Anxiolytics are anti-anxiety agents, or minor tranquilizers, used for the treatment of anxiety and its related physical and psychological symptoms. Various anti-anxiety medications have been evaluated for effects on chemotherapy-induced nausea and vomiting, dyspnea, pain, peripheral neuropathy, and hot flashes, as well as anxiety. In many cases, individual drugs, rather than the class of drugs, may be identified as a specific intervention for Putting Evidence Into Practice classification.
Holland, J.C., Morrow, G., Schmale, A., Derogatis, L., Stefanek, M., Berenson, S., . . . Feldstein, M. (1991). A randomized clinical trial of alprazolam versus progressive muscle relaxation in cancer patients with anxiety and depressive symptoms. Journal of Clinical Oncology, 9, 1004–1011.
The 10-day study had two arms: alprazolam 0.5 mg three times a day or progressive muscle relaxation three times a day.
A randomized controlled trial (nonblinded) design was used.
There was significant decrease in anxiety (HARS, ABS, SCL-90 subscale) and depression (SCL-90 subscale) in both treatment arms (p < 0.001). There was minimal change in pulse and blood pressure.
Mentes, S.D., Unsal, D., Baran, O., Argun, G., & Ertunc, F.N. (2005). Effect of sedation with midazolam or propofol on patient’s comfort during cancer chemotherapy: A prospective, randomized, double-blind study in breast cancer patients. Journal of Chemotherapy, 17, 327–333.
The trial had three arms: Group 1 – chemotherapy control, Group 2 – chemotherapy plus midazolam, and Group 3 – chemotherapy plus propofol.
The study reported on a sample of 45 patients with breast cancer (s/p mastectomy, second chemotherapy).
Turkey
A randomized controlled trial design was used.
Clinical Global Impression Scale (CGI) for anxiety
Midazolam and propofol significantly decreased anxiety, with propofol being better.
It is unclear which groups completed the CGI measure.
Razavi, D., Allilaire, J.F., Smith, M., Salimpour, A., Verra, M., Desclaux, B., . . . Blin, P. (1996). The effect of fluoxetine on anxiety and depression symptoms in cancer patients. Acta Psychiatria Scandinavica, 94, 205–210.
This trial randomized patients to two arms: one group received fluoxetine, and the other group received placebo for five weeks.
Patients with cancer (N = 115) were randomized to two arms: fluoxetine treatment (n = 45) versus placebo (n = 46) for five weeks.
A randomized, controlled, double-blinded trial design was used.
Response rate (HADS) score < 8 after five weeks was not significantly higher in the fluoxetine group compared to the placebo group. There was significant decrease in mean scores on the SCL90-R in the fluoxetine group. There was no difference between groups on MADRS, HAS, or SQOLI.
Lower scores on subscales of the SQL90-R may reflect changes in anxiety levels between groups.
The authors did not mention power of effect size.
Torta, R., Siri, I., & Caldera, P. (2008). Sertraline effectiveness and safety in depressed oncological patients. Supportive Care in Cancer, 16, 83–91.
To examine the effectiveness and safety of the antidepressant sertraline (selective serotonin reuptake inhibitor) in treating somatic and emotional symptoms of depression in patients with cancer
To evaluate the effect of sertraline treatment on quality of life (QOL)
The intervention was a 12-week trial with a flexible dose regimen of sertraline. Patients started at a dosage of 25 mg/day, with a possible increase to 100 mg/day. The treatment response was assessed at baseline (T0), week 4 (T1), and week 12 (T2).
Patients were undergoing the active treatment phase of care.
An open-label, noncomparative, prospective pilot study design was used.
Mean daily dose of sertraline was 57.50 (+_18.74) mg at T1 and 57.41 (+_18.10) mg at T2. Both mean depression scores, analyzed by HADS and MADRS scales, and HADS anxiety scores significantly decreased during the 12 weeks of study (all p values < 0.05). Mean Mini-MAC scores showed that hopelessness and anxious preoccupation decreased significantly at T2 compared with T0 (p < 0.05). QOL improved over time (p < 0.05). CGI was improved over the treatment period; however, no statistical tests were involved. No severe adverse effects were observed. Six patients reported varying degrees of side effects (nausea, agitation, insomnia, and dizziness).
Sertraline may be effective for the treatment of depressed outpatients with cancer. However, stronger evidence is needed.
Nurses can inform patients of a possible option to decrease depressive symptoms during chemotherapy.
Wald, T.G., Roger, R.G., Noyes, R., Carroll, B.T., & Clamon, G.H. (1993). Rapid relief of anxiety in cancer patients with both alprazolam and placebo. Psychosomatics, 34, 324–332.
This randomized trial had two arms: alprazolam (0.5 mg) versus placebo. Dose increased over one week to 4 mg/day. Enrollment lasted four weeks.
The study reported on a sample of 36 inpatients and outpatients with cancer receiving treatment and/or follow-up.
A randomized, controlled, double-blinded trial design was used.
There was significant decrease in anxiety in both groups during week 1. There was no significant difference between alprazolam and placebo on anxiety for both self-rated and interviewer-rated scales.
RESOURCE TYPE: Consensus-based guideline
PHASE OF CARE: Not specified or not relevant
Limited information on the quality of evidence was retrieved. All recommendations were mainly consensus based.
This guideline provides very general level treatment algorithms based on the results of an initial distress screening, and recommends further assessment and intervention determination if overall distress is 4 or above on the distress thermometer.