Effectiveness of acupuncture and a cumin-based herbal formula on anthropometric indices of overweight patients: a randomized double-blind placebo-controlled clinical trial

Abstract

Objectives

To evaluate the effectiveness of a Persian Medicine herbal formula and a Traditional Chinese Medicine intervention (acupuncture) on the improvement of weight and anthropometric indices of overweight patients.

Methods

This study was a randomized placebo-controlled double-blind clinical trial. A total of 200 overweight patients were randomly divided into 4 groups receiving either (1) Herbal capsule, (2) placebo capsule, (3) acupuncture, or (4) sham acupuncture. Herbal capsules were filled with hydroethanolic extract of Cuminum cyminum L. seed, Apium graveolens L. seed, Ruta graveolens L. seed, Trachyspermum ammi (L.) Sprague seed, Origanum majorana L. leaf, and sodium tetraborate and placebo capsules with avicel. Patients received two 500mg capsules or 12 acupuncture sessions over 8 weeks. Study outcomes, consisted of weight, body mass index (BMI), anthropometric indices including chest, arm, wrist, waist, hip, and leg circumferences, and waist/hip ratio (WHR), were evaluated 3 times: before treatment, after 4 weeks, and after 8 weeks.

Results

The herbal formula significantly reduced weight, BMI, WHR, and chest and waist circumferences compared to the placebo capsule (P < 0.05). Furthermore, acupuncture improved all study outcomes, except WHR, compared to sham acupuncture (P < 0.05). Despite the effects of herbal formula and acupuncture were the same on WHR and chest, waist, and leg circumferences (P < 0.05), acupuncture reduced weight, BMI, and arm, wrist, and hip circumferences more than herbal formula (P < 0.05).

Conclusion

Complementary and alternative therapeutic methods, such as herbal treatments and acupuncture, show promising effects in improving weight and anthropometric indices of overweight patients.

Introduction

Globally, obesity is a significant public health issue that contributes to various chronic illnesses and socioeconomic challenges, including type II diabetes, cancers, cardiovascular diseases, asthma, sleep apnea, gallbladder disease, osteoarthritis, and chronic back pain [1, 2]. Over the past three decades, rate of obesity have risen among adults, all over the world. Unexpectedly, it is also observed in low- and middle-income countries due to uncontrolled urbanization and dietary shifts from traditional to Westernized diets [3]. World Health Organization (WHO) reported that, approximately two billion adults worldwide are overweight and 650 million obese [2]. In Iran, the prevalence of obesity is estimated at 23.2% among adults, 15.6% in males and 30.4% in females[1]. According to the escalating global obesity rates and their impact on public health, there is a pressing need for effective, safe, and affordable treatment options for managing obesity[1].

The clinical management of obesity encompasses a range of approaches, from lifestyle interventions to conventional medications. Although lifestyle modification has been recommended as the first-line management strategy, this treatment faces several challenges, including suboptimal responses and low adherence rates. Consequently, patients often require additional interventions [4].

Conventional weight loss medications, while commonly used, have limitations in terms of efficacy and safety data. These medications have been associated with adverse outcomes such as primary pulmonary hypertension, valvulopathy, acute pancreatitis, an increased risk of hemorrhagic stroke, cerebrovascular events, suicide, and myocardial infarction [2]. Given these concerns, many patients resort to Complementary and Alternative Medicine (CAM) for managing obesity. CAM for controlling body weight suggests herbal supplements and non-pharmaceutical interventions such as non-invasive body-contouring, acupuncture, and electroacupuncture [4].

Persian herbal medicines, commonly prescribed for obesity, have demonstrated reducing effects on body weight, body mass index (BMI), fat mass, and appetite in clinical trials involving animal models or human studies [5]. Among the herbs frequently used in Persian Medicine, Carum carvi L., Bunium persicum (Boiss.), Cuminum cyminum L., Anethum graveolens L., Foeniculum Vulgare Mill, Trachyspermum ammi L., Origanum vulgare, Carum carvi, Trachyspermum copticum, and Ruta graveolens stand out. However, the evidence supporting their efficacy in managing obesity remains limited [6, 7].

Additionally, acupuncture serves as an effective adjunctive non-pharmacological treatment widely employed in CAM for reducing body weight and anthropometric indices [8, 9]. Nevertheless, the existing evidence is not convincing due to methodological limitations in trials (such as the absence of sham acupuncture as a control group and small participant numbers). Consequently, well-designed studies are needed to comprehensively evaluate the effectiveness of acupuncture in treating obesity [8].

