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Paediatrica Indonesiana Effectiveness of Cyproheptadine in The Paediatrica Indonesiana VOLUME 49 September NUMBER 5 Original Article Effectiveness of cyproheptadine in the prevention of childhood migraine Zulkarnain, Johannes Saing, Yazid Dimyati, Bistok Saing Abstract Background Migraine is one of the causes of recurrent headache eadache, more particularly migraine, is a LQFKLOGKRRG&\SURKHSWDGLQHLVZHOONQRZQDVDQDQWLKLVWDPLQH frequent health problem in children and but there are few studies revealing the drug’s effect in pediatric migraine. DGROHVFHQWV+HDGDFKHVDUHHVWLPDWHGWR Objective To determine the effectiveness of cyproheptadine in the EHRFFXUUHGLQXSWRRIDGROHVFHQWV prophylactic treatment of childhood migraine. +DQGRI\RXQJHUFKLOGUHQ0LJUDLQHKDVWKHJUHDWHVW Methods$UDQGRPL]HGSODFHERFRQWUROOHGFOLQLFDOWULDOVWXG\ impact on children and parents. It occurs in up to was performed at Medan. One hundred children with migraine DFFRUGLQJWRWKH,QWHUQDWLRQDO+HDGDFKH6RFLHW\FULWHULDZHUH FKLOGUHQZLWKDJHEHWZHHQDQG\HDUVDQG 1 LQFOXGHGLQWKHVWXG\6XEMHFWVZHUHGLYLGHGLQWRWZRJURXSVDQG LQFKLOGUHQDJHGWR\HDUV Although the HDFKJURXSZDVJLYHQHLWKHUPJF\SURKHSWDGLQHRUSODFHERIRU DWWDFNVRIPLJUDLQHPD\VWDUWDWDQ\DJHWKHLQFLGHQFH ZHHNV+HDGDFKHIUHTXHQF\ZDVPHDVXUHGLQKHDGDFKHGD\VSHU SHDNVLQHDUO\WRPLGDGROHVFHQFHMigraine, as month, duration was measured in hours and functional disability defined by the research group on headache of the ZDVPHDVXUHGE\3HGLDWULF0LJUDLQH'LVDELOLW\$VVHVVPHQW 3HG0,'$6 7KHHIILFDF\ZDVPHDVXUHGEHIRUHLQWHUYHQWLRQ World Federation of Neurology, is a familial disorder DOVRDQGPRQWKVDIWHULQWHUYHQWLRQ FKDUDFWHUL]HGE\UHFXUUHQWDWWDFNVRIKHDGDFKH Results$WRWDORISDWLHQWVZLWKDJHUDQJLQJIURPWR\HDUV widely variable in intensity, frequency, and duration. ROG ZLWKPHDQ\HDUV ZHUHWUHDWHGZLWKF\SURKHSWDGLQH $WWDFNVDUHXVXDOO\XQLODWHUDODQGDUHDVVRFLDWHGZLWK RUSODFHERIRUKHDGDFKH&RPSDUHGWREDVHOLQHWKHUHZDVD anorexia, nausea and vomiting. In some cases, these VLJQLILFDQWGLIIHUHQFHRQ3HG0,'$6JUDGLQJRIPLJUDLQHVLQERWK JURXSV 3 +HDGDFKHIUHTXHQF\DQGGXUDWLRQSHUPRQWK DUHSUHFHGHGE\ RUDVVRFLDWHGZLWK QHXURORJLFDODQG were significantly different after treatment with cyproheptadine mood disturbances.3 7KH:RUOG+HDOWK2UJDQL]DWLRQ 3 &,WRDQG3 &, WR55 FRPSDUHGWRSODFHERJURXS 3! EXW WKHUHZHUHVLGHHIIHFWVRIF\SURKHSWDGLQHXSWR Conclusion&\SURKHSWDGLQHDSSHDUVWREHHIIHFWLYHDVDQ alternative prophylactic treatment of childhood migraine. Presented at the 14th,QGRQHVLDQ&RQJUHVVRI3HGLDWULFV,QGRQHVLDQ +RZHYHUSHGLDWULFLDQVVKRXOGFRQVLGHUWKHVLJQLILFDQWVLGHHIIHFWV 3HGLDWULF6RFLHW\6XUDED\D-XO\thth of this drug. [Paediatr Indones. 