Topical Atorvastatin Emulgel May Reduce Pain Post-hemorrhoidectomy

Jessica Swain, Mercer University College of Pharmacy

Hemorrhoids is defined as the symptomatic enlargement and/or distal displacement of anal cushions.  Risk factors for hemorrhoids include: aging, obesity, abdominal obesity, depressive mood, pregnancy, constipation, and prolonged straining. [1]

The effect of topical atorvastatin on wound healing has not been evaluated.  The American College of Gastroenterology (ACG) recommends excision of thrombosed external hemorrhoids, symptomatic treatment for internal hemorrhoids using topical over-the-counter therapies, and office procedures, such as rubber-band ligation, for internal hemorrhoids that remain symptomatic after lifestyle modifications and over-the-counter medications. [2]

Postoperative care for an excisional hemorrhoidectomy may include nonsteroidal anti-inflammatory drugs supplemented by opioid analgesics.  Stool softeners and bulking agents are recommended to ease the passage of stool post-procedure.  Topical metronidazole 10% and topical diltiazem have been shown to decrease postoperative pain.  [3]

 

Effects of Topical Atorvastatin (2%) on Post-hemorrhoidectomy Pain and Wound Healing: A Randomized Double-Blind Placebo-Controlled Clinical Trial [4]
Design Prospective, double-blind, placebo-controlled, randomized; N= 66
Objective To investigate the efficacy of atorvastatin emulgel in reducing postoperative pain after open hemorrhoidectomy
Study Groups Placebo (n= 33); atorvastatin (n= 33)
Methods The first dose of atorvastatin or placebo was applied by the surgeon immediately after surgery and then was self administered by the patient under the instruction of a trained nurse to ensure correct application.  Patients were instructed to use 1 cm of emulgel on perianal skin every 12 hours for the first 14 days after surgery.  In the first 24 hours after surgery, patients received opioid analgesics (25 mg pethidine injection).  After discharge (24 hours after surgery), patients were instructed to apply the emulgel every 12 hours, take acetaminophen (500 mg) every 8 hours for pain control if required, and magnesium hydroxide (30 mL/day) until postoperative day 14.  Pain scores at rest and during defecation were assessed using a visual analog scale (0= no pain; 10= worst pain experienced).  Wound healing was assessed by the surgeon who recorded the amount of mucosal covering at the wound.
Duration December 2014 to March 2016
Primary Outcome Measure Postoperative pain at rest, pain during defecation, mean pethidine consumption during the first 24 hours after surgery, mean acetaminophen consumption 2-14 days after surgery, and wound healing
Baseline Characteristics
Atorvastatin Placebo
Mean age, years 37.39 38.15
Female, n 29 28
Results
Atorvastatin Placebo p-value
Pain score at rest
  12 hours after surgery 2.91 2.91 1
  24 hours after surgery 1.64 2.36 0.128
  48 hours after surgery 1.33 1.88 0.079
Pain scores during defecation
  24 hours after surgery 3.71 5.09 0.363
  48 hours after surgery 4.24 5.04 0.25
  1 week after surgery 2.52 4.06 0.0004
  2 weeks after surgery 1.24 1.97 0.003
Atorvastatin Placebo p-value
Pethidine consumption, mg
  12 hours after surgery 11.46 13.86 0.46
  24 hours after surgery 6.52 6.06 0.87
Acetaminophen, g
  24 to 48 hours after surgery 0.84 1.05 0.24
  48 hours to 1 week after surgery 2.59 4.21 0.027
  1 to 2 weeks after surgery 1.7 4 0.043

Atorvastatin vs. placebo difference in wound healing 1 week post-hemorrhoidectomy: p= 0.56
Atorvastatin vs. placebo difference in wound healing 2 weeks post-hemorrhoidectomy: p= 0.04

Adverse Events Common Adverse Events: mild pruritus (incidence not reported)
Serious Adverse Events: severe bleeding (atorvastatin- 3%)
Percentage that Discontinued due to Adverse Events: 0%
Study Author Conclusions Atorvastatin emulgel (2%) can reduce postoperative pain at rest and during defecation.   Atorvastatin improved healing in patients post-hemorrhoidectomy compared with placebo.

Patients receiving atorvastatin emulgel still needed as much analgesic medication as placebo for the first 48 hours after surgery; thus, atorvastatin emulgel should not be used as single agent in the management of post-hemorrhoidectomy pain.  There was not much clinical difference in the pain scores of patients at two weeks; however, the placebo group needed 4 g of acetaminophen a day versus 1.7 g of acetaminophen needed in the atorvastatin group.  Atorvastatin’s effect on wound healing is thought to be mediated by the pleiotropic effects of statins, such as anti-inflammatory, immunomodulatory, antioxidant, and metabolic activities.  It may also be due to improved microvascular reperfusion in the affected skin and soft tissue with the use of atorvastatin.  

 

References

  1. Lohsiriwat V. Treatment of hemorrhoids: A coloproctologist’s view. World J Gastroenterol. 2015;21(31):9245-52.
  2. Wald A, Bharucha AE, Cosman BC, Whitehead WE. ACG clinical guideline: management of benign anorectal disorders. Am J Gastroenterol. 2014;109(8):1141-57.
  3. Mounsey AL, Halladay J, Sadiq TS. Hemorrhoids. Am Fam Physician. 2011;84(2):204-10.
  4. Ala S, Alvandipour M, Saeedi M, et al. Effects of Topical Atorvastatin (2 %) on Posthemorrhoidectomy Pain and Wound Healing: A Randomized Double-Blind Placebo-Controlled Clinical Trial. World J Surg. 2017;41(2):596-602.
Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s