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Editors Selection IGR 16-3

Miscellaneous: Can acupuncture be an effective adjunct therapy for glaucoma? This rigorous RCT may provide answers

Comment by Vivek Gupta & Tanuj Dada on:

There are conflicting reports about the utility of acupuncture for glaucoma with evidence both in favour of benefit ¹ and lack of it.² Studies have also indicated increase in IOP right after acupuncture sessions.³ The primary objective of this single-center, parallel-arm, randomized controlled trial (ClinicalTrials.gov NCT05753137) is to evaluate acupuncture in patients with mild-moderate POAG. In addition to standard routine ophthalmic care, intervention group (n=25) receives traditional Chinese medicine–style acupuncture at the six bilateral ophthalmic related acupoints, and control group (n=25) on six bilateral non-ophthalmic acupoints, once a week for 6 weeks. Participant, assessor and statisticians will be masked to group allocation. Primary outcome measures are change in IOP between baseline and 12 weeks, and IOP measured pre-acupressure and 15 minutes post-acupressure session. Secondary outcomes include best corrected visual acuity, visual fields, optical coherence tomography (OCT), OCT angiography, Glaucoma Symptom Scale, Glaucoma Quality of Life-15 questionnaire, heart rate, and blood pressure.

We note a few methodological issues in the present protocol. The inclusion criterion of age ≥ 20 years will not be appropriate for POAG alone as Juvenile glaucoma cases may be included. Excluding those using any drugs that affect IOP, conflicts with inclusion criteria (1 or 2 glaucoma drugs). Criteria for success / failure are not defined. Authors are not assessing change in diurnal fluctuations of IOP which may influence the measure of effect. In sample size calculation, statistical power mentioned as 95% CI, is confusing since CIs are linked to type 1 error probability and not to power (1-type 2 error probability). Based on our estimates using G*Power calculator, for an effect-size d of 0.4, 5% type-1 error probability, and 80% power, a sample size of 100+100 is needed for independent samples comparison, indicating the study may be underpowered. Authors also need to specify use of intention to treat or per-protocol analysis. We are hopeful that the trial will address shortcomings in existing studies noted by Law and colleagues in their systematic review.²

Results of this trial, if conducted well, would be a valuable addition. Traditional forms of medicine such as yoga and mindfulness have been shown to be beneficial in POAG and OHT. Allostatic load is also emerging as a risk factor for glaucoma.⁴ Diastolic BP, homo-cysteine, triglycerides, total cholesterol, high-density lipoprotein, low-density lipoprotein, body mass index, serum cortisol, glycosylated hemoglobin, albumin, creatinine clearance, and Creactive protein. High-risk thresholds were determined based on biological cutoffs of each biomarker. One point was assigned for each biomarker reading above cutoff and were summated to obtain AL score; score ≥ 4 was considered high. Mean age of glaucoma patients was 60.82 ± 6.26 and 60.14 ± 6.72 years in controls (P = 0.602) It may be worth exploring biophysiological parameters and assess changes in stress and allostatic load among the trial participants to gain insights on the holistic impact of this intervention.

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