Vandecasteele, K., Ost, P., Oosterlinck, W., Fonteyne, V., Neve, W. D., & Meerleer, G. D. (2012). Evaluation of the efficacy and safety of salvia officinalis in controlling hot flashes in prostate cancer patients treated with androgen deprivation. Phytotherapy Research: PTR, 26(2), 208-213.

DOI Link

Study Purpose

The study measured the efficacy and side effects of treatment with salvia officinalis for hot flashes in men with prostate cancer treated with androgen deprivation.

Intervention Characteristics/Basic Study Process

Salvia officinalis extract was provided in 150 mg tablets to be taken 3 times daily.  Thujone was confirmed to be absent from the product.  Patients were to complete a hot flash diary daily.  Patients were seen in clinic every 1-2 weeks for 10 weeks at which time they turned in diaries, received a new supply of the salvia tablets, and had a clinical examination and bloodwork.

Sample Characteristics

Nine men, with a mean age of 68 years (range 62-73), were enrolled. All had prostate cancer, were receiving androgen deprivation therapy, and were experiencing hot flashes. Patients were excluded if they were unlikely to comply with the protocol or had an uncooperative attitude

 

Setting

  • SITE:  Single site 
  • SETTING TYPE: Outpatient 
  • LOCATION:  Belgium

Phase of Care and Clinical Applications

PHASE OF CARE: Transition phase after active treatment

Study Design

 This was a quasiexperimental feasibility study.

Measurement Instruments/Methods

Participants and researchers used the following instruments and measures:
  • Hot flash diary
  • Moyad hot flash scale (rates as mild, mod or severe according to experience) calculated as total score
  • Hot-flash related daily interference scale (HFRDIS)
  • Hormone levels
     

Results

Salvia use reduced hot flashes from a pretreatment mean Moyad score of 112 to a posttreatment mean of 54 (p = .002).  There was a decrease in LH and FSH levels.  There were no significant effects on testosterone, blood pressure, or cholesterol levels.  Hot flash reduction appeared within the first 3 weeks.  After this time, Moyad scores were essentially stable.  Sub-group analysis of  8 patients who had at least grade 2 hot flashes at baseline showed a substantial variability of responses.  One patient developed a skin rash that may have been associated with the use of salvia

Conclusions

 Salvia officinalis was associated with reduction in hot flash scores and minimal side effects in this small pilot study.

Limitations

Study limitations include the following:
  • Small sample (< 30)
  • Risk of bias (no control group) 
  • Risk of bias (no blinding)  
  • Risk of bias (no random assignment)
  • Measurement validity/reliability questionable*
  • Subject withdrawals ≥ 10%  
  • Use of total Moyad hot flash scores per week has not been tested for validity or reliability.    
     

Nursing Implications

This study provides little information to support use of salvia officinalis for hot flashes in these patients.  The sample size is too small and study design insufficient to examine potential efficacy and the actual side effect profile of this intervention.  Larger, well-designed clinical trials are needed.