Open-label, randomized, parallel-group controlled clinical trial of massage for treatment of depression in HIV-infected subjects.

OBJECTIVES: The study objectives were to determine whether massage therapy reduces symptoms of depression in subjects with human immunodeficiency virus (HIV) disease. DESIGN: Subjects were randomized non-blinded into one of three parallel groups to receive Swedish massage or to one of two control groups, touch or no intervention for eight weeks. SETTINGS/LOCATION: The study was conducted at the Department of Psychiatry and Behavioral Neurosciences at Cedars-Sinai Medical Center in Los Angeles, California, which provided primary clinical care in an institutional setting. SUBJECTS: Study inclusion required being at least 16 years of age, HIV-seropositive, with a diagnosis of major depressive disorder. Subjects had to be on a stable neuropsychiatric, analgesic, and antiretroviral regimen for >30 days with no plans to modify therapy for the duration of the study. Approximately 40% of the subjects were currently taking antidepressants. All subjects were medically stable. Fifty-four (54) subjects were randomized, 50 completed at least 1 week (intent-to-treat; ITT), and 37 completed the study (completers). INTERVENTIONS: Swedish massage and touch subjects visited the massage therapist for 1 hour twice per week. The touch group had a massage therapist place both hands on the subject with slight pressure, but no massage, in a uniform distribution in the same pattern used for the massage subjects. OUTCOME MEASURES: The primary outcome measure was the Hamilton Rating Scale for Depression score, with the secondary outcome measure being the Beck Depression Inventory. RESULTS: For both the ITT and completers analyses, massage significantly reduced the severity of depression beginning at week 4 (p ≤ 0.04) and continuing at weeks 6 (p ≤ 0.03) and 8 (p ≤ 0.005) compared to no intervention and/or touch. CONCLUSIONS: The results indicate that massage therapy can reduce symptoms of depression in subjects with HIV disease. The durability of the response, optimal "dose" of massage, and mechanisms by which massage exerts its antidepressant effects remain to be determined.

Biofeedback interventions for gastrointestinal conditions: a systematic review.

OBJECTIVE: To review evidence for the efficacy of biofeedback in the treatment of gastrointestinal problems. DATA SOURCES: Studies were identified through a search of MEDLINE, HealthSTAR, EMBASE, Allied and Complementary Medicine, MANTIS, PsycINFO, Social Science Citation Index, Science Citation Index, and CINAHL. STUDY SELECTION: Studies were selected if they used biofeedback as the intervention, addressed the treatment of a gastrointestinal condition, and included a control group. DATA EXTRACTION: All titles (4397), articles, and/or abstracts (1362) were evaluated by 2 independent reviewers who extracted data on study design and quality, sample size, type of intervention, and outcomes. DATA SYNTHESIS: We found 16 controlled trials of biofeedback for gastrointestinal problems. Ten studies had a comparison group that did not receive biofeedback (5 studies on constipation and/or encopresis, 3 on fecal incontinence, 1 on constipation, and 1 on abdominal pain). Of the 10 studies that had a "no biofeedback" control arm, 7 provided sufficient data to calculate an effect size. Of these 7 studies, 2 favored biofeedback: 1 study revealed a reduction in fecal incontinence among adults, and the other study showed an improvement in constipation with fecal incontinence (encopresis) among children. The other 5 had nonsignificant results. Three studies had a "no biofeedback" comparison arm but insufficient data to calculate an effect size. One of these studies in adult fecal incontinence reported statistically significant improvement. CONCLUSIONS: The evidence is insufficient to support the efficacy of biofeedback for these gastrointestinal conditions.

Severe hepatotoxicity associated with the dietary supplement LipoKinetix.

BACKGROUND: LipoKinetix (Syntrax, Cape Girardeau, Missouri) is a dietary supplement marketed for weight loss. OBJECTIVE: To describe a possible causal association between LipoKinetix and hepatotoxicity. DESIGN: Case series. SETTING: Outpatient clinic, tertiary care hospital, and U.S. Food and Drug Administration databases. INTERVENTION: Routine medical and supportive care. MEASUREMENTS: Clinical and laboratory evaluation. RESULTS: All patients developed acute hepatotoxicity within 3 months of starting LipoKinetix. At presentation, symptoms and results of laboratory tests were characteristic of acute hepatitis. All patients recovered spontaneously after LipoKinetix use was discontinued. Three of the seven patients, including one who developed fulminant hepatic failure complicated by cerebral edema, were taking LipoKinetix alone at the time of presentation. Of the four patients who were taking multiple supplements, two resumed taking supplements other than LipoKinetix without incident. CONCLUSIONS: The use of LipoKinetix may be associated with hepatotoxicity. Despite extensive evaluations, no other cause for hepatotoxicity could be identified in the seven patients studied.