Randomized Control Study of the Effects of Turmeric Mouthwash on Oral Health Status, Treatment-Induced Mucositis, and Associated Oral Dysfunctions Among Patients With Head and Neck Cancer.

BACKGROUND: Oral mucositis is the most severe and debilitating adverse effect of cancer treatment, resulting in inadequate nutritional intake, treatment disruptions, and dose alteration, leading to increased hospital costs and decreased tumor control. OBJECTIVE: The aim of this study was to determine the effectiveness of turmeric mouthwash on oral health status and onset and severity of treatment-induced oral mucositis and associated oral dysfunctions among head and neck cancer patients. METHODS: A randomized controlled design was adopted (CTRI/2018/06/014367). Turmeric mouthwash was administered to the experimental group (n = 46) and benzydamine mouthwash was given to the control group (n = 46). Oral health status and mucositis were graded using the Oral Health Assessment Tool and the World Health Organization oral toxicity criteria, respectively. Oral dysfunctions were measured by a patient-reported oral mucositis symptom scale and xerostomia short-form inventory. All outcome variables were measured weekly during the entire course of radiation therapy. RESULTS: Both groups were comparable with regard to their demographic and outcome variables ( P > .05). The incidence of intolerable mucositis in the control group was 100% compared with 17.8% in the experimental group. Repeated-measures analysis of variance demonstrated significant differences in the onset and severity of oral mucositis ( P = .001), oral health status ( P = .001), and oral dysfunctions ( P = .001) between the experimental and control groups. CONCLUSION: Turmeric mouthwash was effective in reducing the severity of oral mucositis and associated oral dysfunctions as compared with benzydamine mouthwash. IMPLICATIONS: Use of turmeric, a nontoxic and cost-effective intervention, can be an alternative to the traditional management of oral mucositis.

Effect of Honey-Lemon Spray Versus Benzydamine Hydrochloride Spray on Radiation-Induced Acute Oral Mucositis in Head and Neck Cancer Patients: A Pilot, Randomized, Double-Blind, Active-Controlled Clinical Trial.

Introduction: Oral mucositis (OM) is the most prevalent side effect in patients with head and neck cancer (HNC). It causes an obvious decrease in quality of life (QoL) in these patients, so different medications have been recommended for OM, however, without optimal response. This randomized trial aimed to assess the effects of a honey-lemon spray compared with benzydamine hydrochloride in prevention of radiation-induced OM in patients with HNC. Materials and Methods: Forty-six patients with HNC received external beam radiotherapy for 5 days per week. Patients were randomized to treatment with either benzydamine hydrochloride spray or honey-lemon spray for 5 weeks and continued for 1 week after the end of treatment. The oral cavity was examined weekly, with a score given to each site based on the degree of mucositis using a 4-point scale, and a mean mucositis score was calculated as the primary outcome. Occurrence of OM, pain, QoL, and adverse effects were defined as secondary outcomes. Patients, therapists, and outcome assessors were blinded to group allocation. Results: No significant group differences occurred in the mucositis score, pain, or QoL. Mucositis occurrence rates were higher in the benzydamine hydrochloride group compared with the honey-lemon group (hazard ratio = 2.1, 95% confidence interval: 1.1 to 4.2). Two patients in the honey-lemon group had mild nausea and burning throat; no adverse effects occurred in the benzydamine hydrochloride group. Conclusions: There were no significant group differences in mucositis severity between patients treated with honey-lemon spray and benzydamine hydrochloride. The potential preventive effects of honey-lemon spray need to be confirmed in further trials. The trial registration number is IRCT20161024030467N1.

The effect of three different solutions on preventing oral mucositis in cancer patients undergoing stem cell transplantation: a non-randomized controlled trial: A Turkish study - NON-RANDOMISED TRIAL.

