Braga, F.T., Santos, A.C., Bueno, P.C., Silveira, R.C., Santos, C.B., Bastos, J.K., & Carvalho, E.C. (2014). Use of Chamomilla recutita in the prevention and treatment of oral mucositis in patients undergoing hematopoietic stem cell transplantation: A randomized, controlled, phase II clinical trial. Cancer Nursing. Advance online publication. 

To identify the dosage of the liquid extract Chamomila recutita (C recutita) in mouthwash needed to reduce the incidence and intensity of oral mucositis in adult patients undergoing allogenic ​hematopoietic stem cell transplantation (HSCT)

Forty patients were randomized to one of four groups to receive routine care or routine care plus mouthwash containing a liquid extract of C recutita at .5%, 1%, or 2%. The liquid extract of C recutita was obtained at a one to one ratio by a percolation test, and the extract was standardized in 10.7 mg/mL of apigenin-7-glucoside, 20.8% w/v of dry residue, with a density of 1,002 g/mL. The final product had a pH range of 5.42–5.7, a relative density of 1.03 g/mL, and a total bacterial, fungal, and yeast count of less than 10 UFC/g. Patients receiving the intervention used the solution twice per day for one minute, one hour before breakfast and dinner beginning on the first day of conditioning and ending when oral mucosa healed or a granulocyte count exceeded 500 mm³ for three consecutive days (if a patient did not develop mucositis). Patients were instructed to spit out the solution. All patients received the standard of care, which included training for patients to brush their teeth and tongues at least three times per day and after meals, to use an extra-soft toothbrush and nonabrasive toothpaste, to remove dental devices, and to rinse with a .12% chlorhexidine solution twice per day. Data were collected daily from the start to the conclusion of the intervention period. 

• N = 40  
• MEAN AGE = 36.4 years
• MALES: 62%, FEMALES: 38%
• KEY DISEASE CHARACTERISTICS: The most frequent diseases recorded at baseline were aplastic anemia (9), acute myeloid leukemia (9) and acute lymphoblastic leukemia (8). The conditioning regimens were busulfan with cyclophosphamide, fludarabine with melphalan, and fludarabine with busulfan.
• OTHER KEY SAMPLE CHARACTERISTICS: Patients undergoing HSCT were recruited between January and August 2011 at a Brazilian cancer hospital.

• SITE: Single-site    
• SETTING TYPE: Inpatient    
• LOCATION: Brazilian Cancer Hospital

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care, palliative care 

Randomized, phase II clinical trial

• World Health Organization (WHO) scale for oral toxicity
• Likert scale to measure tolerability of intervention (taste, smell, and color)
• Likert scale to measure nausea and vomiting

The experimental group at the 1% dosage (30%, n = 3) demonstrated a reduced incidence of oral mucositis compared to the control group (90%, n = 9; p = .01), a reduced intensity compared to the control group (p = .01), and a reduced duration of oral mucositis (intervention mean = 1.9 days, control mean = 5.7 days; p = .01). The formulation was well-tolerated by patients, and it was considered safe as no moderate to severe adverse effects were identified. Of the patients who received the 2% solution, 40% (n = 4) did not develop mucositis. Patients receiving the 1% solution had the fewest ulcerative lesions (30%), and the control group had the most (90%). In this study, 84% of patients receiving any dose of the intervention rated the solution as “pleasant” or “very pleasant” with only mild side effects reported in any group.

The use of mouthwash containing 1% C recutita extract is associated with a reduced incidence, intensity, and duration of mucositis in adult patients undergoing allogenic HSCT. Patients using the C recutita solution found it tolerable, and only minimal side effects were reported by the patients in this study.

• Small sample (< 100)
• Risk of bias (no blinding)
• Other limitations/explanation: It is unclear whether other interventions were used during this study to treat mucositis.

The findings of this study provide grounds for a phase III clinical trial involving a larger number of subjects. The results of this investigation will help nurses and other health professionals in choosing the dosage of C recutita to be used to manage oral mucositis in patients undergoing HSCT. Research is limited at this time.