No pain, no gain: Measuring treatment effects in fybromyalgia

Thesis introduction and outlineThis thesis, although written by a rheumatologist, originates from a patient initiative.In 1996 Ben Weerdmeester chaired the Dutch association of fibromyalgia patients FES (Fibromyalgiepatiënten Eendrachtig Sterk).Individual patients suffering from fibromyalgia had experienced positive results from thalasso therapy, a form of balneotherapy popular in Mediterranean countries.The executive committee of the FES thought it sensible to research this form of treatment scientifically and were willing to invest money in such a study.In an open pilot study, 14 patients visited a thalasso centre in Hammamet, Tunisia, and were enthusiastic about the treatment.Further funding for the project was granted by the Dutch Arthritis Association (Vereniging Nationaal Reumafonds) and the Foundation for Fundraising in Public Health (Stichting Fondsenwervingsacties Volksgezondheid).By the summer of 1998, I was asked to join this project.At that time I was specialising in Rheumatology, while also collecting data for the development of the Rheumatoid Arthritis Articular Damage score (RAAD).I was asked to change my subject from 'objective joint damage in a hardcore rheumatic disease' to 'alternative treatment of subjective symptoms in a chronic pain syndrome', which is something quite different.The study protocol looked solid, however, and the inclusion of a cost-effectiveness analysis made it less 'soft'.It seemed a unique and challenging project to me.Somewhat hesitantly I accepted the job.Chapter 1 of this thesis presents an overview of what was known about fibromyalgia at the time and what has been added to the literature since.By the end of March 1999, a first group of patients went to Jerba, Tunisia, followed by a second and third group in May 2000.I was pleased with their enthusiasm during the spa treatment.During follow-up it was encouraging to see the dedication of the participants, both in the intervention group and in the control group.The effects of spa treatment on FM symptoms and health-related quality of life are described in chapter 2. Results of the cost-effectiveness analysis are presented in chapter 3.With the follow-up of the spa study still going on, a new study opportunity arose.A randomised controlled trial (RCT) was set up to study if the antidepressant venlafaxine was superior to placebo in reducing pain and other fibromyalgia symptoms.This trial is described in chapter 4. At the time when we were conducting this study, an article was published on a RCT studying the effect of fluoxetine, also an antidepressant, in FM [1].Much to our surprise, in this RCT no improvement was described in patients taking placebo.This is in sharp contrast with most other drug trials for FM.We commented on this lack of a placebo effect in a Letter to the Editor, which is included as chapter 5 in this thesis.In both our trials the Fibromyalgia Impact Questionnaire (FIQ) was one of the outcome measures.Since our Dutch translation of the FIQ had not been validated yet, we also included various questionnaires for which a validated Dutch version existed.Using the data sets from both trials, we tested whether our version of the FIQ was a valid outcome measure of health-related quality of life in FM patients.The results of this validati-Chapter 1 C h a p t e r 2 Spa treatment for primary fibromyalgia syndrome: A combination of thalassotherapy, exercise and patient education improves symptoms and quality of life

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