Pycnogenol

Evaluate and compare effectiveness of topical vitamin E and pycnogenol (pine bark extract) in treatment of chemotherapy-induced oral mucositis.

Children were randomly assigned to the use of vitamin E, pycnogenol, or sterile water rinses. All were also to follow a uniform oral care protocol, including brushing with a soft tooth brush and chlorhexidine mouth rinse 3 times/day. All study interventions were applied topically three times a day using a dropper. Medications were stored in a refrigerator before usage. The medication was kept in the patient’s mouth for 30 seconds and then swallowed. Patients were blinded to the treatment group. Patients were followed for seven days.

The study was comprised of 72 patients, with a mean age of 9.25 and a range of 6-15 years.

MALES 79%, FEMALES 21%

KEY DISEASE CHARACTERISTICS: All had hematological cancers, including ALL, AML, and NHL, and all were in induction or intensification phases of treatment.

SITE: Single site

SETTING TYPE: Multiple settings

LOCATION: India

PHASE OF CARE: Active antitumor treatment

APPLICATIONS: Pediatrics

 Single, blind, randomized placebo controlled

• WHO oral mucositis grading scale
• Oral Mucositis Assessment Scales (OMAS)
• Children’s International Mucositis Evaluation Scale
   

Mucositis grades in those receiving either vitamin E or pine bark extract were significantly lower than those on placebo (p </= 0.006). OMAS scores declined significantly and consistently across days 1-7, while these scores remained the same in the placebo group. There was significant improvement in pain scores in both intervention groups from day 4 onward, compared to placebo. There were no significant differences in study outcomes between those treated with vitamin E or pine bark.

Topical vitamin E and pine bark extract (pycnogenol) were of benefit in reducing severity of mucositis and pain associated with mucositis in these patients.

• Small sample (<100)
• Risk of bias (no blinding)
• Unintended interventions or applicable interventions not described that would influence results.*
• Other limitations/*explanation. Short study duration. Baseline mucositis scores not described, and it is not known if there were differences between study groups at baseline. ANOVA was used, but it is not clear what the potential time effect was, as mucositis declined in all subjects. Patients were blinded, but evaluators were not. There is no information provided regarding compliance with the oral care regimen, though it is stated that compliance was evaluated, it is not clear how. There is no information provided about use of analgesics.

Topical vitamin E and pine bark extract may have some promise for the management of oral mucositis. Further research on these interventions is warranted.