A Recent Study. Looking for a Cure.

Last updated on March 3, 2008, a study posted by the National Institute of Dental and Craniofracial Research (NIDCR) evaluated the safety and effectiveness of a new treatment for Sjogren’s syndrome, thalidomide, a medication used to successfully treat other autoimmune diseases. In this autoimmune disease in particular, as we already know, the immune system attacks the body's tear glands and salivary glands, causing dry mouth and dry eyes.

Women with Sjogren's syndrome who have dry eyes and dry mouth were eligible for this study. Women who may be pregnant or who wish to one day become pregnant were not considered for the study because severe birth defects are associated with thalidomide. Also, since Sjogren's syndrome affects many fewer men than women, men are excluded from this pilot study.

Candidates were screened with a medical history, physical examination, blood and urine tests, electrocardiogram, chest X-ray and pregnancy test. Tests were also be done to measure the conduction of electrical impulses along the nerves and to evaluate dryness of the eyes.

Participants were randomly assigned to take either thalidomide or a placebo. The thalidomide dosage was increased gradually from a starting dose of 50 Mg. up to 300 Mg., depending on side effects. Women of childbearing age who had a tubal ligation or longstanding infertility were administered pregnancy tests every few weeks to avoid the possible random pregnancy. The “guinea pigs” for this study were told to come to the clinic to be checked out every four weeks throughout the course of the administration. At each visit, they were: asked to rate the progression of their dry eyes, given questionnaires to fill out, asked to submit saliva samples, and given Rose-Bengal or Schimer’s tests. They were also given blood tests to measure blood cell count and immunity substances found in the blood and liver. Urine tests were taken to monitor kidney functions. And lastly, nerve conduction tests were given. These measured the speed with which nerves conduct electrical impulses. Two nerves in the arm and one nerve in the leg were tested. Every week, participants were contacted by telephone to report any random side effects.

Information on the results are not currently up on the website. As soon as I read results, I will post them.

Pilocarpine

In earlier posts, I mentioned pilocarpine and other artificial lubricants to help mitigate Sjogren’s syndrome symptoms. Oral pilocarpine is used to treat dry mouth caused by Sjogren's syndrome and chemotherapy. A common type of artificial Pilocarpine is a "cholinergic" drug, or a drug that mimics the effects of the chemical acetylcholine in the human body, which is produced by nerve cells. Acetylcholine is the messenger between nerve cell to nerve cell interaction, and between nerve cells and organs that they control. For example, acetylcholine is responsible for causing the salivary glands to make saliva and the lacrimal glands to make tears to lubricate the eyes.
In addition to its effects on the salivary and lacrimal glands, acetylcholine controls the production of fluid within the eye, and pilocarpine eye drops have been used to treat glaucoma for many years. In 1994, an oral formulation of pilocarpine was approved by the FDA for the treatment of dry mouth caused by radiation therapy for head and neck cancer, a treatment that damages the salivary glands and reduces their production of saliva. In 1998, the oral preparation was approved for the management of Sjogren's syndrome, an autoimmune disease that damages the salivary and lacrimal glands. There is no generic form of this medication. Prescriptions are, however, available. Generally, the average dosage is 5mg- 7.5mg, and it is inexpensive considering the fact that it is a prescription medicine only. Oral pilocarpine usually is taken three or four times daily. The maximum effect occurs in approximately one hour but may occur later if it is taken with food. The effects last three to five hours. Excessive sweating (diaphoresis) is a frequent side effect of pilocarpine. Other side effects include chills, dizziness, excessive tearing, increased need to urinate, visual disturbances, diarrhea, difficulty swallowing, abdominal pain, nausea, vomiting, and slow heart rate. Of course, before you start a dose of anything you should consult your doctor. This treatment may help you!