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Effects of Naturopathic Interventions on Symptoms

Original Published in
The American Naturopathic Medical Association Monitor

Original Research

Robert J. Thiel, Ph.D., N.D. Director of Research, Center for Natural Health Research

Key words: seasonal allergic rhinitis, hay fever, naturopathy, homeopathy, refined carbohydrates

Thiel, R.J. Effects of Naturopathic Interventions on Symptoms Associated with Seasonal Allergic Rhinitis. ANMA Monitor 1 (2): 4-9, 1997

INTRODUCTION

An eighty-day clinical trial was conducted during the spring season involving forty-nine adults who suffered from seasonal allergic rhinitis. The objective of the trial was to determine if various naturopathic interventions could reduce the severity of symptoms associated with the disease.

The trial site was the San Joaquin Valley of central California. The area produces vine, tree, and field crops and has high pollen counts [1]. The air quality is considered below state and federal guidelines for ozone, carbon monoxide, and PM 10 (particulate matter ten microns
or smaller in diameter) [2].

METHODOLOGY

Subjects

The clinical trial included 40 participants and 9 non-participants. Thirty-one of the forty participants were female. The average (mean) age was 46 years.

Participants were non-institutionalized volunteers with a history of seasonal allergic rhinitis. Additional inclusion criteria included age of at least 20 years, report of symptoms which were most pronounced during the period of the trial, residence in the central San Joaquin Valley, and the ability to provide informed consent. Participants completed a symptom-severity questionnaire before and after the period of the clinical trial. The non-participant group
consisted of those who originally inquired about participation, completed the initial symptom severity questionnaire, suffered from the disease during the time period, but chose to not actively participate.

Protocols

Protocol selection was based upon the investigator's research into previous studies and examination of case histories. The trial was an attempt to test these approaches under "real world" conditions and intentionally did not control the use and frequency of medications
(medications are further discussed in the results section).

Avoidance of certain refined carbohydrates (dietary restrictions) was recommended for all participants in both protocols. Specifically, participants were instructed to avoid all foods containing white sugar (sucrose or dextrose) and white wheat flour. Some health advocates
have suggested that white sugar consumption can predispose one to hay fever [3] or worsen symptoms associated with it [4]. In order to not adversely affect caloric intake, as well as to encourage greater compliance, subjects were allowed to consume foods containing other
sweeteners such as honey, fructose, aspartame, etc. It was also suggested that participants substitute products containing whole wheat for products containing white flour (whole wheat products have a lower glycemic effect than white flour products [5] and greater amounts of
trace minerals [6]).

Protocol 1 included the preceding dietary restrictions plus the consumption of a real or placebo homeopathic remedy. Twenty-two people were assigned to protocol 1. The homeopathic remedies used in this trial were: Aconite, Nux Vomica, Sabadilla, Allium Cepa, and Diluted Pollen (containing seven local pollens). For this experiment, homeopathics and diluted pollens were provided in the 12x potency. The homeopathic portion of the trial was double-blind.

Protocol 2 was the combination of diet restrictions and homeopathic remedies in protocol 1, plus combination nutritional supplements. Participants were automatically assigned to protocol 2 unless they were taking vitamin/mineral supplements or medications containing retinoid derivatives. The separation into protocols one and two was to reduce the possibility of developing hyper-vitaminosis A [7]. Eighteen participants were assigned to protocol 2. The combination nutritional supplements they were given contained various vitamins,
minerals, bovine materials, and herbs. The vitamins and minerals contained in them (daily quantities shown in parentheses) was as follows: vitamin A (5,000 i.u.), vitamin B-1 (7 mg.), vitamin B-12 (57 mcg.), niacin (20 mg.), pantothenic acid (200 mg.), vitamin C (800
mg.), vitamin E (20 i.u.), calcium (719 mg.), magnesium (100 mg.), manganese (50 mg.), and montmorillonite (400 mg.). The bovine materials included adrenal (80 mg.), liver (45 mg.), lung (20 mg.), pancreas (90 mg.), parathyroid (2.5 mg.), spleen (9 mg.), and thymus
(10 mg.). The supplements also contained the herb fenugreek (50 mg.) and other materials (the actual supplements used were from Nutri-West and were Calc-Acid, Core Level D-Tox, and Histo-Cal). The combination nutritional supplementation of this trial was single-blind.