OBJECTIVE: To evaluate the effect of different solutions administered to patients undergoing stem cell transplantation on oral mucositis. METHODS: The non-randomised controlled trial was conducted at a Istanbul Medipol Mega university hospital in Turkey between May 2014 and June 2016, and comprised patients undergoing stem cell transplantation. They were divided into three groups. Group 1 had patients using chlorhexidine gluconate and benzydamine hydrochloride solution. Group 2 had those using calcium and phosphate solution. Group 3 patients were using black mulberry syrup. Data was collected using a structured questionnaire and the World Health Organisation mucositis assessment scale. Assessment was done on days 7, 14 and 21. Clinical significance of oral solutions was statistically determined. RESULTS: Of the 83 patients, 30(36%) were in group 1, 28(34%) in group 2, and 25(30%) in group 3. On day 7, there was no significant difference in terms of grades among the groups (p>0.05). On day 14, grade 2 mucositis was seen in 2(8%) patents in group 3, 5(17.9%) in group 2 and 5(16.7%) in group 1; Grade 3 mucositis was seen in 2(6.7%) patients in group 1, but none in the other two groups. On day 21, grade 3 mucositis was present in 2(8.0%) in group 3, 2(7.1%) in group 2, and 4(13.3%) in group 1. CONCLUSIONS: The use of black mulberry and calcium-phosphate solutions was found to be beneficial in preventing and treating oral mucositis.

Pharmacological modulation of radiation-induced oral mucosal complications.

Radiation-induced mucositis is a common toxicity, especially in patients with head and neck cancers. Despite recent technological advances in radiation therapy, such as intensity-modulated radiotherapy, radiation-induced mucositis is still causing treatment disruptions, negatively affecting patients' long and short term quality of life, and impacting medical resources use with economic consequences. The objective of this article was to review the latest updates in the management of radiation-induced mucositis, with a focus on pharmaceutical strategies for the prevention or treatment of mucositis. Although numerous studies analysing the prevention and management of oral radiation-induced mucositis have been conducted, there are still few reliable data to guide daily clinical practice. Furthermore, most of the tested drugs have shown no (anti-inflammatory cytokine, growth factors) or limited (palifermin) effect. Therapies for acute oral mucositis are predominantly focused on improving oral hygiene and providing symptoms control. Although low-level laser therapy proved efficient in preventing radiation-induced oral mucositis in patients with head and neck cancer, this intervention requires equipment and trained medical staff, and is therefore insufficiently developed in clinical routine. New effective pharmacological agents able to prevent or reverse radio-induced mucositis are required.

Actualización del tratamiento del síndrome de boca ardiente / Upgrade treatment of burning mouth syndrome

El síndrome de boca ardiente se considera un 'dolor urente en la lengua o en otra localización de la mucosa oral sin signos patológicos específicos con evolución de al menos 4-6 meses', según la Asociación Internacional para el estudio del Dolor (IASP). La prevalencia oscila entre el 0,7% - 4,6%, siendo más frecuente en el sexo femenino (7:1) en la etapa peri-postmenopáusica. La etiología es multifactorial, por lo que debemos eliminar los factores locales, sistémicos y psicológicos que como factores precipitantes o consecuentes, están siempre presentes en esta entidad. En cuanto al tratamiento hemos de retirar los agentes causantes de la patología y disminuir en la medida de lo posible la sintomatología. A pesar de haber obtenido resultados con las terapias descritas en las revisiones sistemáticas y en los estudios clínicos son necesarios más ensayos clínicos aleatorizados, con muestras homogéneas, diseños apropiados y periodos de seguimiento prolongados que permitan evaluar la eficacia clínica y los posibles efectos adversos a largo plazo (AU)

Burning mouth syndrome is considered a burning pain in the tongue or in another location of the oral mucosa without specific pathological features with the development in at least 4-6 months, according to the International Association for the Study of Pain (IASP). The prevalence ranges from 0.7% - 4.6%, being more common in females (7:1) in the peri-menopausal stage. The etiology is multifactorial, so we must delete local, systemic and psychological factors as precipitating or consequential factors are always present in this entity. Despite of the results obtained with the therapies described in systematic reviews and clinical studies more randomized clinical trials with homogeneous samples, appropriate designs and longer follow-up periods to evaluate the clinical efficacy and potential adverse effects are needed long term (AU)

Comparative Efficacy of Aloe vera and Benzydamine Mouthwashes on Radiation-induced Oral Mucositis: A Triple-blind, Randomised, Controlled Clinical Trial.

