Abstract

Background: Serratiopeptidase is an enzymatic drug that has anti-inflammatory and analgesic effects. Chronic pain at the site of vaccination is considered as an AEFI. In this report, we discuss a case of a 16-year-old female with chronic pain following vaccination and use of serratiopeptidase as an analgesic for her symptoms. Case Presentation: A 16-year-old female came to the primary health care center with pain in the left arm (over the deltoid region) followed by MR vaccination. On examination, there were no any neuromuscular deficits. Her pain was graded 6/10 according to the Numerical Rating Scale for pain. She was given serratiopeptidase for 10 days, which led to the resolution of her symptoms. Conclusion: Here, the case of chronic pain followed by vaccination is presented where the patient was prescribed with serratiopeptidase following failure to resolve her symptoms by other means. Despite the lack of any solid clinical evidence supporting its usage, patient outcome questions whether it is actually a potent analgesic or a placebo drug.

1. Introduction

Serratiopeptidase is promoted as an anti-inflammatory agent and an analgesic drug, although the clinical data suggest that the efficacy of the drug is limited. Serratiopeptidase is usually used at an adult dosage of 10 mg thrice daily. Serratiopeptidase is an extracellular proteolytic enzyme produced by Serratia marcescens which is a type of bacteria isolated from the intestine of the silkworm Bombyx mori. ¹

Chronic pain at the vaccination site is a type of an AEFI. The AEFI includes an array of adversities that occur in the vaccinated individuals following vaccination at different time frames. Some of the AEFIs are acute, while some occur several days after vaccination. Acute reactions include the appearances of rashes, fever, difficulty in breathing and generalized itching, which can lead to a lethal reaction, anaphylactic shock. ²

Out of the late adversities observed following vaccination, pain at the site of vaccination is the commonly encountered adverse event by general practitioners. In the report, 16-year-old female with pain at the site of vaccination is described.

2. Case Presentation

A 16-year-old female came to the primary health care center with the chief complaint of pain in the left arm (over the deltoid region) at the site of vaccination followed by measles-rubella vaccination. She was vaccinated during the nationwide Measles-Rubella vaccination campaign, which started between February 25^th and March 3^rd, 2024.

She had experienced mild pain following the vaccination which gradually increased in severity over a period of 4 weeks. Her pain became severe following the use of her arm while performing daily chores and other usual activities. The NRS was used for grading the pain, which came out was 6/10 as described by the patient. ³

On examination, there was no tenderness upon palpation. Moreover, there was no limitation in the range of motion of the arm. She did not complain of any tingling sensation or any numbness in the deltoid region. The biceps and tendon reflexes were elicited normally, and the power in her arm was 5/5. ⁴

She had been prescribed NSAIDS for her symptoms with no avail over the period of 3 weeks. She had no history of intake of any other medications.

She had no history of similar symptoms following vaccination in the past. There was no history of any psychiatric illness in the patient or in the family. There was no history of chronic pain in the family.

She had undergone X-ray imaging of her left shoulder including the forearm, in the anteroposterior and lateral views, no abnormalities were observed in the X-ray image.

As she had no any positive outcomes following the administration of NSAIDS, she was prescribed the following medication:

- Tab. Serratiopeptidase 5 mg per oral b.i.d. for 5 days.

She was informed about the limited clinical studies suggesting the analgesic role of this drug. She was also counseled regarding possible complications following vaccination, as her symptoms might suggest one of them. She was asked to visit the center again after 5 days.

Following the completion of the doses, she visited the center again. She experienced a marked reduction in her symptoms and the distress. Using the NRS to rate her pain after the use of medication for 5 days, she stated that her pain was now 2/10. ³ She was then prescribed the same medication for 5 more days and was asked to visit the center after 5 days. She subsequently presented with no symptoms.

3. Discussion and Conclusion

Serratiopeptidase is an enzymatic drug with anti-inflammatory and mild analgesic effects. Furthermore, inhibiting the release of pain-inducing amines such as bradykinin from inflamed tissues may help alleviate pain. ⁵

It is also available in different combinations along with NSAIDS, such as diclofenac, acetaminophen(paracetamol), and aceclofenac. In particular, the analgesic activity of serratiopeptidase, which is said to be due to its ability to block the release of biogenic amines, needs to be evaluated with appropriate research methodology. The studies that have been conducted to date are mostly placebo-controlled trials and lack an active comparator. However, further extensive clinical studies need to be conducted before its therapeutic effects are well defined.

In the case discussed above, multiple factors might have contributed to her chronic pain. She might have a low threshold of pain, or not been counseled well about the pain that might occur following the vaccination. Psychosocial factors might also contribute to these findings. Similarly, the improper vaccination leads to injury to nearby structures, which is a well-documented possibility. It is also difficult to assess the main cause of her pain in the settings such as primary health care centers with limited resources where the case was discussed and managed.

However, due to the lack of proper scientific evidence regarding the mechanism and efficacy of serratiopeptidase, it remains unclear whether this enzyme actually has an analgesic effect or simply acts as a placebo in such cases.

Abbreviations

AEFI: adverse events following immunization; NSAIDS: non-steroidal anti-inflammatory drugs; MR: measles-rubella; NRS: numerical rating scale.

Declarations

Ethical Approval and Consent to participate

Not Applicable

Consent for publication

Written informed consent was obtained from the patient for publication of this case report and any accompanying images if any. A copy of the written consent is available for review by the Editor-in-Chief of this journal.

Availability of supporting data

Data sharing is not applicable to this article because no datasets were generated or analyzed during the current study.

Competing interests

The authors declare that they have no competing interests.

Funding

This study was not funded.

Authors’ contributions

Ashok P is responsible for the conceptual design and produced the initial draft of the manuscript, which was edited by Arya G. All the authors read and approved the final manuscript.

ACKNOWLEDGEMENT

We thank all the staff members of the Urban Health Promotion Centre, Butwal.

References