Methodological Evaluation of Clinical Trials in Radioactive Iodine Therapy for Thyroglobulin Positive and Radioactive Iodine Negative Metastases_Chinese Journal of Evidence-Based Medicine

Authors：

MA Chao ¹ , KUANG An ren ¹ , WU Tai xiang ²

1.Department of Nuclear Medicine; West China Hospital; Sichuan University; Chengdu 610041; China2.Chinese Evidence based Medicine Centre; West China Hospital; Sichuan University; Chengdu 610041; China;

Corresponding author：

Keywords：

Differentiated thyroid carcinoma; Iodine radioisotope; Quality evaluation

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Objective 　To evaluate the quality of controlled trials on 131I therapy for thyroglobulin positive and radioactive iodine negative metastases（131I WBS-/Tg+）.
Methods 　We electronically searched MEDLINE (1966 to Mar. 2004), EMBASE (1984 to 2003), The Cochrane Central Register of Controlled Trial, CENTRAL (Issue 2, 2004), CBMdisc (1978 to 2004) and CNKI (1994 to 2004), and handsearched 5 radiotherapy and endocrinology journals (Jan. 1980 to Apr. 2003). The methodological quality of included studies was assessed by using quality assessment criteria of the Cochrane systematic review guideline.
Results 　Three non-randomized controlled trials were included. One was historical controlled trial, and two prospective trials. The sample sizes of three trials were 26, 60 and 70 respectively without mentioning the calculation base. The comparability of baseline was mentioned but not comparable across the trials. No double blind studies were used in the assessment of 131I efficacy. The time of follow-up varied from 2 to 15 years. None studies mentioned the side effects of 131I therapy for 131I WBS-/Tg+ metastases. Only two studies applied statistical methods properly.
Conclusions 　Problems about allocation of groups, double blind, sample size, and follow-up period continue to exist in published controlled trials. RCT or prospective controlled trials of high quality are urgently needed in order to define the efficacy and safety of 131I therapy for 131I WBS-/Tg+ metastases.

Citation： MA Chao,KUANG An ren,WU Tai xiang. Methodological Evaluation of Clinical Trials in Radioactive Iodine Therapy for Thyroglobulin Positive and Radioactive Iodine Negative Metastases. Chinese Journal of Evidence-Based Medicine, 2005, 05(3): 252-236. doi: Copy

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1. 王家良. 随机对照试验. 见: 王家良, 主编. 临床流行病学[M]. 第2版. 上海: 上海科学技术出版社; 2001. p. 61.
2. 田蓉, 潘明志, 匡安仁. Tg升高131I显像阴性的甲状腺癌患者131I疗效评价[J],中华核医学杂志, 2003; 23(1): 27～28.
3. 刘关键, 王家良. 临床科研中正确抉择统计学方法. 见: 王家良, 主编. 临床流行病学[M]. 第2版. 上海: 上海科学技术出版社; 2001. p. 227.
4. 倪宗瓒, 几种非参数统计方法. 见: 倪宗瓒, 主编. 医学统计学[M]. 第2版. 北京: 人民卫生出版社, 1998.p. 180.
5. Wang JL. Randomized Controlled Trials. In: Wang JL, editor in chief. Clinical epidemiology[M]. 2nd ed. Shanghai: Shanghai Science and Technical Public house; 2001. p. 61.
6. Koh JM, Kim ES, Ryu JS, Hong SJ, Kim WB, Shong YK. Effects of therapeutic doses of 131I in thyroid papillary carcinoma patients with elevated thyroglobulin level and negative 131I whole-body scan: comparative study[J]. Clin Endocrinol (Oxf), 2003; 58(4):421-427.
7. Tian R, Pan MZ, Kuang AR. Evaluation of 131I therapy for differentiated thyroid carcinoma patients with elevated Tg and negative 131I whole body scan[J]. Chin J Nucl Med, 2003; 23(1): 27-28.
8. Pacini F, Agate L, Elisei R, Capezzone M, Ceccarelli C, Lippi F, Molinaro E, Pinchera A. Outcome of differentiated thyroid cancer with detectable serum Tg and negative 131I whole body scan: comparison of patients treated with high 131I activities versus untreated patients[J]. J Clin Endocrinol Metab, 2001; 86(9): 4 092-4 097.
9. Liu GJ, Wang JL. Correct Choose of Statistics Methods in Clinical Research. In: Wang JL, editor in chief. Clinical epidemiology[M], 2nd ed. Shanghai: Shanghai Science and Technical Public house; 2001. p. 227.
10. Spencer CA, Takeuchi M, Kazarosyan M, Wang CC, Guttler RB, Singer PA, Fatemi S, LoPresti JS, Nicoloff JT. Serum thyroglobulin measurement and prognostic significance in patients with differentiated thyroid carcinoma[J]. J Clin Endocrinol Matab, 1998; 83(4): 1 121-1 127.
11. Ni ZZ. Non-parametric statistics. In: Ni ZZ, editor in chief, Medical Statistics[M]. 2nd ed. Beijing: People’s Heath Publishing House, 1998.p. 180.
12. Hyer S, Vini L, O’Connell M, Pratt B, Harmer C. Testicular dose and fertility in men following 131I therapy for thyroid cancer[J]. Clin Endocrinol (Oxf), 2002; 56(6): 755-758.

Chinese Journal of Evidence-Based Medicine

Methodological Evaluation of Clinical Trials in Radioactive Iodine Therapy for Thyroglobulin Positive and Radioactive Iodine Negative Metastases

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