Psyllium Seed Powder (Indian Husks) by Freeda Vitamins

EFFECTIVE

• Constipation. Consuming oral soluble fibers, such as black psyllium, is effective for short-term treatment of constipation. Details: The U.S. Food and Drug Administration (FDA) considers black psyllium to be generally recognized as safe and effective (GRASE) as an over-the-counter (OTC) laxative for short-term treatment of constipation (272,93218). After oral administration, the laxative effect of black psyllium occurs within 12-72 hours. Continued use for 2-3 days is necessary for maximum laxative benefit (93214).

LIKELY EFFECTIVE

• Coronary heart disease (CHD). Consuming products that contain soluble fiber, such as black psyllium, may reduce the risk of CHD when used as part of a diet low in saturated fat and cholesterol. Details: In 1998, the U.S. Food and Drug Administration (FDA) authorized a health claim stating that the addition of soluble fiber, such as that from black psyllium, to a diet low in saturated fat and cholesterol might reduce the risk of CHD. The daily dietary intake of psyllium husk must be 7 grams or more (93216).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Cancer. Although there has been interest in using oral black psyllium for cancer, there is insufficient reliable information about the clinical effects of black psyllium for this purpose.
• Diabetes. It is unclear if black psyllium is beneficial for the prevention or treatment of diabetes. Details: Preliminary clinical research in adults with type 2 diabetes shows that taking black psyllium 15 grams orally daily for 10 days reduces fasting blood glucose by 28 mg/dL when compared with baseline (19156). The US Food and Drug Administration (FDA) has allowed a qualified health claim stating that psyllium husk may reduce the risk of type 2 diabetes. However, the FDA has concluded that there is very little scientific evidence supporting this claim (102827).
• Diarrhea. Although there has been interest in using oral black psyllium for diarrhea, there is insufficient reliable information about the clinical effects of black psyllium for this purpose.
• Hypertension. It is unclear if oral black psyllium is beneficial in patients with hypertension. Details: A meta-analysis of 11 randomized clinical trials in normotensive or hypertensive adults shows that using psyllium 3.7-15 grams daily for 1-6 months reduces systolic blood pressure by an average of 2 mmHg when compared with placebo. Subgroup analyses suggest that psyllium is more effective at reducing systolic blood pressure when taken for at least 8 weeks and in those with higher baseline blood pressure. Taking psyllium did not appear to affect diastolic blood pressure; however, some analyses suggest that taking psyllium may reduce diastolic blood pressure in certain subgroups, such as those with higher baseline blood pressure (102826). It is not clear if any reduction in blood pressure achieved with psyllium would be considered clinically significant. Additionally, it is not clear whether these studies used black psyllium or blond psyllium supplements.
• Nonalcoholic fatty liver disease (NAFLD). It is unclear if oral black psyllium is beneficial in patients with NAFLD. Details: Preliminary clinical research in overweight adults newly diagnosed with NAFLD shows that taking black psyllium 10 grams orally daily, in divided doses before lunch and dinner for 12 weeks, decreases body weight by about 2 kg and body mass index (BMI) by about 0.7 kg/m2 when compared with baseline. However, the changes in weight and BMI from baseline were similar to those in a control group receiving only standard care. This study may have been inadequately powered to detect a difference between groups (93215).
• Obesity. It is unclear if oral black psyllium can improve weight loss in overweight or obese adults. Details: A meta-analysis of 22 trials using psyllium 1.7-21 grams daily for 2-36 weeks in overweight or obese adults shows that taking psyllium does not have a significant effect on body weight, body mass index, or waist circumference. However, the validity of this study is limited by several sources of heterogeneity (102825). Additionally, it is not clear whether these studies used black psyllium or blond psyllium supplements. More evidence is needed to rate black psyllium for these uses.

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LIKELY SAFE ...when used orally with appropriate fluid intake, short-term (12,272). Black psyllium has been used with apparent safety in doses of 15-30 grams daily for up to 6 months (19156,10091,93215,102826). The U.S. Food and Drug Administration (FDA) requires over-the-counter medicines that contain dry or incompletely hydrated psyllium to carry a warning that they should be taken with at a least a full glass of liquid to reduce the risk of choking. This labeling also applies to foods containing psyllium that are marketed with a claim of reducing the risk of coronary heart disease (93217,93218).

