Daniel Pach

Safety of acupuncture: results of a prospective observational study with 229,230 patients and introduction of a medical information and consent form

Background: To evaluate the safety of acupuncture in a large number of patients receiving conventional health care and, based on these results, to develop a new medical consent form for acupuncture. Methods: The prospective observational study included patients who received acupuncture treatment for chronic osteoarthritis pain of the knee or hip, low back pain, neck pain or headache, allergic rhinitis, asthma, or dysmenorrhoea. After treatment, all patients documented adverse events associated with acupuncture (defined as adverse effects). Patients who reported a need for treatment due to an adverse effect completed an additional standardised questionnaire on the most important adverse effect. Based on this data and considering ethical and legal aspects a new consent form was developed. Results: A total of 229,230 patients received on average 10.2 ± 3.0 acupuncture treatments. Altogether, 19,726 patients (8.6%) reported experiencing at least one adverse effect and 4,963 (2.2%) reported one which required treatment. Common adverse effects were bleedings or haematoma (6.1% of patients, 58% of all adverse effects), pain (1.7%) and vegetative symptoms (0.7%). Two patients experienced a pneumothorax (one needed hospital treatment, the other observation only). The longest duration of a side effect was 180 days (nerve lesion of the lower limb). The resulting medical consent form consists of five modules: Introduction to acupuncture and moxibustion, Risks of acupuncture treatment, Conditions which can increase the risk, Doctor’s statement, and Consent. Conclusion: Acupuncture provided by physicians is a relatively safe treatment and the proposed consent form could support both patients and professionals in the process of obtaining informed consent.

Characterizing acupuncture stimuli using brain imaging with fMRI: A systematic review and meta-analysis of the literature

Background The mechanisms of action underlying acupuncture, including acupuncture point specificity, are not well understood. In the previous decade, an increasing number of studies have applied fMRI to investigate brain response to acupuncture stimulation. Our aim was to provide a systematic overview of acupuncture fMRI research considering the following aspects: 1) differences between verum and sham acupuncture, 2) differences due to various methods of acupuncture manipulation, 3) differences between patients and healthy volunteers, 4) differences between different acupuncture points. Methodology/Principal Findings We systematically searched English, Chinese, Korean and Japanese databases for literature published from the earliest available up until September 2009, without any language restrictions. We included all studies using fMRI to investigate the effect of acupuncture on the human brain (at least one group that received needle-based acupuncture). 779 papers were identified, 149 met the inclusion criteria for the descriptive analysis, and 34 were eligible for the meta-analyses. From a descriptive perspective, multiple studies reported that acupuncture modulates activity within specific brain areas, including somatosensory cortices, limbic system, basal ganglia, brain stem, and cerebellum. Meta-analyses for verum acupuncture stimuli confirmed brain activity within many of the regions mentioned above. Differences between verum and sham acupuncture were noted in brain response in middle cingulate, while some heterogeneity was noted for other regions depending on how such meta-analyses were performed, such as sensorimotor cortices, limbic regions, and cerebellum. Conclusions Brain response to acupuncture stimuli encompasses a broad network of regions consistent with not just somatosensory, but also affective and cognitive processing. While the results were heterogeneous, from a descriptive perspective most studies suggest that acupuncture can modulate the activity within specific brain areas, and the evidence based on meta-analyses confirmed some of these results. More high quality studies with more transparent methodology are needed to improve the consistency amongst different studies.

Qigong versus exercise versus no therapy for patients with chronic neck pain: a randomized controlled trial.

