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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Depression. Although there has been interest in using oral 1,4-butanediol for depression, there is insufficient reliable information about the clinical effects of 1,4-butanediol for this purpose.
• Insomnia. Although there has been interest in using oral 1,4-butanediol for insomnia, there is insufficient reliable information about the clinical effects of 1,4-butanediol for this purpose.
• Muscle strength. Although there has been interest in using oral 1,4-butanediol to increase muscle strength, there is insufficient reliable information about the clinical effects of 1,4-butanediol for this purpose.
• Obesity. Although there has been interest in using oral 1,4-butanediol for weight loss, there is insufficient reliable information about the clinical effects of 1,4-butanediol for this purpose. More evidence is needed to rate 1,4-butanediol for these uses.

(Read more about 1,4-BUTANEDIOL)

Alpha hydroxy acids represent a group of natural chemicals that are used alone or in combination. See specific monographs for effectiveness information.

(Read more about ALPHA HYDROXY ACIDS (AHAs))

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Acute bronchitis. Although there is interest in using oral quillaia for acute bronchitis, there is insufficient reliable information about the clinical effects of quillaia for this condition.
• Asthma. Although there is interest in using oral quillaia for asthma, there is insufficient reliable information about the clinical effects of quillaia for this condition.
• Chronic obstructive pulmonary disease (COPD). Although there is interest in using oral quillaia for COPD, there is insufficient reliable information about the clinical effects of quillaia for this condition.
• Diabetic foot ulcers. Although there is interest in using topical quillaia for diabetic foot ulcers, there is insufficient reliable information about the clinical effects of quillaia for this purpose.
• Hypercholesterolemia. Oral quillaia has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in Korean adults with total cholesterol levels greater than 220 mg/dL shows that taking a partially purified extract of quillaia and yucca, 0.3 mg three times daily for 4 weeks, decreases total cholesterol by around 13% and low-density lipoprotein (LDL) cholesterol by around 17% when compared with baseline (99888). The validity of this finding is limited by the lack of a statistical comparison with the placebo group.
• Pressure ulcers. Although there is interest in using topical quillaia for pressure ulcers, there is insufficient reliable information about the clinical effects of quillaia for this purpose.
• Seborrheic dermatitis. Although there is interest in using topical quillaia for seborrheic dermatitis, there is insufficient reliable information about the clinical effects of quillaia for this purpose.
• Tinea pedis. Although there is interest in using topical quillaia for tinea pedis, there is insufficient reliable information about the clinical effects of quillaia for this purpose.
• Venous leg ulcers. Although there is interest in using topical quillaia for venous leg ulcers, there is insufficient reliable information about the clinical effects of quillaia for this purpose. More evidence is needed to rate quillaia for these uses.

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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Acne. Oral red soapwort has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small, unblinded study in young adults with facial acne suggests that application of a cream containing red soapwort root extract 0.32%, elecampane flower and leaf extract 0.8%, and black nightshade leaf extract 0.8%, 2 to 3 times daily for 6 weeks, reduces acne severity index scores by 55%, 85%, and 91% from baseline at 2, 5, and 6 weeks, respectively, compared with no change in the placebo group (105733). It is unclear if this effect is due to red soapwort, other ingredients, or the combination. The poor study methodology and reporting of results, and the lack of statistical comparison to the placebo group, limit the validity of these findings. More evidence is needed to rate red soapwort for this use.

