Nocebo expectations rather than placebo expectations affect topical pain relief: A randomized clinical trial.

Patients' expectations and beliefs regarding the potential benefits and harms of medical interventions may induce placebo and nocebo effects, and affect the response to pain therapies. In a randomized clinical trial, we examined the effect of placebo and nocebo expectations on pain relief and adverse events (AEs) in association with a topical treatment among 65 cancer survivors experiencing chronic musculoskeletal pain. Participants received either a 1% camphor-based topical pain patch or a placebo treatment for 14 days. We measured pain severity with the worst pain item of the Brief Pain Inventory (BPI) at baseline and 14 days and treatment expectations at baseline with validated expectation questionnaires. We found that high vs. low nocebo expectations decreased pain severity improvements by 2.5 points (95% confidence interval [CI] -3.8 to -1.2; p<0.001) on a 0-10 numeric rating scale of the BPI and pain response rate by 42.7% (95% CI 0.2-0.6; p<0.001) at day 14, irrespective of placebo expectation status or treatment arms. Patients with high vs. low nocebo expectations in the true arm reported 22.4% more unwanted AEs. High nocebo expectations were associated with increased AEs by 39.5% (odds ratio: 12.0, 95% CI 1.2, 145.5; p=0.029) and decreased pain response in the true arm vs. placebo. Our study demonstrated that nocebo expectations, rather than placebo expectations, elevate the risk of AEs and compromise the effect of topical pain interventions. The findings raise the possibility that nocebo expectations may worsen somatic symptoms through heightening central pain amplification and should be further investigated.

Interest in and Barriers to Practicing Yoga among Family Caregivers of People with Cancer.

Background: Family caregivers of people with cancer report high levels of psychological distress. Yoga, with well-documented mental health benefits, could be a useful intervention to address distress in this population. However, little is known about yoga practices among cancer caregivers. The present study evaluates their interest in and barriers to yoga practice. Methods: We conducted a cross-sectional survey study of family caregivers of cancer patients at five suburban satellite locations of an academic cancer center. Survey items and statistical analyses focused on yoga usage as well as interest in and barriers to yoga practice. Results: Among 539 participants, most were females (64.8%), white (84.2%), and caring for a spouse or partner (54.7%). Interest in practicing yoga among study participants was 42.3%. Increased interest was independently associated with being females (odds ratio [OR] = 3.30, 95% confidence interval [CI] = 1.98-5.51, P < 0.001) and employed (part-time: OR = 2.58, 95% CI = 1.1-6.18, P = 0.03; full-time: OR = 1.77, 95% CI = 1.1-2.01, P = 0.02). Few participants (6.3%) were currently practicing yoga, although 31% had done so in the past. Sixty-one percent of those who had practiced before their loved one's diagnosis stopped practicing yoga afterward. Commonly cited barriers to yoga practice included time constraints (37.3%) and psychological obstacles (33.6%). About a quarter of those who had never practiced yoga lacked awareness of yoga's benefits (26.6%). Conclusion: Despite the low use of yoga, interest in practicing was moderately high, especially among women and employed caregivers. As caregivers face numerous barriers to yoga practice, strategies are needed to overcome these barriers and help them access yoga's health benefits.

COMT Val158Met Affects the Analgesic Response to Acupuncture Among Cancer Survivors With Chronic Pain.

Catechol-O-methyltransferase (COMT) is the major enzyme involved in the catabolism of dopamine, a neurotransmitter in the brain's reward system. The common COMT polymorphism Val158Met (rs4680 G>A) modulates pain response to opioids through a reward-motivated mechanism; however, its role in nonpharmacological pain medicine has not been clinically characterized. We genotyped 325 participants from a randomized controlled trial of cancer survivors with chronic musculoskeletal pain. We found that carrying methionine at position 158 (158Met) of COMT, encoded by the A allele, significantly increased the analgesic response to electroacupuncture (74% vs 50%; odds ratio [OR]: 2.79; 95% confidence interval [CI]: 1.31, 6.05; P < .01), but not to auricular acupuncture (68% vs 60%; OR: 1.43; 95% CI: .65, 3.12; P = .37) or usual care (24% vs 18%; OR: 1.46; 95% CI: .38, 7.24; P = .61) compared to Val/Val. These findings raise the possibility that COMT Val158Met might be an important predictor of analgesic response to electroacupuncture, providing novel insights into precision nonpharmacologic pain management tailored to individual genetic backgrounds. PERSPECTIVE: This work suggests the modulating effects of the polymorphism in COMT Val158Met on the response to acupuncture. Further research needs to validate these findings, increase the mechanistic understanding of acupuncture, and guide further development of acupuncture as a precision pain management strategy.