Statistical significance was determined at P < 0.05 using multiple regression analysis. Regression analysis is a technique which calculates correlation of independent variables to a dependent variable.

RESULTS

90.0% of participants reported improvement, 2.5% reported no change, and 7.5% reported a worsening of symptoms. 11.1% of the non-participants reported improvement, 44.4% reported no change, and 44.4% reported a worsening of symptoms. Actually, 94.7% of those
participants who could have been expected to improve (based on diet changes made and whether or not they received placebos or real supplements) reported improvement. Table 1 shows the regression output.

Table 1. Regression Output:
Constant -0.012
Std Err of Y Est 0.292
R Squared 0.381
No. of Observations 49
Degrees of Freedom 45
Correlation Coefficient Sign 0.617
5.489
P Value < 0.03
X Coefficients: Diet Alone 36.8%; Homeopathics 6.1%; Supplements 23.5%
Std Err of Coefficients: Diet Alone 0.112; Homeopathics 0.10; Supplements 0.094

The x coefficients in Table 1 suggest that avoidance of refined carbohydrates contributed an approximate 36.8% improvement, consuming real single remedy homeopathics an additional 6.1%, and consumption of the nutritional supplements an additional 23.5%. These results also
suggest that combination of dietary restrictions, real single-remedy homeopathics, and nutritional supplements was more helpful for improving the symptoms associated with seasonal allergic rhinitis, than either individually. For example, if a someone in the trial reduced refined carbohydrates 100%, took a real single remedy homeopathic, and took the nutritional supplements, this individual could have been expected to improve by approximately 66.4% (+/- 14.6%). For an opposite example, if a someone did not reduce refined carbohydrate consumption, did not take a real single-remedy homeopathic, and did not take the nutritional supplements, this individual could have been expected to improve (negative indicates a
worsening of symptoms) by approximately -1.2% (+/- 14.6%).

The results demonstrate that the nutrition-based approaches used were a significant factor for improvement in this trial (P < 0.03).

Other variables may have played a role in improvement. For example, since most of the participants had been taking medication in prior years, the use of medication may also have had a role on the results. 85% of participants (34/40) had been taking medications for their
seasonal allergic rhinitis. 88.2% of those who normally took medication (30/34) reduced or eliminated (10 totally eliminated taking medication) their consumption of medications during the period of this clinical trial compared to the same period last year, and yet improved.

Age appeared to have a small negative effect on improvement, but was not statistically shown to have been a major factor. None of the participants reported improvement unless they were taking real homeopathics and/or the combination nutritional supplements and/or reduced their consumption of the restricted items.

As stated earlier, each participant ranked the severity of their symptoms at the beginning and end of the clinical trial. As can be seen in Table 2, participants reported improvement for all monitored symptoms.

Table 2. AVERAGE (MEAN) IMPROVEMENT BY SYMPTOM

% Improvement

Sneezing 48.28%
Watery Eyes 46.43%
Running Nasal Mucus 50.00%
Post Nasal Drip 46.88%
Pain in Sinus Cavity 50.00%
Nose Congested 48.39%
Dry Nasal Mucus 52.38%
Itching Eyes or Sinuses 41.94%
Tired Eyes 57.14%
Itching Throat or Mouth 38.46%
Exhaustion/Tiredness 41.38%
Other 66.67%
Overall Average 47.65%

DISCUSSION

Although it is doubtful that the subjects in this experiment were clinically allergic to sucrose or dextrose or refined wheat flour (none of the participants listed allergies to any of those items), it
is likely that they may have been somewhat sensitive to those foods. Food sensitivities (or intolerance) are defined to include nonimmunologic mediated defects such as enzyme defects, food toxins, microbiotic contamination, and idiosyncratic reactions [8]. Since food allergies often trigger asthmatic attacks [9], it could be speculated that consumption of foods that one is sensitive to may increase symptoms associated with seasonal allergic rhinitis.

