Table 3.
Safety of Saliva plant administration in chronic human trials
| Study | Study design | Population | Salvia treatment | Adverse events |
|---|---|---|---|---|
| Akhondzadeh et al. [80] | 4-month, double-blind, placebo-controlled study | 30 patients with Alzheimer’s disease with an average age of 72 years | Ethanolic extract of S. officinalis, 60 drops daily | No difference in adverse events between Salvia and placebo conditions over the 4-month trial, except for near-statistically significant reductions in agitation (p = 0.09) in Salvia-treated patients |
| Perry et al. [79] | 6-week, open-label design | 11 patients aged 76–95 years with probable Alzheimer’s disease | 50 µL essential oil of S. lavandulaefolia, titrated to 3 capsules daily over 3 weeks | Increased blood pressure in two patients with a history of hypertension |
| Bommer et al. [89] | 8-week, open-label design | 69 women aged between 50 and 65 years (mean age 56 years), at least 12 months since last menstruation, at least five hot flushes daily | Once daily, 280-mg S. spissum tablet. Extract was thujone-free. Extraction process not detailed | 10 adverse events among 6 patients, of which 2 were related to study medication (mild abdominal pain and mild diarrhoea in one patient) |
| Vandecasteele et al. [90] | 8-week, open-label design | 10 prostate cancer patients (median age 68) receiving androgen deprivation therapy and experiencing hot flashes | One 150-mg S. officinalis capsule, 3 times daily. Extract was thujone-free. Extraction process not detailed | Non-significant decrease in luteinising hormone and follicular stimulating hormone. One patient experienced acneiform skin eruption after 6 weeks on Salvia. Causal connection with sage could not be ruled out |
| Behradmanesh et al. [91] | 12-week, double-blind, placebo-controlled study | 80 type II diabetic patients (average age 52 years) who had not reached the ideal control of the disease | One, 150-mg S. officinalis tablet, 3 times daily. Extraction process not detailed | 2 patients on active treatment reported mild gastrointestinal complaints, but did not require withdrawal from study |
| Kianbakht et al. [92] | 8-week, double-blind, placebo-controlled study | 67 patients aged 20–60 years with newly diagnosed primary hyperlipidaemia | One, 500-mg ethanolic/aqueous extract of S. officinalis tablet, 3 times daily | No reported adverse events |