Emotions, Bodily Changes, and the Social Environment: How Did Early Psychosomatic Medicine Consider the Social Dimension in Health and Disease?

OBJECTIVE: Social relationships play an important role in human health and disease processes, and the field of psychosomatic medicine currently integrates social factors in its theoretical models and clinical interventions. This article provides a historical perspective on the field of psychosomatic medicine in the United States and examines the extent to which early American psychosomatic medicine incorporated the impact of social relationships on health and disease outcomes. METHODS: We searched PubMed across all issues of Psychosomatic Medicine for key words related to emotions versus social processes. Article counts are compared for these key words. We then performed a narrative review to analyze how concepts of associations among emotional, interpersonal, and physiological variables evolved in early publications. RESULTS: Of 5023 articles found in Psychosomatic Medicine, 1453 contained an emotional, 936 a social search term, and 447 contained both. In the qualitative review, influences of the social environment on emotional states and physiology were recognized already in the 1930s but they only played a subordinate role in early Psychosomatic Medicine. Publications often lacked a clear working model how interpersonal events exert their impact on physiology. With increasing understanding of developmental and neural mechanisms, a more differentiated view evolved. CONCLUSIONS: Early publications in psychosomatic medicine mainly focused on associations between emotions and physiology. However, some highlighted the importance of interpersonal and social factors. Later, the understanding of emotions, social relationships, and physiology with their developmental and neurobiological correlates have led to a fuller "biopsychosociocultural" understanding of health and disease, although more research on and within these networks is urgently needed.

An approach to the concept of tonic: suggested definitions and historical aspects.

In traditional medicine, especially CAM, the concept of (herbal) tonics has a long history in the different medical systems (TEN -- Traditional European Naturopathy; TCM - Traditional Chinese Medicine). Nevertheless, the ideas concerning the function of a tonic differ, e.g., stimulation of body functions, strengthening of organ function, enhancement of adaption, and well-being. Although no exact pharmacodynamic or pharmacokinetic properties of tonics can be given, the following general definition, even in the transcultural comparison between European and Chinese concepts, seems meaningful: A tonic is an agent that has the capability to restore and/or maintain the physiological functioning of an organ system, leading to the subjective feeling of well-being of the patient treated with it.

[Clinical studies in peripheral arterial occlusive disease: update from the aspects of a meta-narrative review]. / Klinische Studien bei peripherer arterieller Verschlusskrankheit: Update unter den Aspekten eines meta-narrativen Reviews.

BACKGROUND: Atherosclerosis is a systemic disease. Its association with the metabolic syndrome requires a multimodal therapy setting, to alleviate symptoms and for primary and secondary prevention. In the planning of the therapy, information about evidence of the interventions and a rationale for reasonable combinations are important. METHOD: For compiling a meta-narrative review (MNR) on the evidence of complementary and conventional pharmaco-therapy in peripheral arterial occlusive disease (PAOD), the literature was searched for meta-analyses of randomized controlled trials (RCTs). These were evaluated taking into account network-pharmacological aspects and research parameters. RESULTS: 4 suitable meta-analyses were found. In comparison to placebo, treatments with verum showed a significant improvement of the maximum walking distance of 63.5 m (95% confidence interval (CI) 27.11-99.91 m; Padma 28, Tibetan Formula), 41.3 m (95% CI -7.1-89.7 m; cilostazol, phosphodiesterase IIl inhibitor), 43.8 m (95% CI 14.1-73.6 m; pentoxifylline, rheological drug), and 71.2 m (95% CI 13.3-129.0 m; naftidrofuryl, rheological drug). Only for Padma 28, clinical relevance, defined as an increase of the maximum walking distance by >100 m, was analyzed and reached by 18.2% of the verum and 2.1% of the placebo patients (odds ratio 10; 95% CI 3.03-33.33). 1 conventional and 1 complementary drug additionally showed to have significant pleiotropic effects (Padma 28 and cilostazol (e.g. reduction of triglycerides)). CONCLUSIONS: According to meta-analytic evidence, naftidrofuryl and Padma 28 show clinically relevant efficacy for the treatment of early stages of PAOD. The extent to which the theoretically possible combination of different drugs contributes to improve the systemic disease under a network-pharmacological rationale remains to be shown in a multi-armed RCT.

