A Double-Masked, Placebo-Controlled Study of Fluoxetine for Hypochondriasis

Abstract

This study assessed the efficacy, durability, and tolerability of fluoxetine for hypochondriasis, a disorder for which controlled pharmacological trials are scarce. Fifty-seven patients with hypochondriasis were enrolled: 12 discontinued during the placebo run-in, and 45 were randomized to either fluoxetine or placebo for 12 weeks (acute treatment). Responder status was defined as a Clinical Global Impression rating for hypochondriasis of much or very much improved. Secondary outcome measures included severity of hypochondriasis, somatization, anxiety, and depression. Responders to acute treatment entered a 12-week maintenance phase to week 24. Sustained responders at week 24 entered a 12-week double-masked discontinuation phase. Primary analysis used the intent-to-treat sample. More patients responded with improvement in hypochondriasis when given fluoxetine compared with placebo, starting at week 8 (50.0% vs 19.0%, P = 0.03) and continuing to week 12 (62.5% vs 33.3%, P = 0.05). Mean dose at week 12 dose was 51.4 mg (SD, +/-23 mg). The acute treatment response was maintained to week 24 with more responders in the fluoxetine compared with the placebo group (54.2% vs 23.8%, P = 0.04). Significant improvement was not noted on the continuous secondary outcomes measures of hypochondriasis, with the exception of the Clinical Global Impression hypochondriasis severity scale at week 24. Likelihood of response was not associated with severity of psychiatric comorbidity. Durability of response after controlled drug discontinuation could not be reasonably assessed, given the small sample size of patients who entered the discontinuation phase (n = 10). Fluoxetine was well tolerated, with no significant differences in discontinuation due to side effects between treatment groups. Fluoxetine is a moderately effective and well-tolerated treatment for hypochondriasis.

Cognitive behavioral therapy versus paroxetine in the treatment of hypochondriasis: An 18-month naturalistic follow-up

“…Furthermore, duration, comorbidity and benzodiazepine use did not predict the course of hypochondriacal symptoms during the follow-up period. The results with regard to the efficacy of CBT or a pharmacological treatment with an SSRI are in concordance with the results of the recent placebo-controlled study of Fallon et al (2008) who concluded that fluoxetine is a moderately effective treatment for hypochondriasis with durable efficacy over a follow-up period of 6 months.…”

“…Moreover, paroxetine appeared to be as effective as CBT (Greeven et al, 2007). Recently, Fallon et al (2008) published a double-masked placebo-controlled study of fluoxetine for hypochondriasis. After a follow-up period of 6 months the improvement of patients taking fluoxetine was maintained and the percentages of responders in the fluoxetine and the placebo group still differed significantly from each other in the advantage of the fluoxetine group.…”

Evidence-based pharmacological treatment of anxiety disorders, post-traumatic stress disorder and obsessive-compulsive disorder: A revision of the 2005 guidelines from the British Association for Psychopharmacology

“…The condition is characterised by excessive concern over health, constant fear of undiagnosed disease that physicians may have missed, and the characteristic behaviours of repeated checking and need for medical reassurance. Pharmacological treatment is not normally acceptable to patients, as those with marked health anxiety are typically very sensitive to adverse effects of medication: but fluoxetine showed some benefit over placebo, though this was not pronounced and occurred late in treatment (8-12 weeks [I (PCT)] (Fallon et al, 2008). Psychological treatments have been found beneficial [I (M)] ( Thomson and Page, 2007), and include behavioural stress management (Clark et al, 1998) ([II]), cognitive behaviour therapy, in both face-to-face and internet format (Hedman et al, 2011b;Seivewright et al, 2008;Sørensen et al, 2011) (Tyrer et al, 2014).…”

Long-Term Follow-Up of Hypochondriasis After Selective Serotonin Reuptake Inhibitor Treatment

“…This follow-up study included all 58 patients from either of 2 SSRI treatment studies: 14 from an open-label study of fluvoxamine 5 and 45 from a double-masked, placebo-controlled trial of fluoxetine, 6 with one patient participating in both. These treatment studies recruited individuals through media advertisements and primary care clinic screenings.…”

“…Further details are available in previous publications. 5,6 Measures at Baseline and at Follow-Up At baseline, all participants were assessed with the Structured Clinical Interviews for DSM-III-R (later DSM-IV; SCID I and SCID II) for the diagnosis of Axis I and II disorders. Other assessments included the Whiteley Index for hypochondriasis severity, 9 the Beck Depression Inventory, 10 the Hamilton Anxiety Scale, 11 the Medical Outcomes Study 36-item Short-Form Health Survey for functional status, 12 and the Brief Physical and Sexual Abuse Questionnaire for history of traumatic events before age 16.…”