Effect of Acupuncture and Low Caloric Diet on Primary Hypothyroidism and Irregular Menstruation in Infertile Women

Cairo University (CU)

Status and phase: Completed; Phase 2

Conditions: PCO; Primary Hypothyroidism; Irregular Menstruation; Acupuncture

Treatments: Dietary Supplement: low caloric diet; Drug: Thyroxine; Device: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05804149

No:P.T.REC/012/002825

Details and patient eligibility

About

the goal of this randomize clinical trial is to compare in 60 infertile women with hypothyroidism. selected from national Nutritional institute out clinic. the main question it aims to answer is:

• There an effect of acupuncture and low caloric diet on primary hypothyroidism and irregular menstruation in infertile women.

all participants were received• thyroxine tablets (levothyroxine) • a low caloric diet regime.

researchers compared study group (30 infertile women with hypothyroidism) to see the effect of acupuncture sections on hypothyroidism.

Full description

Each woman was instructed carefully about the assessment and treatment procedures and a consent form has been signed by each woman before starting of this study,

• Each patient in the study group was instructed about the beneficial effect of the Acupuncture.
• Each woman in the study group assumed supine position for the points (DU20, GB20, ST9, LI4, RN6, RN4, SP9, ST36, SP6, KI3, LR2). and prone position for DU14, BL15, BL20, BL23, DU4 with uncovered treatment area, which was cleaned with alcohol and hair was removed.

Acupuncture was applied on a room temperature of 37. Fine sterile needles used with a size 0.25x25mm. They were inserted to various depths (2-5 cm) at acupoints points on the body according to site and fat deposition. 16 needles were used in the treatment.

Enrollment: 60 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sixty PCOS women will be evaluated for presence of hirsutism, acne, irregular menses. They will be diagnosed for presence of cysts by Ultrasonography apparatus.
• They will complain from primary hypothyroidism. Their thyroid-stimulating hormone (TSH) will be >4.0mu/l and free tetraiodothyronine (FT4) will be <0.8ng/dl.
• Their luteinizing hormone / follicle-stimulating hormone (LH/FSH) ratio will be <1.
• Their age will range from 20-35 years old.
• Their body mass index (BMI) will be > 25 kg/m2 and < 39.9 kg/m2.

Exclusion criteria

• History of previous neurological disorders, previous thyroidectomy, and surgical removal of uterus.
• Presence of hemorrhage, carcinoma, metal implants and using of immune suppressant drugs.
• Presence of endometriosis, uterine fibroids, primary ovary insufficiency, fallopian tube damage or blockage, pelvic adhesion, autoimmune disorders, implantation failure, and infections.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

study group

Experimental group

Description:

Each patient in the study group will be instructed about the beneficial effect of the acupuncture. * Each woman in the study group will assume side lying position with uncovered treatment area, * thyroxine tablets (levothyroxine) (1tablet per day) describe by the physician. Levothyroxine is usually taken 30-60 minutes before breakfast, or four hours after food, as certain substance such as food and calcium can inhabit the absorption of levothyroxine. * low caloric diet regime consisting of 1200 to 800Kcal/ day for 4 months. * Fine sterile needles will be used with a size 0.25x25mm. They will be inserted to various depths (2-5 cm) at acupoints points on the body according to site and fat deposition. 16 needles will be used in the treatment

Treatment:

Device: acupuncture

Dietary Supplement: low caloric diet

Drug: Thyroxine

control group

Other group

Description:

Each woman in both groups (control and study) will receive thyroxine tablets (levothyroxine) (1tablet per day) describe by the physician. Levothyroxine is usually taken 30-60 minutes before breakfast, or four hours after food, as certain substance such as food and calcium can inhabit the absorption of levothyroxine Each woman in both groups will follow a low caloric diet regime consisting of 1200 to 800Kcal/ day for 4 months. The regime will start with 1200 Kcal for the first month and 1100 for the second month then 900 Kcal for the third month until reach 800 Kcal in fourth month.

Treatment:

Dietary Supplement: low caloric diet

Drug: Thyroxine