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Biomedical subjects

Rosa N Schnyer

Publications and source records attributed to Rosa N Schnyer.

8 recordsLinked to original sources
PubMed2006

Sham device v inert pill: randomised controlled trial of two placebo treatments.

OBJECTIVE: To investigate whether a sham device (a validated sham acupuncture needle) has a greater placebo effect than an inert pill in patients with persistent arm pain. DESIGN: A single blind randomised controlled trial created from the two week placebo run-in periods for two nested trials that compared acupuncture and amitriptyline with their respective placebo controls. Comparison of participants who remained on placebo continued beyond the run-in period to the end of the study. SETTING: Academic medical centre. PARTICIPANTS: 270 adults with arm pain due to repetitive use that had lasted at least three months despite treatment and who scored > or =3 on a 10 point pain scale. INTERVENTIONS: Acupuncture with sham device twice a week for six weeks or placebo pill once a day for eight weeks. MAIN OUTCOME MEASURES: Arm pain measured on a 10 point pain scale. Secondary outcomes were symptoms measured by the Levine symptom severity scale, function measured by Pransky's upper extremity function scale, and grip strength. RESULTS: Pain decreased during the two week placebo run-in period in both the sham device and placebo pill groups, but changes were not different between the groups (-0.14, 95% confidence interval -0.52 to 0.25, P = 0.49). Changes in severity scores for arm symptoms and grip strength were similar between groups, but arm function improved more in the placebo pill group (2.0, 0.06 to 3.92, P = 0.04). Longitudinal regression analyses that followed participants throughout the treatment period showed significantly greater downward slopes per week on the 10 point arm pain scale in the sham device group than in the placebo pill group (-0.33 (-0.40 to -0.26) v -0.15 (-0.21 to -0.09), P = 0.0001) and on the symptom severity scale (-0.07 (-0.09 to -0.05) v -0.05 (-0.06 to -0.03), P = 0.02). Differences were not significant, however, on the function scale or for grip strength. Reported adverse effects were different in the two groups. CONCLUSIONS: The sham device had greater effects than the placebo pill on self reported pain and severity of symptoms over the entire course of treatment but not during the two week placebo run in. Placebo effects seem to be malleable and depend on the behaviours embedded in medical rituals.

Acupuncture Analgesia↗
PubMed2006

Adolescent endometriosis-related pelvic pain treated with acupuncture: two case reports.

BACKGROUND: Chronic pelvic pain in adolescents accounts for 10% of outpatient gynecology visits, and 70% of adolescent patients whose pelvic pain is unresponsive to initial therapy have endometriosis. To date, there has been no published research investigating the use of acupuncture for adolescents with chronic pelvic pain and/or endometriosis. METHODS: This paper presents two case reports describing the impact of a course of acupuncture on adolescent girls with endometriosis-related chronic pelvic pain of more than 1 year. RESULTS: Both patients, undergoing between 9 and 15 treatments over a 7- to 12-week period, experienced modest improvement in pain as measured by oral self-reports of pain on a scale from 1 to 10, as well as self or family-reported improvement in headaches, nausea and fatigue. No adverse effects were reported. CONCLUSIONS: These case reports provide preliminary evidence that acupuncture may be an acceptable and safe adjunct treatment therapy for some adolescents with endometriosis-related pelvic pain refractory to standard antiendometriosis therapies. These observations suggest that a prospective, randomized controlled trial of the safety and efficacy of acupuncture for this population may be warranted.

Activities of Daily Living↗
PubMed2006

Acupuncture for depression: a randomized controlled trial.

OBJECTIVE: To assess the efficacy of acupuncture as an intervention for major depressive disorder (MDD). METHOD: Acupuncture was examined in 151 patients with MDD (DSM-IV) who were randomly assigned to 1 of 3 groups in a double-blind randomized controlled trial. The specific intervention involved Traditional Chinese Medicine (TCM)-style acupuncture with manual stimulation for depression; the control conditions consisted of (1) a nonspecific intervention using a comparable number of legitimate acupuncture points not specifically targeted to depressive symptoms and (2) a waitlist condition, which involved waiting without intervention for 8 weeks. After 8 weeks, all patients received the depression-specific acupuncture. Each 8-week intervention regimen consisted of 12 acupuncture sessions delivered in an acupuncturist's office in the community. The primary outcome measure was the 17-item Hamilton Rating Scale for Depression. The study was conducted from February 1998 to April 2002. RESULTS: Twenty patients terminated treatment before the completion of the 8-week intervention (13%) but not differentially by study group. Random regression models of the intent-to-treat sample revealed that although patients receiving acupuncture improved more than those awaiting intervention, no evidence of differential efficacy of the depression-specific over nonspecific intervention was found. Response rates in acupuncture-treated patients were relatively low after 8 weeks (22% and 39% for specific and nonspecific intervention groups, respectively), with the response rate after the entire 16-week trial reaching 50%. CONCLUSION: Although TCM manual acupuncture is a well-tolerated intervention, results fail to support its efficacy as a monotherapy for MDD. It can't be ruled out that factors unique to the implementation of acupuncture in this research study may have limited the efficacy of interventions compared to those provided in naturalistic settings. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov identifier NCT00010517.

