Phase 2 Completed N=70 Randomized Triple-blind Treatment

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

Irritable Bowel Syndrome

Source: ClinicalTrials.gov NCT00587860 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2010

Primary outcomePrimary: Overall Bowel Symptom Scores (BSS) — 76; 44 Scores on a scale

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Bowel Symptom Scores (BSS)	76; 44	—
SECONDARY Bowel Symptom Score (BSS) Amongst Subgroups	32; 17; 25.8; 16; 35.8; 23.5	—
SECONDARY Adequate Relief ≤ 50% During the Last 4 Weeks of Therapy	32; 62; 50; 26; 18; 12	—
SECONDARY Irritable Bowel Syndrome - Quality of Life (IBS-QoL) Score	18.8; 14.7	—
SECONDARY Center for Epidemiologic Studies Depression Scale (CES-D) Score	3.0; 2.5	—
SECONDARY IBS Symptoms Moderately or a Lot Better	5; 5; 24; 25; 6; 5	—
SECONDARY Bowel Symptom Score (BSS) at 24 Weeks	65; 60	—

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00587860). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.