Researchers develop herbal mouthwash to help oral cancer patients

Ayurveda-based product reduces pain and infections in radiation-induced mucositis

A herbal concoction made from plants prescribed in Ayurveda to combat ulcers and infections has been found to be effective in reducing the intensity of a severely painful condition called mucositis in patients undergoing radiation therapy for oral cancer.

The cheap and effective mouthwash has been developed, clinically tested and patented by the Rajiv Gandhi Centre for Biotechnology (RGCB) - a premier R&D institute under Government of India’s Department of Biotechnology along with the Regional Cancer Centre (RCC) in Thiruvananthapuram — and efforts are now on to commercialise the product.

RGCB Director Prof. M Radhakrishna Pillai said the herbal mouthwash, by mitigating the toxicity associated with radiation therapy, could have a significant impact on improving the treatment continuity and cure rates for oral cancer.

The mouthwash is a simple supernatant liquid obtained by dissolving in water equal quantities of powdered dried leaves and bark of Neem (Azadiracta indica); fruits of  Amla (Emblica officinalis), Yellow Myrobalan/Haritaki (Terminalia chebula) and Beleric Myrobalan/Bibhitaki (Terminalia bellirica); and dried liquorice (Glycyrrhiza glabra) roots.

All of these plants are well documented in Ayurvedic texts as having anti-microbial, anti-inflammatory, mucolytic or analgesic properties that have been tried and found effective individually or in various combinations.

Researchers at the Thiruvananthapuram-based RGCB believed these properties could be extended to relieve the problems associated with oral mucolitis, a painful side-effect of radiation therapy given to oral cancer patients.

“Radiotherapy plays an important role in the management of oral cancer, but it does not distinguish between cancerous and healthy cells. Irradiation of glands decreases saliva production causing dryness of mouth, and eventually bacterial and fungal overgrowth which can affect food intake and be very painful, causing many to break or discontinue the treatment,” said Prof. Radhakrishnan.

In association with the RCC, RGCB researchers conducted a randomised controlled clinical trial of the product on 148 oral cancer patients undergoing radiation treatment. The clinical trial was done under the supervision of Dr K Ramadas, Medical Superintendent of RCC, who was also one of the investigators.

Around half the patients were administered the herbal mouthwash four times daily and the rest were put in a control group given soda saline mouthwash. They were assessed weekly by a physician, who was blinded to the randomisation, for mucositis, pain and use of pain-killers, antibiotics and anti-fungals.

By Day 22 of the treatment, when the radiation is most damaging, patients in the group administered the mouthwash had significantly lowered pain and reduced use of analgesics and antibiotics compared to the control group. Over a six month period, these patients experienced less dryness of mouth, had lower intolerance to spicy food and overall better quality of life.

“The intensity of pain is a major limiting factor in radiotherapy. The mouthwash itself may not have anti-cancer properties, but by reducing toxicity it lowers treatment cost, hospitalisation, allows patients to complete their treatment,” Prof. Pillai said.

RGCB - which not only conducts basic research aimed at new discoveries and innovation but also has a centre to focus on translating this into applications and products - is discussion with potential commercial partners to market the mouthwash.

The overall cost of the treatment works out to around 0.16 US Dollars (less than Rs 10) per day. “RGCB does not intend to derive any financial benefit from this product, our only aim is to make sure it is affordable and accessible to cancer patients,” Prof. Pillai added.

Oral cancer is the 11th most common cancer globally and two-thirds of the cases are in developing countries.

Prof. Pillai said they are hoping to name the commercial product after Dr Divya Ravindran, the researcher who initiated the project but passed away last year.

The latest innovation, which was presented at a research conclave titled Ayurveda Inspired Discovery held as part of the 6th World Ayurveda Congress (WAC) in New Delhi, is the result of one of many research projects on plant and natural products currently underway at the RGCB. The institute has major research interest in the biological and molecular mechanisms of Ayurvedic therapeutics and has been scientifically documenting various plant and natural products used in traditional medicines.

For instance, another research detailed at the conclave examined the clinical efficacy of curcumin, the compound derived from turmeric, in treating oral potentially malignant lesions (OPML), which often precede oral cancers. There is plenty of “test tube” data, but the RGCB researchers put their clinical relevance to test in a multi-centre, randomized controlled study involving 223 patients.

Currently there are no effective chemoprevention strategies to treat OPML, but the study results showed that treating patients with curcumin reconstituted in turmeric oil at a specific dosage (of 3.6 gms) for six months was found to be clinically effective and durable.

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