Clinical Pilot Study of Rectal Suppository Containing Combined Extract of Cissus quadrangularis Linn. and Acmella paniculata (Wall ex. DC.) R. K. Jansen in Acute Hemorrhoids

Background. Cissus quadrangularis Linn. (CQ) is a medicinal plant with good evidence for the treatment of hemorrhoids, listed in the Thai National List of Herbal Products in the oral dosage form. Acmella paniculata (Wall ex. DC.) R. K. Jansen. (AP) is a medicinal plant with a local anesthetic effect. Objective. To investigate the potential of rectal suppositories containing CQ and AP extracts to alleviate symptoms of hemorrhoids compared with the commercialized rectal suppository containing hydrocortisone and cinchocaine. Materials and Methods. Hemorrhoid outpatients (n = 105) with different severity grades (I, II, or III) from eight hospitals in northern Thailand were included in this study. Hemorrhoid severity was graded by proctoscopy associated with either anal pain or bleeding related to hemorrhoids or both. The patients were randomly allocated to two groups: CQ-AP group (n = 52) or the commercialized rectal suppository group (n = 53). One suppository was rectally administered twice daily in the morning and at bedtime for seven days. Evaluations were performed by physicians on days 1, 4, and 8 of the study. The primary endpoints were bleeding and prolapse size, while the secondary endpoint was anal pain. Results. Baseline demographics, lifestyle, constipation, number of prolapses, grade of hemorrhoid severity, and duration of experiencing hemorrhoids were comparable in both groups of patients. The effects of CQ-AP and the commercialized rectal suppository on bleeding, prolapse size, and anal pain were comparable. The patients in both groups were satisfied with both products at comparable levels and stated a preference for further use in the case of hemorrhoids recurrence. In terms of safety, the patients in the commercialized rectal suppository group experienced a higher incidence of adverse events, including anal pain and bleeding. Conclusion. Rectal suppositories containing a combined extract of CQ and AP show potential in alleviating hemorrhoidal symptoms with a good safety profile.

The Effect of Rectal Suppository of Anethum graveolens on the Postpartum Hemorrhage Rate: Evidence from a Single-Blind Clinical Trial Study

Background: Postpartum hemorrhage (PPH) is a leading cause of mortality and morbidity worldwide. Anethum graveolens (dill) is one of the recommended herbs to reduce bleeding. Objectives: This study aimed to evaluate the efficacy of rectal suppository of Anethum graveolens on the postpartum hemorrhage (PPH). Methods: Following a randomized clinical design, 70 eligible pregnant women admitted for vaginal delivery to Umm-al-Banin Hospital in Mashhad (Iran) in 2018 were recruited in this trial. Subjects were selected by available method and randomly assigned into two groups of intervention and control. Both groups, immediately after the delivery, received routine hospital interventions. Instantly after the expulsion of the placenta, the intervention group received the first dose of rectal suppository and the subsequent doses up to five doses at intervals of 30 min. PPH was measured by weighing the blood bags and pads for 4h after labor. Data were collected using a sample selection checklist, demographic and pregnancy information forms, birth, infant, and placenta information forms, and partograph sheets. Data were analyzed by SPSS version 22 using an independent t-test or the Mann-Whitney test. Results: The two groups were homogeneous in terms of mediating variables. The mean bleeding rate at the end of the first fourth after delivery was 306.2 ± 11.2 cc in the control group and 282.4 ± 9.6 cc in the intervention group. Therefore, there was a statistically significant difference concerning post-delivery bleeding between the two groups (P = 0.001). Conclusions: Based on the findings, the rectal suppository of Anethum graveolens could effectively reduce the PPH without any adverse effects. Therefore, this efficient herbal approach is suggested to overcome the PPH.

