Evaluating efficacy and feasibility of transcutaneous electrical nerve stimulation for postoperative pain after video-assisted thoracoscopic surgery: A randomized pilot trial.

BACKGROUND: Transcutaneous electrical nerve stimulation (TENS) has been applied for pain relief after surgical procedures. This study evaluated whether TENS after video-assisted thoracoscopic surgery (VATS), in addition to opioid administration, decreased postoperative pain and pain medication use. METHODS: In a controlled trial, 56 patients scheduled to undergo VATS were randomly assigned to TENS plus opioids (Group 1) or opioids alone (Group 2) for 48 h. RESULTS: Forty patients completed the study. Pain scores and use of oral morphine equivalents (OMEs) were not significantly different between the groups during the first and second 24 h. A decreased use of OMEs between the first and second 24 h was significant for Group 1 (P = .005) but not for Group 2 (P = .11); a decreased use of OMEs between groups was not significant (P = .35). CONCLUSIONS: A larger, well-powered clinical trial is indicated to evaluate the effects of TENS for pain control after a VATS procedure. Clinical Trial No.: NCT01046695.

The effect of grape seed extract on estrogen levels of postmenopausal women: a pilot study.

The role of estrogens in breast cancer (BC) development is widely accepted, leading to the development of selective estrogen receptor modulators and aromatase inhibitors for BC treatment and prevention. However, because of potential adverse effects, healthy women with high risk of BC are hesitant to take them. Preliminary evidence from animal studies shows that grapes may have an aromatase-inhibiting effect, decreasing estrogen synthesis and increasing androgen precursors. We conducted a randomized, double-blind, dose-finding early-phase trial on the effect of grape seed extract (GSE) on estrogen levels. Postmenopausal women who met study inclusion criteria (N = 46) were randomly assigned to daily GSE at a dose of 200, 400, 600, or 800 mg for 12 weeks. Primary outcome was change in plasma levels of estrogen conjugates from baseline to 12 weeks posttreatment. Thirty-nine participants (84.8%) completed the study. GSE in the 4 daily doses did not significantly decrease estrogen or increase androgen precursors.

Physicians' attitudes toward complementary and alternative medicine and their knowledge of specific therapies: 8-year follow-up at an academic medical center.

The purpose of this study was to determine changes in attitude toward complementary and alternative medicine (CAM) therapies and knowledge of specific CAM therapies among internists at our institution. We compared the results of a survey given in 2004 and 2012. During this time period, the attitudes of physicians in our department of medicine toward CAM became much more positive, and physicians showed an increased willingness to use CAM to address patient care needs. However, knowledge of and experience with many specific CAM treatments did not change. These results will be used to develop further educational interventions and research studies.

Feasibility and effect of chair massage offered to nurses during work hours on stress-related symptoms: a pilot study.

This study assessed feasibility and effect of weekly, 15-min chair massages during work for 38 nurses. Mean Perceived Stress Scale-14 (PSS-14), Smith Anxiety Scale (SAS), linear analog self-assessment scale (LASA), and symptom visual analog scale (SX-VAS) scores were tracked at baseline, 5 weeks, and 10 weeks. Of 400 available massage appointments, 329 were used. At 10 weeks, mean PSS-14 score decreased from 17.85 to 14.92 (P = .002); mean SAS score, from 49.45 to 40.95 (P < .001). Mean LASA score increased from 42.39 to 44.84 (P = .006); mean SX-VAS score, from 65.03 to 74.47 (P < .001). Massages for nurses during work hours reduced stress-related symptoms.

Feasibility and effectiveness of massage therapy for symptom relief in cardiac catheter laboratory staff: a pilot study.

