Dietary supplementation with plant extracts for amelioration of persistent myofascial discomfort in the cervical and back regions: a randomized double-blind controlled study – PubMed Black Hawk Supplements

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CONCLUSION: Dietary supplementation for 12 weeks of a blend of polyphenolic standardized extracts of rosemary, ashwagandha, and sesame was effective in reducing the intensity of pain in subjects with chronic myofascial cervical and back pain.
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Dietary supplementation with plant extracts for amelioration of persistent myofascial discomfort in the cervical and back regions: a randomized double-blind controlled study - PubMed

Dietary supplementation with plant extracts for amelioration of persistent myofascial discomfort in the cervical and back regions: a randomized double-blind controlled study

Silvia Pérez-Piñero et al. Front Nutr. .

Abstract

Background: Back pain is a common health problem that affects both workers and older people, reducing their quality of life. The primary objective was to assess the effect of dietary supplementation with plant extracts of rosemary, ashwagandha, and sesame consumed for 12 weeks on the intensity of back pain.

Methods: A single-center randomized double-blind study with three parallel arms depending on the product consumed. The duration of treatment was 12 weeks. The investigational product, Berelief®, contained a blend of three polyphenolic standardized extracts: rosemary (Rosmarinus officinalis L.), ashwagandha (Withania somnifera L.), and sesame (Sesamum indicum L.) seed. Two doses were tested: low dose (400 mg) and high dose (800 mg). There were 42 subjects in the placebo group, 39 in the low dose and 42 in the high dose groups. Study variables included back pain intensity [VAS score, Patient-Reported Outcomes Measurement Information System (PROMIS-29), and Cornell Musculoskeletal Discomfort Questionnaire; functionality Roland-Morris Disability (RMD) questionnaire]; quality of life (QoL) [36-item Short Form Survey (SF-36), the Beck Depression Inventory-II (BDI-II), the State-Trait Anxiety Inventory (STAI), and the Perceived Stress Scale (PSS)]; sleep quality [accelerometer and Pittsburgh Sleep Quality Index (PSQI)].

Results: The improvement in back pain recorded by the visual analogue scale (VAS) at the study visits after the beginning of treatment, as well as on a weekly basis recorded in the diary card was significantly higher in the intervention group than in the placebo group (p < 0.044 dose-low; p < 0.005 dose-high). Significant differences in pain intensity of the PROMIS-29 (p = 0.002) and upper back pain in the Cornell questionnaire (p = 0.011) in favour of the investigational product were found. Furthermore, benefits in improving health-related quality of life, mood and sleep quality were also detected.

Conclusion: Dietary supplementation for 12 weeks of a blend of polyphenolic standardized extracts of rosemary, ashwagandha, and sesame was effective in reducing the intensity of pain in subjects with chronic myofascial cervical and back pain.

Keywords: ashwagandha; back pain; food supplement; herbal extracts; quality of life; randomized clinical trial; rosemary; sesame.

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Conflict of interest statement

NC, PN, MC, and FJL-R were employed by the Monteloeder S.L. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1

Flow chart of the study population.

Figure 2
Figure 2

Changes of VAS scores during the study period (error bars ±1 standard deviation) (*indicates statistically significant differences between the placebo group and the investigational product groups; see text for p values at each time points).

Figure 3
Figure 3

Weekly percentage changes of VAS scores in the study groups. *Significant differences in comparison with placebo.

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Grants and funding

The author(s) declare that financial support was received for the research, authorship, and/or publication of this article. This research was funded by Spanish Centre for the Development of Industrial Technology (CDTI) and co-financed by the European Union’s ERDF funds (project name and code: Naturelief DI-20210105).

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Dietary supplementation with plant extracts for amelioration of persistent myofascial discomfort in the cervical and back regions: a randomized double-blind controlled study – PubMed