A randomised, double‐blinded study comparing giving etoricoxib vs. placebo to female patients with fibromyalgia

Abstract

Objectives: Current therapeutic approaches to fibromyalgia syndrome (FMS) do not provide satisfactory pain control to a high percentage of patients. This unmet need constantly fuels the pursuit for new modalities for pain relief. This randomised, double-blind, controlled study assessed the efficacy and safety of adding etoricoxib vs. placebo to the current therapeutic regimen of female patients with FMS. Methods: In this double-blind, placebo-controlled study, female patients were randomised to receive either 90 mg etoricoxib once daily or placebo for 6 weeks. Several physical and mental parameters were assessed throughout the study. The primary end-point was the response to treatment, defined as ≥ 30% reduction in the average Brief Pain Inventory score. Secondary outcomes were changes in the Fibromyalgia Impact Questionnaire, SF-36 Quality of Life assessment questionnaire and Hamilton rating scales for anxiety and depression. Results: Overall, 73 patients were recruited. Although many outcome measures improved throughout the study, no difference was recorded between the etoricoxib-and placebo-treated groups. The Brief Pain Inventory, Fibromyalgia Impact Questionnaire, The Hamilton Anxiety and Depression scores did not differ between the two groups. Conclusions: This is the first randomised, double-blind study assessing the effect of adding etoricoxib to pre-existing medications for female patients with FMS. Although being mildly underpowered this study clearly has shown that etoricoxib did not improve pain scores and did not lead to any beneficial mental or physical effects. What's knownNon-steroidal anti-inflammatory drugs (NSAIDs) and COX-2-selective agents are often used by patients with FMS, usually for temporary relief of pain. Nevertheless, solid data supporting this use are absent.

Efficacy of anti‐inflammatory treatment on major depressive disorder or depressive symptoms: meta‐analysis of clinical trials

“…). We identified 39 studies covering 44 RCTs with a total of 10 891 individuals: 14 trials ( N = 4451) studied NSAIDs [five add‐ons , eight monotherapy except one trial where 45% of patients were on antidepressant medication ], 12 ( N = 3868) studied cytokine inhibitors [all as monotherapy except for one study where 62% of the patients were treated with antidepressants ], 9 ( N = 2118) studied statins [three add‐ons and six monotherapy ], 3 ( N = 119) studied pioglitazone as add‐on , 3 ( N = 162) studied minocycline [two add‐ons and one monotherapy ], and 3 ( N = 173) studied glucocorticoids as monotherapy . Of these, eight RCTs could not be included since we did not have access to the necessary data, neither published or after contact to the authors.…”

Inflammation, Lifestyle Factors, and the Microbiome‐Gut‐Brain Axis: Relevance to Depression and Antidepressant Action

“…For example, a double‐blind and placebo controlled clinical trial in patients suffering from osteoarthritis demonstrated a significant decrease of depressive symptoms after treatment with ibuprofen, naproxen, and celecoxib 79 . Celecoxib is an NSAID with antidepressant efficacy, as previously demonstrated in clinical trials with patients with colorectal cancer, 80 and female patients with fibromyalgia 81 . Similarly, an animal investigation demonstrated that celecoxib, ibuprofen, and indomethacin were effective in reducing depressive‐like behaviors as observed in the forced swim test and in a model of IFNα‐induced depression in mice 82 .…”

“… 79 Celecoxib is an NSAID with antidepressant efficacy, as previously demonstrated in clinical trials with patients with colorectal cancer, 80 and female patients with fibromyalgia. 81 Similarly, an animal investigation demonstrated that celecoxib, ibuprofen, and indomethacin were effective in reducing depressive‐like behaviors as observed in the forced swim test and in a model of IFNα‐induced depression in mice. 82 Although there are some promising data from a large‐scale clinical trial, NSAIDs have yet to prove effective.…”

Cannabis and Cannabinoids in the Treatment of Rheumatic Diseases

“…13 Ibuprofen, a non-steroidal anti-inflammatory drug (NSAID) usually used for the treatment of musculoskeletal pain, was not found to be an effective treatment option, 16 and a randomized doubleblinded study that compared the addition of etoricoxib, a selective COX-2 inhibitor, to pre-existing medical therapy with the addition of placebo in female fibromyalgia patients found that etoricoxib did not improve patients' pain, sleep, or disability parameters. 17 While tramadol (a weak opioid with mild SNRI activity) was found to be potentially effective in alleviating fibromyalgia pain, 13 opioids in general may cause an exacerbation of symptoms in this patient population. 7 Cannabis and cannabinoids were recommended for the treatment of neuropathic pain, 18 and, due to the similarities between neuropathic pain and fibromyalgia, as previously mentioned, it is not unreasonable to hypothesize that cannabis or cannabinoids might be effective for fibromyalgia-associated pain as well.…”