Music Therapy for Pain in Black and White Cancer Patients: A Retrospective Study.

CONTEXT: Racial pain disparities present challenges to cancer symptom management. Music therapy has demonstrated benefits for pain and is a promising treatment option for diverse populations due to music's multicultural presence. However, Black cancer patients are under-represented in music therapy trials. OBJECTIVES: This study compared pain severity, treatment approaches, and responses to music therapy between Black and white cancer patients. The findings will be used to generate hypotheses for future music therapy research to address racial disparities in pain management. METHODS: We conducted a retrospective program evaluation of Black and white patients who received music therapy at an NCI-Designated Comprehensive Cancer Center. We used the Edmonton Symptom Assessment Scale (ESAS) to assess pain. We abstracted opioid use, music therapy referral reasons, and treatment approaches from the electronic health record. RESULTS: Among 358 patients, 18% were Black, 42% reported moderate-to-severe pain, and 47% received opioids. Black patients reported higher baseline pain than white patients, but similar proportions of Black and white patients received opioids. Greater proportions of Black patients received music therapy referrals for pain (73% vs. 56%, P = 0.04) and engaged in active techniques (92% vs. 82%, P = 0.04). Black and white patients reported clinically meaningful pain reduction of similar magnitude after music therapy. Black patients discussed spirituality more commonly during music therapy, whereas white patients focused on family bonds. CONCLUSION: Black and white patients reported clinically meaningful pain reduction through varying music therapy approaches. Our findings may help inform cultural adaptations of music therapy to address racial pain disparities in oncology.

Effects of Vigorous Versus Restorative Yoga Practice on Objective Cognition Functions in Sedentary Breast and Ovarian Cancer Survivors: A Randomized Controlled Pilot Trial.

PURPOSE: Many cancer survivors experience cancer-related cognitive impairment (CRCI). We conducted a randomized controlled pilot trial of 2 types of yoga practice and evaluated their effects on participants' objective cognitive function. METHODS: Sedentary breast or ovarian cancer survivors were randomized to practice either restorative yoga (with more meditative practice and minimal physical exertion) or vigorous yoga (with considerable physical exertion and minimal meditative practice) in 60-minute supervised sessions 3 times a week for 12 weeks, followed by 12 weeks of home practice. We used the NIH Toolbox Cognition Domain to evaluate participants at baseline, week 12, and week 24. RESULTS: We enrolled 35 participants. For women in the restorative yoga group, overall cognitive function was statistically significantly improved at weeks 12 and 24 compared to baseline (P = .03 and 0.004; Cohen's D = 0.3 and 0.5). Fluid cognitive function also significantly improved at weeks 12 and 24 (P = .02 and 0.0007; Cohen's D = 0.3 and 0.6), whereas improvements in crystallized cognition were not significant. For women in the vigorous yoga group, significant improvement was only seen in tasks of crystallized cognition at week 24 (P = .03; Cohen's D = 0.5). Between-group comparisons showed that at week 24, women in the restorative yoga group had significantly higher scores on fluid cognition tasks. CONCLUSIONS: Patients who participated in yoga practice demonstrated improvement in objective cognitive function over time. Restorative yoga may be more effective in improving fluid cognitive function at week 24 when compared to vigorous yoga. These promising findings should be confirmed in definitive studies. TRIAL REGISTRATION: Clinicaltrials.gov; NCT02305498 (Date Registered: December 2, 2014).

In the weeds: a retrospective study of patient interest in and experience with cannabis at a cancer center.

