Are Sham Acupuncture Interventions More Effective than (Other) Placebos? A Re-Analysis of Data from the Cochrane Review on Placebo Effects

Background and Objective: A recent Cochrane review on placebo interventions for all kinds of conditions found that `physical placebos' (which included sham acupuncture) were associated with larger effects over no-treatment control groups than `pharmacological placebos'. We re-analyzed the data from this review to investigate whether effects associated with sham acupuncture differed from those of other `physical placebos'. Methods: All trials included in the Cochrane review as investigating `physical placebos' were classified as investigating either (sham) acupuncture or other physical placebos. The latter group was further subclassified into groups of similar interventions. Data from the Cochrane review were re-entered into the RevMan 5 software for meta-analysis. The primary analysis was a random-effects analysis of trials reporting continuous outcomes of trials that used either sham acupuncture or other physical placebos. Results: Out of a total of 61 trials which reported a continuous outcome measure, 19 compared sham acupuncture and 42 compared other physical placebos with a no-treatment control group. The trials re-analyzed were highly heterogeneous regarding patients, interventions and outcomes measured. The pooled standardized mean difference was -0.41 (95% confidence interval -0.56, -0.24) between sham acupuncture and no treatment and -0.26 (95% CI -0.37, -0.15) between other physical placebos and no treatment (p value for subgroup differences = 0.007). Significant differences were also observed between subgroups of other physical placebos. Conclusion: Due to the heterogeneity of the trials included and the indirect comparison our results must be interpreted with caution. Still, they suggest that sham acupuncture interventions might, on average, be associated with larger effects than pharmacological and other physical placebos

Long-Term Effects of Traditional Chinese Medicine and Hypnotherapy in Patients with Severe Endometriosis - a Retrospective Evaluation

Background: 15% of patients with severe endometriosis suffer from pain symptoms in spite of pharmacological and surgical treatments. In this retrospective study we aimed to assess the effectiveness of a combined therapy of Traditional Chinese medicine and hypnotherapy (systemic autoregulation therapy, SART) as a novel treatment for endometriosis-associated symptoms. Patients and Methods: 47 patients with severe endometriosis, which were treated with SART, were followed-up by standardized telephone interviews. Follow-up data were compared to baseline assessments. Results: Median follow-up time was 5 years. The median intensity of endometriosis-associated pain had decreased from 8 to 3 points on a 0-10 point visual analogue scale (p < 0.001). 18 patients (38%) were free of pain, and the number of patients using pain medication had decreased from 38 to 19 (from 81% to 40%). 17 out of the 31 women trying for a pregnancy (55%) showed a total of 21 births at follow-up. Exploratory analyses revealed that larger decreases in pain scores correlated significantly with longer treatment durations, suggesting a dose-response relationship. Conclusion: Treatment of endometriosis with a holistic approach of Chinese medicine and hypnotherapy may result in a substantial reduction of pain as well as increased birth rates in patients with therapy-refractory endometriosis. Randomized controlled studies to further investigate the effectiveness of SART are highly warranted

Sympathetic Arousal during a Touch-Based Healing Ritual Predicts Increased Well-Being

Objective. There is mounting evidence that more elaborate treatment rituals trigger larger nonspecific effects. The reasons for this remain unclear. In a pilot field study, we investigated the role of psychophysiological changes during a touch-based healing ritual for improvements in subjective well-being. Methods. Heart rate, respiratory rate, and skin conductance levels (SCL) were continuously assessed in 22 subjects before, during, and after a touch-based healing ritual. Participants rated their expectations and subjective well-being was assessed before and after the ritual by the "Short Questionnaire on Current Disposition". Results. Subjective wellbeing increased significantly from before to after the ritual. The analysis of psychophysiological changes revealed a significant increase in respiratory rate from baseline to ritual, while skin conductance, heart rate, and heart rate variability did not change. Increases in SCL as well as decreases in respiratory rate from baseline to ritual were significantly associated with improvements in subjective well-being. Regression analyses showed increases in SCL to be the only significant predictor of improvements in wellbeing. conclusion. Higher sympathetic arousal during a touch-based healing ritual predicted improvements in subjective wellbeing. Results suggest the occurrence of an anticipatory stress response, that is, a state of enhanced sympathetic activity that is known to precede relaxation