Acupuncture↗
PubMed2005

Development of a Chinese medicine assessment measure: an interdisciplinary approach using the delphi method.

BACKGROUND: The diagnostic framework and clinical reasoning process in Chinese medicine emphasizes the contextual and qualitative nature of a patient's illness. Chinese medicine assessment data may help interpret clinical outcomes. OBJECTIVES: As part of a study aimed at assessing the validity and improving the inter-rater reliability of the Chinese diagnostic process, a structured assessment instrument was developed for use in clinical trials of acupuncture and other Chinese medical therapies. STUDY DESIGN: To foster collaboration and maximize resources and information, an interdisciplinary advisory team was assembled. Under the guidance of two group process facilitators, and in order to establish whether the assessment instrument was consistent with accepted Chinese medicine diagnostic categories (face validity) and included the full range of each concept's meaning (content validity), a panel of Traditional Chinese Medicine (TCM) expert clinicians was convened and their responses were organized using the Delphi process, an iterative, anonymous, idea-generating and consensus-building process. An aggregate rating measure was obtained by taking the mean of mean ratings for each question across all 10 experts. RESULTS: Over three rounds, the overall rating increased from 7.4 (SD = 1.3) in Round 1 to 9.1 (SD = 0.5) in Round 3. The level of agreement among clinicians was measured by a decrease in SD. CONCLUSIONS: The final instrument TEAMSI-TCM (Traditional East Asian Medicine Structured Interview, TCM version) uses the pattern differentiation model characteristic of TCM. This modular, dynamic version was specifically designed to assess women, with a focus on gynecologic conditions; with modifications it can be adapted for use with other populations and conditions. TEAMSI-TCM is a prescriptive instrument that guides clinicians to use the proper indicators, combine them in a systematic manner, and generate conclusions. In conjunction with treatment manualization and training it may serve to increase inter-rater reliability and inter-trial reproducibility in Chinese medicine clinical trials. Testing of the validity and reliability of this instrument currently is underway.

Data Interpretation, Statistical↗
PubMed2004

Acupuncture: a promising treatment for depression during pregnancy.

BACKGROUND: Few medically acceptable treatments for depression during pregnancy are available. The aim of this randomized controlled pilot study was to determine whether acupuncture holds promise as a treatment for depression during pregnancy. METHODS: Sixty-one pregnant women with major depressive disorder and a 17-item Hamilton Rating Scale for Depression (HRSD17) score >or=14 were randomly assigned to one of three treatments, delivered over 8 weeks: an active acupuncture (SPEC, N=20), an active control acupuncture (NSPEC, N=21), and massage (MSSG, N=20). Acupuncture treatments were standardized, but individually tailored, and were provided in a double-blind fashion. Responders to acute phase treatment (HRSD17 score<14 and >or=50% reduction from baseline) continued the treatment they were initially randomized to until 10 weeks postpartum. RESULTS: Response rates at the end of the acute phase were statistically significantly higher for SPEC (69%) than for MSSG (32%), with an intermediate NSPEC response rate (47%). The SPEC group also exhibited a significantly higher average rate of reduction in BDI scores from baseline to the end of the first month of treatment than the MSSG group. Responders to the acute phase of all treatments combined had significantly lower depression scores at 10 weeks postpartum than nonresponders. LIMITATIONS: Generalizability is limited by the small sample and its relative homogeneity. CONCLUSION: Acupuncture holds promise for the treatment of depression during pregnancy.

Acupuncture Therapy↗
PubMed2002

Bridging the gap in complementary and alternative medicine research: manualization as a means of promoting standardization and flexibility of treatment in clinical trials of acupuncture.

INTRODUCTION: An important methodological challenge encountered in acupuncture clinical research involves the design of treatment protocols that help ensure standardization and replicability while allowing for the necessary flexibility to tailor treatments to each individual. Manualization of protocols used in clinical trials of acupuncture and other traditionally-based complementary and alternative medicine (CAM) systems facilitates the systematic delivery of replicable and standardized, yet individually-tailored treatments. OBJECTIVES: To facilitate high-quality CAM acupuncture research by outlining a method for the systematic design and implementation of protocols used in CAM clinical trials based on the concept of treatment manualization. METHODS: A series of treatment manuals was developed to systematically articulate the Chinese medical theoretical and clinical framework for a given Western-defined illness, to increase the quality and consistency of treatment, and to standardize the technical aspects of the protocol. In all, three manuals were developed for National Institutes of Health (NIH)-funded clinical trials of acupuncture for depression, spasticity in cerebral palsy, and repetitive stress injury. In Part I, the rationale underlying these manuals and the challenges encountered in creating them are discussed, and qualitative assessments of their utility are provided. In Part II, a methodology to develop treatment manuals for use in clinical trials is detailed, and examples are given. CONCLUSIONS: A treatment manual provides a precise way to train and supervise practitioners, enable evaluation of conformity and competence, facilitate the training process, and increase the ability to identify the active therapeutic ingredients in clinical trials of acupuncture.

Acupuncture Therapy↗