Impact of body mass index on the efficacy of acupuncture treatment of postprandial distress syndrome: secondary analysis of a randomized clinical trial

doi:10.19852/j.cnki.jtcm.2026.02.016

Abstract

Abstract:

OBJECTIVE: To assess the impact of body mass index (BMI) on the effectiveness of acupuncture in treating postprandial distress syndrome (PDS).

METHODS: Data from 278 patients enrolled in a prior multicenter, randomized, sham-controlled trial were analyzed in this secondary study. Patients were classified into three groups according to baseline BMI: low, normal, and high. The primary outcome was the response rate after 4 weeks of treatment. The χ² test was used to examine the effect of BMI on acupuncture efficacy. After multiple imputation for missing data, logistic regression analysis was performed to evaluate this association. A sensitivity analysis was conducted by combining the low and normal BMI groups. In addition, BMI was analyzed as a continuous variable using logistic regression to explore its relationship with treatment efficacy in the acupuncture group.

RESULTS: The χ² test revealed a statistically significant difference, with the acupuncture group demonstrating a markedly higher response rate than the sham group (82.91% vs51.79%, χ² = 25.34, P <0.001). In both the normal and high BMI categories, the response rate in the acupuncture group (82.91%) was higher than that in the sham acupuncture group (48.21%) (χ² = 25.34, P <0.001). Following multiple imputation, logistic regression analysis demonstrated a significant overall association between BMI category and treatment response (P <0.001). Acupuncture showed superior efficacy compared with sham acupuncture [OR =1.97, 95% CI(1.34, 2.90), P <0.001]. At week 4, response rates were 68.4% in the low BMI group, 81.7% in the normal BMI group, and 96.3% in the high BMI group (χ²= 6.303, P =0.043). A significant difference was observed only between the low and high BMI groups (χ² = 6.717, P =0.010). Sensitivity analysis showed that the high BMI group achieved significantly better outcomes than the non-high BMI group in elimination rates at week 8 and week 12 (χ² = 4.571, P =0.033; χ² = 4.589, P =0.032). Logistic regression analysis indicated that BMI was an independent predictor of response rate at week 4 [OR =1.186, 95% CI(1.010, 1.394), P =0.038] and elimination rate at week 12 [OR =1.126, 95% CI(1.002, 1.265), P =0.047], whereas no significant associations were observed at other follow-up points.

CONCLUSION: This subgroup analysis indicated that acupuncture improved PDS symptoms across different BMI categories. Acupuncture was suggested as a viable therapeutic option for patients with PDS, particularly those with a higher BMI.

Key words: acupuncture, body mass index, postprandial distress syndrome, secondary analysis

LI Yuejie, YANG Guang, LIU Luping, YANG Jingwen, LIU Cunzhi. Impact of body mass index on the efficacy of acupuncture treatment of postprandial distress syndrome: secondary analysis of a randomized clinical trial[J]. Journal of Traditional Chinese Medicine, 2026, 46(2): 439-446.

Figures/Tables 6

Figure 1 Study flow diagram. BMI: body mass index.

Table 1 Participant baseline characteristics

Item		Low-BMI	Normal-BMI	High-BMI
Mean age (years, $ \bar{x} \pm s$)		36.8±10.5	42.4±14.1	42.6±11.5
Sex [n (%)]	Female	14 (73.7)	57 (80.3)	15 (55.6)
	Male	5 (26.3)	14 (19.7)	12 (44.4)
Education (years, $ \bar{x} \pm s$)		14.8±2.1	15.2±3.5	14.6±2.8
Mean disease duration (months, $ \bar{x} \pm s$)		57.2±48.6	52.3±53.6	69.7±74.6
Marital status [n (%)]	Married	14 (73.7)	50 (70.4)	22 (81.5)
	Single	5 (26.3)	21 (29.6)	5 (18.5)
Occupation	Mental work	16 (84.2)	62 (87.3)	24 (88.9)
	Manual work	3 (15.8)	9 (12.7)	3 (11.1)
Endoscopy findings [n (%)] ^a	Normal	1 (8.3)	0 (0.0)	5 (26.3)
	Chronic superficial gastritis	8 (66.7)	30 (71.4)	9 (47.4)
	Chronic nonatrophic gastritis	3 (25.0)	12 (28.6)	5 (26.3)
Helicobacter pylori status [n (%)] ^b	Positive	5 (26.3)	13 (20.0)	7 (29.2)
	Negative	14 (73.7)	52 (80.0)	17 (70.8)