A pilot study was conducted to assess the feasibility and efficacy of massage therapy for cardiac catheterization laboratory staff. Staff members (N = 50) were randomly assigned to 5 or 10 weekly 30-min massages, followed by outcomes assessment. A control group (n = 10) receiving no massage therapy underwent comparable assessment. Visual analog scales, the t test, and the repeated measures model evaluated fatigue, pain, relaxation, stress/anxiety, tension/discomfort, and scheduling ease at baseline, 5 weeks, and 10 weeks. The Aickin separation test was used to assess feasibility of further research. Overall, 90% (337/375) of massage appointments were used. No significant effects were observed, but the Aickin separation test supported further research on massage therapy for fatigue, pain, relaxation, and tension/discomfort. Conducting massage therapy in the workplace is logistically feasible. Larger, longitudinal trials are warranted to better evaluate its effects on staff.

Use of complementary and alternative medicine by patients seen at the dermatology department of a tertiary care center.

The use of complementary and alternative medicine (CAM) among patients with dermatologic conditions has not been well studied. The aim of this study was to evaluate the frequency and pattern of CAM use in patients referred to the dermatology department of a tertiary care center. Patients referred to the dermatology department of an academic tertiary referral center between February 2, 2010, and February 10, 2010, were invited to participate in an 86-question survey regarding CAM use during the previous year. A total of 300 patients completed the survey, of whom 154 (51%) were women. Eighty-two percent (n = 247) of the respondents had used some type of CAM during the previous year. The most frequently used treatment and technique was massage therapy (33%), and the most commonly used vitamin was vitamin C (31%). Herbs or other dietary supplements were used by 58% (n = 173) of patients. Seventy-eight percent (n = 235) of patients stated that physicians should consider incorporating CAM approaches into their treatment recommendations, and 89% of patients (n = 267) stated that our dermatology department should study CAM approaches in research studies. CAM utilization is high among patients at a large academic dermatology department. Patients indicated a strong preference for having CAM approaches incorporated into their treatment recommendations and believed in the value of clinical studies to further refine the role of CAM.

Evaluation of a biofeedback-assisted meditation program as a stress management tool for hospital nurses: a pilot study.

OBJECTIVE: To assess whether a self-directed, computer-guided meditation training program is useful for stress reduction in hospital nurses. DESIGN: We prospectively evaluated participants before and after a month-long meditation program. The meditation program consisted of 15 computer sessions that used biofeedback to reinforce training. Participants were instructed to practice the intervention for 30 minutes per session, four times a week, for four weeks. Visual analogue scales were used to measure stress, anxiety, and quality of life (assessments were performed using Linear Analogue Self-Assessment [LASA], State Trait Anxiety Inventory [STAI], and Short-Form 36 [SF-36] questionnaires). Differences in scores from baseline to the study's end were compared using the paired t test. RESULTS: Eleven registered nurses not previously engaged in meditation were enrolled; eight completed the study. Intent-to-treat analysis showed significant improvement in stress management, as measured by SF-36 vitality subscale (P = .04), STAI (P = .03), LASA stress (P = .01), and LASA anxiety (P = .01). Nurses were highly satisfied with the meditation program, rating it 8.6 out of 10. CONCLUSIONS: The results of this pilot study suggest the feasibility and efficacy of a biofeedback-assisted, self-directed, meditation training program to help hospital nurses reduce their stress and anxiety. Optimal frequency of use of the program, as well as the duration of effects, should be addressed in future studies.

Dietary soy supplement on fibromyalgia symptoms: a randomized, double-blind, placebo-controlled, early phase trial.

