Satisfaction and Feasibility Evaluation of an Electronic Massager-Expert Manipulative Massage Automation (EMMA): A Pilot Study.

BACKGROUND: Electronic massagers have gained popularity for their non-invasive and cost-effective approach to healthcare. However, existing electronic massagers require manual manipulation, leading to inconsistency. OBJECTIVE: To investigate the feasibility and acceptability of the Electronic Massager-Expert Manipulative Massage Automation (EMMA) among the American population. METHODS: A single-arm pilot study was conducted at Mayo Clinic Rochester campus. Participants received massage therapy with the EMMA treatment model and completed a demographics and Satisfaction Survey Questionnaire. Data were collected using REDCap, and statistical analysis was performed. RESULTS: Twenty healthy volunteers (13 women, 7 men; median age, 47 years) participated and completed the intervention within 2 weeks. No adverse events were reported. Overall, the acceptability and satisfaction of massage utilizing EMMA were high, with all participants finding the study worthwhile, willing to participate again, and willing to recommend the study to others. Regarding the overall experience, 65.0% reported a better-than-expected experience. Responses to open-ended post-treatment questions showed that most participants enjoyed the warmth (35%), pressure (25%), and relaxation (20%) provided by EMMA, with the majority suggesting no changes or improvements were needed. However, some participants expressed a desire for an expanded massage area (20%). CONCLUSIONS: This study suggests that the EMMA massager has high acceptability and satisfaction among healthy volunteers, thus demonstrating its feasibility. However, further research is needed to optimize EMMA and assess its clinical effectiveness.

Clinical outcome measures reporting in randomized trials evaluating Tuina therapy for chronic nonspecific low back pain: A systematic review.

BACKGROUND: Tuina has gained widespread attention and utilization for the management of chronic nonspecific low back pain (CNLBP). However, evidence-based guidance for choosing accurate and appropriate outcome measures of Tuina is lacking. The objective of this study is to systematically synthesize the existing outcome measures reported in randomized controlled trials (RCTs) evaluating Tuina therapy in CNLBP. METHODS: Electronic literature searches were conducted in multiple English and Chinese databases from their inception to May 2022. RCTs were included if they involved clinical outcome measures in Tuina treatment for patients with CNLBP. Outcome instruments for each study were extracted and analyzed. Evidence from included studies were assessed using the Cochrane risk-of-bias tool. RESULTS: Of the 735 identified articles, 17 articles with 1628 participants were included. Measurement domains in these RCTs were mainly reported in terms of pain (94%) and physical activity (71%), followed by safety (41%), Chinese medicine outcome (35%), and quality of life (12%). Moreover, several limitations with existing outcomes were reported, including lack of emphasis on the evaluation of quality of life, inadequate safety monitoring, as well as insufficient and vague Chinese medicine outcome measures. All trials were deemed to be of poor methodological quality. CONCLUSION: Pain and physical disability were the most frequently studied outcome domains in CNLBP treated by Tuina therapy. More rigorous and high-quality trials with appropriately selected outcome measures are needed in the future.

Mindfulness Using a Wearable Brain Sensing Device for Health Care Professionals During a Pandemic: A Pilot Program.

OBJECTIVE: The purpose of this feasibility pilot study was to evaluate safety and adherence of a wearable brain sensing wellness device designed to reduce stress among healthcare professionals (HCP). METHODS: A total of 40 HCP were invited to participate in an open-label pilot study. Participants were asked to use a brain sensing wearable device (MUSE-S™) on a daily basis to reduce their stress, for a total of 90 days. Total study participation duration was 180 days. Study enrollment began in August 2021 and ended December 2021. The exploratory outcomes included stress, depression, sleep, burn-out, resilience, quality of life, and cognition. RESULTS: Among the 40 HCP in study, the majority were female (85%), white (87.5%) and with an average age of 41.3 ± 11.0 years (SD). Participants used the wearable device an average of 23.8 times over a 30-day period with a mean duration of 5.8 min with each use. Study results demonstrate the positive impact of guided mindfulness using the wearable device MUSE-S™ and its accompanying application (APP). A statistically significant improvement was found for a reduction in stress (P < .001) and improvement in resilience (P = .02), quality of life (P = .003), and cognition (P < .001). The majority (91.9%) of the participants indicated they felt more relaxed after using the device, and 73% indicated they would continue to use this device at end-of-study. No adverse effects were reported. CONCLUSION: Study results show that 3 to 10 min of guided meditation during work hours through the use of a brain sensing wearable device is safe and acceptable, with associated health benefits for HCP.