Study Design. Randomized controlled trial. Objective. To evaluate whether qigong is more effective than no treatment and not inferior to exercise therapy. Summary of Background Data. Lifetime prevalence of chronic neck pain is close to 50%. Qigong is often used by patients, although, the evidence is still unclear. Methods. Patients (aged 20–60 years) with chronic neck pain (visual analog scale, VAS ≥40 mm) were randomized to 1) qigong or 2) exercise therapy (18 sessions over 6 months) or 3) waiting list (no treatment). At baseline and after 3 and 6 months, patients completed standardized questionnaires assessing neck pain (VAS), neck pain and disability, and quality of life (Short Form SF-36 questionnaire, SF-36). The primary endpoint was average pain in the last 7 days on VAS at 6-month follow-up. Statistical analysis included generalized estimation equation models adjusted for baseline values and patient expectation. Results. A total of 123 patients (aged 46 ± 11 years, 88% women) suffering from chronic neck pain for 3.2 (SD ± 1.6) years were included. After 6 months, a significant difference was seen between the qigong and waiting list control groups (VAS mean difference: −14 mm [95% CI = −23.1 to −5.4], P = 0.002). Mean improvements in the exercise group were comparable to those in the qigong group (difference between groups −0.7 mm [CI = −9.1 to 7.7]) but failed to show statistical significance (P = 0.092). Neck pain and disability, and SF-36 results also yielded superiority of qigong over no treatment and similar results in the qigong and exercise therapy groups. Conclusion. Qigong was more effective than no treatment in patients with chronic neck pain. Further studies could be designed without waiting list control and should use a larger sample to clarify the value of qigong compared to exercise therapy.

Treatment of the adverse effects from acupuncture and their economic impact: a prospective study in 73,406 patients with low back or neck pain.

The aim was to investigate the frequency of adverse effects due to acupuncture treatment, the need for treatment and the costs in patients with chronic low back or neck pain.

Homoeopathic versus Conventional Therapy for Atopic Eczema in Children: Medical and Economic Results

Background: One of five children visiting a homoeopathic physician is suffering from atopic eczema. Objective: To examine the effectiveness, safety and costs of homoeopathic versus conventional treatment in usual care. Methods: In a prospective multicentre comparative observational non-randomised study, 135 children (homoeopathy n = 48 vs. conventional n = 87) with mild to moderate atopic eczema were included. The primary outcome was the SCORAD (Scoring Atopic Dermatitis) at 6 months. Further outcomes at 6 and 12 months also included quality of life of parents and children, use of conventional medicine, treatment safety and disease-related costs. Results: The adjusted SCORAD showed no significant differences between the groups at both 6 months (homoeopathy 22.49 ± 3.02 [mean ± SE] vs. conventional 18.20 ± 2.31, p = 0.290) and 12 months (17.41 ± 3.01 vs. 17.29 ± 2.31, p = 0.974). Adjusted costs were higher in the homoeopathic than in the conventional group: for the first 6 months EUR 935.02 vs. EUR 514.44, p = 0.026, and for 12 months EUR 1,524.23 vs. EUR 721.21, p = 0.001. Quality of life was not significantly different between both groups. Conclusion: Taking patient preferences into account, homoeopathic treatment was not superior to conventional treatment for children with mild to moderate atopic eczema.

Moxa sticks: Thermal properties and possible implications for clinical trials

OBJECTIVES The aim of the study was to examine the infrared spectrum and the irradiance of different types of moxa sticks to develop a basis for a moxa stick control therapy. DESIGN An IR radiometer was used to measure the spectral infrared irradiance of seven glowing moxa sticks of different types in dependence of distance to the heat. RESULTS All sticks investigated showed a similar spectral distribution of the emitted IR radiation with maxima of about 83.5-87.5% in the range long-wavelength IR radiation (IR-C) and with small contributions of both short wavelength IR radiation (IR-A) between 2.2% and 5.5% and of middle wavelength IR radiation (IR-B) between 9.0% and 12.1% of the total IR emission. CONCLUSIONS Study results showed that only a small proportion of the IR radiation emitted by moxa sticks is capable of affecting subepidermal tissue. This finding indicates that thermal effects of moxa sticks are caused primarily by superficial effects on the skin. Because most heat receptors are located in the superficial skin, it thus appears impossible to separate the effects of moxa sticks from the sensation of heat. These results should be taken into account while developing placebo or sham moxibustion devices.

Stimulation of gastric slow waves with manual acupuncture at acupuncture points ST36 and PC6 – A randomized single blind controlled trial

Background  To investigate the effects of stimulated and non‐stimulated manual acupuncture at ST36 and PC6 on gastric myoelectrical activity and autonomic function.

