Overview

Why use an orange peel extract to battle occasional heartburn?
Because orange peel extract works with the body, rather than fighting against it†:

Unlike many traditional products, a clinically-studied orange peel extract will not reduce mineral absorption, inhibit protein digestion, or shut down acid production. Contrary to many common solutions, it works with your body's natural digestive processes.†

Why use Heartburn Free^®†with ROH10^®?
It provides lasting relief from occasional heartburn for up to six months or more:†

Heartburn Free^®†with ROH10^® delivers relief from occasional heartburn, acid indigestion, and upset stomach.† With Heartburn Free, every-other-day supplementation brings everyday occasional heartburn relief - your stomach and esophagus will thank you for it.†

After completing the initial regimen, symptoms of occasional heartburn occur much more infrequently.† And, if they do return after the initial 10 capsule regimen, a single capsule of Heartburn Free should provide relief.†

Unique formulation you won't find anywhere else:

Its key ingredient, orange peel extract (ROH10^®), provides lasting relief without shutting down the production of stomach acid.† Heartburn Free also doesn't reduce mineral absorption or inhibit protein digestion.†

Directions

Adult (18 and older) Dosage: Upon first experiencing symptoms, take one softgel capsule every other day for 20 days, and one softgel capsule as needed for occasional relief thereafter.

Best if taken one-half hour before or one hour after meals, with water or your favorite beverage. Do not bite or open capsule, swallow whole.

Pill Size

Interactions and Depletions

Technical Data

Description

Heartburn Free®† is a patented (United States Patent #6,420,435) dietary supplement to relieve occasional acid indigestion and upset stomach. Its all-natural key ingredient provides lasting relief for occasional heartburn.† Heartburn Free®† does not interfere with protein digestion or mineral absorption, and does not shut down acid production or adversely affect acid-producing cells.†

Introduction

How Does It Work?

The orange peel extract used in Heartburn Free®† is standardized to contain a minimum of 98.5% d-limonene. d-Limonene is a monoterpene, naturally occurring in citrus and a wide variety of other plant species.¹ Orange peel extract's mechanism of action has not been fully elucidated. Scientists believe that Heartburn Free®† supports healthy peristalsis, moving food through the stomach effectively and efficiently.²† In a laboratory study, researchers found that orange peel extract exerts a spasmogenic activity and the spasmogenic activity was associated with the levels of d-limonene in the extract.³†

Heartburn Free®† may also work as a surfactant.† A surfactant is a substance that reduces the surface tension of liquids. Heartburn Free®† reduces the surface tension of the liquid contents in the stomach, further decreasing the potential for occasional heartburn.²†

Heartburn Free®† is effective in relieving occasional heartburn and acid indigestion.²† In a clinical setting, participants were asked to take one 1000 mg capsule of Heartburn Free®† every day or every other day. About 32% of participants achieved relief as early as day 2 of their regimen, with a gradual increase in percentage to 89% of participants achieving relief by day 14.²†

In a double blind placebo controlled study, participants were randomized to an every day or every other day regimen, with half the participants taking Heartburn Free®† and the other half taking a placebo capsule of soy bean oil. The percentage of participants who reported relief was much higher in the group receiving Heartburn Free®† than that in the placebo group.²

As demonstrated in clinical trials, the beneficial effects of Heartburn Free®† appear to develop over time, with the best results attained after following a ten capsule regimen. As with other dietary supplements (such as garlic or glucosamine sulfate [whose beneficial results are generally not experienced until after 6 weeks of regular ingestion]) there is a lag time before optimal relief of occasional heartburn is achieved. However, after completing the initial regimen, most persons experience a decrease of their occasional heartburn symptoms as a well as a longer duration of time between occurrence of occasional symptoms. For days when occasional symptoms may be experienced following the 10 capsule regimen, a single capsule of Heartburn Free®† should provide relief.

The key ingredient in Heartburn Free®†, d-limonene, has also been well studied for its support of healthy cell development.† Intracellular communication, incorporating a number of biochemicals, is vital to healthy cell development.⁴ d-Limonene is a farnesyl transferase inhibitor that has shown support of healthy cell development.† Several laboratory studies have suggested d-limonene supports healthy cellular communication.^5-10†

Recommendations

Upon first experiencing symptoms, take one softgel capsule every other day for 20 days, and one softgel capsule as needed for occasional relief thereafter. Best if taken one-half hour before or one hour after meals, with water or your favorite beverage. Do not bite or open capsule, swallow whole.

Precautions

In general, d-limonene has fairly low toxicity. It is listed on the Food and Drug Administration's GRAS list (Generally Recognized As Safe). There is no evidence that d-limonene has teratogenic or embroyotoxic effects. It also does not pose a carcinogenic or nephrotoxic risk to humans.¹

In humans, d-limonene has also been found to be safe and without toxicity when 1000 mg was ingested. In healthy volunteers, no toxicity was encountered at a dose of approximately 7000 mg.¹¹ In one study, the maximum tolerated dose of oral administration was found to be approximately 15 grams per day (or 15,000 mg/day). No serious adverse effects were observed below this dose. Rare gastrointestinal symptoms are the most common reactions associated with the ingestion of d-limonene.¹⁰ Therefore, this product's dose range is well below levels that produced gastrointestinal effects.

Pregnant or nursing women should not take Heartburn Free®*. Although no toxic effects for d-limonene have been found at recommended dosage levels, there has been no research specifically examining potential effects on fetal development. Therefore, as a precaution, this product is not recommended for pregnant or nursing women.

This product is also not recommended for those people who have an ulcer or suspect an ulcer, as a burning and irritating sensation may result. Until clinical trials using all age groups have been completed, Heartburn Free®† should not be given to children.³

How Is It Supplied?