Most patients with fibromyalgia use complementary and alternative medicine (CAM). Properly designed controlled trials are necessary to assess the effectiveness of these practices. This study was a randomized, double-blind, placebo-controlled, early phase trial. Fifty patients seen at a fibromyalgia outpatient treatment program were randomly assigned to a daily soy or placebo (casein) shake. Outcome measures were scores of the Fibromyalgia Impact Questionnaire (FIQ) and the Center for Epidemiologic Studies Depression Scale (CES-D) at baseline and after 6 weeks of intervention. Analysis was with standard statistics based on the null hypothesis, and separation test for early phase CAM comparative trials. Twenty-eight patients completed the study. Use of standard statistics with intent-to-treat analysis showed that total FIQ scores decreased by 14% in the soy group (P = .02) and by 18% in the placebo group (P < .001). The difference in change in scores between the groups was not significant (P = .16). With the same analysis, CES-D scores decreased in the soy group by 16% (P = .004) and in the placebo group by 15% (P = .05). The change in scores was similar in the groups (P = .83). Results of statistical analysis using the separation test and intent-to-treat analysis revealed no benefit of soy compared with placebo. Shakes that contain soy and shakes that contain casein, when combined with a multidisciplinary fibromyalgia treatment program, provide a decrease in fibromyalgia symptoms. Separation between the effects of soy and casein (control) shakes did not favor the intervention. Therefore, large-sample studies using soy for patients with fibromyalgia are probably not indicated.

The effect of chair massage on muscular discomfort in cardiac sonographers: a pilot study.

BACKGROUND: Cardiac sonographers frequently have work-related muscular discomfort. We aimed to assess the feasibility of having sonographers receive massages during working hours in an area adjacent to an echocardiography laboratory and to assess relief of discomfort with use of the massages with or without stretching exercises. METHODS: A group of 45 full-time sonographers was randomly assigned to receive weekly 30-minute massage sessions, massages plus stretching exercises to be performed twice a day, or no intervention. Outcome measures were scores of the QuickDASH instrument and its associated work module at baseline and at 10 weeks of intervention. Data were analyzed with standard descriptive statistics and the separation test for early-phase comparative trials. RESULTS: Forty-four participants completed the study: 15 in the control group, 14 in the massage group, and 15 in the massage plus stretches group. Some improvement was seen in work-related discomfort by the QuickDASH scores and work module scores in the 2 intervention groups. The separation test showed separation in favor of the 2 interventions. CONCLUSION: On the basis of the results of this pilot study, larger trials are warranted to evaluate the effect of massages with or without stretching on work-related discomfort in cardiac sonographers. TRIAL REGISTRATION: NCT00975026 ClinicalTrials.gov.

Measurement of quality of life and participant experience with the mindfulness-based stress reduction program.

Clinical studies of MBSR have reported efficacy in treating pain, mood disorders, arthritis, sleep disturbances, and stress. Several academic medical institutions in the United States offer MBSR to their patients, but it has never been offered at Mayo Clinic. The objective of this study was to collect quality-of-life data from subjects who participated in the first MBSR program offered at Mayo Clinic. The class was taught as a collaborative effort with the University of Minnesota that had an established MBSR program. Sixteen participants completed a validated, 12-question, linear analogue self-assessment instrument, administered at the beginning and end of the program. Comparison of assessment scores using paired t-tests showed statistically significant improvement in overall quality of life (P=0.04), mental well-being (P=0.005), physical well-being (P<0.001), emotional well-being (P<0.001), level of social activity (P=.02), and spiritual well-being (P=0.006). Although positive changes also were observed for frequency of pain, severity of pain, level of fatigue, level of support from friends and family, and financial and legal concerns, they were not statistically significant. A short intervention in the education of mindfulness significantly improved quality of life for participants.

Dietary supplement S-adenosyl-L-methionine (AdoMet) effects on plasma homocysteine levels in healthy human subjects: a double-blind, placebo-controlled, randomized clinical trial.