PURPOSE: To compare the efficacy of an Aloe vera mouthwash with a benzydamine mouthwash in the alleviation of radiation- induced mucositis in head and neck cancer patients using a triple-blind, randomised controlled trial. MATERIALS AND METHODS: Twenty-six eligible head and neck cancer patients who were to receive conventional radiation therapy at the radiation oncology department were randomised to receive an Aloe vera mouthwash or a benzydamine mouthwash. Mucositis severity was assessed during the course of radiation therapy using the WHO grading system. RESULTS: At baseline, there was no difference in the distribution of mucositis severity between the two groups. The mean interval between radiation therapy and onset of mucositis was similar for both groups (Aloe vera 15.69±7.77 days, benzydamine 15.85±12.96 days). The mean interval between the start of radiation therapy and the maximum severity of mucositis were was also similar in both the Aloe vera and benzydamine groups (Aloe vera 23.38±10.75 days, benzydamine 23.54±15.45 days). Mean changes of mucositis severity over time in both groups were statistically similar and the effect of both treatments did not change signficantly with time (p=0.09). CONCLUSION: Aloe vera mouthwash was as beneficial as benzydamine mouthwash in alleviating the severity of radiation-induced mucositis and showed no side effects. The Aloe vera mouthwash could be an alternative agent in the treatment of radiation-induced mucositis in patients with head and neck cancers.

Gel de própolis mucoadesivo versus solução de cloridrato de benzidamina na prevenção da mucosite oral em pacientes irradiados em região de cabeça e pescoço. Ensaio clinico, cego, randomizado: fase II / Propolis mucoadhesive gel versus Benzydamine Hydrochloride Solution to Prevention of Oral Mucositis in Patients Irradiated in Head and Neck Region. A phase II study randomized and blind

Os efeitos colaterais mais conhecidos em cavidade bucal, durante a radioterapia para o tratamento de câncer em região da cabeça e pescoço, são a mucosite e a candidose. Essas alterações são potencializadas pela hipossalivação em decorrência de alterações nas glândulas salivares. Existem diversos protocolos para o controle da mucosite, hipossalivação e candidose bucais nesses pacientes, entretanto, nenhum deles é totalmente eficaz. A Própolis possui atividade analgésica, anti-inflamatória, antifúngica e cicatrizante. Essas características farmacológicas conferem à Própolis um grande potencial para prevenir as alterações na cavidade bucal dos pacientes que serão submetidos à radioterapia. O objetivo deste trabalho foi avaliar a efetividade do Gel contendo Própolis na prevenção da mucosite e candidose em comparação com o cloridrato de benzidamina. Vinte e seis pacientes foram incluídos no estudo. Os pacientes foram aleatorizados em dois grupos, sendo que o grupo 1 usou o cloridrato de benzidamina e o grupo 2 o gel de Própolis. Tanto os pacientes do grupo 1 , como os pacientes do grupo 2 usaram os produtos 3 (três) vezes ao dia, durante todo o período da radioterapia e duas semanas após o término do tratamento e todos foram avaliados semanalmente. Os resultados obtidos mostraram que 84,6% dos pacientes eram do sexomasculino e que 19,2% dos pacientes mantinham o hábito de fumar e consumir bebidas alcoólicas. A dose média de radioterapia foi 6466,1 Gys. Após a análise final dos dados, observou-se que o Gel de Própolis apresentou melhor efetividade na prevenção da mucosite, a partir da 17a sessão de radioterapia, quando comparado ao grupo cloridrato de benzidamina. Setenta e oito por cento (78,6%) dos pacientes avaliaram o produto como bom, enquanto 85,7% o indicariam para pacientes com a mesma condição. O estudo mostrou que o controle da inflamação na mucosa bucal pelo Gel contendo Própolis foi melhor...

The best known side effects in the oral cavity during radiotherapy for the treatment of cancer in the head and neck, are mucositis and candidiasis. These changes are enhanced by hyposalivation due to changes in the salivary glands. There are many protocols for the control of mucositis, hyposalivation, and oral candidiasis in these patients however, none iscompletely effective. Propolis has analgesic, anti-inflammatory, antifungal and healing activity. These pharmacological characteristics give propolis great potential to prevent changes in the oral cavity of patients undergoing radiotherapy. The aim of this study was to evaluate the effectiveness of the gel containing propolis in preventing mucositis and candidiasis compared with benzydamine hydrochloride. Twenty-six patients were included in this study. Patients were divided into two groups with group 1 used the benzydamine hydrochloride and group 2 gel propolis. Both group used the products three times a day during the whole period of radiotherapy and two weeks after the end of treatment and all patients were evaluated weekly...