Clinical studies on the efficacy and safety of Padma 28, a complex herbal formulation from Tibetan medicine: an overview.

BACKGROUND: Padma 28 is an herbal formula from Tibetan Medicine, which since 35 years has been registered in Switzerland as a drug for the symptoms of circulatory disorders. Over this time, a large body of scientific literature has accumulated. The aim of this article was to give an overview of the clinical studies. METHODS: A systematic literature search was done in PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials (CCRCT). The clinical trials found were assessed regarding fields of application, efficacy, and safety, as well as methodological quality and level of evidence. RESULTS: 29 trials (1 meta-analysis, 21 controlled trials, 7 open trials) and 3 retrospective case studies were found. They deal with different indications and include a total of 1,704 verum (of these, 697 children), 333 placebo, and 394 untreated or healthy patients. Dropouts and withdrawals were 2.5 and 3.5 times higher in the placebo than in the verum group, respectively. The highest level of evidence for the use of Padma 28 was found in the indication of intermittent claudication (11 trials). Indications of efficacy were also found in other vascular (6 trials) and different inflammatory diseases (12 trials). CONCLUSIONS: The results suggest a favorable safety profile for Padma 28, also in the children examined (41% of the study population). Furthermore, the results show a broad field of applications. According to clinical evidence, Padma 28 has shown to be a safe and effective symptomatic treatment option for atherosclerosis-related diseases such as intermittent claudication. It also seems to have a potential for application in certain chronic inflammatory diseases such as recurrent respiratory tract infections, viral hepatitis, and multiple sclerosis. However, further randomized controlled trials (RCT) are needed to confirm these findings.

Preliminary data of a HAMD-17 validated symptom scale derived from the ICD-10 to diagnose depression in outpatients.

BACKGROUND: In outpatient settings diagnostic classification of depressive symptoms is mostly descriptive based on ICD-10. Depending on clinical experience and consultation time, diagnosis can be verified by validated scales. However, physicians working in primary care are familiar with ICD-10 criteria. Therefore, the aim of the present study was to examine the feasibility of the validation of an ICD-10-derived symptom scale for depression. METHODS: For this preliminary trial we generated a symptom scale derived 1:1 from the diagnostic criteria for depression given in the ICD-10 with 10 items. The Hamilton Rating Scale for Depression (HAMD-17) was used as reference in a population of 226 outpatients suffering from depressive symptoms. Correlation between scales as well as sensitivity and specificity of the ICD-10 scale were calculated. RESULTS: The generated ICD-10 symptom scale for depression could be analyzed in 219 patients and showed a significant and strong correlation with the HAMD-17 (p < 0.0001; ρ = 0.75). The best tradeoffs between specificity and sensitivity of the ICD-10 score were found at 10 points for the lower and 14 points for the upper cut-off. Overall sensitivity and specificity was 76.7 and 88.6%. Almost two thirds (i.e. 65.3%) of the patients were correctly classified by the ICD-10 scale. CONCLUSION: The ICD-10 symptom scale examined in the current population was found to have fair correlation with the HAMD-17 as well as, in face of the limited variance of the patients' condition, acceptable sensitivity and specificity. Therefore, this preliminary study showed that the ICD-10-derived symptom scale seems appropriate to be investigated in a thorough validation trial.

[Early encounters of German-language explorers with the Tibetan medicine in Siberia in the modern era]. / Frühe neuzeitliche Begegnungen deutschsprachiger Forscher mit der tibetischen Medizin in Sibirien.

