Misoprostol Oral Rinse

Misoprostol Oral Rinse

PEP Topic 
Mucositis
Description 

Misoprostol is a prostaglandin analogue that acts upon gastric cells to inhibit secretion of gastric acid. It has been used to prevent ulcers in people who take medicines such as aspririn and NSAIDs. Misoprostol is available as a tablet to take orally. A topical application of misoprostol was examined in the treatment of mucositis.

Effectiveness Not Established

Research Evidence Summaries

Lalla, R. V., Gordon, G. B., Schubert, M., Silverman, S., Jr, Hutten, M., Sonis, S. T., et al. (2012). A randomized, double-blind, placebo-controlled trial of misoprostol for oral mucositis secondary to high-dose chemotherapy. Supportive Care in Cancer, 20, 1797-1804.

doi:10.1007/s00520-011-1277-7
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Study Purpose:

The purpose of this study was to determine if a misoprostol oral rinse would reduce the severity of mucositis in patients receiving high-dose chemotherapy for autologous stem cell transplant.

Intervention Characteristics/Basic Study Process:

This multi-center study employed a randomized, double blind, placebo controlled, parallel-group design. Participants were assigned to the misoprostol arm or placebo arm. Subjects swished and gargled the misoprostol or placebo solution (in 15 ml of water), held it in their mouths for 60 seconds, and then swallowed. Administration began 45 min. to 2 hours before the initiation of the conditioning regimen and then every 8 hours until 24 hours after the conditioning regimen was complete. All subjects also received instructions on standard care and instructed not to use other oral care for 1 hour after the misoprostol or placebo solution. The Oral Mucositis Index was used to grade mucositis every 2 to 3 days.

Sample Characteristics:

The study was comprised of 48 patients, 22 in treatment arm and 26 in placebo group, with an age greater than or equal to 18 years.
MALES 30%, FEMALES 70%
KEY DISEASE CHARACTERISTICS: Lymphoma, multiple myeloma, or solid tumor patient undergoing autologous stem cell transplant.
OTHER KEY SAMPLE CHARACTERISTICS: Patients could not have been receiving cisplantin/carboplatin conditioning regimens or total body irradiation.

Setting:

SITE: Multi-site

SETTING TYPE: Inpatient

LOCATION: Six participating sites in the United States

Phase of Care and Clinical Applications:

PHASE OF CARE: Active antitumor treatment
APPLICATIONS: Palliative care

Study Design:

Randomized, double-blind, placebo-controlled, parallel group design

Measurement Instruments/Methods:

  • Modified Oral Mucositis Index
  • Clinical examination by calibrated examiners
  • Photographs
  • Visual Analog Scale
  • Pain Affect Faces Scale
  • Length of hospital stay
  • Days of parental nutrition

Results:

No statistically significant differences in Oral Mucositis Index scores. No statistically significant differences in the peak mucositis severity scores. No statistically significant differences in pain ratings, length of hospital stay, or days of total parenteral nutrition. There were no serious adverse events.

Conclusions:

There was not a statistically significant benefit to using a misoprostol rinse in deterring the development or the severity of oral mucositis in patients undergoing autologous stem cell transplant. There was also no decrease in the length of stay or the use of total parenteral nutrition.

Limitations:

Small sample (<100)

Findings not generalizable

Other limitations/*explanation: The patient population was limited to only those cancer patients undergoing autologous stem cell transplant.

Nursing Implications:

This study provides no evidence to support using a misoprostol mouth rinse to prevent the development of mucositis, decrease the severity of mucositis, decrease the length of stay, or decrease the use of total parenteral nutrition in patients undergoing a non-TBI based or non-cisplatin/carboplatin-based conditioning regimen for autologous stem cell transplant.

Veness, M.J., Foroudi, F., Gebski, V., Timms, I., Sathiyaseelan, Y., Cakir, B., et al. (2006). Use of topical misoprostol to reduce radiation-induced mucositis: Results of a randomized, double-blind, placebo-controlled trial. Australasian Radiology, 50(5), 468–474.

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Intervention Characteristics/Basic Study Process:

200 mcg of misoprostol or placebo was dissolved in 15 ml of water. Patients swished in oral cavity for two minutes, then swallowed. Patients were advised to gargle before swallowing.