• 09110;10 Softgel Capsules

Storage Recommendations

Store at controlled room temperature, 59° to 86° F (15° – 30° C).

References

1. Limonene, Monograph. Crit Rev Food Sci Nutr. 1999;39:259-265.
2. Wilkins J, Heggers J, Willette R, Wilkins JS. Relief of heartburn naturally. Unpublished data. Wilkins Research, Galveston Texas.
3. Lis-Balchin M, Hart S, Deans SG, Eaglesham E. Comparison of the pharmacological and antimicrobial action of commercial plant essential oils. J Herb Spices Med Plants. 1996;4:69-86.li>
4. LeMarbre PJ, Groenwald SL. Biology of cancer. In: Groenwald SL, Hansen Frogge M, Goodman M, Henke Yarbo C. Cancer Nursing: Principles and Practice. 4th ed. Sudbury, Ma: Jones and Bartlett; 1997: 17-26.
5. Hakim IA, Harris RB, Ritenbaugh C. Citrus peel use is associated with reduced risk of squamous cell carcinoma of the skin. Nutr Cancer. 2000;37:161-168.
6. Giri RK, Parija T, Das BR. d-limonene chemoprevention of hepatocarcinogenesis in AKR mice: inhibition of c-jun and c-myc. Oncol Rep. 1999;6:1123-1127.
7. Bardon S, Picard K, Martel P. Monoterpenes inhibit cell growth, cell cycle progression, and cyclin D1 gene expression in human breast cancer cell lines. Nutr Cancer. 1998;32:1-7.
8. Nakaizumi A, Baba M, Uehara H, Iishi H, Tatsuta M. d-Limonene inhibits N-nitrosobis(2-oxopropyl) amine induced hamster pancreatic carcinogenesis. Cancer Lett. 1997;117:99-103.
9. Kawamori T, Tanaka T, Hirose Y, Ohnishi M, Mori H. Inhibitory effects of d-limonene on the development of colonic aberrant crypt foci induced by azoxymethane in F344 rats. Carcinogenesis. 1996;17:369-732.
10. Vigushin DM, Poon GK, Boddy A, et al. Phase I and pharmacokinetic study of D-limonene in patients with advanced cancer. Cancer Research Campaign Phase I/II Clinical Trials Committee. Cancer Chemother Pharmacol. 1998;42:111-117.
11. Crowell PL, Elson CE, Bailey HH, Elegbede A, Haag JD, Gould MN. Human metabolism of the experimental cancer therapeutic agent d-limonene. Cancer Chemother Pharmacol. 1994;35(1):31-37.

Additional Information

Occasional heartburn incidence is widespread in the United States; as many as 30% of Americans experience heartburn discomfort at least once a month. Almost 10% of adults in the United States experience daily heartburn.¹ While heartburn may be a common complaint, it is not a trivial one. Heartburn is often quite distressing, accounting for significant pain and discomfort, even though occasional heartburn itself is not considered a disease.²

The lower esophageal sphincter (LES) is a muscular band located at the junction of the esophagus and the stomach.^3,4 The LES prevents the back flow of gastric juices into the esophagus through the creation of pressure, which closes the lower end of the esophagus. The LES pressure relaxes after each swallow to allow food into the stomach. Heartburn occurs when LES pressure is weak or when pressure within the stomach exceeds LES pressure.⁵

Gastric juices are comprised of hydrochloric acid, pepsin, and at certain times, bile. Hydrochloric acid assists in the digestion of food and effectively destroys harmful bacteria. While the stomach has a protective barrier to prevent irritation from gastric juices, the esophagus does not. The pain and discomfort of heartburn is the result of esophageal irritation by gastric juices, primarily hydrochloric acid.⁴

Many factors can cause disturbance in effective LES pressure regulation. Certain foods, such as fried or fatty foods, spicy foods, chocolate, alcohol, and caffeine, all decrease LES pressure.3 Studies have shown that cigarette smoking, eating large meals, and obesity relaxes the LES.^6,2 Certain body positions can also lower LES pressure. Lying on one's side immediately after eating, bending down, and lifting heavy objects can cause heartburn.⁷

While the development of heartburn may be multi-factorial, it is thought primarily a consequence of altered motility states in the esophagus and stomach.^2,8,5

References

1. National Digestive Diseases Information Clearinghouse. Gastroesophageal reflux disease. Available at: http://www.niddk.nih.gov/health/digest/pubs/heartbrn/. Accessed August 17, 2001.
2. Dajani EZ. Gastroesophageal reflux disease: pathophysiology and pharmacology overview. J Assoc Acad Minor Phys. 2000;11:7-11.
3. Norris J, Ed. Gastroesophageal reflux. In: Professional Guide to Diseases. 5th ed. Springhouse, Pa: Springhouse Corporation, 1995: 660-663.
4. Porth CM. Gastroesophageal reflux. In: Pathophysiology: Concepts of Altered Health States. 5th ed. Philadelphia, Pa: Lippincott; 1998: 722-723.
5. Clouse RE, Richter JE, Heading RC, Janssens J, Wilson JA. Functional esophageal disorders. Gut. 1999;45:II31-1136.
6. Smit CF, Copper MP, van Leeuwen JA, Schoots IG, Stanojcic LD. Effect of cigarette smoking on gastropharyngeal and gastroesophageal reflux. Ann Otol Rhino Laryngol. 2001;110:190-193.
7. Clark CS, Kraus BB, Sinclair J, Castell DO. Gastroesophageal reflux induced by exercise in healthy volunteers. JAMA. 1989;261:3599-3601.
8. Diener U, Patti MG, Molena D, Fisichella PM, Way LW. Esophageal dysmotility and gastroesophageal reflux disease. J Gastrointest Surg. 2001;5:260-265.

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