Acupuncture and dry eye: current perspectives. A double-blinded randomized controlled trial and review of the literature

Figures & data

Table 1 Study criteria

Inclusion Criteria

1. 18 years of age or older

2. Previous diagnosis of dry eye disease (DED) by an ophthalmologist

3. Persistent signs and symptoms of DED for at least 1 month

Exclusion Criteria

1. Intraocular surgery or laser within 90 days

2. History of acupuncture treatment within the past year

3. Known history of adverse reaction to acupuncture

4. Pregnancy

5. Breast feeding

Figure 1 Schematic diagram of the study design.

Table 2 Demographic data and baseline values in true and sham acupuncture treatment groups

Characteristic	True acupuncture	Sham
		Acupuncture
	Group (n=24)	Group (n=25)
Age (average)	54±13	60±14
Age range	24–83	24–83
Females	20	19
Pre-menopausal	4	3
Post-menopausal	16	16
Males	4	6
Female/male ratio	5:1	19:6
Computer use (hours/day)	4±3	4±4

Note: Wherever applicable, data are presented as mean ± SD.

Table 3 Atmospheric conditions at evaluation points throughout the study

	Treatment	Baseline	1 Month	3 Month	6 Month
Mean temperature (°F)	T	60±15	59±16	49±17	39±17
	S	60±12	61±16	46±17	38±15
Dew point (°F)	T	47±15	48±16	39±19	27±16
	S	49±12	48±17	33±16	28±16
Relative humidity (%)	T	64±13	68±18	71±22	65±20
	S	67±13	64±13	63±315	70±21

Note: Data are presented as mean ± SD.

Abbreviations: T, true treatment; S, sham treatment.

Figure 2 Ocular Surface Disease Index (OSDI). OSDI was evaluated at baseline and after 1 week, 1, 3, and 6 months in patients receiving either true (n=24) or sham (n=25) acupuncture treatment. True acupuncture treatment significantly improved OSDI when compared to sham treatment only after 6 months (*p=0.04). Also, OSDI scores significantly improved 1 week after true acupuncture treatment and continued to improve (†p<0.05).

Table 4 Secondary outcomes were evaluated at 1, 3 and 6 months

Outcome measure	Treatment	Baseline	1 Month	3 Month	6 Month	N	p-values */**/***
TBUT	T	3±3	3±3	3±3	3±3	24	<0.9/0.5/0.3
	S	3±2	3±3	3±3	2±2	25
Schirmer’s test	T	10±8	9±6	10±7	11±9	24	<0.3/0.4/0.3
	S	9±7	11±7	8±4	10±6	25
Ocular surface grading	T	8±4	6±4	7±4	7±4	24	<0.5/0.1/0.4
	S	6±3	5±3	6±3	6±2	25
Artificial tear application (questionnaire)	T	3±3	3±3	3±3	2±2	24	<0.5/0.3/0.3
	S	4±3	3±3	3±2	3±3	25
Frequency of eye closing (questionnaire)	T	6±4	3±4	3±5	3±4	24	<0.2/0.002/0.2
	S	5±4	3±3	4±4	3±3	25

Notes: *Comparison of True vs Sham treatment groups. **Compared to baseline within the True treatment group. ***Compared to baseline within the Sham treatment group. Data are presented as mean ± SD.

Abbreviations: T, true treatment; S, sham treatment; TBUT, tear film break-up time.

Table 5 General questionnaire DED symptoms score

DED symptoms	Treatment	Baseline	1 Month	3 Month	6 Month	N	p-Values */**/***
Discomfort	T	2±1	1±1†	1±1†	1±1†	24	>0.9/0.01/0.02
	S	2±1	2±1	1±1†	1±1†	25
Dryness	T	3±1	2±1†	2±1†	1±1†	24	>0.9/0.001/0.01
	S	3±1	2±1†	2±1†	2±1†	25
Scratchiness	T	2±1	1±1†	1±1†	1±1†	24	>0.9/0.001/0.3
	S	2±1	1±1	1±1†	1±1†	25
Burning	T	1±1	1±1	1±1	1±1	24	>0.6/0.1/0.1
	S	2±2	1±2	1±1	1±1	25
Stinging	T	1±1	1±1	1±1	1±1	24	>0.9/0.1/0.3
	S	1±1	1±1	1±1	1±1	25
Tiredness	T	2±1	1±1	1±2	1±1†	24	>0.4/0.1/0.2
	S	2±1	2±2	2±1	2±1	25
Redness	T	2±1	1±1†	1±1	1±1†	24	>0.3/0.01/0.1
	S	2±2	1±2	1±1	1±2	25
Watering	T	1±1	1±1	1±1	0±1	24	>0.2/0.4/0.5
	S	1±1	1±1	1±1	1±1	25
Blurring	T	1±1	1±1	1±1	1±1	24	>0.4/0.1/0.1
	S	2±2	1±1	1±1	1±1	25
Decreased Vision	T	1±1	1±1	1±1	1±1	24	>0.5/0.6/0.2
	S	1±2	1±1	1±1	1±1	25

Notes: *Comparison of True vs Sham treatment groups. **Compared to baseline within the True treatment group. ***Compared to baseline within the Sham treatment group. † Intragroup comparison to baseline. Responses were assigned numerical scores, 0=never, 1=rarely, 2=sometimes, 3=frequently and 4=constantly. The higher the score the worse the symptoms. A Kruskal–Wallis test was performed on ranks to achieve statistical differences, as these data do not follow normal distribution.

Abbreviations: T, true treatment; S, sham treatment; DED, dry eye disease.