Placebo effects in primary insomnia.

Placebo effects are commonly observed in insomnia clinical trials. With the advent of longer-term trials, such effects appear to be remarkably robust and durable. In this paper we review the classic factors that are believed to contribute to placebo effects and how these factors operate in insomnia randomized clinical trials. Beyond this we suggest that the episodic nature of insomnia may interact with patient preferences for intermittent dosing in such a way as to sustain placebo effects in the long term. An appreciation of the latter phenomenon may provide increased power to detect therapeutic outcomes and may be used to potentiate clinical gains.

Acustimulation wrist bands are not effective for the control of chemotherapy-induced nausea in women with breast cancer.

This experiment examined the efficacy of an acustimulation wrist band for the relief of chemotherapy-induced nausea using a randomized three-arm clinical trial (active acustimulation, sham acustimulation, and no acustimulation) in 96 women with breast cancer who experienced nausea at their first chemotherapy treatment. Five outcomes related to wrist band efficacy (acute nausea, delayed nausea, vomiting, QOL, and total amount of antiemetic medication used) were examined. The five outcomes were examined separately using analysis of covariance controlling for age and severity of past nausea. There were no significant differences in any of these study measures among the three treatment conditions (P>0.1 for all). Study results do not support the hypothesis that acustimulation bands are efficacious as an adjunct to pharmacological antiemetics for control of chemotherapy-related nausea in female breast cancer patients.

Effect of paroxetine hydrochloride (Paxil) on fatigue and depression in breast cancer patients receiving chemotherapy.

BACKGROUND: Fatigue can significantly interfere with a cancer patient's ability to fulfill daily responsibilities and enjoy life. It commonly co-exists with depression in patients undergoing chemotherapy, suggesting that administration of an antidepressant that alleviates symptoms of depression could also reduce fatigue. METHODS: We report on a double-blind clinical trial of 94 female breast cancer patients receiving at least four cycles of chemotherapy randomly assigned to receive either 20 mg of the selective serotonin re-uptake inhibitor (SSRI) paroxetine (Paxil, SmithKline Beecham Pharmaceuticals) or an identical-appearing placebo. Patients began their study medication seven days following their first on-study treatment and continued until seven days following their fourth on-study treatment. Seven days after each treatment, participants completed questionnaires measuring fatigue (Multidimensional Assessment of Fatigue, Profile of Mood States-Fatigue/Inertia subscale and Fatigue Symptom Checklist) and depression (Profile of Mood States-Depression subscale [POMS-DD] and Center for Epidemiologic Studies-Depression [CES-D]). RESULTS: Repeated-measures ANOVAs, after controlling for baseline measures, showed that paroxetine was more effective than placebo in reducing depression during chemotherapy as measured by the CES-D (p = 0.006) and the POMS-DD (p = 0.07) but not in reducing fatigue (all measures, ps > 0.27). CONCLUSIONS: Although depression was significantly reduced in the 44 patients receiving paroxetine compared to the 50 patients receiving placebo, indicating that a biologically active dose was used, no significant differences between groups on any of the measures of fatigued were observed. Results suggest that modulation of serotonin may not be a primary mechanism of fatigue related to cancer treatment.

Treatment of radiotherapy-induced fatigue through a nonpharmacological approach.

BACKGROUND: Cancer-related fatigue (CRF) is a frequently occurring, burdensome side effect of radiation therapy that can result in detrimental effects to health-related quality of life (HRQL). The findings from a pilot study examining the efficacy of the complementary and alternative practice of Polarity Therapy (PT) in reducing CRF and improving HRQL are reported. METHODS: Fifteen women undergoing radiation therapy for breast cancer and experiencing fatigue were randomized to receive 1, 2, or no PT treatments. Treatments were given 1 week apart to the patients receiving 2 treatments. Fatigue and HRQL were assessed at baseline prior to PT, 3 days following the first PT treatment (week 1), and 3 days following the second PT treatment (week 2). RESULTS: There was a statistically significant improvement in both CRF and HRQL in the 10 patients who received a PT treatment compared to the 5 control patients at the week 1 assessment. In addition, there was a statistically significant difference among the 3 treatment groups in improvement in CRF at the week 2 assessment. This finding, coupled with a visual inspection of the means, supports the plausibility of a dose response concerning PT. CONCLUSION: Results from this pilot investigation suggest that PT may have a positive influence on CRF and HRQL in women undergoing radiation treatment for breast cancer. Randomized, controlled clinical trials with larger sample sizes are needed.

Acupressure and acustimulation bands for control of nausea: a brief review.

We review the published literature examining the efficacy of acupressure and acustimulation wrist bands for the relief of nausea, with special emphasis on the alleviation of nausea associated with pregnancy. We also present preliminary data from an open-label study on the efficacy of acustimulation bands for control of chemotherapy nausea. The literature supports the conclusion that Neiguan-point stimulation by acupressure and acustimulation wrist bands for nausea relief is efficacious for many patients.