Anti-Reflux-B Syrup

Adjuvant treatment for alleviation of symptoms of Gastroesophageal Reflux Disease (GERD)

Aloe vera gel contains various substances for healing of wounds, healing of heat-related damage, burns and alleviation of inflammation. Among the therapeutic uses of Aloe vera gel, is its use in treatment of  returning of the stomach’s contents back up into the esophagus (GERD). This condition is caused by the abnormal relaxation of the Lower Esophageal Sphincter (LES), in which the return of the stomach’s acidic contents back up into the esophagus results in damage to the esophageal mucus and manifestations like heartburn, dry coughs, halitosis, sleep disorders, hemorrhage and esophageal ulcers.

Pharmacological treatment of GERD is based on the two following principles:

1- Raising the PH of the stomach’s contents, in a way that they would not be harmful, in case they return to the esophagus.

2- Increasing the tonicity of LES, in way that it prevents the contents of the stomach from returning to the esophagus.

The exact mechanisms of action of Aloe vera gel are not known. However, in vivo, Aloe vera gel and its constituents rectify the immunosuppression caused by UV waves. Also, in vitro, several constituents of Aloe vera gel and its total gel have manifested anti-oxidant activity.  Acemannan, which is of the main ingredients in Aloe vera gel has immunostimulant properties.

Aloe vera is a popular medication for treatment of a broad spectrum of gastrointestinal disorders. It has been demonstrated that Aloe vera improves various parameters of GI function, including PH of GI tract, in healthy individuals.

Following a primary report indicating the efficacy of Aloe vera gel in treatment of peptic ulcer, extensive studies have been carried out on animal models and also in human. Jusuf et. al. have reported that Aloe vera inhibits gastric acid secretion.

Also, in rats in which the pylorus was surgically blocked, alocetin A present in Aloe reduced acid and pepsin secretion and prevented formation of gastric ulcer induced by indomethacin.

In another study, it has been demonstrated that Aloe vera reduces leukocyte adhesion and TNF-α levels, causes an increase in Interleukin-10, and so, accelerates healing of gastric ulcer. Also, an emulsion made by mixing of this plant’s extract and gel with mineral oil has been used for treatment of gastric ulcer. It seems that the anti-ulcer properties of Aloe vera are due to its anti-inflammatory, cytoprotective, emollient and mucus stimulating properties. As, according to the results of previous studies, Aloe vera has a good potency in reduction of acid and pepsin secretion, and due to the key role of these two factors in damaging the esophagus, this plant has promising potential for treatment of GERD. On the other hand, in numerous studies, the anti-inflammatory and wound healing properties of this plant has been demonstrated, and if GERD is accompanied with damage and inflammation, Aloe vera is expected to have beneficial effects.

According to the results of a placebo-controlled, randomized clinical trial on 58 patients with Irritable Bowel Syndrome (IBS) with a predominance of diarrhea, in the first month, 35% of those who were administered Aloe vera responded to this treatment (in comparison to 22% in the placebo group). Generally, the patients taking Aloe vera manifested statistically significant therapeutic response in comparison to placebo (43% against 22%).

In a placebo-controlled, randomized, double-blind clinical trial, the efficacy and safety of the use of Aloe vera gel (twice per day, 100 ml each time, for 4 weeks) was studied in patients with ulcerative colitis. Use of Aloe vera resulted in improvement in clinical remission in 30% of the patients (in comparison to 7% in the placebo group) and alleviation of symptoms in 37% of patients (in comparison to 7% in the placebo group). Simple Clinical Colitis Activity Index and histological score significantly decreased in patients receiving Aloe vera, but remained unchanged in the placebo group.

1-2 teaspoonful (5-10 ml) before breakfast and before sleep.

Dosage form

Syrup

 

Packaging

120 ml syrup bottle in cardboard box

Patient information leaflet inside

Ingredients

Aloe vera leaf gel (Aloe vera), with its anthraquinone substances having been adjusted to a proper amount. 

 

Active Ingredients

Polysaccharides including acemannan, glucomannan, anthraquinone glycosides like aloin, aloe-emodin and barbaloin

Contraindications and Cautions

  • Known hypersensitivity to Aloe vera.
  • Pregnancy and individuals who plan to get pregnant (B3).
  • There is no information regarding the use of Aloe vera gel during lactation.

Adverse Effects

Generally, oral use of Aloe vera gel is well tolerated. Nonetheless, dermatitis has been reported after ingestion and local administration of Aloe vera gel.

In a case study and in vivo, a reduction in serum levels of thyroid proteins (T3, T4) due to Aloe vera intake has been reported.

 

Drug Interaction

Based on present evidence, no precautions need to be taken regarding drug interactions.

 

Administration during Pregnancy and Lactation

Not to be taken during pregnancy. There is no information regarding use of Aloe vera gel during lactation.

 

Further Notes

  • Shake well before use.
  • Like all other medication, keep Anti-Reflux-B Syrup away from sight and reach of children.
  • Change in urine color to yellow-brown or red is of no clinical importance and might be due to anthraquinone metabolites that might have entered the gel upon extraction.
  • Keep in cool and dry place.

Keep this leaflet; you may need to read it again.

Based on presence of about 5 mg polysaccharide per 5 ml of syrup.