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Coenzyme Q10 as a potential add-on treatment for patients suffering from painful diabetic neuropathy: results of a placebo-controlled randomized trial

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Abstract

Background

We hypothesized that the addition of coenzyme Q10 (CoQ10) to pregabalin might be helpful in improving symptoms in patients suffering from painful diabetic neuropathy (PDN).

Methods

One hundred twelve patients with PDN were randomly allocated to receive CoQ10 + pregabalin (57 patients) or placebo + pregabalin (55 patients). Besides pregabalin (150 mg/day), the patients, upon their group assignment, received CoQ10 at a dosage of 100 mg every 8 h or matched placebo for 8 consecutive weeks. The primary efficacy measure was the changes in the pain intensity from baseline to endpoint measured on an 11-point NRS (numeric rating scale). Secondary efficacy measures included the changes in the pain-associated sleep interference score (SIS) as well as the patients’ global improvement with treatment measured on the Clinicians’ and Patients’ Global Impression of Change (CGIC/PGIC).

Results

On the intent‑to‑treat population (ITT) analysis, the CoQ10 + pregabalin regimen resulted in significantly greater pain relief than the placebo + pregabalin regimen. By the end of week 2, the decrease in the mean pain NRS score was similar in both groups, but at the end of weeks four and eight, the decrease in the mean pain NRS score was significantly greater in patients taking CoQ10 + pregabalin than in those taking placebo + pregabalin (p value = 0.01 and < 0.001, respectively). Likewise, at the end of week 8, the decrease in the pain-associated SIS was significantly greater in the patients supplemented with CoQ10 compared to placebo. Furthermore, the proportion of the responder patients (those having ≥ 50% decline in the mean pain NRS score) as well as the proportion of patients rated ‘‘very much’’ or ‘‘much improved’’ on the CGIC/PGIC scales were also significantly higher in the CoQ10 + pregabalin-treated patients than placebo + pregabalin-treated patients.

Conclusions

Our data support the idea that diabetic patients suffering from PDN may benefit from using antioxidant and anti-inflammatory supplements like CoQ10. However, further studies are required before supplementation with CoQ10 can be recommended for treating PDN. Trial registration. The trial was registered at Iranian Registry of Clinical Trials (identifier code: IRCT20120215009014N385). Registration date: 2021–02-21.

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Availability of data and material

The datasets used and analyzed during the current study are available from the corresponding author on reasonable request up to 2 years after publication.

Code availability

Not applicable.

Abbreviations

PDN:

Painful diabetic neuropathy

CoQ10:

Coenzyme Q10

NFkB:

nuclear factor kappa B

ROS:

reactive oxygen species

SF-MPQ:

Short-Form McGill Pain Questionnaire

VAS:

visual analog scale

NRS:

numeric rating scale

SIS:

sleep-interference scores

PGIC:

Patient Global Impression of Change

CGIC:

Clinician Global Impression of Change

ITT:

the intent to treat population

LOCF:

last observation carried forward

NSS:

neuropathy symptoms score

NIS:

neuropathy impairment score

hsCRP:

C-reactive protein

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Acknowledgements

We are grateful to all patients who participated in this study.

Funding

This research was supported by funding from the vice-chancellor for research and technology, Hamadan University of Medical Sciences, Hamadan, Iran (Grant No: 140002211123). This grant was not assigned to the manuscript writing, editing, and publication fee.

Author information

Authors and Affiliations

  1. Department of Clinical Pharmacy, School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave, Hamadan, 6517838678, Iran

    Paryan Amini & Maryam Mehrpooya

  2. Department of Internal Medicine, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran

    Firozeh Sajedi

  3. Department of Clinical Pharmacy, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran

    Mahtabalsadat Mirjalili

  4. Modeling of Noncommunicable Diseases Research Center, School of Public Health, Hamadan University of Medical Sciences, Hamadan, Iran

    Younes Mohammadi

Authors
  1. Paryan Amini
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  2. Firozeh Sajedi
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  3. Mahtabalsadat Mirjalili
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  4. Younes Mohammadi
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  5. Maryam Mehrpooya
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Contributions

Conceptualization: Mehrpooya and Amini, Methodology: Mirjalili, Mehrpooya, and Sajedi, Data acquisition: Amini, Mirjalili, and Sajedi, Statistical analysis: Mohammadi and Mehrpooya, Writing—original draft preparation: Amini and Mirjalili, Writing—review and editing: Sajedi and Mehrpooya. All authors contributed to the interpretation of the results and read and approved the final manuscript.

Corresponding author

Correspondence to Maryam Mehrpooya.

Ethics declarations

Ethics approval and consent to participate

The trial protocol was according to the Declaration of Helsinki as revised in 1989, and the study protocol was approved by the research and ethics committee at Hamadan University of Medical Sciences (Ethical number: IR.UMSHA.REC.1399.678). The patients/participants provided their written informed consent to participate in this study.

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Since the research does not include any information identifying individuals, there is no need for consent for publication for this work.

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The authors declare no competing interests.

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Amini, P., Sajedi, F., Mirjalili, M. et al. Coenzyme Q10 as a potential add-on treatment for patients suffering from painful diabetic neuropathy: results of a placebo-controlled randomized trial. Eur J Clin Pharmacol 78, 1899–1910 (2022). https://doi.org/10.1007/s00228-022-03407-x

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