2009;49:286-91]. )URPWKH'HSDUWPHQWRI&KLOG+HDOWK0HGLFDO6FKRRO8QLYHUVLW\RI North Sumatera, Medan, Indonesia. Keywords: cyproheptadine, prophylaxis, childhood migraine Reprint request to: =XONDUQDLQ0''HSDUWPHQWRI&KLOG+HDOWK 0HGLFDO6FKRRO8QLYHUVLW\RI1RUWK6XPDWHUD-O%XQJD/DX1R 0HGDQ,QGRQHVLD7HO)D[ ([email protected] 286Paediatr Indones, Vol. 49, No. 5, September 2009 Zulkarnain et al:&\SURKHSWDGLQHLQSUHYHQWLQJPLJUDLQH :+2 FRQVLGHUVWKDWVHYHUHPLJUDLQHFDQEHDV VXEMHFWVZHUHWKHIROORZLQJRQHRIWKHFULWHULDVXFKDV disabling as quadriplegia.4,5 WZRRUPRUHDWWDFNVSHUPRQWKWKDWSURGXFHGLVDELOLW\ Approach to migraine treatment involves acute ODVWLQJRUPRUHGD\VSHUPRQWKFRQWUDLQGLFDWLRQ DERUWLYH DQGSUHYHQWLYH SURSK\ODFWLF 3UHYHQWLYH WRRUIDLOXUHRIDFXWHWUHDWPHQWVWKHXVHRIDERUWLYH WUHDWPHQWJLYHQHYHQLQWKHDEVHQFHRIDWWDFNVLV PHGLFDWLRQPRUHWKDQWZLFHSHUZHHNDQGWKH aiming to reduce the frequency and severity of the presence of uncommon migraine conditions including PLJUDLQHDWWDFNPDNHDFXWHDWWDFNVPRUHUHVSRQVLYH hemiplegics migraine, migraine with prolonged aura, to abortive therapy, and perhaps also improve the or migraines infarction. We excluded patients from patient’s quality of life.On average, two thirds WKHVWXG\LQWKHSUHVHQFHRIDQ\RIWKHIROORZLQJ RISDWLHQWVZLOOKDYHUHGXFWLRQLQKHDGDFKH FKURQLFGDLO\KHDGDFKHVPRUHWKDQRQHW\SHRI frequency with most preventive drugs.4 Many clinical KHDGDFKHLQFOXGLQJFOXVWHUKHDGDFKHVFRH[LVWLQJ trials in children using expensive drugs such as sodium PHGLFDOQHXURORJLFDORUSV\FKLDWULFGLVRUGHUSUHYLRXV valproate and topiramate show good outcome. treatment with three or more migraine prophylactic &\SURKHSWDGLQHKDVDORZFRVWVRPHWLPHVLWLVXVHG PHGLFDWLRQVKLVWRU\RISUHYLRXVF\SURKHSWDGLQHXVH by pediatric neurologist, however only Rao et al who history of noncompliance with previous migraine had studied this drug compared with other drug. medications and obesity. Migraine is a common cause of headache in children 7KHVWXG\ZDVDSSURYHGE\WKH(WKLFV&RPPLWWHH and it significantly reduces school attendances, but of University of North Sumatera. As part of the not may has studied about the phenomenon.We standard assessment, detailed questionnaires at initial compared cyproheptadine with placebo to determine DQGIROORZXSHYDOXDWLRQVZHUHREWDLQHG7KLV their