To date, studies investigating CAM interventions for obesity have been limited in number, lacking randomized designs, and have not directly compared pharmacological and non-pharmacological CAM treatments. Hence, there is a pressing need for additional clinical research to enhance our understanding of effective obesity management strategies. Notably, our study represents the first randomized controlled trial that directly compares the effects of acupuncture with an herbal formula derived from Persian Medicine (PM) textbooks in obese patients.

Materials and methods

Study design

This study was a randomized, placebo-controlled clinical trial with 4 parallel arms conducted in the outpatient clinic of the School of Persian Medicine, Tehran University of Medical Sciences affiliated by 2023–2024. The ethical approval code was received from the Tehran University of Medical Sciences ethics committee (code: IR.TUMS.MEDICINE.REC.1400.1380) and the protocol of the study was registered at the Iranian Registry of Clinical Trials (IRCT) (code: IRCT20171007036614N2).

Participants

Patients of either sex and age between 25 to 65 years old with BMI in the overweight range (25 ≤ BMI < 30) were included.

Inclusion criteria

• Not using any medicine or regimen for weight loss within the last 6 months

• Not in pregnancy or breast-feeding period

• Not using alcohol or smoking

• Lack of any serious underlying disease such as malignancies, asthma, imbalance of sex hormones, diabetes mellitus, hypertension, uncontrolled hypothyroidism, liver, kidney or heart disorders, or using anticoagulant medications

• Lack of allergic reaction history to herbal treatments

Exclusion criteria

• Not good adherence to the intervention: not regular consumption of oral capsules or being absence for more than 2 acupuncture sessions

• Abnormal menstrual bleeding

• Using herbal treatments for any reason

• Unwilling to continue the study

• Family history of breast cancer

• Any change in regular diet or physical activity during the study

Randomization and Blindness

After obtaining informed consent from eligible patients, they were divided into 2 different strata based on their tendency and adherence to the treatment. Strata 1 only received oral capsule (real intervention or placebo) and strata 2 only received acupuncture (real intervention or placebo). In each stratum, patients were randomly divided into 2 groups: either real intervention or placebo: in stratum 1, patients in group A received herbal capsule treatment and in group B patients received placebo capsule and in stratum 2 patients in group C received acupuncture and patients in group D patients received sham acupuncture as placebo. For each stratum, random allocation of the patients was performed using block randomization method (AABB, BBAA, ABAB, BABA, ABBA, and BAAB same as CCDD, DDCC, CDCD, DCDC, CDDC, and DCCD). Each block was assigned a number from 1 to 6 and to reach the optimum sample size (50 patients in each group), 25 random numbers were generated using an online random number generator. At the beginning of the study, each patient was allocated to the first free place. For the blindness, patients were not aware about their group, either real intervention or placebo, as well as outcome assessor who was not aware of study groups and evaluated patients by their code of intervention. Furthermore, statistician analyzed data by their code of intervention.

Intervention

Oral capsule

Herbal formula used in this study was obtained from PM text books [6] consisting of C. cyminum seed, A. graveolens seed, R. graveolens seed, T. ammi seed, O. majorana leaf, and sodium tetraborate. Plants were purchased from a validated store and edible grade sodium tetraborate was purchased from Merc company. Herbarium laboratory of Tehran University of Medical Sciences assigned scientific name and herbarium code of each plant (C. cyminum: PMP-3622, A. graveolens: PMP-3624, R. graveolens: PMP-1767, T. ammi: 3620, O. majorana: PMP-2333). Daily dose of the formulation included 1.428 g C. cyminum seeds, 0.572 g A. graveolens seeds, 0.572 g R. graveolens seeds, 0.572 g T. ammi seeds, 0.428 g O. majorana leaves, and 0.428 g sodium tetraborate (totally 4 g per day). To prepare the formula, except sodium tetraborate, appropriate ratio of seeds and leaves were grinded with electrical grinder. The herbal extract was obtained by the maceration of grinded plants in 50% ethanol in 300 gr/Lit for 72 h. Then the extract was concentrated by Rotary Evaporator (WIGGENS) with a vacuum pump to become free from ethanol. Then the extract was put in freezer and after that dried by a freeze-dryer (Dorsatech). Then required amount of sodium tetraborate was added and by using avisel as a filler, 500 mg capsules were filled. Standardization of the treatment was performed by laboratory of School of Persian Medicine, Tehran University of Medical Sciences reporting total phenol and total flavonoid content. They reported the concentration of total phenol 932 mg gallic acid equivalent/ and total flavonoid 14.78 mg of quercetin equivalent/g. Same color 500 mg capsules were filled by avicel as placebo capsules. Both herbal and placebo capsules were put in same appearance jars with a label of the instruction of the using medicine and a code A or B for the group. After preparing the jars, in order to blindness of the researcher and patients, a third party assigned the code A or B to the jars. At the beginning of the study after measuring outcomes a jar with 56 capsules was provided for the patients and they were asked to take 2 capsules per day. After 4 weeks, they were asked to come for the second evaluation and at that time the second jar with 56 capsules was given to the patient for 4 weeks and at the end of 8th week, they came again for the last outcome measurement. During this 8-weeks period of intervention, they were followed by phone calls to investigate the proper use of the medicine and any adverse effect.

