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

NCT00587860 | Completed Phase 2 Results

• 1 other identifier: 132-06
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Overall Bowel Symptom Scores (BSS)

  The primary end point was the overall self-reported BSS after 12 weeks of therapy for all randomized participants to assess for differences between treatment groups at the end of the treatment period (12 weeks). The BSS is a 100-mm visual analog scale for the different symptoms of IBS (pain/discomfort, constipation, diarrhea, and overall severity). Symptoms on the BSS can range from 0 = no pain to 100 = extreme pain.

  After 12 weeks of treatment

Secondary Outcomes (7)

• Bowel Symptom Score (BSS) Amongst Subgroups

  12 weeks

• Adequate Relief ≤ 50% During the Last 4 Weeks of Therapy

  Last 4 weeks of therapy

• Irritable Bowel Syndrome - Quality of Life (IBS-QoL) Score

  12 weeks of treatment

• Center for Epidemiologic Studies Depression Scale (CES-D) Score

  12 weeks

• IBS Symptoms Moderately or a Lot Better

  24 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

St. John's Wort

ACTIVE COMPARATOR

Drug: St. John's wort

Interventions

St. John's wort DRUG

Dosage form: Tablet (450 mg) Dose: 450 mg twice a day, placebo twice a day

Also known as: Latin name: Hypericum perforatum L., Common name: St. John's Wort

St. John's Wort

Placebo DRUG

Dosage form: Tablet (450 mg) Dose: 450 mg twice a day, placebo twice a day

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Hypericum extract LI 160

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Limitations and Caveats

* A majority of the participants were local females with mild symptoms * The number of participants limits power of conclusions * We evaluated the efficacy of SJW in all subtypes of IBS not allowing specific conclusions regarding subtypes

Results Point of Contact

• Title: Yuri A. Saito Loftus, M.D., M.P.H.
• Organization: Mayo Clinic

saito.yuri@mayo.edu

507-284-5010

Study Officials

• Yuri A. Saito Loftus, M.D. M.P.H.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 27, 2007
• First Posted: January 8, 2008
• Study Start: February 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: March 1, 2008
• Last Updated: March 9, 2010
• Results First Posted: March 1, 2010

Record last verified: 2010-03

Locations

US (1)