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The
Personal Experience Profile of Frank Bock, Ph. D. PREDNISONE AND IT'S EFFECTS: OR WHY SHOULD I DIE FROM THE MEDICATION INSTEAD OF THE DISEASE? by F. G. Bock, Ph. D. - 30 March 2001 From the beginning, starting with the diagnosis by Dr. Vendegna, (that I had Idiopathic Pulmonary Fibrosis), he informed me that there can be side effects from taking prednisone, and he listed what a few of those effects can be; such maladies as; (1) Diabetes (2) Decrease in the immune system (3) Swelling of the face and midsection; (4) Osteoporosis; (5) and a few other debilitating disorders. Basically he left the decision up to me concerning the prednisone. My response was that I would rather not since the litany of effects does not sound good. However, If the medication would alleviate the Fibrosis, I might be willing to take the chance. This all transpired in August, 1999. 1 began medication with only an inhalant - Flovent - but a month later, toward the end of September 1999, I took Dr Vee's advice, and began a regimen of taking prednisone once a day. Today is the last day of March, 2001, and I am still taking prednisone, albeit the dosage has been reduced some. Still that means that I have been on the drug for two years and seven months. We keep that length of time in mind because it will be discussed later. This is a list of the side effects that have drastically affected my life, and the doctor who made the judgment that prednisone is the cause. DISORDER DOCTOR 1. herpes zoster virus: "shingles;" McAllen, M.D. DUE TO: Decrease in immune system October 2000; still painful. 2. "sciatica" McAllen, M.D. DUE TO: Decrease in immune system. December 2000; one month. 3 "osteoporosis" McAllen, M.D. PROBABLY DUE TO: Decrease in immune system. February 2001; ongoing. 4. "cataracts in both eyes; McRee, Ophthalmologist DUE TO: Decrease in immune system March 2001. The following are quotations from reliable medical sources concerning the efficacy of prednisone, coupled with some important reasons why it possibly should not be used at all. SOURCE Mailer-Daemon Publication July, 2000 "IPF has been treated empirically with Corticosteroids. Despite the potentially favourable effects of these drugs on several inflammatory processes, only 15-30% of patients with IPF benefit from Corticosteroids. American Thoracic Society Idiopathic Pulmonary Fibrosis: Diagnosis and Treatment. International Consensus Statement. The Joint Statement of the American Thoracic Society (ATS) and the European Respiratory Society (ERS) and adopted by the ATS board of directors, July 1999 and by the ERS Executive Committee, October, 1999. "Despite their ubiquitous use, no prospective, randomized, double-blind, placebo controlled trial has evaluated the efficacy of Corticosteroids in the treatment of IPF.... Historically, most investigators initiate therapy with high-dose Corticosteroids (daily prednisone or prednisolone) for 2 to 4 mos, with a subsequent gradual taper. "To date (1999) we lack sufficient evidence that any treatment improves survival or the quality of life for patients with IPF" "The committee believes that therapy is not indicated for all patients. Importantly, given the limited success of current treatments, the potential benefits of any treatment protocol for an individual patient with IPF may be outweighed by increased risk for treatment-related complications (e.g., age >70 yr, extreme obesity, con commitment illness such as cardiac disease, diabetes mellitus, or osteoporosis, severe impairment in pulmonary function, end stage honeycomb lung on radiographic evaluation)." [Length of Therapy depends on several factors, but focus on evidence at favorable responses to therapy, and decrease in symptoms. In general, long term therapy, from 6 months to 2 years or more calls for closer monitoring and changes in the therapy. Recommended: a. Corticosteroid therapy (prednisone or equivalent) at a dose of 0.5 mg/kg (lean body weight) per day orally for 4 wk, 0.25 mg/kg (LBW) per day for 8 wk and then tapered to 0.125 mg/kg ideal body weight daily or .25 mg/kg (LBW) every other day as initial therapy for IPF]. Conclusion " The committee concludes that no data exist that adequately document any of the current treatment approaches improves survival or the quality of life for patients with IPF. National Jewish Medical and Research Center. September/October2000.
"Oral Corticosteroids -- Prednisone or methylprednisone is frequently the first medication used. For a small percentage of persons, steroids will help decrease inflammation and cause a dramatic improvement. Your response to treatment is related to your ILD and the amount of inflammation present.