Acupuncture

The standard needling method with electrical stimulation was performed by an experienced acupuncturist. Disposable 0.25 × 40 single-use stainless needles (Tony, China) was utilized to stimulate acupoints with even method and 10–15 Hz electrical stimulation was performed by KWD electrode (China). Selected acupoints included ST40, ST36, ST44, ST25-28, ST32, LR2, LR3, CV4, CV6, CV10, CV12, SP13-15, LI13, and GB26. For performing sham acupuncture as the control, non-acupoint areas were selected and superficially stimulated with needles using an off-electrode. Patients were asked to come twice a week for 4 weeks and once a week for next 4 weeks (totally, 12 sessions) to take acupuncture intervention. Outcome assessments were performed before intervention, after 4 weeks and after the last session of intervention. During this 8-weeks period of intervention, they were followed by phone calls to investigate any adverse effect. Only the acupuncturist who was not included in outcome measurement knew which patient receives either real or sham acupuncture.

Study outcomes

The primary outcomes were weight and BMI and the secondary outcomes were other anthropometric indices including chest circumference (CC), waist circumference (WC), arm circumference (AC), wrist circumference (WrC), hip circumference (HC), leg circumference (LC), and waist/hip ratio (WHR).

Weight was measured using a Seca scale (Germany), height was measured shoes-off by a Seca stadiometer (Germany), and BMI was calculated by dividing weight by square height. Measuring other anthropometric indices was performed using an inelastic plastic meter: CC: around the upper body at the level of the nipple, WC: around the lower body at the level of the navel, AC: halfway between the acromion and olecranon on the right arm, WrC: exactly around the right wrist, HC: largest circumference around the buttocks, and LC: around right leg 15 cm above the patella. WHR was calculated by dividing WC by HC. Study outcomes were evaluated 3 times: (1) before intervention, (2) after 4 weeks, and (3) after 8 weeks from the beginning of the study.

Statistical analysis

Considering previous relevant studies using weight as the main outcome, Z = 1.96, σ = 8.37, d = 2.64 (α = 0.05 and β = 0.1), and 25% dropout rate, the sample size computed to be 50 patients in each group, totally 200 patients, using Powe Analysis and Sample Size 11 (PAS-11) software.

$$n=\frac{Z_{\alpha /2}^2{\mathrm{\sigma }}^2}{d^2}$$

n

required sample size

Z

standard normal value at confidence level at 100(1-α)%

σ

referred standard deviation for the variable

d

margin of error

In final report, quantitative data was represented by frequency and percentage and groups were compared using Chi-square and Fisher exact tests. Qualitative data was represented by mean ± standard deviation (SD) or median and 25%-75% percentile. If it was normally distributed, one-way ANOVA with repeated measures and Bonferroni post-hoc was performed. For data without normal distribution, proper non-parametric tests were performed. P value < 0.05 was considered as statistically significant level.

Results

Subjects

Of 238 patients eligible to enroll in the study, 38 declined to participate and 200 patients were divided randomly into 4 groups, each group 50 patients: (1) herbal capsule group (HCG), (2) placebo capsule group (PCG), (3) acupuncture group (ACG), and (4) sham acupuncture group (SAG). In HCG 2 patients were excluded due to stomach pain, 2 for heavy menstrual bleeding, and 3 patients who did not complete follow-up evaluations. In PCG, 3 patients were excluded due to stomach pain and 6 patients did not complete the follow-up evaluations. In ACG 3 patients and in SAG 9 patients failed to receive their acupuncture protocol properly. As shown in Fig. 1 (CONSORT flow diagram), 172 patients were reviewed for the statistical analysis. The baseline characteristics of the patients are represented in Table 1. Most of the patients were female (68.5%) and married (75%) with the age range of 25–65 years old. The mean age of the patients was 42 ± 8, 42 ± 10, 43 ± 5, and 39 ± 10 years old in HCG, PCG, ACG, and SAG, respectively. No significant difference was reported considering age (P > 0.05), between groups; however, the contribution of sex was not same between groups (P < 0.05).

Fig. 1.

Patients’ allocation process (CONSORT flow diagram)

Table 1.