OBJECTIVES: To determine if exogenous S-adenosyl-l-methionine (AdoMet), a commonly used nutritional supplement, increases the level of plasma homocysteine (Hcy), a potential cardiovascular risk factor, in healthy human subjects. DESIGN: Double-blind, placebo-controlled, randomized clinical trial. SETTING: Mayo Clinic, Rochester, Minnesota. SUBJECTS: Fifty-two (52) healthy human volunteers. INTERVENTION: Subjects received placebo or AdoMet (800 mg per day) for 4 weeks. Hcy levels were measured before and after administration of AdoMet or placebo. OUTCOME MEASURES: The primary outcome measure was change in Hcy level. Secondary outcome measures included an interim Hcy determination (at 2 weeks) and changes in levels of high-sensitivity C-reactive protein (hsCRP), lipids, and alanine aminotransferase. RESULTS: There was no statistically significant change in Hcy between groups. Similarly, no statistically significant differences in change in Hcy or hsCRP levels were observed at 2 or 4 weeks. There was a small but statistically significant increase (p < 0.04) in alanine aminotransferase at week 2 and a statistically significant decrease (p < 0.04) in total cholesterol in the AdoMet group compared with the placebo group. CONCLUSIONS: AdoMet at a daily dose of 800 mg for 4 weeks does not appear to significantly affect Hcy levels in the blood.

Patients' attitudes and preferences about participation and recruitment strategies in clinical trials.

OBJECTIVE: To assess attitudes of patients about participation in clinical trials. PATIENTS AND METHODS: This is a self-report survey of 400 patients who underwent general medical evaluations between September and November 2006 at a tertiary care academic medical center in Rochester, MN. We measured knowledge of access to clinical trials, attitudes toward participation, recruitment preferences, and beliefs about research integrity. RESULTS: Of 485 consecutive patients, 400 (82%) completed the survey. Previous participation in clinical trials was reported by 112 patients (28%). Most were unaware of online information about clinical trials (330 [82%]), were satisfied with their current knowledge (233 [58%]), expected their treating physician to inform them about current trials (304 [76%]), and showed equal interest in participating in conventional or complementary intervention trials (174 [44%]). Of the 400 respondents, 321 (80%) found it appropriate to be contacted by mail and 253 (63%) by telephone regarding study participation. Most patients (364 [91%]) wanted to be informed about research findings or else would not participate in future clinical trials (272 [68%]). The most frequently expected compensation was free parking (234 [58%]). Most thought that their safety (373 [93%]) and privacy (376 [94%]) would be guarded. CONCLUSION: Patients are interested in participating in clinical trials but commonly lack adequate information. If patients received more information (through their treating physicians), enrollment might improve. This single-site study has limited generalizability. Future studies involving a diverse group of patients from a broader geographic distribution will help provide more definitive results.

Potential for interactions between dietary supplements and prescription medications.

PURPOSE: The objective of this study was to assess the frequency of clinically significant interactions caused by concurrent use of dietary supplements and prescription medication. METHODS: We conducted a cross-sectional, point-of-care survey and combined the findings with a review of patient medical records. Patients treated at Mayo Clinic (Rochester, Minn) in 6 different specialty clinics were surveyed for their use of dietary supplements. Concurrent use of prescription medications was obtained from patients' medical records. We used the Lexi-Interact online medication and dietary supplement interaction analysis program to assess the potential clinical significance of each interaction. RESULTS: We surveyed 1818 patients; 1795 responded (overall response rate of 98.7%) and 710 (39.6%) reported use of dietary supplements. In total, 107 interactions with potential clinical significance were identified. The 5 most common natural products with a potential for interaction (garlic, valerian, kava, ginkgo, and St John's wort) accounted for 68% of the potential clinically significant interactions. The 4 most common classes of prescription medications with a potential for interaction (antithrombotic medications, sedatives, antidepressant agents, and antidiabetic agents) accounted for 94% of the potential clinically significant interactions. No patient was harmed seriously from any interaction. CONCLUSIONS: A small number of prescription medications and dietary supplements accounted for most of the interactions. The actual potential for harm was low.

Use of complementary and alternative medicine treatments by patients with obstructive sleep apnea hypopnea syndrome.