"Some of the side effects may include: increased appetite, weight gain, high blood pressure, salt and fluid retention, tendency to bruise easily, depression, psychosis or hyperexcitability, tendency to develop diabetes, peptic ulcers, infections, cataracts, and osteoporosis,
National Institute of Health: Monograph: Treatment of Idiopathic Pulmonary Fibrosis with a New Antifibrotic Agent, Perfenidone: Results of a Prospective, Open-label Phase II Study. November 2000.
The Introduction to the Monograph begins with the following two sentences.
"Idiopathic Pulmonary Fibrosis (IPF) is a progressive clinical syndrome of unknown etiology and fatal outcome. Currently available therapies are ineffective and associated with significant adverse effects.
"Current therapies focus on suppressing the inflammatory process. Corticosteroids are most commonly prescribed, although a measurable favorable response is reported in only 23% of patients. This may be because most patients with IPF have had the disease for an extended period, long after the initiation of the inflammatory process." [In their testing of this project the committee discovered that] "The significant adverse effects associated with use of Corticosteroids and immunosuppressive agents contribute to additional morbidity in these patients." "Corticosteroids with or without adjunct immunosuppressive regimen, although considered conventional therapy, is nonspecific, associated with significant adverse effects and poor quality of life, and response rates are only 20 to 30%."
National Heart. Lung and Blood Institute: Monograph:Pharmacological Therapy for Idiopathic Pulmonary Fibrosis: Past, Present and Future. June 1999; The report summarizes a workshop sponsored by the NHLBI and Office of Rare Diseases on September 9-10, 1998. "Idiopathic Pulmonary Fibrosis (IPF) is a devastating illness for which current therapy is minimally effective. If medical therapy for IPF is going to improve over the next decade, controlled clinical trials will be needed to evaluate new drugs and treatment regimens. Interpretation of data on responsiveness to Corticosteroids therapy in earlier studies of IPF is difficult to evaluate because precise pathologic diagnoses were not established. "Corticosteroids are the mainstay of therapy in IPF. (However) "Reevaluation of (early) studies has questioned whether most of the patients who responded to therapy truly had IPF. Recent studies of well-defined patients with IPF suggest that few, if any, patients With IPF respond to Corticosteroid therapy. One study compared prednisone alone to prednisone plus colchicine and there was no additional benefit of colchicine. In another study, the effects of colchicine alone were similar to that of prednisone alone. The only benefit of colchicine therapy was fewer side effects when compared with prednisone." "As an aggregate these observations suggest the current therapy has minimal or no beneficial effect for patients with IPF. In addition, the two most commonly used agents (prednisone and cyclophosphamide) are associated with significant side effects." CHEST 2000: 118:788-794. "Idiopathic Pulmonary Fibrosis: A Practical Approach for Diagnosis and Management" In a study by Douglas, W. W., and colleagues (1998) they observed that those patients receiving prednisone experienced significantly more serious side effects than those receiving colchicine. This (last) finding compliments results from (Hampton, J., and colleagues. 1994).As stated by Hampton, et al., "Only 1 of 16 patients treated with high-dose Corticosteroids (prednisone) experienced an improvement in clinicoradiologic physiologic score after 4 months of treatment. However, virtually all patients were noted to have significant side effects, including: Diabetes mellitus, requiring insulin therapy; avascular necrosis; Corticosteroid myopathy; insomnia; irritability; fatigue; cushingoid features; blurred vision; depression; acne; and peptic ulcer disease." "These results suggest that the host of side effects associated with high-dose Corticosteroid therapy may cause more harm than good for many of these patients. Furthermore It should be emphasized that each of the trials used prednisone as standard therapy." "In view of these findings, one has to wonder why Corticosteroids remain the standard of care for patients with UIP. Beyond lung transplantation, which should be considered, early in those patients who are eligible, the results of these trials indicate that there is currently no treatment available that will unequivocally benefit patients with UIP. We suggest that when confronted with such a patient, perhaps the most appropriate action to take is to explain the pros and cons of available agents, in view of the limited data, and help each patient decide what is best for him or her." Your comments are greatly appreciated. Email Frank at: bockroom@tcsn.net or the Pulmonary Fibrosis Foundation at: breathe@pulmonaryfibrosis.org Disclaimer: All statements in this article are the views of Frank G. Bock, Ph. D. and do not necessarily represent the positions of the Pulmonary Fibrosis Foundation. |
