again that the cyclooxygenase pathway is not involved. Venous thrombosis in the rat was clearly inhibited after oral administration of benzydamine (ED35 8.5 +/- 2.1 mg/kg p.o.). These results indicate that benzydamine possesses antithrombotic properties in the rat which are not based on inhibition of the cyclooxygenase system.

Animals↗
PubMed1987

[Experimental findings on gastric ulcerogenicity and mucosa protection by benzydamine in the rat].

Benzydamine (Tantum) was studied for ulcerogenic and ulcer protective effects in the rat gastric mucosa. Contrary to other non-steroidal antiinflammatory drugs, i.e. acetylsalicylic acid and piroxicam, benzydamine was not ulcerogenic. The lack of ulcerogenicity might be explained by the fact that benzydamine does not inhibit the cyclooxygenase. Ulcer protective properties of benzydamine were observed against acetylsalicylic acid- and ethanol-induced gastric lesions. Vasoprotective mechanisms might be responsible for these effects.

Animals↗
PubMed1986

HPLC determination of benzydamine and its metabolite N-oxide in plasma following oral administration or topical application in man, using fluorimetric detection.

A method for the extraction and quantification of benzydamine and its metabolite N-oxide by liquid chromatography with fluorescence detection in plasma samples is described. This method has adequate sensitivity, specificity and is reproducible. The use of the extraction column allowed a recovery of both benzydamine and its metabolite of over 97% to be obtained. The plasma levels of benzydamine and its metabolite N-oxide were studied after oral administration as sugar-coated tablets or topical application to the vaginal mucosa as a cream to 6 healthy volunteers. After topical application, the plasma concentrations of the unchanged drug and its metabolite are lower than those obtained following oral administration. These data further stress the concept that, whenever possible, topical use should be considered the treatment of choice since, along with a more selective therapy, the incidence of systemic side effects can be considerably reduced.

Administration, Oral↗
PubMed1988

The effect of chlorhexidine and benzydamine mouthwashes on mucositis induced by therapeutic irradiation.

A variety of mouthwashes are frequently used in the management of irradiation-induced mucositis. Benzydamine has recently been introduced for alleviating this condition. Its efficacy as a mouthwash was compared with chlorhexidine in two groups of patients receiving radiotherapy for oral carcinoma. Mucositis and pain were recorded over a 6 week period and oral carriage of Candida species, coliforms and Staphylococcus aureus was assessed using an oral rinse technique. There was no significant difference in the mucositis scores, overall pain scores or the yeast and bacterial species isolated between the two treatment groups. However, 58% (7 out of 12) and 92% (12 out of 13) patients reported oral discomfort when rinsing the mouth with chlorhexidine and benzydamine, respectively. In both groups, the most common coliform isolated was Klebsiella pneumoniae and the carriage of yeasts was significantly greater than that of coliforms. These results indicate that, although the individual patient acceptance of chlorhexidine is better than benzydamine, there is little difference between the two mouthwashes both in controlling pain and mucositis or in the oral carriage of the micro-organisms studied.

Aged↗
PubMed2003

Amperometric biosensor based on monoamine oxidase (MAO) immobilized in sol-gel film for benzydamine determination in pharmaceuticals.

The development and application of a flow-through amperometric biosensor for benzydamine determination in anti-inflammatory drugs is described. The biosensor was obtained by physical entrapment of monoamine oxidase in a sol-gel film applied on platinum or carbon paste conducting support. The sol-gel membranes were prepared using an optimum concentration of 3-aminopropyltriethoxy silane, 2-(3,4-epoxycyclohexyl)ethyl-trimethoxy silane, double distilled water saturated with polyethylene glycol 6000 and HCl. The developed biosensors were incorporated in a single channel flow injection system to enable the determination of benzydamine in the concentration range of 0.05-2.5 mmol l(-1) (with platinum based electrode) or within 0.1-2.5 mmol l(-1) (carbon paste based electrode). The operational stability of the bioanalytical system developed was about 3 months permitting approximately 4700 substrate measurements. The flow injection system developed enables a sampling rate of 20-25 samples h(-1) and relative S.D. of results less than 4%. The analytical usefulness of the proposed procedure was evaluated through analysis of commercial pharmaceutical products containing benzydamine, available on the Portuguese market. The results obtained did not differ significantly from the values resulting from analysis of the same products by the method described in the BP Pharmacopoeia.

Benzydamine↗
PubMed1998

Electron-transfer mechanisms in photosensitization by the anti-inflammatory drug benzydamine.