Use of Complementary and Integrative Medicine Among Patients With Glioblastoma Multiforme Seen at a Tertiary Care Center.

Background: Glioblastoma multiforme (GBM) is among the most aggressive and lethal tumors, with a median survival of 12-15 months. Many patients use complementary and integrative medicine (CIM) therapies to supplement their cancer treatment. Objective: To determine the prevalence of CIM use and identify the most frequently used types of CIM in a cohort of patients with GBM seen at a tertiary care medical center in the United States. Methods: An anonymous survey was mailed through the US Postal Service from August 1, 2019, through February 21, 2020, to patients with GBM. Results: A total of 346 surveys were mailed, and 146 responses (42%) were received. The median age of respondents was 61 years (range, 52-68 years), and 85 (58%) were male. Most patients had undergone surgery (90%), chemotherapy (96%), and radiotherapy (95%). The median time from diagnosis of GBM to survey participation was 18 months (range, 12-31 months). Most respondents (81%) used some form of CIM, most frequently meditation (22%), relaxation and other stress management techniques (19%), chiropractic therapy (16%), and acupuncture (12%). Compared with men, women more commonly meditated (32% vs 16%; P = .046) and practiced yoga (20% vs 6%; P = .04). We observed age-based differences, with younger patients more commonly meditating, practicing relaxation and stress management techniques, and receiving chiropractic therapy (P < .05 for all). Conclusions: Providers should encourage patients with GBM to discuss their interest in CIM therapies and guide them to evidence-based treatments that may help improve their quality of life.

Temporal Trends in Use of Complementary Therapies Among Patients With Cardiovascular Disorders.

This study aimed to evaluate the use and frequency of complementary and integrative medicine (CIM) therapies in an outpatient cohort with cardiovascular disease (CVD) and compare trends over time. This cross-sectional point-of-care prospective study assessed patients attending a cardiology outpatient clinic. As in our 2009 cohort, data were collected with a 17-question survey on demographic characteristics, CVD history, current use and future interest in CIM. In total, 964 patients completed the survey. CIM use continues to be high (2009 vs 2018, 83.4% vs 81.8%) (p = 0.34), with dietary supplements the most common therapy (75% in both studies). We observed increased use of mind-body therapies (28.5% vs 23.9%, p = 0.02), especially meditation, yoga, and tai chi. Of the patients receiving CIM therapies, 41.9% reported using CIM for heart-related symptoms. Relaxation, stress management, and meditation were the top three mind-body therapies for CVD-related symptoms in both cohorts. Reporting of CIM use to clinicians is low (15%) and interest on future use is high (47%). In conclusion, CIM is highly used in cardiology patients-4 of 10 patients use CIM for CVD-related symptoms. Most take dietary supplements, with an increased use of mind-body therapies. Our data highlight the importance of documenting CIM use in practice and the need for research to document efficacy.

Complementary and Alternative Medicine Use by Patients From the Gulf Region Seen in the International Practice of a Tertiary Care Medical Center.

