Journal of Traditional Chinese Medicine ›› 2023, Vol. 43 ›› Issue (4): 770-779.DOI: 10.19852/j.cnki.jtcm.20230526.003
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Dry eye disease due to meibomian gland dysfunction treated with Pinggan Yuyin Qingre formula (平肝育阴清热方): a stratified randomized controlled trial
GAO Yinli1, LIAN Haihong1(
), DENG Shijing2(), DUAN Ying1, ZHANG Peng1, WANG Zhiqun3, ZHANG Yang3
- 1 Department of Traditional Chinese Medicine, Beijing Tongren Hospital, Capital Medical University, Beijing 100005, China
2 Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University; Beijing Ophthalmology and Visual Sciences Key Laboratory, Beijing 100005, China
3 Beijing Institute of Ophthalmology, Beijing Tongren Eye Center, Beijing Key Laboratory of Ophthalmology and Visual Sciences, Beijing Tongren Hospital, Capital Medical University, Beijing 100005, China
-
Received:2022-10-15Accepted:2023-05-04Online:2023-08-15Published:2023-05-26 -
Contact:DENG Shijing, Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University; Beijing Ophthalmology and Visual Sciences Key Laboratory, Beijing 100005, China. dengsj26@163.com. Telephone: +86-10-58268082
LIAN Haihong, Department of Traditional Chinese Medicine, Beijing Tongren Hospital, Capital Medical University, Beijing 100005, China. lianhh@163.com -
Supported by:Capital Health Development Research Project: Clinical Efficacy of the Pinggan Yuyin Qingre Formula in Treating Evaporative Dry Eye Disease Causing by Meibomian Gland Dysfunction(2016-2-2055);Zhi Nan National Famous and Senior Chinese Medicine Experts Inheritance Studio Construction Project(75 (2022));Zhi Nan National Famous and Senior Chinese Medicine Experts Inheritance Studio Construction Project(Personnel and Education Department of the National Administration of Traditional Chinese Medicine promulgated);Sixth Batch of Beijing Municipal Academic Experience Inheritance Project for Traditional Chinese Medicine Experts(160 (2021));Sixth Batch of Beijing Municipal Academic Experience Inheritance Project for Traditional Chinese Medicine Experts(Beijing Administration of Traditional Chinese Medicine promulgated)
Cite this article
GAO Yinli, LIAN Haihong, DENG Shijing, DUAN Ying, ZHANG Peng, WANG Zhiqun, ZHANG Yang. Dry eye disease due to meibomian gland dysfunction treated with Pinggan Yuyin Qingre formula (平肝育阴清热方): a stratified randomized controlled trial[J]. Journal of Traditional Chinese Medicine, 2023, 43(4): 770-779.
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Table 1 Scoring criteria of the main symptoms
| Item | 0 point | 2 points | 4 points | 6 points |
|---|---|---|---|---|
| Dry eyes | None | Occasionally, not obvious | Frequent dryness and discomfort, relieved on its own | Persistent, severe, unbearable dryness |
| Burning sensation in the eyes | None | Occasionally | Persistent, tolerable | Very obvious, intolerable, affecting daily life |
| Itchy eyes | None | Occasionally | Usually | All the time |
| Painful eyes | None | Mild pain in the eyes, occasionally | Persistent pain, tolerable, eye available | Obvious pain, eyes unavailable |
Table 1 Scoring criteria of the main symptoms
| Item | 0 point | 2 points | 4 points | 6 points |
|---|---|---|---|---|
| Dry eyes | None | Occasionally, not obvious | Frequent dryness and discomfort, relieved on its own | Persistent, severe, unbearable dryness |
| Burning sensation in the eyes | None | Occasionally | Persistent, tolerable | Very obvious, intolerable, affecting daily life |
| Itchy eyes | None | Occasionally | Usually | All the time |
| Painful eyes | None | Mild pain in the eyes, occasionally | Persistent pain, tolerable, eye available | Obvious pain, eyes unavailable |
Table 2 Scoring criteria of the secondary symptoms
| Item | 0 point | 1 point | 2 points | 3 points |
|---|---|---|---|---|
| Dizziness | None | Sometimes, occasionally tinnitus | Persistent, frequent tinnitus | Dizziness, persistent tinnitus |