Demographic characteristics

		Group				P value
		Capsule (N = 43)	Placebo (N = 41)	Acupuncture (N = 47)	Sham acupuncture (N = 41)
Sex N (%)	Female	24 (55%)	25 (61%)	41 (87%)	29 (71%)	0.004
	Male	19 (45%)	16 (38%)	6 (13%)	12 (29%)
Age (year) Mean ± standard deviation		42.43 ± 8.79	42.68 ± 10.02	43.57 ± 5.51	39.19 ± 10.34	0.076

Anthropometric indices

Oral capsule groups

There was no significant difference between baseline anthropometric indices of HCG and PCG (P > 0.05) (Table 2). After 4 weeks of intervention, significant reductions were reported in chest and waist circumferences, weight, BMI, and waist/hip ratio (P < 0.05) but no significant changes were reported for arm, wrist, hip, and leg circumferences in HCG (P > 0.05). On the other hand, in PCG none of anthropometric indices including chest, arm, wrist, waist, hip, and leg circumferences, weight, BMI, and waist/hip ratio changed remarkably (P > 0.05). Also, in HCG after 8 weeks of the intervention chest, arm, waist, and leg circumferences, weight, and BMI decreased significantly (P < 0.05), unlike wrist and hip circumferences (P > 0.05). Although in PCG chest, arm, wrist, hip, and leg circumferences did not change significantly (P > 0.05), weight, BMI, waist circumference, and waist/hip ratio increased significantly (P < 0.05). Totally, within-group repeated measurements showed a significant reduction in chest, waist, and leg circumferences, weight, BMI, and waist/hip ratio (P < 0.05) in contrast to non-significant change in arm, wrist, and hip circumferences (P > 0.05) in HCG and significant elevation in weight and BMI (P < 0.05) in contrast to non-significant change of chest, arm, wrist, waist, hip, and leg circumferences and waist/hip ratio (P > 0.05). Furthermore, between group repeated measurements showed significant differences in weight, chest, and waist circumferences (P < 0.05) between HCG and PCG as opposed to arm, wrist, hip, and leg circumferences (P > 0.05) (Table 2, Fig. 2).

Table 2.

