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1.  Mindfulness-based interventions in schools—a systematic review and meta-analysis 
Mindfulness programs for schools are popular. We systematically reviewed the evidence regarding the effects of school-based mindfulness interventions on psychological outcomes, using a comprehensive search strategy designed to locate both published and unpublished studies. Systematic searches in 12 databases were performed in August 2012. Further studies were identified via hand search and contact with experts. Two reviewers independently extracted the data, also selecting information about intervention programs (elements, structure etc.), feasibility, and acceptance. Twenty-four studies were identified, of which 13 were published. Nineteen studies used a controlled design. In total, 1348 students were instructed in mindfulness, with 876 serving as controls, ranging from grade 1 to 12. Overall effect sizes were Hedge's g = 0.40 between groups and g = 0.41 within groups (p < 0.0001). Between group effect sizes for domains were: cognitive performance g = 0.80, stress g = 0.39, resilience g = 0.36, (all p < 0.05), emotional problems g = 0.19 third person ratings g = 0.25 (both n.s.). All in all, mindfulness-based interventions in children and youths hold promise, particularly in relation to improving cognitive performance and resilience to stress. However, the diversity of study samples, variety in implementation and exercises, and wide range of instruments used require a careful and differentiated examination of data. There is great heterogeneity, many studies are underpowered, and measuring effects of Mindfulness in this setting is challenging. The field is nascent and recommendations will be provided as to how interventions and research of these interventions may proceed.
doi:10.3389/fpsyg.2014.00603
PMCID: PMC4075476  PMID: 25071620
mindfulness; children; meta-analysis; systematic review; stress; school-age; resilience
2.  Decreased electrophysiological activity represents the conscious state of emptiness in meditation 
Many neuroscientific theories explain consciousness with higher order information processing corresponding to an activation of specific brain areas and processes. In contrast, most forms of meditation ask for a down-regulation of certain mental processing activities while remaining fully conscious. To identify the physiological properties of conscious states with decreased mental and cognitive processing, the electrical brain activity (64 channels of EEG) of 50 participants of various meditation proficiencies was measured during distinct and idiosyncratic meditative tasks. The tasks comprised a wakeful “thoughtless emptiness (TE),” a “focused attention,” and an “open monitoring” task asking for mindful presence in the moment and in the environment without attachment to distracting thoughts. Our analysis mainly focused on 30 highly experienced meditators with at least 5 years and 1000 h of meditation experience. Spectral EEG power comparisons of the TE state with the resting state or other forms of meditation showed decreased activities in specific frequency bands. In contrast to a focused attention task the TE task showed significant central and parietal gamma decreases (p < 0.05). Compared to open monitoring TE expressed decreased alpha and beta amplitudes, mainly in parietal areas (p < 0.01). TE presented significantly less delta (p < 0.001) and theta (p < 0.05) waves than a wakeful closed eyes resting condition. A group of participants with none or little meditation practice did not present those differences significantly. Our findings indicate that a conscious state of TE reached by experienced meditators is characterized by reduced high-frequency brain processing with simultaneous reduction of the low frequencies. This suggests that such a state of meditative conscious awareness might be different from higher cognitive and mentally focused states but also from states of sleep and drowsiness.
doi:10.3389/fpsyg.2014.00099
PMCID: PMC3925830  PMID: 24596562
EEG; meditation; consciousness; thoughtless emptiness; decreased neural processing
3.  Manual Khalifa Therapy Improves Functional and Morphological Outcome of Patients with Anterior Cruciate Ligament Rupture in the Knee: A Randomized Controlled Trial 
Rupture of the anterior cruciate ligament (ACL) is a high incidence injury usually treated surgically. According to common knowledge, it does not heal spontaneously, although some claim the opposite. Regeneration therapy by Khalifa was developed for injuries of the musculoskeletal system by using specific pressure to the skin. This randomized, controlled, observer-blinded, multicentre study was performed to validate this assumption. Thirty patients with complete ACL rupture, magnetic resonance imaging (MRI) verified, were included. Study examinations (e.g., international knee documentation committee (IKDC) score) were performed at inclusion (t0). Patients were randomized to receive either standardised physiotherapy (ST) or additionally 1 hour of Khalifa therapy at the first session (STK). Twenty-four hours later, study examinations were performed again (t1). Three months later control MRI and follow-up examinations were performed (t2). Initial status was comparable between both groups. There was a highly significant difference of mean IKDC score results at t1 and t2. After 3 months, 47% of the STK patients, but no ST patient, demonstrated an end-to-end homogeneous ACL in MRI. Clinical and physical examinations were significantly different in t1 and t2. ACL healing can be improved with manual therapy. Physical activity can be performed without pain and nearly normal range of motion after one treatment of specific pressure.
doi:10.1155/2014/462840
PMCID: PMC3926243  PMID: 24600477
4.  Conscious Presence and Self Control as a measure of situational awareness in soldiers – A validation study 
Background
The concept of `mindfulness´ was operationalized primarily for patients with chronic stressors, while it is rarely used in reference to soldiers. We intended to validate a modified instrument on the basis of the Freiburg Mindfulness Inventory (FMI) to measure soldiers’ situational awareness (“mindfulness”) in stressful situations/missions. The instrument we will explore in this paper is termed the Conscious Presence and Self Control (CPSC) scale.
Methods
The CPSC and further instruments, i.e., Perceived Stress Scale (PSS), stressful military experiences (PCL-M), life satisfaction (BMLSS), Positive Life Construction (ePLC), and self-perceived health affections (VAS), were administered to 281 German soldiers. The soldiers were mainly exposed to explosive ordnance, military police, medical service, and patients with posttraumatic stress disorders.
Results
The 10-item CPSC scale exhibited a one-factorial structure and showed a good internal consistence (Cronbach´s alpha = .86); there were neither ceiling nor bottom effects. The CPSC scores correlated moderately with Positive Life Construction and life satisfaction, and negatively with perceived stress and health affections. Regression analyses indicated that posttraumatic stress disorder symptoms (negative), and the development of effective strategies to deal with disturbing pictures and experiences (positive) were the best predictor of soldiers´ CPSC scores. Soldiers with health affections exhibiting impact upon their daily life had significantly lower CPSC scores than those without impairment (F=8.1; p < .0001).
Conclusions
As core conceptualizations of `mindfulness´ are not necessarily discussed in a military context, the FMI was adopted for military personnel populations, while its two factorial structure with the sub-constructs `acceptance´ and `presence´ was retained. The resulting 10-item CPSC scale had good internal consistence, sound associations with measures of health affections and life satisfaction, and thus can be used as a short and rapid measure in pre-post mission and interventional studies.
doi:10.1186/1752-4458-7-1
PMCID: PMC3558360  PMID: 23289791
Mindfulness; Conscious presence; Soldiers; Trauma; Validation; Questionnaire
6.  Placebo controls: historical, methodological and general aspects 
Control conditions were introduced through the trial of Mesmerism in Paris. Placebo controls became codified standard in 1946. Although seemingly unchallenged, there are various problems with this received view. The notion of a placebo is only defined from the negative. A positive notion proposed that placebo effects are effects owing to the meaning an intervention has for an individual. Thus, placebo effects are individualized, whereas standard research paradigms reveal only grossly averaged behaviour. Also, placebo effects are context sensitive, dependent on psychological factors such as expectancy, relief of stress and anxiety, and hence can generate strong and long-lasting treatment effects. These, however, are not predictable. Such a situation can lead to the efficacy paradox: sometimes, sham interventions can be more powerful than proved, evidence-based treatments. This situation has methodological consequences. Placebo-controlled randomized trials reveal only part of the answer, whether an intervention is effective. This is valuable information for regulators, but not necessarily also for patients and of limited value for providers. Hence, I have argued that we need to complement the hierarchical model of evidence by a circular one, in which various methods are employed on equal footing to answer different questions.
doi:10.1098/rstb.2010.0401
PMCID: PMC3130405  PMID: 21576144
placebo effect; double blind; efficacy; paradox
7.  Dialectics of mindfulness: implications for western medicine 
Mindfulness as a clinical and nonclinical intervention for a variety of symptoms has recently received a substantial amount of interest. Although the application of mindfulness appears straightforward and its effectiveness is well supported, the concept may easily be misunderstood. This misunderstanding may severely limit the benefit of mindfulness-based interventions. It is therefore necessary to understand that the characteristics of mindfulness are based on a set of seemingly paradoxical structures. This article discusses the underlying paradox by disentangling it into five dialectical positions - activity vs. passivity, wanting vs. non-wanting, changing vs. non-changing, non-judging vs. non-reacting, and active acceptance vs. passive acceptance, respectively. Finally, the practical implications for the medical professional as well as potential caveats are discussed.
doi:10.1186/1747-5341-6-10
PMCID: PMC3117801  PMID: 21586129
8.  Classical homeopathy in the treatment of cancer patients - a prospective observational study of two independent cohorts 
BMC Cancer  2011;11:19.
Background
Many cancer patients seek homeopathy as a complementary therapy. It has rarely been studied systematically, whether homeopathic care is of benefit for cancer patients.
Methods
We conducted a prospective observational study with cancer patients in two differently treated cohorts: one cohort with patients under complementary homeopathic treatment (HG; n = 259), and one cohort with conventionally treated cancer patients (CG; n = 380). For a direct comparison, matched pairs with patients of the same tumour entity and comparable prognosis were to be formed.
Main outcome parameter: change of quality of life (FACT-G, FACIT-Sp) after 3 months.
Secondary outcome parameters: change of quality of life (FACT-G, FACIT-Sp) after a year, as well as impairment by fatigue (MFI) and by anxiety and depression (HADS).
Results
HG: FACT-G, or FACIT-Sp, respectively improved statistically significantly in the first three months, from 75.6 (SD 14.6) to 81.1 (SD 16.9), or from 32.1 (SD 8.2) to 34.9 (SD 8.32), respectively. After 12 months, a further increase to 84.1 (SD 15.5) or 35.2 (SD 8.6) was found. Fatigue (MFI) decreased; anxiety and depression (HADS) did not change.
CG: FACT-G remained constant in the first three months: 75.3 (SD 17.3) at t0, and 76.6 (SD 16.6) at t1. After 12 months, there was a slight increase to 78.9 (SD 18.1). FACIT-Sp scores improved significantly from t0 (31.0 - SD 8.9) to t1 (32.1 - SD 8.9) and declined again after a year (31.6 - SD 9.4). For fatigue, anxiety, and depression, no relevant changes were found.
120 patients of HG and 206 patients of CG met our criteria for matched-pairs selection. Due to large differences between the two patient populations, however, only 11 matched pairs could be formed. This is not sufficient for a comparative study.
Conclusion
In our prospective study, we observed an improvement of quality of life as well as a tendency of fatigue symptoms to decrease in cancer patients under complementary homeopathic treatment. It would take considerably larger samples to find matched pairs suitable for comparison in order to establish a definite causal relation between these effects and homeopathic treatment.
doi:10.1186/1471-2407-11-19
PMCID: PMC3035587  PMID: 21241504
9.  Evaluating Complex Healthcare Systems: A Critique of Four Approaches 
The purpose of this paper is to bring clarity to the emerging conceptual and methodological literature that focuses on understanding and evaluating complex or ‘whole’ systems of healthcare. An international working group reviewed literature from interdisciplinary or interprofessional groups describing approaches to the evaluation of complex systems of healthcare. The following four key approaches were identified: a framework from the MRC (UK), whole systems research, whole medical systems research described by NCCAM (USA) and a model from NAFKAM (Norway). Main areas of congruence include acknowledgment of the inherent complexity of many healthcare interventions and the need to find new ways to evaluate these; the need to describe and understand the components of complex interventions in context (as they are actually practiced); the necessity of using mixed methods including randomized clinical trials (RCTs) (explanatory and pragmatic) and qualitative approaches; the perceived benefits of a multidisciplinary team approach to research; and the understanding that methodological developments in this field can be applied to both complementary and alternative medicine (CAM) as well as conventional therapies. In contrast, the approaches differ in the following ways: terminology used, the extent to which the approach attempts to be applicable to both CAM and conventional medical interventions; the prioritization of research questions (in order of what should be done first) especially with respect to how the ‘definitive’ RCT fits into the process of assessing complex healthcare systems; and the need for a staged approach. There appears to be a growing international understanding of the need for a new perspective on assessing complex healthcare systems.
doi:10.1093/ecam/nel079
PMCID: PMC1978227  PMID: 17965757
complex interventions; research methods; whole systems research
10.  Researching complementary and alternative treatments – the gatekeepers are not at home 
Background
To explore the strengths and weaknesses of conventional biomedical research strategies and methods as applied to complementary and alternative medicine (CAM), and to suggest a new research framework for assessing these treatment modalities.
Discussion
There appears to be a gap between published studies showing little or no efficacy of CAM, and reports of substantial clinical benefit from patients and CAM practitioners. This "gap" might be partially due to the current focus on placebo-controlled randomized trials, which are appropriately designed to answer questions about the efficacy and safety of pharmaceutical agents. In an attempt to fit this assessment strategy, complex CAM treatment approaches have been dissected into standardized and often simplified treatment methods, and outcomes have been limited.
Unlike conventional medicine, CAM has no regulatory or financial gatekeeper controlling their therapeutic "agents" before they are marketed. Treatments may thus be in widespread use before researchers know of their existence. In addition, the treatments are often provided as an integrated 'whole system' of care, without careful consideration of the safety issue.
