Annotated Abstracts of Journal Articles
2014, 2nd Quarter
Annotations by Jane Walker, MBChB
ANNOTATION (Jane Walker)
The Findings: The authors found only nine trials comparing antidepressants with either placebo or no treatment in patients with cancer. They conclude that mianserin, paroxetine, and fluoxetine may be beneficial for “cancer-related depression.”
Strengths and Weaknesses: The strength of this study is the systematic search for relevant trials. It has three main weaknesses: First, the authors included studies conducted in patients who were not diagnosed with depression (and who may not, therefore, be prescribed an antidepressant in clinical practice). Second, there is no systematic description of risk of bias in each of the trials included in the review. Third, the authors were unable to include any trials of many of the commonly used antidepressants limiting the usefulness of their findings.
Relevance: This review reminds us of the lack of evidence for antidepressant medication that is specific to cancer patients with depression, specifically the lack of evidence to guide antidepressant choice.
Objective: Prior reviews evaluating the role of antidepressants in cancer-related depression have drawn conflicting conclusions. These reviews have also not explored differences in efficacy and tolerability between antidepressants. We conducted a meta-analysis to address these limitations.
Method: We searched Medline (1948-2013), the Cochrane Library (1800-2013), the Cumulative Index to Nursing and Allied Health Literature (1986-2013), ClinicalTrials.gov (2013) and meeting abstracts. We included randomized trials comparing antidepressants to placebo or no treatment for cancer-related depression. We used random effects to calculate standardized mean differences (SMD).
Results: Of 5178 potentially eligible citations, 9 trials (1169 subjects) met inclusion criteria. Trials of mianserin found a robust reduction in depression scores at ≥4 weeks of treatment (SMD: 0.60, 95% confidence interval (CI): 0.24-0.95). Similar, but less robust, results were observed with paroxetine (SMD: 0.22, 95% CI: 0.01-0.42) and fluoxetine (SMD 0.34, 95% CI: 0.02-0.66). Conversely, there was no advantage with amitriptyline or desipramine. Compared to placebo, the odds of dropping out due to side effect were higher with fluoxetine and paroxetine and lower with mianserin. Methodological quality was moderate.
Conclusions: Paroxetine, fluoxetine and mianserin improve cancer-related depression but may vary in efficacy and tolerability. High-quality, randomized trials of newer antidepressant agents are needed to identify optimal treatments for managing cancer-related depression.
ANNOTATION (Jane Walker)
The Finding: The researchers planned a four-arm clinical trial to compare the efficacy of citalopram with placebo and mirtazapine with placebo for depressed cancer patients (participants were to be stratified according to their symptom profile). They were unable to recruit any participants and, after removing the placebo arms, were still unable to recruit sufficient numbers. They describe the reasons for poor recruitment and the possible solutions.
Strengths and Weaknesses: This paper’s strength is that it is one of only a few that describes the practical aspects of conducting a real clinical research study in psycho-oncology. Its weakness is that the researchers were not able to put their potential solutions to the test.
Relevance: This description of the challenges of doing clinical research in psychiatry in a medical setting is relevant to all C-L psychiatrists.
Objective: The aim of this report is to discuss the design of an antidepressant clinical trial and discuss the challenges and potential solutions to these challenges to successful recruitment of oncology patients for psychopharmacology trials.
Method: We utilize meeting minutes and investigator discussions to identify the modifiable and nonmodifiable variables that affected successful subject recruitment for this study.
Results: No subjects were enrolled in our placebo-controlled antidepressant trial. After study modification to remove the placebo arm, we enrolled 21 subjects with depression and cancer. We identified the following recruitment difficulties during the study: diagnostic ambiguity in patients with depression and cancer, lowered subject retention in a medically ill population, patient reluctance to enroll in placebo-controlled studies and lack of a standardized referral processes for antidepressant studies in oncology at our institution.
Conclusion: Our experience provides guidance on specific factors that future clinicians and researchers can consider when implementing psychopharmacologic trials in the medically ill.
Fujimori M, Shirai Y, Asai M, Kubota K, Katsumata N, Uchimoti Y
J Clin Oncol. 2014 Jun 9 [Epub ahead of print]
ANNOTATION (Jane Walker)
The researchers found that oncologists who took part in an intensive two-day training program felt more confident about their communication and were better able to provide reassurance and emotional support (primary outcome) during consultations than oncologists who did not take part. Patients of the trained oncologists had lower depression scores (HADS-D) and higher trust in their clinician but there were no differences between the groups in anxiety (HADS-A), distress (HADS-total), or patient satisfaction.
Strengths and Weaknesses: The strengths of this study is that oncologists were randomised to receive the training program or not, and patient as well as oncologist outcomes were measured. The main weakness is that only 30 oncologists took part (of the 153 who were approached).
Relevance: This study is relevant to C-L psychiatrists who provide communication skills training. The training program improved oncologists’ skills and is described as “effective” but the clinical significance of the effects on patient outcomes are unconvincing.
Purpose: The aim of this study was to identify the effects of a communication skills training (CST) program for oncologists, developed based on patient preferences regarding oncologists’ communication.
Participants and Methods: Thirty oncologists were randomly assigned to either an intervention group (IG; 2-day CST workshop) or control group (CG). Participants were assessed on their communication performance during simulated consultation and their confidence in communicating with patients at baseline and follow-up. A total of 1,192 patients (response rate, 84.6%) who had consultations with the participating oncologists at baseline and/or follow-up were assessed regarding their distress using the Hospital Anxiety and Depression Scale, satisfaction with the consultation, and trust in their oncologist after the consultation.
Results: At the follow-up survey, the performance scores of the IG had improved significantly, in terms of their emotional support (P = .011), setting up a supportive environment (P = .002), and ability to deliver information (P = .001), compared with those of the CG. Oncologists in the IG were rated higher at follow-up than those in the CG in terms of their confidence in themselves (P = .001). Patients who met with oncologists after they had undergone the CST were significantly less depressed than those who met with oncologists in the CG (P = .027). However, the CST program did not affect patient satisfaction with oncologists’ style of communication.
Conclusion: A CST program based on patient preferences is effective for both oncologists and patients with cancer. Oncologists should consider CST as an approach to enhancing their communication skills.