The efficacy and safety profile of capsaicin 8% patch versus 5% Lidocaine patch in patients with diabetic peripheral neuropathic pain: a randomized, placebo-controlled study of south Asian male patients

Abstract

Aims

Diabetic peripheral neuropathy affects up to 60% of individuals and often leads to foot ulceration and eventual amputation. When oral therapy has failed to achieve pain relief, the first line local treatment is the 5% lidocaine-medicated plaster which provides local relief. Capsaicin 8% patch is considered a promising topical treatment for diabetic peripheral neuropathy. The present study investigated the efficacy, safety and tolerability of capsaicin 8% patch vs 5% lidocaine patch treatments over 24 weeks in South Asian male diabetic patients with established peripheral diabetic neuropathy.

Methods

Analgesic effectiveness was assessed by observing any change in the Numeric Pain Rating Scale (NPRS) score, Brief Pain Inventory (BPI) for painful diabetic peripheral neuropathy (BPI-DPN question 4) and Patient Global Impression of Change (PGIC). All patients received 4% lidocaine gel/cream for 60 min prior to patch application. The trial was probably underpowered, taking into account the smaller than expected number of participants from the calculated 350 sample size required for the whole study. Two hundred ninety-one individuals were divided into three groups based on treatment regimen; Group LL (Lidocaine + Lidocaine), Group LP (Lidocaine + Placebo), Group LC (Lidocaine + Capsaicin). The treatment procedure was conducted once initially and then repeated once at 12 weeks. The patients were followed up on alternate weeks till 24 weeks after the initial treatment.

Results

Group LC experienced a more significant reduction in the average pain intensity (p < 0.05) during the last twenty-four hours. Group LC showed more significant reduction of pain compared to control (p < 0.01), a baseline score of 5.4 ± 1.2 dropped to 3.2 ± 1.5 by week 24 of treatment. The change in mean daily pain intensity was – 2.2 ± 1.5 [95% CI: −2.45, −1.5]. Group LL and LC experienced a significant overall improvement (slightly, much or very much) in the health status during the study. After the second week of the treatment, patient satisfaction scores were 2.1 ± 1.1 in Group LL which increased to 3.2 ± 1.2 by week 24 of treatment. The capsaicin 8% patch appears to be reasonably well tolerated since there were no discontinuations because of serious drug-related treatment emergent adverse event (TEAEs).

Conclusions

The aim of the present study was to assess the efficacy, safety and tolerability of the 8% capsaicin patch in patients with established painful diabetic neuropathy. There was a sustained treatment response to the initial and repeat treatment of the capsaicin 8% patch over the 24 weeks. The study population was very specific so further studies are required to investigate the generalizability of the results for patients experiencing painful diabetic neuropathy. The patch could be considered as an effective long-term treatment option in individuals with painful diabetic neuropathy, particularly those experiencing inadequate pain relief or side effects from systemic therapies.

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Data availability

The data that support the findings of this study are available on request from the corresponding author; N.H, upon reasonable request.

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Acknowledgments

We thank Dr. Fatima, Dr. Bilal and Dr. Zahra for their work and support.

Funding

The study received the hospital research grant approved by the Punjab Care Hospital Research Council [IAC-0457]. The funders did not have any role in the study design, execution, data collection or analysis and in the manuscript preparation or editing.

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Authors

Contributions

N.H. and A.S.A.S, contributed to the design and implementation of the research. Z.K supervised the work and contributed in data collection and processing. F.J, A.H.I.A.A contributed to the analysis of the results. M.A and A.A.M contributed to the writing of the manuscript.

Corresponding author

Correspondence to Nadia Hussain.

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Conflicts of interest/competing interests

The authors all declare that there is conflict of interest. The research grant was not obtained from any pharmaceutical company or supplier and no author was a member of any study sponsor source.

Ethical approval

The study was approved by the Punjab Care hospital review board (Approval no. 38920), conducted in agreement with the ethical guidelines of the Declaration of Helsinki, Good Clinical Practice guidelines, and applicable regulatory requirement.

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Informed consent was obtained from all individual participants included in the study.

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Hussain, N., Said, A.S.A., Javaid, F.A. et al. The efficacy and safety profile of capsaicin 8% patch versus 5% Lidocaine patch in patients with diabetic peripheral neuropathic pain: a randomized, placebo-controlled study of south Asian male patients. J Diabetes Metab Disord (2021). https://doi.org/10.1007/s40200-021-00741-2

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Keywords

  • Diabetes
  • Diabetic neuropathy
  • Lidocaine
  • Capsaicin
  • Patch treatment