PMID- 24692808
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20140402
LR  - 20211021
IS  - 0011-393X (Print)
IS  - 0011-393X (Linking)
VI  - 69
IP  - 4
DP  - 2008 Aug
TI  - Comparison of methimazole/hydrocortisone ointment with oral methimazole in 
      patients with graves disease: A prospective, randomized, open-label, 
      parallel-group, 18-month study.
PG  - 305-17
LID - 10.1016/j.curtheres.2008.08.004 [doi]
AB  - BACKGROUND: Thionamide antithyroid drugs (ATDs) have certain disadvantages and 
      are associated with some adverse events (AEs). To overcome the problems 
      associated with ATDs, a compound antithyroid ointment (CATO) containing 
      methimazole (MMI) and hydrocortisone has been developed for use as a local 
      thyroid treatment (LTT). OBJECTIVE: The aim of this study was to assess the 
      clinical effectiveness and tolerability of CATO LTT in patients with Graves 
      disease (GD). METHODS: This was a prospective, randomized, open-label, 
      parallel-group clinical trial conducted at the Provincial Hospital Affiliated to 
      Shandong University (Jinan, China). Patients with GD aged 19 to 65 years were 
      randomized to receive either CATO LTT 0.3 g/d or oral MMI 37.5 mg/d (control 
      group) treatment for 18 months, with a 4-year follow-up period. Hyperthyroid 
      symptoms, thyroid function, granulocyte count, liver function, and AEs were 
      assessed at baseline and every 2 weeks until serum thyroid hormone (TH) 
      concentration normalized, at which point patients were assessed monthly. The 
      primary efficacy end points were the duration of treatment required for serum TH 
      concentration to normalize and the remission rate after completing the 18-month 
      treatment regimen. RESULTS: A total of 154 patients (133 women, 21 men; mean [SD] 
      age, 39.6 [11.8] years; all Han Chinese) participated in the study; all patients 
      completed the 18-month treatment period. Compared with the MMI group (n 76), the 
      CATO- treated group (n 78) had a significantly shorter median (range) time to 
      restoration of normal serum thyroid hormone concentration (43 [12-150] vs 22 
      [7-60] days; P < 0.001), a significantly lower rate of recurrence of 
      hyperthyroidism (309/1520 [20.3%] vs 193/1368 [14.1%] person-time; P < 0.001), a 
      significantly lower drug hypothyroidism rate (185/1520 [12.2%] vs 54/1368 [3.9%] 
      person-time; P < 0.001), and a higher remission rate (year 1:46/69 [66.7%] vs 
      65/72 [90.3%] patients, P 0.001; year 2:40/69 [58.0%] vs 60/72 [83.3%] patients, 
      P - 0.001; year 3:34/69 [49.3%] vs 57/72 [79.2%] patients, P < 0.001; and year 
      4:30/69 [43.5%] vs 55/72 [76.4%] patients, P < 0.001). Systemic AEs occurred in 6 
      patients (7.9%) in the MMI group (drug neutropenia, 2 patients [2.6%]; epistaxis, 
      1 [1.3%]; hepatopathy, 1 [1.3%]; and other systemic AEs, 2 [2.6%]), while no 
      systemic AEs were observed/reported in the CATO group. CONCLUSION: This study 
      suggests that CATO LTT was well tolerated and more effective than oral MMI 
      treatment in controlling thyrotoxicosis and promoting remission of GD in these 
      Han Chinese patients.
FAU - Chen, Ling
AU  - Chen L
AD  - Division of Endocrinology, Provincial Hospital Affiliated to Shandong University, 
      Jinan, China.
FAU - Wang, Hong-Qing
AU  - Wang HQ
AD  - Gynecology and Obstetrical Department, Provincial Hospital Affiliated to Shandong 
      University, Jinan, China.
FAU - Gao, Yan-Yan
AU  - Gao YY
AD  - Division of Endocrinology, Affiliated Hospital of Qing Dao University, Qing Dao, 
      China.
FAU - Liang, Jun
AU  - Liang J
AD  - Division of Endocrinology, Xuzhou Central Hospital, Xuzho, China.
FAU - Wang, Men
AU  - Wang M
AD  - Health Department of Dezhou Peoples' Hospital, Dezhou, China.
FAU - Bai, Jie
AU  - Bai J
AD  - Division of Endocrinology, Liaocheng Peoples' Hospital, Liaocheng, China.
FAU - Qi, Wen-Bo
AU  - Qi WB
AD  - Division of Endocrinology, Taian Central Hospital, Taian, China.
FAU - Zhang, Jun-Sheng
AU  - Zhang JS
AD  - Division of Endocrinology, Provincial Hospital Affiliated to Shandong University, 
      Jinan, China.
FAU - Zhang, Jian
AU  - Zhang J
AD  - Medicament Department, Provincial Hospital Affiliated to Shandong University, 
      Jinan, China.
FAU - Ren, Juan-Qing
AU  - Ren JQ
AD  - Medicament Department, Provincial Hospital Affiliated to Shandong University, 
      Jinan, China.
FAU - Li, Hui-Qing
AU  - Li HQ
AD  - Department of Epidemiology, Shandong Academy of Medical Science, Jinan, China.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Curr Ther Res Clin Exp
JT  - Current therapeutic research, clinical and experimental
JID - 0372621
PMC - PMC3969956
OTO - NOTNLM
OT  - antithyroid drugs
OT  - hyperthyroidism
OT  - ointment
OT  - transdermal administration
OT  - treatment
EDAT- 2008/08/01 00:00
MHDA- 2008/08/01 00:01
PMCR- 2008/08/01
CRDT- 2014/04/03 06:00
PHST- 2008/04/07 00:00 [accepted]
PHST- 2014/04/03 06:00 [entrez]
PHST- 2008/08/01 00:00 [pubmed]
PHST- 2008/08/01 00:01 [medline]
PHST- 2008/08/01 00:00 [pmc-release]
AID - S0011-393X(08)00080-5 [pii]
AID - 10.1016/j.curtheres.2008.08.004 [doi]
PST - ppublish
SO  - Curr Ther Res Clin Exp. 2008 Aug;69(4):305-17. doi: 
      10.1016/j.curtheres.2008.08.004.