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Journal of Chinese Integrative Medicine ›› 2009, Vol. 7 ›› Issue (12): 1123-1129.doi: 10.3736/jcim20091206

• Original Clinical Research • Previous Articles     Next Articles

Yunchang Capsule in treatment of functional constipation: A randomized, double-blinded controlled, multicenter trial

Jia Guoa,Rui-ming Zhanga,Zong-wen Huanga,Lei Wanga,Song-shan Liub,Jun-cheng Diaoc,Si-yuan Hud,Bing-hui Line   

  1. a Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China
    b Department of Gastroenterology, Affiliated Hospital, Chengdu University of Traditional Chinese Medicine,Chengdu 611137,Sichuan Province, China
    c Department of Gastroenterology, Affiliated Hospital, Jiangxi University of Traditional Chinese Medicine,Nanchang 330006, Jiangxi Province, China
    d Department of Gastroenterology, the First Affiliated Hospital, Tianjin University of Traditional Chinese Medicine, Tianjin 300150, China
    e Department of Gastroenterology, Fujian Academy of Traditional Chinese Medicine, Fuzhou 350108, Fujian Province, China
  • Received:2009-08-28 Accepted:2009-11-15 Online:2009-12-20 Published:2009-12-15
  • Contact: Zong-wen Huang E-mail:huangzongwen@medmail.com.cn

Background

Although there are some Chinese herbal medicines in treatment of constipation, but no multi-center randomized controlled trials have been carried out to prove their effectiveness.
Objective

To evaluate the safety and efficacy of Yunchang Capsule in treatment of functional constipation with deficiency of both qi and yin and internal accumulation of poisonous pathogenic factors syndrome, and to explore the clinical dosage.Design, setting, participants and interventions: A randomized, double-blinded controlled, multicenter trial was conducted. A total of 240 patients with functional constipation from West China Hospital of Sichuan University, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, the First Affiliated Hospital of Tianjing University of Traditional Chinese Medicine and Fujian Academy of Traditional Chinese Medicine were randomly divided into three groups: low dose group (80 cases), high dose group (80 cases) and control group (80 cases). Patients in the low dose group were treated with two pills (0.35 g/pill) of Yunchang Capsule and one pill of Yunchang Capsule simulant for three times daily; patients in the high dose group were treated with three pills (0.35 g/pill) of Yunchang Capsule for three times daily; and patients in the control group were treated with three pills (0.35 g/pill) of Biantong Capsule for three times daily. The therapeutic course was 14 days. Main outcome measures: Clinical symptoms, syndromes, and adverse effects were observed before and after the treatment, and blood, urine and stool tests, hepatorenal function and electrocardiogram were also examined.
Results

Two cases were excluded, eleven cases were lost to follow-up, and there were 234 patients entered to intention-to-treat (ITT) analysis. After the treatment, the therapeutic effects were calculated by full analysis set (FAS) and per-protocol population set (PPS) analysis respectively. The effects on functional constipation in FAS showed the response rates in the low dose, high dose and control groups were 86.25% (69/80), 82.90% (63/76), and 70.52% (55/78) respectively, and PPS analysis showed the response rates were 85.71% (66/77), 83.56% (61/73), and 70.13% (54/77) respectively. There were no significant differences among the three groups (P>0.05). The effects on traditional Chinese medicine syndrome in FAS showed the response rates in the low dose, high dose and control groups were 78.75% (63/80), 69.74% (53/76), and 67.95% (53/78) respectively, and PPS analysis showed the response rates were 77.92% (60/77), 69.87% (51/73), and 67.53% (52/77) respectively. There were also no significant differences among the three groups (P>0.05). No severe adverse events were observed.
Conclusion

Both low dose and high dose of Yunchang Capsule are effective and safe in treatment of functional constipation with deficiency of both qi and yin and internal accumulation of poisonous pathogenic factors syndrome.

Key words: Chinese herbal drugs, Constipation, Deficiency of both qi and yin, Internal accumulation of poisonous pathogenic factors, Double-blind method, Randomized controlled trial

Figure 1

Diagram of the randomized trial"

"

Items Control group Low dose group High dose group χ2/F P
Cases (Male/Female) 78 (26/52) 80 (21/59) 76 (19/57) 1.550 0.461
Mean age ($\bar{x}$±s, years) 41.69±13.98 41.04±14.16 41.72±13.80 0.060 0.941
Body weight ($\bar{x}$±s, kg) 57.49±8.87 57.46±7.58 58.16±9.33 0.160 0.848
Body height ($\bar{x}$±s, cm) 162.49±6.58 162.16±5.98 162.28±6.67 0.050 0.949
Duration ($\bar{x}$±s, d) 41.32±40.54 41.68±64.68 39.00±38.77 0.070 0.936
Score of primary symptoms ($\bar{x}$±s) 10.33±3.28 9.38±3.08 9.29±2.84 2.770 0.065
Accumulated score of TCM symptoms ($\bar{x}$±s) 15.62±4.19 14.58±3.96 14.50±3.50 1.990 0.139

Table 2

Effect analysis of functional constipation in three groups [Cases (%)]"

Group n Cure Obvious effect Improvement No improvement CMH χ2 P
FAS
Control 78 37 (47.44) 18 (23.08) 14 (17.95) 9 (11.54)
Low dose 80 40 (50.00) 29 (36.25) 9 (11.25) 2 (2.50) 1.975 0.160
High dose 76 41 (53.95) 22 (28.95) 10 (13.16) 3 (3.94)
PPS
Control 77 36 (46.75) 18 (23.38) 14 (18.18) 9 (11.69)
Low dose 77 39 (50.65) 27 (35.04) 9 (11.69) 2 (2.60) 2.018 0.149
High dose 73 39 (53.42) 22 (30.14) 10 (13.70) 2 (2.74)

Table 3

Effect analysis of syndrome of traditional Chinese medicine in three groups [Cases (%)]"

Group n Cure Obvious effect Improvement No improvement CMH χ2 P
FAS
Control 78 26 (33.33) 27 (34.62) 16 (20.51) 9 (11.54)
Low dose 80 36 (45.00) 27 (33.75) 15 (18.75) 2 (2.50) 1.548 0.214
High dose 76 34 (44.74) 19 (25.00) 20 (26.32) 3 (3.95)
PPS
Control 77 25 (32.47) 27 (35.06) 16 (20.78) 9 (11.69)
Low dose 77 35 (45.45) 25 (32.47) 15 (19.48) 2 (2.60) 2.063 0.151
High dose 73 33 (45.21) 18 (24.66) 20 (27.40) 2 (2.74)
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