Effects of mouth-rinse with sesame oil on chemotherapy-induced oral mucositis in patients with hematologic cancer

Abstract

[한글]본 연구는 혈액암환자에서 화학요법에 의해 초래된 구내염에 다량의 항산화물질을 함유한 참기름 함수의 효과를 시험하기 위한 비동등성대조군 시차설계를 기초로한 임상실험연구이다.자료수집 기간은 2004년 3월부터 2005년 10월까지였고, 연구대상은 서울시에 위치한 G 대학병원 혈액암병동에 입원한 환자로 본 연구의 대상기준에 부합되는 환자 18명을 대상으로 하였다. 구내염이 발생되면 OAT와 통증척도를 이용하여 구매염정도 통증을 사정한 다음, 실험군에게는 참기름 5ml를, 대조군에게는 클로르헥시딘 5ml를 1일 5회 1분간 함수하도록 한 후 구내염이 사라질 때까지 매일 아침 10시에 구내염정도와 통증을 사정하였다. 수집된 자료는 SPSS/WIN 12.0을 이용하여 두 그룹의 인구학적 임상적 차이는 t-test와 chi제곱으로분석하였고, 두 그룹의 구내염 점수, 구내염기간 그리고 통증정도와 변화추세는 Repeated ANOVA로 분석하였다.본연구에서 가설검증 결과는 다음과 같다. 1. 제1가설 : “참기름을 제공받는 실험군의 구내염 점수가 클로르헥시딘을 제공받는 대조군의 구내염점수보다 낮을 것이다”는 실험군의 구내염 점수가 대조군보다 통계적으로 유의하게 낮았고 (p=0.0001), 구내염의 변화추세 검증을 위한 분석에서도 두 그룹의 구내염회복 추세에 유의한 차이를 보여 (F=4.22, p=0.0001) 지지되었다.2. 제2가설 : “참기름을 제공받는 실험군의 구내염 기간이 클로르헥시딘을 제공받는 대조군의 구내염 기간보다 더 짧을 것이다”는 실험군의 구내염 기간이 대조군보다 통계적으로 유의한 것으로 나타나 (F=10.05, p=0.0085) 지지되었다. 대조군의 구내염 기간은 19.11(±7.20) 이었고, 실험군은 10.67(±3.46)으로 나타났다.3. 제3가설 : “참기름을 제공받는 실험군의 통증점수가 클로르헥시딘을 제공받는 대조군의 통증점수 보다 낮을 것이다”는 실험군의 통증 점수가 대조군보다 통계적으로 유의하게 낮았고 (p=0.0001), 통증의 변화추세 검증을 위한 분석에서도 두 그룹의 통증회복 추세에 유의한 차이를 보여 (F=12.77, p=0.0018) 지지되었다.결론적으로, 다량의 항산화물질을 함유한 참기름 함수는 항암화학요법으로 인해 발생하는 구내염의 심각성, 기간, 통증에 기존의 chlorhexidine 함수보다 더 효과적인 것으로 나타났다

[영문]Oral mucositis is a significant health concern in patients with hematologic cancer who are undergoing chemotherapy. It causes pain, interferes with nutritional intake and communication, and decreases well-being of the patients. It can also serve as a source of serious infection. Current management of oral mucositis has not always been effective. The purpose of this study was to examine the effect of sesame oil on oral mucositis induced by chemotherapy in patients with hematologic cancer.Using a nonequivalent control group and non-synchronized design, a clinical trial was conducted to compare the effect of sesame oil mouth-rinse with that of usual care. Patients diagnosed with hematologic cancer who had developed chemotherapy-induced oral mucositis were recruited and assigned into either the experimental (sesame-oil, n=9) or control (usual care, n=9) group. Participants in the experimental group received sesame oil gargle 5 times a day, whereas participants in the cont기 group received the usual care consisted of chlorhexidine gargles 5 times a day. Data collection was initiated at the onset of oral mucositis daily at 10 a.m. using the Oral Assessment Tool until the resolution of oral mucositis. The data were collected between March 2004 and August 2005 in G university hospital in Seoul.The data were analyzed using SPSS/WIN 12.0. Baseline group differences in demographic and clinical data were analyzed using t-tests and chi-square tests. Group differences changes over time and the group by time interactions for oral mucositis score, duration of oral mucositis, and pain were analyzed using Repeated measures ANOVA. Differences between the control and experimental group for oral mucositis scores, oral mucositis duration and pain scores according to daily time interval were analyzed using MANOVA. The results of the study are as follows:1) For the 1st hypothesis, “the severity of oral mucositis in patients in the experimental group receiving sesame oil will be lower than those in the control group receiving usual care with chlorhexidine”, there was a significant difference in oral mucositis score between the two groups (F = 6.55, p = 0.0184), indicating that the experimental group had significantly lower severity of oral mucositis than the control group. Similarly, there were significant changes over time (F = 8.19, p = 0.0001) and the group by time interactions (F = 4.22, p=0.0001) indicating that the severity of oral mucositis decreased over time was also statistically different. Moreover, the oral mucositis according to daily time interval between the control and experimental group was significantly different from day 9. Therefore, the 1st hypothesis was supported.2) For the 2nd hypothesis, “oral mucositis duration in participants in the experimental group receiving sesame oil will be shorter than those in the control group receiving usual care with chlorhexidine”, there was a significant group difference in the duration of oral mucositis (F = 10.05, p = 0.008) between the two groups. The mean duration of oral mucositis in experimental group treated with sesame oil was 10.67 (±3.46) days, compared with 19.11 (±7.20) days in the control group. The duration of healing ranged 6-18 days in the experimental group compared with 8-25 days in the control group. Therefore, the 2nd hypothesis was supported.3) For the 3rd hypothesis, “The pain score for participants in the experimental group receiving sesame oil will be lowered than those in the control group receiving usual care with chlorhexidine”, there was a significant difference in pain score between the two groups (F = 12.77, p = 0.018), indicating that the experimental group had significantly lower pain score than the control group. Similarly, there were significant changes over time (F = 9.12, p = 0.0001) and the group by time interactions (F = 2.19, p=0.0055) indicating that the pain of oral mucositis decreased over time was also statistically different. The pain score according to daily time interval between the control and experimental group was significantly different from day 9. Therefore, the 3rd hypothesis was also supported.In conclusion, the findings of the study demonstrate that mouth-rinse of sesame oil, containing abundant antioxidants, is more effective than the current usual care with chlorhexidine in reducing the severity, duration, and pain of chemotherapy-induced oral mucositis in patients with hematologic cancer.