A randomised controlled trial of the monoaminergic stabiliser (-)-OSU6162 in treatment of myalgic encephalomyelitis/chronic fatigue syndrome.

OBJECTIVE: The monoaminergic stabiliser (-)-OSU6162 has in previous studies shown promising effects on mental fatigue after stroke and traumatic brain injury. This study investigated the safety and effectiveness of (-)-OSU6162 in patients with myalgic encephalomyelitis/chronic fatigue syndrome. METHODS: A total of 62 patients were randomly assigned to placebo or (-)-OSU6162. Primary outcomes were assessment on the mental fatigue scale (MFS) and the clinical global impression of change (CGI-C) scale. Secondary outcomes were results on the FibroFatigue scale (FF), the Beck Depression Inventory (BDI), the pain visual analogue scale and neuropsychological tests. Assessments were performed at baseline, after 1 and 2 weeks of treatment and at follow-up after 6 weeks. RESULTS: MFS and CGI-C showed significant improvements for both treatment groups after treatment but not at follow-up; a similar pattern was seen for FF and BDI. However, significant differences between groups could not be demonstrated. On the other hand, correlation analyses showed a significant correlation between (-)-OSU6162 concentration and change in MFS, FF, and BDI score within the concentration interval 0.1-0.7 µM. Exploratory subgroup analyses showed a larger treatment effect with (-)-OSU6162 in improving MFS and FF symptoms in patients on antidepressant therapy compared to those without antidepressant treatment. CONCLUSION: (-)-OSU6162 was found to be safe and well tolerated. When analysing the entire material (-)-OSU6162 was not found to differ significantly from placebo in alleviating fatigue in ME patients but was superior to placebo in counteracting fatigue in a subgroup of ME patients who received concomitant pharmacological treatment for depression.

Vulnerability and Resilience in Patients with Chronic Pain in Occupational Healthcare: A Pilot Study with a Patient-Centered Approach.

OBJECTIVES: The aim of this pilot study was to describe vulnerability and resilience and possible subgroups in patients with chronic work related musculoskeletal pain in occupational healthcare. A second aim was to evaluate a patient-centered approach. METHODS: This study was based on consecutive patients with chronic pain, seen by the same physician and sick-listed full or part time three months or longer. They were included during a period of three months. Patient reported outcome measures (PROM) were administered at baseline and at follow-up after 8 months. A patient-centered approach was applied where the patient's whole situation was taken into account. RESULTS: A dominance of an insecure dismissing attachment pattern and a subnormal sense of coherence (SOC) was reported both at baseline and at follow-up. The patients (n=38) reported significant improvement of pain severity (p=0.01), pain interference (p=0.001), life control (p=0.01), affective distress (p=0.02), and dysfunction (p=0.001) on the multidimensional pain inventory (MPI) and fewer patients were sick-listed full time at follow-up (13 patients versus 21). By means of multivariate data analyses this change in MPI was confirmed and was also correlated with a significant increase in health related quality of life (HRQoL). Moreover subgroups with different outcome at follow-up were identified according to attachment pattern and subgroups on MPI. CONCLUSION: A patient-centered approach may be of value for patients with chronic pain in occupational healthcare, improving pain and dysfunction. Patients with chronic pain are a heterogeneous group where outcome of treatment might be influenced by individual resilience and/or vulnerability.

Response to vitamin B12 and folic acid in myalgic encephalomyelitis and fibromyalgia.

BACKGROUND: Patients with myalgic encephalomyelitis (ME, also called chronic fatigue syndrome) may respond most favorably to frequent vitamin B12 injections, in vital combination with oral folic acid. However, there is no established algorithm for individualized optimal dosages, and rate of improvement may differ considerably between responders. OBJECTIVE: To evaluate clinical data from patients with ME, with or without fibromyalgia, who had been on B12 injections at least once a week for six months and up to several years. METHODS: 38 patients were included in a cross-sectional survey. Based on a validated observer's rating scale, they were divided into Good (n = 15) and Mild (n = 23) responders, and the two groups were compared from various clinical aspects. RESULTS: Good responders had used significantly more frequent injections (p<0.03) and higher doses of B12 (p<0.03) for a longer time (p<0.0005), higher daily amounts of oral folic acid (p<0.003) in good relation with the individual MTHFR genotype, more often thyroid hormones (p<0.02), and no strong analgesics at all, while 70% of Mild responders (p<0.0005) used analgesics such as opioids, duloxetine or pregabalin on a daily basis. In addition to ME, the higher number of patients with fibromyalgia among Mild responders was bordering on significance (p<0.09). Good responders rated themselves as "very much" or "much" improved, while Mild responders rated "much" or "minimally" improved. CONCLUSIONS: Dose-response relationship and long-lasting effects of B12/folic acid support a true positive response in the studied group of patients with ME/fibromyalgia. It's important to be alert on co-existing thyroid dysfunction, and we suspect a risk of counteracting interference between B12/folic acid and certain opioid analgesics and other drugs that have to be demethylated as part of their metabolism. These issues should be considered when controlled trials for ME and fibromyalgia are to be designed.

Time to gain trust and change--experiences of attachment and mindfulness-based cognitive therapy among patients with chronic pain and psychiatric co-morbidity.

The treatment of patients with chronic pain disorders is complex. In the rehabilitation of these patients, coping with chronic pain is seen as important. The aim of this study was to explore the meaning of attachment and mindfulness-based cognitive therapy (CT) among patients with chronic pain and psychiatric co-morbidity. A phenomenological approach within a lifeworld perspective was used. In total, 10 patients were interviewed after completion of 7- to 13-month therapy. The findings reveal that the therapy and the process of interaction with the therapist were meaningful for the patients' well-being and for a better management of pain. During the therapy, the patients were able to initiate a movement of change. Thus, CT with focus on attachment and mindfulness seems to be of value for these patients. The therapy used in this study was adjusted to the patients' special needs, and a trained psychotherapist with a special knowledge of patients with chronic pain might be required.

Quality of life assessed with Short Form 36 – a comparison between two populations with long-term musculoskeletal pain disorders.

PURPOSE: To assess quality of life (QoL) in two groups of patients with long-term musculoskeletal pain with and without psychiatric co-morbidity and to compare them with a reference group of normative controls. The patients in both study groups were sick-listed full or part time for 3 months or more. METHOD: The patients were recruited from a company health service and consulting psychiatry. A generic QoL questionnaire, the SF-36, was used to assess QoL. Each group was compared with age- and gender-matched normative controls. RESULTS: Both groups reported a pronounced impairment of QoL (p < 0.001) compared with their age- and gender-matched populations. The greatest impairment was seen among the patients referred for psychiatric assessment (n = 30). The patients in the company health service (n = 42) reported significantly higher QoL with regard to the dimensions mental health (p < 0.028), social functioning (p < 0.034) and role emotional (p < 0.040) compared with the patients referred for psychiatric assessment. CONCLUSION: Patients with long-term pain in the company health care and patients with psychiatric co-morbidity, sick-listed full or part-time reported severely impaired QoL with regard both to physical, social and mental dimensions. Psychiatric co-morbidity reported even more pronounced impairment of emotional, social and mental dimensions of QoL which might indicate dysfunctional coping strategies.