Anthropometric characteristics¹

Anthropometric index	Time	Group				P value
		Capsule (N = 43)	Placebo (N = 41)	Acupuncture (N = 47)	Sham acupuncture (N = 41)	RM1	RM2	RM3
Weight (Kg)	Before treatment	78.75 (73.50, 88.80)	75 (70, 83.90)	72.20 (70, 77.20)	79.70 (66, 84.40)	< 0.001	< 0.001	0.024
	After 4 weeks	77 (72, 85.10)	71.50 (69, 83)	70.90 (68.70, 77.70)	82.20 (68.50, 85)
	After 8 weeks	78.55 (71.70, 84.20)	73.75 (69, 83.30)	71.40 (67, 75.70)	83.20 (69, 86)
	MD1	-1.21 (-1.75, -0.67)***	1.07 (-0.08, 2.23)	-1.04 (-1.48, -0.61)***	1.61 (1.31, 1.91)***
	MD2	-1.23 (-2.02, -0.44)**	1.80 (0.51, 3.09)**	-2.16 (-2.71, -1.60)***	2.33 (2.07, 2.59)***
	Within group repeated measures	0.001	0.028	< 0.001	< 0.001
BMI (Kg/m2)	Before treatment	28.43 (26.96, 29.07)	28.04 (27.27, 29.17)	28.87 (27.30, 29.52)	29.13 (28.60, 29.33)	< 0.001	< 0.001	0.011
	After 4 weeks	28.18 (26.20, 28.84)	28.04 (26.95, 28.89)	28.60 (27, 28.97)	29.62 (28.61, 30.44)
	After 8 weeks	27.98 (26.57, 28.97)	28.57 (27.54, 29.10)	28.13 (26.38, 28.73)	29.76 (28.96, 30.67)
	MD1	-0.42 (-0.61, -0.23)***	0.38 (-0.04, 0.82)	-0.38 (-0.53, -0.22)***	0.64 (0.52, 0.76)***
	MD2	-0.42 (-0.68, -0.15)**	0.66 (0.16, 1.15)**	-0.81 (-1.02, -0.60)***	0.90 (0.79, 1.02)***
	Within group repeated measures	0.001	0.039	< 0.001	< 0.001
Chest Circumference (cm)	Before treatment	102.75 (100, 108.50)	105.75 (100, 109)	102 (99, 107)	99 (89, 104)	< 0.001	< 0.001	0.442
	After 4 weeks	102 (97, 105)	104 (101, 108)	101 (97, 106)	100 (88, 104)
	After 8 weeks	101.50 (96, 103)	104 (101, 108)	100 (97.50, 105)	102 (88, 105)
	MD1	-1.65 (-2.46, -0.83)**	0.71 (-0.12, 1.55)	-2.05 (-2.83, -1.27)***	0.05 (0.14, 0.24)
	MD2	-2.48 (-3.45, -1.50)***	0.83 (0.01, 1.65)	-2.20 (-2.79, -1.62)***	0.73 (0.41, 1.06)***
	Within group repeated measures	< 0.001	0.063	< 0.001	< 0.001
Arm Circumference (cm)	Before treatment	34 (32, 36)	34 (30, 36)	35 (32, 37)	31 (30, 32)	0.614	< 0.001	0.003
	After 4 weeks	34 (32, 35.50)	33 (31, 36)	33.50 (31.50, 35.50)	32 (30, 32)
	After 8 weeks	33 (32, 35)	33 (30, 36)	32.50 (30.50, 34.50)	31.50 (30, 32)
	MD1	0.01 (-1.54, 1.58)	0.66 (-0.08, 1.42)	-1.40 (-1.75, -1.06)***	0.19 (0.04, 0.34)**
	MD2	-0.11 (-1.87, 1.64)*	0.38 (-0.47, 1.24)	-2.18 (-2.56, -1.81)***	0.19 (0.09, 0.30)**
	Within group repeated measures	0.918	0.177	< 0.001	0.004
Wrist Circumference (cm)	Before treatment	17 (16, 18)	17 (16.25, 19)	16 (16, 18)	16 (15, 17.50)	0.303	< 0.001	< 0.001
	After 4 weeks	17.50 (16.50, 18)	17 (16, 18)	16 (15.50, 17)	16.3 (15, 17.70)
	After 8 weeks	17 (16, 18)	17 (16, 18)	16 (15.50, 17)	16 (15, 18)
	MD1	0.25 (-0.17, 0.67)	-0.11 (-0.44, 0.20)	-0.52 (-0.70, -0.35)***	0.13 (0.02, 0.07)***
	MD2	0.00 (-0.34, 0.34)	0.09 (-0.51, 0.70)	-0.64 (-0.85, -0.42)***	0.21 (0.03, 0.14)***
	Within group repeated measures	0.234	0.648	< 0.001	< 0.001
Waist Circumference (cm)	Before treatment	97.50 (92, 107)	96 (90, 104.50)	100 (94, 107.50)	97 (92, 107)	0.032	< 0.001	0.355
	After 4 weeks	95.50 (90, 107)	97 (88, 103)	95 (90, 102)	98 (94, 110)
	After 8 weeks	94.25 (90, 103)	98 (92, 104)	97 (91, 102)	98.50 (94, 112)
	MD1	-1.78 (-3.42, -0.15)*	-0.61 (-4.93, 3.69)	-3.00 (-4.34, -1.65)***	1.87 (1.63, 2.11)***
	MD2	-2.72 (-4.17, -1.27)**	2.09 (0.08, 4.10)*	-2.49 (-4.14, -0.83)**	2.37 (2.01, 2.73)***
	Within group repeated measures	0.003	0.267	< 0.001	< 0.001
Hip Circumference (cm)	Before treatment	108.50 (103, 113)	109 (104, 112)	111 (106, 115)	104 (102, 108)	0.454	< 0.001	< 0.001
	After 4 weeks	108 (103, 114)	106 (104, 109)	108 (105, 111)	105 (103, 109)
	After 8 weeks	108 (104, 113.50)	106 (103, 110)	107.50 (105, 111)	105 (103, 110)
	MD1	-0.17 (-1.67, -1.32)	-1.09 (-2.14, -0.04)	-2.44 (-3.08, -1.79)***	1.21 (1.06, 1.37)***
	MD2	-0.50 (-1.49, -0.49)	-0.57 (-1.74, 0.60)	-2.70 (-3.46, -1.95)***	1.21 (0.99, 1.44)***
	Within group repeated measures	0.603	0.169	< 0.001	< 0.001
Leg Circumference (cm)	Before treatment	56.25 (51, 60.50)	57 (53, 60.50)	56 (54.50, 60)	53 (52, 55)	0.752	< 0.001	0.266
	After 4 weeks	56.50 (52, 60)	55 (53, 63)	55 (53, 59)	52 (52, 56)
	After 8 weeks	56 (50, 58)	55 (53.50, 63)	55 (53, 56.50)	53 (52, 56)
	MD1	-0.88 (-1.82, -0.05)	0.54 (-5.43, 6.52)	-1.62 (-2.46, -0.77)***	-0.14 (-0.33, 0.04)
	MD2	-2.01 (-3.11, -0.92)**	0.90 (-5.40, 3.59)	-3.00 (-3.80, -2.19)***	0.28 (0.12, 0.43)**
	Within group repeated measures	0.001	0.826	< 0.001	< 0.001
Waist/Hip ratio	Before treatment	0.93 (0.85, 0.96)	0.88 (0.82, 0.96)	0.89 (0.87, 0.93)	0.92 (0.90, 1.03)	0.046	0.120	0.145
	After 4 weeks	0.91 (0.80, 0.95)	0.90 (0.83, 0.98)	0.89 (0.86, 0.93)	0.92 (0.92, 1.05)
	After 8 weeks	0.88 (0.81, 0.96)	0.93 (0.85, 0.98)	0.92 (0.87, 0.93)	0.92 (0.91, 1.05)
	MD1	-0.01 (-0.02, -0.00)*	0.00 (-0.04, 0.04)	-0.00 (-0.02, 0.00)	0.00 (0.00, 0.00)***
	MD2	-0.02 (-0.03, -0.00)**	0.02 (0.00, 0.04)*	0.00 (-0.01, 0.01)	0.01 (0.00, 0.01)***
	Within group repeated measures	0.009	0.344	0.428	< 0.001

