Self-Administration of Auricular Acupuncture in Rural Veterans with Chronic Pain: A Pilot Project.

Expression of Concern: Medical Acupuncture issues an Expression of Concern pertaining to a published article in the October 2021 issue of the journal entitled, "Self-Administration of Auricular Acupuncture in Rural Veterans with Chronic Pain: A Pilot Project," by Brian Lee James, John Welch, and Clint Williamson. (Med Acupunct 33(5):2021.349-352; doi: 10.1089/acu.2021.0007) The journal has received communications from several sources raising significant concerns regarding the claims made in this article as they pertain to the self-administration of Battlefield Acupuncture and patient self-use of acupuncture needles. Each communication states that acupuncture needles are considered FDA-approved medical equipment and are not intended for patient self-administration. An official inquiry with the authors' institution has been launched by the editors and publisher of the journal. Such an inquiry may be a protracted process but the journal will update this notice once a resolution has been reached. Objective: There has been little research on self-administration of auricular acupuncture by patients. This study was conducted to assess the safety and feasibility of self-administration of Battlefield Acupuncture (BFA) with semipermanent needles at intervals of 2 weeks over a timeperiod of 6 months. Materials and Methods: This study was conducted at the Chillicothe Veterans Affairs Medical Center, Chillicothe, OH, USA, and its satellite Community-Based Outpatient Clinics in Ohio. The participants were 12 healthy veteran volunteers (10 males and 2 females) who previously had repeated good responses to BFA administration by a provider. Outcomes of treatment-emergent adverse events and subjective perception of pain relief, compared with provider-administered BFA, were collected telephonically every 2 weeks for 6 months. Results: No treatment-emergent adverse events were reported by any participant over a 6-month time period. Of 12 participants,10 (83%) were able to perform BFA on themselves reliably after a didactic session. Pain relief from self-administration experienced by participants was comparable to that experienced when administered by a provider. Conclusions: In this small pilot study, self-administration of BFA was safe and effective for individuals who had previously received repeated benefit from provider-administered BFA. The contents do not represent the views of the U.S. Department of Veterans Affairs or the United States Government. This research is registered at ClinicalTrials.gov as NCT #: NCT04208659.

Statistical Mediators of the Association Between Mindfulness and Sexual Experiences in Men with Impaired Sexual Function.

Mindfulness-based therapy has shown promise as a treatment for female sexual dysfunction and has the potential to be an efficacious treatment for male sexual dysfunction. However, there has been little empirical evidence regarding the mechanisms through which mindfulness may improve sexual experiences, especially for men. Recent theoretical reviews have suggested potential mediators that may explain the beneficial effects of mindfulness on symptoms of male sexual dysfunction, including reduced avoidance of sex, reduced distraction during sex, and/or reduced activation of negative sexual schemas. We attempted an initial statistical test of these factors as potential mediators of the association between trait mindfulness and multiple sexual outcomes (sexual function, sexual satisfaction, and sexual distress) using a cross-sectional correlational design. A total of 163 men with self-reported current impairments in one or more aspects of sexual function completed self-report scales using a secure online survey. Bivariate correlations indicated that mindfulness was significantly associated with sexual satisfaction, sexual distress, and premature ejaculation, but not other aspects of sexual function. Sexual avoidance statistically mediated the link between mindfulness and sexual satisfaction, both distraction and activation of negative schemas statistically mediated the link between mindfulness and premature ejaculation, and all three factors statistically mediated the link between mindfulness and sexual distress. These results generally supported previous theoretical work and have implications for future treatment outcome research.

Providing psychological support to people in intensive care: development and feasibility study of a nurse-led intervention to prevent acute stress and long-term morbidity.

OBJECTIVES: Adverse psychological outcomes, following stressful experiences in critical care, affect up to 50% of patients. We aimed to develop and test the feasibility of a psychological intervention to reduce acute stress and prevent future morbidity. DESIGN: A mixed-methods intervention development study, using two stages of the UK Medical Research Council framework for developing and testing complex interventions. Stage one (development) involved identifying an evidence base for the intervention, developing a theoretical understanding of likely processes of change and modelling change processes and outcomes. Stage two comprised two linked feasibility studies. SETTING: Four UK general adult critical care units. PARTICIPANTS: Stage one: former and current patients, and psychology, nursing and education experts. Stage two: current patients and staff. OUTCOMES: Feasibility and acceptability to staff and patients of content and delivery of a psychological intervention, assessed using quantitative and qualitative data. Estimated recruitment and retention rates for a clinical trial. RESULTS: Building on prior work, we standardised the preventative, nurse-led Provision Of Psychological support to People in Intensive Care (POPPI) intervention. We devised courses and materials to train staff to create a therapeutic environment, to identify patients with acute stress and to deliver three stress support sessions and a relaxation and recovery programme to them. 127 awake, orientated patients took part in an intervention feasibility study in two hospitals. Patient and staff data indicated the complex intervention was feasible and acceptable. Feedback was used to refine the intervention. 86 different patients entered a separate trial procedures study in two other hospitals, of which 66 (80% of surviving patients) completed questionnaires on post-traumatic stress, depression and health 5 months after recruitment. CONCLUSION: The 'POPPI' psychological intervention to reduce acute patient stress in critical care and prevent future psychological morbidity was feasible and acceptable. It was refined for evaluation in a cluster randomised clinical trial. TRIAL REGISTRATION NUMBER: ISRCTN61088114; Results.