BACKGROUND: Cannabis products, including the cannabinoids CBD and THC, are rising in popularity and increasingly used for medical purposes. While there is some evidence that cannabinoids improve cancer-associated symptoms, understanding regarding appropriate use remains incomplete. PURPOSE: To describe patient experiences with medical cannabis with focus on use contexts and patients' reported benefits and harms. METHODS: A standardized intake form was implemented in a dedicated medical cannabis clinic at an NCI-designated cancer center; data from this form was abstracted for all initial visits from October 2019 to October 2020. We report descriptive statistics, chi-square analysis, and multivariate logistic regression. RESULTS: Among 163 unique new patients, cannabis therapy was commonly sought for sleep, pain, anxiety, and appetite. Twenty-nine percent expressed interest for cancer treatment; 40% and 46% reported past use of CBD and THC, respectively, for medical purposes. Among past CBD users, the most commonly reported benefits were less pain (21%) or anxiety (17%) and improvement in sleep (15%); 92% reported no side effects. Among those with past THC use, reported benefits included improvement in appetite (40%), sleep (32%), nausea (28%), and pain (17%); side effects included feeling "high." Seeking cannabis for anti-neoplastic effects was associated with receipt of active cancer treatment in both univariate and multivariate analysis. CONCLUSION: Cancer patients seek medical cannabis to address a wide variety of concerns despite insufficient evidence of benefits and harms. As more states move to legalize medical and recreational cannabis, cancer care providers must remain aware of emerging data and develop knowledge and skills to counsel their patients about its use.

Yoga for cancer survivors with chemotherapy-induced peripheral neuropathy: Health-related quality of life outcomes.

BACKGROUND: Yoga is a meditative movement therapy focused on mind-body awareness. The impact of yoga on health-related quality of life (HRQOL) outcomes in patients with chemotherapy-induced peripheral neuropathy (CIPN) is unclear. METHODS: We conducted a pilot randomized wait-list controlled trial of 8 weeks of yoga (n = 21) versus wait-list control (n = 20) for CIPN in 41 breast and gynecological cancer survivors with persistent moderate to severe CIPN. HRQOL endpoints were Hospital Anxiety and Depression Scale (HADS), Brief Fatigue Inventory (BFI), and Insomnia Severity Index (ISI). The Treatment Expectancy Scale (TES) was administered at baseline. We estimated mean changes and 95% confidence intervals (CIs) from baseline to weeks 8 and 12 and compared arms using constrained linear mixed models. RESULTS: At week 8, HADS anxiety scores decreased -1.61 (-2.75, -0.46) in the yoga arm and -0.32 (-1.38, 0.75) points in the wait-list control arm (p = 0.099). At week 12, HADS anxiety scores decreased -1.42 (-2.57, -0.28) in yoga compared to an increase of 0.46 (-0.60, 1.53) in wait-list control (p = 0.017). There were no significant differences in HADS depression, BFI, or ISI scores between yoga and wait-list control. Baseline TES was significantly higher in yoga than in wait-list control (14.9 vs. 12.7, p = 0.019). TES was not associated with HADS anxiety reduction and HADS anxiety reduction was not associated with CIPN pain reduction. CONCLUSIONS: Yoga may reduce anxiety in patients with CIPN. Future studies are needed to confirm these findings. CLINICAL TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT03292328.

Understanding interest, barriers, and preferences related to yoga practice among cancer survivors.

PURPOSE: Despite growing evidence supporting the benefits of yoga for cancer-related symptom management, yoga usage among cancer survivors is low. To translate the evidence of yoga benefits into community practice, it is critical to understand interest in yoga as well as barriers and preferences that influence yoga usage among cancer survivors. METHOD: We conducted a cross-sectional survey study among cancer survivors, 18 years or older, with a primary diagnosis of cancer, and receiving treatment or follow-up care at outpatient clinics at five regional academic cancer center sites. We collected data and performed bivariate and multivariable analyses on self-reported yoga usage and interest in and barriers to practicing yoga, as well as preferred location and time for yoga practice. RESULTS: Of 857 participants, 70.0% had never practiced yoga and 52.3% were interested in practicing yoga. Among those interested, 52.5% had never practiced yoga. Lower interest was independently associated with being male (odds ratio [OR] = 0.30, 95% confidence interval [CI] = 0.20-0.44, p < 0.001), unemployed (OR = 0.60, 95% CI = 0.39-0.91, p = 0.016), and white (OR = 0.42, 95% CI = 0.23-0.78, p = 0.005). Commonly cited barriers among those who were interested but had never practiced were not aware of yoga benefits (36.3%), difficulty motivating (28.7%), experiencing symptoms (22.9%), and not enough time (22.0%). Participants indicated "on-site and at a studio near home" (41.5%) as preferred location and evenings (3-8 pm, 34.0%) as preferred time for yoga practice. CONCLUSION: Although more than 50% of patients indicated interest in practicing yoga, use of yoga is low among cancer survivors. Barriers and patient preferences for yoga practice need to be addressed to design effective yoga programs for this population.

