by Nat Jones

Perianal Crohn’s disease, ulcerative proctitis, radiation proctitis—these conditions can be difficult for patients to discuss, but even more challenging to live with. The bottom line is that rectal problems are painful. Fortunately, compounding pharmacists have a specific set of tools and knowledge to help these patients.

Some compounders are familiar with using PCCA’s MucoLox in formulations for patients with oral problems, but this versatile base can be ideal in other mucosal applications as well, including rectal. For those who aren’t familiar with it, MucoLox is a unique liquid-gel base that PCCA invented specifically to deliver active pharmaceutical ingredients to mucosal tissue while improving their contact time with the site of application. This means that it is ideal in compounded medications for nasal, oral, esophageal, gut, vaginal or rectal application, and even wound care. We’re constantly looking for new opportunities and developing new formulas with this base to help bridge the gap between problem and solution, especially when the problem is painful.

Here is some information about these conditions as well as some potential options for patients. Please note that the studies and medical literature I cite here didn’t evaluate the PCCA products or formulas I mention, but they may support sound clinical decisions for patient care on a case-by-case basis.

Crohn’s Disease
Crohn’s disease is an inflammatory bowel disease that can affect any part of the gastrointestinal tract from mouth to anus. The term “perianal Crohn’s disease” is used when inflammation occurs near or at the anus. This can include tags, fissures, abscesses, fistulae or stenosis. It is associated with symptoms such as these:

• Incontinence of stool
• Pain
• Itching
• Bleeding
• Purulent discharge¹

It is a morbid condition that decreases quality of life, and as a last resort, may require surgery. However, non-surgical interventions can help with a number of symptoms.

Researchers have published articles on the use of topical tacrolimus as a non-surgical option for the treatment of perianal Crohn’s disease and ulcerative proctitis. Case studies within this literature showed positive results usually in one to four weeks of therapy.^2,3 PCCA Formula #11933, a rectal gel with tacrolimus in MucoLox and VersaBase® Gel, may be a suitable option for patients with fissures associated with perianal Crohn’s disease. This formula contains MucoLox to improve proximity and contact time of the tacrolimus with the mucosa. PCCA members can access this formula here.

Ulcerative Proctitis
Another problematic rectal condition is ulcerative proctitis, a subcategory of ulcerative colitis that only involves the rectum and is characterized by inflammation and ulceration of the rectal lining. Symptoms of ulcerative proctitis are:

• Diarrhea
• Bleeding 
• Tenesmus 
• Mucus discharge
• Rectal pain
• Accidental bowel leakage

 
Standard drug treatment options for inflammatory-induced ulcerative proctitis include topical aminosalicylates, oral aminosalicylates or topical steroids.⁴ Many cases, however, are resistant to these treatments, but research has shown that topical tacrolimus is a promising option for resistant ulcerative procitis.^5,6 PCCA Formula #11373 is a rectal enema with tacrolimus in MucoLox, making it mucoadhesive, which will likely increase contact time with the mucosa. PCCA members can access this formula here.

Radiation Proctitis
A third condition requiring rectal therapy is radiation proctitis. Radiation therapy causes production of matrix metalloproteases and reactive oxygen species that cause tissue degradation and damage to the endothelial lining of the rectum. This most commonly occurs after radiation treatment for cancers, such as those of the cervix, prostate and colon. Symptoms include: 

• Inflammation
• Pain
• Bleeding
• Diarrhea

The diarrhea from radiation proctitis is commonly treated with oral opioids.⁷ PCCA Formula #11425, a rectal gel with loperamide in MucoLox and VersaBase Gel, may be a non-opioid alternative to this therapy, potentially providing symptomatic relief without the systemic side effects from oral opioids. PCCA members can access this formula here.

Treatment of the degradation in the rectal lining caused by reactive oxygen species is one way to improve healing and resolution of symptoms. PCCA Formula #11928, a combination rectal suspension enema with lidocaine in MucoLox, contains several ingredients that may help with recovery.^8,9 PCCA members can access this formula here. MucoLox, in addition to improving and extending contact time of active pharmaceutical ingredients to the mucosal surface, contains sodium hyaluronate, which may help hydrate the epithelial lining as well.

