Oliveira, S.S., Del Giglio, A.B., Lerner, T.G., Zanellato, R.M., Tiemi, L., Reifur, L., . . . Del Giglio, A. (2013). Paullinia cupana for control of hot flashes in breast cancer patients: A pilot study. Einstein (Sao Paulo, Brazil), 11, 435–438. 

To evaluate the efficacy of Paullinia cupana in decreasing the number and severity of hot flashes in breast cancer survivors

The intervention consisted of 50 mg of dry extract of Paullinia cupana taken orally twice per day for six weeks. If patients presented unacceptable side effects, the intervention was stopped or the patient was removed from the study. All patients were trained to record each hot flash from a week before the initiation of the study until the sixth week. Severity was classified using published reports. The moments that were recorded took place at beginning of week 2 and then weekly until week 6. During each visit, patients' diaries were reviewed to check the severity of symptoms.

• N = 15  
• AGE RANGE = 36–65 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer survivors undergoing hormonal treatment at least three months after chemotherapy or radiotherapy treatment
• OTHER KEY SAMPLE CHARACTERISTICS: May be on aromatase inhibitors or tamoxifen; must be having > 14 hot flashes per week

• SITE: Not specified
• SETTING TYPE: Not specified
• LOCATION: Brazil

• PHASE OF CARE: Transition phase after active treatment

Phase-II pilot study without a control group

• Diaries with self-reported scores were used by patients.
• The number and severity of hot flashes was scored from 1 (mild) to 4 (severe).

Of the 15 patients, 10 had a significant decrease greater than 50% in hot flash severity scores (p < .0001). The results demonstrated a statistically significant decrease in the number of hot flashes experienced by participants (p = .0009).

Although the authors reported a statistically significant decrease in the number and severity of hot flashes with the intervention of Paullinia cupana, there are many concerns regarding this study. The safety and purity of Paullinia cupana need to be established prior to recommendations of use.

• Small sample (< 30)
• Baseline sample/group differences of import
• Risk of bias (no control group) 
• Risk of bias (sample characteristics)
• Unintended interventions or applicable interventions not described that would influence results 
• Measurement/methods not well described
• Measurement validity/reliability questionable 
• Findings not generalizable
• Other limitations/explanation: In using a supplement that is not tested for purity and safety, many variables cannot be proven. Adherence to interventions could be compromised.

It is important to be aware of a supplement (Paullinia cupana) that has been reported to decrease hot flashes in women after breast cancer treatment. Nurses also need to understand that this supplement has not been tested by the U.S. Food and Drug Administration, so the contents of this supplement cannot be proven. This study does not report any adverse effects from the agent; however, caffeine is known to be associated with adverse side effects.