Serratiopeptidase with diclofenac sodium effective for pain after day care obstetric and gynaecological surgeries: Study

The attention of surgeons has been focused on the elements of patient care that can be improved in the light of the modern emphasis on managed care and shorter hospital stays. Reducing or even eliminating post-operative pain, without introducing excessive sedation, promotes rapid mobilization and return to autonomy. Targeted multimodal pain management can reduce postoperative ileus and other adverse reactions to analgesics.

One proteolytic enzyme that has been used to lessen inflammation is serratiopeptidase. Because of its antiinflammatory and anti-edema qualities, enteric coated oral formulations of this enzyme are frequently used in a variety of specialties, including surgery, orthopaedics, otolaryngology, gynecology, and dentistry. When used in conjunction with surgery, nonsteroidal anti-inflammatory drugs, or NSAIDs, have demonstrated their efficacy as analgesics, as evidenced by either a decrease in pain scores or an opioid sparing effect. Diclofenac is one of the NSAIDs commonly prescribed for pain relief. Although the efficacy and safety of Serratiopeptidase and Diclofenac Sodium has been proven in few randomized clinical trials, data regarding the effectiveness of this combination for relief of symptoms in clinical practice settings in obstetric and gynaecological surgeries, are scarce. Therefore, based on a retrospective pooled analysis of data in clinical practice settings, Bapat et al. aimed to assess the fixed dose combination (FDC) of Serratiopeptidase (10 mg) with Diclofenac Sodium (50 mg) in day care obstetric and gynaecological surgeries in daily practice.

This was a single centre, retrospective, observational data collection in reallife scenario. Data of adult women who had undergone day care OBG surgery and received a FDC of Serratiopeptidase (10 mg) with Diclofenac Sodium (50 mg) gastro-resistant tablets TID for period of 24 hours was retrieved and analysed. VAS (Visual Analogue Scale) data on post-operative pain at rest and pain on movement as well as post-operative swelling were analyzed in conjunction with monitoring for adverse events.

Among 61 patient’s data included in the study, 40 (65.57%) had undergone Minimally Invasive Vaginal Hysterectomy (MIVH), 4 (6.56%) had MIVH with Bilateral Salpingo-oophorectomy, and 17 (27.87%) had other OBG surgeries. The average VAS scores for pain at rest (VAS), pain on movement (VAS) and swelling were significantly reduced compared to baseline at all-time points (p>0.001). Clinical global impression of efficacy and safety for 95% physician’s and 93.3% patients was good to very good. FDC was found to be well tolerated without any serious adverse reaction.

Postoperative pain is the major concern in surgeries of obstetrics and gynaecology department and it is associated with the highest severity. So it is highly essential to improve the postoperative pain management in minor surgeries. For certain patients, postoperative pain control still requires improvement despite advancements in pharmacology and surgical techniques. Inadequate management of pain following surgery is linked to longer hospital stays, ER visits, and readmissions. Insufficient postoperative pain control also leads to the development of chronic pain. Multi-modal pain management strategy along with reduction in swelling is needed in post obstetric and gynaecological surgeries.

Serratiopeptidase is a proteolytic enzyme excreted by non-pathogenic Enterobacteria serratia isolated from intestine of silkworms Bombyx mori L Serratiopeptidase exhibits notable analgesic, anti-inflammatory, and antiedema characteristics. This enzyme was discovered to be used for pain, inflammation brought on by trauma, and surgery. It reduces inflammation in three ways: by breaking down blood coagulation-related insoluble protein byproducts, by thinned inflammation- and injury-related fluids, and by speeding up tissue repair. It lessens pain by preventing the amines that cause pain. It also aids in healing by dissolving the dead tissue that surrounds the wounded area. Moreover, serratiopeptidase functions by altering adhesion molecules on the cell surface. Serratiopeptidase is not addictive and does not result in hazardous internal bleeding like NSAID painkillers do. Its application lies in its ability to suppress and eradicate hemorrhage following surgery.

It was found that this enzyme is used for pain relief. It breaks down protein deposits like fibrin in the human body. This is a safe, natural substitute for NSAIDs and steroids that doesn’t have any negative side effects.

A FDC of an effective proteolytic enzyme, Serratiopeptidase and a potent NSAID Diclofenac, complement the action of each other by inhibiting the release of bradykinin and blocking production of prostaglandins. It is approved for use as a pharmaceutical ingredient in India to treat acute pain in conjunction with other medications. This combination not only controls inflammation but also helps in the clearance of exudates and improving microcirculation.

The use of enzymes in medical therapy has been limited. Serratiopeptidase has revealed interesting applications in the field of pain management. Serratiopeptidase has a remarkable record of safety from decades of use by millions of users all around the world. Authors did not record any serious adverse events in our study either. Serratiopeptidase dosage recommendations range from 10 mg to 30 mg daily. It is commonly known that serratiopeptidase reduces pain by preventing the release of molecules that cause pain from inflammatory tissues. Enzymes have a higher affinity and specificity for their targets, which allows them to convert multiple target molecules into desired products. As a result, enzymespecific drugs have been developed to treat a wide range of disorders.

Results of this study provides direct clinical evidence of the efficacy and safety of FDC of Serratiopeptidase and Diclofenac sodium in day care obstetric and gynaecological surgeries in reducing post-operative pain and swelling in the early post-operative period.

Source: Bapat et al. / Indian Journal of Obstetrics and Gynecology Research 2024;11(3):442–446