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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

December 27, 2007
March 2, 2010
February 2006
January 2008   (final data collection date for primary outcome measure)
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.

Self-reported overall Bowel Symptom Scores (BSS) after 12 weeks of treatment will be used as the primary endpoint in this study [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00587860 on ClinicalTrials.gov Archive Site
  • 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.
  • Adequate relief of IBS symptoms at least 50% of the last 4 weeks of therapy [ Time Frame: 12-24 weeks ] [ Designated as safety issue: No ]
  • Overall and individual BSS scores at 12 & 24 weeks [ Time Frame: 12-24 weeks ] [ Designated as safety issue: No ]
  • Adequate relief of IBS symptoms at 24 weeks [ Time Frame: 12-24 weeks ] [ Designated as safety issue: No ]
  • IBS health-related quality of life scores at 12 weeks [ Time Frame: 12-24 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Placebo-Controlled Trial of St. John's Wort for Irritable Bowel Syndrome
A Placebo-Controlled Trial of St. John's Wort for Irritable Bowel Syndrome

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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Irritable Bowel Syndrome
  • 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
  • Drug: Placebo
    Dosage form: Tablet (450 mg) Dose: 450 mg twice a day, placebo twice a day
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: St. John's Wort
    Intervention: Drug: St. John's wort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
March 2008
January 2008   (final data collection date for primary outcome measure)

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)
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00587860
132-06
No
Yuri A. Saito Loftus, M.D., Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Yuri A. Saito Loftus, M.D. M.P.H. Mayo Clinic
Mayo Clinic
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP