Chamomilla recutita

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.

To evaluate the effectiveness of an herbal mouthwash containing Matricaria recutita and Mentha piperita to placebo for the control of oral mucositis among patients undergoing hematopoietic cell transplantation (HCT)

Patients were randomized to placebo or the herbal mouthwash. The herbal mouthwash was formulated with 1% peppermint oil, 1% dried extract of Matricaria recutita (chamomile) and ethanol. The placebo was similar in taste, odor, and color. Both formulations were tested to ensure sterility. One week prior to HCT, patients began the intervention, diluting the mouthwash in preboiled water. They were instructed to gargle with the mouthwash for 30 seconds and then spit it out. The mouthwash was used three times daily after meals. All patients were instructed in oral care and used salt and chlorhexidine mouthwashes three times daily.

• N = 60   
• MEAN AGE = 36.44 years
• MALES: 44.3%, FEMALES: 55.7%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: All were undergoing HCT. Cancers were leukemia, lymphoma, and multiple myeloma.

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Iran

PHASE OF CARE: Active antitumor treatment

Double-blind, placebo-controlled, randomized, controlled trial

• Common Terminology Criteria for Adverse Events (CTCAE) mucositis scale
• Oral mucositis daily assessment
• Symptom severity measured on 0–10 numeric rating scale

No difference in incidence of oral mucositis or time of onset existed between groups. The duration of mucositis was less in the treatment group (p < 0.0001). Patients in the treatment group had lower maximum grades of mucositis (p = 0.006) and lower average daily mucositis grades (p = 0.04). Pain (p = 0.009), oral dryness (p = 0.04), and dysphagia (p = 0.0009) were less severe in the treatment group. Fewer patients in the treatment group required additional treatments, such as narcotics for pain or parenteral nutrition (p < 0.05).

Oral rinses with a chamomile and peppermint mouthwash was associated with a lower severity and shorter duration of oral mucositis.

• Small sample (< 100)
• Measurement/methods not well described
• Timing of study measures and analysis of repeated measures were not well described.

The findings suggest that an oral rinse containing chamomile and peppermint may be helpful for the management of oral mucositis in patients undergoing HCT. Oral mucositis is a common toxicity with high-dose chemotherapy, and few interventions have been shown to be effective. Additional research on the use of chamomile for oral rinses is warranted, and research should include evaluation of oral rinses as an adjunct to other interventions shown to have efficacy.