effectiveness in prophylactic treatment of questionnaire included information about headache childhood migraine. frequency, duration, and characteristics, as well as some general health screening, documentation of school absences, and ratings of functioning at home Methods and school. Frequency was measured in headache days per month, duration was measured in hours, This was a randomized clinical trial with control and functional disability was measured by Pediatric SODFHERVWXG\&RQGXFWHGIURP)HEUXDU\WR0D\ 0LJUDLQH'LVDELOLW\$VVHVVPHQW6FDOH 3HG0,'$6 6XEMHFWVZHUHUHFUXLWHGIURPHOHYHQVFKRROV 3HGLDWULF0LJUDLQH'LVDELOLW\$VVHVVPHQW LQFOXGLQJWKUHHMXQLRUKLJKVFKRROVDQGHLJKWVHQLRU 3HG0,'$6 ZDVDGPLQLVWHUHGWRDOORIWKHSDWLHQWV high schools in Medan, North Sumatera. For each DVSDUWRIWKLVTXHVWLRQQDLUHDWLQLWLDODQGIROORZXS GLVRUGHUDVHULHVRIGHWDLOHGSULPDULO\\HVQRTXHVWLRQV HYDOXDWLRQV3HG0,'$6ZDVDVL[LWHPTXHVWLRQQDLUH ZHUHDVNHG(DFKVXEMHFWZDVDVNHG´+DYH\RXHYHU The initial three questions dealt with impact of had a lot of trouble with headaches?”, if they had a KHDGDFKHRQVFKRROTXHVWLRQDVNHGDERXWVFKRRO SRVLWLYHUHVSRQVHWKHQWKH\ZHUHDVNHGLIWKH\WRRN GD\DEVHQFHVTXHVWLRQDVNHGDERXWSDUWLDOGD\ medication for the headaches and how recently DEVHQFHVDQGTXHVWLRQDVNHGDERXWIXQFWLRQLQJ the headache occurred. A positive response to this DWRUOHVVDELOLW\LQVFKRRO7KHIRXUWKTXHVWLRQ general headache question was used as a nonspecific, assesed the impact due to headache at home and VHQVLWLYHVFUHHQLQJTXHVWLRQWRHVWDEOLVKWKHDWULVN LQFOXGHGLQDELOLW\WRSHUIRUPKRPHZRUNDQGFKRUHV VWXG\VXEMHFWVWRHVWLPDWHWKHLQFLGHQFHRIPLJUDLQH The final two questions assesed disability in social LQWKHVWXG\VXEMHFWVRQIROORZXS IXQFWLRQLQJLQFOXGLQJVSRUWVTXHVWLRQDVNHGDERXW 0LJUDLQHZDVGLDJQRVHGE\FRQVXOWDQWSHGLDWULF FRPSOHWHDEVHQFHIURPDFWLYLWLHVZKLOHTXHVWLRQ neurologist in accordance with The International DVNHGDERXWIXQFWLRQLQJDWRUOHVVRIWKHLUDELOLW\ +HDGDFKH6RFLHW\ ,+6 FULWHULD:HLQFOXGHGDOO 3HG0,'$6ZHUHDVNHGDIWHUFRPSOHWLRQWRUDWHWKHLU VWXGHQWVGLDJQRVHGZLWKPLJUDLQHDFFRUGLQJWR,+6 overall disability due to headache in the preceding 3 ZKRVHDJHUDQJLQJIURPWR\HDUVDQGZKRKDG PRQWKV JOREDOUDWLQJ WKHSDWLHQWVZHUHSURPSWHG experienced migraine. Informed consent was obtained with the choices of none to little, mild, moderate, and from the parents. The selection criteria for study severe. Responses to this question were obtained prior Paediatr Indones, Vol. 49, No. 5, September 2009287 Zulkarnain et