The effectiveness of melatonin for promoting healthy sleep: a rapid evidence assessment of the literature.

A systematic review was conducted using Samueli Institute's Rapid Evidence Assessment of the Literature (REAL) process to determine the evidence base for melatonin as an agent to optimize sleep or improve sleep quality, and generalize the results to a military, civilian, or other healthy, active, adult population. Multiple databases were searched yielding 35 randomized controlled trials (RCTs) meeting the review's inclusion criteria, which were assessed for methodological quality as well as for melatonin effectiveness. The majority of included studies were high quality (83.0%). Overall, according to Grading Recommendations, Assessment Development and Evaluation (GRADE) methodology, weak recommendations were made for preventing phase shifts from jet lag, for improving insomnia in both healthy volunteers and individuals with a history of insomnia, and for initiating sleep and/or improving sleep efficacy. Based on the literature to date, no recommendations for use in shift workers or to improve hormonal phase shift changes in healthy people can be made at this time. Larger and longer-duration RCTs utilizing well characterized products are needed to warrant melatonin recommendations in young, healthy adults.

Methodological complexities associated with systematic review of healing relationships.

BACKGROUND/CONTEXT: There is growing recognition within the field of medicine that healing and healing relationships are important and that developing evidence-based medicine approaches to healing should be an important aspect of this emerging field, including the use of systematic reviews. Health care leaders charged with developing healing initiatives in hospitals often are frustrated in their attempts to find rigorous reviews of the literature to support their programs. OBJECTIVE: The objective of this project was to conduct a systematic review that asked, "What is the return on investment to hospitals that implement programs aimed at enhancing healing relationships?" METHODS: A comprehensive literature search using several electronic databases was conducted to locate studies that evaluated hospital-based programs involving "healing relationships." All studies found were evaluated as to their relevance to the study and screened for methodological quality. RESULTS: Research investigators found broad heterogeneity across the 80 included studies with regard to stated aims, target populations, outcomes measured, measurement tools employed, and evaluation methods used. Only 10 articles were categorized as being methodologically strong. CONCLUSIONS: Results of the systematic review highlighted challenges in synthesizing knowledge about healing that included absence of widely accepted definitions and language around "healing", locating literature published across many different disciplines, and absence of standards for conducting rigorous program evaluations in hospitals. A less formal qualitative review of included studies also revealed themes in the literature that provide clues about the professional, social, cultural, and historical influences that have helped to shape the evidence base to date.

Systematic assessment of the quality of research studies of conventional and alternative treatment(s) of primary headache.

BACKGROUND: Diversity of treatments used for headache, and varied quality of research conduct and reporting make it difficult to accurately assess the literature and to determine the best treatment(s) for patients. OBJECTIVES: To compare the quality of available research evidence describing the effects and outcomes of conventional, and complementary and alternative medicine (CAM) approaches to treating primary (migraine, tension, and/or cluster-type) headache. STUDY DESIGN: A systematic review of quality of research studies of conventional and alternative treatment(s) of primary headache. METHODS: Randomized, controlled clinical trials (RCTs) of treatment(s) of chronic primary headache (in English between 1979 to June 2004) were searched through MEDLINE, PsycInfo, EMBASE, Cochrane Library, and the NIH databases. Studies were evaluated using standard approaches for assessing and analyzing quality indicators. RESULTS: 125 studies of conventional, and 121 CAM treatments met inclusion criteria. 80% of studies of conventional treatment(s) reported positive effects (p<0.05), versus 73% of studies of CAM approaches (chi(2) = 3.798, 1 df, p=0.051). Overall, the literature addressing the treatment of primary headache received a mean Jadad score of 2.72 out of 5 (SD 1.1). The mean Jadad score for studies of conventional therapeutics was significantly better than for those studies of CAM approaches: 3.21 +/- 0.9 vs 2.23 +/- 1.1 (t=7.72, 246 df, mean difference 0.98, p < 0.0005). CONCLUSIONS: Studies of conventional treatments scored higher on reporting quality than studies of CAM approaches. It is possible that these differences may reflect distinctions in 1) methodologic integrity, 2) therapeutic paradigm(s), and/or 3) bias(es) in the approach(es) used to evaluate certain types of therapies. Each of these possibilities -- and the implications -- is addressed and considered.

Auricular acupuncture in the treatment of acute pain syndromes: A pilot study.

