Running head: ALTERNATIVE THERAPY 1

Mankowski, C., Poole, C. D., Ernault, E., Thomas, R., Berni, E., Currie, C. J., … Odeyemi, I.

(2017). Effectiveness of the capsaicin 8% patch in the management of peripheral

neuropathic pain in European clinical practice: the ASCEND study. BMC Neurology,

17(1). doi: 10.1186/s12883-017-0836-z

The study by Mankowski et al. (2017) evaluated the efficacy, tolerance, and quality of

life with the use of the Capsaicin 8% patch on people experiencing Peripheral Neuropathic Pain

(PNP) unrelated to diabetes. The study was made up of 420 patients who received a minimum of

one treatment. The patients were collected from seven European countries and the mean age of

the participants was 61. Patients were deemed eligible to participate in the study if they were at

least 18 years of age, their physician had recommended the Capsaicin 8% patch for their

treatment, had a diagnosis of nondiabetic PNP and had been provided with a consent form.

Patients who had been diagnosed with diabetes, had PNP on only their face or above their

hairline, diagnosed with a psychiatric disorder, or had a prior treatment using capsaicin 8% patch

were ineligible to participate in the study. The patients were divided into six different aetiology

groups, to compare the data between the different causes of PNP. For each treatment, the

location and size of the area in which the patient was experiencing pain was assessed in order to

determine the necessary area of treatment. Each capsaicin 8% patch that was used contained 179

mg of capsaicin and up to four patches were approved per treatment. For the patients who chose

to remain in the study, from the baseline to week 2, there was a reduction of 24.5% within their

mean NPRS score, and from week 2 to week 52 there was a reduction of 37.0%.

This study demonstrates the effectiveness of capsaicin 8% patch as a type of pain therapy

for people who have non-diabtetic PNP. Although the results indicate a positive impact on pain
ALTERNATIVE THERAPY 2

management, it is unclear whether the results can accurately be used as the study lost many

participants over the 52 week period leaving the results skewed, and potentially non-reliable.

This study provided detailed explanations of the participants, the results and the

conclusion. An inclusive concept of PNP was used for this study, allowing for a better

understanding of the effects of the drug. However, the sample size of the study was too small in

regards to the large area of sampling. This can cause a limitation in the interpretation of the

effectiveness of the Capsaicin 8% patch because of the different ways in which various

populations may perceive or define pain.

Simpson, D. M., Robinson-Papp, J., Van, J., Stoker, M., Jacobs, H., Snijder, R. J., … Katz, N.

(2017). Capsaicin 8% Patch in Painful Diabetic Peripheral Neuropathy: A Randomized,

Double-Blind, Placebo-Controlled Study. The Journal of Pain, 18(1), 42–53. doi:

10.1016/j.jpain.2016.09.008

In the double-blind randomized-control study by Simpson et al. (2017), the safety and

efficacy of the Capsaicin 8% patch was tested versus a placebo on patients who experience PNP

related to diabetic neuropathy. This study was made up of 369 patients, 186 were randomly

assigned to receive the capsaicin 8% patch and the other 183 were randomly assigned to the

placebo patch. The mean age of the participants was 63, with over half of the participants being

caucasian and male. Patients were deemed eligible to participate in the study if they were over

the age of 18 and had been diagnosed with painful diabetic peripheral neuropathy (PDPN)

related to type 1 or type 2 diabetes mellitus for at least one year before the study began. Some

exclusion criteria for the study included pain that could not be differentiated from PDPN,

majority of PDPN in or above the ankles, previous or current foot ulcers, and an amputation of

the lower extremities. To measure pain levels the patients were required to call daily to describe
ALTERNATIVE THERAPY 3

their average pain levels within the past 24 hours. After initial application of the patch, patients

returned on weeks 2, 4, 8, and 12 of the 12 week study for physical assessments. The mean

decrease in average daily pain percent from the baseline compared to week 2 through week 8

was 27.4% in the experimental group compared to the placebo group at 20.9%. Between weeks 2

and 12 the average daily pain percent decrease was 28.0% in the experimental group compared

to the placebo group at 21.0%.

Although the Capsaicin 8% patch was shown to be effective for pain management by

lowering the participants pain scale in PDPN the results showed a statistical significance of only

0.025. As the effect of the patch compared to the placebo was small, physicians must assess the

significance of use of the patch compared to other available methods of treatment.

The strengths of this study are evident as it was a randomized, double blind

procedure which is the optimal form of experimental design used in quantitative research studies.

This study had a strong, moderately sized sample that demonstrated that the study was a rigorous

experiment. A limitation in the study was caused by a greater amount of participants in the

capsaicin group (33.9%) reported application sites compared to the placebo group (8.2%). It’s

possible that the patients in the capsaicin group were influenced through the being aware of their

application sites causing the patients to become unblinded, influencing the results of this group.

