Twelve patients suffering from Hayfever participated in New York Chiropractic College’s four week pilot study to explore the effects of Spinal Manipulation and Homeopathic Immunotherapy in the treatment of Hayfever. Although a larger sample size is needed to show precise trends, the groups receiving spinal manipulation showed the most improvement and the group receiving only homeopathic remedies showed the most recovery in the subjective severity index.
Abstract
Objective
To explore the effects of Spinal Manipulation and Homeopathic Immunotherapy in the treatment of Hayfever (or Seasonal Allergic Rhinitis).
Design
Clinical trial, Comparative study, randomized. Four week treatment schedule.
Setting
New York Chiropractic College outpatient facility in Syracuse, NY.
Subjects
Twelve patients between the ages of 17 and 52, suffering from hayfever type of allergies (immediate hypersensitivity). Subjects were entered at random into four treatment groups. Group A, Group B. Group C and Group D. Medical Outcome Studies (MOS) were administered and and symptoms severity was measured subjectively.
Interventions
Group B and Group C received Homeopathic remedy. Group C also received Spinal Manipulation and Group A received Spinal Manipulation only. Group D received Spinal Manipulation and sublingual placebo. Homeopathic remedy and Placebo was self-administered by subjects three to five times per day. Spinal Manipulation was administered two times per week by chiropractic interns at NYCC outpatient facility.
Main Outcome Measures
A RAND-36 Health questionnaire was the main instrument, measuring the subjects functional status, well-being and quality of life. This was administered at the point of entry to the study as well as at the point of completion. A second instrument was a patient diary subjectively measuring severity and frequency of Signs and Symptoms as well as intensity of rhinitis.
Results
No statistically significant differences were found between any of the four treatment groups. A simple means comparison shows:
Group A and Group D with the most improvement in most of the eight subscales of the RAND MOS.
Group B showed the most recovery in the subjective severity index.
Conclusions
The hypothesis that Chiropractic Adjustments and Homeopathic Immunotherapy are synergistic in their effect on Hayfever could not be confirmed. A larger sample size is necessary to establish precise trends.
Key Indexing Terms
Hayfever, Seasonal Allergic Rhinitis, Spinal Manipulation, Homeopathic Immunotherapy, Immediate Hypersensitivity.
Introduction
Hayfever is a Type I (immediate) Hypersensitivity (or Anaphylaxis). Most symptoms involve the upper respiratory tract and conjunctive. The airborne allergens carry antigen which sensitize a host upon first contact by activating Blymphocytes. B-lymphocytes upon antigenic stimulation will differentiate into IgE synthesizing plasma cells. These specific IgE antibodies have an affinity for the Fc receptor sites of mast cells and basophils. Once the IgE has attached to the mediator cell, they are sensitized and upon contact of another specific antigen with the Fab site of the IgE (coupling), a reaction occurs resulting in the release of various inflammatory mediators: histamine (in hayfever is thought to be the most important), serotonin, bradykinin, prostaglandins, eosinophil chemotactic factor, platelet activating factor, leukotriens, thromboxanes etc.1 There is a significant correlation between histamine release and the level of serum IgE. The higher the IgE levels the higher the sensitivity and henceforth the histamine release of mast cells and basophils. T-lymphocytes inhibiting the production of IgE are also involved in the delicate balance of this response. However, Austrian researchers found that nonallergic individuals recognize the same T cell epitopes of Birch Pollen Allergen as atopic patients.2 In recent years, a pathway of IgE regulation was described, essentially based on the reciprocal activities of IL-4 and IL-13 as IgE switch factor and IFN-g as the most important antagonist of this effect.3,4 Innervation of the Immune System by the CNS has been demonstrated for some time.5,6,7,8 Figures One and Two illustrate the Neuroimmunomodulation (NIM) interactions of the CNS. The integrated interactions between the CNS, the endocrine system and immune related organs are somewhat established but not completely understood.9,10 It is also postulated that neuropeptides are involved in the regulation of immune responses as well as the modulation of a hypersensitivity reaction.11,12
Spinal Manipulation (SM) and Neuro-immunomodulation:
The role of the Cervical Sympathetic Trunk in NIM has demonstrated regulatory importance in anaphylaxis and other inflammatory events including hypersensitivity.13 Waddell concludes “The results of the present study suggest that the spinal cord may play a basic role in regulating immune system function.” It is hypothesized that aberrant somatosympathetic reflexes will adversely influence the normal and balanced immune response through spinal fixations14 or the Subluxation Complex. A subluxation by definition results in nociceptive firing patterns to the dorsal horn. Resulting crosstalk to other afferent nerves may well disturb the balance of the autonomic nervous system, interfering with it’s proper modulation of the immune response. Korr’s somatosympathetic reflex hypothesis states: “Proper SNS function is dependent on continuous, accurate sensory