¹ Data is represented by median (Q1, Q3), MD1: mean difference from baseline after 4 weeks; MD2: mean difference from baseline after 8 weeks; RM1: repeated measures comparing capsule and placebo; RM2: repeated measures comparing acupuncture and sham acupuncture; RM3: repeated measures comparing capsule and acupuncture; * P<0.05, ** P<0.01, *** P<0.001

Fig. 2.

Comparison of progression of anthropometric indices between groups in different times: (1) before treatmnt, (2) after 4 weeks, and (3) at the end of the study. A Weight (Kg), B Body Mass Index (BMI), C Chest Circumferece (cm), D Arm Circumferece (cm), E Wrist Circumferece (cm), F Waist Circumferece (cm), G Hip Circumferece (cm), H Leg Circumferece (cm), I Waist/Hip ratio

Acupuncture groups

Except for chest, arm, and hip circumferences that were lower in SAG than ACG at the beginning of the study (P < 0.05), there was no significant difference between SAG and ACG at baseline evaluations (P > 0.05) (Table 2). The results showed that acupuncture decreased all anthropometric indices including chest, arm, wrist, waist, hip, and leg circumferences, weight, and BMI (P < 0.05) except waist/hip ratio (P > 0.05) after 4 weeks and 8 weeks. After 4 weeks in SAG, except for chest and leg circumferences that did not change significantly (P > 0.05), a remarkable reduction was reported for arm, wrist, waist, and circumferences, weight, BMI, and waist/hip ratio (P < 0.05). Moreover, after 8 weeks all anthropometric indices increased (P < 0.05) in SAG. In summary, within-group repeated measurements showed significant change (P < 0.05) in all anthropometric indices in both ACG and SAG except waist/hip ratio which only changed significantly in SAG. Between group repeated measurements showed significant difference (P < 0.05) between ACG and SAG for all anthropometric indices except waist/hip ratio (P > 0.05) (Table 2, Fig. 2).

Comparing real intervention groups

At the baseline evaluations, there was no significant difference between HCG and ACG (P > 0.05) (Table 2). Within-group evaluations of anthropometric indices in HCG and ACG have been reported previously. Our results indicated that acupuncture reduced weight, BMI, arm wrist, and circumferences more than herbal capsule (P < 0.05) but in reducing chest, waist, and leg circumferences and waist/hip ratio both acupuncture and herbal capsule did same (P > 0.05) (Table 2, Fig. 2).

Discussion

This randomized controlled double-blinded trial demonstrated a statistical and clinically significant improvement for an herbal supplement based on PM and acupuncture in obese patients. These two CAM interventions provide opportunities to reduce weight, BMI, CC, AM, LC, and WC after 8 weeks. Valizade et al.[5] formerly have shown positive effects of the herbal supplement ' Mohazzel' (consisting of Origanum vulgare, Carum carvi, Trachyspermum copticum, and Ruta graveolens) on body weight, BMI, and body fat composition. However, our study uniquely investigated the impact of herbal supplementation from Qarabadin Salehi’s PM textbook [6] on anthropometric indices, comparing its effects with acupuncture.

From the PM point of view, obesity is considered a phlegmatic disease, with ‘balgham’ being characterized as ‘Barid Ratab’ (cold and wet) by temperament [10]. The components of herbal formulation in our study, exhibit a hot and dry temperament, which is effective in treating phlegmatic conditions, including obesity [6, 10]. Hot and dry plants contribute to weight loss through various mechanisms, such as enhanced thermogenesis, activation of protein kinases, reduced expression of adipogenesis-related genes, increased energy expenditure, lipid oxidation, and appetite suppression [5, 11, 12].

