Povidone Iodine

Database searched was MEDLINE (1993–2003) for randomized, controlled trials evaluating mucositis interventions.

A total of 50 randomized controlled trials were presented. Other trials and papers were referenced.

• Sample sizes ranged from 10–222.
• Patients were treated with chemotherapy, radiotherapy, and bone marrow transplantation.

The author concluded that most agents require more study.

• Evidence for cryotherapy and bolus 5-fluorouracil was strong.
• Sucralfate studies produced conflicting results and included varying doses and administration frequencies, making comparisons difficult. Most studies indicated no difference in severity or duration. The validity and reliability of the data were questioned because of the measurement scales used.
• Similarly, studies of cytokine-like agents used different doses, making comparisons difficult.
• Moderate evidence suggested that benzydamine is effective in relieving mouth pain caused by radiation-induced mucositis in patients with head and neck cancer. The agent requires additional investigation and study for chemotherapy-induced mucositis.
• Large studies of chlorhexidine mouthwashes have failed to show significant findings; however, the studies may have had inadequate sample sizes, as power analyses were not performed.
• Povidone-iodine showed significant reduction in onset, incidence, total duration, and worst grade of mucositis for patients with head and neck cancer undergoing radiation with carboplatin in two studies. Both studies had sample sizes of 40. Given these sample sizes and specific populations, generalizability of the findings was restricted.
• Oral hygiene protocols were shown to reduce the duration and severity of mucositis; however, the content of the protocols was not proven.

The author noted the problem of variation in study protocols, insufficient sample sizes, and a lack of consensus regarding the scoring system for mucositis.

The author noted the need to include psychotherapeutic interventions and management and pointed out the lack of a quality-of-life tool for mucositis.

The effect of three test mouthwashes and a control were studied.

1. 0.12% chlorhexidine
2. 1% povidone-iodine
3. salt/sodium bicarbonate
4. plain water (control)

Coloring agents, sweeteners, and flavoring agents were added to the mouthwashes so that all had identical color and taste. All were alcohol free.

Patients rinsed mouths with 10 ml of mouthwash BID for six weeks. Patients swished for about two minutes and expectorated, then abstained from eating or gargling for 30 minutes.
 

The study was comprised of 20 patients in each arm of study.

Adult patients with stage II–IV head and neck malignancy scheduled to receive RT of 60 Gy or higher, delivered in 30 fractions over a six-week period.

At least one-third of oral cavity mucosa was included in the radiation field.

Powered for 20 subjects in each arm; 76 completed.

The median age was 54.25–58.2 years.

More men participated than women.
 

July 2003–January 2004

Double-blind, placebo-controlled, randomized clinical trial

Compliance was assessed weekly by checking the level of mouthwash left in bottles.

Mucositis WHO– single examiner

Primary endpoint of study was the end of week 6.
 

Significant difference in mean mucositis scores was observed among all four groups. Post hoc analysis for repeated measure showed a statistically significant difference between the povidone group and control group (p = 0.013) at the end of week 1.

At the end of week 2, povidone, chlorhexidine, and salt/soda groups differed significantly from the control group.

At the end of week 4, significant differences also were observed between the povidone and salt/soda groups (p = 0.16).

At the end of week 5, significant differences were observed between all test groups and the control group. Differences also were observed within test groups.

At the end of week 6, a slightly different trend was observed. Significant differences were observed between the povidone group and all other groups; difference in mucositis among other groups was not statistically significant.
 

Although the volume of solution used was checked weekly, data does not indicate compliance.

No data is available regarding treatment delay.
 

The goal of the study was to define the role of anti-microbial solutions.

Two groups of patients were compared: Normal saline mw povidone-iodine mw.
Group A used NS for oral rinsing and Group B use povidone-iodine diluted 1:100 water. The solutions were blinded to patients. Study nurse started first day and covered the whole inpatient stay. It was a 2 min gargle 4x/day IN the presence of OM the mouthwashes could be more frequent according to patients' wishes. Used soft toothbrush 4 x/day. If bleeding occurred would do only MW

Mouthwash was blinded.

The study was comprised of 132 patients. Patients were treated with hi-dose BEAM or HD-LPAM followed by APSCT.

Study group A had 65 pts or group B had 67 patients, NS or povidone iodine.
 

Multicenter

Jan 2002- June 2004

Prospective, randomized

• OM assessed daily
• WHO scale
• VAS for tolerability
• Temp, oral smears
• Blood cultures with fever
   

No significant difference with oral mucositis (p = 1.0) characteristics in both groups and fever of unknown origin (p = 1.0) and other infections (p = 0.34). Povidone-iodine was less tolerable.

No healing effect with betadine.

OM occurred more significantly in females than in males (p = .0016) and was worse and of longer duration.
 

Patients disliked the taste of povidone-iodine, less use of povidone-iodine.

Note appropriate dose of povidone-iodine.

All patients received initial tooth brushing with a dental brush by a dentist and scaling to teeth with an ultrasonic scaler.

Special care group:
Dentist performed oral care with irrigation and suctioning for 15 minutes three days per week for two to four weeks between 7:00 pm and 8:00 pm after dinner. 20 ml of 0.5% povidone-iodine was ejected through the e-brush, then suctioned. This was done in the mouth, sides of the teeth, tongue, and mucosal surfaces. Patients rinsed with 0.5% povidone-iodine to clean the oral cavity. A combination of physical and chemical cleaning was used.
 

Patients with newly diagnosed esophageal squamous cell carcinoma (SCC) treated with chemoradiotherapy

The study was comprised of 40 patients (20 in the regular oral care group and 20 in the e-brush group).

The mean patient age was 66.2 years (SD = +/– 7.9 years) and 58.0 years (SD = +/– 6.3 years), respectively.
 

October 2003–January 2005

RCT

Oral mucositis was diagnosed by a dentist, assessed every Monday, Wednesday, and Friday.

Japan clinical oncology group criteria-based on NCI-CTC

Bacterial analysis
 

Incidence of oral mucositis was significantly lower in the special care group (4 of 20 [20%] versus 11 of 20 [55%] [p = 0.048]).

Induced stable microflora consisting of oral streptococci
 

Small study; labor intensive intervention; unclear about costs