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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
70
Dosage form: Tablet (450 mg) Dose: 450 mg twice a day, placebo twice a day
Dosage form: Tablet (450 mg) Dose: 450 mg twice a day, placebo twice a day
Mayo Clinic
Rochester, Minnesota, United States
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.
Time frame: After 12 weeks of treatment
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 weeks