Considering the significant role of oxidative stress in the pathophysiology of obesity and the inverse correlation between antioxidant defense indicators and body fat percentage, herbs with antioxidative properties can be valuable in obesity treatment [13]. Previous studies have highlighted the anti-inflammatory, antioxidative, and lipid profile-reducing effects of specific herbs, including C. cyminum [13, 14], A. graveolens [15], R. graveolens [16], T. ammi [17, 18], sodium tetraborate [18] and O. majorana [19]. Recent research has also emphasized the presence of biologically active metabolites in plants, particularly polyphenols, which inhibit pancreatic lipase activity—an approach considered promising for obesity management [20]. Our findings are in agreement with the results obtained from previous studies. A double-blind RCT on adult obese subjects demonstrated that herbal supplement ' Mohazzel' reduced body weight, BMI and body fat composition significantly (P < 0.05) [5]. Furthermore, Kazemipoor et al. (2013) conducted a triple-blind RCT on the anti-obesity effect of caraway extract. This study revealed significant reduction of weight, BMI, body fat percentage, and WHR in overweight and obese women [21]. Similar results were shown in another RCT by Hamidnia et al. (2018). They indicated that Nigella sativa (Family Ranunculaceae), Trachyspermum ammi (Family Apiacea), Zataria multiflora (Family Lamiaceae), Mastic gum (Family anacardiaceae) and honey led to further decrease in BMI, weight, WC and Fat mass compared to orlistat [12]. Zare et al. investigated the effects of 3g/d cumin powder in overweight and obese women. They showed that cumin not only reduce anthropometric indices including weight, BMI, and WC, this supplement improved cholesterol, triglyceride, low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) [22]. Study of Taghizadeh et al. showed significant reduction in weight and BMI following consumption of cumin supplement for eight weeks, compared to placebo [23]. Likely, study of Mohsenpour et al. indicated that consuming 750 mg of the A. graveolens powder can significantly reduce body fat percentage, BMI, and HC; however, weight and WC did not change significantly [24]. Kuru et al. evaluated the effects of a boron-rich diet in obese patients. They showed that boron-rich diet can significantly improve lipid profile as well as reducing weight, BMI, and body fat percentage [25]. The role of O. majorana in reducing weight of obese patients was examined by Ahmed et al. They showed that using 200 or 400 mg/d O. majorana alone or in combination with thyme can significantly reduce weight, BMI, WC, and HC [26]. Also, Aghabeiglooei et al. investigated the effects of an herbal supplement containing anise, fennel, ajwain, and cumin on obese women. They revealed that 2 g/day of this supplement can significantly reduce weight, BMI, WC, and HC [27].

Our findings demonstrate that acupuncture led to greater reductions in weight, BMI, AC, and WrC compared to the herbal capsule (P < 0.05). Despite the complete adherence to the random allocation of samples, there was a significant difference between groups, considering sex variable. Pairwise comparison of groups showed that only acupuncture group is different from other groups and there is no significant difference between other groups. Recent studies showed that in a same population, men are more prone to weight loss than women, probably according to the higher basal metabolic rate [28]. In the present study, despite higher population of women in acupuncture group, results showed better improvements in anthropometric indices, rather than other groups.

As a fundamental component of TCM, acupuncture has a wealth of experience in the prevention and treatment of obesity [8]. According to the main theory of TCM, the pathogenesis of obesity primarily involves blood vessel blockage due to Qi deficiency and phlegm stagnation, which can result from various internal and external factors such as liver Qi stasis and Spleen deficiency. Qi is the vital energy of the body that provide the proper function of different organs. It may be translated as the basal metabolism rate of the body or the function of mitochondria [29]. From the TCM perspective, the key principle for treating uncomplicated obesity is to strengthen the Spleen, eliminate dampness, and resolve Qi stagnation in the Liver to promote blood flow [30].

In our investigation, we proposed specific acupoints based on a differential diagnosis informed by previous research [8, 9, 30]: ST40 expels phlegm and dampness; ST36 tonifies Qi and blood, harmonizes and strengthens the Spleen and Stomach, and expels cold and dampness; ST25-28 Regulates the Spleen, Stomach, and intestines (digestion), dispels Dampness and Damp-Heat, and regulates Qi and Blood; ST44 Ying-Spring point of the stomach and suppressing appetite; LR2 Clears Heat, benefits the Liver; LR3 Spreads Liver Qi and harmonizes the Liver; CV4 nourishes Blood; CV6 Tonifies Qi and regulates the Lower Jiao; CV10 Regulates the Stomach, harmonizes the Middle Jiao, and treats digestive disorders; SP13-15 regulate digestion; GB26 Regulates the Dai Mai (Girdle Vessel) and benefits the lower abdomen [31]. A systematic review by Lu, P. H., et al. (2024) highlighted LI4, ST36, and ST44 as the core acupoint combinations for treating simple obesity [30].

