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Randomized Controlled Trial
. 2020 Mar 19;12(3):821.
doi: 10.3390/nu12030821.

Comparison between Acupuncture and Nutraceutical Treatment with Migratens® in Patients with Fibromyalgia Syndrome: A Prospective Randomized Clinical Trial

Vittorio Schweiger  1 , Erica Secchettin  2 , Cinzia Castellani  3 , Alvise Martini  1 , Elena Mazzocchi  3 , Alessandro Picelli  4 , Enrico Polati  1 , Katia Donadello  1 , Maria Teresa Valenti  3 , Luca Dalle Carbonare  3
Affiliations
Randomized Controlled Trial

Comparison between Acupuncture and Nutraceutical Treatment with Migratens® in Patients with Fibromyalgia Syndrome: A Prospective Randomized Clinical Trial

Vittorio Schweiger et al. Nutrients. .

Abstract

Objectives: Fibromyalgia syndrome (FMS) is a chronic clinical condition characterized by pain, fatigue, altered sleep, and cognitive disturbances. The purpose of this study was to compare two alternative treatments (nutraceutical and acupuncture) in FMS patients through a randomized clinical trial.

Research methods: A total of 60 FMS female patients were randomized for treatment with a nutritional combination containing coenzyme Q10, vitamin D, alpha-lipoic acid, magnesium, and tryptophan (Migratens® Group) or acupuncture treatment (Acupuncture Group) performed according the principles of traditional Chinese medicine (TCM), both for 3 months. Changes in pain and in quality of life (QoL) measured with a Fibromyalgia Impact Questionnaire Score-Revised (FIQ-R) and the Fibromyalgia Severity Scale (FSS) were performed at 1, 3, and 6 months after the start of treatments.

Results: A total of 55 patient completed the study (21 in the Migratens® Group and 34 in the Acupuncture Group). Migratens® treatment shows a statistically significant reduction of pain 1 month after the start of therapy (T1, p = 0.025), strengthened after 3 months with maintenance of treatment (p = 0.012). The efficacy in reducing pain was apparent in the Acupuncture Group at all post-treatment determinations and at follow-up (T1 and T2 p = <0.001). Regarding QoL, improvement in FIQ-R and FSS values was revealed in both groups.

Conclusion: The nutraceutical approach with Migratens® seems to be an effective option to for patients with FMS. Our experience confirmed also the validity of acupuncture in these patients. Considering the complexity of the management of FMS patients, our results suggest a cyclical and sequential, or even concurrent treatment with different approaches, to improve the efficacy and the compliance of patients to long-term treatment.

Keywords: acupuncture; dietary supplementation; fibromyalgia; nutraceutical; pain; quality of life.

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Conflict of interest statement

The authors have no relevant interest to declare.

Figures

Figure 1
Figure 1
Concomitant pharmacological fibromyalgia syndrome (FMS) treatments in 60 eligible patients. SSRI = serotonin selective reuptake inhibitors; SNRI = serotonin noradrenaline selective inhibitors; GBPs = gabapentinoids; TCA = tricyclic antidepressants; BZD = benzodiazepines; OPI = opiates; NSAIDs = non-steroidal anti-inflammatory drugs; MR = muscle relaxants; ACT = acetaminophen.
Figure 2
Figure 2
Study flow chart and follow-up.
Figure 3
Figure 3
Primary efficacy end-point in analyzed populations: change in visual analog scale (VAS) pain score during observation. The score evaluation shows a statistically significantly pain intensity reduction at all the observations except in Migratens® Group at T3 (6 months and 3 months after treatment interruption according study protocol, p = 0.6).
Figure 4
Figure 4
Secondary efficacy end-point in analyzed population: change in Fibromyalgia Impact Questionnaire Score-Revised (FIQ-R) score during observation. The evaluation shows a statistically significantly score reduction only in Acupuncture Group at all the observations (p < 0.001).
Figure 5
Figure 5
Secondary efficacy end-point in analyzed population: change in Fibromyalgia Severity Scale (FSS) score during observation. The evaluation shows a statistically significantly score reduction only in the Acupuncture Group in all the observations (p < 0.0001).
Figure 6
Figure 6
Reduction difference in VAS values in the two treatment groups during observation (values are expressed as mean difference ±SD).
Figure 7
Figure 7
Reduction difference in FIQ-R values in the two treatment groups during observation (values are expressed as mean difference ± SD).
Figure 8
Figure 8
Reduction difference in FSS values in the two treatment groups during observations (values are expressed as mean difference ±SD).
Figure 9
Figure 9
Linear correlation between FIQ-R and depression score expressed as tertiles in the two groups of treatment. Note that in Migratens® Group, the positive correlation observed at baseline (p < 0.05) was lost at the end of follow-up, while it was maintained in the Acupuncture Group (p < 0.05).
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