Since there was not a “masking assessment” at the end of the trial, functional unblinding cannot

be directly determined. The study findings could be considered as a limitation due to the duration

only being 12 weeks and the assessments of only one treatment with capsaicin 8% patch.
ALTERNATIVE THERAPY 4

Capsaicin 8% Patch as an Alternative Therapy

Jamie Apelowicz, Mikayla Closs and Cassandra Delaney

Dr. Jane Mackie

Trent University
ALTERNATIVE THERAPY 5

Capsaicin 8% Patch as an Alternative Therapy

Capsaicin is a potent, selective agonist for the transient receptor potential vanilloid type

1 (TRPV1) ion channel. With the use of high-dose Capsaicin, the TRPV1 at the pain site can be

defunctionalized. This leads to a disruption of the mitochondrial respiration and causes the nerve

fibers to retract, which in turn reduces the pain response being experienced (Mankowski et al.,

2017). Capsaicin 8% has been tested for the treatment of peripheral neuropathic pain (PNP). PNP

can be understood as damage to the nerves located outside of the brain and spinal cord and can

be caused by lesions or diseases of the somatosensory (i.e. diabetes, cancer, and HIV)

(Mankowski et al., 2017). Through this assessment the safety and efficacy of the capsaicin 8%

patch use in PNP treatment will be addressed.

Efficacy and Safety

The studies performed by Mankowski et al. (2017) and Simpson et al. (2017) depict the

capsaicin 8% patch as being an effective alternative therapy for peripheral neuropathic pain

related to various etiologies. However, the efficacy and safety of the intervention is problematic

in some cases. In the non-interventional study conducted by Mankowski et al. (2017) the

participants involved were 95% caucasian. Since the effects of the patch were not equally tested

on other races the safety and efficacy for these cases are unknown. Likewise, the participants in

the study conducted by Simpson et al. (2017) were 71% caucasian meaning the safety and

efficacy for these cases are additionally unknown. Further, in the study by Simpson et al. (2017)

76% of the participants in the intervention group and 71% of the participants in the placebo

group were taking analgesic medications throughout the study. Due to this the exact effect of the

patch on pain cannot be determined, as its effects were not tested individually. Overall, the use of

the capsaicin 8% patch is effective for caucasians experiencing PNP from various etiologies in
ALTERNATIVE THERAPY 6

combination with other analgesic. The safety of the capsaicin 8% patch can be questioned by

looking at the adverse effects experienced in both studies. In the study conducted by Mankowski

et al. (2017) adverse effects were reported by 11% of the participants, these were largely due to

site application reactions. In the study conducted by Simpson et al. (2017) the most common

adverse effects of both groups were also application site reactions. It is unknown why the skin

reactions developed, causing the full safety of the capsaicin 8% patch to be unknown.

Analysis of Data

Upon reviewing the studies on the use of the capsaicin 8% patch in PNP treatment

performed by Mankowski et al. (2017) and Simpson et al. (2017) we have further discussed the

use of the patch in the context of our future nursing practice. We believe that the capsaicin 8%

patch is an effective alternative for those who choose to not use opioids as a form of pain

management in relation to a history of addiction or other reasons. We would advise that

individuals of any population other than caucasian should avoid using this patch or proceed with

caution. This is due to the limited amount of research directed towards other races as both studies

had low diversity, focusing primarily on caucasian individuals. Individuals with CRNP and HIV

should also proceed with caution when choosing to use the capsaicin 8% patch or simply not use

the patch. This is due to the significantly low number of participants with CRNP or HIV within

the subgroups which leads to an improper analysis in regards to these conditions. Even though

this study set a large amount of limitations, due to only being determined safe for the caucasian

race, we do feel that the efficacy seen in these studies would make this an alternative therapy

worth advocating for within this specific population.

ALTERNATIVE THERAPY 7

Conclusion

In conclusion, we would encourage the use of the capsaicin 8% patch in combination

with other mild analgesics for caucasians experiencing PNP due to various etiologies. We would

advise caution for use of this alternative therapy to those of a race other than caucasian due to the

small amount of research done involving these populations. These limitations are applied to this

alternative therapy due to the lack of testing that was done in the studies conducted by

Mankowski et al. (2017) and Simpson et al. (2017). Due to this, we are unable to suggest the use

of the capsaicin 8% patch for those who are not within the population that was largely tested.

However, we have found that for those within the main population that was tested, the use of the

patch is an effective and safe alternative therapy.

ALTERNATIVE THERAPY 8

References

Mankowski, C., Poole, C. D., Ernault, E., Thomas, R., Berni, E., Currie, C. J., … Odeyemi, I.

(2017). Effectiveness of the capsaicin 8% patch in the management of peripheral

neuropathic pain in European clinical practice: the ASCEND study. BMC Neurology,

17(1). doi: 10.1186/s12883-017-0836-z

Simpson, D. M., Robinson-Papp, J., Van, J., Stoker, M., Jacobs, H., Snijder, R. J., … Katz, N.

(2017). Capsaicin 8% Patch in Painful Diabetic Peripheral Neuropathy: A Randomized,

Double-Blind, Placebo-Controlled Study. The Journal of Pain, 18(1), 42–53. doi:

10.1016/j.jpain.2016.09.008