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Journal of Chinese Integrative Medicine ›› 2012, Vol. 10 ›› Issue (3): 279-292.doi: 10.3736/jcim20120306

• Systematic Review • Previous Articles     Next Articles

Systematic review on methodology of randomized controlled trials of post-marketing Chinese patent drugs for treatment of type 2 diabetes

Li-xin Ma,Yu-yi Wang, Xin-xue Li, Jian-ping Liu()   

  1. Center for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China
  • Received:2011-09-30 Accepted:2011-11-01 Online:2012-03-20 Published:2018-04-15

Background: Randomized controlled trial (RCT) is considered as the gold standard for the efficacy assessment of medicines. With the increasing number of Chinese patent drugs for treatment of type 2 diabetes, the methodology of post-marketing RCTs evaluating the efficacy and specific effect has become more important.
Objective: To investigate post-marketing Chinese patent drugs for treatment of type 2 diabetes, as well as the methodological quality of post-marketing RCTs.
Search strategy: Literature was searched from the books of Newly Compiled Traditional Chinese Patent Medicine and Chinese Pharmacopeia, the websites of the State Food and Drug Administration and the Ministry of Human Resources and Social Security of the People’s Republic of China, China National Knowledge Infrastructure Database, Chongqing VIP Chinese Science and Technology Periodical Database, Chinese Biomedical Database (SinoMed) and Wanfang Data. The time period for searching ran from the commencement of each database to August 2011.
Inclusion criteria: RCTs of post-marketing Chinese patent drugs for treatment of type 2 diabetes with intervention course no less than 3 months.
Data extraction and analysis: Two authors independently evaluated the research quality of the RCTs by the checklist of risk bias assessment and the data collection forms based on the CONSORT Statement. Independent double data-extraction was performed.
Results: The authors identified a total of 149 Chinese patent drugs for treatment of type 2 diabetes. According to different indicative syndromes, the Chinese patent drugs can be divided into the following types, namely, yin deficiency and interior heat (n=48, 32%), dual deficiency of qi and yin (n=58, 39%) and dual deficiency of qi and yin combined with blood stasis (n=22, 15%). A total of 41 RCTs meeting the inclusion criteria were included. Neither multicenter RCTs nor endpoint outcome reports were found. Risk bias analysis showed that 81% of the included studies reported randomization for grouping without sequence generation, 98% of these studies did not report concealment of random numbers, 5% used placebo, 10% reported outcome attrition bias and no study employed the analysis of intention-to-treat and 98% reported the diagnostic criteria for type 2 diabetes. The participants mainly consisted of outpatients without complications (76%). The minimum and maximum sample size was 40 and 300 (106±60), respectively.
Conclusion: The inclusion and exclusion criteria and outcome measures did not match the purposes and contents of post-marketing research in the included studies. They also failed to reflect the basic principles of traditional Chinese medicine in the process of diagnosis and treatment. The demographic characteristics of the patients, the indications for medicine and the syndrome differentiation process were not reported sufficiently and transparently. In order to improve the post-marketing research and promote the rational use of Chinese patent drugs, it is recommended that phase Ⅳ clinical trials should establish clear research purpose as well as hypothesis first, and choose scientific and evidence-based study design and outcome measures. In addition, guidelines for implementation of post-marketing research should be developed.

Key words: diabetes mellitus, type 2, randomized controlled trials, Chinese patent drugs, treatment outcome, systematic review

Figure 1

Flow diagram of literature search and screening of post-marketing Chinese patent drugs for treatment of type 2 diabetes CNKI: China National Knowledge Infrastructure Database; VIP: Chongqing VIP Chinese Science and Technology Periodical Database; CBM: Chinese Biomedical Literature Database."

