Anxiolytic effects of a yoga program in early breast cancer patients undergoing conventional treatment: A randomized controlled trial☆
Section snippets
Background
Anxiety and depression are the commonest psychiatric problems encountered in cancer patients. Fear and anxiety associated with diagnosis of cancer, invasive treatment procedures, sexual dysfunction secondary to surgery and radiation, and aversive reactions to chemotherapy are among the common treatment-related side effects observed in cancer patients. Clinical descriptions have noted cancer patient’s fears of the treatment (e.g., being “burned” or “equating radiotherapy with electric current”),
Methods
This is a single centre randomized controlled trial which recruited 98 recently diagnosed women with stage II and III operable breast cancers. The institutional ethics committee of the recruiting cancer centre approved the study. Patients were included if they met the following criteria: (i) women with recently diagnosed operable breast cancer, (ii) age between 30 and 70 years, (iii) Zubrod’s performance status 0–2 (ambulatory >50% of time), (iv) high school education, (v) willingness to
Measures
Before randomization demographic information, medical history, clinical data, intake of medications, investigative notes and conventional treatment regimen were ascertained from all consenting participants. Participants completed the state trait anxiety inventory (STAI) that consists of a separate self-report scale for measuring two distinct anxiety concepts: state anxiety and trait anxiety.29
The A trait scale asks subjects to describe how they generally feel, an attempt to tap individual
Randomization
A person who had no part in the trial randomly allocated consenting participants (n = 98) to either yoga (n = 45) or supportive therapy groups (n = 53). Participants were randomized at the initial visit before starting any conventional treatment. Following randomization participants underwent surgery followed by radiotherapy (RT) and chemotherapy (CT) or any other treatment schedule as shown in Table 1. There were 12 dropouts in yoga and 17 dropouts in control group, respectively following surgery.
Sample size
Earlier studies have reported very large effect size (>1) for anxiety scores with yoga intervention.31 We therefore used a conservative estimate of effect size/standardised difference = 1 for our study. The sample size needed in our study based on formula32 is 17 subjects in each arm with p at 0.05 and 80% power. There were 18 subjects in yoga and 20 subjects in control group who contributed data to the study.
Interventions
The intervention group received an integrated yoga program and the control group received supportive therapy sessions, both imparted individually. Yoga practices consisted of a set of asanas (postures), breathing exercises, pranayama (voluntarily regulated nostril breathing), meditation and yogic relaxation techniques with imagery. The details of these practices are described elsewhere.33 These practices were based on principles of attention diversion, awareness and relaxation to cope with
Statistical methods
Data were analyzed using Statistical Package for Social Sciences version 10.0. We used a per protocol analysis in this study analyzing only those subjects who underwent surgery followed by radiotherapy and six cycles of chemotherapy (in this order) for the study as heterogeneity in treatment modalities and sequence could have confounded the results. A GLM-repeated measures ANOVA was done with the within-subjects factor being time/assessments at six levels and between-subjects factor being
Results
The subjects in our study were recruited and followed-up between January 1999 and June 2004. The groups were comparable with respect to socio-demographic and medical characteristics (see Table 1). Subjects in both groups (control 45%, yoga 39%) received anxiolytic medications during their chemotherapy to prevent aversive responses (alprazolam 0.5 mg once daily for 1 week following chemotherapy infusion). The subjects received anxiolytics as a comedication for only one to two cycles of
Anxiety state
A repeated measures analysis of variance was done on anxiety state scores. Sphericity was assumed with Hyun feldt э at 0.6. Though group by time interaction effects were not significant, the between-subjects effect was significant F (1, 35) = 10.8, p = 0.002. Post hoc tests using Bonferroni correction showed significant decrease in anxiety states in yoga group as compared to control at post-surgery (mean change ± S.E., p value, 95% CI), (4.3 ± 1.96, p = 0.04, 0.2–8.3), mid-RT (5.7 ± 2.2, p = 0.01, 1.3–10.2),
Anxiety trait
A repeated measures analysis of variance was done on anxiety trait scores. Sphericity was assumed with Hyun feldt э at 0.75. Though group by time interaction effects was not significant, the between-subjects effect was significant F (1, 35) = 8.2, p = 0.007. Post hoc tests using Bonferroni correction showed significant decrease in anxiety trait in the yoga group as compared to controls at post-surgery (mean change ± S.E., p value, 95% CI), (6.9 ± 2.4, p = 0.007, 2–11.8), post-RT (5.8 ± 2.1, p = 0.01,
Symptom distress
A repeated measures analysis of variance was done on symptom distress scores. Sphericity was assumed with Hyun feldt э at 1. Group by time interaction effects was significant and between subjects effect was significant F (1, 35) = 14.5, p = 0.001. Post hoc tests using Bonferroni correction showed significant decrease in symptom distress in yoga group as compared to controls at post-surgery (mean change ± S.E., p value, 95% CI), (6.4 ± 2.3, p = 0.009, 1.7–11.1), mid-RT (10.1 ± 2.8, p = 0.001, 4.3–15.8),
Discussion
We compared the effects of a 24-week yoga program with supportive therapy in 38 recently diagnosed breast cancer outpatients undergoing surgery, radiotherapy, and chemotherapy. The results suggest an overall decrease in both anxiety state (reactive anxiety) and trait with time in both the groups. Yoga intervention reduced anxiety state scores by 0.5% following surgery, 4.9% and 6% during and following radiotherapy and 8.5% and 11.6% during and following chemotherapy from their respective
Conclusions
In summary, our yoga-based intervention was effective in reducing reactive anxiety and trait anxiety in early breast cancer patients undergoing conventional cancer treatment. This was probably facilitated through stress reduction and helping the cancer patients to cope better with their illness at various stages of their conventional treatment. Future studies should explore the putative neurophysiologic mechanisms underlying the anxiolytic effects conferred by yoga intervention.
Acknowledgements
We are thankful to Dr Jayashree, Mrs. Anupama for imparting the yoga intervention. We are thankful to Dr. B.N. Gangadhar, Prof and Head, Department of Psychiatry for editing this manuscript. We are thankful to Central Council for Research in Yoga and Naturopathy, Ministry of Health and Family Welfare, Govt. of India for funding this study.
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Sources of support: Central Council for Research in Yoga and Naturopathy, Ministry of Health and Family Welfare, Govt. of India.