BACKGROUND: Patients from various countries may have unique patterns of using complementary and alternative medicine (CAM) and unique reasons for using it. OBJECTIVE: Our objective was to assess the use of CAM among patients from the Gulf region attending the Executive and International Health Program of the Department of General Internal Medicine at Mayo Clinic in Rochester, Minnesota. METHODS: This cross-sectional survey was administered to all patients who were from the Gulf region and were undergoing outpatient evaluation in the Executive and International Health Program. After their initial medical evaluation by a physician, the patients were invited to anonymously complete the modified International Complementary and Alternative Medicine Questionnaire. RESULTS: The survey was completed by 69 patients (41 women, 27 men; mean age, 45.4 years). The most frequently seen providers for CAM treatments were physicians (71.0% of patients), spiritual healers (29.0%), and chiropractors (20.3%). CAM treatments most frequently received from a physician were massage therapy (51.0%), hijama (38.8%), spiritual healing (24.5%), and acupuncture or herbs (16.3%). The most frequently used dietary supplements were ginger (42.0%), bee products (30.4%), and garlic (27.5%). The most common self-help therapies were prayers for health (68.1%), meditation (15.9%), and relaxation techniques (11.6%). CAM therapy, including visits to CAM providers, was used by 92.8% of patients. CAM was mainly used to improve well-being and long-term health conditions rather than for acute illnesses. CONCLUSION: The use of CAM was high among our patients from the Gulf region, and the CAM therapies used by this population differed from the ones used by US patients. Physicians providing care to patients from the Gulf region should be aware of how the use of CAM may affect the care needs of these patients.

Massage Compared with Massage Plus Acupuncture for Breast Cancer Patients Undergoing Reconstructive Surgery.

Objectives: Integrative therapies have been incorporated increasingly into health and wellness in the United States in recent decades. Their potential benefits are under evaluation in various situations, including pain and symptom relief for cancer patients and survivors. This pilot study evaluated whether combining two integrative complementary approaches augments a patient's benefit by reducing postoperative stress, pain, anxiety, muscle tension, and fatigue compared with one integrative complementary approach alone. Design: Patients undergoing autologous tissue breast reconstruction were randomly assigned to one of two postoperative complementary alternative therapies for three consecutive days. All participants were observed for up to 3 months. Subjects: Forty-two participants were recruited from January 29, 2016 to July 11, 2018. Interventions: Twenty-one participants were randomly assigned to massage alone and 21 to massage and acupuncture. Outcome measures: Stress, anxiety, relaxation, nausea, fatigue, pain, and mood (score 0-10) were measured at enrollment before surgery and postoperative days 1, 2, and 3 before and after the intervention. Patient satisfaction was evaluated. Results: Stress decreased from baseline for both Massage-Only Group and Massage+Acupuncture Group after each treatment intervention. Change in stress score from baseline decreased significantly more in the Massage-Only Group at pretreatment and posttreatment (p = 0.03 and p = 0.04). After adjustment for baseline values, change in fatigue, anxiety, relaxation, nausea, pain, and mood scores did not differ between groups. When patients were asked whether they would recommend the study, 100% (19/19) of Massage-Only Group and 94% (17/18) of Massage+Acupuncture Group responded yes (p = 0.49). Conclusion: No additive beneficial effects were observed with addition of acupuncture to massage for pain, anxiety, relaxation, nausea, fatigue, and mood. Combined massage and acupuncture was not as effective in reducing stress as massage alone, although both groups had significant stress reduction. These findings indicate a need for larger studies to explore these therapies further.

Low-level laser therapy for weight reduction: a randomized pilot study.