Table 1

The characteristics of the included randomized controlled trials on postmarketing Chinese patent drugs for type 2 diabetes"

Study Sample size
(n/n)
Male
(%)
Age (years,
mean±standard
deviation or
range)
Inclusion
and exclusion
criteria
Intervention Control Diagnosis
criteria
Outcome
measure
Hao SL 2008[16] 280 (148/132) 48 25 to 75 Yes Shenqi Jiangtang Capsule, three capsules
once, three times daily for three months
Metformin 0.25 g once for three times daily China Diabetes
Association
FPG, 2h PG,
hypoglycemia
rate
Hong YQ 2009[17] 68 (34/34) 62 NA Yes Shenqi Jiangtang Granule 3 g three times daily
plus insulin (Novolin 50R) 30 min before
breakfast and supper daily for three months
Insulin (Novolin 50R) 30 min before
breakfast and supper daily
WHO FPG, 2h PG,
side effects
Zhang JJ 2007[18] 60 (30/30) 58 57.8±5.7 Yes Shenqi Jiangtang particles 3 g two times daily
plus insulin (Novolin 50R) 30 min before
breakfast and supper daily for three months
Insulin (Novolin 50R) 30 min before
breakfast and supper daily
WHO, TCM FPG, 2h PG,
HbA1c, side
effects
Pei YM 2005a[19] 78 (40/38) 50 46.7±5.1 Yes Jinqi Melbine, 24 to 36 tablets three times
daily for three months
Pioglitazone hydrochloride 15 mg orally
before sleep or 30 mg two times daily
WHO FPG, 2h PG
Wang HP 2006a[20] 71 (36/35) 52 47.3±5.0 Yes Jinqi Jiangtang Tablet, 8 tablets three times
daily for three months
Rosiglitazone 4 to 8 mg orally with empty
stomach once daily
WHO FPG, 2h PG
Zhang YM 2009[21] 157 (80/77) 45 63.5±12.6 Yes Jinqi Jiangtang Tablet 7 to 10 tablets
three times daily for three months
Metformin 0.25 to 0.75 mg three times
daily
ADA, TCM Side effects,
hypoglycemia
rate
Qi FL 2007[22] 60 (30/30) NA 58.4±7.7 NA Jinqi Hypoglycemic Tablet three times daily
plus hypoglycemic drug for three months
Hypoglycemic drug WHO FPG, 2h PG,
HbA1c
Shen PL 2005[23] 108 (62/46) 59 60.0±4.1 Yes Jinqi Jiangtang Tablet 7 to 10 tablets plus
acarbose plus metformin three times daily for
three months
Acarbose 50 mg plus metformin 0.5 g
three times daily
ADA FPG, HbA1c
Li LF 2006[24] 100 (50/50) 53 51.65±9.45 Yes Jinqi Jiangtang Tablet 7 to 10 tablets
three times daily plus glipizide for 3 months
Glipizide WHO FPG, 2h PG,
HbA1c
Yu P 2007[25] 65 (32/32) 49 60 to 83 Yes Jinqi Jiangtang Tablet 6 to 10 tablets
three times daily plus glipizide controlled
release tablets for three months
Glipizide controlledrelease tablet 5 to
15 mg once daily
WHO, TCM FPG, 2h PG,
HbA1c, side effects,
hypoglycemia
rate
Wang HP 2006b[20] 72 (37/35) 53 48.1±8.5 Yes Jinqi Jiangtang Tablet 8 tablets three times
daily plus rosiglitazone for three months
Rosiglitazone 4 to 8 mg with empty
stomach once daily
WHO FPG, 2h PG
Xu J 2006[26] 60 (30/30) NA NA Yes Jinqi Hypoglycemic Tablet 8 tablets
three times daily plus hypoglycemic drug for
three months
Hypoglycemic drug WHO, TCM FPG, 2h PG,
HbA1c
Pei YM 2005b[19] 80 (42/38) 50 47.9±8.7 NA Jinqi Melbine 6 to 8 tablets three
times daily plus pioglitazone
hydrochloride for three months