This pilot study used a randomized controlled clinical trial design to compare the effects of standard emergency medical care to auricular acupuncture plus standard emergency medical care in patients with acute pain syndromes. Eighty-seven active duty military personnel and their dependents with a diagnosis of acute pain completed the study, which was conducted in the emergency room (ER) at Malcolm Grow Medical Center, Andrews Air Force Base, Maryland. The primary outcome measure was change in pain level from baseline, as measured by the Numerical Rating Scale. Participants in the acupuncture group experienced a 23% reduction in pain before leaving the ER, while average pain levels in participants in the standard medical care group remained basically unchanged. (p < 0.0005). However, both groups experienced a similar reduction in pain 24 hours following treatment in the ER. More research is needed to elucidate treatment effects and to determine mechanisms.

The healing presence: can it be reliably measured?

Religious and spiritual traditions from all cultures and times describe a spiritual or loving presence as a contributor to healing. In addition, there is a common belief that a special "presence" can exude from certain practitioners. Is it possible to measure a healing presence in an objective and reliable way? Most research on healing has focused on trying to prove spiritual and "energy" healing in comparative tests. However, if a measure of healing presence is to be sensitive and reliable, objective and real-time indicators of such a presence will be needed rather than comparative and statistical outcomes. This paper discusses what healers from various traditions have felt are the primary components of a healing presence, summarizes various attempts to measure healing, and describes two recently published approaches that have potential to provide such an objective and realtime indicator of a healing presence.

A systematic review of the quality of research on hands-on and distance healing: clinical and laboratory studies.

PURPOSE: To systematically review the quality of published experimental clinical and laboratory research involving hands-on healing and distance healing between 1955 and 2001. DATA SOURCES: Studies were identified through comprehensive literature searches on spiritual healing in MEDLINE, PSYCH LIT, EMBASE, CISCOM, and the Cochrane Library from their inceptions to December 2001. STUDY SELECTION: We selected published randomized, controlled trials of spiritual healing (hands-on healing and distance healing) done in clinical and laboratory settings, all of which had been peer reviewed. DATA EXTRACTION: Independent quality assessment of internal validity was conducted on all identified studies using the comprehensive Likelihood of Validity Evaluation scale. Clinical and laboratory studies were analyzed separately and then subdivided into hands-on healing or distance healing interventions. RESULTS: A total of 45 laboratory and 45 clinical studies published between 1956 and 2001 met the inclusion criteria. Of the clinical studies, 31 (70.5%) reported positive outcomes as did 28 (62%) of the laboratory studies; 4 (9%) of the clinical studies reported negative outcomes as did 15 (33%) of the laboratory studies. The mean percent overall internal validity for clinical studies was 69% (65% for hands-on healing and 75% for distance healing) and for laboratory studies 82% (82% for hands-on healing and 81% for distance healing). Major methodological problems of these studies included adequacy of blinding, dropped data in laboratory studies, reliability of outcome measures, rare use of power estimations and confidence intervals, and lack of independent replication. CONCLUSIONS: When laboratory studies were compared to clinical studies in the areas of hands-on healing and distance healing across the quality criteria for internal validity, distance healing studies scored better than hands-on healing studies, and laboratory studies fared better than clinical studies. Many studies of healing contained major problems that must be addressed in any future research.

Alterations in random event measures associated with a healing practice.

OBJECTIVE: To determine whether alterations in random events, as measured by a Random event generator (REG), occur in association with a bioenergy healing practice. DESIGN AND SETTING: Two REGs were set up and run in parallel: one in a bioenergy healer's office and another at a local library as a control. Two multiday sets of data were collected in each setting. A third set was collected in which a reduced amount of attention was placed on the REG by the healer. REG excursions were calculated and compared for (1) overall days in the library and bioenergy healer's office, (2) healing and nonhealing phases in the healing office, and (3) overall excursions during high(sets 1 and 2) and low attention (set 3) by the healer. RESULTS: The library REG produced excursions outside the 95% confidence interval (CI) on 35 of 61 days (58%), and the REG in the healing practice 47 of 51 days (92%) (mean difference, 34%; 95% CI, 18% to 49%; chi(2) = 16.3, 1 df, p < 0.0005). In the healer's office, 0.6496 excursions per segment for healing phases and 0.6548 excursions per segment for nonhealing phases were shown (t = -1.3, 6794 df, p = 0.182). A comparison with chance expectation derived from Monte Carlo runs showed significantly less mean excursions per segment (t = -7.8, 36625 df, p < 0.0005) for healing phases and no difference in nonhealing phases (t = -0.16, 6309 df, p = 0.872). There was no significant difference in excursions between the high- and low-attention situations in the healing practice. CONCLUSIONS: In the presence of a healer, an REG produced greater than chance excursions more often than a control REG in a library setting. The healing and nonhealing phases demonstrated inconsistent results. REG deviations were not influenced by the amount of attention directed toward the machine.