Effectiveness Not Established

Dioctahedral Smectite and Iodine Glycerine Cream (DSIG)

for Mucositis

Dioctahedral smectite is a naturally absorbent clay formed from a sheet of aluminomagnesium silicate. It is thought to reduce microbes, enhance the intestinal barrier, and prevent damage to the mucosa. Iodine is a nonantibiotic antiseptic that has antimicrobial properties.

Research Evidence Summaries

Lin, J.X., Fan, Z.Y., Lin, Q., Wu, D.H., Wu, X.Y., Chen, Y.R., . . . Wan, X.B. (2014). A comparison of dioctahedral smectite and iodine glycerin cream with topical mouth rinse in treatment of chemotherapy induced oral mucositis: A pilot study. European Journal of Oncology Nursing. Advance online publication. 

Study Purpose

To compare the efficacy of dioctahedral smectite and iodine glycerin (DSIG) cream to a topical mouth rinse in the treatment of chemotherapy-induced oral mucositis

Intervention Characteristics/Basic Study Process

After oral mucositis (OM) developed, patients were randomized to receive DSIG or a topical rinse solution administered by two nurses. Nurses were not blinded to the intervention. The DSIG cream consisted of 3 g of dioctahedral smectite and 10 ml of iodine glycerin. The cream was applied to oral mucosa four times per day for one hour during each application while the patient was fasting. The topical mouth solution consisted of saline 400 ml, gentamicin 640,000 u, and vitamin B12 500 mg. Patients rinsed with the solution four times per day and gargled the solution for one minute with each application. Both treatments were administered for five consecutive days. Data were collected daily once OM was identified and continued for five days.

Sample Characteristics

  • N = 130  
  • AVERAGE AGE = < 53 years (46.9%), ≥ 53 years (53.1%)
  • MALES: 72.3%, FEMALES: 27.7%
  • KEY DISEASE CHARACTERISTICS: Multiple types of cancer

Setting

  • SITE: Single-site    
  • SETTING TYPE: Not specified    
  • LOCATION: China

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • Oral Assessment Guide (OAG)

Results

OAG scores were similar between groups on day 1 (p = .23). There was a significant difference in OAG scores on days 2–5 with the topical rinse group having higher scores (days 2–5, 12.1 ± 1.1, 12 ± 1.2, 11.3 ± 1.3, 10.4 ± 1.3, respectively) when compared to the DSIG group (10.2 ± 1, 9.3 ± .9, 8.5 ± .6, 8 ± .2, respectively; all days p < .05). When OAG scores were combined for days 1–5, patients in the topical rinse group had significantly higher overall OAG scores (55.7 ± 4.4) when compared to the DSIG group (45.8 ± 2.6; p < .001). DSIG cream significantly reduced the number of days patients presented with OM (4.68 ± .98 days) when compared to the topical rinse solution (8.76 ± 1.8 days; p < .001). In the DSIG group on day 5, 85.7% of patients showed complete OM regression, 11.1% showed partial regression, and 3.2% progressed. On day 5 in the topical rinse solution group, 3% showed a complete OM regression and 47.8% showed a partial regression. 

Conclusions

Both groups of patients had OM of similar severity on day 1 of the study. Over the five days of the study, when compared to a topical rinse solution, DSIG improved the severity of OM. Patients who received DSIG healed faster than those who received the topical rinse. DSIG is a promising treatment for chemotherapy-induced OM, and additional studies to compare DSIG to other available OM treatments and to study the efficacy of DSIG over a longer period of time are needed. Studies also are needed to determine whether DSIG has a role in the prevention of chemotherapy-induced OM.

Limitations

  • Risk of bias (no blinding)

 

Nursing Implications

DSIG may be a useful intervention for patients who already developed chemotherapy-induced OM. Patients who received the DSIG treatment had less severe OM than those who received a topical rinse solution, and they had a faster rate of healing and more thorough healing. Nurses can conduct physical assessments of patients to determine the extent to which OM is present and educate patients about the various options for OM treatment.

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