Vaginal dilator therapy for women receiving pelvic radiotherapy.

BACKGROUND: Vaginal dilation therapy is advocated after pelvic radiotherapy to prevent stenosis (abnormal narrowing of the vagina), but can be uncomfortable and psychologically distressing. OBJECTIVES: To assess the benefits and harms of different types of vaginal dilation methods offered to women treated by pelvic radiotherapy for cancer. SEARCH METHODS: Searches included the Cochrane Central Register of Controlled Trials (CENTRAL 2013, Issue 5), MEDLINE (1950 to June week 2, 2013), EMBASE (1980 to 2013 week 24) and CINAHL (1982 to 2013). SELECTION CRITERIA: Comparative data of any type, which evaluated dilation or penetration of the vagina after pelvic radiotherapy treatment for cancer. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed whether potentially relevant studies met the inclusion criteria. We found no trials and therefore analysed no data. MAIN RESULTS: We identified no studies for inclusion in the original review or for this update. However, we felt that some studies that were excluded warranted discussion. These included one randomised trial (RCT), which showed no improvement in sexual scores associated with encouraging women to practise dilation therapy; a recent small RCT that did not show any advantage to dilation over vibration therapy during radiotherapy; two non-randomised comparative studies; and five correlation studies. One of these showed that objective measurements of vaginal elasticity and length were not linked to dilation during radiotherapy, but the study lacked power. One study showed that women who dilated tolerated a larger dilator, but the risk of objectivity and bias with historical controls was high. Another study showed that the vaginal measurements increased in length by a mean of 3 cm after dilation was introduced 6 to 10 weeks after radiotherapy, but there was no control group; another case series showed the opposite. Three recent studies showed less stenosis associated with prophylactic dilation after radiotherapy. One small case series suggested that dilation years after radiotherapy might restore the vagina to a functional length. AUTHORS' CONCLUSIONS: There is no reliable evidence to show that routine, regular vaginal dilation during radiotherapy treatment prevents stenosis or improves quality of life. Several observational studies have examined the effect of dilation therapy after radiotherapy. They suggest that frequent dilation practice is associated with lower rates of self reported stenosis. This could be because dilation is effective or because women with a healthy vagina are more likely to comply with dilation therapy instructions compared to women with strictures. We would normally suggest that a RCT is needed to distinguish between a casual and causative link, but pilot studies highlight many reasons why RCT methodology is challenging in this area.

Effect of chlorhexidine gluconate and benzydamine hydrochloride mouth spray on clinical signs and quality of life of patients with streptococcal tonsillopharyngitis: multicentre, prospective, randomised, double-blinded, placebo-controlled study.

OBJECTIVE: To assess the effect of chlorhexidine gluconate and benzydamine hydrochloride mouth spray, used in conjunction with antibiotic treatment, on the intensity of clinical signs and quality of life of patients with group A streptococcal tonsillopharyngitis. METHODS: Patients (n = 147) with streptococcal tonsillopharyngitis were recruited and randomly allocated to either the treatment group (penicillin plus chlorhexidine and benzydamine; n = 72) or control group (penicillin plus placebo; n = 75). Blinded assessments were conducted before and after 10 days' treatment, using an intensity rating scale for clinical sign severity, a visual analogue scale for subjective health state, the Short Form 36 Health Questionnaire for quality of life, and a customised questionnaire for side effects. RESULTS: The treatment group showed a statistically significant reduction in the intensity of clinical signs, compared with the control group. On treatment day 7, there was no significant difference in quality of life between the treatment and control groups. The treatment drugs were well tolerated, and no serious adverse events were observed. CONCLUSION: Chlorhexidine gluconate and benzydamine hydrochloride mouth spray, added to standard antibiotic treatment, significantly alleviate the intensity of clinical signs in patients with streptococcal pharyngitis. Further research is needed using larger sample sizes or alternative control groups.

Relief of radiation-induced oral mucositis in head and neck cancer.