The spreading of Tibetan Buddhism and with it the Tibetan medicine in the region east of Lake Baikal, goes back to the 17th century. At the beginning of the 18th century, German speaking scholars were among the first to undertake scientific expeditions through Siberia. As such they were amongst the first scientists of the modern era who encountered the traditions, concepts, and therapeutic methods of Tibetan medicine. The aim of this article is to describe and analyze these first encounters with Tibetan medicine by the example of selected men of science of the 18th and 19th century. This work is based on extensive studies of sources in archives and libraries in Russia and Switzerland. We found documents related to the following scientists: Daniel Gottlieb Messerschmidt (1685-1735), Johann Georg Gmelin (1709-1755), Erik Laxmann (1737-1796), Friedrich Adelung (1768-1843), and Joseph Rehmann (1779-1831). They mentioned the distribution of Tibetan medicine within Russia, the use of medicinal plants and formulas as well as therapeutic techniques. For the scientific community of the time these first encounters of Europeans with practitioners of Tibetan medicine could not lift Tibetan medicine out of other exotic context in the field of ethnography. For today's researchers, these encounters are an important evidence for more than 300 years of development of Tibetan medicine on the vast territory of Siberia. The practice and the scientific examination of Tibetan medicine in Siberia is an active endeavor until today. The present work shows that it is possible and rewarding to follow up the historic and cultural connections from Europe to Asia via the Siberian link.

Dose-Dependent Effects of the Cimicifuga racemosa Extract Ze 450 in the Treatment of Climacteric Complaints: A Randomized, Placebo-Controlled Study.

Extracts from Cimicifuga racemosa (CR, synonym Actaea racemosa) have shown efficacy in trials in women with menopausal symptoms. Yet, dose dependency remains unclear. Therefore, 180 female outpatients with climacteric complaints were treated for 12 weeks in a randomized, double-blind, placebo-controlled, 3-armed trial (CR extract Ze 450 in 6.5 mg or 13.0 mg, or placebo). Primary outcome was the difference in menopausal symptoms (vasomotor, psychological, and somatic), assessed by the Kupperman Menopausal Index between baseline and week 12. Secondary efficacy variables were patients' self-assessments of general quality of life (QoL), responder rates, and safety. Compared to placebo, patients receiving Ze 450 showed a significant reduction in the severity of menopausal symptoms in a dose-dependent manner from baseline to endpoint (mean absolute differences 17.0 (95% CI 14.65-19.35) score points, P < 0.0001 for 13.0 mg; mean absolute differences 8.47 (95% CI 5.55-11.39) score points, P = 0.0003 for 6.5 mg). QoL and responder rates corresponded with the main endpoint. Changes in menopausal symptoms and QoL were inversely correlated. Reported adverse events and clinical laboratory testing did not raise safety concerns. The CR extract Ze 450 is an effective and well-tolerated nonhormonal alternative to hormone treatment for symptom relief in menopausal women.

Phytodolor® in musculoskeletal disorders: re-analysis and meta-analysis.

BACKGROUND: Treatment of rheumatic or musculoskeletal disorders (MD) is multi-disciplinary and includes herbal analgesics. Although already reviewed, no quantitative evaluation of efficacy and safety of the herbal combination Phytodolor® (STW1) is available. METHODS: We searched in databases and contacted authors and the manufacturer to identify randomized controlled trials (RCTs) examining STW1 in patients with MD. We made a reanalysis of raw data of eligible published and unpublished RCTs and pooled the results for meta-analysis according to Cochrane guidelines and intention-to-treat. Primary outcome measure was patient global assessment of efficacy, secondary outcome measure was pain at rest and on movement. Results were stratified according to treatment groups. RESULTS: Patient data of 11 RCTs were eligible for pooling. In the entire population, STW1 was significantly superior compared to placebo in patients' global assessment of efficacy (group difference for rating very good/good: 20%; placebo 48.9% and STW1 69.1%; p < 0.001; OR 0.43; 95% CI 0.28-0.65) and in the subpopulation 'other rheumatic diseases' (placebo 45.4%; STW1 72.3%; p < 0.001; OR 0.32; 95% CI 0.2-0.52), but not in the subpopulation 'gonarthrosis'. STW1 did not differ significantly compared to non-steroidal anti-inflammatory drugs (NSAIDs), neither in the entire population nor the subpopulations. Similar results were found for pain at rest and on movement. No serious adverse events (AE) but minor AE were reported (placebo 8.1%; STW1 14.2%; NSAIDs 18.9%). CONCLUSION: According to the analysed data, STW1 showed a better pain reduction than placebo in patients with pain due to MD, probably equivalent to NSAIDs, and was well tolerated.

