Randomized Double-Blind Placebo-Controlled Study of Salivary Substitute with Enzymatic System for Xerostomia in Patients Irradiated in Head and Neck Region.

This study aims to compare whether the use of a salivary substitute including an enzymatic system clinically reduces the intensity of xerostomia, as well as exploring the impact that this has on the quality of life, in patients who had received radiotherapy in the head and neck (HNC) region. Forty patients who had completed radiotherapy treatment within 6 months to 1 year previously were allocated into an Enzymatic Spray group (n = 21) or a Placebo arm (n = 19). It should be noted that two patients in the Placebo arm declined to participate during phase 2 of the study. All patients were randomized and used both products three times a day for 30 days. For analysis, xerostomia grade, unstimulated (UWS) and stimulated (SWS) salivary flow rate, and quality of life through the University of Washington Quality of Life Questionnaire validated in Portuguese (UW-QoL) were assessed in two phases: Phase 1 (before the use of the products) and Phase 2 (after 30 days of using the products). All clinical data were collected from medical records. Analyzing the salivary substitute with the enzymatic system, an improvement in xerostomia complaints was observed 30 days after using the product; however, this difference was not statistically significant (p > 0.05). Regarding quality of life, no significant differences were observed in relation to the UW-QoL and saliva domain between the groups in the two phases of the study (p > 0.05). The salivary substitute with the enzymatic system may be effective in reducing radio-induced xerostomia symptoms; however, further research is necessary to evaluate the efficacy of this salivary substitute on oral health.

Estudo randomizado duplo-cego e placebo controlado do substituto salivar com sistema enzimático para xerostomia em pacientes irradiados em região de cabeça e pescoço / Randomized double-blind, placebo-controlled study of salivary substitute with enzymatic system for xerostomia in patients irradiated in the head and neck region

Xerostomia e/ou hipossalivação é uma das mais frequentes complicações orais em pacientes irradiados em região de cabeça e pescoço, com importante impacto na qualidade de vida ao longo do tempo. O objetivo do estudo, foi avaliar a eficácia do Bioxtra Spray® na redução da intensidade de xerostomia e seu impacto na qualidade de vida em pacientes que foram irradiados em região de cabeça e pescoço pela técnica de Radioterapia de Intensidade Modulada (IMRT) ou Radioterapia Conformada Tridimensional (RTC3D), em um período de 8 a 9 meses após o término do tratamento. Foi realizado um estudo prospectivo, randomizado, duplo cego e placebo controlado, com um total de 40 pacientes alocados no Grupo Placebo (n=19) ou Bioxtra Spray® (n=21). Os pacientes utilizaram ambos os produtos três vezes ao dia durante 30 dias. Para as análises, foram realizadas a avaliação da intensidade da xerostomia, avaliação da taxa de fluxo salivar não estimulada e estimulada através da sialometria e a avaliação da qualidade de vida através do Questionário de Qualidade de Vida da Universidade de Washington, validado em português (QQV-UW) em 2 fases: Fase 1 (antes do uso de ambos os produtos); Fase 2 (após 30 dias de uso dos produtos). Em relação à intensidade da xerostomia, não foram observadas melhoras significativas da queixa de boca seca após 30 dias de uso do Bioxtra Spray®( p>0,05). Analisando os exames de sialometria, foi observado que, após 30 dias de uso, o Grupo Bioxtra Spray® apresentou saliva não estimulada e estimulada significativamente maior quando comparado ao Grupo Placebo (p<0,05). Em relação à qualidade de vida, de maneira geral o Grupo Placebo apresentou melhores escores gerais dos domínios do QQV-UW quando comparados ao Grupo Bioxtra Spray® nas duas fases do estudo (p<0,05). Não foram observadas diferenças significativas em relação ao domínio saliva do QQV-UW entre os grupos nas duas fases do estudo. Interessante observar que os pacientes de ambos os Grupos que foram submetidos à técnica IMRT apresentaram índices tanto na taxa de fluxo salivar quanto na qualidade de vida significativamente melhores em ambas as fases do estudo quando comparados à técnica RTC3D. Por fim, concluímos que o Bioxtra Spray®, na metodologia estudada, não apresentou resultados positivos na lubrificação oral e na qualidade de vida dos pacientes. Contudo, estudos em longo prazo que avaliam seu efeito enzimático na proteção dos tecidos orais são recomendados

Xerostomia and/or hyposalivation are common oral complication in patients irradiated in the head and neck region with an important impact on quality of life over time. The aim of this study was to evaluate the effectiveness of Bioxtra Spray® in reducing xerostomia intensity and its impact on the quality of life of patients who were irradiated in the head and neck region by the Intensity Modulated Radiation Therapy (IMRT) or Three Dimensional Conformal Radiotherapy (RTC3D) over a period of 6 months to 1 year after the end of treatment. A prospective, randomized, double-blind, placebo-controlled study was performed, with a total of 40 patients allocated to the Placebo Arm (n= 19) or Bioxtra Spray® (n = 21). Patients used both products three times a day for 30 days and for the analyzes, the evaluation of xerostomia grade, evaluation of the unstimulated and stimulated salivary flow rate through sialometry and the evaluation of quality of life through the University of Washington Quality of Life Questionnaire, validated in Portuguese (UW-QoL) were performed in 2 phases: Phase 1 (before the use of both products); Phase 2 (after 30 days of using both products). Regarding xerostomia grade, no significant improvement in dry mouth complaints was observed after 30 days of use (p> 0.05). Analyzing the sialometry exams, it was observed that after 30 days of use, the Bioxtra Spray® Group showed unstimulated and stimulated salivary flow rate significantly higher when compared to the Placebo Arm (p <0.05). Regarding quality of life, in general, the Placebo Arm had better overall scores than in the UW-QoL domains when compared to the Bioxtra Spray® Group in the two phases of the study (p <0.05). No significant differences were observed in relation to the UW-QoL saliva domain between the groups in the two phases of the study. It is interesting to note that patients from both Groups who underwent the IMRT technique showed significantly better rates of salivary flow and quality of life in both phases of the study when compared to the RTC3D technique. In conclusion, we observed that Bioxtra Spray® did not present positive results in oral lubrication and in patients' quality of life. However, studies evaluating its enzymatic effect in protecting oral tissues are recommended