Stimulated by Di Carlo et al 2023 and Treister-Goltzman et al 2023.[1,2]
FM – fibromyalgia
key to acronyms
MA – manual acupuncture
BMI – body mass index
FIQR – revised fibromyalgia impact questionnaire
FAS – fibromyalgia assessment status
SAPS – self-assessment pain scale
PHQ15 – patient health questionnaire 15 items
PCS – pain catastrophising scale
PDQ – pain detect questionnaire
VAS – visual analogue scale
TPC – tender point count
OR – odds ratio
EA – electroacupuncture
SNL – sciatic nerve ligation
HR – hazard ratio
SMR – standardised mortality ratio
As a clinician who uses acupuncture, I could not ignore the title of this first paper – Predicting acupuncture efficacy in FM.[1] The second paper illustrates the wider importance of the condition for those of us seeing patients with FM, and gives us a reason to consider aspects beyond the pain symptomatology.[2]
Di Carlo et al describe their study as a pragmatic open label study, but it would have been more helpful to include the terms prospective cohort or single arm in the title, since this is effectively a group of patients who all got acupuncture and knew they were getting it. The blinkered EBM fanatics (see Blinding – where’s the bias?) will instantly shrug and dismiss the unblinded uncontrolled data, but pragmatist clinicians will be very interested.
102 FM patients were enrolled and given 8 weekly sessions of MA lasting 30 minutes each. A standard protocol of points was used. 12 needles were used in total – 4 bilateral and 4 in the midline – LR3, SP6, ST36, LI4, CV6, CV12, Yintang, GV20.
A series of outcome measures were recorded before and after the treatment course (T0 to T1) and again after 3 months (T2). These measures included: BMI; FIQR; FAS; SAPA; PHQ15; PCS; PDQ; VAS; and TPC.
Of the initial 102 patients, 96 completed the treatment course, but only 77 provided data at all 3 time points. Only 19 of 96 patients (<20%) attended the final clinical assessment at T2. The main reason given for missing the follow-up visit consisted of logistical problems in reaching the centre. Presumably the same centre they had attended on 8 occasions for the course of MA treatment.
A 30% reduction in the FIQR was considered clinically significant and at T1, 34 out of 77 patients (44.2%) achieved this. At T2, significant improvement persisted in 16 (20.8%).
There were no predictors of a positive treatment response at T1, but in the univariate analysis, treatment failure was associated with TBC (OR=0.45) and a variety of other outcome scales and subscales. In the multivariate analysis the only 2 factors that remained significant predictors of a negative outcome at T1 were TPC (OR=0.49, p=0.01) and magnification (OR=0.68, p=0.04). Magnification refers to a subscale of the PCS.
There were also no predictors of a positive treatment response at T2, but a variety of outcomes were associated with non-response to MA in the univariate analysis. In the multivariate analysis the only item that remained significant was duloxetine use (OR=0.21, p=0.04).
I was surprised by the latter finding since there is a suggestion from laboratory research that an SNRI (milnacipran) can have synergetic actions when combined with EA.[3] This was a neuropathic pain model (SNL) using spinal administration of the drug and a single application of EA, so it is admittedly rather a long way from the clinical scenario of Di Carlo et al.
Finally, another paper popped up on PubMed this week with FM in the title,[2] so I thought I would include it here. It is a systematic review with meta-analysis examining the association of FM with mortality. It includes 8 studies and 188 751 FM patients. The all-cause mortality results were mixed depending on the measures used – increased mortality when using HR and no increase when using SMR.
When data was pooled for specific causes of death, there was a reduction in SMR from cancer but an increase in SMR related to infection, accident, and suicide. The latter was over 3, indicating a considerably increased rate of suicide in patients with FM.
The authors conclude:
Our review provides further proof that fibromyalgia patients should be taken seriously, with particular focus on screening for suicidal ideation, prevention of accidents, and prevention and treatment of infections.
References
1 Di Carlo M, Beci G, Cipolletta E, et al. Predicting acupuncture efficacy in fibromyalgia: results of a pragmatic open-label study. Clin Exp Rheumatol Published Online First: 18 May 2023. doi:10.55563/clinexprheumatol/1xr38b
2 Treister-Goltzman Y, Peleg R. Fibromyalgia and mortality: a systematic review and meta-analysis. RMD Open 2023;9:e003005. doi:10.1136/rmdopen-2023-003005
3 Li C, Ji BU, Kim Y, et al. Electroacupuncture Enhances the Antiallodynic and Antihyperalgesic Effects of Milnacipran in Neuropathic Rats. Anesth Analg 2016;122:1654–62. doi:10.1213/ANE.0000000000001212
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