Effect of adding the herb Achillea millefolium on mouthwash on chemotherapy induced oral mucositis in cancer patients: A double-blind randomized controlled trial

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Abstract

Background

Oral mucositis (OM) is a debilitating side-effect of chemotherapy. It has different complications, including impairment of drinking, eating and even talking, sometimes so severe that physician stops the therapy.

Objective

Investigating the effect of Achillea millefolium distillate solution in the treatment of chemotherapy-induced OM.

Interventions/methods

In this randomized controlled trial, 56 cancer patients with chemotherapy-induced OM were randomly assigned into control and experimental groups in similar blocks based on the severity of OM. The experimental group gargled 15 mL of a mixture of routine solution and distilled A. millefolium 4 times a day for 14 days while the control group gargled 15 mL of routine solution. The severity of OM was assessed at three times before, 7 and 14 days after intervention. Data was analyzed using Wilcoxon, Kruskal–Wallis, Mann–Whitney U, Friedman, Chi-square and Fisher's exact tests.

Results

The mean severity score of OM was 2.39 ± 0.875 in both groups at start of the study that was changed to 1.07 ± 0.85 and 0.32 ± 0.54 in the intervention group in days 7 and 14 (p < 0.001). However, the severity of OM was increased to 2.75 ± 0.87 and 2.89 ± 0.956 in the control group respectively (p < 0.001).

Conclusions

A. millefolium distillate healed OM much more than the routine solution. Therefore, it is suggested to be used in patients with chemotherapy-induced OM.

The study was registered in the Iranian Registry of Clinical Trials, Number: IRCT2013092214729N1.

Introduction

Oral mucositis (OM) refers to mucosal damage secondary to cancer therapy occurring in the oral cavity. Mucositis can be caused by chemotherapy and/or radiation therapy (Lalla et al., 2014). It occurs in approximately 20%–40% of patients receiving conventional chemotherapy, 80% of patients receiving high dose chemotherapy as conditioning for hematopoietic stem cell transplantation, and nearly all patients receiving head and neck radiation therapy (Avritscher et al., 2004, Lalla et al., 2014, Vera-Llonch et al., 2007).

Pain induced by OM disturbs patients and makes it difficult to eat and drink, resulting in indigestion and dehydration (He, 2011, Pavesi et al., 2011, Potting et al., 2006). OM can also disturb speaking and communication with others, resulting in psychological and social stresses (Abedipour et al., 2006). In addition, OM is accompanied by a wide range of oral mucus alterations such as infection and bleeding, which could result in systemic infection (Abedipour et al., 2006, Potting et al., 2006). In severe cases, it can increase the length of hospitalization and even lead the physician to cease the chemotherapy (Pavesi et al., 2011, Potting et al., 2006).

A wide variety of agents have been tested to prevent OM or reduce its severity (Yarom et al., 2013, Lalla et al., 2014). The Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) has published evidence based clinical practice guidelines for mucositis (Lalla et al., 2014), in order to facilitate evidence based patient care and improve outcomes. The current guidelines updated in 2013 examined the evidence for the following interventions: basic oral care, growth factors and cytokines, anti-inflammatory agents, antimicrobials, coating agents, anesthetics, analgesics, Laser and other light therapy, cryotherapy, natural and miscellaneous agents (Lalla et al., 2014). The most commonly used therapies often have no significant effect and sometimes cause additional side-effects (Arora et al., 2008).

Given the side-effects of chemical drugs, complementary therapies in the forms of herbal products are increasingly used all over the world (Adib-Hajbaghery and Hoseinian, 2014).

