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

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587860
First received: December 27, 2007
Last updated: March 2, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Irritable Bowel Syndrome
Drug: St. John's wort
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled Trial of St. John's Wort for Irritable Bowel Syndrome

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Overall Bowel Symptom Scores (BSS) [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Bowel Symptom Score (BSS) Amongst Subgroups [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Median (average) BSS amongst the different IBS subgroups (diarrhea, constipation, pain, and bloating). 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.

  • Adequate Relief ≤ 50% During the Last 4 Weeks of Therapy [ Time Frame: Last 4 weeks of therapy ] [ Designated as safety issue: No ]
    Participants who reported "yes" or "no" to having adequate relief of their IBS symptoms at least 50% during the last 4 weeks of therapy.

  • Irritable Bowel Syndrome - Quality of Life (IBS-QoL) Score [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]
    The IBS-QOL is a self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. The IBS-QOL was measured at baseline, week 12 and week 24. The individual responses to the 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life.

  • Center for Epidemiologic Studies Depression Scale (CES-D) Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    We measured CES-D Score at baseline as well as bi-weekly throughout the study. The CES-D is a self-reported 20 question survey designed to measure depressive symptomatology in the general population. The possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.

  • IBS Symptoms Moderately or a Lot Better [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Number of participants who stated their IBS symptoms were moderately better or a lot better at 24 weeks.

  • Center for Epidemiologic Studies Depression Scale (CES-D) Score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    We measured CES-D Score at baseline as well as bi-weekly throughout the study. The CES-D is a self-reported 20 question survey designed to measure depressive symptomatology in the general population. The possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.

  • Bowel Symptom Score (BSS) at 24 Weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The BSS is a five question, 100-mm visual analog scale of four IBS symptoms (pain/discomfort, bloating, constipation, and diarrhea), and an overall severity scale. The best possible value would be 0 (no symptoms) and the worst is 500 (severe symptoms). BSS was assessed on a bi-weekly basis.


Enrollment: 70
Study Start Date: February 2006
Study Completion Date: March 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Dosage form: Tablet (450 mg) Dose: 450 mg twice a day, placebo twice a day
Active Comparator: St. John's Wort Drug: St. John's wort
Dosage form: Tablet (450 mg) Dose: 450 mg twice a day, placebo twice a day
Other Names:
  • Latin name: Hypericum perforatum L.
  • Common name: St. John's Wort

Detailed Description:

Eligibility criteria:

  1. Established diagnosis of IBS
  2. 18-70 years of age

4) 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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587860

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Yuri A. Saito Loftus, M.D. M.P.H. Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Yuri A. Saito Loftus, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00587860     History of Changes
Other Study ID Numbers: 132-06
Study First Received: December 27, 2007
Results First Received: October 26, 2009
Last Updated: March 2, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 23, 2014