A hypericum extract in the treatment of depressive symptoms in outpatients: an open study.

BACKGROUND: Extracts of Hypericum perforatum have demonstrated in randomized trials (RCTs) to be effective in mild to moderate depressive episodes. However, as their use in daily practice may differ from that in RCTs we have conducted a study to achieve a better estimate of the range and frequency of adverse drug reactions (ADR) and the efficacy. PATIENTS AND METHODS: In an observational study in Germany, adult outpatients with depressive syndrome were treated with an extract of St. John's Wort. Study duration was 12 weeks, with control visits every 4 weeks. Besides anamnestic data, the variables assessed were: evolution of ICD-10 derived symptom score, Global Clinical Impression scale (GCI), and tolerability. RESULTS: 1,778 patients from 304 centers participated in the study (mean duration of disorder 7.3 +/- 18.9 months), and 1,541 patients completed it. At the last control visit the ICD-10 sum score had dropped by 63.1% and the proportion of patients described as 'normal to mildly ill' (GCI-s) had increased from 21.6% at admission to 72.4%. Regarding the GCI-i, 77% of the patients had improved 'very much' or 'much' at the last visit. This was consistent with their self-assessment (76%). Lower age and shorter duration of the disorder were associated with significantly better outcomes. The incidence of ADRs was 3.54% and had been decreasing continuously from the first control visit onwards; serious ADRs did not occur. CONCLUSIONS: The herbal drug was well tolerated, and no new or serious ADR were identified. In view of the limitations inherent to the study design, it can be concluded that extracts of St. John's Wort are effective as an antidepressant in the management of depression in daily practice.

Efficacy and safety of mistletoe preparations (Viscum album) for patients with cancer diseases. A systematic review.

BACKGROUND: Mistletoe is often used as a complementary approach in oncology. Despite experimental anti-tumour effects and several reviews there remains controversy about its clinical role. PATIENTS AND METHODS: Potentially relevant trials were identified to perform a systematic review (databases: e.g. EMBASE, MEDLINE; hand search: e.g. bibliographies; search terms: e.g. mistletoe). To be included, randomised or comparative clinical trials at least had to examine mistletoe preparations standardized according to manufacturing process and to describe interventions explicitly. Additionally, cohort studies were included for reasons of external validity. Results were summarised in tables. RESULTS: 18 clinical trials (>6,800 participants) were included. Their internal quality was mostly low. Due to heterogeneity between trials a meta-analysis was impossible. Regarding efficacy, findings were inconsistent regarding life expectancy, relation to tumour entity, dosing and treatment duration. Yet, studies indicate that quality of life (QoL) is improved. As these findings do not seem to be limited to one of the different parenteral mistletoe preparations reviewed the treatment may be summarised under the umbrella term 'mistletoe therapy'. Regarding safety, 1 serious adverse event (AE) related to mistletoe was described; non-serious AEs were local reactions at injection site. Allergic reactions were rare. CONCLUSION: Supportive 'mistletoe therapy' seems safe and beneficial for QoL in adult patients with solid tumours. But there is an urgent need to confirm its efficacy in patient-centred care in a complex oncological setting. This has to be evaluated systematically in prospective observational trials with validated, multidimensional patient-rated QoL questionnaires and comparisons of different preparations and dosages.

Fixed herbal drug combination with and without butterbur (Ze 185) for the treatment of patients with somatoform disorders: randomized, placebo-controlled pharmaco-clinical trial.