Review for Ukrainian pharmaceutical market of hepatotropic drugs and determining the volumes of their consumption during 2016–2018 years

Hepatobiliary system and biliary tract diseases are common both in the world and in Ukraine (280,000 patients). According to the ATC classification, hepatotropic drugs are divided into three subgroups: А05А, А05В и А05С. The aim of this study was to analyze the assortment of drugs for the pharmacotherapy of diseases of the liver and biliary tract and the volumes of their outpatient consumption during 2016‒2018 years in DDDs/1 000 inhabitants/day. Drugs used for toxic hepatitis and presented in the pharmaceutical market of Ukraine were analyzed. The volumes of their outpatient consumption according to the ATC/DDD methodology based on the «Pharmstandard» system of the «Morion» company were determined, which also made it possible to analyze the assortment of drugs, to determine their dosage forms and manufacturing countries, and to analyze packaging prices. ATC codes identified eight subgroups of drugs, and 158‒167 TNs represent them during 2016‒2018 years. The largest number of TNs were presented A05AA02 Ursodeoxycholic acid (27‒30 TNs, including 19‒21 of foreign origin), А05ВА03 Silymarin (21‒23 TNs, including 9‒11 of foreign origin) and А05ВА50 Different preparations (Essentiale and etc. 35, 37, 34 TNs, including 22, 23 и 20 of foreign origin). Among all drugs of hepatotropic action in Ukraine in the 2018 year, foreign drugs amounted 74 TNs (44,3%) and domestic – 93 TNs (55,7%). The drugs of this group are delivered to Ukraine from 17 countries, the largest part is delivered by Germany (32% of drugs), India (12%), Austria (9%), Italy (7%). According to dosage forms, this group of drugs in 2018 was represented by 17 forms, mainly for the oral route (12 forms), 4 forms – for intravenous injection, and one – rectal suppository. The most consumed were: Different preparations including combined 3.9 DID, Silymarin – 1.48‒1.95 DID, Different preparations (Essentiale ® N, Essentiale ® Forte N, Hofitol) – 1.84‒2.08 DID. The market of drugs used for diseases of the liver and biliary tract in Ukraine in the 2018 year was represented by eight subgroups of 167 TNs, 44.3% of which are foreign-made. Total preparations were presented in forms for the oral route (12 forms), 4 forms – for intravenous injection, and one – rectal suppository. Every year, the consumption of hepatotropic drugs increased slightly: from 8.12 DID to 9.23 DID.

Perbandingan antara Tramadol 100 mg dan Natrium Diklofenak 100 mg Suppositoria untuk Penanganan Nyeri Pasca Seksio Sesarea dengan Blok Subarakhnoid

Latar Belakang: Seksio sesarea menyebabkan nyeri pasca operasi yang signifikan. Tidak ada standar pengelolaan nyeri pasca seksio sesarea. Obat antiinflamasi nonsteroid, natrium diklofenak berkerja meng-inhibisi sintesis prostaglandin (PG) dengan menghambat enzim cyclooxygenase. Tramadol, aktivitas mu-agonis, tidak hanya bekerja pada reseptor opioid, tetapi juga menghambat serotonin (5-HT) dan reuptake noradrenalin.Tujuan: Mengetahui daya guna analgesi 24 jam pasca seksio sesarea antara penggunaan suppositoria rektal tramadol dengan natrium diklofenakMetode:Prospektif, uji klinis acak terkontrol pada 70 pasien status fisik ASA I-II, berusia 19-40 tahun, hamil aterm 37-42 minggu. Indeks Massa Tubuh < 35 kg/m2. Pasien dibagi acak 2 kelompok: kelompok suppositoria rektal natrium diklofenak (D) dan tramadol (T) dengan teknik single blind. Dilakukan penilaian VAS pada kedua kelompok, jumlah penambahan rescue jika VAS ≥3, dan efek samping pada masing-masing kelompok.Hasil: Selama 24 jam pasca operasi, rata-rata frekuensi pemberian tambahan fentanyl kelompok T sebanyak 3,13 kali dan kelompok D 1,7 kali, rata-rata dosis tambahan fentanyl kelompok T sebanyak 155,71 mcg dan kelompok D 67,65 mcg (p=0,000). Rata-rata VAS 24 jam pasca operasi pada kelompok T 2,14 dan pada kelompok D 1,74 (p<0,05). Efek samping, kelompok T terdapat 4 kejadian (11,4%) mual muntah, pada kelompok D tidak ada. Simpulan :Daya guna analgesi natrium diklofenak 100 mg suppositoria rektal lebih baik dibanding tramadol 100 mg suppositoria rektal, dengan efek samping yang lebih kecil pada 24 jam pasca operasi sesar. The Comparison between 100 mg Tramadol and 100 mg Diclofenac Sodium - Suppository for Handling Pain After Cesarean Section Using Subarachnoid Block Abstract Background: Cesarean section inflicts significant postoperative pain. There is no standard for pain management after cesarean section. Non-steroidal anti-inflammatory drugs, diclofenac sodium, work to inhibit the prostaglandin (PG) synthesis, by obstructing the cyclooxygenase enzyme. Tramadol alongside mu-agonist activity, does not only act on opioid receptors, but also inhibits serotonin (5-HT) and noradrenaline reuptake.Objective: To determine the efficacy of 24-hour postoperative cesarean section between of rectal suppositori tramadol and diclofenac sodium.Methods: Prospective, randomized controlled clinical trial to 70 patients with ASA I-II physical status, aged 19-40 years old, pregnancy aterm 37-42 weeks, Body Mass Index <35 kg / m2. The patients were randomly assigned into 2 groups: rectal diclofenac sodium suppository (D) and tramadol (T) groups using single blind technique. VAS assessment was performed in both groups. The amount of rescue was added if the VAS ≥3, and there were side effects in each group.Results: During the 24 hour postoperative period, the mean frequency of supplemental fentanyl to group T was 3.13 times, and group D was 1.7 times. The mean additional dose of fentanyl group T was 155.71 mcg, and group D was 67.65 mcg (p = 0.000 ). The average VAS was 24 hours postoperative in the T group of 2.14, and 1.74 in the D group (p <0.05). For the side effects, T group had 4 occurrences (11.4%) nausea vomiting, and zero in group D. Conclusion: The efficacy of 100 mg diclofenac sodium analgesia of rectal suppository is better than 100 mg tramadol rectal suppository, with smaller side effects within 24 hours after surgery.

