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Comparison Between Cyproheptadine and Ketotifen in the Treatment

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Comparison Between Cyproheptadine and Ketotifen in the Treatment Asian Pacific Journal of Allergy and Immunology (1995) 13: 29 - 35 Cold Urticaria in Thai Children: Comparison between Cyproheptadine and ketotifen in the Treatment Nualanong Visitsunthorn, Montri Tuchinda, and Pakit Vichyanond Cold urticaria syndromes are SUMMARY: The study was performed In 6 Thai children with primary acquired characterized by the development of cold urticaria_ They all suffered from generalized urticaria and two of them aiso urticaria and/or angioedema after cold had angioedema. All of them had normal erythrocyte sedimentation rate, exposure. l In Thai children with complement 3 and negative VORL, TPHA, hepatitis B screen and cold agglutinin urticaria, 1.4% developed symptoms titer. Cryoglobulin was checked in 3 cases and showed negative results A double-blind cross-over study to compare the effectiveness of cyproheptadine after cold exposure.2 The diagnosis of and ketotifen demonstrated that the efficacy of cyproheptadine and ketotifen on cold urticaria is based on history of clinical symptoms and Ice cube test was not significantly different (p>O.05). Both symptoms after cold exposure. Ice cube of them showed good results in the treatment of cold urticaria with mild side test is a simple and easy investigation effects. During the follow up, 5 cases showed complete recovery while the other to confirm diagnosis ofcold urticaria. 3,4 one developed one or two exacerbations per year upon cold exposure. However, Cyproheptadine is one of the H 1 an­ the symptoms were mild and subsided on administration of one or two doses of tagonist which is effective in the treat­ H, antihistamine. Our data demonstrated that ketotifen was as effective as ment of cold urticaria 5-9 and can inhibit cyproheptadine in the treatment of cold urticaria in Thai children. wheal and flare from the ice cube test after 4 weeks of treatment.3 Long term use of antihistamine may be necessary also to compare the clinical symptoms, visit (week 0) as shown in the study in the treatment of cold urticaria so the ice cube score and side effects between protocol in Table 1. On the second visit medication should be harmless. the treatment with cyproheptadine and (week 0) complete blood count, differ­ Cyproheptadine can depress growth in ketotifen. ential white count, stool examination, long term use in childrenlO so other erythrocyte sedimentation rate (ESR), MATERJALS AND METHODS ), effective drugs should be used instead complement 3 (C3 VDRL, TPHA, of cyproheptadine. Ketoti fen is an The double blind cross-over hepatitis B screening (HBs Ag, HBs antihistamine that can prevent mast study was performed in six Thai chil­ Ab, HBcAb), cold agglutinin titer cell degranulation. ll,12 It has been dren with primary acquired cold urticaria shown to prevent clinical urticaria in who were referred to the Allergy Clinic, cold induced urticaria. ll,13-l6 Previous Department of Pediatrics, Faculty of From the Department of Pediatrics. Faculty studies showed lack of significant Medicine Siriraj Hospital, Mahidol of Medicine Siriraj Hospital, Mahidol Univer­ side effects after prolonged use of University, Bangkok, Thailand. On first sity. Bangkok 10700, Thailand. ketotifen. l7,l8 The aims of our study visit, history and physical examination Correspondence : Nualanong Visitsunthorn, were to evaluate the characteristics, included ice cube test were performed. Department of Pediatrics. Faculty of Medicine laboratory findings and clinical course All medications were stopped for a Siriraj Hospital, Mahidol University, Bangkok of Thai children with cold urticaria and week from first (week -1) to second 10700, Thailand_ 30 VISITSUNTHORN, ET AL. throughout the study. A positive ice Table 1. The study protocol. cube test is shown in Fig. l. The clinical score was recorded Group I cyproheptadine ketotifen as percent of improvement (0-100%). The clinical scores recorded were frequency of urticarial attack, size of Group II ketotifen I cyproheptadine '----~ urticarial rash, pruritus, swelling and other systemic symptoms associated with cold exposure. * * * * * * * I I I I I I I The side effects such as drowsi­ -1 o 2 4 6 8 10weeks ness, dry lips, increased appetite and dizziness were scored as tHows: *= follow up and perform ice cube test. o = no side effect 1 == mild side effect (no distur­ bance to normal acti,:,ity) and cryoglobulin were done. The patients were randomly devided into 2 groups (3 patients in each group). Group I: cyproheptadine (0.25 mg/kg/ day divided twice daily) was started at week 0 and continued to week 4 then stopped for 2 weeks as a washed­ out period. At