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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Bleeding. Although there has been interest in using topical yucca for bleeding, there is insufficient reliable information about the clinical effects of yucca for this purpose.
• Dandruff. Although there has been interest in using topical yucca for dandruff, there is insufficient reliable information about the clinical effects of yucca for this purpose.
• Diabetes. Although there has been interest in using oral yucca for diabetes, there is insufficient reliable information about the clinical effects of yucca for this purpose.
• Hypercholesterolemia. Oral yucca has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in adults with hypercholesterolemia shows that taking purified yucca extract in combination with quillaia extract orally three times daily for 4 weeks decreases total and low-density lipoprotein (LDL) cholesterol levels by more than 10% and 15%, respectively, when compared with baseline (86899). The validity of this finding is limited by the lack of statistical comparison to the placebo group.
• Hypertension. Although there has been interest in using oral yucca for hypertension, there is insufficient reliable information about the clinical effects of yucca for this purpose.
• Joint pain. Although there has been interest in using topical yucca for joint pain, there is insufficient reliable information about the clinical effects of yucca for this purpose.
• Migraine headache. Although there has been interest in using oral yucca for migraine headache, there is insufficient reliable information about the clinical effects of yucca for this purpose. More evidence is needed to rate yucca for these uses.

(Read more about YUCCA)

UNSAFE ...when used orally. 1,4-Butanediol, and the closely related products gamma-hydroxybutyrate (GHB) and gamma butyrolactone (GBL), have been linked to at least 131 serious illnesses, including 5 deaths (1318,3678,10640).

PREGNANCY AND LACTATION: UNSAFE
when used orally (1318,3678).

(Read more about 1,4-BUTANEDIOL)

Some alpha hydroxy acids are used topically, while others are used orally, intravaginally, or by inhalation. See specific monographs for safety information.

PREGNANCY AND LACTATION:
See specific monographs for safety information.

(Read more about ALPHA HYDROXY ACIDS (AHAs))

LIKELY SAFE ...when used in amounts commonly found in foods. Quillaia has Generally Recognized As Safe (GRAS) status for use in foods in the US (4912).

POSSIBLY UNSAFE ...when used orally in medicinal amounts. Quillaia contains oxalates and tannins which can cause serious adverse effects when consumed in large amounts (12). There is insufficient reliable information available about the safety of quillaia when used topically.

PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used in medicinal amounts (12); avoid using.

(Read more about QUILLAIA)

LIKELY SAFE ...when used topically. Red soapwort is widely used in soaps and shampoos (6) without reports of adverse effects. There is insufficient reliable information available about the safety of red soapwort when used orally.

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

(Read more about RED SOAPWORT)

LIKELY SAFE ...when used orally in amounts commonly found in foods. Specific species of yucca, including Mojave yucca (Yucca shidigera) and Joshua tree (Yucca brevifolia), have Generally Recognized As Safe (GRAS) status for use in foods in the US (4912). There is insufficient reliable information available about the safety of yucca when used orally as medicine or when applied topically.

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

(Read more about YUCCA)

ALCOHOL (Ethanol) Interaction Rating = Major Do not take this combination. Severity = High •  Occurrence = Probable •  Level of Evidence = C Theoretically, alcohol may increase or decrease the therapeutic and adverse effects of 1,4-butanediol.  Details 1,4-Butanediol is metabolized to gamma-hydroxybutyrate (GHB) by hepatic alcohol dehydrogenase enzymes. Alcohol competitively inhibits alcohol dehydrogenase, which leads to higher blood levels of 1,4-butanediol and lower blood levels of GHB (1430,3678,19609,102836). The clinical effects of this change are not well understood. Most researchers believe that the pharmacologic activity of 1,4-butanediol is dependent on conversion to GHB; however, animal research shows that 1,4-butanediol may also act independently (19609). Also, in humans, concomitant use of GHB and alcohol increases the adverse effects of GHB, possibly by reducing the elimination of GHB. Concomitant use of GHB and alcohol may also cause additive respiratory and central nervous system depression (93831,102834). Therefore, concomitant use of 1,4-butanediol and alcohol may either increase or decrease the risk of adverse effects.

AMPHETAMINES Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, amphetamines may increase or decrease the therapeutic and adverse effects of 1,4-butanediol.  Details 1,4-Butanediol is metabolized to gamma-hydroxybutyrate (GHB). Although some researchers have suggested that amphetamines may antagonize the effects of GHB, this has not been well studied. Also, some case reports suggest that concomitant use might increase the risk of severe side effects, including CNS and respiratory depression (3682).

