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 selfor 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.
Objective Evaluate the evidence for clinical applications of yoga among the pediatric population. Methods We conducted an electronic literature search including CINAHL, Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, Medline, PsycINFO, and manual search of retrieved articles from inception of database until December 2008. Randomized controlled trials (RCTs) and non-randomized controlled trials (NRCTs) were selected including yoga or yoga-based interventions for individuals aged from 0 to 21 years of age. Data were extracted and articles critically reviewed utilizing a modified Jadad score and descriptive methodological criteria with summarization in tables. Results Thirty four controlled studies were identified published from 1979 to 2008, with 19 RCTS and 15 NRCTs. Many studies were of low methodological quality. Clinical areas for which yoga has been studied include physical fitness, cardio-respiratory effects, motor skills/strength, mental health and psychological disorders, behavior and development, irritable bowel syndrome, and birth outcomes following prenatal yoga. No adverse events were reported in trials reviewed. While a large majority of studies were positive, methodological limitations such as randomization methods, withdrawal/dropouts, and details of yoga intervention preclude conclusive evidence. Conclusions There are limited data on the clinical applications of yoga among the pediatric population. Most published controlled trials were suggestive of benefit, but results are preliminary based on low quantity and quality of trials. Further research of yoga for children utilizing a higher standard of methodology and reporting is warranted.
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.
Few complementary and alternative medicine (CAM) institutions require their students to undergo substantive training in research literacy and conduct, and well-developed programs to train CAM institution faculty in research are virtually non-existent. As part of a National Center for Complementary and Alternative Medicine (NCCAM) initiative to increase research capacity at CAM institutions, the New England School of Acupuncture (NESA), in collaboration with the Harvard Medical School (HMS) Osher Institute, was awarded a Developmental Center for Research on Complementary and Alternative Medicine (DCRC) grant. This article discusses a number of initiatives that we designed and implemented to train NESA students, faculty members, and alumni in the foundations of clinical research and to stimulate interest in both participating in research and receiving additional research training. Specific initiatives included a 30-hour faculty "Foundations of Research" course; a year-long course entitled, "How to Write a Publishable Case Report"; institution of a monthly research seminar series; revision of an already required student research course; and the addition of 2 new student-mentored independent research electives. We discuss successes and challenges encountered in developing and administering these initiatives and the overall impact they have had on research culture and productivity at NESA.
Study Objective To assess feasibility, and collect preliminary data for a subsequent randomized, sham-controlled trial to evaluate Japanese-style acupuncture for reducing chronic pelvic pain and improving health-related quality of life (HRQOL) in adolescents with endometriosis. Design Randomized, sham-controlled trial. Settings Tertiary-referral hospital. Participants Eighteen young women (13–22y) with laparoscopically-diagnosed endometriosis-related chronic pelvic pain. Interventions A Japanese style of acupuncture and a sham acupuncture control. Sixteen treatments were administered over 8 weeks. Main Outcome Measures Protocol feasibility, recruitment numbers, pain not associated with menses or intercourse, and multiple HRQOL instruments including Endometriosis Health Profile, Pediatric Quality of Life, Perceived Stress, and Activity Limitation. Results Fourteen participants (out of 18 randomized) completed the study per protocol. Participants in the active acupuncture group (n = 9) experienced an average 4.8 (SD = 2.4) point reduction on a 11 point scale (62%) in pain after 4 weeks, which differed significantly from the control group's (n = 5) average reduction of 1.4 (SD = 2.1) points (P = 0.004). Reduction in pain in the active group persisted through a 6-month assessment; however, after 4 weeks, differences between the active and control group decreased and were not statistically significant. All HRQOL measures indicated greater improvements in the active acupuncture group compared to the control; however, the majority of these trends were not statistically significant. No serious adverse events were reported. Conclusion Preliminary estimates indicate that Japanese-style acupuncture may be an effective, safe, and well-tolerated adjunct therapy for endometriosis-related pelvic pain in adolescents. A more definitive trial evaluating Japanese-style acupuncture in this population is both feasible and warranted.
Introduction: Acupuncture is a complex holistic intervention in which patient–practitioner relationships and healing changes occur in interactive, iterative ways. Qualitative research is one way to capture such complexity. This study sought to understand better the experiences of adolescents involved in acupuncture treatment. Materials and methods: We included a qualitative substudy as part of a pilot randomized sham-controlled study of the use of Japanese acupuncture to treat chronic pelvic pain in adolescent girls. Seven (7) interviews were attained. Themes were double-coded and analyzed using qualitative analysis software. Results: Regardless of treatment arm, all subjects reported positive study-related changes, often attributed to positive qualities of the patient–practitioner relationship. Participants in both the sham and verum acupuncture treatment arms reported in the narratives that they were unsure of their study assignment. In contrast, the study's close-ended success of blinding question suggests that some participants were sure of their treatment allocation. Conclusions: As we continue to study acupuncture using sham controls, we need a better understanding of the possible affects of sham treatments on both treatment outcomes and success of blinding. Qualitative research is one-way to explore subtle emergent changes in participants' experiences.