week 6, ketotifen R (Zaditen , Sandoz, dose < 35 kg:0.5 mg bid; ~ 35 kg: 1 mg bid) was started and continued to week 10. Group II: ketotifen was administered first on week 0 to 4 then 2 week washed-out and 4 weeks of cyproheptadine therapy. Every visit the ice cube test was done. The clinical improvement score and side effect score were informed by the patients and their par­ ents. Ice cube test method One-cubic-inch ice cube was gen­ tly placed without pressure on the ven­ tral surface of forearm for 5 minutes. The result of ice cube test was checked at 10 minutes after the ice cube was removed and score was recorded Fig.1. A positive ice cube test on the forearm of a cold urticaria patient. (Table 2) by the same investigator 2 == modrate side effect (mild Table 2. Determination of ice cube test. disturbance to normal ac­ tivity) Ice cube Findings 3 severe side effect (definite disturbance to normal ac­ o none tivity) 1 red, very little edema The clinical and side effect scores 2 some wheal, slight raise between cyproheptadine and ketoti fen 3 definite wheal were compared at 4 weeks after treat­ 4 large wheal, 1/8 inch height ment. Ice cube scores between cypro­ COLD URTICARIA TREATMENT IN CHILDREN 31 heptadine and ketotifen were compared on the beginning of the treatment, at 2 Table 3. Characteristics of six Thai children with cold urticaria. and 4 weeks after treatment. An cases were followed up for Patient No. more than 5 years to study the course of cold urticaria and occurrence of other 1 2 3 4 5 6 allergic disorders. Age (years) 9 7 8 7 4 7 Sex· M F M M F M Statistical analysis Duration of cold 3 2 3 6 2 6 The results were analyzed by urticaria (months) non-parametric analysis. A p value < Severity of G G G G,A G G,A 0.05 was considered statistically symptoms- significant. Allergic history*** 0 AR 0 Asthma IE Asthma Familial allergic*** RESULTS history AR Urt Urt Urt 0 AR Characteristics of six Thai chil­ Area of cold skin, skin skin skin skin skin, dren with cold urticaria are shown in exposure oral oral Table 3. Mean age of the patients mucosa mucosa was 7 years. Four of them were male . M= male, F= female and two were female. All of the cases - G= generalized, A= angioedema suffered from urticaria for more than *** AR= allergic rhinitis 6 weeks. Mean duration of urticaria IE= Infantile eczema before the study was 3.6 months. all Urt= urticaria of the cases had generalized urticaria 0= none while two of them also suffered from angioedema. Area of cold exposure in all of the cases was skin. Two cases also experienced cold urticaria after Table 4. Laboratory findings in cold urticaria children. oral mucosa exposure to cold (ice and ice cream ingestion). None of them had Patient No. history or dermographism, cholinergic urticaria, aspirin-induced urticaria or 2 3 4 5 6 familial history of cold urticaria. Labo­ Ice cube score 4 2 3 2 3 4 ratory findings of the patients are Total blood eosinophils 410 952 0 603 0 396 shown in Table 4. Only two cases (cells!cu mm) had blood eosinophil counts of more Stool examination Giardia N N N N N than 500 cells/mm3. Stool examination cyst was positive for Giardia fambfia cysts ESR WNL WNL WNL WNL WNL WNL in one case who had blood eosinophil VORL N N N 1: 1 N N 410 cells/mm3. He was treated with Cold agglutinin < 1: 64 1: 4 < 1: 4 < 1: 4 < 1: 4 < 1: 4 metronidazole before the study Hepatitis screening N N N N N N started. Cryoglobulin was done in 3 C3 WNL WNL WNL WNL WNL WNL cases and all were negative. IgG,lgA,lgM WNL WNL WNL WNL WNL WNL Cryoglobulin N N N Comparison between the results of cyproheptadine and ketotifen on N negative clinical improvement is shown in WNL within normal limits Fig. 2. The mean percent of clinical not done improvement of cyproheptadine was 85 ± 6 and ketotifen was 88 ± 6 which were not significantly different heptadine and ketotifen before, at 2 were 3, 2.6 and 0.66 and of ketotifen (p>0.05). Comparison between ice and 4 weeks after treatment were were 3, 2.4 and 0.66, respectively. cube scores after cyproheptadine and not significantly different (p>0.05). Comparison between the mean ketotifen treatment is shown in Fig. 3. The mean ice cube scores of cypro­ side effect scores after cyproheptadine The mean ice cube scores of cypro- heptadine before, at 2 and 4 weeks and ketotifen in Fig. 4 showed trend 32 VISITSUNTHORN, ET AL. year upon cold exposure, However, the symptoms was mild and subsided Clinical improvement (%) on administration of one or two doses of cyproheptadine or ketotifen. The 100 clinical course of six cold urticaria chil­ dren is shown in Table 5, Three of the 90 cases have had no other allergic problems while the others suffered ,",";1 t,:·,: ;::;.-:;.~:;.: from asthma and allergic rhinitis, 80 f- "."'."...................".
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