We propose a five-phase strategy for assessing CAM built on the acknowledgement of the inherent, unique aspects of CAM treatments and their regulatory status in most Western countries. These phases comprise:
1. Context, paradigms, philosophical understanding and utilization
2. Safety status
3. Comparative effectiveness.
4. Component efficacy
5. Biological mechanisms.
Summary
Using the proposed strategy will generate evidence relevant to clinical practice, while acknowledging the absence of regulatory and financial gatekeepers for CAM. It will also emphasize the important but subtle differences between CAM and conventional medical practice.
doi:10.1186/1471-2288-7-7
PMCID: PMC1800863  PMID: 17291355
11.  Circular instead of hierarchical: methodological principles for the evaluation of complex interventions 
Background
The reasoning behind evaluating medical interventions is that a hierarchy of methods exists which successively produce improved and therefore more rigorous evidence based medicine upon which to make clinical decisions. At the foundation of this hierarchy are case studies, retrospective and prospective case series, followed by cohort studies with historical and concomitant non-randomized controls. Open-label randomized controlled studies (RCTs), and finally blinded, placebo-controlled RCTs, which offer most internal validity are considered the most reliable evidence. Rigorous RCTs remove bias. Evidence from RCTs forms the basis of meta-analyses and systematic reviews. This hierarchy, founded on a pharmacological model of therapy, is generalized to other interventions which may be complex and non-pharmacological (healing, acupuncture and surgery).
Discussion
The hierarchical model is valid for limited questions of efficacy, for instance for regulatory purposes and newly devised products and pharmacological preparations. It is inadequate for the evaluation of complex interventions such as physiotherapy, surgery and complementary and alternative medicine (CAM). This has to do with the essential tension between internal validity (rigor and the removal of bias) and external validity (generalizability).
Summary
Instead of an Evidence Hierarchy, we propose a Circular Model. This would imply a multiplicity of methods, using different designs, counterbalancing their individual strengths and weaknesses to arrive at pragmatic but equally rigorous evidence which would provide significant assistance in clinical and health systems innovation. Such evidence would better inform national health care technology assessment agencies and promote evidence based health reform.
doi:10.1186/1471-2288-6-29
PMCID: PMC1540434  PMID: 16796762
12.  The therapeutic effect of clinical trials: understanding placebo response rates in clinical trials – A secondary analysis 
Background and purpose
Placebo response rates in clinical trials vary considerably and are observed frequently. For new drugs it can be difficult to prove effectiveness superior to placebo. It is unclear what contributes to improvement in the placebo groups. We wanted to clarify, what elements of clinical trials determine placebo variability.
Methods
We analysed a representative sample of 141 published long-term trials (randomized, double-blind, placebo-controlled; duration > 12 weeks) to find out what study characteristics predict placebo response rates in various diseases. Correlational and regression analyses with study characteristics and placebo response rates were carried out.
Results
We found a high and significant correlation between placebo and treatment response rate across diseases (r = .78; p < .001). A multiple regression model explained 79% of the variance in placebo variability (F = 59.7; p < 0.0001). Significant predictors are, among others, the duration of the study (beta = .31), the quality of the study (beta = .18), the fact whether a study is a prevention trial (beta = .44), whether dropouts have been documented (beta = -.20), or whether additional treatments have been documented (beta = -.17). Healing rates with placebo are lower in the following diagnoses; neoplasms (beta = -.21), nervous diseases (beta = -.10), substance abuse (beta = -.14). Without prevention trials the amount of variance explained is 42%.
Conclusion
Medication response rates and placebo response rates in clinical trials are highly correlated. Trial characteristics can explain some portion of the variance in placebo healing rates in RCTs. Placebo response in trials is only partially due to methodological artefacts and only partially dependent on the diagnoses treated.
doi:10.1186/1471-2288-5-26
PMCID: PMC1201145  PMID: 16109176
13.  Measuring the effects of acupuncture and homoeopathy in general practice: An uncontrolled prospective documentation approach 
BMC Public Health  2004;4:6.
Background
Despite the increasing demand for acupuncture and homoeopathy in Germany, little is known about the effects of these treatments in routine care. We set up a pragmatic documentation study in general practice funded within the scope of project launched by a German health insurer. Patients were followed-up for up to four years.
Methods
The aim of the project was to study the effects and benefits of acupuncture and/or homoeopathy, and to assess patient satisfaction within a prospective documentation of over 5000 acupuncture and over 900 homoeopathy patients. As data sources, we used the documentation made available by therapists on every individual visit and a standardised quality-of-life questionnaire (MOS SF-36); these were complemented by questions concerning the patient's medical history and by questions on patient satisfaction. The health insurer provided us with data on work absenteeism.
Results
Descriptive analyses of the main outcomes showed benefit of treatment with middle to large-sized effects for the quality of life questionnaire SF-36 and about 1 point improvement on a rating scale of effects, given by doctors. Data on the treatment and the patients' and physicians' background suggests chronically ill patients treated by fairly regular schemes.
Conclusion
Since the results showed evidence of a subjective benefit for patients from acupuncture and homoeopathy, this may account for the increase in demand for these treatments especially when patients are chronically ill and unsatisfied with the conventional treatment given previously.
doi:10.1186/1471-2458-4-6
PMCID: PMC395833  PMID: 15113434

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