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Pulse Dose Therapy,

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Steroid Pulse DOSE

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Pulse therapy means the administration of large doses of drugs in an intermittent manner to enhance the therapeutic effect and reduce the side effects.

The first reported use was used it to successfully prevent renal graft rejection. Subsequently, pulse doses of corticosteroids were used for several other diseases such as lupus nephritis, rheumatoid arthritis and pyoderma gangrenosum, but usually to deal with emergency situations only and not as a preferred method of treatment. Methylprednisolone was the commonest drug used, in a dose of 1 g per dose for a variable number of days.

We first used pulse therapy in a patient having Reiter's disease and could save him from an almost certain death. Continued use of pulses at 1 month intervals led him to a remarkable recovery and a fairly useful life for the next 10 years. For pemphigus, the pulse therapy was first used by us in 1982,for systemic sclerosis in 1989, for pyoderma gangrenosum in 1990,and other diseases in subsequent years. However, we used 100 mg dexamethasone on three consecutive days at 4 week intervals and continued to use the pulses for a specified period even after the patient had recovered from the disease completely. This was done to ensure that the patient would not develop a relapse in future. By now we have used pulse therapy for more than 1000 patients having pemphigus, 100 cases of systemic sclerosis, 25 patients having systemic lupus erythematosus, 20 patients having dermatomyositis, 10 patients having pyoderma gangrenosum and fewer cases of other diseases including extensive lichen planus, prurigo nodularis, generalized morphea, DLE, scleredema, recurrent alopecia universalis, extensive vitiligo, allergic vasculitis, disseminated porokeratosis, Darier's disease, Hailey-Hailey disease, multiple keloids, sarcoidosis, multicentric histiocytosis, and Peyronie's disease with similar success. With this experience over the last nearly 20 years, it seems logical to claim that it is now possible to cure almost all the autoimmune and several other corticosteroid responsive dermatoses and avoid the side effects commonly associated with the conventional daily-dose regimens of corticosteroid administration. To achieve optimum results it is important to strictly follow the regimen recommended by us in all its details. Any compromises have produced inferior results.

   The regimen

The pulse therapy regimen designed by us is called the DCP regimen or the dexamethasone-cyclophosphamide pulse (DCP) therapy regimen. In its present form, it consists of giving 100 mg dexamethasone dissolved in 500 ml of 5% glucose as a slow intravenous drip over 2 hours repeated on 3 consecutive days. On the second day, the patient is also given 500 mg cyclophosphamide in the same drip. This constitutes one DCP. Such DCPs are repeated at exactly 28 day intervals counted from the first day of the pulse. In between the DCPs the patient receives only 50 mg cyclophosphamide orally per day. The DCP regimen is administered in four phases. During the first few months (phase I) the patient may continue to develop recurrences of clinical lesions in between the DCPs and can therefore be given additional treatment (conventional daily doses of oral corticosteroids or additional dexamethasone pulses) to achieve quicker clinical recovery, and these are as a rule withdrawn step-wise during the subsequent DCPs. After the skin and the mucous membrane lesions have subsided completely and the additional medication has been withdrawn, the patient is considered to have entered phase II. During this phase, the patient remains completely alright clinically but receives 9 more DCPs at exactly 28 day cycles along with 50 mg cyclophosphamide orally per day. During the next phase (phase III), the DCPs are stopped and the patient receives only 50 mg cyclophosphamide orally per day for the next 9 months. After this, the treatment for pemphigus is withdrawn completely and the patient is followed up for the next 10 years to look for a relapse if any (phase IV).

During the earlier part of our project, we used to give 6 DCPs during phase II and the duration of phase III was 12 months.

   Indications and contraindications

Since the pulse therapy regimen virtually cures every pemphigus patient for the rest of his life and there are almost no side effects, all pemphigus patients deserve to be treated with this regimen irrespective of whether they are having severe or mild disease. Even those patients who are in clinical remission but have to
take maintenance doses of corticosteroids/immunosuppressive drugs, can be made to give up the maintenance doses by administering them a course of the DCP regimen.

There are almost no contraindications. DCP therapy can be given to patients of all ages but the doses have to be reduced to half for children below the age of 12 years. It can also be given to patients having diabetes mellitus, hypertension, hyperacidity, osteoporosis, tuberculosis, etc., but each patient must receive additional appropriate treatment for the concomitant disease whenever necessary. Diabetic patients need to be given 10 units of soluble insulin for every 500 ml bottle of 5% glucose dissolved in the same drip in addition to the routine treatment for diabetes. Hypertensive patients must monitor the blood pressure regularly and adjust the treatment for hypertension if necessary. Patients having hyperacidity can continue to take antacids or H2 blockers as required and even those having active tuberculosis can continue the pulse therapy along with the anti-tubercular treatment. Viral warts and molluscum contagiosum can also be treated concomitantly along with the pulse therapy.

If a patient has severely infected lesions or there is a serious infection elsewhere, the start of the pulse therapy can be delayed for a week or two till the infection has been brought under control. Similarly patients having herpes zoster, herpes simplex or even chicken pox can be given concomitant treatment with acyclovir and the pulse therapy can be continued except under exceptional circumstances when the viral infection is very severe.

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