STUDY OBJECTIVES: To assess the proportion of patients with obstructive sleep apnea hypopnea syndrome (OSAHS) reporting previous or current use and interest in future use of complementary and alternative medicine (CAM) therapies. DESIGN: Cross-sectional, point-of-care, anonymous survey. SETTING: Sleep disorders center at a Midwest tertiary care center. PARTICIPANTS: Six hundred forty-six consecutive patients undergoing polysomnography. MEASUREMENTS: The survey instrument comprised 45 items specifically related to CAM therapies, in addition to obtaining baseline data. RESULTS: Response rate was 81% (522/646). A total of 406/522 (78%) patients were diagnosed with OSAHS. Mean age +/- SD was 57 +/- 14 years, and 267 participants (66%) were men. Overall, 237 (58%) participants reported ever using CAM. Ever and current CAM use specifically for improving sleep was reported by 20% and 7% of the participants, respectively. Twenty-six percent of participants reported ever using biologic products, and 52% reported ever using nonbiologic CAM treatments. A high proportion (58%) of the participants showed interest in future CAM use for improving sleep. CONCLUSION: A high proportion of patients with OSAHS report previous or current use, and interest in future use, of CAM treatments. This underscores the need to conduct further research in this field.

Gender-specific differences in a patient population with obstructive sleep apnea-hypopnea syndrome.

BACKGROUND: Sleep-related breathing disorders are increasingly recognized as an important cause of morbidity and mortality. Women with obstructive sleep apnea-hypopnea syndrome (OSA) are less likely to be assessed or to receive a diagnosis, and they may have poorer survival rates. OBJECTIVE: This study assessed gender-specific differences in patients with OSA. METHODS: Data were collected with a prospective, point-of-care, anonymous 25-question survey about basic medical information and therapies for patients undergoing polysomnography at the sleep center of a US tertiary care center from January 1 through March 31, 2005. RESULTS: Of the 646 consecutive patients who received the survey, 522 (80.8%) patients completed it, and 406 subsequently received a diagnosis of OSA. Of those 406 patients, 267 (65.8%) were men. Overall mean age was 57 years (56.4 years for men; 56.7 years for women). Alcohol use was more common in men (132 [49.4%]) than in women (43 [30.90,6]) (P < 0.001). Women were more likely to have the following associated comorbidities: obesity (body mass index > or =30) (P = 0.047), fibromyalgia (P < 0.001), migraine (P < 0.001), depression (P = 0.01), and irritable bowel syndrome (P = 0.01). The 4 most frequently reported sleep-related symptoms in both sexes were snoring (279 [68.7%]), lack of energy (235 [57.9%]), difficulty staying asleep (206 [50.7%]), and daytime sleepiness (204 [50.2%]). Lack of energy (P = 0.01), difficulty falling asleep (P = 0.02), and night sweats (P = 0.01) were observed more frequently in women than in men. There was no significant gender difference in the recalled duration of sleep-related symptoms. The mean (SD) apnea-hypopnea index (AHI) was 26.6 (26.6) for men and 22.1 (26.5) for women (P = 0.02). Conventional medications (including prescription and over-the-counter medications) for sleep-related problems were used more by women (35 [25.2%]) than by men (29 [10.9%]) (P < 0.001). CONCLUSIONS: The majority of patients who received a diagnosis of OSA were men (male-female ratio, 2:1), and the mean AHI was higher in men than in women. However, women presented with more nonspecific symptoms than did men, although there was no significant gender-specific difference in the recalled duration of symptoms. In addition, women reported more comorbidities and used significantly more conventional medications for sleep-related problems.

Physicians' attitudes toward complementary and alternative medicine and their knowledge of specific therapies: a survey at an academic medical center.