ANTICONVULSANTS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, concomitant use of 1,4-butanediol with certain anticonvulsants may potentiate respiratory and central nervous system (CNS) depression or increase the risk of seizures.  Details 1,4-Butanediol is metabolized to gamma-hydroxybutyrate (GHB). Concomitant use of anticonvulsants that have sedative effects with GHB may cause serious CNS and respiratory depression (102834). GHB might also reduce the effectiveness of anticonvulsants since it also can cause seizures (3682,3830,102834).

CNS DEPRESSANTS Interaction Rating = Major Do not take this combination. Severity = High •  Occurrence = Probable •  Level of Evidence = D Theoretically, concomitant use of 1,4-butanediol with CNS depressants may potentiate respiratory and CNS depression.  Details 1,4-Butanediol is metabolized to gamma-hydroxybutyrate (GHB). Concomitant use of CNS depressants with GHB may cause serious CNS and respiratory depression (3682,102834).

DIVALPROEX SODIUM (Depakote) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, concomitant use of 1,4-butanediol with divalproex sodium may potentiate adverse effects.  Details 1,4-Butanediol is metabolized to gamma-hydroxybutyrate (GHB). Concomitant use of divalproex sodium with GHB may increases plasma GHB levels by approximately 25% and may increase the risk of adverse effects (102834).

NALOXONE (Narcan) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, concomitant use of 1,4-butanediol with naloxone may antagonize the effects of 1,4-butanediol.  Details 1,4-Butanediol is metabolized to gamma-hydroxybutyrate (GHB). Theoretically, naloxone may antagonize the effects of GHB, but anecdotally, naloxone is not effective for treating GHB poisoning (3682).

NARCOTIC DRUGS Interaction Rating = Major Do not take this combination. Severity = High •  Occurrence = Probable •  Level of Evidence = D Theoretically, concomitant use of 1,4-butanediol with narcotic drugs may potentiate respiratory and central nervous system (CNS) depression. 1,4-Butanediol is metabolized to gamma-hydroxybutyrate (GHB).  Details Concomitant use of narcotic drugs with GHB may cause serious CNS and respiratory depression (3682,3679,19610,102834). In one case report, concurrent use of GHB and heroin was fatal (5807).

RITONAVIR (Norvir) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Concomitant use of 1,4-butanediol with ritonavir may potentiate adverse effects.  Details 1,4-Butanediol is metabolized to gamma-hydroxybutyrate (GHB). Concomitant use of a small dose of GHB with the antiretroviral drugs ritonavir and saquinavir reportedly caused a near-fatal reaction, likely due to inhibition of GHB metabolism (1431).

SAQUINAVIR (Fortovase, Invirase) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Concomitant use of 1,4-butanediol with saquinavir may potentiate adverse effects.  Details 1,4-Butanediol is metabolized to gamma-hydroxybutyrate (GHB). Concomitant use of a small dose of GHB with the antiretroviral drugs ritonavir and saquinavir reportedly caused a near-fatal reaction, likely due to inhibition of GHB metabolism (1431).

TOPIRAMATE (Topamax) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Concomitant use of 1,4-butanediol with topiramate may potentiate adverse effects.  Details 1,4-Butanediol is metabolized to gamma-hydroxybutyrate (GHB). Concomitant use of topiramate with GHB may increases blood levels of GHB. In one case report, a patient regularly taking GHB 4.5 grams twice nightly was hospitalized after initiating treatment with topiramate 25 mg daily. Symptoms included confusion, muscle jerking, miosis, and coma. Plasma levels of GHB were 2.5-fold higher than when GHB was given alone. Potential mechanisms might include decreased GHB breakdown, increased absorption, and/or increased activity (93834).

(Read more about 1,4-BUTANEDIOL)

(Read more about ALPHA HYDROXY ACIDS (AHAs))

IMMUNOSUPPRESSANTS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, concomitant use of quillaia with immunosuppressant drugs might decrease the effectiveness of these drugs.  Details In vitro research shows that some quillaia constituents have immunostimulant effects (6,11,3851,99885).

