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

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
St. John's wort
Placebo
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

St. John's Wort

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Bowel Symptom Score (BSS) Amongst Subgroups
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
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
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
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
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
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
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.

Full Information

First Posted
December 27, 2007
Last Updated
March 2, 2010
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00587860
Brief Title
A Placebo-Controlled Trial of St. John's Wort for Irritable Bowel Syndrome
Official Title
A Placebo-Controlled Trial of St. John's Wort for Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Eligibility criteria: Established diagnosis of IBS 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
St. John's Wort
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
St. John's wort
Other Intervention Name(s)
Latin name: Hypericum perforatum L., Common name: St. John's Wort
Intervention Description
Dosage form: Tablet (450 mg) Dose: 450 mg twice a day, placebo twice a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dosage form: Tablet (450 mg) Dose: 450 mg twice a day, placebo twice a day
Primary Outcome Measure Information:
Title
Overall Bowel Symptom Scores (BSS)
Description
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.
Time Frame
After 12 weeks of treatment
Secondary Outcome Measure Information:
Title
Bowel Symptom Score (BSS) Amongst Subgroups
Description
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.
Time Frame
12 weeks
Title
Adequate Relief ≤ 50% During the Last 4 Weeks of Therapy
Description
Participants who reported "yes" or "no" to having adequate relief of their IBS symptoms at least 50% during the last 4 weeks of therapy.
Time Frame
Last 4 weeks of therapy
Title
Irritable Bowel Syndrome - Quality of Life (IBS-QoL) Score
Description
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.
Time Frame
12 weeks of treatment
Title
Center for Epidemiologic Studies Depression Scale (CES-D) Score
Description
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.
Time Frame
12 weeks
Title
IBS Symptoms Moderately or a Lot Better
Description
Number of participants who stated their IBS symptoms were moderately better or a lot better at 24 weeks.
Time Frame
24 weeks
Title
Center for Epidemiologic Studies Depression Scale (CES-D) Score
Description
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.
Time Frame
24 weeks
Title
Bowel Symptom Score (BSS) at 24 Weeks
Description
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.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuri A. Saito Loftus, M.D. M.P.H.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States

12. IPD Sharing Statement

Links:
URL
http://clinicaltrials.mayo.edu
Description
Mayo Clinic Clinical Trials

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

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