Active, Self-Care Complementary and Integrative Medicine Therapies for the Management of Chronic Pain Symptoms: A Rapid Evidence Assessment of the Literature

Abstract

Purpose: With the recent developments in evidence-based complementary medicine, the Indian systems of medicine (ISM) with its multimodal individualized treatment, perceives many challenges in conducting randomized controlled trials (RCTs). A clear understanding of these challenges is a basic step in determining the feasibility of RCTs and development of research methods in this field. The aim of our study was to identify the important methodological considerations specific for ISM (Ayurveda and Siddha) in conducting a RCT and to review systematically all currently undertaken controlled trials of ISM regarding these features. Methods: We formulated a 18 point checklist in a PICO (Population Intervention Comparison Outcomes) format including usage of ISM concepts in diagnosis and outcome assessment, whole treatment package or integrated treatment as intervention, choice of comparison groups, a non-inferiority hypothesis with the benefit of safety, etc. For the systematic review, we identified all controlled trials published between January 2000 and December 2012. Basic and design specific characteristics of the trials were extracted and analyzed. Results: The searches retrieved 295 articles, of which 70 controlled trials were identified. Only about 20 to 30% of the trials used ISM concept in diagnosis and outcome assessment. About 20% tested integrated interventions. There were 11 different types of comparison groups used. All the trials studied a superiority hypothesis and only 29% involved an active surveillance for safety outcome. However, RCTs adopting ISM principles, using relevant comparison groups, and further high methodological qualities could be found. Conclusion: Our research showed that there is ample room for improvement of ISM clinical trial designs. The formulated checklist of specific methodological features can help ISM trialists plan better RCTs. Though current RCTs about ISM often show deficiencies in methodological considerations, we could find examples of successful adaptation of RCT methodologies and hence evidence for its feasibility in ISM.Purpose: Preoperative anxiety is associated with a negative surgery experience and increased morbidity. Complementary Medicine (CM) therapies have been shown to reduce preoperative anxiety, however, comparative effectiveness of such therapies has not been conducted. We compared the effectiveness of individualized CM treatments, a generic guided imagery CD, and standard of care on preoperative anxiety. Methods: Patients undergoing surgery were assessed for anxiety using a VAS questionnaire at entry to the holding room area. Thereafter, patients were randomized into individualized CM treatments (acupuncture, guided imagery, reflexology, combined reflexology and guided imagery) on top of standard of care (SOS anxiolytics), a generic guided imagery CD, and standard of care alone. Prior to transfer to the surgery theater, a repeat evaluation was conducted. Results: 58 patients received guided imagery, 41 acupuncture, 41 reflexology, 65 combined reflexology and ...

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