The purpose of this study was to evaluate the attitudes of physicians at an academic medical center toward complementary and alternative medicine (CAM) therapies and the physicians' knowledge base regarding common CAM therapies. A link to a Web-based survey was e-mailed to 660 internists at Mayo Clinic in Rochester, MN, USA. Physicians were asked about their attitudes toward CAM in general and their knowledge regarding specific CAM therapies. The level of evidence a physician would require before incorporating such therapies into clinical care was also assessed. Of the 233 physicians responding to the survey, 76% had never referred a patient to a CAM practitioner. However, 44% stated that they would refer a patient if a CAM practitioner were available at their institution. Fifty-seven percent of physicians thought that incorporating CAM therapies would have a positive effect on patient satisfaction, and 48% believed that offering CAM would attract more patients. Most physicians agreed that some CAM therapies hold promise for the treatment of symptoms or diseases, but most of them were not comfortable in counseling their patients about most CAM treatments. Prospective, randomized controlled trials were considered the level of evidence required for most physicians to consider incorporating a CAM therapy into their practice. The results of this survey provide insight into the attitudes of physicians toward CAM at an academic medical center. This study highlights the need for educational interventions and the importance of providing physicians ready access to evidence-based information regarding CAM.

Use of complementary and alternative medical therapies by patients referred to a fibromyalgia treatment program at a tertiary care center.

OBJECTIVE: To evaluate the frequency and pattern of complementary and alternative medicine (CAM) use in patients referred to a fibromyalgia treatment program at a tertiary care center. PATIENTS AND METHODS: Patients referred to the Mayo Fibromyalgia Treatment Program between February 2003 and July 2003 were invited on their initial visit to participate in a survey regarding CAM use during the previous 6 months. An 85-question survey that addressed different CAM domains was used. RESULTS: Of the 304 patients invited to participate, 289 (95%) completed the survey (263 women and 26 men). Ninety-eight percent of the patients had used some type of CAM therapy during the previous 6 months. The 10 most frequently used CAM treatments were exercise for a specific medical problem (48%), spiritual healing (prayers) (45%), massage therapy (44%), chiropractic treatments (37%), vitamin C (35%), vitamin E (31%), magnesium (29%), vitamin B complex (25%), green tea (24%), and weight-loss programs (20%). CONCLUSION: CAM use is common in patients referred to a fibromyalgia treatment program.

Gamma-heavy chain disease: review of 23 cases.

We report the cases of 23 patients with gamma-heavy chain disease seen at our institution (8 patients previously reported, 15 new patients). There were 15 women and 8 men; the median age at diagnosis was 68 years (range, 42-87 yr). Sixteen patients had an associated lymphoplasma cell proliferative disorder, 3 had a lymphoplasma cell proliferative disorder and an autoimmune disorder, another 3 had an autoimmune disorder only, and 1 had no underlying disease. The lymphoplasma cell proliferative disorder was disseminated in 10 patients and localized in 6. Patients with localized lymphoplasma cell proliferative disorder included 3 with plasmacytoma (1 tongue, 1 submandibular area, and 1 thyroid), 2 with lymphoplasma cell proliferative disorder involving the bone marrow only, and 1 with amyloid of the skin. At the time of diagnosis, lymphadenopathy was present in 8 patients, splenomegaly in 7, and hepatomegaly in 1. A monoclonal spike on serum protein electrophoresis was documented in 19 patients. gamma-Heavy chain was documented by immunofixation in the serum of all patients; 2 had an additional immunoglobulin M-lambda. gamma-Heavy chain was present in the urine in 19 of 22 patients. Sixteen patients were treated for lymphoplasma cell proliferative disorder or autoimmune disorder (14 with chemotherapy, 1 splenectomy, and 1 thyroidectomy followed by radiation therapy). For 5 patients, treatment was not felt to be necessary; 2 patients were thought to be too sick for treatment. Of the 16 patients treated, 6 had a complete clinical response (in 2, gamma-heavy chain disappeared; in 2, gamma-heavy chain persisted; and for 2, no serologic follow-up was available); in 10 patients, clinical disease persisted (in 3, gamma-heavy chain disappeared; in 6, it persisted; and for 1, no serologic follow-up was available). Of 7 patients not treated, 2 died within 5 months; 1 died after 15 months; 2 had no clinical disease at latest follow-up, although gamma-heavy chain persisted; and 2 had no change in clinical and serologic status. The median duration of follow-up was 33 months (range, 1-261 mo). Median survival was 7.4 years.