Pioglitazone hydrochloride 15 mg orally
once befere sleep or 30 mg two times daily
WHO FPG, 2h PG
Gao YF 2007[27] 300 (150/150) 47 54.2±13.9 Yes Jinlida particles 9 g two or three times daily
for six months
Liuwei Dihuang Pill 9 g two or three times
daily
WHO FPG, 2h PG,
HbA1c
Zheng X 2001[28] 68 (40/28) 44 34 to 72 NA Jinlida Condensed Pill 9 to 27 g two times
daily plus glibenclamide for six months
Glibenclamide 2.5 mg to 7.5 mg daily
based on FPG
WHO FPG, 2h PG
Liu LL 2009[29] 200 (100/100) 62 48.84±7.03 NA Clonidine 4 capsules three times daily
plus metformin for three months
Metformin 2.5 mg three times daily ADA FPG, 2h PG,
HbA1c
Zhou P 1997[30] 65 (33/32) 54 49.4±8.9 Yes Kelening Capsule 12 to 18 capsules
three times daily for three months
Glibenclamide 0.5 h before meal once or
twice daily
WHO, TCM FPG, 2h PG,
HbA1c, side
effects
Wei DX 2007[31] 125 (63/62) 69 49.3±5.3 NA Liuwei Dihuang Oral Liquid 10 mL two times
daily plus gliclazide plus acarbose for three months
Gliclazide 80 mg twice plus acarbose 100 mg
three times daily
WHO, TCM FPG, 2h PG,
HbA1c, side effects,
hypoglycemia
rate
Guan X 2006[32] 108 (53/55) NA 58.71±7.60 Yes Liuwei Dihuang Soft Capsule 9.6 g two times
daily plus Ginkgo Leaf Tablet 9.6 mg
three times daily for 18 months
Placebo of Liuwei Dihuang Soft Capsule
plus placebo of Ginkgo Leaf Tablet
WHO, TCM FPG, 2h PG,
HbA1c, symptom
and syndrome
improvement score
Wang XX 2007[33] 40 (20/20) 53 59.52±5.97 Yes Liuwei Dihuang Soft Capsule 1.14 g two
times daily plus Ginkgo Leaf Tablet 9.6 mg
three times daily for six months
Placebo of Liuwei Dihuang Soft Capsule
plus placebo of Ginkgo Leaf Tablet
WHO FPG, 2h PG,
HbA1c
Lin JY 2004[34] 64 (32/32) 88 50.81±6.71 Yes Liuwei Dihuang Pill 3 g or Jingui Shenqi Pill
3 g three times daily plus gliclazide for
12 months
Gliclazide 80 to 240 mg daily WHO, TCM FPG, A1c, QOL
score,
hypoglycemia
rate
Cheng HQ 1997a[35] 80 (50/30) 31 38 to 79 Yes Shengjin Xiaoke Capsule 3 g three times daily
for three months
Yuquan Pill 9 g four times daily WHO FPG, 2h PG,
HbA1c,
hypoglycemia
rate
Zhu LQ 2009[36] 138 (70/68) 56 62.34±9.83 Yes Tangmaikang Granule 5 g three times daily
plus hypoglycemic drug for three months
Hypoglycemic drug three times daily WHO, TCM FPG, 2h PG,
HbA1c
Du W 2010[37] 142 (70/72) 56 NA Yes Tangmakang Granule 5 g three times daily
plus metformin for three months
Metformin 0.5 g three times daily WHO FPG, 2h PG,
HbA1c, side effects
Zhou JT 2009[38] 60 (30/30) 52 60.2±9.5 Yes Tangmaikang Granule 5 g three times daily
plus metformin plus gliclazide for three
months
Metformin 0.25 g plus gliclazide 80 mg
two times daily
WHO, TCM FPG, 2h PG,
HbA1c,
hypoglycemia
rate
Cheng PR 2010[39] 64 (34/30) 56 NA Yes Tangmaikang Granule 5 g three times daily
plus insulin of conventional dosage for
three months
Insulin of conventional dosage ADA, TCM FPG
Pan H 2008[40] 86 (41/45) 72 52.8±NA Yes Tangmaikang Granule 5 g three times daily
plus insulin (Novolin 30R/50R) conventional
dosage for three months