Sample Characteristics:

The study was comprised of 83 patients with squamous cell carcinoma of the head and neck, older than 18 with a total radiation dose higher than 50 Gy.
Misoprostol arm: n = 42
Placebo arm: n = 41
 

Setting:

1999–2002

Study Design:

Double-blind, placebo-controlled, randomized trial

Measurement Instruments/Methods:

Extent of RTOG grade 3 mucositis (incidence and duration).

Secondary endpoints were time to development of mucositis, extent of grade 2 mucositis, patient weight, general well-being using VAS, and oropharyngeal or oral soreness.

RTOG, VAS
 

Results:

No significant differences were found for endpoints. More patients in the misoprostol arm reported increased levels of oral or oropharyngeal soreness.

Limitations:

Did not accrue adequate patients according to statistical analysis.

12% patient withdrawals

Guideline/Expert Opinion

Nicolatou-Galitis, O., Sarri, T., Bowen, J., Di Palma, M., Kouloulias, V.E., Niscola, P., . . . Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO). (2013). Systematic review of anti-inflammatory agents for the management of oral mucositis in cancer patients. Supportive Care in Cancer , 21(11), 3179–3189.

doi: 10.1007/s00520-013-1847-y
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Purpose & Patient Population:

PURPOSE: Systematically review literature and define updated clinical practice guidelines regarding use of anti-inflammatory agents

TYPES OF PATIENTS ADDRESSED: Patients receiving chemotherapy or radiation therapy

Type of Resource/Evidence-Based Process:

RESOURCE TYPE: Evidence-based guideline

PROCESS OF DEVELOPMENT: Studies evaluated using Hadorn criteria and assigned levels of evidence on Somerfield criteria by independent reviewers. Findings were integrated into guidelines based on overall level of evidence for each intervention.

DATABASES USED: MEDLINE (1966–December 31, 2010)

KEYWORDS: aminosalicylic acid, amifostine, amlexanox, anti-inflammatory, anti-TNF, anti-tumor necrosis factor, aspirin, Benadryl®, benzydamine, betamethasone, celecoxib, corticosteroid, dexamethasone, diphenhydramine, Ethyol®, flurbiprofen, histamine, hydrocortisone, ibuprofen, indomethacin, infliximab, irsogladine, lactoferrin, mesalazine, misoprostol, N-acetylcysteine, non-steroidal anti-inflammatory agents, NSAIDS, orgotein, prednisone, prostaglandin, RK-02-02, salicylic acid, steroid, thalidomide, TNF antibody, TNF inhibitor, and tumor necrosis factor/TNF

INCLUSION CRITERIA: Articles involving anti-inflammatory agents for prevention or treatment of oral mucositis

Phase of Care and Clinical Applications:

PHASE OF CARE: Active antitumor treatment

Results Provided in the Reference:

Forty-one studies were included in the review involving use of multiple anti-inflammatory agents.

Guidelines & Recommendations:

  • Benzydamine mouthwash is recommended for prevention in patients with head and neck cancer receiving moderate-dose radiation therapy without concomitant chemotherapy.
  • Misoprostol is not recommended for use of prevention of radiation-induced oral mucositis.
  • For all other anti-inflammatory agents, no guidelines were deemed possible due to insufficient evidence.

Limitations:

  • Most evidence reported was from studies of patients with head and neck cancer.
  • Very few studies per individual agent were reviewed, and the level of evidence was low for all but benzydamine.

Nursing Implications:

Two new guidelines were identified by this systemic review. The panel suggests that misoprostol mouthwash should not be used for the prevention of radiation-induced oral mucositis in patients with head and neck cancer. The other new guideline the panel recommends is benzydamine mouthwash for the prevention of oral mucositis in patients with head and neck cancer receiving moderate-dose radiation therapy (up to 50 Gy) without concomitant chemotherapy. In addition to this, the lack of clear evidence supporting the use of any anti-inflammatory agent other than benzydamine, the use of anti-inflammatory agents continues to be a promising strategy for the prevention and treatment of oral mucositis. More well-designed studies are needed to examine the use of anti-inflammatory agents for oral mucositis in various cancer care settings.


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