Yoga for Chemotherapy-Induced Peripheral Neuropathy and Fall Risk: A Randomized Controlled Trial.

BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) is a common, debilitating side effect that worsens quality of life and increases the risk of falls in cancer survivors. Evidence of yoga's safety and efficacy in treating CIPN is lacking. METHODS: In a randomized controlled study, we assigned breast and gynecological cancer survivors with persistent moderate-to-severe CIPN pain, numbness, or tingling with a score of 4 or greater (0-10 numeric rating scale [NRS]) for at least 3 months after chemotherapy to 8 weeks of usual care or yoga focused on breathwork and musculoskeletal conditioning. Primary endpoint was treatment arm differences for NRS, and secondary endpoints were Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity subscale (FACT/GOG-Ntx), and Functional Reach Test after week 8. We tested treatment arm differences for each outcome measure using linear mixed models with treatment-by-time interactions. All statistical tests were two-sided. RESULTS: We randomly assigned 41 participants into yoga (n = 21) or usual care (n = 20). At week 8, mean NRS pain decreased by 1.95 points (95% confidence interval [CI] = -3.20 to -0.70) in yoga vs 0.65 (95% CI = -1.81 to 0.51) in usual care (P = .14). FACT/GOG-Ntx improved by 4.25 (95% CI = 2.29 to 6.20) in yoga vs 1.36 (95% CI = -0.47 to 3.19) in usual care (P = .035). Functional reach, an objective functional measure predicting the risk of falls, improved by 7.14 cm (95% CI = 3.68 to 10.59) in yoga and decreased by 1.65 cm (95% CI = -5.00 to 1.72) in usual care (P = .001). Four grade 1 adverse events were observed in the yoga arm. CONCLUSION: Among breast and gynecological cancer survivors with moderate-to-severe CIPN, yoga was safe and showed promising efficacy in improving CIPN symptoms.

Association Between Music Therapy Techniques and Patient-Reported Moderate to Severe Fatigue in Hospitalized Adults With Cancer.

PURPOSE: Cancer-related fatigue is a prevalent, debilitating symptom that contributes to increased health care utilization among hospitalized patients. Music therapy is a nonpharmacological intervention that uses active (eg, singing, selecting songs) and passive (eg, listening) techniques. Preliminary evidence from small trials suggests a potential benefit for cancer-related fatigue in the inpatient setting; however, it remains unclear which techniques are most effective. METHODS: A cross-sectional mixed-methods study was performed to compare cancer-related fatigue before and after active or passive music therapy. Cancer-related fatigue was captured via the Edmonton Symptom Assessment Scale fatigue item. Patients were asked to provide postsession free-text comments. RESULTS: A total of 436 patients (mean [standard deviation] age, 62.2 [13.4] years; n = 284 [65.1%] women; n = 294 [67.4%] white; active music therapy n = 360 [82.6%]; passive music therapy n = 76 [17.4%]) with a range of primary malignancies participated. Active music therapy was associated with a 0.88-point greater reduction in cancer-related fatigue (95% CI, 0.26 to 1.51; P = .006; Cohen's D, 0.52) at postsession as compared with passive music therapy when restricting the analysis to patients who rated their baseline cancer-related fatigue as moderate to severe (ie, ≥ 4; n = 236 [54.1%]). Free-text responses confirmed higher frequencies of words describing positive affect/emotion among active music therapy participants. CONCLUSIONS: In a large sample of inpatient adults with diverse cancer disease types, active music therapy was associated with greater reduction in cancer-related fatigue and increased reporting of positive affect/emotions compared with passive music therapy. Additional research is warranted to determine the specific efficacy and underlying mechanisms of music therapy on cancer-related fatigue.

Reduction of Opioid Use by Acupuncture in Patients Undergoing Hematopoietic Stem Cell Transplantation: Secondary Analysis of a Randomized, Sham-Controlled Trial.