(Read more about QUILLAIA)

(Read more about RED SOAPWORT)

(Read more about YUCCA)

General ...1,4-butanediol is generally considered unsafe for any use. Any benefits do not outweigh the risks of toxicity.
Most Common Adverse Effects:
Orally: Agitation, amnesia, anxiety, bradycardia, chest tightness, confusion, hallucinations, nausea, tremor, vomiting.
Serious Adverse Effects (Rare):
Orally: Cardiac arrest, coma, death, respiratory depression.

Cardiovascular ...Orally, 1,4-butanediol and its metabolite, gamma-hydroxybutyrate (GHB), can cause chest tightness, bradycardia, and cardiac arrest (1318,3678,3679,6016,10640,37465,10658,93820).

Gastrointestinal ...Orally, 1,4-butanediol can cause nausea and vomiting, diarrhea, and fecal incontinence (1318,3678,3679,10640,37465).

Neurologic/CNS ...Orally, 1,4-butanediol is metabolized to gamma-hydroxybutyrate (GHB), and its psychoactive effects are primarily due to GHB (102837). 1,4-Butanediol also causes similar CNS toxic effects to GHB, including amnesia, combativeness, confusion, agitation, coma, seizures, and death (1318,3678,3679,10640,37465). After 1,4-butanediol overdoses, sedation gradually increases, consistent with gradual conversion to GHB (102837). 1,4-Butanediol overdose can also present with features suggesting toxic alcohol poisoning (102837). Neurologic and CNS withdrawal symptoms of 1,4-butanediol, GHB, and GBL include insomnia, tremor, anxiety, hallucinations, and delirium (1430,10375,10640).

Pulmonary/Respiratory ...Orally, 1,4-butanediol, especially in overdose, can cause breathing problems and respiratory depression that can require intubation (1318,3678,3679,10640,37465).

(Read more about 1,4-BUTANEDIOL)

General ...Alpha hydroxy acids represent a group of natural chemicals, some of which can cause adverse effects. See specific monographs for safety information.

(Read more about ALPHA HYDROXY ACIDS (AHAs))

General ...Orally, quillaia seems to be well tolerated when consumed in foods; however, it is associated with significant adverse effects at higher doses due to its oxalate and tannin content. A thorough evaluation of safety outcomes has not been conducted.
Serious Adverse Effects (Rare):
Orally: Coma, convulsions, diarrhea, gastrointestinal tract mucosal damage, hemolysis, and kidney failure.

Gastrointestinal ...Orally, large amounts of quillaia are associated with diarrhea, stomach pain, and other gastrointestinal disturbances. Quillaia powder can be caustic to esophageal and gastrointestinal mucosae (12).

Hematologic ...Orally, taking large amounts of quillaia has been associated with red blood cell hemolysis (11).

Neurologic/CNS ...Orally, taking large amounts of quillaia has been associated with convulsions and coma (12).

Renal ...Orally, quillaia combines with calcium to form crystals of calcium oxalate which can precipitate in the renal tubules and cause acute kidney failure (12).

(Read more about QUILLAIA)

General ...Orally, there is limited reliable information available about the safety of red soapwort. Topically, red soapwort is well tolerated.

Gastrointestinal ...Orally, red soapwort has been reported to cause stomach irritation (2), nausea, and vomiting (7).

(Read more about RED SOAPWORT)

General ...There is currently a limited amount of information on the adverse effects of yucca. A thorough evaluation of safety outcomes has not been conducted.

Dermatologic ...Topically, yucca has been reported to cause phytodermatitis (68294). In one case report, an atopic gardener developed contact urticaria after occupational exposure to weeping fig, spathe flower, and yucca. Allergen skin tests were positive for all three plants (49961).

Gastrointestinal ...Orally, the saponins in yucca can be irritating to mucous membranes and might cause gastrointestinal irritation (7,4077).

Pulmonary/Respiratory ...Environmental exposure to yucca has been associated with allergic rhinitis in 59 patients who exhibited sensitization to yucca after allergen skin testing (86902).

(Read more about YUCCA)