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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: St. John's wort
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Dosage form: Tablet (450 mg) Dose: 450 mg twice a day, placebo twice a day<br>|
| Active Comparator: St. John's Wort<br> | Drug: St. John's wort<br>* Dosage form: Tablet (450 mg) Dose: 450 mg twice a day, placebo twice a day<br>* Other names: Common name: St. John's Wort;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 
| 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. | 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. | 12 weeks of treatment | 
| 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. | 12 weeks | 
| 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. | 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. | 24 weeks | 
| 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. | 24 weeks |