OBJECTIVE: To evaluate acupuncture as a nonpharmacologic intervention for pain management in patients undergoing hematopoietic stem cell transplantation (HSCT). METHODS: Adult patients with multiple myeloma undergoing high-dose melphalan chemotherapy and autologous peripheral blood HSCT were randomized to receive either true (TA) or sham acupuncture (SA) once daily for five days starting on the day after chemotherapy. Use of pain medications and pain scores were assessed at baseline and at days 5, 15, and 30 after transplantation. RESULTS: Among 60 evaluable subjects, the SA group (vs TA) had greater than five times odds of increasing pain medication use from baseline. Among patients who were opioid nonusers at baseline, all 15 patients in the TA group remained free from opioid use at the end of the study. In contrast, 20% of those in the SA group (four of the 20 patients) started to use opioids after chemotherapy and stem cell infusion (day 5) and 40% (eight of the 20) had become opioid users by day 30 after HSCT (Fisher exact test P = 0.006). Among patients who were taking opioids at baseline, 14% in the TA group vs 10% in the SA group increased opioid intake at day 5, and 21% (TA) vs 30% (SA) at day 30 (P = 0.86). CONCLUSIONS: Acupuncture appears to significantly reduce the need for pain medications during HSCT and the number of post-HSCT opioid users among baseline opioid nonusers. It warrants further studies as an opioid-sparing intervention for pain in HSCT patients.

Putative Antidepressant Effect of Chamomile (Matricaria chamomilla L.) Oral Extract in Subjects with Comorbid Generalized Anxiety Disorder and Depression.

Objectives: This exploratory analysis examined the putative antidepressant effect of Matricaria chamomilla L. (chamomile) extract in subjects with generalized anxiety disorder (GAD) with or without comorbid depression. It was hypothesized that chamomile extract would demonstrate similar anxiolytic activity in both subgroups, but superior antidepressant activity in GAD subjects with comorbid depression. Design: As part of a randomized double-blind placebo-controlled trial of chamomile extract for relapse prevention of GAD, 179 subjects received initial therapy with open-label chamomile extract 1500 mg daily for 8 weeks. Linear mixed-effect models were used to identify clinically meaningful changes in anxiety and depression symptoms between diagnostic subgroups. Settings/Location: The study took place at the University of Pennsylvania in Philadelphia, PA. Subjects: Subjects were ≥18 years old with a primary DSM IV-TR diagnosis of GAD. They were subcategorized into two diagnostic groups: GAD without comorbid depression (n = 100) and GAD with comorbid depression (n = 79). Interventions: Open-label chamomile extract 1500 mg was given daily for 8 weeks. Outcome measures: Generalized anxiety disorder (GAD-7), Hamilton rating scale for anxiety, Beck anxiety inventory, Hamilton rating scale for depression (HRSD), the six-item core HRSD (items 1, 2, 3, 7, 8, and 13), and the Beck depression inventory (BDI). Results: The authors observed similar anxiolytic effects over time in both diagnostic subgroups. However, there was a greater reduction in HRSD core symptom scores (p < 0.023), and a trend level reduction in HRSD total scores (p = 0.14) and in BPI total scores (p = 0.060) in subjects with comorbid depression. Conclusions: M. chamomilla L. may produce clinically meaningful antidepressant effects in addition to its anxiolytic activity in subjects with GAD and comorbid depression. Future controlled trials in subjects with primary major depressive disorder are needed to validate this preliminary observation.

A Technology-Assisted, Brief Mind-Body Intervention to Improve the Waiting Room Experience for Chemotherapy Patients: Randomized Quality Improvement Study.

BACKGROUND: Patients waiting for chemotherapy can experience stress, anxiety, nausea, and pain. Acupressure and meditation have been shown to control such symptoms. OBJECTIVE: This study aimed to evaluate the feasibility and effectiveness of an integrative medicine app to educate patients about these self-care tools in chemotherapy waiting rooms. METHODS: We screened and enrolled cancer patients in chemotherapy waiting rooms at two Memorial Sloan Kettering Cancer Center locations. Patients were randomly assigned into an intervention arm in which subjects watched acupressure and meditation instructional videos or a control arm in which they watched a time- and attention-matched integrative oncology lecture video. Before and after watching the videos, we asked the patients to rate four key symptoms: stress, anxiety, nausea, and pain. We performed the analysis of covariance to detect differences between the two arms postintervention while controlling for baseline symptoms. RESULTS: A total of 223 patients were enrolled in the study: 113 patients were enrolled in the intervention arm and 110 patients were enrolled in the control arm. In both groups, patients showed significant reductions in stress and anxiety from baseline (all P<.05), with the treatment arm reporting greater stress and anxiety reduction than the control arm (1.64 vs 1.15 in stress reduction; P=.01 and 1.39 vs 0.78 in anxiety reduction; P=.002). The majority of patients reported that the videos helped them pass time and that they would watch the videos again. CONCLUSIONS: An integrative medicine self-care app in the waiting room improved patients' experiences and reduced anxiety and stress. Future research could focus on expanding this platform to other settings to improve patients' overall treatment experiences.