Availability of Research Results on Traditional Chinese Pharmacotherapy

Introduction: The use of Traditional Chinese Medicine (TCM) has been increasing in the Western world over the last few years. Although Traditional Chinese Pharmacotherapy (TCP) plays a central role in TCM treatment in China, acupuncture is a more common form of treatment in the Western world than TCP. Objective: The aim of our study was to evaluate the quantity and availability of clinical trials on TCP using Medline. Methods: Medline searches were performed in PubMed (1966–June 2001) using the MeSH (Medical Subjects Heading) term ‘drugs, Chinese herbal.’ In a second step we restricted the search to meta-analyses, reviews, randomized controlled trials and clinical trials. Additionally we used the PubMed-Research- Methodology-Filter. Abstracts and information concerning the publication type were used to assess the available information. Results: Using the MeSH term ‘drugs, Chinese herbal’, 6,504 publications (50% in Chinese) published in 662 journals were identified. The specific search using the PubMed-Research-Methodology-Filter adjusted to ‘therapy’ and ‘specificity’ identified 118 studies (11 reviews, 55 randomized controlled trials, 26 controlled trials, 7 longitudinal studies, 12 experiments, and 7 others), 65 of which were written in English. Most studies used western diagnoses for treatment. The most common investigated diagnosis was atopic dermatitis (7 trials) followed by angina pectoris (6 trials). Conclusion: Only limited information about TCP research is accessible for physicians using PubMed. Moreover, half of the studies are published in Chinese. The PubMed-Research- Methodology-Filter proved to be an effective tool in restricting the search to relevant publications.

German Translation of the Southampton Needle Sensation Questionnaire: Use in an Experimental Acupuncture Study

Objective: To create a German version of the Southampton Needle Sensation Questionnaire (SNSQ) in order to measure deqi (needling sensation) in subjects receiving different forms of acupuncture and to evaluate the translated questionnaire in an acupuncture study. Methods: A forward and backward translation procedure was applied to create a German version of the SNSQ. Discrepancies between translations were resolved by consensus. Healthy participants from an experimental acupuncture trial were asked to fill in the resulting questionnaire comprising of 17 items (none (0) to intense (3)) and a visual analogue scale (VAS) for pain (0–100 mm) after receiving either sham or real acupuncture with or without stimulation. The questionnaire was validated using factor analysis and correlation analysis. Results: Questionnaires from 63 subjects (mean 27.1 years; 69.8% female) were included in the analysis. Participants tended to score toward the low end of each of the 17 items (mean sum score (± SD): 8.9 ± 7.0). Four factors with eigenvalues > 1 were identified using exploratory factor analysis. Both of the original subscales, aching deqi (AD) and tingling deqi (TD), showed good internal consistency (Cronbach’s α: AD: 0.71; TD: 0.78) and medium test-retest reliability (AD: r = 0.538, p = 0.002; TD: r = 0.603, p < 0.001). AD feeling (r = 0.574, p < 0.001) and TD feeling (r = 0.496, p < 0.001) correlated with the VAS for pain. Conclusion: Factor structure of the original questionnaire could not be reproduced with the German version of the SNSQ in an experimental setting. The questionnaire could not discriminate between pain and deqi. Further research is needed to create a German tool which is more suitable to measure deqi.

Differential cerebral response to somatosensory stimulation of an acupuncture point vs. two non-acupuncture points measured with EEG and fMRI

Acupuncture can be regarded as a complex somatosensory stimulation. Here, we evaluate whether the point locations chosen for a somatosensory stimulation with acupuncture needles differently change the brain activity in healthy volunteers. We used EEG, event-related fMRI, and resting-state functional connectivity fMRI to assess neural responses to standardized needle stimulation of the acupuncture point ST36 (lower leg) and two control point locations (CP1 same dermatome, CP2 different dermatome). Cerebral responses were expected to differ for stimulation in two different dermatomes (CP2 different from ST36 and CP1), or stimulation at the acupuncture point vs. the control points. For EEG, mu rhythm power increased for ST36 compared to CP1 or CP2, but not when comparing the two control points. The fMRI analysis found more pronounced insula and S2 (secondary somatosensory cortex) activation, as well as precuneus deactivation during ST36 stimulation. The S2 seed-based functional connectivity analysis revealed increased connectivity to right precuneus for both comparisons, ST36 vs. CP1 and ST36 vs. CP2, however in different regions. Our results suggest that stimulation at acupuncture points may modulate somatosensory and saliency processing regions more readily than stimulation at non-acupuncture point locations. Also, our findings suggest potential modulation of pain perception due to acupuncture stimulation.