| Vexation and irritability | None | Vexation, occasional irritability | Upset, impatient, irritable | Uncontrollable vexation and irritability |
| Insomnia and excessive dreaming | None | Occasionally insomnia and forgetfulness | Wake up during sleeping sometimes, excessive dreaming, often forget things | Sleepless all night, forget things quickly |
| Dry mouth | None | Mild dry mouth and throat | Dry mouth and throat | Dry mouth and throat with the desire to drink |
| Sore waist | None | Mild soreness, stop by beating | Persistent, weak knees, cannot carry heavy things | Unbearable sore waist and weak knees, cannot walk |
| Yellow urine | None | Have | ||
| Dry stool | None | Have |
Table 2 Scoring criteria of the secondary symptoms
| Item | 0 point | 1 point | 2 points | 3 points |
|---|---|---|---|---|
| Dizziness | None | Sometimes, occasionally tinnitus | Persistent, frequent tinnitus | Dizziness, persistent tinnitus |
| Vexation and irritability | None | Vexation, occasional irritability | Upset, impatient, irritable | Uncontrollable vexation and irritability |
| Insomnia and excessive dreaming | None | Occasionally insomnia and forgetfulness | Wake up during sleeping sometimes, excessive dreaming, often forget things | Sleepless all night, forget things quickly |
| Dry mouth | None | Mild dry mouth and throat | Dry mouth and throat | Dry mouth and throat with the desire to drink |
| Sore waist | None | Mild soreness, stop by beating | Persistent, weak knees, cannot carry heavy things | Unbearable sore waist and weak knees, cannot walk |
| Yellow urine | None | Have | ||
| Dry stool | None | Have |
Figure 1 Flow diagram of the study MGD: meibomian gland dysfunction.
Figure 1 Flow diagram of the study MGD: meibomian gland dysfunction.
Table 3 Baseline characteristics
| Item | Control group (n = 57) | Treatment group (n = 59) |
|---|---|---|
| Age (years) | 42.00 (32.00-49.50) | 41.00 (31.00-49.00) |
| Gender [n (%)] | ||
| Male | 22 (39) | 18 (31) |
| Female | 35 (61) | 41 (69) |
| Duration of DED (years) | 8.00 (5.00-12.00) | 10.00 (6.00-12.00) |
| MGD level [n (%)] | ||
| MGD 1 | 18 (32) | 19 (32) |
| MGD 2 | 19 (33) | 20 (34) |
| MGD 3 | 20 (35) | 20 (34) |
| Score of the properties of MG secretion (scores) | 2.00 (2.00-2.00) | 2.00 (2.00-2.00) |
| Score of palpebral margins (scores) | 2.00 (1.00-2.00) | 2.00 (2.00-2.00) |
| NITBUTav (seconds) | 8.69 (5.62-10.50) | 8.23 (6.18-11.31) |
| LLT (nm) | 65.00 (50.00-92.00) | 60.00 (42.00-80.00) |
| TCM syndrome score (scores) | 13.00 (11.00-15.00) | 13.00 (11.00-17.00) |
Table 3 Baseline characteristics
| Item | Control group (n = 57) | Treatment group (n = 59) |
|---|---|---|
| Age (years) | 42.00 (32.00-49.50) | 41.00 (31.00-49.00) |
| Gender [n (%)] | ||
| Male | 22 (39) | 18 (31) |
| Female | 35 (61) | 41 (69) |
| Duration of DED (years) | 8.00 (5.00-12.00) | 10.00 (6.00-12.00) |
| MGD level [n (%)] | ||
| MGD 1 | 18 (32) | 19 (32) |
| MGD 2 | 19 (33) | 20 (34) |
| MGD 3 | 20 (35) | 20 (34) |
| Score of the properties of MG secretion (scores) | 2.00 (2.00-2.00) | 2.00 (2.00-2.00) |
| Score of palpebral margins (scores) | 2.00 (1.00-2.00) | 2.00 (2.00-2.00) |
| NITBUTav (seconds) | 8.69 (5.62-10.50) | 8.23 (6.18-11.31) |
| LLT (nm) | 65.00 (50.00-92.00) | 60.00 (42.00-80.00) |
| TCM syndrome score (scores) | 13.00 (11.00-15.00) | 13.00 (11.00-17.00) |
Figure 2 Comparison of the score of the properties of MG secretion A: total comparison; B-E: subgroup comparison. B: the subgroup variable was gender; C: the subgroup variable was age; D: the subgroup variable was duration; E: the subgroup variable was MGD level. Control group: treated only with sodium hyaluronate eye drops (n = 57); treatment group: treated with PGYYQR granules and sodium hyaluronate eye drops (n = 59). MG: meibomian gland; MGD: meibomian gland dysfunction; PGYYQR: Pinggan Yuyin Qingre formula. Compared with the control group, aP < 0.01, bP < 0.05 (Wilcoxon test).