Mesenchymal Differentiation and Organ Distribution of Established Human Stromal Cell Lines in NOD/SCID Mice

Two human stromal cell lines were established previously from bone marrow-derived primary long-term cultures by immortalization using the SV40 large T antigen and cellular cloning. After irradiation, the fibroblast-like cell lines L87/4 and L88/5 support hematopoietic differentiation of allogeneic cord blood cells in vitro. The stromal cells do not express CD34 and CD50, but some adhesion molecules and integrins, such as CD44, CD54 and CD58. Their expression profiles on RNA and protein levels are suggestive of their osteogenic potency. The quality and quantity of osteocalcin and osteopontin protein expression depended on the culture conditions. Expression of the osteogenic markers increased over time in culture, especially in cells growing in clusters. The stromal cells also expressed collagens I and V, but did not show any expression of collagens II and III. The potentially osteoblastic stromal cells were transplanted into NOD/SCID recipient mice by intravenous injection and were found in various mesenchymal organs up to 10 weeks after transplantation. Osteocalcin-positive human stromal cells could be detected in the bone marrow, thymus, liver, brain and gut of the recipient animals. In summary, there is evidence that human bone-marrow-derived stromal cells have to be considered mesenchymal progenitors, persistently expressing osteogenic markers in vitro and in vivo. Copyright (C) 2001 S, Karger AG, Basel

Widespread use of pure and impure placebo interventions by GPs in Germany

Aim. To collect data on the use of placebo interventions by GPs in Germany. Methods. A questionnaire was mailed to 400 randomly selected GPs in Bavaria. Non-responders were reminded by telephone after 4 weeks and were given a second copy of the questionnaire after a further 3 weeks. Results. In all, 208 completed questionnaires were returned. The majority of GPs (88%) have used a placebo at least once in their practice; 45% have used pure placebos, such as saline injections and sugar pills, at least once last year; the median frequency of use was 5 [interquartile range (IQR), 2-10]. The use of impure placebos during the past year was more common: 76% of GPs have used impure placebos, i.e. medical interventions that have pharmacological or physical activity but have no intrinsic effect (e.g. pharmacological or physical action) on the patient's disease or its symptoms, with a median frequency of 20 times per year (IQR, 10-50). The main reason for the use of placebo was a possible psychological effect, followed by the expectation of patients to receive a treatment. For the majority of GPs placebo interventions were ethically justified if they were used for a possible psychological effect. Conclusions. Placebo interventions are a widely accepted part of medical treatment in German general practices and are used primarily for their psychological effects. Impure placebos are used much more frequently than pure placebo

Effects of emotional valence and arousal on acoustic duration reproduction assessed via the "dual klepsydra model"

We report results of an acoustic duration reproduction task with stimulus duration of 2, 4, and 6s, using 45 emotionally negative, positive, and neutral sounds from the International Affective Digitized Sounds System, in a sample of 31 young healthy participants. To investigate the influence of induced emotions on perceived duration, the effects of emotional modulation were quantified in two ways: (1) via model-free indices (aggregated ratios of reproduced times),and (2) via dual klepsydra model (Dkm)-based estimates of parameters of internal time representation. Both data-analytic approaches reveal an effect of emotional valence/arousal, namely, a significantly longer reproduction response for emotional stimuli than for the neutral stimuli. The advantage of the Dkm-based approach is its ability to disentangle stimulus-related effects, which are represented by "flow intensities," from general effects which are due to the lossy character of temporal integration. We explain the rationale of the Dkm-based strategy and interpret the observed effect within the Dkm-framework as transient increase of internal "flows." This interpretation is in line with recent conceptualizations of an "embodiment" of time where the model-posited flows correspond to the ongoing stream of interoceptive (bodily) neural signals. Neurophysiological findings on correlations between the processing of body signals and the perception of time provide cumulative evidence for this working hypothesis