This study was a prospective, randomized clinical trial carried out to explore the efficacy of payayor in the prevention and relief of radiation-induced oral mucositis compared with benzydamine. Sixty patients with head and neck cancer, who have started to receive radiotherapy and met predetermined criteria, were randomly assigned into each group to use assigned products 3 times a day from the first to the last day of radiation. The first group used glycerin payayor, a Thai prepared herbal product, by dripping it into the mouth. Another group rinsed their mouths with benzydamine hydrochloride. The World Health Organization Mucositis Grading System was used to assess oral status every week and 2 weeks after radiation. Comparison of time to the onset, pain, severity, xerostomia, postponement of treatment, satisfaction of the solution, and body weight between the 2 groups was performed by t test. The average time to the onset of oral mucositis in the payayor group was significantly later, and its severity and pain score were less than those of the benzydamine group throughout the study period. Significantly higher satisfaction with the solution and higher body weight at the end of the study were shown in the payayor group. Payayor seemed to be superior to benzydamine for preventing and relieving radiation-induced oral mucositis.

Chemotherapy-induced oral mucositis: new approaches to prevention and management.

Oral mucositis is a common and significant toxicity of cancer chemotherapy. It is under-reported and not well treated, particularly in patients that receive high-dose therapy with an autologous or allogenic stem cell transplant. Two recently published retrospective analyses of patient complaints following stem cell transplantation have identified oral mucositis as the worst toxicity reported by patients, and what is more important is that patients indicated that oncology healthcare team members do a poor job of managing and providing methods of symptom relief. Twenty percent of patients surveyed indicated they received no symptom relief at all.

Actividad antibacteriana de la bencidamina HCI / Antibacterial activity of the benzidamine HCI

En el presente trabajo se valora la eficacia antibacteriana del colutorio Tantum verde® y la de su, presuntamente, único principio activo, la bencidamina clorhidrato. Para ello, se ensayó la actividad in vitro de la bencidamina HCl y del Tantum verde mediante la obtención de las correspondientes CMI (Concentración Mínima Inhibitoria) siguiendo la técnica de la dilución en medio sólido. Inicialmente, se estudiaron ocho cepas de uso común en el laboratorio y, posteriormente, el estudio fue ampliado a cepas de patógenos bucales aisladas de muestras clínicas. Los estudios realizados, demuestran una eficacia bactericida real frente a patógenos bucales pertenecientes a géneros tales como Actinomyces, Bacillus, Actinobacillus, Veillonella o Streptococcus. Además, el Tantum verde como colutorio posee, en general, una mayor actividad antibacteriana que la demostrada por su principal principio activo, la bencidamina HCl, por lo que cabe pensar que la presencia de etanol a baja concentración, en su composición contribuye de forma notable a la acción antibacteriana (AU)

[Combination therapy of transcutaneous electric nerve stimulation and iontophoresis with benzydamine and diclofenac]. / Kombinationstherapie von Transkutaner Elektrischer Nerven-Stimulation und Iontophorese mit Benzydamin und Diclofenac.

Combined Therapy of Transcutaneous Electrical Nerve Stimulation and Iontophoresis with Benzydamine and Diclofenac. The combination of transcutaneous electrical nerve stimulation (TENS) and the iontophoresis of benzydamine and diclofenac in a counter-current field is a new method in the treatment of chronical pain of the head and neck region. Prior to a clinical study this method was tested in a preliminary examination in 15 healthy volunteers. Clinical and physical data were investigated from which a theoretical maximum value of the quantity of iontophorised non-steroidal antiphlogistics (NSAI) could be calculated. The actual achievable absorption is discussed. Based on these data it is concluded that a good effective tissue concentration of benzydamine and diclofenac can be achieved with iontophoresis by means of TENS.

[Treatment of prostatic disorders with a combination of Prunus africana and benzidamine]. / Tratamiento de las affecciones prostáticas con la combinacion de "prunus" africana y benzidamina.

A combination of Prunus africana and benzidamine has been administered to thirty-seven patients suffering from several prostate processes, with a predominance of prostatites and prostate adenoma into first two phases in the male and pseudoprostatism in the female. The patients' ages ranged between 28 and 82 years. Good results were achieved in 90% of the cases and there was perfect tolerance in 85%. The authors explain the methods of study and discuss the results. As there are no toxic or hormone risks, their final conclusion is to recommend this combination for prostate patients before attempting any other solution.