Anxiolytics

Anxiolytics

PEP Topic 
Anxiety
Description 

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.

Effectiveness Not Established

Research Evidence Summaries

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.

Print

Intervention Characteristics/Basic Study Process:

The 10-day study had two arms: alprazolam 0.5 mg three times a day or progressive muscle relaxation three times a day.

Sample Characteristics:

  • The study reported on a sample of 147 patients.
  • Sample age range was 18–70 years.
  • Patients were receiving active cancer treatment at three centers.
  • Patients had Karnofsky scores greater than 60.

Study Design:

A randomized controlled trial (nonblinded) design was used.

Measurement Instruments/Methods:

  • Covi Anxiety Scale
  • Raskin Depression Scale
  • Hamilton Anxiety Rating Scale (HARS)
  • Symptom Checklist–90 (SCL-90)
  • Patient’s Global Impression Scale
  • Physiologic measures: Pulse and blood pressure

Results:

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.

Limitations:

  • The study yielded equivocal findings regarding alprazolam and progressive relaxation. 
  • The study had no long-term follow-up, only a 10-day period.
  • The sample was largely white (87%) and female (64%).
  • Older study

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.

Print

Intervention Characteristics/Basic Study Process:

The trial had three arms: Group 1 – chemotherapy control, Group 2 – chemotherapy plus midazolam, and Group 3 – chemotherapy plus propofol.

Sample Characteristics:

The study reported on a sample of 45 patients with breast cancer (s/p mastectomy, second chemotherapy).

Setting:

Turkey

Study Design:

A randomized controlled trial design was used.

Measurement Instruments/Methods:

Clinical Global Impression Scale (CGI) for anxiety

Results:

Midazolam and propofol significantly decreased anxiety, with propofol being better.

Limitations:

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.

doi: 10.1111/j.1600-0447.1996.tb09850.x
Print

Intervention Characteristics/Basic Study Process:

This trial randomized patients to two arms: one group received fluoxetine, and the other group received placebo for five weeks.

Sample Characteristics:

Patients with cancer (N = 115) were randomized to two arms: fluoxetine treatment (n = 45) versus placebo (n = 46) for five weeks.

Study Design:

A randomized, controlled, double-blinded trial design was used.

Measurement Instruments/Methods:

  • Hospital Anxiety and Depression Scale (HADS)
  • Symptom Checklist–90–Revised (SCL90-R)
  • Montgomery-Åsberg Depression Rating Scale (MADRS)
  • Hamilton Anxiety Scale (HAS)
  • Spitzer Quality of Life Index (SQOLI)

Results:

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.

Conclusions:

Lower scores on subscales of the SQL90-R may reflect changes in anxiety levels between groups.

Limitations:

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.

doi: 10.1007/s00520-007-0269-0
Print

Study Purpose:

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)

Intervention Characteristics/Basic Study Process:

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).

Sample Characteristics:

  • The study reported on a sample of 35 patients with cancer.
  • Mean patient age was 51.97 years, with a range of 23–72 years (SD = 13.26).
  • The sample was 86% female and 14% male.
  • Cancer type was diverse, but the majority (54%) had breast cancer. Cancer stage was diverse, with relatively even distribution.
  • All patients were undergoing chemotherapy during the study, and all were diagnosed with mood disorder at baseline.

Setting:

  • Single site
  • Outpatient setting

Phase of Care and Clinical Applications:

Patients were undergoing the active treatment phase of care.

Study Design:

An open-label, noncomparative, prospective pilot study design was used.

Measurement Instruments/Methods:

  • Hospital Anxiety and Depression Scale (HADS): To measure depression and anxiety
  • Montgomery-Åsberg Depression Rating Scale (MADRS): To measure depression
  • Mini-Mental Adjustment to Cancer (Mini-MAC) Scale: To measure psychological response to the diagnosis of cancer
  • Clinical Global Impression (CGI): To measure severity of psychological illness
  • Dosage Record and Treatment Emergent Symptom (DOTES) Scale: To measure adverse effects of the clinical treatments and their possible relation with the drug used
  • Quality of Life Index: To measure QOL

Results:

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).

Conclusions:

Sertraline may be effective for the treatment of depressed outpatients with cancer. However, stronger evidence is needed.

Limitations:

  • The study had a small sample, with less than 100 patients.
  • Internal validity is limited due to the lack of control group, the lack of control over the time lapse since cancer therapy, and the small sample size.
  • External validity is limited due to the nature of the sample (i.e., small size and single setting).
  • Lack of information regarding measurements for validity and reliability is a minor flaw.

Nursing Implications:

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.

doi: 10.1016/S0033-3182(93)71866-6
Print

Intervention Characteristics/Basic Study Process:

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.

Sample Characteristics:

The study reported on a sample of 36 inpatients and outpatients with cancer receiving treatment and/or follow-up.

Setting:

  • Single site
  • Midwest teaching hospital

Study Design:

A randomized, controlled, double-blinded trial design was used.

Measurement Instruments/Methods:

  • Hospital Anxiety and Depression Scale (HADS)
  • Score > 7 on HADS and DSM-III criteria for anxiety, panic disorder, or adjustment disorder
  • Hamilton Anxiety Rating Scale (HAM-A) (interviewer), Symptom Checklist–90-R (SCL-90-R) (self-rated)
  • Hamilton Depression Rating Scale (HAM-D) (interviewer), Beck Depression Inventory (BDI) (self-rated)
  • Global Rating Scale (GRS) (self-rated)

Results:

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.

Limitations:

  • The study had a small sample size.
  • The study points out that participation in a clinical trial may make one more susceptible to the placebo response.
  • The average dose was only 1.2 mg/day; patients in study were unwilling to increase dose to therapeutic dosages.

Menu