St. John's Wort in the Treatment of Raynaud's Phenomenon

NCT00351117 | Completed Phase 3

• 2 other identifiers: R-06-355250347647
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This trial will test the efficacy of St. John's Wort (SJW) as a supplement, in the treatment of Raynaud's phenomenon (RP). The investigators are hypothesizing that taking SJW 300mg, 3 times a day will decrease the frequency, duration, and severity of RP attacks when compared to placebo. Patients with RP will answer questionnaires and self-evaluate their symptoms of RP as a baseline. Then they will be assigned to either a treatment (will receive SJW capsules) or placebo (will receive non-therapeutic capsules) group. They will be required to take their capsules, self-evaluate their progress and be evaluated every two weeks in a clinic. The treatment phase will last six weeks. This trial will be conducted in a way to mimic the normal usage of natural products. Patients will not be required to stop any current treatment for RP.

Conditions

Raynaud's Disease

Keywords

St. John's Wort; Selective Serotonin Receptor Inhibitor; Microvasculature; Natural Health Products

Outcome Measures

Primary Outcomes (3)

• Frequency of Raynaud's Phenomenon (RP) attacks

  6 weeks

• Duration of RP attacks

  6 weeks

• Severity of RP attacks

  6 weeks

Secondary Outcomes (2)

• Daily functions questionnaires (HAQ, SF-36, DASH)

  6 weeks

• Biological markers of endothelial damage (V-CAM, I-CAM, VEGF, etc.)

  6 weeks

Study Arms (2)

1

EXPERIMENTAL

St. John's wort 300mg PO TID

Drug: St. John's Wort

2

PLACEBO COMPARATOR

Lactose in capsule matching the St. John's wort. 300mg PO TID

Drug: Lactose

Interventions

St. John's Wort DRUG

SJW in capsule form 300 mg PO TID

Also known as: Webber natural brand, product number 5006.

1

Lactose DRUG

lactose in gelatin capsule that same as St. John's wort

2

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or Females between 16 and 70 years old
• Primary or secondary Raynaud's phenomenon, as diagnosed by a rheumatologist
• Clinical need for treatment of Raynaud's phenomenon
• Experiences at least 7 attacks per week
• Willing and able to provide informed consent

You may not qualify if:

• Prior allergic reaction to St. John's Wort
• Pregnancy or possibility or pregnancy in the next 4 months
• Women that are currently breastfeeding
• Depression requiring treatment
• Use of SSRIs or other antidepressants with the exception of low dose amitriptyline used for reasons other than depression
• Use of drugs that are potentiated by St. John's Wort, such as cyclosporine, coumadin, digoxin, and theophylline. The complete list of contraindicated medications can be received from investigator
• Clinically significant non-compliance with past therapies
• Anticipated need for surgery (sympathectomy) in the next three months

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

Rheumatology Clinic, St. Joseph's Health Care

London, Ontario, N6A 4V2, Canada

Location

Related Publications (9)

• Schrader E. Equivalence of St John's wort extract (Ze 117) and fluoxetine: a randomized, controlled study in mild-moderate depression. Int Clin Psychopharmacol. 2000 Mar;15(2):61-8. doi: 10.1097/00004850-200015020-00001.

  PMID: 10759336 BACKGROUND

• Coleiro B, Marshall SE, Denton CP, Howell K, Blann A, Welsh KI, Black CM. Treatment of Raynaud's phenomenon with the selective serotonin reuptake inhibitor fluoxetine. Rheumatology (Oxford). 2001 Sep;40(9):1038-43. doi: 10.1093/rheumatology/40.9.1038.

  PMID: 11561116 BACKGROUND

• Pope J. Raynaud's phenomenon (primary). Clin Evid. 2003 Jun;(9):1339-48. No abstract available.

  PMID: 12967424 BACKGROUND

• Bolte MA, Avery D. Case of fluoxetine-induced remission of Raynaud's phenomenon--a case report. Angiology. 1993 Feb;44(2):161-3. doi: 10.1177/000331979304400213. No abstract available.

  PMID: 8434812 BACKGROUND

• Brenner R, Azbel V, Madhusoodanan S, Pawlowska M. Comparison of an extract of hypericum (LI 160) and sertraline in the treatment of depression: a double-blind, randomized pilot study. Clin Ther. 2000 Apr;22(4):411-9. doi: 10.1016/S0149-2918(00)89010-4.

  PMID: 10823363 BACKGROUND

• Pope JE, Prashker M, Anderson J. The efficacy and cost effectiveness of N of 1 studies with diclofenac compared to standard treatment with nonsteroidal antiinflammatory drugs in osteoarthritis. J Rheumatol. 2004 Jan;31(1):140-9.

  PMID: 14705233 BACKGROUND

• Jaffe IA. Serotonin reuptake inhibitors in Raynaud's phenomenon. Lancet. 1995 May 27;345(8961):1378. doi: 10.1016/s0140-6736(95)92582-1. No abstract available.

  PMID: 7752794 BACKGROUND

• Knuppel L, Linde K. Adverse effects of St. John's Wort: a systematic review. J Clin Psychiatry. 2004 Nov;65(11):1470-9. doi: 10.4088/jcp.v65n1105.

  PMID: 15554758 BACKGROUND

• Lecrubier Y, Clerc G, Didi R, Kieser M. Efficacy of St. John's wort extract WS 5570 in major depression: a double-blind, placebo-controlled trial. Am J Psychiatry. 2002 Aug;159(8):1361-6. doi: 10.1176/appi.ajp.159.8.1361.

  PMID: 12153829 BACKGROUND

Related Links

• American website of institute of arthritis: general medical information on Raynaud's Disease
• Canadian complementary and alternative medicine research group: contains details on how to conduct a natural product trials and has a lot of resources.
• A database that is linked to MedLine and does searches for herbal medicine only.
• Health Canada Natural Health product site: information on regulation and legislature

MeSH Terms

Conditions

Raynaud Disease

Interventions

Hypericum extract LI 160; Lactose

Condition Hierarchy (Ancestors)

Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Janet E Pope, MD, MPH

  Associate Professor of Medicine University of Western Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 11, 2006
• First Posted: July 12, 2006
• Study Start: March 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: July 14, 2009

Record last verified: 2009-07

Locations

CA (1)