Crucera-SGS [Discontinued] by Thorne

POSSIBLY EFFECTIVE

• Prostate cancer. Oral sulforaphane seems to delay increases in levels of prostate specific antigen (PSA) in patients with prostate cancer. Details: One clinical study in adults who have undergone radical prostatectomy shows that taking a specific sulforaphane product (Prostaphane, Nutrinov) 20 mg three times daily for 6 months attenuates a rise in PSA levels after 3 months, with an 86% increase in the time needed for PSA levels to double when compared with placebo (95251). A small clinical study in adults with recurrent prostate cancer shows that taking a sulforaphane-rich broccoli sprout extract 35.2 mg daily for up to 20 weeks increases the time needed for PSA levels to double by 57% when compared to pre-treatment changes in PSA levels (95260).

POSSIBLY INEFFECTIVE

• Helicobacter pylori. Oral sulforaphane does not seem to improve the H. pylori eradication rate when used in combination with triple therapy treatment. Details: Clinical research shows that taking one capsule of broccoli sprout extract 250 mg, providing sulforaphane 1 mg, three times daily for 4 weeks in combination with clarithromycin-based triple-therapy treatment does not increase H. pylori eradication rate when compared with triple therapy alone or in combination with Saccharomyces boulardii (108138).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Age-related cognitive decline. It is unclear if oral sulforaphane is beneficial for improving cognitive function in older adults. Details: Clinical research in older adults shows that taking the sulforaphane precursor glucoraphanin (Kagome Co., Ltd.) 30 mg daily for 12 weeks modestly improves some measures of cognitive function, specifically working memory and processing speed, when compared with placebo. Half of all patients also underwent brain-training by playing a specific game (Brain Age) 15 minutes daily and the other half played an active control game (Tetris). However, the combination of brain-training and glucoraphanin does not seem to be more beneficial than either intervention alone (108133).
• Allergic rhinitis (hay fever). It is unclear if oral sulforaphane is beneficial for allergic rhinitis. Details: Clinical research in patients with grass-induced allergic rhinitis shows that using a daily steroid nasal spray in conjunction with an oral broccoli seed and sprout extract (Avmacol, Nutramax) 1500 mg daily, providing sulforaphane 60-70 micromoles, for 3 weeks improves nasal flow and symptom severity for up to about 30 minutes when compared with using a saline spray and oral placebo. However, use of either intervention alone did not improve nasal flow or symptoms when compared with placebo (108132). This study was small and may not have been adequately powered to detect beneficial effects of sulforaphane alone.
• Asthma. It is unclear if oral sulforaphane is beneficial for asthma. Details: Preliminary clinical research in adults with asthma shows that taking broccoli sprout extract containing sulforaphane 17.6 mg daily for 14 days attenuates the bronchoconstriction effects of methacholine by approximately 21% when compared to baseline. However, after taking sulforaphane, 20% of patients experienced a worsening of bronchoconstriction and 20% experienced no change. Taking sulforaphane did not improve most measures of pulmonary function, including forced expiratory volume, forced vital capacity, lung capacity, and residual capacity (95262).
• Autism spectrum disorder. It is unclear if oral sulforaphane is beneficial in children or adults with autism spectrum disorder; any benefits seen in clinical studies may not be considered clinically significant. Details: Research is conflicting on whether sulforaphane improves symptoms of autism. One small clinical study in children 4-12 years old with moderate to severe autism symptoms shows that taking sulforaphane 10-20 mg daily in combination with risperidone for 10 weeks improves irritability scores by 14% and hyperactivity scores by 12% when compared with placebo and risperidone. However, it is unclear if these improvements are clinically meaningful. Taking sulforaphane did not improve stereotypic, social/lethargy, or speech scores when compared with placebo. Children weighing up to 45 kg took approximately 10 mg daily and children weighing at least 45 kg took approximately 20 mg daily (104537). In contrast, a small clinical study in children 3-12 years old with moderate to severe autism symptoms shows that taking sulforaphane as a specific broccoli seed and sprout extract blend (Avmacol, Nutramax) daily for 15 weeks does not improve clinical impressions or most symptoms of autism when compared with placebo. The extract blend was dosed to provide approximately 1 mcmol sulforaphane per pound or 2.2 mcmol per kg body weight (108131). This study was small and may not have been adequately powered to detect differences between groups. Another very small clinical study in children aged 3-7 years old with autism spectrum disorder shows that taking a specific product containing broccoli sprout powder standardized for sulforaphane (BroccoPhane, Bioriginal) with red radish sprout daily for 36 weeks does not improve measures of aberrant behavior, communication, play and imagination, restricted