LIKELY UNSAFE ...when black psyllium is used orally without adequate fluid intake due to the risk for choking and gastrointestinal obstruction (2,18,93218). ...when granular dosage forms containing black psyllium are used as over-the-counter (OTC) laxatives. The U.S. Food and Drug Administration (FDA) states that these granular dosage forms are not generally recognized as safe and effective (GRASE) as OTC laxatives due to an increased risk of choking and gastrointestinal obstruction (93219).

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally with appropriate fluid intake (272).

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CARBAMAZEPINE (Tegretol) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, black psyllium might reduce the effects of carbamazepine and increase the risk for convulsions.  Details Theoretically, black psyllium might reduce carbamazepine absorption. A preliminary study using blond psyllium reported decreased carbamazepine bioavailability due to binding of the drug to psyllium, as well as reduction of available fluid in the gut for dissolution of the drug (539). This interaction may also occur with black psyllium.

DIGOXIN (Lanoxin) Interaction Rating = Minor Be watchful with this combination. Severity = Moderate •  Occurrence = Unlikely •  Level of Evidence = B Theoretically, taking black psyllium at the same time as digoxin might reduce digoxin absorption and decrease digoxin levels.  Details Psyllium might bind digoxin in the gut (12). However, some clinical evidence suggests that psyllium does not impact digoxin absorption (10098).

ETHINYL ESTRADIOL Interaction Rating = Minor Be watchful with this combination. Severity = Moderate •  Occurrence = Unlikely •  Level of Evidence = D Theoretically, taking black psyllium at the same time as ethinyl estradiol might alter levels of estradiol.  Details Concurrent use of blond psyllium with ethinyl estradiol results in a slight increase in the extent of ethinyl estradiol absorption and a slower rate of absorption. This is unlikely to be clinically significant (12421).

LITHIUM Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, taking black psyllium at the same time as lithium might reduce lithium absorption.  Details The fiber in black psyllium might reduce lithium absorption and plasma levels. Some case reports describe a reduction in plasma lithium levels with concomitant administration of blond psyllium. This was reversed when psyllium was stopped (540,92194). This interaction may also occur with black psyllium.

METFORMIN (Glucophage) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, black psyllium might increase the therapeutic and adverse effects of metformin.  Details Animal research shows that concurrent consumption of blond psyllium with metformin slows and increases the absorption of metformin (99433). This interaction may also occur with black psyllium. To avoid changes in absorption, take psyllium 30-60 minutes after metformin.

OLANZAPINE (Zyprexa) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking black psyllium at the same time as olanzapine might reduce olanzapine absorption.  Details The fiber in black psyllium might decrease the absorption of olanzapine. A single case report describes a reduction in the effectiveness of olanzapine when it was concomitantly administered with an unspecified type of psyllium 3 grams orally twice daily. This effect was reversed when psyllium was stopped (106858).

ORAL DRUGS Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = B Theoretically, psyllium might increase, decrease, or have no effect on the absorption of oral drugs.  Details Psyllium seems to have variable effects on drug absorption. To avoid changes in absorption, take psyllium 30-60 minutes after oral medications. Animal research shows that blond psyllium delays and increases the absorption of metformin and ethinyl estradiol (12421,99433). Case reports and animal research suggest that blond psyllium might reduce absorption of lithium, digoxin, olanzapine, and carbamazepine (12,18,272,93214,106858). Finally, some pharmacokinetic studies show that psyllium does not affect the absorption of levothyroxine or warfarin (12420,103940). Although many of these studies evaluated blond psyllium, the fiber content in black psyllium may have similar effects.

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General ...Orally, black psyllium is generally well tolerated when taken with adequate fluids.
Most Common Adverse Effects:
Orally: Bloating, flatulence.
Serious Adverse Effects (Rare):
Orally: Bowel obstruction, esophageal obstruction.

Gastrointestinal ...Black psyllium can cause flatulence and bloating. These effects are generally transient and can be reduced by increasing the daily dose gradually (93214). Taking black psyllium with too little fluid can lead to esophageal or intestinal obstruction (18,93217,93218).

Immunologic ...Several psyllium species have been associated with sensitization and allergic reactions, especially in people exposed to airborne psyllium dust, such as nurses preparing doses of psyllium powder, and workers in psyllium processing plants (93214). Symptoms of occupational exposure include rhinitis, conjunctivitis, wheezing, asthma, and urticarial rashes (18,93214). Severe anaphylactic reactions have been reported in individuals with occupational exposure who then ingest psyllium products (2329,8079,9246).

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