Startseite Effects of evening primrose oil on treating painful diabetic neuropathy: a randomized, double-blind, clinical trial
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Effects of evening primrose oil on treating painful diabetic neuropathy: a randomized, double-blind, clinical trial

  • Ayub Gholami , Neda Koulaeinejad EMAIL logo und Mehrali Rahimi
Veröffentlicht/Copyright: 23. Mai 2025

Abstract

Objectives

Diabetic neuropathy results in chronic pain. Traditional treatments often offer limited relief, prompting the exploration of alternative therapies like Evening Primrose Oil (EPO). This study aimed to assess the efficacy of EPO in the treatment of painful diabetic neuropathy.

Methods

In this interventional clinical trial, Patients were randomly assigned to three groups. Group A, consisted of 24 patients, received 1,000 mg of EPO soft gel capsules every 12 h. Group B, consisted of 21 patients, received 1,000 mg of EPO soft gel capsules daily. Group C, also with 21 patients, was divided so that half of the patients received placebo capsules daily and the other half every 12 h. After 4 weeks, patients returned, and questionnaires were completed. Statistical analysis of the data was conducted using SPSS version 25.

Results

Groups A and B showed significant reductions in visual analog scale (VAS) pain scores, with Group A achieving the most improvement (mean pre-test: 5.96; post-test: 4.63). Analysis of covariance (ANCOVA) revealed significant differences in post-intervention scores (p<0.001) for VAS and Neuropathy total symptom score-6 (NTSS-6), indicating effective interventions. Treatment A was more effective than Treatment B for reducing pain (VAS mean difference= −0.52; p=0.044) and McGill Pain Questionnaire (MPQ) scores (mean difference= −9.56; p<0.001).

Conclusions

EPO could serve as a valuable alternative therapy for managing painful diabetic neuropathy with fewer side effects than traditional treatments. Further research is warranted to validate these results and explore EPO treatment long-term efficacy and safety.


Corresponding author: Dr. Neda Koulaeinejad, Assistant Professor, Department of Clinical Pharmacy, Faculty of Pharmacy, Pharmaceutical Sciences Branch, Islamic Azad University, Tehran, Iran, E-mail:

Acknowledgments

Authors thank Dr. Sadeghi and Dr. Masoud Karimloo for statistical consultation. We would like to thank the support of the head and also the help of the staff and nurses of the Research Clinic of Endocrine Glands at Ayatollah Taleghani Hospital, Kermanshah University of Medical Sciences for their contribution.

  1. Research ethics: The ethical approval for this study was obtained from ethics Committee of Islamic Azad University of Medical Sciences, under the ethics code [IR.IAU.PS.REC.1401.102]. This trial was conducted in accordance with the Declaration of Helsinki and its subsequent revisions (as revised in 2013).

  2. Informed consent: Informed consent was obtained from all individuals included in this study, or their legal guardians or wards.

  3. Author contributions: The author has accepted responsibility for the entire content of this manuscript and approved its submission.

  4. Use of Large Language Models, AI and Machine Learning Tools: None declared.

  5. Conflict of interest: The authors state no conflict of interest.

  6. Research funding: None declared.

  7. Data availability: The raw data can be obtained on request from the corresponding author.

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Received: 2025-02-05
Accepted: 2025-05-02
Published Online: 2025-05-23

© 2025 Walter de Gruyter GmbH, Berlin/Boston

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