Association of low-dose naltrexone and transcranial direct current stimulation in fibromyalgia, 2022, Hendges de Paula et al

Abstract

Introduction
Fibromyalgia is a complex, generalized, and diffuse chronic musculoskeletal pain. Pharmacological approaches are widely used to relieve pain and increase quality of life. Low-Dose Naltrexone (LDN) was shown to increase the nociceptive threshold in patients with fibromyalgia. Transcranial Direct Current Stimulation (tDCS) is effective for pain management.

Objective
The purpose of this study was to evaluate the analgesic and neuromodulatory effects of a combination of LDN and tDCS in patients with fibromyalgia.

Methods
This was a randomized, double-blinded, parallel, placebo/sham-controlled trial (NCT04502251; RBR-7HK8N) in which 86 women with fibromyalgia were included, and written informed consent was obtained from them. The patients were allocated into four groups: LDN + tDCS (n = 21), LDN + tDCS Sham (n = 22), placebo + tDCS (n = 22), and placebo+tDCS Sham (n = 21). The LDN or placebo (p.o.) intervention lasted 26 days; in the last five sessions, tDCS was applied (sham or active, 20 min, 2mA). The following categories were assessed: sociodemographic, Visual Analog Pain Scale (VAS), Pain Catastrophizing Scale (PCS), State-Trait Anxiety Inventory (STAI), Fibromyalgia Impact Questionnaire (FIQ), Beck Depression Inventory (BDI-II), Profile of Chronic Pain Scale (PCP:S), Pain Pressure Threshold (PPT), and Conditioned Pain Modulation (CPM). Blood samples were collected to analyze BDNF serum levels.

Results
At baseline, no significant difference was found regarding all measurements. VAS pain was significantly reduced in the LDN + tDCS (= 0.010), LDN + tDCS Sham (p = 0.001), and placebo+tDCS Sham (p = 0.009) groups. In the PCP:S, the LDN+tDCS group showed reduced pain frequency and intensity (p = 0.001), effect of pain on activities (p = 0.014) and emotions (p = 0.008). Depressive symptoms reduced after all active interventions (p > 0.001).

Conclusion
Combined LDN+tDCS has possible benefits in reducing pain frequency and intensity; however, a placebo effect was observed in pain using VAS, and further studies should be performed to analyze the possible association.

Open access, https://www.sciencedirect.com/science/article/pii/S010400142200104X

 

They compare symptoms before vs. after rather than comparing against the placebo arm? That leads me to infer that they analyzed the data the right way, got a negative result, so started p-hacking so they could publish something. I'm no expert at stats, but if you eyeball their chart, there's no clear effect.

I began pondering this extensively in the shower. That even though scientists are doing a little research on ME/CFS and related conditions, an enormous amount of potential is lost due to human incompetence and broken incentives. If we did better research, we could have treatments by now. I became angry as I considered how the problems in medical science (the replication crisis, p-hacking, pressure to publish positive results) have confined millions to their beds, imprisoned in their homes, deathly ill, for decades. If you do a biased experiment in astronomy or physics, nobody will be harmed. But in medicine, you'll strike healthy years off people's lives by missing discoveries. But somehow...the standards in other sciences seem higher than in medicine. And the people who publish junk science get rewarded in the form of academic standing or potential sales, while forcing patients to continue suffering. They might even believe they're helping us because they don't consider the opportunity cost: They could've done a good study instead of a poor one.