Awareness of Yoga for Supportive Care in Cancer: Implications for Dissemination.

Objectives: Evidence indicates there are beneficial physical and psychosocial effects from practicing yoga in cancer patients and survivors. Despite yoga having been incorporated into National Comprehensive Cancer Network guidelines for symptoms ranging from fatigue to pain, patients' use of yoga for supportive care is low, ranging from 6% to 12%. This study aims to evaluate the awareness of yoga as therapy in an academic cancer center and the preferences for information delivery in this population. Design: We conducted a cross-sectional survey study at an urban academic cancer center. Responses regarding awareness and use of yoga were evaluated; those responding "not aware" were analyzed for preferences in information delivery. Univariate analysis was used to further characterize awareness of yoga for supportive care. Results: Of 303 respondents, 68% were female, 77% were white, and 75% were college educated. Despite access to yoga at the cancer center, 171 (56%) patients expressed they were not aware of the availability of yoga. Male patients were more likely to be unaware of yoga (72.4% vs. 48.8%, p = 0.045). Awareness did not vary by age, race, educational attainment, marital status, cancer type, or cancer stage. Of the 171 "not aware" patients, 87.6% expressed desire for information in the form of printed material, followed by 80.4% for e-mail, 37.6% for smartphone application, and 27.6% for social media. Non-white respondents were more likely to express interest in receiving information by smartphone. Conclusions: More than half of cancer patients were unaware of the yoga program despite advertising across the institution. Patients prefer varying methods for information receipt, with preferences differing by sociodemographic factors. Targeted education and outreach using appropriate engagement is needed to improve the awareness of yoga for symptom control in cancer patients.

Determinants of mobile technology use and smartphone application interest in cancer patients.

BACKGROUND: Supportive care is a critical component of the treatment of cancer patients that is underutilized; patient lack of information about these services is an important barrier. Mobile technologies may be useful tools for delivering information, but cancer patient use of and interest in using them to learn about supportive care services have not been described. This study evaluates factors associated with cancer patient use of mobile technologies and interest in smartphone applications for information delivery about supportive care. METHODS: We conducted a cross-sectional survey among cancer patients from one urban academic hospital and 11 community hospitals. Patients self-reported use of mobile technologies and interest in smartphone applications. Multivariate logistic analysis was used to identify determinants of mobile technology use and smartphone interest. RESULTS: Among 631 participants, 466 (74%) reported regular use of mobile devices and 242 (39%) expressed an interest in supportive care information via smartphone applications. Patients under 45 were more likely to use a mobile device (Adjusted Odds Ratio [AOR] 6.8, 2.8-16.9 95% CI, P < 0.001) and were interested in smartphone applications for delivery of information (AOR 3.2, 1.8-5.9 95% CI, P < 0.001). Non-white patients had similar use of mobile technology compared to whites but reported greater interest in smartphone application-based information (AOR 3.4, 2.1-5.5 95% CI, P < 0.001). CONCLUSION: Many patients expressed interest in smartphone application-based information about supportive care services, especially those who are younger and non-white. Future studies should investigate the characteristics of patients and smartphones applications that will optimize information delivery through a mobile technology platform.

Influence of family on expected benefits of complementary and alternative medicine (CAM) in cancer patients.

BACKGROUND: Cancer patients often use complementary and alternative medicine (CAM) based on recommendations from family. However, the relationship between family endorsement of CAM and the patient's expectation of its benefits has never been quantified. METHODS: Between 2010 and 2011, we conducted a cross-sectional survey study among patients with a diagnosis of cancer recruited from thoracic, breast, and gastrointestinal medical oncology clinics at a single academic cancer center. We performed multivariate linear regression analyses to evaluate the relationship between perceived family endorsement of and expected benefits from CAM, adjusting for covariates. RESULTS: Among the 962 participants, 303 (31.3%) reported family endorsement of CAM use. Younger patients and those who had college or higher education were more likely to report family endorsement (both p < 0.05). Patients with family support had expectation scores that were 15.9 higher than patients without family support (coefficient 15.9, 95% CI 13.5, 18.2, p < 0.001). Participants with family encouragement of CAM use were also more likely to expect CAM to cure their cancer (12 vs. 37%) and prolong their life (24 vs. 61%). These relationships remained highly significant after adjusting for covariates). CONCLUSIONS: Family endorsement of CAM use is strongly associated with patient expectation of its clinical efficacy, including expectations for cure and improved survival. These findings underscore the importance of including family in counseling and education on CAM use in order to achieve realistic patient expectations, maximize benefits, and avoid potential medical adverse effects through herb-drug interactions or rejections of conventional care.