It is interesting to note that all persons who took real single-remedy homeopathics reported improvement. The mixed pollen dilution was not shown to have been effective, however. This could have been because the dilution only contained seven different pollens, whereas there are
normally substantial quantities of at least twenty-one different pollens/mold spores in the air during the spring months [10].

The results of taking the nutritional supplements in this clinical trial, which contained vitamins A, C, E, and other substances appeared to enhance the reduction of severity of symptoms associated with seasonal rhinitis; they may also help reducing toxicity of airborne pollutants. Previous research has indicated that the combined effects of vitamins C and E and beta-carotene seemed to have had beneficial effects on persons living in areas with airborne environmental toxins [11,12].

30 of the participants reported that they reduced the amount of medications that they normally took for their hay fever. Side effects associated with commonly used rhinitis medications (such as antihistamines and nasal corticosteroids) include drowsiness, headache, insomnia, nausea, nasal irritation, nervousness, and wheezing [13,14]. The reduction of consumption of medications would suggest an additional benefit from employing nutrition-based approaches as an adjunct to medical treatment, that of decreasing the likelihood of side effects from the medications.

Avoidance of certain refined carbohydrates, consuming single-remedy homeopathics, and taking combination nutritional supplements did reduce reported symptom severity of seasonal allergic rhinitis adults residing in the San Joaquin Valley (P <0.03). These approaches may
also be helpful for dealing with the effects of air pollution [15]. Further research into the area of naturopathy and airborne particulates is encouraged to see if researchers in other geographic
locations would reach similar conclusions.

REFERENCES

[1] Ipps DT. Nature and Causes of the PM 10 Problem in California. Technical Support Division of the State of California Air Resources Board, Sacramento. pp. 3-4, May 1987
[2] Sweet J. Fresno County 1990 air quality data summary. San Joaquin Valley Unified Air Pollution Control District, Fresno, p.1, 1991
[3] Lee R. Therapeutic Food Manual. National Academy of Research Biochemists, Biloxi (Miss.), p. 28, Circa 1957
[4] Tilden JH. Toxemia Explained. Life Science Institute, Manchaca (Tex.), pp. 37-39, Circa 1926
[5] Holm J, Bjorck I. Bioavailability of starch in various wheat-based bread products: evaluation of metabolic responses in healthy subjects and rate and extent of in vitro starch digestion. Am J Clin Nutr 55: 420-429, 1992
[6] Whitney EN and Nunnelley EM. Understanding Nutrition. West Publishing, St. Paul, Table H-1: H22-H32, 1987
[7] Geubel AP, de Galocsy C, Alves N, Rahier J, Dive C. Liver Damage caused by therapeutic vitamin A administration: Estimate of dose-related toxicity in 41 cases. Gastroenterology 100: 1701-1709, 1991
[8] Chandra R. Food allergy: diagnosis and strategies for prevention. Nutr and the M.D., 17 (4): 1-3, 1991
[9] Spector S. Common triggers of asthma. Postgraduate Med 90 (3): 50-58, 1991
[10] Ziering WH. California, Fresno. In: Statistical Report of the Pollen and Mold Committee of the American Academy of Allergy, Ross Laboratories, Columbus (OH), pp. 3-4, 1982
[11] Crystal RG. Oxidants and respiratory tract epithelial injury: pathogenesis and strategies for therapeutic intervention. J Med 91 (Suppl. 3C): 3C - 44S, 1991
[12] Menzel DE. The effects of the exposure of air pollution on the need for antioxidant vitamins. In: Beyond deficiency: new views on the function and health effects of vitamins. Academy of Sciences Abstract 13, February 9-12, 1992
[13] Histamines and Antihistamines. In: Remington's Pharmaceutical Sciences. Mack Publishing, Easton (PA), pp. 1123-1131, 1991
[14] Antihistamines/Antipruitics/Other Allergy Agents. In: Compendium of Drug Therapy. McGraw-Hill, NY, pp. 16-18, 1988
[15] Scarbeck, K. Indoor city life may increase asthma mortality. Family Practice News: 39, January 15, 1996


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