CHAPTER -II

REVIEW OF LITERATURE

A review of relevant literatures was collected to generate a picture of what is known about a particular situation. Relevant literature to those sources that are important in providing in depth knowledge related to make changes in practice or to study a selected problem.

Literatures relevant for this study reviewed and have been organized in,

2.1 Research studies related to oral mucositis

2.2 Research studies related to effectiveness of povidone iodine mouthwash

2.3 Research studies related to effectiveness of chlorhexidine mouthwash

2.4 Research studies related to effectiveness of povidone iodine mouthwash and chlorhexidine mouthwash

2.1 Research studies related to oral mucositis: A prospective observational study was conducted to examine the burden of mucositis and risk of complications in head and neck cancer patients receiving radiation with or without chemotherapy. Oral mucositis was assessed two, four and six weeks by using questionnaire for head and neck cancer. A 12 team instrument was used to measuring mouth and throat soreness and pain and limitation in oral functions. Data was collected at every weeks and results showed that oral mucositis was initially developed who is with radiation therapy and severe mucositis and throat soreness occurred in 76 percent of patients (Bjarnason, G.,2005).

Oral mucositis is a common and significant problem of cancer chemotherapy, especially patients who receives high-dose therapy. Two recently published retrospective analyses of patient complaints following chemotherapy 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 (Ronald., 2005).

A descriptive study was conducted to find out the incidence of oral mucositis in cancer treatment. Patients receiving radiation therapy and chemotherapy were included in the study. Patients oral cavity was assessed weekly and identified that patients receiving chemotherapy oral mucositis usually develops from 10 to 12 days of administration and in radiation therapy mucositis occurred after 7 to 10 days of administration, the incidence and severity was high in patients receiving both (Verdi. C.,2005).

A study was conductd to explore the relationship between oral mucositis and selected clinical and economic outcomes of patients with radiation and chemotherapy. Subjects who were participated in this study consisted of 92 patients from eight centers. Oral mucositis scoring system (Oral Mucositis Assessment Scale) was used to assess oral mucositis and examined the relationship between patients peak oral mucositis scores and days with fever, the occurrence of infection, days of total parenteral nutrition (TPN), and days of injectable narcotic therapy, days in hospital, total hospital charges for the index admission, and vital status at 100 days. Results showed that Patients’ peak oral mucositis scores reached the full range of possible values (0 to 5) and were significantly (P<0.05) correlated with all of the outcomes and it revealed that oral mucositis is associated with significantly worse clinical and economic outcomes in cancer treatment ( Fayed, L.,2004).

2.2 Research studies related to effectiveness of povidone iodine mouthwash on radiation or chemotherapy induced oral mucositis: A randomized double blind clinical study was conducted to determine and compare the efficiency of povidone iodine mouthwash, chamomile and normal saline mouthwash for the treatment of oral mucositis. The study was conducted on 83 patients who receiving chemotherapy and have oral mucositis. ANOVA and ‘t’test was used for data analysis. Significant difference was found between povidone iodine mouthwash, chamomile and normal saline group in the score of severity of stomatitis (p=0.017), stomatitis pain (p=0.027). The findings indicated that povidone iodine mouthwash and chamomile have equal efficiency in chemotherapy induced oral mucositis as compared to the normal saline group

( Farrington, M.,2010).

A prospective randomized controlled trial was conducted to assess the efficiency of povidone iodine mouthwash on radio and chemotherapy treatment with 40 patients undergoing radiation or chemotherapy in head and neck region. Twenty patients rinsed povdone iodine mouthwash four times daily while other group for comparison rinsed with sterile water. Clinical examination of oral mucositis was done weekly. In povidone iodine group the mean oral mucositis grade was 1 and in the comparison group mean oral mucositis grade was 3. The study also showed that duration of healing of oral mucositis in povidone iodine group was 2.75 weeks and in the control group it was 9.25 weeks. This showed that the incidence, severity and duration of radiotherapy and chemotherapy induced oral mucositis can be significantly reduced by oral rinsing with povidone iodine mouthwash (Fleischer,W., 2007).

The wide antiseptic effects including antiviral, antibacterial, and antifungal efficacy and good tolerability have resulted in the frequent use of povidone-iodine (PVP-iodine) as a preventive and therapeutic drug in radiotherapy- and chemotherapy-induced oral mucositis. A prospective randomized trial using prophylactic PVP-iodine mouthwashes in addition to standard treatment with topical nystatin, rutosides, panthenol and systemic immunoglobulin demonstrated a reduction in the incidence, severity, and duration of oral mucositis in 40 patients with head and neck cancer (Velicer,C.,2001).

