Complementary and alternative healthcare use by participants in the PACE trial of treatments for chronic fatigue syndrome

Highlights

• CAM use is very common in patients with chronic fatigue syndrome (CFS) involving approximately two thirds of patients.

• Its use is not associated with any important clinical outcomes.

• The main predictors of CAM use are female sex and local ME group membership.

• These observations are important for clinicians and should be discussed with CFS patients.

Abstract

Background

Chronic Fatigue Syndrome (CFS) is characterised by persistent fatigue, disability and a range of other symptoms. The PACE trial was randomised to compare four non-pharmacological treatments for patients with CFS in secondary care clinics. The aims of this sub study were to describe the use of complementary and alternative medicine (CAM) in the trial sample and to test whether CAM use correlated with an improved outcome.

Method

CAM use was recorded at baseline and 52 weeks. Logistic and multiple regression models explored relationships between CAM use and both patient characteristics and trial outcomes.

Results

At baseline, 450/640 (70%) of participants used any sort of CAM; 199/640 (31%) participants were seeing a CAM practitioner and 410/640 (64%) were taking a CAM medication. At 52 weeks, those using any CAM fell to 379/589 (64%). Independent predictors of CAM use at baseline were female gender, local ME group membership, prior duration of CFS and treatment preference. At 52 weeks, the associated variables were being female, local ME group membership, and not being randomised to the preferred trial arm. There were no significant associations between any CAM use and fatigue at either baseline or 52 weeks. CAM use at baseline was associated with a mean (CI) difference of 4.10 (1.28, 6.91; p = 0.024) increased SF36 physical function score at 52 weeks, which did not reach the threshold for a clinically important difference.

Conclusion

CAM use is common in patients with CFS. It was not associated with any clinically important trial outcomes.

Introduction

Chronic Fatigue Syndrome (CFS) is a relatively common condition affecting between 0.4% and 2.6% of the population, depending on the definition used [1]. Some regard Myalgic Encephalomyelitis (ME) as a separate disorder from CFS, whereas others think they are synonymous [2]. The condition is characterised by debilitating, persistent fatigue, muscle pain and other symptoms such as headaches, poor sleep and post-exertion malaise; sore throat and tender lymph nodes are reported by the minority of patients with CFS [3]. CFS affects all races and socio-economic groups.

CFS is a clinical diagnosis based on history and a comprehensive range of investigations which exclude other causes of fatigue. It involves comparing the patient's symptoms and history with diagnostic criteria; the Oxford criteria [4], the International 1994 criteria [3], and the National Institute for Health and Care Excellence (NICE) criteria [2].

Complementary and alternative medicine (CAM) is difficult to define and both culturally and contextually specific. Its use may be a surrogate for empowerment and self-help [5], [6]. Patients with chronic illnesses utilise CAM [7] for diverse reasons including engagement in one's own health, positive expectations of treatment and the need for hope [5], [7]. CAM treatments used by those with CFS include massage therapy, relaxation, meditation, homoeopathy, acupuncture, naturopathy and herbal therapies [7], [8], [9], [10]. Two systematic reviews of CAM for CFS found most studies were small, had poor methodology and produced inconclusive evidence [7], [10]. CAM use generally is greater among women, higher socio-demographic groups, those with more education and in long-term chronic illness [11], [12]. Both health characteristics and demographic factors contribute independently to CAM use [12] with over 90% of people with fibromyalgia using CAM [13], [14].

The PACE trial was a randomised controlled trial comparing four treatments for CFS; standard medical care alone (SMC), and SMC supplemented by one of three therapies: cognitive behavioural therapy (CBT), graded exercise therapy (GET), adaptive pacing therapy (APT) [15], [16]. All CAM treatments in this study were funded outside the study.

This paper presents an in-depth analysis of the CAM data from the PACE trial dataset. The PACE trial represents the largest prospective dataset that has meticulously recorded the details of CAM in this particular population over 12 months. Our objectives in analysing this data were to understand the following: 1) the use of CAM at baseline and over the course of the trial; 2) the demographic and clinical associations with CAM use cross-sectionally post randomisation and prospectively at follow up; 3) the associations with treatment outcomes.