Effect of galantamine hydrobromide in chronic fatigue syndrome: a randomized controlled trial.

CONTEXT: There is no established pharmacological treatment for the core symptoms of chronic fatigue syndrome (CFS). Galantamine hydrobromide, an acetyl cholesterone inhibitor, has pharmacological properties that might benefit patients with CFS. OBJECTIVE: To compare the efficacy and tolerability of galantamine hydrobromide in patients with CFS. DESIGN, SETTING, AND PATIENTS: Randomized, double-blind trial conducted June 1997 through July 1999 at 35 outpatient centers in the United Kingdom (n = 17), United States (n = 14), the Netherlands (n = 2), Sweden (n = 1), and Belgium (n = 1) involving 434 patients with a clinical diagnosis of CFS (modified US Centers for Disease Control and Prevention criteria). INTERVENTIONS: A total of 89 patients were randomly assigned to receive 2.5 mg of galantamine hydrobromide; 86 patients, 5.0 mg; 91 patients, 7.5 mg; and 86 patients, 10 mg (these patients received medicine in the tablet form 3 times per day); a total of 82 patients received matching placebo tablets 3 times per day. MAIN OUTCOME MEASURES: The primary efficacy variable was the global change on the Clinician Global Impression Scale after 4, 8, 12, and 16 weeks of treatment. Secondary outcomes were changes in core symptoms of CFS on the Chalder Fatigue Rating Scale, the Fibromyalgia Impact Questionnaire, and the Pittsburgh Sleep Quality Index; changes in quality of life on the Nottingham Health Profile; and assessment of plasma-free cortisol levels and cognitive performance on a computer-based battery of tests. RESULTS: After 16 weeks, there were no statistically significant differences between any of the galantamine or placebo groups in clinical condition on the Clinician Global Impression Scale, or for any of the secondary end points. Exploratory regression analysis failed to detect any consistent prognostic factor that might have influenced the primary or any secondary outcome measures. CONCLUSION: This trial did not demonstrate any benefit of galantamine over placebo in the treatment of patients with CFS.

Seasonality prevalence and incidence of depressive disorder in a general practice sample: identifying differences in timing by caseness.

A total of 2225 consecutive consulting general practice patients attending a North London Health Centre over the course of a year were screened and interviewed for the presence of psychiatric disorder using the GHQ and SADS; 196 patients suffering from RDC depressive disorders were identified and followed up for a further 12 months. A difference in prevalence incidence and recovery time was identified between major and minor depression. Various associations between season of onset and a range of variables were observed. Logistic modelling identified interactions between some of these variables some of which have not been explored in previous studies.

Fluid retention syndrome and fibromyalgia.

Fluid retention syndrome (FRS) or idiopathic oedema is an unusual clinical entity almost exclusively seen in women, which remains under-diagnosed and poorly understood. It can produce a variety of symptoms ranging from headaches and blurring of vision to abdominal pains and diarrhoea [1]. More commonly it presents with symptoms of bloating, fatigue and generalized weakness. We describe four cases of FRS who presented to the rheumatology clinic with signs and symptoms of fibromyalgia. We also discuss the common features of these two conditions and argue that rheumatologists need to be aware of this condition.

A. I. F. Scott & C. P. L. Freeman's "Edinburgh Primary Care Depression Study.

"OBJECTIVE--To compare the clinical efficacy, patient satisfaction, and cost of three specialist treatments for depressive illness with routine care by general practitioners in primary care. DESIGN--Prospective, randomised allocation to amitriptyline prescribed by a psychiatrist, cognitive behaviour therapy from a clinical psychologist, counselling and case work by a social worker, or routine care by a general practitioner. SUBJECTS AND SETTING--121 patients aged between 18 and 65 years suffering depressive illness (without psychotic features) meeting the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Third Edition for major depressive episode in 14 primary care practices in southern Edinburgh. MAIN OUTCOME MEASURES--Standard observer rating of depression at outset and after four and 16 weeks. Numbers of patients recovered at four and 16 weeks. Total length and cost of therapist contact. Structured evaluation of treatment by patients at 16 weeks. RESULTS--Marked improvement in depressive symptoms occurred in all treatment groups over 16 weeks. Any clinical advantage of specialist treatments over routine general practitioner care were small, but specialist treatment involved at least four times as much therapist contact and cost at least twice as much as routine general practitioner care. Psychological treatments, especially social work counselling, were most positively evaluated by patients. CONCLUSIONS--The additional costs associated with specialist treatments of new episodes of mild to moderate depressive illness presenting in primary care were not commensurate with their clinical superiority over routine general practitioner care. A proper cost-benefit analysis requires information about the ability of specialist treatment to prevent future episodes of depression.

The psychological complications of therapeutic abortion.

Psychological or psychiatric disturbances occur in association with therapeutic abortions but they seem to be marked, severe, or persistent in only a minority (approximately 10%) of women. These consist mostly of caseness depression and anxiety. Psychoses are very uncommon, being reported in only 0.003% of cases - most of whom have a history of previous psychiatric illness. Certain groups are especially at risk from adverse psychological sequelae; these include those with a past psychiatric history, younger women, those with poor social support, the multiparous, and those belonging to sociocultural groups antagonistic to abortion. This is not to overlook the fact that, adopting a crisis-resolution framework, subsequent termination of an unwanted pregnancy is itself 'therapeutic'. A better understanding of the nature of the risk factors would enable clinicians to identify vulnerable women for whom some form of psychological intervention might be beneficial.

'Puerperal psychosis' following male-to-female sex reassignment?

Psychosis is reported following abrupt withdrawal of oestrogen and surgery for male-to-female sex reassignment. The resemblance of the patient's mental state to puerperal psychosis suggested a hormonal aetiology.

Depressive disorder in primary care.

Since the pioneering study of psychiatric morbidity in primary care by Shepherd et al in 1966, it has become increasingly apparent that a substantial proportion (between 20% and 25%) of patients consulting their GP are suffering from some form of psychiatric disturbance (Goldberg & Blackwell, 1970; Hoeper et al, 1979). The composition of this psychiatric morbidity has been shown to be almost wholly affective in nature and largely mild in degree. In their important review Jenkins & Shepherd (1983) recently summarised the now extensive findings relating to overall minor psychiatric morbidity in primary care. However, recent collaborative studies between psychiatrists and GPs have identified that within this dilute pool of minor disorders, lurks a significant but poorly served population of patients suffering from depressive disorders which are by no means minor in degree. A number of crucial issues regarding this depression in primary care emerge which the present paper aims to review. In particular, how common is it, and how severe? How does it present and what, if any, are its special characteristics? What is the precise relationship between depressive symptoms and depressive illness presenting to the GP and what is the relationship between physical illness and depression? And finally, what is the course and outcome of depression in this setting and what are the indications for and effect of treatment?