Herbal drugs are often used in patients with somatoform disorders yet, the available evidence is limited. The aim of the present short-term study was to evaluate in a pharmaco-clinical trial the additional benefit of butterbur in a fixed herbal drug combination (Ze 185 = 4-combination versus 3-combination without butterbur and placebo) in patients with somatoform disorders.For a 2-week treatment in patients with somatization disorder (F45.0) and undifferentiated somatoform disorder (F45.1), 182 patients were randomized for a 3-arm trial (butterbur root, valerian root, passionflower herb, lemon balm leaf versus valerian root, passionflower herb, lemon balm leaf versus placebo). Anxiety (visual analogue scale - VAS) and depression (Beck's Depression Inventory - BDI) served as primary parameters, Clinical Global Impression (CGI) was a secondary parameter.The 4-combination was significantly superior to the 3-combination and placebo (4-combination > 3-combination > placebo) in all the primary and secondary parameters (PP-population). Analysis of the ITT population confirmed these results. As to safety, no serious adverse events occurred. In total 9 non-serious adverse events were documented but the distribution did not differ significantly between the treatment groups.This herbal preparation (Ze185) showed to be an efficacious and safe short-term treatment in patients with somatoform disorders.

Aspects of quality of primary care provided by physicians certified in phytotherapy in Switzerland.

BACKGROUND: Data on the use of phytotherapy in primary care are scarce and difficult to compare (e.g. different health-care systems, study designs). OBJECTIVE: Are there differences in Switzerland regarding demographic data, practice structure, process of care and outcome/ treatment satisfaction between primary care physicians certified in phytotherapy (CAM) and physicians performing conventional primary care (COM) and their patients? MATERIAL AND METHODS: Subgroup analysis of the data of phytotherapy of an observational study (2 cross-sectional surveys with 3 questionnaires) which was performed as part of a nationwide evaluation program on complementary medicine (PEK). A descriptive analysis was used to compare data. RESULTS: In survey A, 20 CAM and 191 COM physicians participated, of which 14 and 84, respectively, continued for survey B and recruited at least 276 CAM and 1,395 COM patients. Findings show that CAM physicians had less technical equipment (e.g. x-rays) than COM physicians, their consultation time was 25% longer, and they used more non-drug therapies. Whereas in the SF-36 no differences could be identified between the groups, the EUROPEP showed significant differences in favour of CAM patients. CONCLUSIONS: Preliminary data of the comparison between CAM and COM physicians indicate few differences in demographic and practice structure data. Yet, due to differences in the process of care CAM patients showed better treatment satisfaction than COM patients. This is probably due to their doctors' communicative qualities and patient-oriented skills. To which degree this might be triggered due to phyto-pharmacosemiotic aspects needs to be investigated in a future study.

An updated systematic review with meta-analysis for the clinical evidence of silymarin.

BACKGROUND: The potential benefit of silymarin (special extract from the fruits of Silybum marianum) in the treatment of liver diseases remains a controversial issue. METHODS: For this systematic review electronic databases identified 65 papers for the search terms silymarin, silibinin, silicristin or milk thistle and clinical trial. Only 19 complied with the criteria'double-' or 'single-blind'. These publications were analysed from a clinical point of view and meta-analytic calculations were performed. RESULTS: The clinical evidence ofa therapeutic effect of silymarin in toxic liver diseases is scarce. There is no evidence of a favourable influence on the evolution of viral hepatitis, particularly hepatitis C. In alcoholic liver disease, comparing with placebo, aspartate aminotransferase was reduced in the silymarin-treated groups (p = 0.01) while alkaline phosphatase was not. In liver cirrhosis, mostly alcoholic, total mortality was 16.1% with silymarin vs. 20.5% with placebo (n.s.); liver-related mortality was 10.0% with silymarin vs. 17.3% with placebo(p = 0.01). CONCLUSIONS: Based on the available clinical evidence it can be concluded - concerning possible risks /probable benefits - that it is reasonable to employ silymarin as a supportive element in the therapy of Amanita phalloides poisoning but also (alcoholic and grade Child 'A') liver cirrhosis. A consistent research programme, consolidating existing evidence and exploring new potential uses,would be very welcome.