A Multidimensional Treatment Plan for Chronic Fatigue Syndrome

This study was designed to test the validity of a multitherapeutic approach to the treatment of chronic fatigue syndrome. The interventions were a wheat-free diet with nutritional supplementation; the homoeopathic treatment of allergies; homoeopathic constitutional prescribing; and psychotherapy. The protocol was cumulative with each phase of the treatment being added at monthly intervals. The subjects were the next 81 patients referred to the Glasgow Homoeopathic Hospital, UK with chronic fatigue syndrome who fulfilled the Oxford criteria. The outcome was assessed by clinical evaluation and a battery of health questionnaires. Sixty-five percent of the patients enrolled in the study had evidence of a viral trigger and 57.8% of those who completed the study had one or more allergies. Seventy percent of the patients who completed the study benefited. Patients improved from month to month with the introduction of each treatment arm, and plateaued thereafter, suggesting that all aspects of the treatment plan had a beneficial effect. Diet and the treatment of allergies are interventions which could be implemented by any doctor with a minimum of training, and can provide a useful and cost-effective approach to the treatment of chronic fatigue syndrome. In the case of male patients it may be wise to explain the diet also to the wife or partner. This work was a pilot study which appears to be worth validating with a placebo-controlled randomized trial.

Keywords: chronic fatigue syndrome, immune system, wheat-free diet, allergy, homoeopathy, psychotherapy.

INTRODUCTION

Chronic fatigue syndrome (CFS) is a condition of disputed aetiology, although antibodies to a variety of viruses have been found and viral infections have been implicated in a number of cases [ 1-4].

CFS has a number of features in common with chronic organophosphate poisoning and with a syndrome which has been termed wheat-related syndrome (WRS) which involves sensitivity to wheat but not to gluten [ 5]. These include profound weariness and fatigue, muscle weakness, impairment of memory and concentration, anxiety, palpitations and panic attacks, unrefreshing sleep and a tendency to recurrent infections. In WRS symptoms are triggered by the consumption of wheat but not other grains [ 5]. In our experience neither a wheat-free diet on its own nor conventional management has much effect in relieving the symptoms of CFS.

Since a number of aspects of CFS indicated possible immune system impairment, a therapeutic package was devised with a view to improving immune system function.

The first stage was the introduction of a wheat-free diet and nutritional supplements. Co-enzyme Q10 [ 6] and oil of evening primrose [ 7] are believed to improve immune system function. Magnesium helps to relieve muscle pain [ 8]. Fluoride is also an immune system suppressant [ 9-13], hence patients were advised to avoid it in toothpastes and other dental preparations.

Since allergies are an aspect of immune system dysfunction and other workers have found an increased incidence of allergies in patients suffering from CFS, [ 3, 14-18], the second stage was the homoeopathic treatment of any inhalant allergies that might be present.

Homoeopathy works on the principle that what a substance can cause in the way of symptomatology, it can also alleviate or cure. In other words the medicinal substance produces a similar disease picture to the illness it is used to treat. The remedies are prepared by a process of sequential dilution and mechanical shock, thus producing the homoeopathic potencies which stimulate the body's ability to heal itself. In the case of allergies, the remedy given was the homoeopathically prepared allergen. The constitutional remedy is selected for each patient individually on the basis of his or her symptomatology, precipitating factors for the illness, such as injury, infection, emotional upsets or stress, his or her reactions to environmental factors such as temperature or weather, dietary idiosyncrasies, and emotional and mental characteristics. This was added to the treatment plan in the third month.

In the fourth month psychotherapeutic techniques were introduced, aimed at improving self-image and accessing inner resources. This was included since many CFS patients have a poor self-image and a negative self-image may impair immune system function [ 19, 20]. A recent study [ 21] found cognitive therapy useful in CFS.

This protocol was tested on a series of new referrals to the out-patient department of patients with CFS.

PATIENTS AND METHODS

An unselected group of the next 81 patients referred to the out-patient department of the Glasgow Homoeopathic Hospital with a diagnosis of CFS, who fulfilled the Oxford criteria [ 22, 23], were invited to take part in the study. All agreed to do so. There were 61 females and 20 males. Age range was 10-59 years with a mean of 35.1 years. Duration of illness ranged from 6 months to 13 years with a mean of 2.1 years. All had severe disabling fatigue as the major presenting symptom and all had enjoyed good health prior to the onset of the illness. They were referred to the Homoeopathic Hospital because they had not experienced any benefit from conventional treatment.

The treatment protocol which had been devised was cumulative, bringing in new therapies at monthly intervals (Table 1).

At the first visit, a history was taken and a clinical examination carried out. Base-line questionnaires using the personal health, NFER Nelson GHQ 30, Spielberger state-trait and semantic grid questionnaires described previously [ 5], were completed. These questionnaires, taken together, assess both the physical and psychological aspects of health. A reduction in the scores indicates improvement. Change in clinical status was assessed after 4 months and at the 6-month end of trial visit.

The diet, identical to that used in the previous study [ 5], was explained to the patients at the first visit and the necessary diet sheets, appropriate recipes and details of the dietary supplements were given. Further questionnaires were also given for completion prior to the next visit.

Screening for allergies was performed at the second interview using a modified prick test on the volar surfaces of both forearms, and standard allergens (Bencard) [ 24]. The allergens tested were house dust (which includes the mites, droppings and dust), mixed grass pollens, cat fur, dog hair and horse dander. This test is routinely used in the authors' clinic and is quickly and easily performed. In no case did the negative controls give a positive result. Positive controls were not used. For those patients who showed positive prick tests, the appropriate homoeopathic treatment was commenced using House Dust 200 (which had been shown to be more effective than purified, potentized mite [ 25]), mixed grass pollens 30, cat fur 30 and dog hair 30 for house dust, pollen, cat and dog allergies respectively. Where more than one allergy was present, each of the indicated remedies was given one week apart. Patients did not have more than one remedy on any one day. Patients who did not show a positive skin test simply continued the diet and dietary supplements.

In the third month, the indicated homoeopathic constitutional remedy was added to the treatment plan and, in the fourth month, the psychotherapeutic techniques were introduced. There were two groups of exercises; firstly a number of positive affirmations aimed at improving self-image, self-esteem, confidence, enthusiasm, creativity, energy levels and general health; and secondly a series of exercises based on "The Power of Your Other Hand" [ 26] in which, using the non-dominant hand, the individual is trained to access inner talents and resources with a view to achieving inner peace and healing.

The results of each successive stage of the treatment regime were assessed monthly by means of the questionnaires, and clinically at 4 months. The study was continued for 6 months when a final assessment, both questionnaire and clinical, was made. The results of the questionnaire assessments were analyzed by the Wilcoxon matched-pairs signed-ranks test [ 27].

RESULTS

Of the 81 patients enrolled in the study, 17 (21%), 10 female and 7 male, dropped out. Two of these found it impossible to organize the wheat-free diet, one was a baker and therefore could not avoid working with wheat, and 2 withdrew on religious grounds related to the ego-strengthening exercises. Four others improved but failed to complete the study. The reasons why they and the remaining 8 patients dropped out could not be ascertained.

Sixty-four patients completed the study, 51 female and 13 male, mean age 34.1 years and mean duration of illness 1.7 years.

Fifty-three of the 81 patients (65%) had a history of a viral trigger, although this was characterized serologically in only 20 cases (24.7%). Eleven had suffered from Coxsackie B infection, 4 had had glandular fever, 2 developed CFS after chicken pox and 1 each was triggered by shingles, mumps and 1 by whooping cough. These tests had been carried out in other hospital departments prior to the patients' referral to the Glasgow Homoeopathic Hospital.

Of the 64 patients who completed the study, 37 (57.8%) proved to have positive prick tests; to house dust in all 37 cases. Ten had, in addition, positive tests to grass pollens; 2 to house dust, grass pollens and cats; and 1 to house dust and dogs.

Of these 64 patients, 45 (70%, 56% of entrants) reported a clinical improvement with a positive effect on daily living. The same patients reported improvement in the six questionnaire scores, apart from 4 patients who did not improve their scores in either the Spielberger or semantic grid tests. No patient deteriorated.

The mean monthly scores on the six questionnaires showed a steady decline over the first four months and then steadied. The improvement was most pronounced in women and greatest in the first month (Figure 1). Mean scores on each questionnaire at baseline and 4 months are shown in Table 2 for all patients who completed the study, subgrouped by sex and allergic status. For each questionnaire, the score after 4 months for the group as a whole was significantly lower than on entry, signifying both a physical improvement and a move towards a more positive and optimistic mental attitude. Significant reductions were also obtained for the allergic, non-allergic and female subgroups, but not for the men.

More women improved than men (38/51 as compared with 7/13, a difference which is not quite significant by the Chi2 test), but there were no differences among the 45 patients who improved and the 19 who did not with respect to mean age (33.8:34.8 years), mean duration of symptoms (1.8:1.3 years), or the proportion with a viral trigger (62%:63%). Marginally fewer of the responders had allergies (56%:63%) but the difference was not significant.

DISCUSSION

In this study, 70% of the patients improved on treatment and these improvements were maintained until the end of the trial. The study did not include a control group since it was designed to assess whether a cumulative protocol might be beneficial in CFS. However, in a trial in which essential fatty acids were compared with placebo in the treatment of chronic fatigue syndrome [ 7] only 17% of the placebo group had improved at the end of 3 months. An improvement of 70% in the present study far exceeds this.

CFS is a chronic illness [ 28]. The patients who took part in the present study had been ill for periods ranging from 6 months to 13 years and all had been referred to the Glasgow Homoeopathic Hospital because of lack of progress with orthodox management. It is likely that the therapeutic package described here had a positive impact on the disease outcome. The improvements were consistent across all the parameters assessed, indicating both physical and psychological improvements. Clinical improvement, or lack of it, correlated with the results of the questionnaires.

The wheat-free diet and the nutritional supplements appeared to be the most helpful component of the treatment plan (Figure 1). It was, however, the first intervention to be introduced, and it is possible that whichever treatment was introduced first may have appeared the most beneficial.

Questionnaire results improved monthly from baseline to month 4 as each new component of the therapeutic package was added. From month 4 to month 6 the results remained unchanged (Figure 1). This suggests that all components of the treatment package offered benefits to the group as a whole. It is therefore difficult to explain why the patients who did not have allergies improved to the same extent as those who had. In common with the findings of others, the majority of the patients who completed the study had allergies, and an even higher proportion reported a viral trigger, again in line with other work. This is in keeping with the view that disturbed immune system function has a part to play in the aetiology of CFS, and the therapeutic package was designed specifically with this possibility in mind. Over two-thirds of the patients who completed the trial benefited from the therapy, but allergies and viral triggers made no difference to the outcome. Bearing in mind the variable natural history of the disorder and the difficulty in agreeing on a consensus case definition, it is likely that CFS, as currently defined, is a heterogeneous group of conditions of differing aetiology, and that the presence of allergies and a precipitating viral infection are effects of immune system dysfunction rather than its cause. This may explain why the presence of these two factors did not influence the patients' response to treatment. However, the fact that a package designed to enhance the immune system had an apparently significant benefit appears to confirm the suggestion that immune system dysfunction is a core factor in the symptomatology of CFS.

Significantly more women responded than men and the results for all parameters were better for women than men. This may in part be explained by the greater importance attached to health by women and their better insight into the importance of diet. It may also be more difficult for men to follow a diet as they do not, in general, have control over the family menus. The higher drop-out rate in men may reflect this fact and underlines the need to interview the wives or partners of male patients, to stress the importance of diet in the overall therapeutic package. The men did not benefit from the dietary arm as much as the women, and this may reflect the importance of diet as a starting point in the management of CFS.

The present work was a pilot study designed to test the merits of the therapeutic package. Since the results appear favourable, a randomized, controlled trial is in order to confirm or refute the present findings.

The treatment regime described here is inexpensive, non-invasive and was beneficial to over two-thirds of the patients who completed the study and improvements were maintained to the end of the study. Although constitutional homoeopathic prescribing and psychotherapy are somewhat specialized, both a wheat-free diet with nutritional supplements and the homoeopathic treatment of allergies can be implemented with relatively little training or homoeopathic expertise. It is hoped that these techniques will be of benefit to doctors who treat patients with CFS.

ACKNOWLEDGEMENT

The authors wish to thank Dr Harper Gilmour of the Department of Public Health, University of Glasgow, for statistical advice.

TABLE 1. Treatment regime
A B
C

First month Wheat-free diet

Supplements

Coenzyme Q10, 60 mg-1 day for first
month then 30 mg-1 day

Oil of evening primrose, 1000 mg-1 day

Magnesium OK, 1-2 tablets daily

Avoidance of fluoride, e.g. fluoride toothpaste

Second month Continue as above

Homoeopathic treatment of allergies
as indicated, 1 powder/1 month

Third month Continue therapies from months 1 and 2

Addition of homoeopathic constitutional
remedies, not oftener than one dose monthly

Only one homoeopathic remedy to be taken on any
one day

Fourth month Continue therapies from months 1,2 and 3

Addition of psychotherapeutic techniques for
improving self-image and accessing inner
resources

Fifth month As month 4

Sixth month As month 4
TABLE 2. Mean values (with SD) for the questionnaires for the 64 patients, those with and those without allergies and for women and men
Legend for Chart:

B - Personal health questionnaire Base-line
C - Personal health questionnaire 4 Months
D - GHQ 3Q Likert Base-line
E - GHQ 3Q Likert 4 Months
F - GHQ 3Q GHQ Base-line
G - GHQ 3Q GHQ 4 Months
H - Spielberger State Base-line
I - Spielberger State 4 Months
J - Spielberger Trait Base-line
K - Spielberger Trait 4 Months
L - Semantic grid Base-line
M - Semantic grid 4 Months

A B C D E
F G H I
J K L M

Full group 158.1 118.9[*] 48.4 27.9[*]
16.4 6.9[*] 62.9 47.2[*]
50.3 41.8[*] 51.9 42.9[*]

(24.9) (34.8) (16.7) (18.4)
(8.5) (8.7) (12.7) (18.4)
(11.3) (13.9) (10.4) (12.0)

No allergies 153.4 114.8[*] 45.7 26.2[*]
14.4 6.5[*] 63.1 46.0[*]
48.7 41.4[*] 51.4 42.2[*]

(23.6) (33.6) (14.3) (18.0)
(7.8) (8.4) (12.1) (18.5)
(10.1) (14.5) (9.8) (11.4)

Allergies 161.5 121.9[*] 50.5 29.0[*]
17.3 7.2[*] 62.7 48.0[*]
51.6 42.2[*] 52.2 43.4[*]

(25.6) (35.9) (18.3) (18.9)
(8.8) (9.0) (13.4) (18.5)
(12.2) (13.6) (10.9) (12.6)

Women 171.6 116.5[*] 50.0 26.6[*]
17.3 6.5[*] 64.1 45.7[*]
50.5 41.0[*] 52.8 42.6[*]

(22.9) (35.5) (17.6) (18.3)
(8.7) (8.6) (12.9) (18.8)
(11.7) (14.1) (10.5) (12.4)

Men 150.3 128.3 41.8 33.1
12.8 8.8 58.4 52.8
49.6 45.0 48.5 44.2

(21.2) (31.4) (10.5) (19.0)
(6.6) (9.1) (11.4) (16.1)
(10.0) (13.1) (9.5) (11.0)

Normal scales Range 48-100 Mean 4.02
(SE 0.06)

[*] Significantly lower than at baseline p < 0.01.
S: FIG 1. Mean scores for the six questionnaires over 6 months (Shaded Circle men; Triangle women; -- whole group).

REFERENCES
[1] Behan WMH, More IAR, Behan PO. Mitochondrial abnormalities in the postviral fatigue syndrome. Acta Neuropathol 1991; 83: 61-5.

[2] Levy JA. Viral studies of chronic fatigue syndrome. Clin Infect Dis 1994; 18(1): S117-20.

[3] Buchwald AL, Komaroff AL. Laboratory findings in chronic fatigue syndrome. EOS special issue, "Chronic Fatigue Syndrome", 1995, 15-9.

[4] Jones JF. Viruses as causative agents of the chronic fatigue syndrome. EOS special issue, "Chronic Fatigue Syndrome", 1995, 20-3.

[5] Gibson SLM, Gardner APW, Gibson RG. A clinical evaluation of a wheat-free diet. J Nutr Environ Med 1995; 5: 243-53.

[6] Bliznakov EG, Hunt GL. The Miracle Nutrient, Coenzyme Q10. Wellingborough: Thorsons Publishing Group, 1986.

[7] Behan PO, Behan WMH, Horrobin D. Effect of high doses of essential fatty acids on the postviral fatigue syndrome. Acta Neurol Scand 1990; 82: 209-16.

[8] Cox IM, Campbell MJ, Dowson D. Red blood cell magnesium and chronic fatigue syndrome. Lancet 1991; 337: 757-60.

[9] Gabler WL, Leong PA. Fluoride inhibition of polymorphonuclear leukocytes. J Dent Res 1979; 58: 1933-9.

[10] Gabler WL, Creamer HR, Bullock WW. Effect of fluoride on the kinetics of superoxide generation. (Abstract). J Dent Res 1985; 64: 281.

[11] Gabler WL, Creamer HR, Bullock WW. Modulation of the kinetics of induced neutrophil superoxide generation by fluoride. J Dent Res 1986; 65: 1159-65.

[12] Gibson SLM. Effects of fluoride on immune system function. Complementary Medical Research 1992; 6: 111-3.

[13] Gomez-Ubric JL, Liebana J, Gutierrez J, Castillo A. In vitro immune modulation of polymorphonuclear leukocyte adhesiveness by sodium fluoride. Eur J Clin Invest 1992; 22: 659-61.

[14] Levine Pit. Summary and perspective: Epidemiology of chronic fatigue syndrome. Clin Infect Dis 1994; 18(1): S57-60.

[15] Majeed T, Behan PO. Clinical overview of chronic fatigue syndrome. EOS special issue, "Chronic Fatigue Syndrome", 1995, 8-14.

[16] Barker E, Fujimura SF, Fadem MB, Landay AL, Levy JA. Immunologic abnormalities associated with chronic fatigue syndrome. Clin Infect Dis 1994; 18(l): S 136-41.

[17] Ojo-Amaize EA, Conley EJ, Peter JB. Decreased natural killer cell activity is associated with severity of chronic fatigue immune dysfunction syndrome. Clin Infect Dis 1994; 18(1): S157-9.

[18] Tirelli U, Pinto A. Immunological abnormalities in chronic fatigue syndrome. EOS special issue "Chronic Fatigue Syndrome", 1995, 59-62.

[19] Silva J, Stone RB. You the Healer. Tiburon, CA: H.J. Kramer, Inc., 1989.

[20] McDermott I, O'Connor J. NLP and Health. London: Thorsons, 1996.

[21] Sharpe M, Hawton K, Simkin S, Surawy C, Hackmann A, Klimes I, Peto T, Warrell D, Seagroatt V. Cognitive behaviour therapy for the chronic fatigue syndrome; a randomised controlled trial. BMJ 1996; 312: 22-6.

[22] Sharpe MC, Archard LC, Banatvala JE, Borysiewicz LK, Clare AW, David A. et al. A report-chronic fatigue syndrome: guidelines for research. J R Soc Med 1991; 84:118-21.

[23] Dinan TG. The chronic fatigue syndrome: a neuroendocrine perspective. EOS special issue, "Chronic Fatigue Syndrome", 1995, 24-7.

[24] Nelson WE, Vaughan VC, McKay RJ (Editors). Textbook of Pediatrics, ninth edition. Philadelphia, PA: W.B. Saunders Company 1969.

[25] Gibson RG, Gibson SLM. A new aspect of psora--the recognition and treatment of house dust mite allergy. B Hom J 1980; 69:151-8.

[26] Capacchione L. The Power of Your Other Hand., North Hollywood, CA: Newcastle Publishing Company Inc., 1988.

[27] Siegel S. Nonparametric statistics for the behavioral sciences. Tokyo: McGraw-Hill Kogakusha Ltd., 1956.

[28] Levine PH. The history and epidemiology of chronic fatigue syndrome (CFS). EOS special issue, "Chronic Fatigue Syndrome", 1995, 4-7.

~~~~~~~~

By Sheila L. M. Gibson, MD BSc MF HOM and Robin G. Gibson, MB FRCP DCH BDS FF HOM

Adapted by MD BSc MF HOM and MB FRCP DCH BDS FF HOM

Share this with your friends