Is Sham Laser a Valid Control for Acupuncture Trials?

Methodological problems of acupuncture trials focus on adequate placebo controls. In this trial we evaluated the use of sham laser acupuncture as a control procedure. Thirty-four healthy volunteers received verum laser (invisible infrared laser emission and red light, 45 s and 1 J per point) and sham laser (red light) treatment at three acupuncture points (LI4, LU7 and LR3) in a randomized, double-blinded, cross-over design. The main outcome measure was the ratio of correct to incorrect ratings of treatment immediately after each session. The secondary outcome measure was the occurrence of deqi-like sensations at the acupuncture points and their intensity on a 10-fold visual analog scale (VAS; 10 being the strongest sensible sensation). We pooled the results of three former trials to evaluate the credibility of sham laser acupuncture when compared to needle acupuncture. Fifteen out of 34 (44%) healthy volunteers (age: 28 ± 10.7 years) identified the used laser device after the first session and 14 (41%) after the second session. Hence, both treatments were undistinguishable (P = .26). Deqi-like sensations occurred in 46% of active laser (2.34 VAS) and in 49.0% of sham laser beams (2.49 VAS). The credibility of sham laser was not different from needle acupuncture. Sham laser acupuncture can serve as a valid placebo control in laser acupuncture studies. Due to similar credibility and the lack of sensory input on the peripheral nervous system, sham laser acupuncture can also serve as a sham control for acupuncture trials, in order to evaluate needling effects per se

New treatment options for fibromyalgia: critical appraisal of duloxetine

Fibromyalgia syndrome (FMS) is a chronic condition characterized by widespread pain, tender points, fatigue, and sleep disturbance. FMS leads to high disability levels, poor quality of life, and extensive use of medical care. Effective pharmacological treatment options are rare, and treatment effects are often of limited duration. Duloxetine is a new selective serotonin and norepinephrine reuptake inhibitor that is licensed for the treatment of pain in diabetic neuropathy. So far two randomized, placebo-controlled trials have investigated the short-term safety and efficacy of duloxetine 60 mg/day and 120 mg/day in patients suffering from FMS over a period of 12 weeks. Both dosages were superior to placebo in pain relief, and improvement in quality of life and depressive symptoms. The analgesic effect was largely independent of the antidepressant action of duloxetine. The higher dose of 120 mg/day further reduced the tender point count and elevated the tender point pain thresholds. Only mild to moderate adverse effects were reported. Duloxetine 60 mg/day and 120 mg/day has proven to be beneficial in the treatment of FMS symptoms. As true for other antidepressants further studies are needed to assess the long-term efficacy and safety of duloxetine as an additional pharmacological treatment option in FMS

Badania kliniczne nad skutecznością łagodnej hipertermii całego ciała metodą podczerwieni filtrowanej wodą jako uzupełnienie standardowej rehabilitacji multimodalnej w leczeniu fibromialgii

Wstęp: Określenie czy łagodna hipertermia całego ciała metodą podczerwieni filtrowanej wodą (NI-WBH) przynosi dodatkowe korzyści, kiedy jest stosowana jako uzupełnienie standardowej rehabilitacji multimodalnej (MR) w porównaniu z MR bez NI-WBH u pacjentów z syndromem fibromialgii (FM). Metody: Stu trzydziestu dziewięciu pacjentów z niemieckiego szpitala rehabilitacyjnego spełniających kryteria ACR 1990 dla rozpoznania FM losowo podzielono do grupy pacjentów poddanej terapii NI-WBH (podniesienie temperatury wewnętrznej ciała do 38,1ºC, po której następowała faza podtrzymania temperatury przez okres 15 min) oraz MR i grupy poddanej tylko MR, dwa razy w tygodniu przez okres 3 tygodni. Większość pomiarów dotyczyła bólu emocjonalnego oraz bólu sensorycznego i oceniono ją za pomocą niemieckiej wersji McGill Pain Questionnaire z pomiarami: wyjściowym, bezpośrednio po terapii, 3 oraz 6 miesięcy po terapii, a następnie poddano analizie w celu leczniczym. Wyniki: Powtórzone analizy kowariancji wykazały znaczne różnice pomiędzy obydwoma pomiarami pierwotnymi na korzyść NI-WBH + MR w porównaniu z samą MR (P < 0,001 dla bólu emocjonalnego, P = 0,001 dla bólu sensorycznego). Wtórne analizy intensywności bólu, jakości życia z FM oraz oceny punktów wrażliwych wykazały podobne wyniki. Umiarkowane efekty terapii zaobserwowano we wszystkich przypadkach poddanych pomiarom (w zakresie 0,41–0,75). Efekty niepożądane powiązane z NI-WBH zaobserwowano u 14 z 69 uczestników (20%), ale u wszystkich ustąpiły przed upływem 30 minut. Dyskusja: Z badania wynika, że NI-WBH jest wartym uwagi uzupełnieniem MR w leczeniu FM. Forum Reumatol. 2019, tom 5, nr 3: 105–117 Przedrukowano za zgodą z: Thomas Brockow, MD, Andreas Wagner, MD, Annegret Franke, PhD, Martin Offenbächer, MD, MPH, oraz L. Resch, MD, PhD, A Randomized Controlled Trial on the Effectiveness of Mild Water-filtered Near Infrared Whole-body Hyperthermia as an Adjunct to a Standard Multimodal Rehabilitation in the Treatment of Fibromyalgia. The Clinical Journal of Pain/Clin J Pain 2007; 23(1): 67–75. www.clinicalpain.co

Management of fibromyalgia syndrome – an interdisciplinary evidence-based guideline