2.3 Research studies related to effectiveness of chlorhexidine mouthwash on radiation or chemotherapy induced oral mucositis: A randomized control trail was conducted to assess the effectiveness of chlorhexidine mouthwash on oral mucositis in patients receiving chemotherapy, total of 130 patients were participated in a clinical trial with pre-post design and single blind system. Subjects were divided into two groups using chlorhexidine mouthwash and placebo as control group. Patients in two groups received daily oral hygiene instructions and were examined daily until the mucositis heal. The results showed that mucositis and its related pain were disappeared after 8 to 14 days and 13 to 14 days respectively (Setiawan., 2004).

A prospective randomized cross over study was conducted to assess the effectiveness of two oral care protocols differing in the type of mouthwashes. The mouthwashes used for this study were chlorhexidine versus benzydamine. Forty patients undergoing chemotherapy were allocated to receive chlorhexidine first and then benzydamine protocol. Subjects were evaluated in intervals of 3 to 4 days by using WHO grading for mucositis and 10cm visual analogue scale for oral symptom evaluation. The results showed that a significant difference in mean area of oral mucositis grade for subjects received chlorhexidine mouthwash compared to those received benzydamine and revealed that chlorhexidine may be helpful in palliating mucositis symptoms in chemotherapy (Cheng, K.F.,2003).

A randomized double blind study was conducted to determine whether chlorhexidine mouthwash could alleviate radiation induced oral mucositis. Patients were scheduled to receive radiation therapy to include greater than one third of oral cavity mucosa were selected for the study. Twenty five patients were randomized to receive the chlorhexidine mouthwash, while twenty four received placebo mouthwash. The result showed that chlorhexidine mouthwash provided benefit to patient receiving radiation therapy to the oral mucosa and suggesting that chlorhexidine mouthwash is determental in clinical situation (Gulavita, S et al., 2000).

2.4 Research studies related to effectiveness of povidone iodine mouthwash and chlorhexidine mouthwash on radiation or chemotherapy induced oral mucositis: An experimental study was done to assess the effect of three alcohol-free mouthwashes on radiation-induced oral mucositis in patients with head and neck malignancies. Eighty patients with head and neck malignancies, scheduled to undergo curative radiotherapy, were randomly assigned to receive one of the three alcohol-free test mouthwashes (0.12% chlorhexidine, 1% povidone-iodine, or salt/soda) or a control. The patients were instructed to rinse with 10 ml of the mouthwash, twice a day, for a period of 6 weeks. Mucositis was assessed at baseline and at weekly intervals during radiation therapy, using the World Health Organization criteria for grading of mucositis. Among the 76 patients who completed the study, patients in the povidone-iodine group had significantly lower mucositis scores when compared to the control group from the first week of radiotherapy. Their scores were also significantly lower when compared to the salt/soda and chlorhexidine groups from the fourth and fifth week, respectively, after radiotherapy. This study shows that use of povidone-iodine mouthwash can reduce the severity and delay the onset of oral mucositis due to antineoplastic radiotherapy (Kumar,M., 2008).

The effectiveness of commonly used mouthwashes for the prevention and treatment of chemotherapy-induced oral mucositis: a systematic review of daily chlorhexidine mouthwash was often recommended for preventing chemotherapy-induced oral mucositis. Povidone-iodine, NaCl 0.9%, water salt soda solution and chamomile mouthwash were also recommended. However, the effectiveness of these mouthwashes was unclear. A systemic review was conducted to assess the effectiveness of mouthwashes in preventing and treating chemotherapy-induced oral mucositis. Based on study quality, three out of five randomized controlled trials were included in a meta-analysis. The results failed to detect any beneficial effects of chlorhexidine as compared with sterile water, or NaCl 0.9%. The severity of oral mucositis was shown to be reduced by 30% using a povidone-iodine mouthwash as compared with sterile water in a single randomized controlled trial. These results do not support the use of chlorhexidine mouthwash to prevent and treat oral mucositis. (Potting,C., 2006).

Meta analysis was done to evaluate the effectiveness of intervention for the prevention and management of oral mucositis in cancer patients treated with head and neck radiotherapy and chemotherapy by using randomized clinical trials. The main aim of the study was the prevention of oral mucositis in cancer patients undergoing head and neck radiation. The Meta analysis included 45 studies in which different interventions were evaluated. The interventions were local application of chlorhexidine mouthwash, povidone iodine mouthwash, oral cooling and administration of amifosline. The results showed that no single intervention completely prevent or treat oral mucositis

( Stockman, M.A., 2006).