Obesity and overweight is a global health crisis and novel methods of treatment are needed to address it. Low-level laser therapy (LLLT) is a currently available non-invasive procedure for lysing excess fat, but there is a lack of consensus exists on LLLT frequency and limited research from studies of LLLT. The purpose of this pilot study is to compare the effect of three of the most common LLLT frequencies on weight, waist circumference, body fat percentage, and quality of life. Sixty overweight (body mass index (BMI) 25-29.9 kg/m2) adult participants were randomized to 12 LLLT treatments: (1) three times weekly for 4 weeks, (2) twice weekly for 6 weeks, or (3) once weekly for 12 weeks. All participants attended an in-person visit at baseline and at weeks 4, 6, 12, and 26. Participants were recruited September 30, 2016 through to August 27, 2017. The majority of the 60 participants were female (90%) with an average age of 43.7 years (± 9.2 years). Most participants (98%) completed 10 or more of the 12 LLLT treatments. When comparing across treatment groups, the greatest reductions from baseline were observed in those assigned to twice weekly for 6 weeks in weight (1 ± 1.7 (±SD) kg by week 6), waist circumference (- 2.0 ± 3.2 in. by week 6 and - 1.5 ± 3.2 in. by week 26), body mass index (- 0.4 ± 0.6 kg/m2), and body fat mass (- 1.1 ± 1.6 kg). This group also had the most significant improvement from baseline in quality of life (+ 0.5 ± 0.8 by week 6), body satisfaction (+ 0.2 ± 0.4 by week 6 and week 26), and body appreciation (+ 0.2 ± 0.3 by week 6 and + 0.3 ± 0.3 by week 26). LLLT twice weekly for 6 weeks could be proposed as the optimal frequency and duration for the management of body weight. Trial registration: https://clinicaltrials.gov/ct2/show/NCT02877004. Registered August 24, 2016.

Use of a Wearable EEG Headband as a Meditation Device for Women With Newly Diagnosed Breast Cancer: A Randomized Controlled Trial.

Background: Breast cancer diagnosis and treatment affect quality of life and stress and are associated with fatigue. Meditation interventions are effective strategies for patients with breast cancer but are often limited by poor access, high cost, substantial time commitment, and poor adherence. In this feasibility study, we investigated the use of a portable, wearable, electroencephalographic device for guided meditation practices by breast cancer patients during the period from breast cancer diagnosis until 3 months after surgical treatment. Methods: We enrolled women (age = 20-75 years) who had received a recent diagnosis of breast cancer and planned to undergo surgical treatment. Participants were randomly assigned to perform guided meditation with the device (intervention group) or receive CD-based stress-reduction education (control group). Surveys were used to measure stress, quality of life, and fatigue at baseline, within 4 days before surgery, up to 14 days after surgery, and at 3 months after surgery. Results: In the intervention group, 15 of 17 participants (88.2%) completed the study; in the control group, 13 of 13 participants completed the study (100%). Participants in both groups had less fatigue and stress and improved quality of life at 2 weeks and 3 months after surgery compared with baseline, but there were no significant intergroup differences at any time point. Conclusion: The use of this wearable electroencephalographic device for meditation is a feasible strategy for patients with breast cancer.

Family-Based Mindful Eating Intervention in Adolescents with Obesity: A Pilot Randomized Clinical Trial.

Mindfulness has gained attention in the treatment of obesity. However, there is a paucity of data on family-based training in mindful eating in children. The objective of this pilot randomized clinical trial was to evaluate the feasibility and acceptability of a family-based mindful eating intervention (MEI) in adolescents with obesity, and to compare the efficacy of the MEI versus standard dietary counseling (SDC) for decreasing weight and improving cardiometabolic risk markers. Twenty-two adolescents (age 14.5⁻17.9 years) and parent pairs were randomized to the MEI or SDC. The MEI was administered in four 90-min sessions over 10 weeks and SDC was provided at baseline, 12 weeks, and 24 weeks. Despite the requirement of more frequent visits with the MEI, adolescents and parents attended 100% of the sessions and there were no dropouts in that group. High density lipoprotein (HDL) cholesterol increased in the SDC group, but not in the MEI group. Adolescents receiving the MEI demonstrated an increase in awareness at 24 weeks (p = 0.01) and a decrease in distraction during eating at 12 weeks (p = 0.04), when compared with the SDC group. The family-based MEI showed feasibility and acceptability in adolescents with obesity. Future studies with more intense therapy and larger sample sizes are warranted to examine the role of mindful eating in treating pediatric obesity.

An integrated digital/clinical approach to smoking cessation in lung cancer screening: study protocol for a randomized controlled trial.