Figure 2 Response rate and elimination rate at all patients A: response rate of acupuncture and sham-acupuncture at weeks 4, 8, 12 and 16; B: elimination rate of acupuncture and sham-acupuncture at weeks 4, 8, 12 and 16. The acupuncture group was given twelve 20-min acupuncture sessions. The sham-acupuncture group was given superficial skin penetration (2 to 3 mm in depth) at non-acupoints group without De Qi manipulations. Statistical analyses were measured by independent-sample t-test to analyze the differences between the groups. Data were shown as percentages of patients (acupuncture group: n = 117; sham-acupuncture group: n = 112). aP < 0.001, compared with sham-acupuncture group; bP < 0.01, compared with sham-acupuncture group.

Figure 3 Response rate and elimination rate based on overall treatment effect A: response rate based on overall treatment effect of low-BMI group, normal-BMI and high-BMI group at weeks 4, 8, 12 and 16; B: elimination rate based on overall treatment effect of low-BMI group, normal-BMI and high-BMI group at weeks 4, 8, 12 and 16. The low-BMI group was defined as patients who received acupuncture treatment with a baseline BMI < 18.5 kg/m². The normal-BMI group was defined as patients who received acupuncture treatment with a baseline BMI between 18.5-23.9 kg/m². The high-BMI was defined as patients who received acupuncture treatment with a baseline BMI > 23.9 kg/m². BMI: body mass index. Statistical analyses were measured by Pearson’s χ2 test, with post-hoc pairwise comparisons adjusted by Bonferroni correction when significant differences were detected. Data were shown as percentages of patients (low-BMI group: n = 19; normal-BMI group: n = 71; high-BMI group: n = 27). aP < 0.0125 vs high-BMI.

Figure 4 Response rate and elimination rate based on the sensitivity analysis A: response rate based on the sensitivity analysis of non-high BMI group and high BMI group at weeks 4, 8, 12 and 16; B: elimination rate based on the sensitivity analysis of non-high BMI group and high BMI group at weeks 4, 8, 12 and 16. The non-high BMI group was defined as patients who received acupuncture treatment with a baseline BMI ≤ 23.9 kg/m². The high-BMI was defined as patients who received acupuncture treatment with a baseline BMI > 23.9 kg/m². BMI: body mass index. Statistical analyses were measured by independent-sample t-test to analyse the differences between the groups. Data were shown as percentages of patients (non-high BMI group: n = 90; high-BMI group: n = 27). aP < 0.05, compared with high-BMI group.

Table 2 Primary and secondary outcomes for the BMI group

Outcome			OR	95% CI	P value
Primary outcome	Response rate at week 4		1.186	1.010, 1.394	0.038^a
Secondary outcome	Response rate	Week 8	1.090	0.932, 1.275	0.282
		Week 12	1.040	0.902, 1.198	0.589
		Week 16	0.997	0.881, 1.128	0.960
	Elimination rate	Week 4	1.081	0.960, 1.217	0.199
		Week 8	1.090	0.971, 1.224	0.144
		Week 12	1.126	1.002, 1.265	0.047^a
		Week 16	1.088	0.970, 1.220	0.150
	Early satiation		1.055	0.946, 1.177	0.337
	Postprandial fullness		1.085	0.970, 1.212	0.152
	Upper abdominal bloating		1.063	0.956, 1.183	0.258

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