Additional Lifestyle Factors
Treatment of inflammatory bowel conditions may also require that patients reduce or eliminate pro-inflammatory food from their diets. It might be necessary to implement a complete gut repair protocol, which includes, but is not limited to, probiotics and glutamine. A high-fiber diet and plenty of water are usually helpful for these patients as well.

If PCCA members have any questions about MucoLox formulations and applications, please call our Clinical Services department at 800.331.2498.

Nat Jones, RPh, FIACP, is a Clinical Compounding Pharmacist at PCCA. He has over 40 years of experience in hospital and community pharmacy, and he owned and operated independent pharmacies for almost 20 years before joining the staff of PCCA in 2014. Nat is also a Fellow of the International Academy of Compounding Pharmacists. He has delivered presentations at professional seminars for 20 years on topics including general pharmacy compounding, wound care, pain management, hormone replacement therapy, dermatology and cosmetics, among others.

A version of this article was originally published in the Apothagram, PCCA’s members-only magazine.

References
1.    de Zoeten, E. F., Pasternak, B. A., Mattei, P., Kramer, R. E., & Kader, H. A. (2013). Diagnosis and treatment of perianal Crohn disease: NASPGHAN clinical report and consensus statement. Journal of Pediatric Gastroenterology and Nutrition, 57(3), 401–412. https://doi.org/10.1097/MPG.0b013e3182a025ee
2.    Sandborn, W. J., Present, D. H., Isaacs, K. L., Wolf, D. C., Greenberg, E., Hanauer, S.B., … Sandler, R. S. (2003). Tacrolimus for the treatment of fistulas in patients with Crohn’s disease: A randomized, placebo-controlled trial. Gastroenterology, 125(2), 380–388
3.    Hart, A. L., Plamondon, S., & Kamm, M. A. (2007). Topical tacrolimus in the treatment of perianal Crohn’s disease: Exploratory randomized controlled trial. Inflammatory Bowel Diseases, 13(3), 245–253. https://doi.org/10.1002/ibd.20073
4.    Regueiro, M. D. (2004). Diagnosis and treatment of ulcerative proctitis. Journal of Clinical Gastroenterology, 38(9), 733–740.
5.    Navas-López, V. M., Blasco-Alonso, J., Girón Fernández-Crehuet, F., Serrano Nieto, M. J., Gallego-Gutiérrez, S., Luque Pérez, S., & Sierra Salinas, C. (2014). Successful treatment for ulcerative proctitis with rectal tacrolimus in an 8-year-old girl with intolerance to mesalamine. Clinical Journal of Gastroenterology, 7(4), 320–323. https://doi.org/10.1007/s12328-014-0506-2  
6.    Lawrance, I. C., & Copeland, T. S. (2008). Rectal tacrolimus in the treatment of resistant ulcerative proctitis. Alimentary Pharmacology and Therapeutics, 28(10), 1214–1220. https://doi.org/10.1111/j.1365-2036.2008.03841.x
7.    Fuccio, L., Guido, A., & Andreyev, H. J. (2012). Management of intestinal complications in patients with pelvic radiation disease. Clinical Gastroenterology and Hepatology, 10(12), 1326–1334. https://doi.org/10.1016/j.cgh.2012.07.017
8.    Vetvicka, V., Vetvickova, J. (2011). β(1-3)-D-glucan affects adipogenesis, wound healing and inflammation. Oriental Pharmacy and Experimental Medicine, 11(3), 169–175. https://doi.org/10.1007/s13596-011-0024-4  
9.    Klimberg, V. S., Salloum, R. M., Kasper, M., Plumley, D. A., Dolson, D. J., Hautamaki, R. D., … Souba, W. W. (1990). Oral glutamine accelerates healing of the small intestine and improves outcome after whole abdominal radiation. Archives of Surgery, 125(8), 1040–1045. https://doi.org/10.1001/archsurg.1990.01410200104017

These statements are provided for educational purposes only. They have not been evaluated by the Food and Drug Administration, and are not to be interpreted as a promise, guarantee or claim of therapeutic efficacy or safety. The references cited did not necessarily evaluate PCCA products or formulas included in these statements. The information contained herein is not intended to replace or substitute for conventional medical care, or encourage its abandonment.