Most of ancient civilizations used different forms of herbal medicines. Among herbal plants, Achillea millefolium has attracted attentions due to its wide range of therapeutic effects. It is a well known herb from the asteraceae family, and has been extensively used in ancient medicine for treating different diseases in general and burns, injuries and infections in particular. One of the most important therapeutic effects of A. millefolium is its antibacterial effect on a wide range of pathogens (Aggarwal et al., 2011, Saeidnia et al., 2011, Tajik and Jalali, 2009). A. millefolium fresh flowers have been used to resolve respiratory problems (Düsman et al., 2013). It also was employed as anti-allergic (Aggarwal et al., 2011), anti-congestion, and expectorant (Nemeth and Bernath, 2008). Its flowers' distillates contain chamazulene, cineol, borneol (Orav et al., 2006), caffeic acid and salicylic acid with antibacterial, antispasmodic and anti-inflammatory effects (Aggarwal et al., 2011, Pires et al., 2009, Saeidnia et al., 2011, Saeidnia et al., 2005). Some ingereduants of A. millefolium also exert beneficial effects on nervous, cardiovascular and digestive systems (Aggarwal et al., 2011). Despite historical background of this herb, reports about its application in treatment of wounds and injuries are rare (Tajik and Jalali, 2009). Aljancic et al. showed its significant inhibitory effect on candida albicans and bacillus subtilis in-vitro. They also reported that, the flavonoids existed in A. millefolium essence prevents the growth of aspergillus niger (Aljancic et al., 1999).

Sökmen et al. have also studied the antimicrobial effects of A. millefolium distillate on 12 bacterial species and 2 types of yeast. They have reported that though its aqueous extract had no antibacterial activity, the methanol one and the herb distillate had considerable antimicrobial activity (Sökmen et al., 2004). In another study, 32 separate ingredients have been extracted from A. millefolium, among which Comphor and Eucalyptol have significant inhibitory effects on candida albicens and clostridium perfringens. Also, Borneol and Piperitone in A. millefolium are two other compounds with considerable bacterial inhibitory activity (Sökmen et al., 2003).

During conversation with cancer patients, some revealed that to mitigate oral wounds, they gurgle A. millefolium distillate based on the recommendations received from some traditional groceries. Therefore, given the anti-inflammatory and antimicrobial effects of the plant, prevalence of chemotherapy-induced OM, and lack of studies on the effects of A. millefolium on chemotherapy induced oral muscositis, the present study was designed to investigate the effect of A. millefolium distillate-contained solution on the chemotherapy-induced OM.

Section snippets

Study design and participants

This clinical trial study was conducted on cancer patients with chemotherapy-induced OM referring to Shahid Beheshti Hospital in Kashan, Iran, from September 2013 to January 2014.

The patients were under chemotherapy and received an anti-inflammatory drug (Dexamethasone 8 mg) as well. Inclusion criteria were as follows: having clinical signs of chemotherapy-induced OM, being at age of 20 years old or over, complete consciousness, having no history of allergy, allergic rhinitis and asthma, no

Results

The number of patients' participated in this study was 56. No significant difference was observed in terms of mean age between the experimental (56.46 ± 14.32) and control group (55.54 ± 14.01) (P = 0.8). In total, 67.9% of the experimental group and 64.3% of the control group were married. There was no significant difference between the two groups regarding artificial teeth, smoking habit, type of cancer, chemotherapy regimens and other demographic information (Table 1).

Before receiving the

Discussion

The present study was designed to investigate the effect of adding A. millefolium distillate on mouthwash on chemotherapy-induced OM. In this study, the severity of OM was significantly reduced in the experimental group receiving the A. millefolium-contained solution. It was interesting that more than 71% of the patients in this group were completely healed at day 14 of the experiment. No previous studies are available on using A. millefolium to treat OM due to cancer chemotherapy. However,

Conclusion

Since the mixture of A. millefolium distillate with the routine solution used in this study could decrease the severity of OM due to chemotherapy and had no side effects, this solution might be used for all patients during chemotherapy. Given the A. millefolium distillate was mixed with ward's routine solution, it is suggested that A. millefolium distillate alone be used to clearly define its effect on improvement of OM. Also the mixture of A. millefolium distillate with other types of

Conflicts of interest

None declared.

Acknowledgments

This article is the report of a Master's thesis, funded by Kashan University of Medical Sciences with the grant number 9282. We would like to thank the research deputy of Kashan University of Medical Sciences for its funding, as well as the management of Shahid Beheshti Hospital, head nurse of oncology and chemotherapy department, and Kashan Barij Esans Company's laboratory for their cooperation. All the patients who patiently participated in the study were also appreciated.

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