On the other hand, there are some possible mechanisms as to how acupuncture helps with obesity, including regulating lipid metabolism, modulating inflammatory responses, suppressing appetite, and promoting white adipose tissue (WAT) browning [32]. Current studies have confirmed that obesity is related to inflammation and that levels of the proinflammatory cytokines IL-6 and TNF-α increase in individuals with obesity [33]. Results of another study indicated that acupuncture can significantly reduce levels of the proinflammatory factor TNF-α, adiponectin and increase the levels of the anti-inflammatory factor IL-10 and serum leptin [34, 35]. In addition, in an obese rat model, Qiang et al. reported that acupuncture on ST44 and ST36 could decrease adipocyte size and prompt lipolysis in WAT by inducing the expression of uncoupling protein-1 (UCP-1) to promote WAT browning [36]. As reported in the results section, acupuncture improved all study outcomes, except WHR, compared to sham acupuncture (P < 0.05). Zhong et al. found similar result in comparing the WHR changes between acupuncture and sham acupuncture [37]. The two systematic review and meta-analysis of eleven RCTs by Zhang et al. (2017) and of eight RCTs by Zhong et al. (2020) showed that acupuncture is an effective treatment for simple obesity. These systematic reviews reported that body fat mass, WC and HC changes after acupuncture treatment was statistically significant (p < 0.05) compared with sham treatment. Conversely to our study result, in these two studies body weight was not statistically significantly different between the acupuncture and sham acupuncture groups (p > 0.05) [37, 38]. In a systematic review and meta-analysis by Yao et al. results of 12 clinical trials involving 1151 obese patients showed that acupuncture can significantly reduce BMI and WC [39]. And overview of systematic reviews evaluated 38 systematic reviews on the effects of acupuncture on obesity. This study showed that different methods of acupuncture have beneficial effects on weight and BMI [8].

This herbal supplement and acupuncture can improve simple obesity by increasing energy consumption and oxidation of lipids and reducing pro-inflammatory factors and appetite, which has been supported by many modern pharmacological studies [13, 20, 34].

Strengths and limitations

The present study included 3 trials together: (1) comparing a herbal formula capsule with its placebo, (2) comparing acupuncture with its placebo, and (3) comparing herbal formula with acupuncture in the treatment of obesity. We compared two different CAM methods, Persian Medicine and Traditional Chinese Medicine: one of them oral herbal treatment, the other one a manual semi-invasive treatment. One limitation of this study was the difficulty of adherence to treatment of patients in sham acupuncture group. Because they did not get a desirable result, it was difficult to convince them to come for treatment regularly.

Conclusion

This study showed that compared to placebo, cumin-based herbal formula can be effective in reducing weight, BMI, CC, WC and WHR. Although this product significantly reduced LC, this change were not significant compared to placebo. Also, the effect of this supplement on AC, WrC and HC was not significant. Except for WHR, the acupuncture receiving group experienced a significant decrease in other indicators including weight, BMI, CC, AC, WrC, WC, HC, and LC compared to the sham acupuncture group. Comparing the two groups of herbal medicine and acupuncture showed that acupuncture had a significant effect on weight loss, BMI, AC, WrC, and HC. The effect of these two groups on other indicators was not significantly different from each other. This study showed that complementary and alternative therapeutic methods, such as herbal treatments and acupuncture, show promising effects in improving weight and anthropometric indices of overweight patients. However, more well-designed clinical trials with higher sample sizes are needed to approve the results.

Abbreviations

AC

Arm circumference

BMI

Body Mass Index

CAM

Complementary and Alternative Medicine

CC

Chest circumference

HC

Hip circumference

IL

Interleukin

LC

Leg circumference

PM

Persian Medicine

TCM

Traditional Chinese Medicine

TNF-α

Tumor Necrosis Factor-α

UCP-1

Uncoupling protein-1

WAT

White adipose tissue

WC

Waist circumference

WHR

Waist/hip ratio

WrC

Wrist circumference

Funding

This study is the final report of Mohammad Sadegh Adel-Mehraban Ph.D. thesis (code: 56785) supported by Tehran University of Medical Sciences.

Data availability

Data are available from the corresponding author upon reasonable request.

Declarations

Ethical approval

The ethical approval code was received from the Tehran University of Medical Sciences ethics committee (code: IR.TUMS.MEDICINE.REC.1400.1380) and the protocol of the study was registered at the Iranian Registry of Clinical Trials (IRCT) (code: IRCT20171007036614N2).

Competing interests

The authors declare no conflict of interest.