Activity of 5-chloro-pyrazinamide in mice infected with Mycobacterium tuberculosis or Mycobacterium bovis.

BACKGROUND & OBJECTIVES: Pyrazinamide is an essential component of first line anti-tuberculosis regimen as well as most of the second line regimens. This drug has a unique sterilizing activity against Mycobacterium tuberculosis. Its unique role in tuberculosis treatment has lead to the search and development of its structural analogues. One such analogue is 5-chloro-pyrazinamide (5-Cl-PZA) that has been tested under in vitro conditions against M. tuberculosis. The present study was designed with an aim to assess the activity of 5-Cl-PZA, alone and in combination with first-line drugs, against murine tuberculosis. METHODS: The minimum inhibitory concentration (MIC) of 5-Cl-PZA in Middlebrook 7H9 broth (neutral pH) and the inhibitory titre of serum from mice that received a 300 mg/kg oral dose of 5-Cl-PZA 30 min before cardiac puncture were determined. To test the tolerability of orally administered 5-Cl-PZA, uninfected mice received doses up to 300 mg/kg for 2 wk. Four weeks after low-dose aerosol infection either with M. tuberculosis or M. bovis, mice were treated 5 days/wk with 5-Cl-PZA, at doses ranging from 37.5 to 150 mg/kg, either alone or in combination with isoniazid and rifampicin. Antimicrobial activity was assessed by colony-forming unit counts in lungs after 4 and 8 wk of treatment. RESULTS: The MIC of 5-Cl-PZA against M. tuberculosis was between 12.5 and 25 µg/ml and the serum inhibitory titre was 1:4. Under the same experimental conditions, the MIC of pyrazinamide was >100 µg/ml and mouse serum had no inhibitory activity after a 300 mg/kg dose; 5-Cl-PZA was well tolerated in uninfected and infected mice up to 300 and 150 mg/kg, respectively. While PZA alone and in combination exhibited its usual antimicrobial activity in mice infected with M. tuberculosis and no activity in mice infected with M. bovis, 5-Cl-PZA exhibited antimicrobial activity neither in mice infected with M. tuberculosis nor in mice infected with M. bovis. INTERPRETATION & CONCLUSION: Our findings showed that 5-Cl-PZA at doses up to 150 mg/kg was not active in chronic murine TB model. Further studies need to be done to understand the mechanism and mode of inactivation in murine model of tuberculosis.

Raltitrexed (Tomudex) versus standard leucovorin-modulated bolus 5-fluorouracil: Results from the randomised phase III Pan-European Trial in Adjuvant Colon Cancer 01 (PETACC-1).

OBJECTIVES: PETACC-1 assessed if raltitrexed is non-inferior to 5-fluorouracil and leucovorin for relapse-free survival (RFS) and overall survival (OS) in adjuvant stage III colon cancer. METHODS: Non-inferiority required both HR for RFS and OS<1.25 at 1-sided alpha=0.05. Patients (1921) were randomised to six cycles of 5-FU/LV (n=969) or eight cycles of raltitrexed (n=952). We report the final results in 993 eligible patients who started and completed the allocated treatment (489 5-FU/LV and n=504 Raltitrexed) of whom respectively 146 and 148 died, respectively. RESULTS: The trial closed prematurely when 17 (1.9%) raltitrexed-related deaths were reported. Haematological and gastrointestinal toxicities were more frequent with 5-FU/LV, liver toxicities with raltitrexed. Raltitrexed was stopped for toxicity in 13.2% and 5-FU/LV in 8.5%. Sixty-day mortality was 9% versus 7%. With 4.1 years median follow-up, the HR for RFS was 1.16 (90% CI 0.99-1.37) and that for OS was 1.01 (90% CI 0.84-1.23). CONCLUSION: The trial failed to demonstrate non-inferiority of raltitrexed. FUNDING: Free drugs and financial support from AstraZeneca.