The novel anti-inflammatory drug benzydamine has been show to photosensitize the reduction of Nitro Blue Tetrazolium, ferricytochrome c and copper (II) bathocuproinedisulphonate in aqueous solutions (pH 7.4, 30 degrees C) when irradiated with UV light at its maximum absorption wavelength of 308 nm. The reduction reactions all proceed most efficiently when the solutions are deoxygenated, clearly indicating that direct electron transfer occurs from the excited state of the sensitizer to the substrate. In aerated solutions the reduction reactions are slower and are partially inhibited by superoxide dismutase, suggesting that superoxide anion could be involved as an intermediate when oxygen is present. Benzydamine also photosensitizes the oxidation of 1-histidine and 2,5-dimethylfuran by the singlet oxygen pathway in aerated solutions. The ability of benzydamine to participate as sensitizer in several types of photochemical reaction is relevant to the observed clinical photosensitivity of the drug.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed1999

Benzydamine hydrochloride oral rinses in management of burning mouth syndrome. A clinical trial.

OBJECTIVE: The purpose of this study was to evaluate the efficacy of the topical use of benzydamine hydrochloride 0.15% oral mouthwashes in the control of burning mouth syndrome symptoms. STUDY DESIGN: In this double-blind, randomized, longitudinal investigation, each of 30 patients with burning mouth syndrome was assigned to one of 3 management modalities. Those in group A received an oral rinse solution of benzydamine hydrochloride 0.15% 3 times a day for 4 weeks, those in group B received a placebo 3 times a day for 4 weeks, and those in group C did not receive any kind of treatment. A visual analog scale was used for evaluation of the symptoms; a Kruskal-Wallis analysis of variance exact test was performed on the resulting data. RESULTS: The findings of this investigation failed to reveal significant differences among the groups. CONCLUSIONS: The clinical application of benzydamine hydrochloride oral rinses in the treatment of patients with burning mouth syndrome did not demonstrate significative efficacy in comparison with use of a placebo solution.

Administration, Topical↗
PubMed1977

A double-blind clinical study with benzydamine 3% cream on soft tissue injuries in an occupational health centre.

A double-blind, controlled clinical study with benzydamine hydrochloride 3% cream was conducted in an Occupational Health Centre on fifty patients with soft tissue injuries (two mild, ten moderate and thirteen severe cases in the placebo group and one mild, thirteen moderate and twelve severe cases in the active group). The trial demonstrated the significant therapeutic superiority of 3% benzydamine cream over inactive placebo in all six qualitative parameters for traumatic inflammatory changes at the end of a six-day assessment and a marked improvement of symptoms event two days after the onset of therapy. In addition, tbe incidental use of ultrasound therapy together with the standard treatment revealed the value of the active drug as an effective couplant. Neither group suffered any side-effects. Although the size of population studied was small, it was apparent that active treatment with benzydamine was a distinct aid to healing of soft tissue injuries and this should be confirmed with further large-scale clinical trials.

Administration, Topical↗
PubMed1987

Comparative evaluation of benzydamine oral rinse in children with antineoplastic-induced stomatitis.

This nonblinded, crossover study was undertaken to compare the extent and duration of analgesia after administration of benzydamine 0.15% oral rinse and Hospital for Sick Children (HSC) mouthwash for pain (nystatin 7000 U/ml, lidocaine viscous 0.58 ml/ml in NaCl 0.9%) in pediatric patients with antineoplastic-induced stomatitis. Each mouthwash was administered as a paint or a gargle q2h while the child was awake on two consecutive days. Patients older than three years were asked to describe their pain by means of a pictorial or a visual analog scale. Pain was assessed by the investigator, parent, or nurse caring for the patient as well as the patient whenever possible before each dose and 10, 30, and 60 minutes after the first three doses each day for four days. Stomatitis severity was graded daily. Four patients completed the study protocol; an additional three patients dropped out of the study due to severe stinging when benzydamine oral rinse was administered. The case histories of the patients who completed the study are presented. Both preparations reduced pain for at least one hour in most instances but not for two hours. Three of four patients elected to continue treatment with HSC mouthwash for pain. Study recruitment was halted due to the ethical concern of continuing with the knowledge that benzydamine oral rinse causes oral pain and stinging, especially in patients with severe stomatitis.

Adolescent↗
PubMed2004

Topical benzydamine cream and the relief of pressure pain.

OBJECTIVE: To determine whether topical benzydamine hydrochloride 3% cream is more effective than placebo in reducing pain related to pressure areas in palliative care patients. DESIGN: Randomized double-blind, placebo-controlled trial. SETTING: Three specialist palliative care units in the north of England, with local ethical committee approval for all sites. SUBJECTS: Hospice in-patients with pain related to pressure areas. INTERVENTIONS: A single application of either benzydamine hydrochloride 3% cream or placebo cream to the painful pressure area. MAIN OUTCOME MEASURES: Pain assessed using 100 mm VAS, an 11-point numerical pain score and a five-point pain relief score. RESULTS: There was no statistically significant difference between topical benzydamine hydrochloride 3% cream and placebo cream in reducing pain related to pressure areas in palliative care patients. CONCLUSIONS: This study does not demonstrate a statistically significant difference between the two treatments. However the study does provide reliable information with respect to the use of different pain measurement tools in late-stage palliative patients. It also provides information regarding the baseline characteristics of this group of patients which may be useful in the planning of any future similar studies.

Administration, Cutaneous↗