Comparative study of diclofenac suppository with tramadol suppository in addition to acetaminophen for post caesarian analgesia

Background: Pain after emergency and elective caesarean section may adversely affect patient’s recovery and breastfeeding initiation. The aim of present study was to compare the analgesic efficacy of diclofenac suppository-intravenous acetaminophen (APAP) combination, tramadol suppository-intravenous APAP combination and intravenous APAP alone for postoperative pain relief after caesarean section.Methods: We designed a randomized double-blind control study. Three hundred parturient scheduled for caesarean section were randomized to receive diclofenac rectal suppository (100 mg), tramadol rectal suppository (100 mg) or glycerin rectal suppository in Group A, B and C respectively (100 parturient in each group). All the women routinely received 1000 mg acetaminophen intravenously. Assessment of pain was done using a visual analogue scale (VAS) at 0, 1, 6, 12, 18 and 24 hours. injection Pentazocine 0.3 mg/kg IV was given as rescue analgesia when VAS score > 30.Results: The mean VAS score was significantly higher in Group C as compared to Group A and Group B (p value < 0.001). This suggests better efficacy of multimodal treatment as compared to monotherapy. Group A as compared to Group B showed better efficacy in term of VAS score at 12 and 18 hours (p = 0.05, p = 0.02 respectively).Conclusions: We found that when controlling for socio-demographic characteristics, combination of either diclofenac or tramadol suppository with acetaminophen has significantly better results when compared with monotherapy of acetaminophen alone in post-operative analgesia after caesarean section. However, the combination of diclofenac suppository has proved to be superior in comparison to tramadol suppository.

Preparation and Standardization of Jatyadi Ghrita Rectal Suppository

Jatyadi Ghrita is a very well known formulation used for wound healing, anorectal disorders like fissure, fistula or any chronic wound. These wound healing properties of Jatyadi ghrita can be used in modern dosage form like suppository, suppositories are used to improve local effect of Jatyadi ghrita because of its easy application and minimum local discomfort. These suppositories are made by fusion or melt method by using cocoa butter as a base, and melted mixture of both are poured into molds and after cooling suppositories are collected from molds and stored in fridge. Temperatures plays major role in preparation of this fusion or melt method suppositories. An attempt has been made for preparation and standardization of Jatyadi ghrita suppositories. Standard Preparation method and Visual examination, melting point, liquefaction time of suppositories are studied under this project.