The sleep-inducing effect and safety of an herbal tea containing valerian and lemon balm were subject to a preliminary open pilot study. Subjects were 14 female volunteers (age 35 ± 11, BMI 21 ± 3 kg/m²) who complained of poor sleep. After obtaining informed consent, subjects took daily 2 cups of herbal teas containing valerian and lemon balm for 1 week, followed by a control week, during which they had two cups of hot water. OSA sleep questionnaires and VAS scales were recorded every day. Sleep quality increased at the 2^nd day after starting the tea, and sleep induction and sleep maintenance were improved in particular. Those whose complaints were severe experienced greater relief than those who complaint a little. Some cases reported transient sleepiness and gastrointestinal complaints. However, these symptoms disappeared spontaneously. The safety and effectiveness of this sleep-inducing herbal tea was ascertained.

Approximately 100 kinds of Foods for Specified Health Use (FOSHU) are used to “control postprandial elevated blood glucose level”. In this review, we describe their safety and effectiveness.

60 cancer patients between the ages of 20 and 80 who had completed a main treatment were randomly administered Tabebuia Avellanedae (Taheebo) extract 2.0 g/day (usual dosage), 4.0 g/day (2 times dosage), or 6.0 g/day (3 times dosage) for 6 months. A blood biochemical exam, urinalysis, adverse effects, several immunological parameters, urine 8-OHdG and QOLsurvey were evaluated. Five patients dropped out, but there was no direct cause and effect between the extract and dropout. Although several items of the blood biochemical exam revealed slight variation within the normal limits, distinct abnormities were not detected. Furthermore, side effects like allergic symptoms were not found. Immune parameters and urine 8-OHdG did not change significantly. CRP, which is a sensitive marker of inflammation, was significantly improved, and this may suggest the possibility of this extract helping to prevent hardening of blood vessels due to arteriosclerosis. In Japan, long-term food safety tests have rarely been done, therefore we recommend that more of these exams be carried out.

Objective: Gagome kombu (Kjellmaniella crassifolia), an edible brown seaweed grown around the southern area of Hokkaido, is known to abundantly contain fucoidan. Previous studies show that on animals, fucoidan from Gagome kombu (GKF) exhibits immune-enhancing, anti-cancer and anti-influenza virus capabilities. In this study, we focused on the elderly and evaluated the safety and immune-efficacy of GKF.
Methods: Eighteen (18) Japanese elderly subjects were chosen to ingest the test samples (3 tablets/day containing 50 mg GKF and lactic acid bacteria) for 8 weeks. Before ingestion and every 4 weeks thereafter (4^th and 8^th week), blood chemistry analysis, hematological analysis, urinalysis and immune analysis were conducted.
Result: Test results showed no adverse clinical changes in blood and urinary analysis. In addition, no serious symptoms were observed. Moreover, GKF markedly decreased serum IgE levels.
Conclusion: These results indicate that in the case of elderly, GKF is a safe functional food ingredient.

Objective: Fucoidan, a sulfated polysaccharide in Gagome kombu (GKF) is known to exhibit immune-enhancing and anti-cancer activities. Recently, cancer patients use various dietary supplements containing fucoidan and mushroom extracts. However, there have been few reports on the safety and efficacy of fucoidan-containing supplements. In this study, we examined the safety of long-term ingestion of GKF in cancer patients.
Methods: Twenty six (26) Japanese cancer patients—16 of whom (male 6, female 10, age 62.8 ± 10.7) have completed cancer treatment and 10 (male 4, female 6, 67.0 ± 10.6) still under treatment and regularly taking anti-cancer drugs and hormone pills—were chosen to ingest GKF-containing supplements (200–300 mg/day) for 8 weeks. Before ingestion and every 4 weeks thereafter (4^th and 8^th week), blood chemistry analysis, hematological analysis, urinalysis and immune analysis were conducted.
Result: There were no adverse clinical changes in blood and urinary analysis. In addition, no serious adverse effects were observed.
Conclusion: These results indicate long-term ingestion of GKF is indeed, safe for cancer patients.