input to the CNS from the musculoskeletal system. Segmental dysfunction will cause segmental sympathetic hyperactivity.” Contemporary chiropractic research suggests that SM has an effect on mediators and neuropeptides involved in the immune response. KDPGF2a (a prostaglandin) serum levels were reduced after SM and sham manipulation,15 plasma level morphonuclear (PMN) neutrophils and substance P were increased after SM.16 In addition phagocytic monocytes were increased after SM.17 No matter what the precise pathways may turn out to be, anecdotal evidence suggests a connection between NIM and SM. Homeopathic Immunotherapy Tradition-ally, homeopathic immunotherapy has been successfully employed to desensitize patients suffering from hayfever.18,20 It is most commonly administered sublingual as are most homeopathic remedies. The effectiveness of homeopathy has been demonstrated for almost two Centuries25 and the question whether it is a placebo effect has been repeatedly addressed in modern research.19,20 Apparently it is not a placebo effect, the homeopathic ‘healing crisis’ is testimony to that fact as well. In theory allopathic allergy shots come close to the homeopathic ‘Law of Similars’ and to the basic homeopathic philosophy of improving the ‘Vital Force’ (immune response) and using the ‘microdose’ (dilute amounts of allergens) to accomplish an improvement (balance) of the hyperreactive immune response. There is strong clinical evidence that immunotherapy effectively reduces the severity of symptoms of inhalant allergy. After some weeks or months of immunotherapy, most patients have a change in the reactivity of their peripheral basophils.21 Immuno-therapy reduces the production of IgE while increasing production of the IgG and IgA (blocking antibodies). In reality it introduces minute (subclinical) amounts of allergens to the immune system to give the modulating mechanisms an opportunity to recognize allergens without hyperreaction. It has been shown, that this does desensitize some patients.21
Synergistic Effect of SA and Homeopathic Immunotherapy (HIT)
This study is an attempt to compare two alternative treatment modes and to investigate their effects as single treatment and combined treatment protocols. Concurrent with the above presented evidence, it can be theorized, that a sensible combination of these two treatment modalities may produce broader clinical results.
METHODS
Thirty-six people responded to ads and flyers posted in Syracuse, New York, soliciting subjects suffering from hayfever. After an initial telephone interview, 24 patients came to the clinic for a work-up. A complete patient history was taken and a complete physical and chiropractic exam was performed on each candidate. The nasal mucosa was inspected to differentiate particularly sinusitis from rhinitis.
Inclusion criteria
Suffering from hayfever for a minimum of three consecutive years and seasons. Ages between 17 and 65. Must be able to appear at clinic twice a week for four weeks.
Exclusion criteria
Subjects with additional diseases and allergies with the exception of mild asthma. Received chiropractic treatment or homeopathic treatment within the past six months. After this selection process, 18 subjects qualified as only suffering from hayfever and were entered at random into four treatment groups. Thirteen subjects finished the study and complete sets of data could be obtained. Sample size for Group A was four, Group B three, Group C two and Group D four.
Treatment Protocol
–Group A received chiropractic treatment only. <br>
–Group B received homeopathic treatment only. <br>
–Group C received both treatment modalities. <br>
–Group D received chiropractic treatment and a sublingual placebo. <br>
Treatment time was four weeks (28 days). Chiropractic treatment consisted of Spinal Manipulation of any segment which was found to be fixed or subluxated from level C0 through T4. The diagnosis of which segment to adjust was arrived by through motion palpation and static palpation. The technique employed was Diversified Technique, utilizing high velocity, low amplitude thrusts. All subjects receiving chiropractic treatment had cervical x-rays (A/P,Lat,Obl.) taken to rule out any pathologies in the upper spine. The chiropractic treatment was then administered twice a week. Homeopathic Immunotherapy and Placebo treatment: Each subject was given a bottle with a dropper containing a homeopathic remedy in an 20% alcohol base with the following ingredients: Allium cepa 6x, Arsenicum lodatum 6x, Euphrasia 6x, Sabadilla 6x, Silicea 6x, Adrenalinum 6x, Amaranthus 12x, Aster 12x, Chenopodium 12x, Cocklebur 12x,
Daisy 12x, Dandelion 12x, Goldenrod 12x, Histaminum 12x, Honeysuckle lax, Marsh Elder 12x, Mugwort 12x, Ragweed 12x, Timothy Grass 12x. The placebo bottles looked identical, the liquid tasted identical and was not distinguishable by either clinician or subject. This part of the study was double-blind and bottles had been marked by the manufacturer with numbers only. Each subject was instructed on how to use the sublingual remedy or placebo and it was then self administered by the subjects three to five times each day. Diary entries and twice weekly clinic visits ensured compliance. Ten subjects were treated through the entire treatment time by one intern, three subjects were treated by two additional interns. Measurement procedures: Two instruments were employed to measure the subjects progress and assess their health status.
Instrument I
The RAND 36-Item Health Survey 1.0 was administered the first day of the study and at the last day of the study. Eight subscales measuring quality of life, functioning and well being categories are the main outcome measures.
Instrument II
A Patient Diary in which subjects kept track of their visits, their remedy or placebo administrations and a pain/misery analog scale (looms) which measures the subjective degree of severity of symptoms including runny nose, sneezing, itchy eyes and nasal congestion.
Data Analysis
Due to the small sample sizes, parametric analysis of the data collected is not practical. Analysis of variance was not performed for the same reason. We employed nonparametric Mann-Whitney U – Wilcoxon Rant Sum Tests to compare the eight subscales of Grp A versus Grp C which examines the effect of the addition of Homeopathic treatment to Chiropractic treatment, and Grp B versus Grp C which examines the effect of the addition of Chiropractic treatment to Homeopathic treatment. Z values were calculated for all 16 comparisons. A simple comparison of mean values of the four groups in the eight subscales was calculated as well. The data of the subjective severity index was calculated into mean values of each group for each treatment day.
RESULTS
Examining the effect of the addition of chiropractic treatment to the Homeopathic treatment or vice versa we found no statistical significant difference. Table One lists the Z-values of the eight subscales: Physical functioning (PF), Role limitations due to physical health (RLP), Role limitations due to emotional problems (RLE), Energy/Fatigue (EF), Emotional well-being (EW), Social Functioning (SF), Pain (PA), General Health (GH). Comparing mean values however, it appears that Grp A and Grp D have the greatest improvement among the four groups in most categories. Table Two and Figure Three illustrate this result. Comparing mean values of the subjective severity index shows Grp A and Grp C doing worse while Grp B and Grp D were reporting the least severe symptoms over the 28 day period. (See Figure Four).
DISCUSSION
Hayfever presents itself in a clinical setting with seasonal attacks of conjunctive, nasal congestion, rhinitis and sneezing. Some of the more subjective symptoms are clouded thinking, forgetfulness and fatigue. One can measure the serum IgE and if it’s high, the level of symptoms will be predictably high. When the frost kills the ragweed, IgE levels will be back to normal and patients will be back to normal. For many reasons, among them practicality (cost-effective) and safety, a patient based paradigm was chosen. The RAND 36-Item Health survey is being implemented more often within the health professions, which increases it’s usefulness in comparing outcome measures between different subject populations.22,23 Chiropractors treat the patient, not the disease. This investigator had no choice but to research the disease; however, we measured the subjects’ quality of life and functional status and the treatment is conservative and in support of the Innate Intelligence the ultimate modulator of the immune response.
CONCLUSIONS
The sample sizes of this study were too small to draw any meaningful conclusion. Perhaps more questions were postulated than answers found. However there are correlations which need to be investigated in a larger study with subject groups and sample sizes. This will also allow the proper statistical analysis to be applied, i.e., a family-wise alpha level of .05, testing between two groups and ANOVA multiple comparison with repeated measurements for several groups. None of these could be performed in this study due to the small sample sizes. A longer treatment period is also essential, due to the inherent seasonal character of hayfever.
ACKNOWLEDGEMENTS
The following NYCC faculty members were very helpful in various stages of this study: Michael Howard, DC; Joe Miller, DC; Brian Matayoshi, PhD. Former NYCC faculty members: Wes Canfield, MD; Abbas Qutab, MD. Special thanks to Dr. Meridel Gatterman (NYCC faculty) for editing advice on this paper and to James Hulbert of NWCC, Bloomington, Minnesota for his assistance with the statistical evaluation. This study was supported by a grant from CLINICA International, Bellingham,WA (a homeopathic trademark) and by the Research Department of New York Chiropractic College, Seneca Falls, NY.
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Parts of this figure were reproduced from N.H. Spectator, 1981, “Connection between CNS and the immune system.”
Hahnemann S., “The Organon: The Art of Healing,” 1810.</ol>” “Bernard E. Straile, DC, a graduate of New York Chiropractic College, currently practices in Marcellus, New York. Dr. Straile has been involved in research since 1975 at the University of Konstanz, Germany, where he holds a degree in psychology. He is presently enrolled in the Neurology Diplomate program at Cleveland Chiropractic College and is President of Alternative Apothecary, a professional in-office pharmacy franchise complementary to chiropractic. Dr. Straile may be reached by fax at 315-673-3162.