An exploratory study of salivary cortisol changes during chamomile extract therapy of moderate to severe generalized anxiety disorder.

OBJECTIVES: Dysfunctions in stress biology are hypothesized to contribute to anxiety disorders, and to be ameliorated during successful treatment, but limited clinical data exist to support this hypothesis. We evaluated whether increases in morning cortisol and the diurnal cortisol slope, markers of stress biology, are associated with clinical response to chamomile therapy among subjects with generalized anxiety disorder (GAD). METHODS: Among 45 subjects with DSM-IV diagnosed GAD in an open-label clinical trial of chamomile, salivary cortisol was assessed for three days each pre- and post-treatment, at 8am, 12pm, 4pm, and 8pm. Mixed model analyses assessed whether GAD symptom change predicted the degree to which cortisol levels changed during treatment. RESULTS: Symptom improvement during treatment was significantly associated with pre-to-post treatment changes in cortisol. Subjects who experienced more symptomatic improvement experienced significant increases in their morning salivary cortisol (ß = 0.48, p < 0.001), and a greater decrease in cortisol from morning to the rest of the day (ß = 0.55, p < 0.001). In addition, at baseline a lower cortisol level (ß = -0.24, p = 0.023) and a lesser decrease in cortisol after morning (ß = 0.30, p = 0.003) were associated with greater symptomatic improvement. CONCLUSION: Increases in morning salivary cortisol and the diurnal cortisol slope are associated with symptom improvement in chamomile treatment of GAD. Response to treatment for GAD could partially stem from normalization of stress biology dysfunction, but further work involving establishing abnormalities within-sample, ruling out of confounds (e.g., sleep), and a placebo control is necessary to conclude an amelioration effect. REGISTRATION CODE: NCT01072344. URL: https://clinicaltrials.gov/ct2/show/NCT01072344.

Specific expectancies are associated with symptomatic outcomes and side effect burden in a trial of chamomile extract for generalized anxiety disorder.

OBJECTIVE: Patient expectancies are hypothesized to contribute to the efficacy and side effects of psychiatric treatments, but little research has investigated this hypothesis in the context of psychopharmacological therapies for anxiety. We prospectively investigated whether expectancies predicted efficacy and adverse events in oral therapy for Generalized Anxiety Disorder (GAD), controlling for confounding patient characteristics correlating with outcomes. METHODS: Expectancies regarding treatment efficacy and side effects were assessed at baseline of an eight week open-label phase of a trial of chamomile for Generalized Anxiety Disorder (GAD). The primary outcome was patient-reported GAD-7 scores, with clinical response and treatment-emergent side-effects as secondary outcomes. Expectancies were used to predict symptomatic and side-effect outcomes. RESULTS: Very few baseline patient characteristics predicted either type of expectancy. Controlling for a patient's predicted recovery based on their baseline characteristics, higher efficacy expectancies at baseline predicted greater change on the GAD-7 (adjusted ß = -0.19, p = 0.011). Efficacy expectancies also predicted a higher likelihood of attaining clinical response (adjusted odds ratio = 1.69, p = 0.002). Patients with higher side effect expectancies reported more side effects (adjusted log expected count = 0.26, p = 0.038). Efficacy expectancies were unrelated to side effect reports (log expected count = -0.05, p = 0.680), and side effect expectancies were unrelated to treatment efficacy (ß = 0.08, p = 0.306). CONCLUSIONS: Patients entering chamomile treatment for GAD with more favorable self-generated expectancies for the treatment experience greater improvement and fewer adverse events. Aligning patient expectancies with treatment selections may optimize outcomes. REGISTRATION: Trial Number NCT01072344 at ClinicalTrials.gov.