interests, or social responsiveness and interaction when compared with placebo (112450). Sulforaphane has also been evaluated in older children or young adults. A small study in males 13-27 years of age with autism shows that taking sulforaphane daily for 18 weeks improves behavior scores by 33% and social scores by 17% when compared with placebo. After treatment discontinuation, behavior and social scores returned to baseline levels. Dosing was weight-based as follows: sulforaphane 26.6 mg daily in those weighing at least 91 kg, 17.6 mg daily in those weighing 45-91 kg, and 8.8 mg daily in those weighing up to 45 kg (95267). A small study in males and females 7-21 years of age with autism shows that taking sulforaphane as a specific broccoli seed and sprout blend (Avmacol, Nutramax Laboratories Consumer Care, Inc.) daily for 12 weeks improves social scores by 6%, but does not affect behavior scores, when compared with baseline. It is unclear if this improvement is clinically meaningful. The product used in this study contains glucoraphanin and myrosinase and was dosed to provide approximately 2.5 mcmol of glucoraphanin per pound of body weight (98501). The validity of these findings is limited by the lack of a comparator group.
• Cancer. Although there is interest in using oral sulforaphane for cancer, there is insufficient reliable information about the clinical effects of sulforaphane for this condition.
• Chronic obstructive pulmonary disease (COPD). It is unclear if oral sulforaphane is beneficial for COPD. Details: Preliminary clinical research shows that taking sulforaphane 4.4 mg or 26.6 mg daily for 4 weeks does not improve symptoms of COPD when compared with placebo (95268).
• Depression. It is unclear if oral sulforaphane is beneficial for depression. Details: A small clinical trial in patients with mild to moderate depression related to cardiac interventions shows that taking sulforaphane (Acer) 30 mg daily for 6 weeks reduces depression score by at least 50% in 30% of patients, compared with only 7% of those taking placebo. However, there was no significant difference in remission rate between groups (108136).
• Exercise-induced muscle damage. It is unclear if oral sulforaphane is beneficial for exercise-induced muscle damage. Details: A small clinical trial in adult males shows that taking sulforaphane 30 mg daily for 4 weeks attenuates an increase in creatine kinase levels at 24 hours following heavy resistance exercise when compared with placebo. This suggests that sulforaphane may reduce muscle damage associated with exercise (108135). However, another small preliminary clinical trial in young adult males shows that taking the sulforaphane precursor glucoraphanin (Kagome Co., Ltd.) 30 mg daily, starting 2 weeks before exercise and continuing until 4 days after, does not reduce markers of muscle damage, including aldolase, aspartate aminotransferase, lactate dehydrogenase, or creatine kinase, when compared with not taking sulforaphane (108134).
• Exercise-induced muscle soreness. It is unclear if oral sulforaphane is beneficial for exercise-induced muscle soreness. Details: A small preliminary clinical trial in young adult males shows that taking the sulforaphane precursor glucoraphanin (Kagome Co., Ltd.) 30 mg daily, starting 2 weeks before exercise and continuing until 4 days after, reduces palpation-related muscle soreness and improves range of motion two days after exercise when compared with not taking sulforaphane. However, there was no difference between groups on days 1, 3, or 4 and there was no difference in pain related to extension (108134).
• Liver disease. Although there is interest in using oral sulforaphane to improve liver health, there is insufficient reliable information about the clinical effects of sulforaphane for this use.
• Pregnancy-induced hypertension. It is unclear if oral sulforaphane is beneficial for hypertension during pregnancy. Details: A small nonrandomized clinical trial in patients with pregnancy-induced hypertension or pre-eclampsia shows that taking broccoli extract modestly decreases diastolic, but not systolic, blood pressure, when compared with baseline. Patients took a single dose of either four or eight tablets of a myrosinase-activated broccoli seed extract (BroccoMax, Jarrow Formulas) providing an unknown dose sulforaphane (108130). This study was small and may not have been adequately powered to detect differences in blood pressure.
• Schizophrenia. It is unclear if oral sulforaphane is beneficial for schizophrenia. Details: Preliminary clinical research in patients with schizophrenia shows that taking sulforaphane as a specific broccoli seed and sprout blend (Avmacol, Nutramax) daily for 16 weeks does not improve positive or negative symptoms when compared with taking placebo (108137).
• Sickle cell disease. Although there is interest in using oral sulforaphane for sickle cell disease, there is insufficient reliable information about the clinical effects of sulforaphane for this condition.
• Sunburn. Although there is interest in using topical sulforaphane for sunburn prevention, there is insufficient reliable information about the clinical effects of sulforaphane for this use. More evidence is needed to rate sulforaphane for these uses.