Figure 2 Comparison of the score of the properties of MG secretion A: total comparison; B-E: subgroup comparison. B: the subgroup variable was gender; C: the subgroup variable was age; D: the subgroup variable was duration; E: the subgroup variable was MGD level. Control group: treated only with sodium hyaluronate eye drops (n = 57); treatment group: treated with PGYYQR granules and sodium hyaluronate eye drops (n = 59). MG: meibomian gland; MGD: meibomian gland dysfunction; PGYYQR: Pinggan Yuyin Qingre formula. Compared with the control group, aP < 0.01, bP < 0.05 (Wilcoxon test).
Figure 3 Comparison of the score of palpebral margins A: total comparison; B-E: subgroup comparison. B: the subgroup variable was gender; C: the subgroup variable was age; D: the subgroup variable was duration; E: the subgroup variable was MGD level. Control group: treated only with sodium hyaluronate eye drops (n = 57); treatment group: treated with PGYYQR granules and sodium hyaluronate eye drops (n = 59). MGD: meibomian gland dysfunction; PGYYQR: Pinggan Yuyin Qingre formula. Compared with the control group, aP < 0.01, bP < 0.05 (Wilcoxon test).
Figure 3 Comparison of the score of palpebral margins A: total comparison; B-E: subgroup comparison. B: the subgroup variable was gender; C: the subgroup variable was age; D: the subgroup variable was duration; E: the subgroup variable was MGD level. Control group: treated only with sodium hyaluronate eye drops (n = 57); treatment group: treated with PGYYQR granules and sodium hyaluronate eye drops (n = 59). MGD: meibomian gland dysfunction; PGYYQR: Pinggan Yuyin Qingre formula. Compared with the control group, aP < 0.01, bP < 0.05 (Wilcoxon test).
Figure 4 Comparison of the secondary outcome A: comparison of NITBUTav, compared with the control group, aP < 0.05 (t-test); B: comparison of LLT; C: comparison of TCM syndrome score at 4 and 8 weeks, compared with the control group, aP < 0.01 (Wilcoxon test). Control group: treated only with sodium hyaluronate eye drops (n = 57); treatment group: treated with PGYYQR granules and sodium hyaluronate eye drops (n = 59). NITBUTav: the average noninvasive tear breakup time; LLT: lipid layer thickness; TCM: traditional Chinese medicine; PGYYQR: Pinggan Yuyin Qingre formula.
Figure 4 Comparison of the secondary outcome A: comparison of NITBUTav, compared with the control group, aP < 0.05 (t-test); B: comparison of LLT; C: comparison of TCM syndrome score at 4 and 8 weeks, compared with the control group, aP < 0.01 (Wilcoxon test). Control group: treated only with sodium hyaluronate eye drops (n = 57); treatment group: treated with PGYYQR granules and sodium hyaluronate eye drops (n = 59). NITBUTav: the average noninvasive tear breakup time; LLT: lipid layer thickness; TCM: traditional Chinese medicine; PGYYQR: Pinggan Yuyin Qingre formula.
Table 4 Comparison of the clinical efficacy of the two groups
| Group | n | Recovery (n) | Excellent (n) | Effective (n) | Invalid (n) | Total effective rate (%) |
|---|---|---|---|---|---|---|
| Control | 57 | 0 | 3 | 26 | 28 | 50.9 |
| Treatment | 59 | 1 | 10 | 39 | 9 | 84.7 a |
Table 4 Comparison of the clinical efficacy of the two groups
| Group | n | Recovery (n) | Excellent (n) | Effective (n) | Invalid (n) | Total effective rate (%) |
|---|---|---|---|---|---|---|
| Control | 57 | 0 | 3 | 26 | 28 | 50.9 |
| Treatment | 59 | 1 | 10 | 39 | 9 | 84.7 a |
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