Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
BMJ Open. 2023 Oct 21;13(10):e074957. doi: 10.1136/bmjopen-2023-074957.
Fibromyalgia syndrome (FMS) is defined as a medical condition with chronic widespread musculoskeletal pain accompanied by mood disorders, fatigue and sleep disturbances. Treatment of this condition can often be challenging. As nutrition in general and nutritional interventions in the context of illness management become more and more important, current research also focuses on the relevance of diets for FMS, including gluten as field of interest. To date, there is no clear evidence that a gluten-free diet or other nutritional interventions are significantly important for the reduction of pain in the context of FMS. Only a very few studies show that FMS patients respond to a gluten-free diet and that cytokine production (also in FMS) can be reduced through the change. However, these studies have not investigated whether and to what extent cognitive factors, such as the expectation of symptom reduction triggered by diet, play a role. Recent research shows that treatment expectation plays an important role in the course of the disease and in the effectiveness of treatment approaches. For example, there are promising pain treatment options using open-label placebos (OLPs), which show that expectation alone, rather than the pharmacological substance of medication, can reduce pain experience. In our study protocol, we hypothesise that treatment expectation can be positively influenced by the given information regarding the placebos, resulting in improved treatment outcomes for pain and indigestions.
In this trial, patients with FMS will undergo a food challenge and take an OLP (patients will be informed about the placebo), followed by a 3-week OLP treatment. The subjects will be randomised into four groups: (a) gluten-free porridge+neutral OLP instructions; (b) gluten-free porridge+positive OLP instructions; (c) gluten-containing porridge+neutral OLP instructions and (d) gluten-containing porridge+positive OLP instructions. Patients will be recruited via different institutions and support groups in Hamburg. The inclusion criteria are (a) diagnosed FMS, (b) absence of wheat allergy, coeliac disease or pain-related red flags and (c) being a minimum age of 18 years. The study requires 100 subjects to assess the primary outcomes: pain intensity and occurence of indigestion. Secondary outcomes are functional capacity, treatment expectation, and different pain-related and inflammation-related blood parameters. The measure time points will be before and after the food challenge and before and after the 3-week OLP treatment.
Ethical approval was obtained in October 2021 from the Hamburg Medical Ethics Council. The results of the study will be disseminated through publications, presentations and conference meetings.
German Clinical Trials Register (DRKS; DRKS00027130).
纤维肌痛综合征（FMS）定义为一种慢性广泛性肌肉骨骼疼痛伴情绪障碍、疲劳和睡眠障碍的疾病。这种疾病的治疗通常具有挑战性。由于营养在一般情况下以及在疾病管理中的营养干预变得越来越重要，因此目前的研究也侧重于饮食对 FMS 的相关性，包括作为研究领域的麸质。迄今为止，没有明确的证据表明无麸质饮食或其他营养干预措施对 FMS 疼痛的缓解有显著意义。只有极少数研究表明 FMS 患者对无麸质饮食有反应，并且通过这种改变可以减少细胞因子的产生（在 FMS 中也是如此）。然而，这些研究并未调查认知因素（例如饮食引发症状减轻的期望）是否以及在何种程度上发挥作用。最近的研究表明，治疗期望在疾病过程和治疗方法的有效性中起着重要作用。例如，使用开放性安慰剂（OLP）进行有希望的疼痛治疗选择，这表明仅期望而不是药物的药理学物质就可以减轻疼痛体验。在我们的研究方案中，我们假设治疗期望可以通过给予关于安慰剂的信息而得到积极的影响，从而改善疼痛和消化不良的治疗效果。
在这项试验中，患有 FMS 的患者将进行食物挑战并服用 OLP（患者将被告知安慰剂），然后进行 3 周的 OLP 治疗。受试者将随机分为四组：（a）无麸质粥+中性 OLP 说明；（b）无麸质粥+阳性 OLP 说明；（c）含麸质粥+中性 OLP 说明和（d）含麸质粥+阳性 OLP 说明。患者将通过汉堡的不同机构和支持团体招募。纳入标准为：（a）诊断为 FMS；（b）无麸质过敏、乳糜泻或与疼痛相关的红色标记；（c）年龄至少 18 岁。该研究需要 100 名受试者来评估主要结局：疼痛强度和消化不良的发生。次要结局是功能能力、治疗期望以及不同的与疼痛相关和与炎症相关的血液参数。测量时间点将在食物挑战前后以及 3 周 OLP 治疗前后进行。
2021 年 10 月，汉堡医学伦理委员会批准了该研究的伦理。研究结果将通过出版物、演讲和会议会议进行传播。
德国临床试验注册处（DRKS；DRKS00027130）。