BACKGROUND: Delivering effective tobacco dependence treatment that is feasible within lung cancer screening (LCS) programs is crucial for realizing the health benefits and cost savings of screening. Large-scale trials and systematic reviews have demonstrated that digital cessation interventions (i.e. web-based and text message) are effective, sustainable over the long-term, scalable, and cost-efficient. Use of digital technologies is commonplace among older adults, making this a feasible approach within LCS programs. Use of cessation treatment has been improved with models that proactively connect smokers to treatment rather than passive referrals. Proactive referral to cessation treatment has been advanced through healthcare systems changes such as modifying the electronic health record to automatically link smokers to treatment. METHODS: This study evaluates the impact of a proactive enrollment strategy that links LCS-eligible smokers with an evidence-based intervention comprised of a web-based (WEB) program and integrated text messaging (TXT) in a three-arm randomized trial with repeated measures at one, three, six, and 12 months post randomization. The primary outcome is biochemically confirmed abstinence at 12 months post randomization. We will randomize 1650 smokers who present for a clinical LCS to: (1) a usual care control condition (UC) which consists of Ask-Advise-Refer; (2) a digital (WEB + TXT) cessation intervention; or (3) a digital cessation intervention combined with tobacco treatment specialist (TTS) counseling (WEB + TXT + TTS). DISCUSSION: The scalability and sustainability of a digital intervention may represent the most cost-effective and feasible approach for LCS programs to proactively engage large numbers of smokers in effective cessation treatment. We will also evaluate the impact and cost-effectiveness of adding proven clinical intervention provided by a TTS. We expect that a combined digital/clinical intervention will yield higher quit rates than digital alone, but that it may not be as cost-effective or feasible for LCS programs to implement. This study is innovative in its use of interoperable, digital technologies to deliver a sustainable, scalable, high-impact cessation intervention and to facilitate its integration within clinical practice. It will add to the growing knowledge base about the overall effectiveness of digital interventions and their role in the healthcare delivery system. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03084835 . Registered on 9 March 2017.

Randomized pilot trial of yoga versus strengthening exercises in breast cancer survivors with cancer-related fatigue.

PURPOSE: Fatigue is one of the most common and bothersome refractory symptoms experienced by cancer survivors. Mindful exercise interventions such as yoga improve cancer-related fatigue; however, studies of yoga have included heterogeneous survivorship populations, and the effect of yoga on fatigued survivors remains unclear. METHODS: We randomly assigned 34 early-stage breast cancer survivors with cancer-related fatigue (≥4 on a Likert scale from 1-10) within 1 year from diagnosis to a 12-week intervention of home-based yoga versus strengthening exercises, both presented on a DVD. The primary endpoints were feasibility and changes in fatigue, as measured by the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF). Secondary endpoint was quality of life, assessed by the Functional Assessment of Cancer Therapies-Breast (FACT-B). RESULTS: We invited 401 women to participate in the study; 78 responded, and we enrolled 34. Both groups had significant within-group improvement in multiple domains of the fatigue and quality of life scores from baseline to post-intervention, and these benefits were maintained at 3 months post-intervention. However, there was no significant difference between groups in fatigue or quality of life at any assessment time. Similarly, there was no difference between groups in adherence to the exercise intervention. CONCLUSIONS: Both DVD-based yoga and strengthening exercises designed for cancer survivors may be good options to address fatigue in breast cancer survivors. Both have reasonable uptake, are convenient and reproducible, and may be helpful in decreasing fatigue and improving quality of life in the first year post-diagnosis in breast cancer patients with cancer-related fatigue.

Trial of intensive acupuncture for smoking cessation: a pilot study.

