614/PSYLLIUMtwenty-five subjects were included in the study and received
either placebo or Psyllium (5 gm three times daily) over a 6-
week period. Prior to the treatment period, all patients
participated in a 6-week period of diet counseling. Fasting
plasma glucose, total cholesterol, LDL cholesterol and
triglyceride levels were significantly reduced in the Psyllium
treatment group compared to placebo. HDL significantly
increased in the Psyllium treatment group compared to the
placebo group, suggesting Psyllium as a useful adjunct to
diet in Type 2 diabetes (Rodriguez-Moran, 1998).Hypercholesterolemia/HyperglycemiaThe safety and effectiveness of Psyllium husk fiber as an
adjunct to diet was evaluated in patients with type 2 diabetes
and mild- to-moderate hypercholesterolemia. After a 2-week
dietary stabilization phase, 34 patients were randomly
assigned to receive 5.1 gm psyllium or placebo twice daily
for an 8 week period. The Psyllium group had significant
improvements in glucose and lipid values compared with the
placebo group. Serum total and LDL-cholesterol concentra-
tions were 8.9% (P < 0.05) and 13.0% (P = 0.07) lower,
respectively, in the Psyllium treatment group compared to
the placebo group. All day and postprandial glucose concen-
trations were 11.0% (P < 0.05) and 19.2% (P< 0.01) lower in
the Psyllium treatment group than in the placebo group
(Anderson, 1999).Ulcerative ColitisThe objective of an open label, parallel-group, randomized
clinical trial was to assess the efficacy and safety of Plantago
ovata seeds compared to mesalamine in maintaining remis-
sion in ulcerative colitis patients. One hundred and five
ulcerative colitis patients who were in remission received
oral treatment with Plantago ovata seeds (10 gm twice daily),
mesalamine (500 mg three times daily), or Plantago ovata
seeds plus mesalamine at the same doses. After 12 months,
treatment failure rate was 40% in the Plantago ovata seed
group, 35% in the mesalamine group, and 30% in the
Plantago ovata plus mesalamine group. The probability of
continued remission was similar between all treatment
groups (Mantel-Cox test, p = 0.67; intent-to-treat analysis),
thus implicating the herb might be as effective as mesala-
mine to maintain remission in ulcerative colitis (Fernandez-
Banares F, 1999).INDICATIONS AND USAGE
Approved by Commission E:
- Constipation
- Diarrhea
- Raised levels of cholesterol
- Hemorrhoids
PDR FOR HERBAL MEDICINESPsyllium is used for disorders where easy bowel movements
with a loose stool is desirable (e.g., in patients with anal
fissures and hemorrhoids; following anal/rectal surgery; and
during pregnancy).
Unproven Uses: In Folk medicine, the herb is used internally
for inflammation of the mucous membrane of the urogenital
tract and gastrointestinal tract, and dysentery. Externally,
Psyllium is used for gout, rheumatism, furuncles and as an
analgesic.
Indian Medicine: Psyllium is used for gastritis, chronic
diarrhea, constipation, dysentery, dry cough, gout, gonor-
rhea, nephropathy, dysuria, duodenal ulcers and
hemorrhoids.
CONTRAINDICATIONS
The drug is contraindicated in patients who have pathologi-
cal narrowing in the gastrointestinal tract, obstruction or
threatening obstruction of the bowel (ileus), or difficulties in
regulating diabetes mellitus.
PRECAUTIONS AND ADVERSE REACTIONS
General: Incorrect administration procedures (with too little
fluid) can cause the product to swell and lead to obstruction
of the esophagus or of the intestine,, particularly with older
people. Patients with exocrine pancreatic insufficiency
should avoid use of Psyllium due to inhibitory actions on
pancreatic lipase (Hansen, 1987).
Allergic Reactions/Anaphylaxis: Allergic reactions ranging
from sneezing to chest congestion and wheezing were
reported in three nurses after Psyllium use (Ford, 1992). One
patient reported anaphylaxis after Psyllium ingestion, and
had experienced recurrent rhinitis and asthma related to
Psyllium exposure for the past 15 years (Vaswani, 1996).
IgE mediated anaphylaxis was reported after the ingestion of
Psyllium seed laxative (Seggav, 1984). Occupational allergic
rhinitis reaction was confirmed by elevation of antipsyllium
IgE after exposure to a Psyllium-based powdered laxative
(Schwartz, 1989).
Flatulence Symptoms: Psyllium did not cause greater gas-
eous symptoms compared to placebo reported in one study
(Zumarraga, 1997). One study decreased flatulence symp-
toms by adding psyllium to half the usual dose of bile acid
sequestrant resins to maintain efficacy and tolerability of
resins (Spence, 1995).
Drug Interactions: The absorption of other drugs taken
simultaneously may be delayed. There is a possibility that
insulin dosage adjustment (downward) will be necessary
when diabetics use psyllium products.
DOSAGE
Mode of Administration: The whole or coarsely-chopped
drug as well as other galenic preparations are used internally-