The prevalence of fibromyalgia syndrome (FMS) of 1–2% in the general population associated with high disease-related costs and the conflicting data on treatment effectiveness had led to the development of evidence-based guidelines designed to provide patients and physicians guidance in selecting among the alternatives. Until now no evidence-based interdisciplinary (including patients) guideline for the management of FMS was available in Europe

Trying to be perfect in an imperfect world: A person-centred test of perfectionism and health in fibromyalgia patients versus healthy controls

The Stress and Coping Cyclical Amplification Model of Perfectionism in Illness posits, that in the context of a chronic illness, both perfectionistic strivings and concerns contribute to poor health outcomes. Similarly, person-centred models, such as the tripartite model of perfectionism, claim that high levels of both perfectionism concerns and strivings reflect an “unhealthy” perfectionism that takes a toll on well-being. To date there are few comparative tests of these models for physical and mental health outcomes in healthy versus chronically ill individuals. The aim of the current study was to investigate the implications of perfectionism for health by testing how within-person combinations of perfectionism varied in relation to health outcomes, and between fibromyalgia patients (n = 89) and healthy controls (n = 123). Supporting both models, within-person combinations of high perfectionistic strivings and concerns were associated with high stress and poor mental and physical health compared to other within-person combinations. These links were more robust for fibromyalgia patients compared to controls, and stress mediated the association with physical health outcomes only for the fibromyalgia patients. Findings support the value of taking a person-centred approach for understanding how perfectionistic strivings contributes to poor health in the context of chronic illness

Etoricoxib - preemptive and postoperative analgesia (EPPA) in patients with laparotomy or thoracotomy - design and protocols

<p>Abstract</p> <p>Background and Objective</p> <p>Our objective was to report on the design and essentials of the <it>Etoricoxib </it>protocol<it>- Preemptive and Postoperative Analgesia (EPPA) </it>Trial, investigating whether preemptive analgesia with cox-2 inhibitors is more efficacious than placebo in patients who receive either laparotomy or thoracotomy.</p> <p>Design and Methods</p> <p>The study is a 2 × 2 factorial armed, double blinded, bicentric, randomised placebo-controlled trial comparing (a) etoricoxib and (b) placebo in a pre- and postoperative setting. The total observation period is 6 months. According to a power analysis, 120 patients scheduled for abdominal or thoracic surgery will randomly be allocated to either the preemptive or the postoperative treatment group. These two groups are each divided into two arms. Preemptive group patients receive etoricoxib prior to surgery and either etoricoxib again or placebo postoperatively. Postoperative group patients receive placebo prior to surgery and either placebo again or etoricoxib after surgery (2 × 2 factorial study design). The Main Outcome Measure is the cumulative use of morphine within the first 48 hours after surgery (measured by patient controlled analgesia PCA). Secondary outcome parameters include a broad range of tests including sensoric perception and genetic polymorphisms.</p> <p>Discussion</p> <p>The results of this study will provide information on the analgesic effectiveness of etoricoxib in preemptive analgesia and will give hints on possible preventive effects of persistent pain.</p> <p>Trial registration</p> <p>NCT00716833</p

Gratitude mediates quality of life differences between fibromyalgia patients and healthy controls

Purpose: Despite a growing literature on the benefits of gratitude for adjustment to chronic illness, little is known about gratitude in medical populations compared to healthy populations, or the degree to which potential deficits in gratitude might impact quality of life. The purpose of the present study was to (1) examine levels of gratitude and quality of life in fibromyalgia patients and healthy controls and (2) consider the role of gratitude in explaining quality of life differences between fibromyalgia patients and healthy controls. Methods: Participants were 173 fibromyalgia patients and 81 healthy controls. All participants completed measures of gratitude, quality of life, and socio-demographics. Results: Although gratitude was positively associated with quality of life, levels of gratitude and quality of life were lower in the fibromyalgia sample relative to the healthy controls. This difference in gratitude partially mediated differences in quality of life between the two groups after controlling for socio-demographic variables. Conclusions: Our findings suggest that gratitude is a valuable positive psychological trait for quality of life in people with fibromyalgia. Interventions to improve gratitude in this patient population may also bring enhancement in quality of life

A Pilot Study of a Mindfulness-Based Stress Reduction Programme in Patients Suffering from Atopic Dermatitis

Introduction: Patients with atopic dermatitis (AD) have several potential stressors including the symptoms of the disease itself, the stigmatization due to their appearance, and emotional and psychological strain. Psychological factors and stress can trigger and exacerbate the symptoms of skin diseases and there is evidence that stress has a relevant clinical effect on the function of skin cells in vivo. Our objective was to evaluate in a pilot study the feasibility, acceptance, and effectiveness of a Mindfulness-Based Stress Reduction (MBSR) programme in AD patients in a clinical setting. Methods: 10 patients took part in an 8-week MBSR programme, which included, e.g., mindful and conscious awareness of the body and bodywork, and seated meditation. We assessed sociodemographics and disease related variables with standardized measures at predefined time points including Score of Atopic Dermatitis, Patient Oriented Eczema Measure, Dermatology Life Quality Index, Perceived Stress Questionnaire, Freiburg Mindfulness Inventory (FMI), and others. Participants also gave qualitative feedback regarding the effects of the intervention. Results: The mean age was 53.10 years (SD = 15.04), seven patients were female, and disease duration was 36.6 years (SD = 25.5). Calculating pre-post effect sizes (Cohen’s d), the FMI indicated significant improvement in the “presence” and “acceptance” subscales. There was also tendency for less stress. This was confirmed by the qualitative statements of the participants. Conclusions: The MBSR programme is feasible and acceptable for AD patients. Considering the long disease history and the severity of disease burden, the effects of this intervention seem promising as an adjunct to conventional treatments for patients with AD