Functional Dyspepsia

The Acid Reflux Strategy

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Several essential oils have been used in the treatment of functional (nonulcer) dyspepsia. All of the published trials have concerned the commercial preparation known as Enteroplant®, an enteric-coated capsule containing 90 mg of Mentha x piperita, and 50 mg of Carum carvi essential oils.

The combination of peppermint and caraway essential oils has been shown to act locally in the gut as an antispasmodic (Micklefield et al., 2000, 2003) and to have a relaxing effect on the gallbladder (Goerg and Spilker, 2003). The antispasmodic effect of peppermint is well documented and that of caraway essential oil has also been demonstrated (Reiter and Brandt, 1985). The latter alone has also been shown to inhibit gallbladder contractions in healthy volunteers, increasing gallbladder volume by 90% (Goerg and Spilker, 1996).

One of the first studies involved 45 patients in a double-blind, placebo-controlled multicenter trial with the administration of Enteroplant thrice daily for 4 weeks. It was found to be superior to placebo with regard to pain frequency, severity, efficacy, and medical prognosis. Clinical Global Impressions were improved for 94.5% of patients using the essential oil combination (May et al., 1996).

The activity of Enteroplant (twice daily) was compared with that of cisapride (30 mg daily), a serotonin 5-HT4 agonist that stimulates upper gastrointestinal tract motility, over a 4-week period.

This double-blind, randomized trial found that both products had comparable efficacy in terms of pain severity and frequency, Dyspeptic Discomfort Score, and Clinical Global Impressions (Madisch et al., 1999).

Another double-blind, randomized trial administered either Enteroplant or placebo twice daily for 28 days. Pain intensity and pressure, heaviness, and fullness were reduced in the test group by 40% and 43% as compared to 22% for both in the placebo group, respectively. In addition, Clinical Global Impressions were improved by 67% for the peppermint/caraway combination whereas the placebo scored 21% (May et al., 2000).

Holtmann et al. (2001) were the first to investigate the effect of Enteroplant (twice daily) on disease-specific quality of life as measured by the Nepean Dyspepsia Index. All scores were significantly improved compared to the placebo. In 2002, the same team also demonstrated that patients suffering with severe pain or severe discomfort both responded significantly better in comparison with the placebo.

Approximately 50% of patients suffering from functional dyspepsia are infected with Helicobacter pylori (Freidman, 1998). The Helicobacter status of 96 patients and the efficacy of Enteroplant were compared by May et al. (2003). They found that patients with Helicobacter pylori infection demonstrated a substantially better treatment response than those who were not infected. However, a previous study found no efficacy differences between infected and noninfected functional dyspepsia patients (Madisch et al., 2000) and so the effect of the presence of the bacterium on Enteroplant treatment has yet to be elucidated.

A short review of the literature concluded that treatment with the fixed peppermint/caraway essential oil combination had demonstrated significant efficacy in placebo-controlled trials, had good tolerability and safety, and could thus be considered for the long-term management of functional dyspepsia patients (Holtmann et al.,2003).

11.7 GASTROESOPHAGEAL REFLUX

á-Limonene has been found to be effective in the treatment of gastroesophageal reflux disorder. Nineteen patients took one capsule of 1000 mg á-limonene every day and rated their symptoms using a severity/frequency index. After 2 days, 32% of patients had significant relief and by day 14, 89% of patients had complete relief of symptoms (Wilkins, 2002).

A double-blind, placebo-controlled trial was conducted with 13 patients who were administered one 1000 mg capsule of á-limonene daily or on alternate days. By day 14, 86% of patients were asymptomatic compared to 29% in the placebo group (Wilkins, 2002).

The mechanism of action of á-limonene has not been fully elucidated in this regard but it is thought that it may coat the mucosal lining and offer protection against gastric acid and/or promote healthy peristalsis.

11.8 HYPERLIPOPROTEINEMIA

Girosital is a Bulgarian encapsulated product consisting of rose essential oil (68 mg) and vitamin A in sunflower vegetable oil. Initial animal studies found that rose oil administered at 0.01 and 0.05 mL/kg had a hepatoprotective effect against ethanol. Dystrophy and lipid infiltration were lowered and glycogen tended to complete recovery, suggesting a beneficial effect of rose oil on lipid metabolism (Kirov et al., 1988a).

Girosital was administered to 33 men with long-standing alcohol abuse, twice daily for 3 months. It significantly reduced serum triglycerides and low-density lipoprotein and increased the level of HDL-cholesterin; it was particularly effective for the treatment of hyperlipoproteinemia types IIb and IV. Liver lesions relating to alcohol intoxication improved and subjective complaints such as dyspeptic symptoms and pain were reduced (Konstantinova et al., 1988).

The hypolipidemic effect of Girosital was again studied by giving a capsule once daily for 20 days in 35 patients with hyperlipoproteinemia. In type IIa hyperlipoproteinemia cases, the total lipids were reduced by 23.91% and the total cholesterol by 10.64%. For type IIb patients, the total lipid reduction was 15.93%, triglycerides fell by 25.45%, and cholesterol by 14.06%; in type IV cases the reductions were 33.83%, 25.33%, and 36%, respectively. Girosital was more effective in comparison with the treatment with bezalipe and clofibrate (Stankusheva, 1988).

Thirty-two patients with hyperlipoproteinemia and arterial hypertension were administered one Girosital capsule twice daily for 110 days. A marked reduction in hyperlipoproteinemia was demonstrated in all patients. The hypocholesterolemic effect manifested first in type IIa patients after 20 days, and later in type IIb cases. Reduction of serum triglycerides in type IIb began 50 days after the commencement of treatment (Kirov et al., 1988b).

A further study (Mechkov et al., 1988) examined the effect of Girosital capsules twice daily for 110 days in 30 patients with cholelithiasis, liver steatosis, and hyperlipoproteinemia. Total cholesterol decreased after 20 days of treatment although it tended to rise slightly later in the test period. The triglycerides were most affected in hyperlipoproteinemia types IIb and IV. The b -lipoprotein values were not altered by the treatment.

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