BACKGROUND: Despite the significant decline in smoking rates in the USA over the last 50 years, 42 million Americans continue to smoke. Although the combination of behavioural counselling with FDA-approved medications offers the best evidence-based treatment approach, 12-month relapse rates remain at >60%. Both healthcare providers and patients are searching for alternative treatment options. Most acupuncture trials have yielded poor results for smoking cessation; however, most trials have not used an intense treatment protocol and maintained treatment for at least 12 weeks. METHODS: We designed a pilot study to address these methodological problems. Twenty-eight smokers were recruited to attend two 1 h acupuncture sessions weekly for 12 weeks. Primary endpoints included completion rate, acceptability of the protocol and side effects. Secondary endpoints included carbon monoxide (CO)-confirmed, 7-day point prevalence quit rates at 12 weeks and 26 weeks. RESULTS: Sixteen of the 28 patients enrolled (57%) completed 12 weeks of treatment. Of the 17 patients who completed the end-of-study questionnaire, 94% (16/17) rated the programme as helpful, and 82% noted they would recommend it to friends for smoking cessation. Three of the 28 who initially enrolled in the study were confirmed abstinent at 12 weeks (10.7%); one of the 28 (3.6%) was abstinent at 26 weeks. CONCLUSIONS: A larger study with a slightly less rigorous and more acceptable treatment protocol is feasible and should be considered.

Acupuncture in the postoperative setting for breast cancer patients: a feasibility study.

Acupuncture is used to treat a variety of symptoms and conditions associated with cancer and cancer treatments. The present study was performed to evaluate the feasibility of providing acupuncture in the hospital setting for breast cancer patients and to evaluate the short-term effect of acupuncture on stress, anxiety, and pain. This was an open label study conducted at Mayo Clinic Hospital, Methodist and Saint Marys Campus, Rochester, Minnesota. A total of 20 adult breast cancer patients undergoing mastectomy and/or breast reconstruction were recruited and offered daily acupuncture intervention beginning postoperative day 1 and continuing for the duration of the hospital stay. Outcome measures included the Symptom Visual Analog Scale (VAS) and Satisfaction Question and Was-it-Worth-it (WIWI) Questionnaire. It was found that acupuncture is a feasible option for postoperative breast cancer patients. In addition, it can significantly decrease the levels of anxiety (p = 0.0065), tension/muscular discomfort (p < 0.001) and pain (p = 0.023). The association between acupuncture and relaxation was found to be statistically borderline (p = 0.053). This feasibility study showed that acupuncture can be integrated into a busy postsurgical clinical practice. These results also suggest that acupuncture may be an important intervention in the postoperative setting for breast cancer patients.

Maternal vitamin D supplementation to improve the vitamin D status of breast-fed infants: a randomized controlled trial.

OBJECTIVE: To determine whether a single monthly supplement is as effective as a daily maternal supplement in increasing breast milk vitamin D to achieve vitamin D sufficiency in their infants. PATIENTS AND METHODS: Forty mothers with exclusively breast-fed infants were randomized to receive oral cholecalciferol (vitamin D3) 5000 IU/d for 28 days or 150,000 IU once. Maternal serum, breast milk, and urine were collected on days 0, 1, 3, 7, 14, and 28; infant serum was obtained on days 0 and 28. Enrollment occurred between January 7, 2011, and July 29, 2011. RESULTS: In mothers given daily cholecalciferol, concentrations of serum and breast milk cholecalciferol attained steady levels of 18 and 8 ng/mL, respectively, from day 3 through 28. In mothers given the single dose, serum and breast milk cholecalciferol peaked at 160 and 40 ng/mL, respectively, at day 1 before rapidly declining. Maternal milk and serum cholecalciferol concentrations were related (r=0.87). Infant mean serum 25-hydroxyvitamin D concentration increased from 17±13 to 39±6 ng/mL in the single-dose group and from 16±12 to 39±12 ng/mL in the daily-dose group (P=.88). All infants achieved serum 25-hydroxyvitamin D concentrations of more than 20 ng/mL. CONCLUSION: Either single-dose or daily-dose cholecalciferol supplementation of mothers provided breast milk concentrations that result in vitamin D sufficiency in breast-fed infants. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov NCT01240265.

S-adenosyl-L-methionine (SAMe) for smoking abstinence: a randomized clinical trial.