Insulin (Novolin 30R/50R) conventional
dosage
WHO FPG, 2h PG,
side effects
Niu YF 2006[41] 55 (28/27)) 65 46.5±10.4 Yes Xiaoke Pill 5 to 15 pills three times daily for
three months
Glibenclamide 1.25 to 3.75 mg twice daily WHO, TCM FPG, 2h PG,
HbA1c, side effects,
hypoglycemia rate
Shi MY 2000[42] 162 (98/64) 54 49.6±8.5 Yes Xiaoke Pill 10 to 15 pills two or three times
daily for three months
Glibenclamide 5 to 7.5 mg two or three
times daily
WHO FPG, 2h PG,
HbA1c, symptom
improvement
score, hypoglycemia
rate
Liu L 2000[43] 120 (60/60) 45 58.23±5.35 Yes Tangmaikang Granule 5 g three times daily
for three months
Kelening Capsule 4 capsules three times
daily
TCM FPG, 2h PG,
hypoglycemia
rate
Li X 2010[44] 120 (60/60) 53 35 to 80 Yes Yulan Jiangtang Capsule 2 to 3 capsules
two times daily plus glimepiride for
four months
Glimepiride 2 to 4 mg daily WHO, TCM FPG, 2h PG,
HbA1c
Cheng HQ 1997b[45] 50 (25/25) 46 42 to 68 Yes Yusanxiao Capsule 3.2 g three times daily
for three months
Yuquan Pill 9 g four times daily WHO, TCM FPG, 2h PG,
HbA1c,
hypoglycemia rate
Yuan XY 2011a[46] 120 (60/60) 58 30 to 65 Yes Tianmai Xiaoke Tablet 0.24 g two times
daily plus metformin 0.25 g three times daily
for three months
Metformin 0.5 g three times daily WHO FPG, 2h PG,
HbA1c, side
effects
Yuan XY 2011b[47] 80 (40/40) 53 45 to 70 Yes Tianmai Xiaoke Tablet 0.24 g two times
daily plus insulin (Novolin 30R) for
three months
Insulin (Novolin 30R) conventional dosage WHO FPG, 2h PG,
HbA1c, side
effects
Hu ZX 2006[48] 180 (70/
55/55)
50 54.1±8.1 Yes Jiangtangning Capsule 4 to 6 capsules
three times daily for four months
Shiwei Yuquan Capsule 4 capsules
three times daily or gliquidone tablet
30 mg three times daily
WHO, TCM FPG, 2h PG,
hypoglycemia
rate
Shen XL 2010[49] 80 (50/30) 54 46.6±7.9 Yes Shisanwei Yuquan Pill 10 g three times daily
for three months
Shenqi Jiangtang Capsule 3 capsules
three times daily
Practical Internal
Medicine, TCM
FPG, 2h PG,
HbA1c, side
effects,
hypoglycemia
rate
Wen ZQ 2011[50] 60 (30/30) 53 45 to 70 Yes Tianmai Xiaoke Tablet 0.24 g two times
daily plus insulin for three months
Pioglitazone hydrochloride 30 mg daily
plus insulin
WHO FPG, 2h PG,
HbA1c, side
effects
Xiong WX 2009[51] 254 (119/135) 45 29 to 83 NA Shenqi Shanyao Plaster 1 patch sticking 5 to
7 d plus Shanyao Shenqi Pill for three
months
Shanyao Shenqi Pill 8 to 15 capsules
three times daily
WHO FPG, 2h PG,
hypoglycemia
rate
Zhang XK 2010[52] 120 (81/39) 49 54.69±10.20 Yes Qiyao Xiaoke Capsule 6 capsules three times
daily plus gliclazide sustainedrelease tablet
for three months
Gliclazide sustainedrelease tablet 30 mg
daily
NA FPG, 2h PG,
HbA1c, side
effects,
hypoglycemia rate
Zhang WS 2008[53] 80 (40/40) 54 42±11 Yes Tangniaole Capsule for three months Xiaoke Pill Internal Medicine,
TCM
FPG, 2h PG,
symptom
improvement
score, hypoglycemia
rate
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doi: 10.1513/pats.200706-073JK
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