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LIKELY SAFE ...when used orally in amounts found in foods (10264).

POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts. Sulforaphane-rich broccoli sprout extract has been used with apparent safety in clinical studies at a sulforaphane dose of up to 35.2 mg daily for up to 20 weeks (95260,95262,95265,95267,95268,104537,108136,108137,108138). A specific brand of sulforaphane (Prostaphane, Nutrinov) has been used with apparent safety in clinical research at a dose of up to 60 mg daily for up to 6 months (95251). A specific broccoli seed extract (BroccoMax, Jarrow Formulas) containing glucoraphanin 180 mg daily has been used with apparent safety in clinical research for up to 8 weeks (95269).

CHILDREN: LIKELY SAFE
when used orally in amounts found in foods (10264). There is insufficient reliable information available about the safety of sulforaphane in medicinal amounts.

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts found in foods (10264). There is insufficient reliable information available about the safety of sulforaphane in medicinal amounts.

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CYTOCHROME P450 1A2 (CYP1A2) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, sulforaphane might alter the levels and clinical effects of CYP1A2 substrates.  Details Animal and in vitro research shows that sulforaphane inhibits CYP1A2 enzyme activity. However, its precursor glucoraphanin also appears to increase the expression of the CYP1A2 enzyme, which could lead to increased metabolism of CYP1A2 substrates (12701,105083,105085). These effects have not been reported in humans.

CYTOCHROME P450 2E1 (CYP2E1) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, sulforaphane might increase the levels and effects of CYP2E1 substrates.  Details In vitro evidence shows that sulforaphane inhibits CYP2E1 enzymes (105083). This interaction has not been reported in humans.

CYTOCHROME P450 3A4 (CYP3A4) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, sulforaphane might increase the levels and effects of CYP3A4 substrates.  Details Animal and in vitro research shows that sulforaphane inhibits CYP3A4 enzyme activity and downregulates its expression (105083,105434,105435). This interaction has not been reported in humans.

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General ...Orally, sulforaphane seems to be well tolerated.
Most Common Adverse Effects:
Orally: Bowel discomfort, heartburn, stomach upset, and vomiting.

Gastrointestinal ...Orally, sulforaphane and sulforaphane-rich extracts can cause bowel discomfort, stomach upset, heartburn, and vomiting (95251,95252,95260,95265,95267,95268,98501,104537,108132). A specific stabilized form of sulforaphane (Cavamax W6) caused mild stomach upset in 60% of subjects in a small study (95252). However, in some clinical studies, the gastrointestinal side effects reported with sulforaphane did not occur more frequently than with placebo (95268).

Hepatic ...Orally, sulforaphane has been associated with one case of elevated liver enzyme levels. However, the patient ran a marathon the day before testing, and levels returned to normal within one week (95262).

Neurologic/CNS ...Orally, sulforaphane has been reported to cause headache in one clinical study (104537). In another clinical trial, insomnia and irritability were reported (108131). Sulforaphane has also been associated with two cases of seizure in males with autism. In one case, a patient with a recent history of seizure experienced a seizure after taking sulforaphane for 3 weeks. In another case, a patient with seizures which had been well-controlled with antiepileptic drugs for more than 1 year experienced a seizure 3 weeks after discontinuing sulforaphane. It is unclear if sulforaphane precipitated seizures in these patients (95267).

Other ...Orally, sulforaphane has been reported to cause increased weight gain. In one clinical study in males 13-27 years of age with autism, patients taking sulforaphane gained an additional 4 pounds on average over 18 weeks when compared with those taking placebo (95267).

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