OBJECTIVES: S-Adenosyl-L-methionine (SAMe) is a dietary supplement commonly used to treat depression. SAMe facilitates dopamine and norepinephrine synthesis in the central nervous system. This study investigated the efficacy of SAMe for increasing tobacco abstinence among cigarette smokers. DESIGN: A randomized, blinded, placebo-controlled, three-arm, dose-ranging clinical trial was conducted. Subjects were randomly allocated to receive SAMe 1600 mg or 800 mg by mouth every day or a matching placebo for 8 weeks. All subjects received a behavioral smoking cessation intervention. Self-reported smoking abstinence was biochemically confirmed with exhaled-air carbon monoxide. SUBJECTS: Subjects in the study comprised 120 adults. RESULTS: One hundred and twenty (120) subjects with a mean age of 40.0±14.0 (SD) years were enrolled. Participants smoked an average of 19.6±8.6 cigarettes per day for 21±13.2 years. The study dropout rate was high (42.5%). By intention-to-treat analysis, no significant differences were observed in abstinence rates at 8 and 24 weeks between SAMe dose groups and placebo. SAMe did not attenuate withdrawal symptoms among abstinent subjects. Rates of gastrointestinal side-effects were higher with SAMe 1600 mg/d compared to placebo. CONCLUSIONS: SAMe did not increase smoking abstinence rates. Abstinence and tobacco withdrawal data from this clinical trial suggest that SAMe holds little promise for the treatment of tobacco dependence.

Spirituality in tobacco dependence: a Mayo Clinic survey.

CONTEXT: With widespread interest in natural remedies and "wholistic" treatments, there has been a renewed focus on the impact of spirituality related alternative therapy for many current chronic diseases. OBJECTIVE: To assess the potential impact of spiritual beliefs on lifestyle choices such as tobacco use, we conducted a patient survey. DESIGN/SETTING: This cross-section study was conducted using a 27-question survey of patients seen at the Mayo Clinic over a 14-week period. PATIENTS: We invited all patients (smokers and nonsmokers) seen in several Mayo Clinic divisions to participate in this voluntary survey. INTERVENTIONS: The survey included demographic information, history of tobacco use or nonuse, and assessment of spirituality. MAIN OUTCOME MEASURE: Among the 501 patients who participated, 370 were nonsmokers and 131 were smokers. Compared with smokers, nonsmokers more often participated in religious activities such as regular weekly church attendance (48% vs. 24%), daily prayer, and Bible study (49% vs. 24%; P < .001). Current smoking was negatively correlated with religious activities. However, after adjustment for demographic factors, there was no significant difference in intrinsic spirituality (importance of religion) between the two groups (P < .130). RESULT: Nonsmokers are more likely to engage in religious activities such as prayer, Bible study, and regular church attendance. Further studies may be helpful to clearly define the potential impact of spirituality on smoking cessation.

A randomized clinical trial of St. John's wort for smoking cessation.

INTRODUCTION: St. John's wort (SJW) is a widely used herbal supplement. The predominant mechanism(s) accounting for the activity of SJW in vivo are, however, unclear. The purpose of this study was to investigate the efficacy of SJW for smoking cessation. METHODS: We conducted a randomized, blinded, placebo-controlled, three-arm, dose-ranging clinical trial. A total of 118 subjects were randomly allocated to receive SJW 300 mg, 600 mg, or a matching placebo tablet 3 times a day combined with a behavioral intervention for 12 weeks. Self-reported smoking abstinence was biochemically confirmed with expired air carbon monoxide. RESULTS: Mean age of the study participants was 37.6 +/- 12.4 years; they smoked an average of 20.0 +/- 6.6 cigarettes per day for 20 +/- 12.1 years. The study dropout rate was high (43%). By intention-to-treat analysis, no significant differences were observed in abstinence rates at 12 and 24 weeks between SJW dose groups and placebo. SJW did not attenuate withdrawal symptoms among abstinent subjects. Abstinence rates did not differ by study group among subjects who took at least 75% of their study medication. No significant side-effects were noted with SJW. CONCLUSIONS: In this randomized trial, SJW did not increase smoking abstinence rates. Our data, in combination with data from other studies, suggest that SJW has little role in the treatment of tobacco dependence.