al:&\SURKHSWDGLQHLQSUHYHQWLQJPLJUDLQH WRGLVFXVVLQJ3HG0,'$6VFRUHVDQGWKHLUVLJQLILFDQFH ZHUHUDQGRPO\GLYLGHGLQWRWZRJURXSVFKLOGUHQ ZLWKWKHSDWLHQWV0HDQ3HG0,'$6VFRUHVZLWK LQWKHWUHDWPHQWJURXSZLWKF\SURKHSWDGLQHDQG standard deviations were determined for each of the FKLOGUHQLQSODFHERJURXS'XULQJWKHIROORZXSWKH four global rating responses. second months, there were two dropouts from the 6XEMHFWVZHUHUDQGRPL]HGLQWRWZRJURXSVXVLQJ treatment group. The intention to treat analysis was simple randomization method. Anthropometric data SHUIRUPHGRQDOOVXEMHFWVXQWLOWKHHQGRIVWXG\DIWHU was recorded including body weight and the height. 3 months. )LUVWJURXS $ UHFHLYHGF\SURKHSWDGLQHPJGD\ From the questionnaires and physical examination RQFHGDLO\GXULQJEHGWLPH7KHVHFRQGJURXS % before intervention, there were no significant received placebo containing saccharum lactis once GLIIHUHQFHVRQVXEMHFWV·FKDUDFWHULVWLFEHWZHHQWKH GDLO\GXULQJEHGWLPHDQGUHTXHVWHGWRWDNHLWLQWKH WZRJURXSV Table 1 6L[W\WZR RISDWLHQW VDPHPDQQHUDVWKHF\SURKHSWDGLQH6XEMHFWVGLGQRW had a clinical diagnosis of migraine without aura, NQRZZKHWKHUWKHFDSVXOHFRQWDLQHGF\SURKHSWDGLQH DQG KDGPLJUDLQHZLWKDXUD2IWKHVH or placebo, both groups got therapy for 3 months. All SDWLHQWVVXEMHFWVZHUHPDOHDQGZHUHIHPDOH VXEMHFWVZHUHUHDVVHVVHGDIWHUPRQWKIRUWZRJURXS·V 7KHPHDQ3HG0,'$6UDZVFRUHZDVIRUHDFKJOREDO F\SURKHSWDGLQHRUSODFHER$WWKHIROORZXSYLVLW rating category for the total group, the initial group frequency and duration of headaches were determined DQGWKHIROORZXSJURXS%DVHGRQWKHFRQYHUJHQFH for the preceding 4 ZHHNVDQGKHDGDFKHVFRUHVIURP RISDWLHQWJOREDOUDWLQJVZLWK3HG0,'$6UDZVFRUH daily diaries were calculated at monthly intervals. D3HG0,'$6JUDGLQJV\VWHPZDVGHYHORSHG8VLQJD All headache diaries were filled in by the SULQFLSOHRIQRQRYHUODSSLQJZHUDQJHGWKHVFRUHVWR children. After the third month’s treatment, each JUDGH, OLWWOHWRQRQHDQGPLOGGLVDELOLW\ *UDGH FKLOGZDVDVNHGWRLQGLFDWHWKHSUHIHUUHGWUHDWPHQW ,, PRGHUDWHDQGVHYHUHGLVDELOLW\ ! in the diary. The code was opened for the treatment Migraine frequency in cyproheptadine group only, because it was considered ethically unacceptable Table 2 GHFUHDVHGIURP 6' WR 6' to withhold adequate treatment until the whole trial 3 &,WR ZKLOHLQ ZDVFRPSOHWHG&KLOGUHQZHUHDVNHGWRUHSRUWDQ\ placebo group, the frequency was only decreased from DGYHUVHHYHQWVGXULQJWKHIROORZXSYLVLWVDQGLQWKH 6' WR 6' 3 &, KHDGDFKHGLDULHV'LDULHVZHUHFROOHFWHGZKHQWKH
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