A Placebo-Controlled Trial of St. John's Wort for Irritable Bowel Syndrome

Mayo Clinic

Status and phase

Completed

Phase 2

Conditions

Irritable Bowel Syndrome

Treatments

Drug: Placebo

Drug: St. John's wort

Study type

Interventional

Funder types

Other

Identifiers

NCT00587860

132-06

Details and patient eligibility

About

This study is being done to see if St. John's wort helps people with irritable bowel syndrome, otherwise known as "IBS". St. John's wort is a herbal supplement derived from the St. John's wort plant. It has been shown to be helpful in several medical conditions such as depression as well as other pain syndromes.

Full description

Eligibility criteria:

Established diagnosis of IBS
18-70 years of age

U.S. resident 5) English-speaking (able to provide consent and complete questionnaires) 6) Able to participate in all aspects of the study

You will be asked to do the following:

Undergo a screening interview and physical examination
Take a urine pregnancy test (if applicable)
Take a study pill twice daily for 12 weeks(3 months)
Complete daily symptom diaries and bi-weekly questionnaires for 12 weeks.
Complete a questionnaire at 6 months after the active phase of the study is over.

Enrollment

70 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Established diagnosis of IBS
Meet Rome II diagnostic criteria for IBS
18-70 years of age
U.S. resident
English-speaking (able to provide consent and complete questionnaires)
Able to participate in all aspects of the study

Exclusion criteria

Known alternative/concurrent gastrointestinal diagnosis (e.g. Crohn's disease, ulcerative colitis, microscopic colitis, celiac sprue, chronic pancreatitis or pancreatic insufficiency, scleroderma, chronic intestinal pseudo-obstruction, bacterial overgrowth, recent (<6 months) intestinal bacterial/protozoal/ parasitic infections, HIV, fecal incontinence, small bowel or colonic resection, pelvic floor dysfunction, paraplegia or quadriplegia)
Current symptoms of severe depression, as measured by Center for Epidemiological Studies Depression Scale (CES-D) score
Mental retardation or any condition requiring a legal guardian
Current or past history of psychotic disorder (schizophrenia, bipolar disorder)
Recent or current use (within past 30 days) of select mood or pain or symptom-altering medications:
- benzodiazepine use
- substance abuse
- narcotic use
- antihistamine use
- barbiturates
- zaleplon (Sonata)
Recent or current use (within past 30 days) of drugs that interact with SJW:
- antidepressants or antipsychotics
- tramadol (Ultram)
- sumatriptan (Imitrex)
- digoxin (Lanoxin)
- anticonvulsants (e.g. carbamazepine or phenytoin)
- immunosuppressants: cyclosporine and tacrolimus
- HIV protease inhibitors (e.g. indinavir), non-nucleoside reverse transcriptase inhibitors (e.g. nevirapine)
- warfarin (Coumadin)
- theophylline
- chemotherapy
- sulfa-containing drugs
- piroxicam (Feldene)
- simvastatin (Zocor)
- sibutramine (Meridia)
- verapamil (Calan or Isoptin)
Planned surgery (especially transplant) or anesthesia exposure during trial
Known photosensitivity or planned photodiagnostic or phototherapy procedures
Are pregnant, lactating, likely to become pregnant during medication phase and not willing to use a reliable form of contraception (barrier contraceptives, diaphragm, injections, intrauterine device, surgical sterilization, and abstinence)
Recent or current use (within 30 days) of SJW, other herbal products for IBS, investigational drug use
Known allergy to SJW
Significant acute or chronic progressive neurologic, hepatic, renal, cardiovascular, respiratory or metabolic disease
Recent history of alcohol or substance dependence use or abuse
Another household member or relative participating in the study
Professional drivers or operators of heavy machinery
Major cardiovascular events in the last 6 months
Use of IBS-specific drugs such as tegaserod (Zelnorm) and Lotronex (Alosetron) (within 30 days)