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

Tracking Information
First Submitted Date ICMJE	December 27, 2007
First Posted Date ICMJE	January 8, 2008
Results First Submitted Date	October 26, 2009
Results First Posted Date	March 1, 2010
Last Update Posted Date	March 9, 2010
Study Start Date ICMJE	February 2006
Actual Primary Completion Date	January 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 2, 2010)	Overall Bowel Symptom Scores (BSS) [ Time Frame: After 12 weeks of treatment ]; 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.
Original Primary Outcome Measures ICMJE; (submitted: January 7, 2008)	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 ]
Change History	Complete list of historical versions of study NCT00587860 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: March 2, 2010)	Bowel Symptom Score (BSS) Amongst Subgroups [ Time Frame: 12 weeks ]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 ]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 ]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 ]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 ]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 ]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 ]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.
Original Secondary Outcome Measures ICMJE; (submitted: January 7, 2008)	Adequate relief of IBS symptoms at least 50% of the last 4 weeks of therapy [ Time Frame: 12-24 weeks ]; Overall and individual BSS scores at 12 & 24 weeks [ Time Frame: 12-24 weeks ]; Adequate relief of IBS symptoms at 24 weeks [ Time Frame: 12-24 weeks ]; IBS health-related quality of life scores at 12 weeks [ Time Frame: 12-24 weeks ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Placebo-Controlled Trial of St. John's Wort for Irritable Bowel Syndrome
Official Title ICMJE	A Placebo-Controlled Trial of St. John's Wort for Irritable Bowel Syndrome
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.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
Condition ICMJE	Irritable Bowel Syndrome
Intervention ICMJE	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
Study Arms	Placebo Comparator: Placebo Intervention: Drug: Placebo; Active Comparator: St. John's Wort Intervention: Drug: St. John's wort
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: January 7, 2008)	70
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	March 2008
Actual Primary Completion Date	January 2008 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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)
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 70 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00587860
Other Study ID Numbers ICMJE	132-06
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Yuri A. Saito Loftus, M.D., Mayo Clinic
Study Sponsor ICMJE	Mayo Clinic
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Yuri A. Saito Loftus, M.D. M.P.H. Mayo Clinic
PRS Account	Mayo Clinic
Verification Date	March 2010
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP