1995 November, Evidence Suggesting Immunomodulatory Efficacy From A Herbal Extract (Infoweb resources staff notes: We have no information on the writer of this article (listed below). For all we knw, he may be a shareholder or employee of the parmaceutical comapny whose product he touts. Nonetheless, it is our policy to disseminate any information on the web that we can uncover. The tone of this note is not meant to suggest any dubious thoughts about this writer, only that in this case, we don’t have the normal means of verification or credibility in passing on this report.)
This report presents clinical observations and laboratory evidence suggesting immunomodulatory efficacy from an extract of the herb, secale cereale, (rye). Enhanced wound healing, anti-infective effects, topical analgesia, anti-inflammatory effects, anti-pyretic, bronchodilatory, anti-allergy and tumour necrosis activity, as well as improvement in immunological disorders observed in a range of human and animal disease, lend some credibility to such a contention.
INTRODUCTION
The following presentation describes some of my clinical experiences with two formulations of a purified extract of secale cereale, (Oralmat Drops and Acno Cream. Schumacher Pharmaceuticals, Melbourne). In my view these observations suggest immunomodulatory activity by the extract. Should this prove to be the case, it is an immunodulator which is effective, non-toxic, inexpensive and easily administered. It is also a freely available non- prescription item which can be used alone, or as complementary therapy to traditional medications.
By comparison, pharmacologically produced Immunomodulators available to the medical profession are expensive, frequently toxic and require close medical and laboratory supervision during and after administration.
Available biochemical evidence in the form of a broad range of inhibition assays supports my assertion of immunomodulation, whilst comprehensive reports of the effectiveness of the extract in wound healing and viral infections experienced in the equine industry, support some of my clinical observations in humans.
Although in its infancy in the human clinical setting, I believe this extract in its various formulations has the potential of relieving many of the symptoms of a substantial percentage of the patient population. It may also prove to be a potent tool in preventing the progression or reducing the severity of relapse of conditions such as multiple sclerosis and AIDS. Because of its efficacy in certain conditions such as Raynaud’s disease and chronic fatigue syndrome, it may also become the basis of an important research tool to study these conditions.
Hopefully, because of its marked efficacy over and above many “natural” therapies, the extract may also assist in bridging the gap between traditional and alternative medicine.
I have presented below a list of observations which I believe points to the homeostasic effects of the extract, most likely by immunomodulatory means. These are only observations and I have no illusions about this being a scientific document. There is available however, a series of inhibition assay results performed on the extract by an international pharmaceutical company which provides strong biochemical evidence supporting my views. These assays point to high degrees of inhibition of substance P, calcitonin gene related protein, glycine, quisqualate, somatostatin, VIP, central cholecystokinin, para-amino clonidine and NK3 receptor binding.
In clinical terms, this translates into potential uses for the extract as an analgesic, anti-inflammatory, and vasodilator. There are also indications that it could be useful in stroke and other degenerative brain pathologies. According to one clinical biochemist, the extract clearly has immunomodulatory characteristics.
SUMMARY OF CLINICAL EVIDENCE SUGGESTING IMMUNOMODULATORY ACTIVITY
1. Remarkable rates of wound healing are frequently seen in lacerations, superficial burns, varicose and arterial ulcers and diabetic foot ulcers. The absence of bacterial infection during treatment suggests T4-cell stimulation. This appears to be rapid i.e. within hours of the first application. A thin membranous epithelialisation is often seen over open wounds and burns within 24 hours of application of either the cream or solution. This appears to be important in excluding infection. Several cases of chronic leg ulcers, always returning positive swabs for bacteria, reverted to the negative state following application of the extract. This phenomenon is supported by clinical observation.
2. Viral infections, are in many cases strongly suppressed both by the solution and the cream. e.g. in herpes zoster, herpes simplex and warts. In some patients, cold and flu symptoms disappear within hours of administration. Bacteriostatic and mycostatic effects also suggest immune stimulation.
3. Asthmatics often experience symptomatic relief within one to two weeks of commencement of treatment with Oralmat, and are able to begin reducing their ashma medication. Perhaps this suggests prostaglandin inhibition affecting bronchial smooth musculature. The relief of hay fever, even in severe, chronic sufferers is usually quite rapid. Patients sometimes report the drops “affecting” them within a few seconds of sublingual application. Frequently, nasal congestion, rhinitis and periorbital inflammation and pruritus are relieved within ten minutes of application.
4. Patients with chronic fatigue due to multiple sclerosis, post-viremia, AIDS or other causes, often show remarkable improvement in fatigue within one to two weeks of commencement of therapy. I am unaware of any possible explanation for this phenomenon.
5. A tendency towards homeostasis in sufferers of diabetes mellitus, (? glibenclamide binding) glaucoma, hepatitis C and chronic lymphatic leukemia has been observed and/or reported. i.e. symptoms improve, relapses are fewer and less severe, and less medication is required.
6. Equine veterinary surgeons and trainers report rapid clinical improvement in horses suffering from nodular pharyngeal hyperplasia, commonly known as “the strangles”. Dogs suffering “kennel cough”, an upper respiratory tract infection, also respond quickly to treatment.
7. Solar keratoses and basal cell carcinomas gradually recede and disappear after regular application of the cream suggesting tumour necrosis factor activity.
8. Hardened, keratinised skin frequently softens soon after application of the cream. Profuse desquamation disappears (appears to dissolve) within minutes of application of the cream to scaly lesions.
9. Acutely inflamed osteoarthritic joints often revert to the pre-inflammatory state within 10 to 15 minutes of application of the cream. Chronically inflamed joints also respond favourably, the elimination of stiffness being a major feature of treatment. I have observed many elderly patients regain mobility of joints that have been stiff for years.
10. Rapid vasodilatation occurs in both hands in Raynaud’s disease following application of the cream to one hand. By comparison, vasoconstriction occurs when applied to chilblains. This may add weight to the theory that Raynaud’s is an immunologically rather than a sympathetically mediated disorder. It may also explain the often short-lived effects of sympathectomy. The potential use of the extract in research in this and related areas e.g. causalgia, is clear.
CLINICAL DISCUSSION
Most of the following reports have been derived from my own consultations with patients. Frequently, patients have been seen only once, and no follow-up has been possible. Others I have managed to follow up regularly over several months. There are many other reports from other sources, both anecdotal and testimonial, some to which I will refer. I am well aware of the relative non-validity of case reports per se, but this anthology does, I believe, go some way towards confirming the immunomodulatory nature of the extract.
Being a general practitioner I have been able to use the extract across a broad spectrum of medical conditions. Often this has been in a “last resort” situation, where chronicity was a feature, and the patient’s condition had stagnated or was becoming worse. Many patients have experienced symptomatic relief, and some have been cured. Many conditions improved when nothing else worked, as in refractory osteoarthritis, multiple sclerosis, chronic fatigue, Raynaud’s disease, teething, chronic cough, acute otitis media, epicondylitis and fracture pain. Now other general practitioners, consultants and alternative therapists are beginning to use the extract in a variety of clinical settings. Hopefully this report will provide a sort of “confidence-matrix” within which therapists can try out the extract for themselves.
Anti-inflammatory Effects
The cream has repeatedly proven its efficacy as an anti- inflammatory agent. This effect is most pronounced in the treatment of osteoarthritis, where patients frequently report significant relief of symptoms sometimes as little as 10 minutes after application of a small amount of the cream over the affected joint margins. Other patients experience symptomatic improvement within a few days to a week. Most patients experience at least some relief of symptoms.
One can conjecture a prostaglandin inhibitory effect or substance P inhibition or both in this setting. However, an as yet undiscovered immunological pathway as demonstrated by rapid relief of joint stiffness may be responsible. On the other hand, it seems paradoxical that rheumatoid arthritis responds initially to the cream, but the relief is short lived. Joint stiffness is not markedly affected as in osteoarthritis, and further applications seem to have little if any effect. These patients might benefit more from systemic treatment in combination with topical application of the cream and traditional medications, particularly if immunosuppressants are being used.
Osteoarthritis
An 80 year old woman suffered from a stiff, painful monoarthritis of the knee, which no longer responded to NSAIDS or intra-articular steroids. She was told by her orthopedic surgeon to “learn to live with the pain” as nothing more could be done for her. Approximately 10 minutes after applying the cream to the joint margins, she had regained almost a full range of pain-free movement. She remained symptom-free several months later using the cream once at night.
Epicondylitis
I have treated many patients with this troublesome problem, usually to good effect. Occasionally cure is effected in a few days after regular application of the cream. More commonly, pain is relieved and functionality restored for several hours after application. The cream may have to be used regularly or intermittently over a period of months or perhaps years, but the patient at least enjoys an improved quality of life. Simple Ganglion
Ganglia sometimes respond quite rapidly to application of the cream, when they soften, and diminish in size. This can happen over a period of ten minutes or so. The pain of tender nodules is also relieved. Ingrown Toenail
Patients receive rapid relief of pain from application of the cream, the swelling and inflammation settles quickly, the skin softens and infection is eradicated. Cervical Pain
I have used the cream on many patients with cervical myalgia and related disorders such as shoulder-hand syndrome. Some patients have responded, but results have been generally disappointing.
Osteochondritis
The cream can be very useful in this condition if applied regularly.
Periorbital Inflammation
A young male presented with severe pain in his left eye. There was associated bilateral periorbital edema which rendered him unable to open his eyes for closer examination. The cream was applied and within five minutes he was able to open his eyes sufficiently to be examined. By ten minutes, the periorbital swelling had completely resolved. He had opthalmic herpes simplex. Plantar Fasciitis
Several patients responded to treatment with the cream, symptoms disappearing in as little as three days. Other patients enjoyed relief of symptoms but required extended treatment.
Trochanteric bursitis
This condition has responded well in every case I have so far treated. One 75 year old male in particular required only one application of the cream. He had had pain for over two years.
Temporo-mandibulitis
3 patients with pain in a temporo-mandibular joint responded within minutes to topical application of the cream over the affected area. One patient showed no response but was lost to follow up. Tendonitis
Patients suffering from inflammatory conditions of tendinous tissue generally do very well soon after applying the cream. Symptomatic relief is usually quite rapid, but follow up data is not available.
Topical Analgesic Effects – Acute Skin Excoriations
A young restaurant manager presented with acute perianal excoriation, probably stress related, which was painful on sitting and standing. The cream was applied giving instant relief of pain and the lesion healed completely in two days. Aural Abscess
A woman presented with severe pain in the right ear, headache and fever for three days due to an external canal absces unresponsive to analgesics and antibiotics. She had not slept nor been able to move her head for 72 hours. Oralmat drops were applied over the abscess and the cream smeared around the auricle. Ten minutes later the abscess was incised and drained causing minimal pain, the patient’s headache resolved and she felt and looked well. Metastatic Bone Pain
Several patients suffering from metastatic bone pain enjoyed rapid pain relief following application of the cream. Although the duration of analgesia was only in the order of 2 to 3 hours, I believe this area of efficacy warrants thorough investigation and further development. The possibility of a rapid-onset, effective, non-narcotic, non- toxic analgesic for cancer patients can not rightly be ignored.
Adenitis/Orchitis
Application of the cream to inflamed glandular tissue, including orchitis, rapidly relieves the pain and helps to reduce swelling. This may be beneficial in preventing complications of mumps.
Dental Abscess, Toothache, Extractions, and Oral Lesions
Dental pain frequently responds to Oralmat when standard analgesics prove ineffective. Apthous and other mouth ulceration also actively heals.
Fractures
Several patients with fractured ribs received considerable pain relief, being able to breathe normally ten or fifteen minutes following application of the cream. Finger fractures show rapid resolution of soft tissue swelling, inflammation and pain soon after the cream is applied. If applied to the skin at the extremities of a plastered fracture, swelling inside the plaster is also reduced leading to pain relief. I believe this is an important finding in enhancement of fracture healing due to reduction of edema and increased resistance to infection the extract affords.
Gingivitis
Oralmat drops brushed regularly on to infected gums tends to eliminate infection and inflammation producing healthy periodontal tissue.
Hyperesthesia
The cream applied to hyperesthetic areas, particularly in osteoarthritis, and various dermatoses often brings rapid relief of symptoms.
Oral Thrush
Oralmat is highly effective in rapidly relieving the pain of oral thrush and eliminating the infection.
Otalgia
Oralmat instilled in the ear is particularly effective in relieving the pain of otalgia, presumably by reducing inflammation in the external canal and/or the tympanic membrane. A few drops in the mouth of a screaming child suffering from acute otitis media is also very effective in easing pain, presumably due to decongestion of the Eustachian tubes.
Paronychia
Several cases of paronychia were treated by surgical drainage approximately five minutes after application of the cream. The procedures were virtually painless.
Hematomata and Other Soft Tissue Injuries.
Regular application of the cream to hematomata, bruising, bone tenderness etc. leads to rapid and significant pain relief and resorption of blood in the superficial and deep tissues. Subungual hematomas resorb if the cream is applied to the surrounding skin.
Sunburn
The cream provides rapid relief of the pain of sunburn, assists in healing and prevents blistering if applied early.
Wound Healing
Burns
Because of its presumed immunomodulatory, topical analgesic, anti-infective and wound healing enhancement properties, Oralmat in a spray format should have an excellent future in the treatment of all types of burns, both superficial and deep. Although I have only used the cream on superficial burns, skin regeneration, pain and infection control is excellent while scarring is minimal or absent. Similar effects with deeper burns could reasonably be expected.
Decubitus Ulcers
Unofficial trials using the cream on decubitus ulcers have given mixed results, although some users have reported enhanced healing and absence of infection during treatment.
Diabetic Foot Ulcers
These tend to respond well according to other reports, although my personal experience is limited. One would expect improvement in this setting due to the vaso-modulatory effect of the cream, topical analgesic effects, anti- bacterial and enhanced wound healing capabilities.
Lacerations
Sutured lacerations clearly heal better with Acno or Oralmat applied than without. Suture lines tend to “seal” within 24 hours of application and ooze and inflammation is diminished or absent. I have not seen infection in an extract treated wound. This is possibly due to T4 Cell stimulation and subsequent antibacterial effects.
Varicose Ulcers
Many reports exist of enhanced healing of varicose ulcers using the extract. Compression dressings are not required, nor is strict sterile technique. Second daily, light dressings appear to achieve what more conventional and intensive therapies do, but more quickly, without infection and at a fraction of the cost.
Allergic Disorders
Cough – Acute and Chronic
Patients with chronic cough due to upper respiratory tract infection or allergy enjoy relief of symptoms, sometimes within several hours after taking Oralmat. Thick, viscid mucous softens, the cough loosens and the patient is able to expectorate with ease. Alternatively, or additionally, the cream can be applied over the larynx which also relieves the cough of upper respiratory tract infections more effectively than traditional cough medicines.
Chronic Urticaria
This troublesome condition has not responded to Oralmat after medium term use in two patients. The cream can give some relief, but treatment overall has been unsatisfactory.
Hay Fever, Sinusitis and Eustachian Catarrh
After taking the extract, patients often begin to notice symptomatic relief of hayfever symptoms as little as five or ten minutes after the first dose. Acute and chronic sinusitis sufferers also fare well. One has the impression of rapid decongestion of drainage tubes leading to resolution of sinus headache.
Cardio-pulmonary Disorders Bronchial Asthma
Asthmatics are frequently able to reduce their regular medication, and respiratory function improves. This is possibly due to the extract’s immune strengthening properties boosting resistance to various antigens, stress, viral infections etc.. I have used Oralmat in all age groups, and have seen good results in a significant number of patients.
An 83 year old chairbound, asthmatic, emphysematous female spent at least two hours a day on nebulisation. She also had a severe cough for years for which she was well known. Four days after instituting Oralmat on a twice daily dosage, her cough had disappeared and she was able to reduce her bronchodilatory therapy. Three days later, she had reduced her nebulisation to twenty minutes a day, her chest had cleared dramatically, she looked and felt well, and she was able to walk several blocks unaided. Congestive cardiac Failure
Several elderly patients suffering from congestive cardiac failure reported improved exercise tolerance and reduced peripheral edema as an incidental finding when treated with Oralmat for other problems. Whether or not this is due to bronchodilatory effects (prostaglandin inhibition), direct effects on the myocardium or other factors, remains to be seen.
Dermatological Disorders
There are many dermatological uses for the cream, for instance in.acute lesions, pruritus, pain or desquamation. Acutely itchy or painful lesions such as chicken pox, moniliasis, excoriated and allergic eczema, often respond a few minutes after application. Both solar keratoses and basal cell carcinomas tend to regress and resolve spontaneously after daily use, suggesting tumour necrosis factor activity.
Allopecia Areata
One patient was treated both systemically and topically, but no improvement was noted.
Corns and Cracked Heels
The cream is a remarkably effective hypertrophic skin softener, rapidly easing the pain and fissuring of cracked heels. Corns soften and can often be peeled off within a few days.
Psoriasis
According to other sources, psoriasis tends to respond in the medium to long term to oral/systemic treatment rather than to the cream.
Endocrinological Disorders
Diabetes Mellitus
Note: Several diabetics, both insulin and non-insulin dependent, have reported a tendency for their blood glucose to fall, a reduction in their insulin requirements, and greater ease of maintaining stable blood sugar levels when taking the extract regularly. This finding is perhaps compatible with increased glibenclamide binding shown by inhibition assay.
Gastro-Enterological Disorders
Chronic Pancreatitis and Peptic Ulcer
Several patients have reported relief of peptic ulcer symptoms after taking Oralmat for a few weeks. One patient with chronic pancreatitis was relieved of his post-prandial pain within a week.
Gynecological/Urological Disorders
Note: Given the effects of the extract on solar keratoses and basal cell carcinomas, it is conceivable that cervical dysplasias could respond to application of the extract, obviating the need for operative procedures. Genital warts also respond to treatment.
In several cases where vaginal inflammatioin prevented physical examination, the application of the cream relieved pain sufficiently to proceed with examination.
Dysmenorrhea
Several patients have reported relief of period pain following the application of the cream to the lumbar region. Although the pain was rapidly relieved, the effect lasted only a few hours. This possibly suggests prostaglandin inhibition.
Dysuria
Chronic idiopathic dysuria and the dysuria of urinary tract infection is rapidly relieved by application of a small amount of cream over the urethral orifice. Thrush
Pruritus is quickly relieved by application of the cream, usefully complementing standard anti-fungal therapy.
Immunological Disorders
Overview
An important use for the extract may be found in the treatment of immunological disorders. The tendency towards remission in AIDS, multiple sclerosis, cancer and chronic fatigue syndrome; the symptomatic relief in asthma, hay fever, Raynaud’s disease and related disorders, and the resurgence of vitality in the elderly, seems to point to wards this contention. The ability of some patients to overcome the adverse effects of chemotherapy while taking Oralmat, also lends support.
AIDS
A verbal report of five men AIDS sufferers in Johannesburg remaining in remission five months after commencing Oralmat prompted me to prescribed it for two AIDS patients, both with T4 cell counts under 150. Within two weeks of commencement of therapy, both experienced marked reduction in fatigue, felt well and have since suffered fewer viral infections. Another five AIDS patients in the United States “reported feeling better, more energy, with colds knocked out in short order”. Immunosuppression
A 44 year old female suffered severe immunosuppression all her life following a reaction to chloramphenicol in infancy. Ever since, she has been slow to heal from even minor skin wounds, often taking three months or more to recover. Since applying the cream and taking Oralmat on a regular basis, her skin lesions now tend to heal in a few days. Post Viral Fatigue
Significant relief of fatigue is often experienced, but symptoms tend to return on cessation of treatment. effected
Chronic Fatigue Syndrome
Given the various factors supporting the extract’s immunomodulatory properties, one would expect it to perform well in CFS, which I have observed in several patients. Symptoms usually abate within 7 to 10 days, some patients reporting dramatic improvement. Others have less marked effects, but quality of life is usually enhanced.
Mouth Ulcers
The absence of pharmaceutical agents which actively heal mouth (apthous, post-irradiation and chemotherapy) ulcers, gives Oralmat a special place as a therapeutic agent. A preliminary trial on 16 patients suffering from post-irradiation/chemotherapy ulcers experienced almost immediate relief of pain and the ulcers healed in all cases within 1 to 16 days. (median 8 days, mean 8.2 days). Multiple Sclerosis
Six patients suffering from multiple sclerosis have had excellent responses to Oralmat, demonstrated by significant and sometimes dramatic reduction in fatigue within seven to ten days of commencement of therapy on a three times a day dosage. Several reports from other sources have provided equally significant improvement in fatigue, fewer and less severe relapses. There has so far been no improvement in long standing neurological symptoms, but patients’ quality of life has improved in all cases.
The Elderly
Many elderly patients have responded well to two or three drops of the extract daily. A significant number of patients show increased vitality resulting in a greater degree of physical independence. One however must be judicious in the use of the extract in that frail patients’ improved activity levels may exceed their ability to cope physically.
Infectious Diseases
Note: The extract as been tested for but has shown no in- vitro anti-viral activity.
Herpes Simplex and Herpes Zoster
Many patients suffering from herpes simplex and zoster have been successfully treated using the cream. If treated pre-eruption, cold sores tend not to erupt. Developed lesions respond by contracting then forming a scab which disappears in two or three days. In most cases, pain resolves within minutes of application of the cream. However, some patients show no response to treatment. Herpes zoster can respond dramatically to application of the drops or the cream.
Viremia
Many patients have been relieved of acute and chronic rhinitis, headache, fever, malaise, myalgias and other viral symptoms from application of the cream over the posterior aspect of the neck or the forehead and nasal region. Children in particular frequently respond rapidly to the anti-pyretic effects of the cream and tend to recover from viral symptoms within five to ten minutes. Although these effects may only last several hours, the extract often successfully complements the effects of oral analgesics.
A woman requested a medical certificate because of a severe sore throat, cervical myalgia, throbbing headache and naso-sinus congestion. She was extremely pale and looked unwell. The cream was massaged into the nape of the neck. Within ten minutes, her colour had returned, her symptoms resolved and she decided to go to work as usual. Note: The dramatic nature of this patient’s response is unusual in adults but is seen frequently in young children. Many adults do however report some symptomatic relief, particularly of rhinitis and headache.
Neurological Disorders Migraine
Some patients reported improvement in migrainous symptoms, one AIDS patient in particular whose migraines remitted when he began taking Oralmat regularly. Other patients have reported no response to the extract.
Neurovascular Disorders
Pernio (chilblains) and Ischemic Pain (Diabetic)
Both these conditions rapidly respond to the application of the cream, but the duration of action has not been ascertained.
Reflex Sympathetic Dystrophy
An 83 year old woman suffered causalgia of her right hand following ulnar nerve disentrapment. Her hand was completely dysfunctional for 12 months. On examination, there was deep cyanosis of the entire hand, absent sensation and movement. The cream was applied resulting in instantaneous vasoconstriction and pallor of the hand. About one minute later, the hand began to turn pink becoming as warm as the other hand within about three minutes. Over the next five minutes, her sensation returned, the shooting pains disappeared, and a small amount of finger movement returned. After approximately ten minutes, she was able to lift a light plastic cylinder off the table, claiming this was “a miracle”. Her symptoms were only relieved for two or three hours, after which her pain returned. She was not prepared to try the cream again. However, she did accept topical application over her ulnar nerve at the elbow and enjoyed almost immediate relief of causalgia in her forearm and hand and an increased range of movement at the elbow. This was shortlived however, and within a minute her range of movement reduced, and the causalgia (“painful pins and needles”) increased.
Raynaud’s Disease
A 2 year old girl presented with intensely cold, blanched hands having had symptoms intermittenly for a month. All digits were affected. Watched by a medical colleague, I applied a small amount of cream to the palmar surface of the child’s fifth finger and within approximately 20 seconds, all digits simultaneously turned pink and warm. This phenomenon has been observed in many adult patients. Note: Due to the efficacy of the cream in Raynaud’s disease, a Melbourne cardiologist is planning controlled clinical trials of the product.
Hyperhidrosis
No clinical improvement has been noted. In a patient with combined Raynaud’s and hyperhidrosis, vasodilatation occurred but there was no effect on sweating.
Miscellaneous Disorders
Globus Hystericus
A colleague used various natural therapies on a female patient who had suffered from globus hystericus for many years. She had undergone multiple investigations and traditional treatment including psychotherapy to no avail. Application of the cream to the anterior aspect of the patient’s neck relieved her symptoms. Comment: Perhaps this woman’s response warrants a more critical review of this troublesome condition which is usually attributed to “psychogenic” causes.
Teething
One drop of Oralmat orally, or applying the cream to the nape of the neck is often very effective in pacifying a teething infant.
Treatment Issues Dosage
The recommended full adult dose of Oralmat is three drops sub-lingually three times a day. This may be necessary, but I have found that a twice daily dosage can be just as effective, later reducing to once a day. It basically depends on the patient’s response to treatment. For chronic conditions such as chronic asthma, chronic fatigue syndrome and multiple sclerosis, patients should be advised to stay on maintenance therapy indefinitely. In children and the elderly, treatment should be commenced at the lowest possible dosage which aids relief of symptoms.
The Therapeutic Goods Administration advises against giving the extract to children under the age of six years. I see no reason for this recommendation, and have used the extract in all age groups to good effect. The benefits to the child, parents and doctor derived from using it in teething, acute otitis media, cough, pyrexia, influenza and allergies outweigh concerns about toxicity.(See below). This is particularly relevant when one considers the adverse efects of some commonly used pharmaceutical products.
Adverse Effects
Formal toxicity testing on rats receiving 5 gms./kg of the final product over a period of 25 days produced no evidence of toxicity, and…”This lack of toxicity of the actives is not unexpected when one considers the natural sources of the actives.” (J. Taylor, toxicity report)
Having treated hundreds of patients with both formulations, there have been few adverse effects, all of which have been minimal. One patient, allergic to rye, developed a mild skin rash which disappeared on cessation of treatment. However, one or more ingredients of the cream may have been responsible. Occasionally patients report mild somnolence, which is usually relieved by taking the drops at night. One elderly woman felt a little dizzy soon after taking the drops, but her symptoms soon disappeared.
Pregnancy
I have deliberately avoided using the extract in pregnant women. However, one would not expect a staple cereal to be injurious to either mother or fetus.
Other Potential Applications
When one considers the likely mode of action and observed efficacy of the extract, many potentially beneficial areas in medicine spring to mind. For instance, in the prophylaxis and treatment of inflamed intravenous cannula sites; thrombophlebitis; auto-immune diseases; skin grafts; organ transplants; viral prophylaxis in the working population and overseas travellers; colostomy sites; amputation stumps and, most importantly, in the treatment of burns. The cream should be in every first-aid kit and in every home for treatment of cuts, scratches, burns, bruises and other minor injuries. The list is endless and will continue to grow.
Conclusion
This report has attempted to outline the clinical benefits of a cereal extract in a broad range of medical conditions. It has not attempted to produce a scientific rationale for its mode(s) of action but to provide a means whereby others can compare their own experiences. It is hoped the report will stimulate comment and discussion and encourage formal research into various aspects of the extract’s multiple areas of activity to the ultimate benefit of patients.
Dr. Chris Reynolds, Melbourne, Australia, 19 November,1995.
Brought to you by the Global Reproductive Health Forum Issues at Harvard University in Boston, Massachusetts