Therapy dogs are increasingly being incorporated into numerous clinical settings. However, there are only a handful of studies that have focused on the impact of animal-assisted activity or therapy sessions on the wellbeing of the therapy dogs. Furthermore, these studies show mixed results. The goal of this study was to provide an in-depth picture of the effects of these interactions on the dogs involved by considering multiple physiological measures known to be associated with emotional state (continuous heart rate, heart rate variability, pre- and post-session tympanic membrane temperatures, and salivary cortisol and oxytocin concentrations). Nineteen Mayo Clinic Caring Canine therapy dogs completed five 20-minute animal-assisted activity (AAA) visits each in an outpatient clinical setting (Mayo Clinic Fibromyalgia and Chronic Fatigue Clinic). From a physiological perspective, the dogs showed a neutral to positive response to the AAA sessions. Heart rate (HR) was significantly lower at the end of the session compared with the beginning of the session (F = 17.26, df1 = 1, df2 = 29.7, p = 0.0003). The right tympanic membrane temperature was lower post-session (F = 8.87, df1 = 1, df2 = 107, p = 0.003). All other emotional indicators remained stable between pre- and post-session. These results suggest that the dogs involved were not negatively affected by their participation in the AAA. Moreover, there was some evidence suggesting the dogs may have been in a more relaxed state at the end of the session (lower HR and lower right tympanic membrane temperature) compared to the beginning of the session.

To study the direct physiological and emotional impact of an animal-assisted activity (AAA) session (a form of complementary and integrative medicine) in patients with fibromyalgia (FM). The study population consisted of 221 participants with FM who were attending Mayo Clinic's Fibromyalgia Treatment Program between August 5, 2017, and September 1, 2018. This was a randomized controlled trial. Participants were randomly assigned to either the treatment group (a 20-minute session with a certified therapy dog and handler) or the control group (a 20-minute session with a handler only). To gain a better understanding of the direct physiological and emotional effects of AAA in patients with FM, we used multiple noninvasive physiologic-emotional biomarkers, including salivary cortisol and oxytocin concentrations, tympanic membrane temperatures, and various cardiac parameters, in addition to standardized pain and mood-based questionnaires. Results show a decrease in heart rate, an increase in heart rate variability, an increase in well-being survey scores, an increase in salivary oxytocin, and subsequent tympanic membrane temperature changes, suggesting that participants in the treatment group were in a more positive emotional-physiologic state as a result of the AAA session compared with the control group. Our results suggest that a 20-minute therapy dog visit in an outpatient setting can significantly and positively impact the physical and mental health of patients with FM.

Fibromyalgia (FM) is a chronic pain sensitivity syndrome characterized by diffuse musculoskeletal pain and many other systemic manifestations. Low-dose naltrexone (LDN) has been increasingly used as an off-label treatment option in FM. However, current evidence on the safety and efficacy of LDN in patients with FM is not well known. To systematically assess the current evidence on the safety and efficacy of LDN use in the treatment of FM. A comprehensive bibliographic search was conducted on EBM Reviews – Cochrane Central Register of Controlled Trials, EBM Reviews – Cochrane Database of Systematic, Embase, Ovid MEDLINE(R) and Epub Ahead of Print, In-Process, In-Data-Review & Other Non-Indexed Citations, Daily and Versions and Scopus databases in September 2022. Inclusion criteria were articles that were published in English, focusing on clinical trials involving LDN for the treatment of FM. Two reviewers independently screened and extracted the data. A qualitative analysis was used due to the high methodological heterogeneity between studies. The electronic search produced 805 articles. After applying the inclusion criteria, 9 articles (one RCT, two case reports, two case series, and four pilot trials) were selected for evaluation. LDN intervention protocols, study designs, and follow-up periods were different among the included studies. Overall, LDN was found to be effective in the symptomatic management of FM, and of the 78% of included studies that evaluated for safety, no severe adverse events were reported. Proving the efficacy and safety of low-dose naltrexone is a future possibility based on current study data, but the level of scientific evidence is limited. Future well-designed trials with large sample sizes are required.

To reevaluate the frequency and pattern of complementary and integrative medicine (CIM) use in patients with fibromyalgia (FM). Consecutive patients with FM who were referred to the Mayo Clinic fibromyalgia treatment program from January 5 through July 27, 2017, were invited to complete a survey about their use of CIM therapies in the preceding 6 months. The survey asked about 3 primary CIM domains: treatments and techniques, vitamins and minerals, and herbs and other dietary supplements. For direct comparative purposes, we reused the survey instrument from our prior analogous study of CIM use, performed in 2003. Of the 310 patients who completed the survey, 304 (98.1%) reported using some form of CIM, similar to the percentage reported in our 2003 study (98%). The most frequently used CIM therapies in the current cohort were spiritual healing (54.0% [163 of 302]), massage therapy (50.0% [152 of 304]), chiropractic treatments (39.3% [118 of 300]), aromatherapy (39.0% [117 of 300]), exercise for a specific medical problem (38.6% [117 of 303]), melatonin (37.9% [77 of 203]), magnesium (36.3% [107 of 295]), green tea (36.1% [73 of 202]), and fish oil (34.5% [68 of 197]). We noted numerous substantial differences from the 2003 data in terms of the pattern of CIM use. The use of CIM therapies among patients with FM continues to be extremely common for adult patients of all ages. Given the continued high prevalence of CIM use, health care professionals must have awareness and knowledge of these various modalities and their potential incorporation into a multifaceted FM treatment regimen.

To investigate sex-related differences in patients with fibromyalgia (FM) in terms of demographic characteristics and clinical features, including tender point count (TPC), mood disorders, sleep problems, FM symptom severity, fatigue, cognitive dysfunction, and quality of life (QOL). We studied 668 consecutive patients with FM (606 women) from May 1, 2012, to November 30, 2013. Validated questionnaires assessed outcomes of depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder-7), sleep problems (Medical Outcomes Study Sleep Scale), FM symptom severity (Revised Fibromyalgia Impact Questionnaire), fatigue (Multidimensional Fatigue Inventory), cognitive dysfunction (Multiple Ability Self-report Questionnaire), and QOL (36-Item Short Form Health Survey). Nonparametric Mann-Whitney U and Pearson χ2 tests were used to compare continuous and categorical outcome measures, respectively, between men and women. Linear regression models were performed for all continuous dependent variables, adjusting for age, body mass index, ethnicity, marital status, and highest education level completed. P<.05 was considered statistically significant. The Benjamini-Hochberg procedure was used to adjust for multiple comparisons. Multiple linear regression analysis revealed a significant association of female sex and greater TPC (P<.001), lower overall FM symptom severity (lower overall Revised Fibromyalgia Impact Questionnaire score; P=.03), and higher QOL subscale score for vitality (36-Item Short Form Health Survey vitality subscale score; P=.02). After adjustment for multiple comparisons, only the association between female sex and greater TPC remained significant. There were no sex-related differences in demographic characteristics, depression, anxiety, sleep problems, FM symptom severity, cognitive dysfunction, and QOL. A higher TPC may be associated with female sex in patients with FM. The assumption of other sex-based differences in the clinical presentation of FM was not supported in our study.

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.